J Clin Nurs 2019281085ndash1099 emsp|emsp1085copy 2018 John Wiley amp Sons Ltdwileyonlinelibrarycomjournaljocn
Received2August2017emsp |emsp Revised8October2018emsp |emsp Accepted3November2018DOI101111jocn14720
R E V I E W
Experiences of living with varicose veins A systematic review of qualitative research
Elizabeth Lumley12 emsp|emspPatrick Phillips12 emsp|emspAhmed Aber1emsp|emsp Helen Buckley‐Woods1emsp|emspGeorgina L Jones3emsp|emspJonathan A Michaels1
1School of Health and Related Research The University of Sheffield Sheffield UK2SheffieldTeachingHospitalsNHSFoundationTrustNorthernGeneralHospitalSheffieldUK3DapertmentofPsychologySchoolofSocialSciences Leeds Beckett University Leeds UK
CorrespondenceElizabeth Lumley School of Health and Related Research The University of Sheffield Sheffield UKEmail elumleysheffieldacuk
Funding informationThispaperpresentsindependentresearchfundedbytheNationalInstituteforHealthResearch(NIHR)undertheProgrammeGrantsforAppliedResearchprogramme(RPPG‐1210‐12009)Theviewsexpressedare those of the authors and not necessarily thoseoftheNHStheNIHRortheDepartmentofHealth
AbstractAimToidentifythesymptomsandqualityoflifeimpactsthatareimportantfromtheperspective of patients with varicose veins and to compare identified themes toitemsinvaricoseveinpatient‐reportedoutcomemeasures(PROMs)Background Varicose veins are common worldwide and are considered a chronic conditionwithimplicationsforqualityoflifeTreatmentispredominantlyconserva‐tivethereforeunderstandingpatientsrsquoexperiencesof livingwithvaricoseveins isimportanttoinformtheprovisionofclinicalcarePROMsareoftenusedtocollectdataaboutpatientsrsquoqualityoflifeDesignThematicsynthesisofqualitativeresearchreportedaccordingtoENTREQguidelinesMethods Multiple electronic databases including MEDLINE and CINAHL were systematically searched to identify qualitative research examining experiences ofadults with varicose veins Thematic synthesis was then conducted on the included studiesResultsThreestudiesmettheinclusioncriteriathequalityofthestudieswashighTherangeandintensityofreportedsymptomsandparticipantsexperiencesoflivingwithvaricoseveinswerevariedFiveoverarchingthemeswereidentifiedphysicalpsychologicalandsocialimpactofvaricoseveinsadaptingtovaricoseveinsandrea‐sonsforseekingtreatmentTheoverallkeythemetoemergewasadaptationwithpatientsdemonstratinghowtheyadaptedtothevariousimpactsConclusionThisreviewdemonstratesthatvaricoseveinshaveawiderangeofsymp‐tomsandmayhaveasignificant impactonqualityof lifepeoplemadesignificantadaptationstoenablethemtolivetheirlivesasfullyaspossibleRelevance to Clinical PracticeHealthcare professionals need to be aware of therangeofsymptomsandtheirimpactonqualityoflifeTheuseofPROMstogatherinformationaboutqualityoflifeandsymptomsiswellestablishedgloballyhoweverPROMscurrentlyusedmaynot capture the full extentof the impactonpatientsqualityoflife
K E Y W O R D S
patient‐reportedoutcomemeasuresPROMsqualitativeresearchqualityoflifesymptomssystematic review varicose veins
1086emsp |emsp emspensp LUMLEY Et aL
1emsp |emspINTRODUC TION
Varicoseveins(VV)arearelativelycommonvascularconditionglob‐allywithworldwide prevalence ranging from 5 to 15 formenand2to29forwomen (HealthQualityOntario (HQO)2011)VeinproblemsareamongstthemostcommonchronicconditionsinNorthAmericaandWesternEurope(VascularDiseaseFoundation2005)LowerlimbVVareestimatedtobetheseventhmostcommonreasonforphysicianreferralintheUnitedStates(USA)affectinganestimated35oftheUSpopulation(HQO2011)VVarealsothemostprevalentvascularconditiontreatedbyphysiciansinAustralia(Wong2016)
It is estimated that VV affect at least a third of the UnitedKingdom(UK)(EvansLeeAllanRuckleyampFowkes2014)andupto40ofthegeneralpopulation(Robertsonetal2016)
VVareoneof anumberof symptomsassociatedwithchronicvenous insufficiency (CVI) and chronic venousdisease (CVD)CVIoccurs when the venous wall andor valves in the leg veins are not workingeffectivelycausingbloodtocollectintheveinsTherefluxofbloodresultsinVVwhichbecomeenlargedlumpyandvisibleandareusuallypresentinlowerlimbs
VV cause symptoms such as throbbing pain aching swellingcrampingitchingandbleeding(PalfreymanampMichaels2009)VV‐associatedsymptomsandconsequentialrestrictionsontheabilitytowalkandstandcanhaveasubstantialimpactonpatientqualityof life (QoL) (Darvall BateAdamampBradbury 2012Kahn et al2004)
Anestimated30ofpeoplewithVVwilldevelopskinchangessuch as eczema oedema and skin discoloration associated with CVD(Leeetal2015) Inadditionbetween3and6ofpeoplewith VVwill progress to developing venous leg ulcers (VLU) an‐otherchronicconditionassociatedwithCVI (National InstituteforHealthandCareExcellence(NICE)2013)Approximately2ofUKNationalHealthService(NHS)resourcesarespentonmanagingve‐nous disease (Shingler Robertson Boghossian amp Stewart 2013)with35659VVprocedures carriedout in theNHS in20092010alone(NICE2013)
VVcanbetreatedconservativelythroughtheuseofcompres‐sion hosiery and lifestyle advice Compression therapy does notactively treat CVD and it is used to manage symptoms such asswellingheavinessandpainandtohelpbloodflowandvenousre‐turnthusslowingdiseaseprogression(NICE2013)Patientsshouldalsoreceiveadviceregardingweightlifestylemeasurestopreventsymptomsworseningsuchaselevatinglegsandtheimportanceofskincare(NICE2013)
However adherence to treatment can be an issue and the ev‐idence base for the effectiveness of these approaches is limited(Shingler et al 2013) Alternatively invasive treatments such asendothermalablation foamsclerotherapyandsurgerymaybere‐quiredtoreducesymptomsandslowdiseaseprogression
Decisions on how and when to treat VV are subject to varia‐tion across theUK and are based on local interpretation ofNICE
guidance and referral guidelines by regional clinical commission‐inggroups(CCG)(LimGohelShepherdampDavies2010MarsdenPerryKelleyampDavies2013)QoLissuesmaybedecidingfactorsin treatment decisions therefore understanding the effect that VV haveonQoLisimportant
OnemethodofcollectingdataaboutQoListheuseofpatient‐reportedoutcomemeasures(PROMs)PROMscompriseofaseriesof structured questions that ask patients about their health andhealth‐related QoL from their point of view (Devlin amp Appleby2010)PROMsprovide informationabout the impactofadiseaseoritsassociatedtreatmentfromapatientsrsquoperspectivetheydonotaskaboutsatisfactionwithorexperienceofhealthcareservices
PROMsareusedinternationallybyhealthorganisationsbothtocollectroutinedatatoinformpolicydecisionsandbyindividualcli‐nicians togatherpatient information inorder toguideclinicalandshareddecision‐making(Black2013)PROMsareeithergenericsotheycanbeusedacrossdifferentpopulationsandhealthconditionsandcanallowcomparisonbetweengroupsortheycanbedisease‐orcondition‐specificcontainingitemsthataremorerelevanttothatspecificgroup
PROMs are used globally although their use is better estab‐lishedincountriessuchastheUKtheNetherlandsSwedenandtheUSA (Williams SansoniMorrisGrootemaatampThompson2016)IntheUSAtheFoodandDrugAdministration(FDA)recommendedthat PROMs should be included in all clinical trials (FDA 2009)
What does this paper contribute to the wider global clinical community
bull This review identifies that there are a wide range of symptoms of varicose veins and that symptoms canhavea significant impactonpatientsrsquoqualityof life Itdemonstrates that patients often adapt their lives inordertocopewiththerangeofimpactsthattheirvari‐cose veins have
bull Ithighlightsthatanumberofdifferentinstrumentscanbe used to measure the effects of varicose veins how‐everitisclearthatnoinstrumentcurrentlycapturesthefullimpactofvaricoseveinsonqualityoflife
bull Healthcare professionals need to ensure patients arefullyinformedofallaspectsoftheirconditioninordertohelpwithself‐managementincreaseadherencetocom‐pression therapy allay unfounded fears and managetreatmentexpectations
bull Familiaritywiththefindingsofexistingqualitativelitera‐ture through qualitative reviews or employment ofqualitative researchmethods such as interviews ena‐blesanin‐depthunderstandingoftherangeandsever‐ityofsymptomsandresultingimpactonqualityoflifeexperiencedbypatients
emspensp emsp | emsp1087LUMLEY Et aL
Morerecently in2016acommissionwasestablished inAustraliatoreviewtherationaleanduseofPROMsinordertohelpembedtheuseofPROMsintheAustralianhealthcaresystem(Williamsetal2016)
DespitetheincreasinguseofPROMsinclinicalpracticeitisim‐portanttonotethattherearelimitationsintheiruseduetoissuesofvalidityandreliabilityrelatedtothenatureofself‐reportRelyingonpatientstoself‐reporttheirhealthcanbechallengingparticularlywithpatientssufferingfromcognitivedeficitsparalysisordementiathosewhomaynotreadorspeakEnglishorthosethatarenotlit‐erate(childrenandbabies)ProxyversionsofPROMs(egthatcanbecompletedbycaregivers)andPROMsdesignedforcompletionbyspecificgroupssuchaschildrendoexisthowevertherelianceonself‐reportinghealthpresentsanissuefortheuseofPROMsinsomecontexts (DevlinampAppleby 2010) PROMsdata should thereforebeseenascomplementingratherthanreplacingclinicalandotherinformationaboutpatients
Since2009intheUKNHSprovidershavebeenrequiredtocol‐lectPROMsforfoursurgicalproceduresincludingVVtreatmenttheotherthreeproceduresareherniarepairandhipandkneereplace‐mentsCompletionofPROMsisvoluntaryandpatientsareundernoobligation to take part In 2013ndash2014 PROMcompletion rates forVVpatientswereconsiderablylowerthanfortheotherproceduresjust405comparedwithhipandkneesurgeryatnearly86and94andanaverageof76acrossall fourprocedures (HealthandSocialCare InformationCentre (HSCIC)2016)Theredoesnot ap‐peartobeanyestablishedreasonwhyVVPROMcompletionratesaresocomparativelypoorhoweveroneexplanationcouldbe thatthe PROMs being used do not contain items that are relevant toVVpatientsTheNHScurrentlyusesthegenericPROMtheEQ5DEQ5D‐VAS(EuroQol1990)andthecondition‐specificAberdeenVVQuestionnaire(AVVQ)(Garrattetal1993)todatethereisnopub‐lishedevidence that theEQ5Dhasbeenvalidated forusewithVVpatients
A recent systematic review (Aber et al 2017) was conductedto identify PROMs that have undergone some kind of publishedvalidation for use with VV patients and assess their psychometricpropertiesThreedisease‐specificPROMstheAVVQ(Garrattetal1993)VVSymptomQuestionnaire(VVSymQ)(PatyTurner‐BowkerElashampWright2016)andSpecificQoLOutcomeResponse‐Venous(SQOR‐V) (Guex Zimmet Boussetta Nguyen amp Taieb 2007) andonegenericPROMtheShort‐Form36(SF‐36)(WareampSherbourne1992)wereidentifiedThereviewconcludedthatbasedonitspsy‐chometricpropertiestheAVVQwasthemostappropriatedisease‐specific instrumentwith evidenceof construct validity testndashretestreliabilityand responsivenessbut lessevidence forcontentvalidityandacceptabilityAnexampleofthequestionsfromtheAVVQcanbeseeninAppendixS1TheSF‐36wasthemostsuitablegenericPROMforusewithpatientswithVVwithsatisfactoryresponsivenessandacceptability but with limited assessment of other psychometricproperties
Currently NICE VV guidance suggests that ldquoQuality‐of‐lifemeasures are unlikely to reflect severity of disease because of
variations inperceptionof symptomsrdquo (NICE2013) thereforeit is necessary to assess whether these existing PROMs actu‐ally reflect the symptomsand issues that aremost relevant topatients
Content validity of PROMs is the extent to which items ona test are representative of what is intended to be measuredContent validity when developing PROMs can be enhanced byusing qualitative researchmethods such as interviewswith pa‐tientstodeterminewhichissuesarerelevanttothepatientgroupand using these findings to develop the items incorporated intothePROM
WhetherusedinclinicalpracticeorasaresearchtoolPROMsshouldberigorouslydevelopedtoensurethattheyadequatelyrep‐resentandcapturetheexperiencesofthepopulationtheyaretobe used with
QoLiscentraltotheindividualpatientsexperienceofhealthanddiseasemeasures ofQoLmust domore than describe a patientshealth in terms of what health professionals and society believeconstitutes health (Carr amp Higginson 2001) The measurement ofimprovementsorotherwiseinQoLassociatedwithpatient‐centredcareshouldpreferablybeperformedusingPROMsthathavebeenconstructedwiththe involvementofthoseexperiencingthehealthstate
Thisqualitativeevidencesynthesisisrelatedtotheidentifica‐tionandevaluationofexistingcondition‐specificorgenericPROMsthathavebeenvalidatedforuseinpopulationswithvascularcondi‐tionsThesynthesisisalsoanintegralpartofthedevelopmentofanewPROMspecificallyanelectronicpatientquestionnaire(ePAQ‐VAS)foruseinthispopulationThereviewcomplementsaseriesofotherprojectsundertakenaspartofaNationalInstituteforHealthResearch (NIHR) Programme GrantmdashThe Vascular ProgrammeGrant (VPG) Project ID RP‐PG‐1210‐12009) which has the aimof evaluating vascular services and making recommendations re‐gardingpatient‐focusedcareProgrammeworkstreamsincludethefollowing
bull Similarreviewsofqualitativeevidenceoffourothervascularcon‐ditions(abdominalaorticaneurysm(AAA)carotidarterydisease(CAD)peripheralarterialdisease(PAD)andVLU)
bull FivesystematicreviewsidentifyingandevaluatingPROMsusedbypatientswithfivevascularconditions (AAACADPADVLUandVV)
bull Primary qualitative research into the experience of living withthese five vascular conditions
11emsp|emspAims
1 The primary aim of this qualitative evidence synthesis was toexamine the symptoms and QoL domains that are importantfrom the perspective of patients with VV
2 Asecondaryaimwastocomparethethemesidentifiedinthesyn‐thesistoitemsinPROMscurrentlyusedwithVVpatients
1088emsp |emsp emspensp LUMLEY Et aL
2emsp |emspMETHODS
This systematic review was conducted using explicit systematicmethods to reduce the riskofbias andprovide reliable findings inaccordancewithpublishedguidelines(HigginsampGreen2011)spe‐cifically a thematic synthesis was conducted as this is a recognised methodusedinsystematicreviewsofqualitativeresearchwhichpre‐servesanexplicitandtransparent linkbetweenreviewconclusionsand the primary researchThomas andHarden (2008) This reviewfollows the design established in a prepublished protocol (Duncanetal2016)titledldquoUnderstandingtheexperienceandimpactofliv‐ingwithavascularconditionfromthepatientsrsquoperspectiverdquoandisreported according to the ldquoEnhancing Transparency in ReportingtheSynthesisofQualitativeResearchrdquo (ENTREQ) statement (TongFlemmingMcInnesOliverampCraig 2012) The ENTREQ checklistcanbeseeninsupplementaryFileS1
21emsp|emspStudy identification and selection
Studies were included if they were primary qualitative researchstudies including populations of adults with VV and published inEnglishMixed‐methods studies where details of data collectionanalysesandresultsofthequalitativeportionofthestudywerere‐portedseparatelywereincludedAppendixS2showstheeligibilitycriteria
SearcheswereconductedinCinahlEmbaseMedlinePsycINFOScience Citation Index and the Social Science Citation Index andProQuest dissertations and theses No language or date restric‐tionswereappliedasan initialscopingsearchhad identifieda lackof available literature in this subject area Additionally reference lists of included studies and related reviews were scrutinised and cita‐tionsearcheswereconducted(seeAppendixS3forfulldetailsofthesearchstrategy)
Tworeviewers(ELandPP)independentlyscreenedthetitleandabstract of all studies identified by the searches with reference to theinclusionandexclusioncriteriainthepublishedprotocolAllpo‐tentialfull‐textpaperswerereadanddiscussionwasusedtoresolveanydifferenceofopinionAthirdresearcher(AA)wasavailableforconsultation if consensus could not be reached
22emsp|emspData extraction and quality assessment
Dataextractionwasconductedusingastudy‐specificdataextrac‐tion form details of author date country research design method ofanalysisaimsandobjectivessampleincludingageandgenderdiagnosisandeligibilitycriteriawerecollected (AppendixS4)TheCritical Appraisal Skills Programme (CASP) qualitative researchchecklistwasemployedtoassessthemethodologicalqualityoftheincluded papers including trustworthiness and relevance (CASP2014)TheCASPchecklistwaschosenas itassessesboththeap‐propriatenessandqualityofreportingandiscommonlyusedinqual‐itative reviews of evidence (CarrollampBooth 2014) The checklistcomprisesoftenquestionsaboutthequalitativemethodologyand
areansweredeitherldquoyesrdquoldquonordquoorldquounclearrdquoQualityassessmentwasconductedindependentlybytworesearchers(ELandPP)andanydiscrepancieswereresolvedthroughdiscussionfollowingtheCASPcriteria
23emsp|emspData analysis
Eachfull‐textpaperwasuploadedelectronicallyintoNVIVO10(QSRInternational Burlington USA) the reviewers read through eachof thepapers to familiarise themselveswith thestudyand resultsthe results sections were then analysed using thematic synthesis (ThomasampHarden2008)
Interobserveragreementofcodingwascheckedandconsensuswashighshowingsubstantialalmostperfectorperfectagreementwithkappacoefficientratingcommonlybetween061and1(VieraampGarrett2005)
Aprovisionalthematicframework(AppendixS5)wasdevelopedusingconceptualdomainsfromPROMsvalidatedforusewithVVpa‐tients(AppendixS6)thatwereidentifiedinaseparatereview(Aberetal2017)
InitialcodingofthetextwasconductedindependentlylinebylinewithrelevantsectionsandquotationshighlightedandassignedtothespecificnodesoftheprovisionalthematicframeworkTherewasthepotentialtoconstrainorlimitthedeductionofnewthemesbyusingapreliminaryframeworkhoweveritdidnotpredeterminethefinalthemes
Comparisons were made across the three included studiesmatching emergent themes to those already established in the frameworkWherenewconceptswereidentifiedadditionalthemeswerecreatedandpreviouslycodedpaperswerere‐visitedtoestab‐lishwhetheranyaspectsoftheirfindingsmatchedthenewlycreatedthemeTheclassificationoftextaccordingtoexistingandemergentthemesiscomparabletothedevelopmentofdescriptivethemesinthematicanalysis (ThomasampHarden2008)wherethemesremainldquoclose to theprimary studyrdquo Figure1demonstrates the synthesisprocess
3emsp |emspRESULTS
A total of 1804 referenceswere identified following the removalof duplicates 1318 citations were screened of these 56 full‐textarticleswereretrievedandscreenedforeligibilityofthese53wereexcludedReasonsforexclusionwereasfollowsThepaperwasnotavailable in English the study populationwas not clearly definedsolelyasVVor thestudywasnotqualitative researchordidnotdetail data collection or analysis methods Study selection is detailed in thePRISMAflowdiagram (MoherLiberatiTeetzlaffampAltman2009)(Figure2)
Three independent studies that met the inclusion criteriawere identified (Table 1) The studieswere published between2004 and2016 andwere conducted in Sweden (n=1) and theUK (n=2)
emspensp emsp | emsp1089LUMLEY Et aL
31emsp|emspQuality assessment
The overall quality of the included studies was high with posi‐tive responses formost items on the CASP checklist (AppendixS7) Positive responses indicate that the paper hasmet the rel‐evantCASPcriteriaforcredibilityandrigourHowevertwoofthethreestudiesdidnotfullyconsidertherelationshipbetweentheresearcherandstudyparticipantsthereforepotentiallyintroduc‐ingbias into the researchprocessStudieswerenotexcludedorweightedbasedonquality
4emsp |emspTHEMES
FiveoverarchingthemeswereidentifiedphysicalimpactofVVpsy‐chologicalimpactsocialimpactadaptingtoVVandreasonsforseeking
treatmentWithinthesemainthemesfurthersubthemeswereidenti‐fiedsymptomssymptommanagementphysicalfunctionworryanxi‐etyappearancesocialrestrictionsandrelationships(Table2)
41emsp|emspPhysical impact
ThephysicalimpactofVVwasevidentacrossallthreeincludedpa‐persaswere thesubthemesof symptomsmanagementof symp‐tomsandphysicalfunction
411emsp|emspSymptoms
Descriptionsofpainheavinessanditchingwerecommontopar‐ticipants in all three studieswith swelling reported in only twopapers Cramps tingling and numbness were also reported astroublesomesymptoms(FranzampWann‐Hansson2015)reflecting
F I G U R E 1 emspApplicationofframeworksynthesis[Colourfigurecanbeviewedatwileyonlinelibrarycom]
Familiarisation
Comparison of PROMs including identification and
interpretation of itemsdomains
Development of provisional framework of themes and
subthemes for use in analysis of included studies
Systematic identification of qualitative research studies
examining the experiences of people living with VV
Provisional framework for analysis entered into NVIVO
Reviewers familiarize themselves with included studies and upload
papers as sources into NVIVO
Iterative process of line-by-line coding of included studies in NVIVO with categorisation to
putative themes including addition of and categorisation to
new emergent themes
Continuous re-examination of analysed studies as new themes
emerge and the thematic framework develops to ensure a comprehensive and consistent analysis has been conducted
Thematic framework finalised facilitating a coherent synthesis
presentation and discussion of the impact of VV on QoL with reference
to itemsdomains in PROMs used with VV populations
Familiarisation with PROMs validated in populations
with VV
1090emsp |emsp emspensp LUMLEY Et aL
thebroadrangeofphysicalsymptomsdescribedacrossthethreepapers The symptomsoftenhad an impact onother aspects oflifesuchassleepresulting inparticipantsfeelingtiredThedis‐tressassociatedwithsymptomsisclearlydescribedbysomestudyparticipantswhilstforothersthesymptomswerelesstroubling
They drive me mad absolutely mad with the itching Ill scratch them and scratch them thatmuch that ImakethemlikeyouknowscratchmarksImakethembleedwiththescratchmarks Participant13mdashPalfreymanetal
ItusedtoaffecteverythingIwoulddoeverydayhellipitwas really awfulhellipmy legswere so soreanduncom‐fortable Patient14mdashHudsonetal
TheywerentpainfulexactlybutermattheendofthedayIwouldbeconsciousofthemliketheywereachyyouknownotpainful Patient9mdashHudsonetal
412emsp|emspManagement of symptoms
Allthreepaperscontaineddescriptionsofhowparticipantsuseddif‐ferentstrategiestomanagetheimpactoftheirsymptomsThemaincoping strategies employedwere elevationof legs and theuseofcreamsointmentsandcompressionhosieryHoweverwherethesestrategieswereineffectiveorinappropriateindividualscalledupontheir own internal resources
Theuseofcompressionhosierywasvieweddifferently inthetwostudiesthatcommentFranzandWannHansenwhilstacknowledgingthedifficultiesinvolvedinwearingcompressionhosieryreportbenefitsin reducing swelling and suggest and that for some individuals the use of stockingsiscrucialtogettingeverydayworkdoneIncontrastPalfreymanetalreportawidespreaddissatisfactionwiththeuseofcompressionho‐sierybypatientswhichtosomeextentseemedtobesharedbyclinicians
The doctor (at the outpatient clinic) asked if I usedstockingsIsaidtheyreawasteoftimeHesaysldquoYouthinksoIminclinedtoagreewirsquothatrdquo Participant1mdashPalfreymanetal
Palfreymanetalalsonotedtheuseofanalgesiatomanagepainanddiscomfortwithoneparticipantdescribingtheuseofarangeofnonsteroidal anti‐inflammatories (NSAIDs) with varying effects andanotherparticipantusingparacetamolcodeinecombinations
Themanagement of symptoms theme is directly linked to theldquoAdaptingtoVVrdquothemeasallthreepapersreporthowparticipantsmakelifeadaptationsaswellaspracticalonestorelievesymptomsinanefforttocopewithalifewithVV
ThelastfewdaysIliterallycrawledthroughthedoorandhadtositdownwithmyfeetuphightogetthebloodandswellingdown Patient14mdashHudsonetal
I put creamon you know soothing cream like cala‐mine and stuff like that and that voltarol gel thatsquitegood Participant5ndashPalfreymanetal
F I G U R E 2 emspPRISMA2009flowdiagram
Records idenfied through database searching
(n = 1804)
Addional records idenfied through other sources
(n = 0)
Records aer duplicates removed (n = 1318)
Records screened (n = 1318)
Records excluded (n = 1262)
Full-text articles assessed for eligibility
(n = 56)
Full-text arcles excluded with reasons
(n = 53)
Studies included in qualitave synthesis
(n = 3)
emspensp emsp | emsp1091LUMLEY Et aL
IfeelthatthelegbecomesalittlemoreswollenwhenI dont have the stockings on especially downherewherethesocksenditmaybemorepronouncedifIdonthavethecompressionstockingson Informant4mdashFranzandWann‐Hansson
SoItriedthemuptokneelikepopsocksandwhenyou had them on for a bit well they give you some right pain you knowwhere the veins swellWhenyouvehademonabittheyresotightstockingsyourgladtogethomeandgetemoff Participant1mdashPalfreymanetal
413emsp|emspPhysical function
None of the papers identified that VV prevented specific activi‐tiesofdaily living suchaspersonal careorhouseworkhoweverthey clearly showed that participants experienced limitations intheir daily lives for instance being able to participate in leisureactivitieswalkingdistancesorexerciseTheserestrictionssome‐times resulted fromphysical problemswhenundertaking certainactivitieshoweversomeindividualswhilstphysicallyableplaced
limitationsontheiractivitiesduetotheappearanceoftheVVthisdemonstratesaclosecrossoverbetweenthephysicalandpsycho‐logical themes The consequences of the physical impact of VVwerebestdescribedasldquonotbeingabletolivelifefullyrdquo(FranzandWann‐Hansson)
Twopapers(PalfreymanetalFranzandWann‐Hansson)identi‐fiedthatVVcouldaffecttheworklivesofparticipantsbothduetophysicalandpsychologicalfactorsFranzandWann‐Hanssonfoundboth those that were still working and those that were now retired spokeof the struggleof copingwith symptomsand trying to findrelief at work
Ifoundthatthey(mylegs)getverytiredandheavyifIamonmyfeetfortoolongorIhavetowalktoofarso it was always at the back of my mind that my legs weretoosoreifIdidtoomuchhellipPatient20mdashHudsonet al
42emsp|emspPsychological impact
Psychological impactencompassedsubthemesofworryoranxietyandappearance
TA B L E 1 emsp Includedstudies
Author and year Country Research design Sample Main findings
FranzandWann‐Hansson(2015)
Sweden Exploratoryqualitativestudywithphenomenologicalapproach
12(purposivesample) TheessencemeantadaptingtoalifewithVVrelieving discomfort from legs with an unfavorableappearance
Phenomenologicalreduction Age56(mean)range32ndash72) Gender (42male) (512)
Copingwithdiscomfortinvolveddealingwiththe disease emotionally and finding strategiesthathelpedtorelievesymptomshoweverlivingwithldquorepulsiverdquolegswasseen as embarrassing and many found the need to hide their condition
HudsonOgdenandWhiteley(2015)
UK Qualitativesemi‐structuredinterviews(qualitativesectionofamixed‐methodsstudyincludinganRCT)
20 (four from each arm of thewiderRCT)
Fourthemescaptured (1)Negativeemotionsassociatedwithsymptoms (2)Unpreparednessforthesurgicalprocess (3)Feelingcaredfor (4)Improvementsinwell‐being
Thematic analysis Age(mean)508years Gender (30male) (620)
Anoverarchingthemeofrelationshipswasidentified VVhadadetrimentalimpactonQoLpriortosurgerypostsurgeryQoLimproved
PalfreymanDrewery‐CarterRigbyMichaelsandTod(2004)
UK Qualitativeusingsemi‐ structured interviews
16(purposivesample) ParticipantsattributedawiderangeofsymptomstotheirVVandwereactivelyseekingtreatmentwiththeexpectationthattheywouldgainsymptomrelief
Framework analysis Age(mean) 51years(range20ndash75) Gender (19male) (316)
ThesymptomsattributedtoVVhadasignificantnegativeimpactonQoLandlifestyle Improvingthecosmeticappearanceoftheir legs was seen as a secondary benefit
1092emsp |emsp emspensp LUMLEY Et aL
421emsp|emspWorry or anxiety
InallstudiesparticipantsexpressedworriesaboutdeteriorationofVVandtheriskoffutureproblemssuchasVLUordeepveinthrom‐bosis (DVT)Thisanxietywassometimes rooted inexperiencesoffamily or friends
Wellthenthethoughtscamethatitcouldbesome‐thinglikethat(ulcers)whichisstarting Informant4mdashFranzandWann‐Hansson
InoticedascratchandIwasveryworriedaboutopen‐ingsomeskinorsomethingyouknowandpossiblygettinganulcer Patient10mdashHudsonetal
Therewasalsoafeelingamongsttheparticipantsthatif they had surgical treatment itwould prevent anyfurtherdeteriorationhellip AuthorsmdashPalfreymanetal
422emsp|emspAppearance
ThepsychologicaleffectofVVwasalsorelatedtoappearancethiswasreportedinallthreepapersandincludedpersonalfeelingsofembarrass‐mentdisgustandfeelingself‐consciousTherewasalsotheimpactofthereactionsofothersortheworryaboutapotentialnegativereaction
Iwas just veryaware thatmy legs shouldntbe likethis and that if they were more normal and less ugly
TA B L E 2 emspThemesidentifiedfromincludedpapers
Main theme SubthemePalfreyman et al (2004)
Hudson et al (2015)
Franz amp Wann‐Hansson (2015)
1Physicalimpact Symptoms
Heaviness
Itching
Pain
Swelling times
Othersymptoms(phlebitistiredness)
Sleep times
Management of symptoms
Copingstrategies
Compression times
Analgesia times times
Elevation
Physical function
Limitations
Work times
2Psychologicalimpact Worryanxiety
Futurehealthproblems
Deterioration
Appearance
Personalfeelings(embarrass‐mentself‐consciousdisgust)
Reactions of others
Self‐imageself‐esteem times times
3Impactonsocialfunctioning Restrictions
Relationships
4Reasonsforseekingtreatment Symptomrelief times
Cosmeticconcerns times
Preventfutureproblems times
5AdaptingtoVV Lifeadaptations
Clothingadaptations
emspensp emsp | emsp1093LUMLEY Et aL
andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal
hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal
ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson
These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming
I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal
Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson
Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions
She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal
43emsp|emspSocial impact
Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships
431emsp|emspRestrictions
Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise
ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo
ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson
If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal
ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them
432emsp|emspRelationships
TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships
One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal
IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal
44emsp|emspReasons for seeking treatment
Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact
More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal
OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
1086emsp |emsp emspensp LUMLEY Et aL
1emsp |emspINTRODUC TION
Varicoseveins(VV)arearelativelycommonvascularconditionglob‐allywithworldwide prevalence ranging from 5 to 15 formenand2to29forwomen (HealthQualityOntario (HQO)2011)VeinproblemsareamongstthemostcommonchronicconditionsinNorthAmericaandWesternEurope(VascularDiseaseFoundation2005)LowerlimbVVareestimatedtobetheseventhmostcommonreasonforphysicianreferralintheUnitedStates(USA)affectinganestimated35oftheUSpopulation(HQO2011)VVarealsothemostprevalentvascularconditiontreatedbyphysiciansinAustralia(Wong2016)
It is estimated that VV affect at least a third of the UnitedKingdom(UK)(EvansLeeAllanRuckleyampFowkes2014)andupto40ofthegeneralpopulation(Robertsonetal2016)
VVareoneof anumberof symptomsassociatedwithchronicvenous insufficiency (CVI) and chronic venousdisease (CVD)CVIoccurs when the venous wall andor valves in the leg veins are not workingeffectivelycausingbloodtocollectintheveinsTherefluxofbloodresultsinVVwhichbecomeenlargedlumpyandvisibleandareusuallypresentinlowerlimbs
VV cause symptoms such as throbbing pain aching swellingcrampingitchingandbleeding(PalfreymanampMichaels2009)VV‐associatedsymptomsandconsequentialrestrictionsontheabilitytowalkandstandcanhaveasubstantialimpactonpatientqualityof life (QoL) (Darvall BateAdamampBradbury 2012Kahn et al2004)
Anestimated30ofpeoplewithVVwilldevelopskinchangessuch as eczema oedema and skin discoloration associated with CVD(Leeetal2015) Inadditionbetween3and6ofpeoplewith VVwill progress to developing venous leg ulcers (VLU) an‐otherchronicconditionassociatedwithCVI (National InstituteforHealthandCareExcellence(NICE)2013)Approximately2ofUKNationalHealthService(NHS)resourcesarespentonmanagingve‐nous disease (Shingler Robertson Boghossian amp Stewart 2013)with35659VVprocedures carriedout in theNHS in20092010alone(NICE2013)
VVcanbetreatedconservativelythroughtheuseofcompres‐sion hosiery and lifestyle advice Compression therapy does notactively treat CVD and it is used to manage symptoms such asswellingheavinessandpainandtohelpbloodflowandvenousre‐turnthusslowingdiseaseprogression(NICE2013)Patientsshouldalsoreceiveadviceregardingweightlifestylemeasurestopreventsymptomsworseningsuchaselevatinglegsandtheimportanceofskincare(NICE2013)
However adherence to treatment can be an issue and the ev‐idence base for the effectiveness of these approaches is limited(Shingler et al 2013) Alternatively invasive treatments such asendothermalablation foamsclerotherapyandsurgerymaybere‐quiredtoreducesymptomsandslowdiseaseprogression
Decisions on how and when to treat VV are subject to varia‐tion across theUK and are based on local interpretation ofNICE
guidance and referral guidelines by regional clinical commission‐inggroups(CCG)(LimGohelShepherdampDavies2010MarsdenPerryKelleyampDavies2013)QoLissuesmaybedecidingfactorsin treatment decisions therefore understanding the effect that VV haveonQoLisimportant
OnemethodofcollectingdataaboutQoListheuseofpatient‐reportedoutcomemeasures(PROMs)PROMscompriseofaseriesof structured questions that ask patients about their health andhealth‐related QoL from their point of view (Devlin amp Appleby2010)PROMsprovide informationabout the impactofadiseaseoritsassociatedtreatmentfromapatientsrsquoperspectivetheydonotaskaboutsatisfactionwithorexperienceofhealthcareservices
PROMsareusedinternationallybyhealthorganisationsbothtocollectroutinedatatoinformpolicydecisionsandbyindividualcli‐nicians togatherpatient information inorder toguideclinicalandshareddecision‐making(Black2013)PROMsareeithergenericsotheycanbeusedacrossdifferentpopulationsandhealthconditionsandcanallowcomparisonbetweengroupsortheycanbedisease‐orcondition‐specificcontainingitemsthataremorerelevanttothatspecificgroup
PROMs are used globally although their use is better estab‐lishedincountriessuchastheUKtheNetherlandsSwedenandtheUSA (Williams SansoniMorrisGrootemaatampThompson2016)IntheUSAtheFoodandDrugAdministration(FDA)recommendedthat PROMs should be included in all clinical trials (FDA 2009)
What does this paper contribute to the wider global clinical community
bull This review identifies that there are a wide range of symptoms of varicose veins and that symptoms canhavea significant impactonpatientsrsquoqualityof life Itdemonstrates that patients often adapt their lives inordertocopewiththerangeofimpactsthattheirvari‐cose veins have
bull Ithighlightsthatanumberofdifferentinstrumentscanbe used to measure the effects of varicose veins how‐everitisclearthatnoinstrumentcurrentlycapturesthefullimpactofvaricoseveinsonqualityoflife
bull Healthcare professionals need to ensure patients arefullyinformedofallaspectsoftheirconditioninordertohelpwithself‐managementincreaseadherencetocom‐pression therapy allay unfounded fears and managetreatmentexpectations
bull Familiaritywiththefindingsofexistingqualitativelitera‐ture through qualitative reviews or employment ofqualitative researchmethods such as interviews ena‐blesanin‐depthunderstandingoftherangeandsever‐ityofsymptomsandresultingimpactonqualityoflifeexperiencedbypatients
emspensp emsp | emsp1087LUMLEY Et aL
Morerecently in2016acommissionwasestablished inAustraliatoreviewtherationaleanduseofPROMsinordertohelpembedtheuseofPROMsintheAustralianhealthcaresystem(Williamsetal2016)
DespitetheincreasinguseofPROMsinclinicalpracticeitisim‐portanttonotethattherearelimitationsintheiruseduetoissuesofvalidityandreliabilityrelatedtothenatureofself‐reportRelyingonpatientstoself‐reporttheirhealthcanbechallengingparticularlywithpatientssufferingfromcognitivedeficitsparalysisordementiathosewhomaynotreadorspeakEnglishorthosethatarenotlit‐erate(childrenandbabies)ProxyversionsofPROMs(egthatcanbecompletedbycaregivers)andPROMsdesignedforcompletionbyspecificgroupssuchaschildrendoexisthowevertherelianceonself‐reportinghealthpresentsanissuefortheuseofPROMsinsomecontexts (DevlinampAppleby 2010) PROMsdata should thereforebeseenascomplementingratherthanreplacingclinicalandotherinformationaboutpatients
Since2009intheUKNHSprovidershavebeenrequiredtocol‐lectPROMsforfoursurgicalproceduresincludingVVtreatmenttheotherthreeproceduresareherniarepairandhipandkneereplace‐mentsCompletionofPROMsisvoluntaryandpatientsareundernoobligation to take part In 2013ndash2014 PROMcompletion rates forVVpatientswereconsiderablylowerthanfortheotherproceduresjust405comparedwithhipandkneesurgeryatnearly86and94andanaverageof76acrossall fourprocedures (HealthandSocialCare InformationCentre (HSCIC)2016)Theredoesnot ap‐peartobeanyestablishedreasonwhyVVPROMcompletionratesaresocomparativelypoorhoweveroneexplanationcouldbe thatthe PROMs being used do not contain items that are relevant toVVpatientsTheNHScurrentlyusesthegenericPROMtheEQ5DEQ5D‐VAS(EuroQol1990)andthecondition‐specificAberdeenVVQuestionnaire(AVVQ)(Garrattetal1993)todatethereisnopub‐lishedevidence that theEQ5Dhasbeenvalidated forusewithVVpatients
A recent systematic review (Aber et al 2017) was conductedto identify PROMs that have undergone some kind of publishedvalidation for use with VV patients and assess their psychometricpropertiesThreedisease‐specificPROMstheAVVQ(Garrattetal1993)VVSymptomQuestionnaire(VVSymQ)(PatyTurner‐BowkerElashampWright2016)andSpecificQoLOutcomeResponse‐Venous(SQOR‐V) (Guex Zimmet Boussetta Nguyen amp Taieb 2007) andonegenericPROMtheShort‐Form36(SF‐36)(WareampSherbourne1992)wereidentifiedThereviewconcludedthatbasedonitspsy‐chometricpropertiestheAVVQwasthemostappropriatedisease‐specific instrumentwith evidenceof construct validity testndashretestreliabilityand responsivenessbut lessevidence forcontentvalidityandacceptabilityAnexampleofthequestionsfromtheAVVQcanbeseeninAppendixS1TheSF‐36wasthemostsuitablegenericPROMforusewithpatientswithVVwithsatisfactoryresponsivenessandacceptability but with limited assessment of other psychometricproperties
Currently NICE VV guidance suggests that ldquoQuality‐of‐lifemeasures are unlikely to reflect severity of disease because of
variations inperceptionof symptomsrdquo (NICE2013) thereforeit is necessary to assess whether these existing PROMs actu‐ally reflect the symptomsand issues that aremost relevant topatients
Content validity of PROMs is the extent to which items ona test are representative of what is intended to be measuredContent validity when developing PROMs can be enhanced byusing qualitative researchmethods such as interviewswith pa‐tientstodeterminewhichissuesarerelevanttothepatientgroupand using these findings to develop the items incorporated intothePROM
WhetherusedinclinicalpracticeorasaresearchtoolPROMsshouldberigorouslydevelopedtoensurethattheyadequatelyrep‐resentandcapturetheexperiencesofthepopulationtheyaretobe used with
QoLiscentraltotheindividualpatientsexperienceofhealthanddiseasemeasures ofQoLmust domore than describe a patientshealth in terms of what health professionals and society believeconstitutes health (Carr amp Higginson 2001) The measurement ofimprovementsorotherwiseinQoLassociatedwithpatient‐centredcareshouldpreferablybeperformedusingPROMsthathavebeenconstructedwiththe involvementofthoseexperiencingthehealthstate
Thisqualitativeevidencesynthesisisrelatedtotheidentifica‐tionandevaluationofexistingcondition‐specificorgenericPROMsthathavebeenvalidatedforuseinpopulationswithvascularcondi‐tionsThesynthesisisalsoanintegralpartofthedevelopmentofanewPROMspecificallyanelectronicpatientquestionnaire(ePAQ‐VAS)foruseinthispopulationThereviewcomplementsaseriesofotherprojectsundertakenaspartofaNationalInstituteforHealthResearch (NIHR) Programme GrantmdashThe Vascular ProgrammeGrant (VPG) Project ID RP‐PG‐1210‐12009) which has the aimof evaluating vascular services and making recommendations re‐gardingpatient‐focusedcareProgrammeworkstreamsincludethefollowing
bull Similarreviewsofqualitativeevidenceoffourothervascularcon‐ditions(abdominalaorticaneurysm(AAA)carotidarterydisease(CAD)peripheralarterialdisease(PAD)andVLU)
bull FivesystematicreviewsidentifyingandevaluatingPROMsusedbypatientswithfivevascularconditions (AAACADPADVLUandVV)
bull Primary qualitative research into the experience of living withthese five vascular conditions
11emsp|emspAims
1 The primary aim of this qualitative evidence synthesis was toexamine the symptoms and QoL domains that are importantfrom the perspective of patients with VV
2 Asecondaryaimwastocomparethethemesidentifiedinthesyn‐thesistoitemsinPROMscurrentlyusedwithVVpatients
1088emsp |emsp emspensp LUMLEY Et aL
2emsp |emspMETHODS
This systematic review was conducted using explicit systematicmethods to reduce the riskofbias andprovide reliable findings inaccordancewithpublishedguidelines(HigginsampGreen2011)spe‐cifically a thematic synthesis was conducted as this is a recognised methodusedinsystematicreviewsofqualitativeresearchwhichpre‐servesanexplicitandtransparent linkbetweenreviewconclusionsand the primary researchThomas andHarden (2008) This reviewfollows the design established in a prepublished protocol (Duncanetal2016)titledldquoUnderstandingtheexperienceandimpactofliv‐ingwithavascularconditionfromthepatientsrsquoperspectiverdquoandisreported according to the ldquoEnhancing Transparency in ReportingtheSynthesisofQualitativeResearchrdquo (ENTREQ) statement (TongFlemmingMcInnesOliverampCraig 2012) The ENTREQ checklistcanbeseeninsupplementaryFileS1
21emsp|emspStudy identification and selection
Studies were included if they were primary qualitative researchstudies including populations of adults with VV and published inEnglishMixed‐methods studies where details of data collectionanalysesandresultsofthequalitativeportionofthestudywerere‐portedseparatelywereincludedAppendixS2showstheeligibilitycriteria
SearcheswereconductedinCinahlEmbaseMedlinePsycINFOScience Citation Index and the Social Science Citation Index andProQuest dissertations and theses No language or date restric‐tionswereappliedasan initialscopingsearchhad identifieda lackof available literature in this subject area Additionally reference lists of included studies and related reviews were scrutinised and cita‐tionsearcheswereconducted(seeAppendixS3forfulldetailsofthesearchstrategy)
Tworeviewers(ELandPP)independentlyscreenedthetitleandabstract of all studies identified by the searches with reference to theinclusionandexclusioncriteriainthepublishedprotocolAllpo‐tentialfull‐textpaperswerereadanddiscussionwasusedtoresolveanydifferenceofopinionAthirdresearcher(AA)wasavailableforconsultation if consensus could not be reached
22emsp|emspData extraction and quality assessment
Dataextractionwasconductedusingastudy‐specificdataextrac‐tion form details of author date country research design method ofanalysisaimsandobjectivessampleincludingageandgenderdiagnosisandeligibilitycriteriawerecollected (AppendixS4)TheCritical Appraisal Skills Programme (CASP) qualitative researchchecklistwasemployedtoassessthemethodologicalqualityoftheincluded papers including trustworthiness and relevance (CASP2014)TheCASPchecklistwaschosenas itassessesboththeap‐propriatenessandqualityofreportingandiscommonlyusedinqual‐itative reviews of evidence (CarrollampBooth 2014) The checklistcomprisesoftenquestionsaboutthequalitativemethodologyand
areansweredeitherldquoyesrdquoldquonordquoorldquounclearrdquoQualityassessmentwasconductedindependentlybytworesearchers(ELandPP)andanydiscrepancieswereresolvedthroughdiscussionfollowingtheCASPcriteria
23emsp|emspData analysis
Eachfull‐textpaperwasuploadedelectronicallyintoNVIVO10(QSRInternational Burlington USA) the reviewers read through eachof thepapers to familiarise themselveswith thestudyand resultsthe results sections were then analysed using thematic synthesis (ThomasampHarden2008)
Interobserveragreementofcodingwascheckedandconsensuswashighshowingsubstantialalmostperfectorperfectagreementwithkappacoefficientratingcommonlybetween061and1(VieraampGarrett2005)
Aprovisionalthematicframework(AppendixS5)wasdevelopedusingconceptualdomainsfromPROMsvalidatedforusewithVVpa‐tients(AppendixS6)thatwereidentifiedinaseparatereview(Aberetal2017)
InitialcodingofthetextwasconductedindependentlylinebylinewithrelevantsectionsandquotationshighlightedandassignedtothespecificnodesoftheprovisionalthematicframeworkTherewasthepotentialtoconstrainorlimitthedeductionofnewthemesbyusingapreliminaryframeworkhoweveritdidnotpredeterminethefinalthemes
Comparisons were made across the three included studiesmatching emergent themes to those already established in the frameworkWherenewconceptswereidentifiedadditionalthemeswerecreatedandpreviouslycodedpaperswerere‐visitedtoestab‐lishwhetheranyaspectsoftheirfindingsmatchedthenewlycreatedthemeTheclassificationoftextaccordingtoexistingandemergentthemesiscomparabletothedevelopmentofdescriptivethemesinthematicanalysis (ThomasampHarden2008)wherethemesremainldquoclose to theprimary studyrdquo Figure1demonstrates the synthesisprocess
3emsp |emspRESULTS
A total of 1804 referenceswere identified following the removalof duplicates 1318 citations were screened of these 56 full‐textarticleswereretrievedandscreenedforeligibilityofthese53wereexcludedReasonsforexclusionwereasfollowsThepaperwasnotavailable in English the study populationwas not clearly definedsolelyasVVor thestudywasnotqualitative researchordidnotdetail data collection or analysis methods Study selection is detailed in thePRISMAflowdiagram (MoherLiberatiTeetzlaffampAltman2009)(Figure2)
Three independent studies that met the inclusion criteriawere identified (Table 1) The studieswere published between2004 and2016 andwere conducted in Sweden (n=1) and theUK (n=2)
emspensp emsp | emsp1089LUMLEY Et aL
31emsp|emspQuality assessment
The overall quality of the included studies was high with posi‐tive responses formost items on the CASP checklist (AppendixS7) Positive responses indicate that the paper hasmet the rel‐evantCASPcriteriaforcredibilityandrigourHowevertwoofthethreestudiesdidnotfullyconsidertherelationshipbetweentheresearcherandstudyparticipantsthereforepotentiallyintroduc‐ingbias into the researchprocessStudieswerenotexcludedorweightedbasedonquality
4emsp |emspTHEMES
FiveoverarchingthemeswereidentifiedphysicalimpactofVVpsy‐chologicalimpactsocialimpactadaptingtoVVandreasonsforseeking
treatmentWithinthesemainthemesfurthersubthemeswereidenti‐fiedsymptomssymptommanagementphysicalfunctionworryanxi‐etyappearancesocialrestrictionsandrelationships(Table2)
41emsp|emspPhysical impact
ThephysicalimpactofVVwasevidentacrossallthreeincludedpa‐persaswere thesubthemesof symptomsmanagementof symp‐tomsandphysicalfunction
411emsp|emspSymptoms
Descriptionsofpainheavinessanditchingwerecommontopar‐ticipants in all three studieswith swelling reported in only twopapers Cramps tingling and numbness were also reported astroublesomesymptoms(FranzampWann‐Hansson2015)reflecting
F I G U R E 1 emspApplicationofframeworksynthesis[Colourfigurecanbeviewedatwileyonlinelibrarycom]
Familiarisation
Comparison of PROMs including identification and
interpretation of itemsdomains
Development of provisional framework of themes and
subthemes for use in analysis of included studies
Systematic identification of qualitative research studies
examining the experiences of people living with VV
Provisional framework for analysis entered into NVIVO
Reviewers familiarize themselves with included studies and upload
papers as sources into NVIVO
Iterative process of line-by-line coding of included studies in NVIVO with categorisation to
putative themes including addition of and categorisation to
new emergent themes
Continuous re-examination of analysed studies as new themes
emerge and the thematic framework develops to ensure a comprehensive and consistent analysis has been conducted
Thematic framework finalised facilitating a coherent synthesis
presentation and discussion of the impact of VV on QoL with reference
to itemsdomains in PROMs used with VV populations
Familiarisation with PROMs validated in populations
with VV
1090emsp |emsp emspensp LUMLEY Et aL
thebroadrangeofphysicalsymptomsdescribedacrossthethreepapers The symptomsoftenhad an impact onother aspects oflifesuchassleepresulting inparticipantsfeelingtiredThedis‐tressassociatedwithsymptomsisclearlydescribedbysomestudyparticipantswhilstforothersthesymptomswerelesstroubling
They drive me mad absolutely mad with the itching Ill scratch them and scratch them thatmuch that ImakethemlikeyouknowscratchmarksImakethembleedwiththescratchmarks Participant13mdashPalfreymanetal
ItusedtoaffecteverythingIwoulddoeverydayhellipitwas really awfulhellipmy legswere so soreanduncom‐fortable Patient14mdashHudsonetal
TheywerentpainfulexactlybutermattheendofthedayIwouldbeconsciousofthemliketheywereachyyouknownotpainful Patient9mdashHudsonetal
412emsp|emspManagement of symptoms
Allthreepaperscontaineddescriptionsofhowparticipantsuseddif‐ferentstrategiestomanagetheimpactoftheirsymptomsThemaincoping strategies employedwere elevationof legs and theuseofcreamsointmentsandcompressionhosieryHoweverwherethesestrategieswereineffectiveorinappropriateindividualscalledupontheir own internal resources
Theuseofcompressionhosierywasvieweddifferently inthetwostudiesthatcommentFranzandWannHansenwhilstacknowledgingthedifficultiesinvolvedinwearingcompressionhosieryreportbenefitsin reducing swelling and suggest and that for some individuals the use of stockingsiscrucialtogettingeverydayworkdoneIncontrastPalfreymanetalreportawidespreaddissatisfactionwiththeuseofcompressionho‐sierybypatientswhichtosomeextentseemedtobesharedbyclinicians
The doctor (at the outpatient clinic) asked if I usedstockingsIsaidtheyreawasteoftimeHesaysldquoYouthinksoIminclinedtoagreewirsquothatrdquo Participant1mdashPalfreymanetal
Palfreymanetalalsonotedtheuseofanalgesiatomanagepainanddiscomfortwithoneparticipantdescribingtheuseofarangeofnonsteroidal anti‐inflammatories (NSAIDs) with varying effects andanotherparticipantusingparacetamolcodeinecombinations
Themanagement of symptoms theme is directly linked to theldquoAdaptingtoVVrdquothemeasallthreepapersreporthowparticipantsmakelifeadaptationsaswellaspracticalonestorelievesymptomsinanefforttocopewithalifewithVV
ThelastfewdaysIliterallycrawledthroughthedoorandhadtositdownwithmyfeetuphightogetthebloodandswellingdown Patient14mdashHudsonetal
I put creamon you know soothing cream like cala‐mine and stuff like that and that voltarol gel thatsquitegood Participant5ndashPalfreymanetal
F I G U R E 2 emspPRISMA2009flowdiagram
Records idenfied through database searching
(n = 1804)
Addional records idenfied through other sources
(n = 0)
Records aer duplicates removed (n = 1318)
Records screened (n = 1318)
Records excluded (n = 1262)
Full-text articles assessed for eligibility
(n = 56)
Full-text arcles excluded with reasons
(n = 53)
Studies included in qualitave synthesis
(n = 3)
emspensp emsp | emsp1091LUMLEY Et aL
IfeelthatthelegbecomesalittlemoreswollenwhenI dont have the stockings on especially downherewherethesocksenditmaybemorepronouncedifIdonthavethecompressionstockingson Informant4mdashFranzandWann‐Hansson
SoItriedthemuptokneelikepopsocksandwhenyou had them on for a bit well they give you some right pain you knowwhere the veins swellWhenyouvehademonabittheyresotightstockingsyourgladtogethomeandgetemoff Participant1mdashPalfreymanetal
413emsp|emspPhysical function
None of the papers identified that VV prevented specific activi‐tiesofdaily living suchaspersonal careorhouseworkhoweverthey clearly showed that participants experienced limitations intheir daily lives for instance being able to participate in leisureactivitieswalkingdistancesorexerciseTheserestrictionssome‐times resulted fromphysical problemswhenundertaking certainactivitieshoweversomeindividualswhilstphysicallyableplaced
limitationsontheiractivitiesduetotheappearanceoftheVVthisdemonstratesaclosecrossoverbetweenthephysicalandpsycho‐logical themes The consequences of the physical impact of VVwerebestdescribedasldquonotbeingabletolivelifefullyrdquo(FranzandWann‐Hansson)
Twopapers(PalfreymanetalFranzandWann‐Hansson)identi‐fiedthatVVcouldaffecttheworklivesofparticipantsbothduetophysicalandpsychologicalfactorsFranzandWann‐Hanssonfoundboth those that were still working and those that were now retired spokeof the struggleof copingwith symptomsand trying to findrelief at work
Ifoundthatthey(mylegs)getverytiredandheavyifIamonmyfeetfortoolongorIhavetowalktoofarso it was always at the back of my mind that my legs weretoosoreifIdidtoomuchhellipPatient20mdashHudsonet al
42emsp|emspPsychological impact
Psychological impactencompassedsubthemesofworryoranxietyandappearance
TA B L E 1 emsp Includedstudies
Author and year Country Research design Sample Main findings
FranzandWann‐Hansson(2015)
Sweden Exploratoryqualitativestudywithphenomenologicalapproach
12(purposivesample) TheessencemeantadaptingtoalifewithVVrelieving discomfort from legs with an unfavorableappearance
Phenomenologicalreduction Age56(mean)range32ndash72) Gender (42male) (512)
Copingwithdiscomfortinvolveddealingwiththe disease emotionally and finding strategiesthathelpedtorelievesymptomshoweverlivingwithldquorepulsiverdquolegswasseen as embarrassing and many found the need to hide their condition
HudsonOgdenandWhiteley(2015)
UK Qualitativesemi‐structuredinterviews(qualitativesectionofamixed‐methodsstudyincludinganRCT)
20 (four from each arm of thewiderRCT)
Fourthemescaptured (1)Negativeemotionsassociatedwithsymptoms (2)Unpreparednessforthesurgicalprocess (3)Feelingcaredfor (4)Improvementsinwell‐being
Thematic analysis Age(mean)508years Gender (30male) (620)
Anoverarchingthemeofrelationshipswasidentified VVhadadetrimentalimpactonQoLpriortosurgerypostsurgeryQoLimproved
PalfreymanDrewery‐CarterRigbyMichaelsandTod(2004)
UK Qualitativeusingsemi‐ structured interviews
16(purposivesample) ParticipantsattributedawiderangeofsymptomstotheirVVandwereactivelyseekingtreatmentwiththeexpectationthattheywouldgainsymptomrelief
Framework analysis Age(mean) 51years(range20ndash75) Gender (19male) (316)
ThesymptomsattributedtoVVhadasignificantnegativeimpactonQoLandlifestyle Improvingthecosmeticappearanceoftheir legs was seen as a secondary benefit
1092emsp |emsp emspensp LUMLEY Et aL
421emsp|emspWorry or anxiety
InallstudiesparticipantsexpressedworriesaboutdeteriorationofVVandtheriskoffutureproblemssuchasVLUordeepveinthrom‐bosis (DVT)Thisanxietywassometimes rooted inexperiencesoffamily or friends
Wellthenthethoughtscamethatitcouldbesome‐thinglikethat(ulcers)whichisstarting Informant4mdashFranzandWann‐Hansson
InoticedascratchandIwasveryworriedaboutopen‐ingsomeskinorsomethingyouknowandpossiblygettinganulcer Patient10mdashHudsonetal
Therewasalsoafeelingamongsttheparticipantsthatif they had surgical treatment itwould prevent anyfurtherdeteriorationhellip AuthorsmdashPalfreymanetal
422emsp|emspAppearance
ThepsychologicaleffectofVVwasalsorelatedtoappearancethiswasreportedinallthreepapersandincludedpersonalfeelingsofembarrass‐mentdisgustandfeelingself‐consciousTherewasalsotheimpactofthereactionsofothersortheworryaboutapotentialnegativereaction
Iwas just veryaware thatmy legs shouldntbe likethis and that if they were more normal and less ugly
TA B L E 2 emspThemesidentifiedfromincludedpapers
Main theme SubthemePalfreyman et al (2004)
Hudson et al (2015)
Franz amp Wann‐Hansson (2015)
1Physicalimpact Symptoms
Heaviness
Itching
Pain
Swelling times
Othersymptoms(phlebitistiredness)
Sleep times
Management of symptoms
Copingstrategies
Compression times
Analgesia times times
Elevation
Physical function
Limitations
Work times
2Psychologicalimpact Worryanxiety
Futurehealthproblems
Deterioration
Appearance
Personalfeelings(embarrass‐mentself‐consciousdisgust)
Reactions of others
Self‐imageself‐esteem times times
3Impactonsocialfunctioning Restrictions
Relationships
4Reasonsforseekingtreatment Symptomrelief times
Cosmeticconcerns times
Preventfutureproblems times
5AdaptingtoVV Lifeadaptations
Clothingadaptations
emspensp emsp | emsp1093LUMLEY Et aL
andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal
hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal
ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson
These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming
I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal
Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson
Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions
She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal
43emsp|emspSocial impact
Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships
431emsp|emspRestrictions
Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise
ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo
ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson
If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal
ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them
432emsp|emspRelationships
TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships
One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal
IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal
44emsp|emspReasons for seeking treatment
Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact
More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal
OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
emspensp emsp | emsp1087LUMLEY Et aL
Morerecently in2016acommissionwasestablished inAustraliatoreviewtherationaleanduseofPROMsinordertohelpembedtheuseofPROMsintheAustralianhealthcaresystem(Williamsetal2016)
DespitetheincreasinguseofPROMsinclinicalpracticeitisim‐portanttonotethattherearelimitationsintheiruseduetoissuesofvalidityandreliabilityrelatedtothenatureofself‐reportRelyingonpatientstoself‐reporttheirhealthcanbechallengingparticularlywithpatientssufferingfromcognitivedeficitsparalysisordementiathosewhomaynotreadorspeakEnglishorthosethatarenotlit‐erate(childrenandbabies)ProxyversionsofPROMs(egthatcanbecompletedbycaregivers)andPROMsdesignedforcompletionbyspecificgroupssuchaschildrendoexisthowevertherelianceonself‐reportinghealthpresentsanissuefortheuseofPROMsinsomecontexts (DevlinampAppleby 2010) PROMsdata should thereforebeseenascomplementingratherthanreplacingclinicalandotherinformationaboutpatients
Since2009intheUKNHSprovidershavebeenrequiredtocol‐lectPROMsforfoursurgicalproceduresincludingVVtreatmenttheotherthreeproceduresareherniarepairandhipandkneereplace‐mentsCompletionofPROMsisvoluntaryandpatientsareundernoobligation to take part In 2013ndash2014 PROMcompletion rates forVVpatientswereconsiderablylowerthanfortheotherproceduresjust405comparedwithhipandkneesurgeryatnearly86and94andanaverageof76acrossall fourprocedures (HealthandSocialCare InformationCentre (HSCIC)2016)Theredoesnot ap‐peartobeanyestablishedreasonwhyVVPROMcompletionratesaresocomparativelypoorhoweveroneexplanationcouldbe thatthe PROMs being used do not contain items that are relevant toVVpatientsTheNHScurrentlyusesthegenericPROMtheEQ5DEQ5D‐VAS(EuroQol1990)andthecondition‐specificAberdeenVVQuestionnaire(AVVQ)(Garrattetal1993)todatethereisnopub‐lishedevidence that theEQ5Dhasbeenvalidated forusewithVVpatients
A recent systematic review (Aber et al 2017) was conductedto identify PROMs that have undergone some kind of publishedvalidation for use with VV patients and assess their psychometricpropertiesThreedisease‐specificPROMstheAVVQ(Garrattetal1993)VVSymptomQuestionnaire(VVSymQ)(PatyTurner‐BowkerElashampWright2016)andSpecificQoLOutcomeResponse‐Venous(SQOR‐V) (Guex Zimmet Boussetta Nguyen amp Taieb 2007) andonegenericPROMtheShort‐Form36(SF‐36)(WareampSherbourne1992)wereidentifiedThereviewconcludedthatbasedonitspsy‐chometricpropertiestheAVVQwasthemostappropriatedisease‐specific instrumentwith evidenceof construct validity testndashretestreliabilityand responsivenessbut lessevidence forcontentvalidityandacceptabilityAnexampleofthequestionsfromtheAVVQcanbeseeninAppendixS1TheSF‐36wasthemostsuitablegenericPROMforusewithpatientswithVVwithsatisfactoryresponsivenessandacceptability but with limited assessment of other psychometricproperties
Currently NICE VV guidance suggests that ldquoQuality‐of‐lifemeasures are unlikely to reflect severity of disease because of
variations inperceptionof symptomsrdquo (NICE2013) thereforeit is necessary to assess whether these existing PROMs actu‐ally reflect the symptomsand issues that aremost relevant topatients
Content validity of PROMs is the extent to which items ona test are representative of what is intended to be measuredContent validity when developing PROMs can be enhanced byusing qualitative researchmethods such as interviewswith pa‐tientstodeterminewhichissuesarerelevanttothepatientgroupand using these findings to develop the items incorporated intothePROM
WhetherusedinclinicalpracticeorasaresearchtoolPROMsshouldberigorouslydevelopedtoensurethattheyadequatelyrep‐resentandcapturetheexperiencesofthepopulationtheyaretobe used with
QoLiscentraltotheindividualpatientsexperienceofhealthanddiseasemeasures ofQoLmust domore than describe a patientshealth in terms of what health professionals and society believeconstitutes health (Carr amp Higginson 2001) The measurement ofimprovementsorotherwiseinQoLassociatedwithpatient‐centredcareshouldpreferablybeperformedusingPROMsthathavebeenconstructedwiththe involvementofthoseexperiencingthehealthstate
Thisqualitativeevidencesynthesisisrelatedtotheidentifica‐tionandevaluationofexistingcondition‐specificorgenericPROMsthathavebeenvalidatedforuseinpopulationswithvascularcondi‐tionsThesynthesisisalsoanintegralpartofthedevelopmentofanewPROMspecificallyanelectronicpatientquestionnaire(ePAQ‐VAS)foruseinthispopulationThereviewcomplementsaseriesofotherprojectsundertakenaspartofaNationalInstituteforHealthResearch (NIHR) Programme GrantmdashThe Vascular ProgrammeGrant (VPG) Project ID RP‐PG‐1210‐12009) which has the aimof evaluating vascular services and making recommendations re‐gardingpatient‐focusedcareProgrammeworkstreamsincludethefollowing
bull Similarreviewsofqualitativeevidenceoffourothervascularcon‐ditions(abdominalaorticaneurysm(AAA)carotidarterydisease(CAD)peripheralarterialdisease(PAD)andVLU)
bull FivesystematicreviewsidentifyingandevaluatingPROMsusedbypatientswithfivevascularconditions (AAACADPADVLUandVV)
bull Primary qualitative research into the experience of living withthese five vascular conditions
11emsp|emspAims
1 The primary aim of this qualitative evidence synthesis was toexamine the symptoms and QoL domains that are importantfrom the perspective of patients with VV
2 Asecondaryaimwastocomparethethemesidentifiedinthesyn‐thesistoitemsinPROMscurrentlyusedwithVVpatients
1088emsp |emsp emspensp LUMLEY Et aL
2emsp |emspMETHODS
This systematic review was conducted using explicit systematicmethods to reduce the riskofbias andprovide reliable findings inaccordancewithpublishedguidelines(HigginsampGreen2011)spe‐cifically a thematic synthesis was conducted as this is a recognised methodusedinsystematicreviewsofqualitativeresearchwhichpre‐servesanexplicitandtransparent linkbetweenreviewconclusionsand the primary researchThomas andHarden (2008) This reviewfollows the design established in a prepublished protocol (Duncanetal2016)titledldquoUnderstandingtheexperienceandimpactofliv‐ingwithavascularconditionfromthepatientsrsquoperspectiverdquoandisreported according to the ldquoEnhancing Transparency in ReportingtheSynthesisofQualitativeResearchrdquo (ENTREQ) statement (TongFlemmingMcInnesOliverampCraig 2012) The ENTREQ checklistcanbeseeninsupplementaryFileS1
21emsp|emspStudy identification and selection
Studies were included if they were primary qualitative researchstudies including populations of adults with VV and published inEnglishMixed‐methods studies where details of data collectionanalysesandresultsofthequalitativeportionofthestudywerere‐portedseparatelywereincludedAppendixS2showstheeligibilitycriteria
SearcheswereconductedinCinahlEmbaseMedlinePsycINFOScience Citation Index and the Social Science Citation Index andProQuest dissertations and theses No language or date restric‐tionswereappliedasan initialscopingsearchhad identifieda lackof available literature in this subject area Additionally reference lists of included studies and related reviews were scrutinised and cita‐tionsearcheswereconducted(seeAppendixS3forfulldetailsofthesearchstrategy)
Tworeviewers(ELandPP)independentlyscreenedthetitleandabstract of all studies identified by the searches with reference to theinclusionandexclusioncriteriainthepublishedprotocolAllpo‐tentialfull‐textpaperswerereadanddiscussionwasusedtoresolveanydifferenceofopinionAthirdresearcher(AA)wasavailableforconsultation if consensus could not be reached
22emsp|emspData extraction and quality assessment
Dataextractionwasconductedusingastudy‐specificdataextrac‐tion form details of author date country research design method ofanalysisaimsandobjectivessampleincludingageandgenderdiagnosisandeligibilitycriteriawerecollected (AppendixS4)TheCritical Appraisal Skills Programme (CASP) qualitative researchchecklistwasemployedtoassessthemethodologicalqualityoftheincluded papers including trustworthiness and relevance (CASP2014)TheCASPchecklistwaschosenas itassessesboththeap‐propriatenessandqualityofreportingandiscommonlyusedinqual‐itative reviews of evidence (CarrollampBooth 2014) The checklistcomprisesoftenquestionsaboutthequalitativemethodologyand
areansweredeitherldquoyesrdquoldquonordquoorldquounclearrdquoQualityassessmentwasconductedindependentlybytworesearchers(ELandPP)andanydiscrepancieswereresolvedthroughdiscussionfollowingtheCASPcriteria
23emsp|emspData analysis
Eachfull‐textpaperwasuploadedelectronicallyintoNVIVO10(QSRInternational Burlington USA) the reviewers read through eachof thepapers to familiarise themselveswith thestudyand resultsthe results sections were then analysed using thematic synthesis (ThomasampHarden2008)
Interobserveragreementofcodingwascheckedandconsensuswashighshowingsubstantialalmostperfectorperfectagreementwithkappacoefficientratingcommonlybetween061and1(VieraampGarrett2005)
Aprovisionalthematicframework(AppendixS5)wasdevelopedusingconceptualdomainsfromPROMsvalidatedforusewithVVpa‐tients(AppendixS6)thatwereidentifiedinaseparatereview(Aberetal2017)
InitialcodingofthetextwasconductedindependentlylinebylinewithrelevantsectionsandquotationshighlightedandassignedtothespecificnodesoftheprovisionalthematicframeworkTherewasthepotentialtoconstrainorlimitthedeductionofnewthemesbyusingapreliminaryframeworkhoweveritdidnotpredeterminethefinalthemes
Comparisons were made across the three included studiesmatching emergent themes to those already established in the frameworkWherenewconceptswereidentifiedadditionalthemeswerecreatedandpreviouslycodedpaperswerere‐visitedtoestab‐lishwhetheranyaspectsoftheirfindingsmatchedthenewlycreatedthemeTheclassificationoftextaccordingtoexistingandemergentthemesiscomparabletothedevelopmentofdescriptivethemesinthematicanalysis (ThomasampHarden2008)wherethemesremainldquoclose to theprimary studyrdquo Figure1demonstrates the synthesisprocess
3emsp |emspRESULTS
A total of 1804 referenceswere identified following the removalof duplicates 1318 citations were screened of these 56 full‐textarticleswereretrievedandscreenedforeligibilityofthese53wereexcludedReasonsforexclusionwereasfollowsThepaperwasnotavailable in English the study populationwas not clearly definedsolelyasVVor thestudywasnotqualitative researchordidnotdetail data collection or analysis methods Study selection is detailed in thePRISMAflowdiagram (MoherLiberatiTeetzlaffampAltman2009)(Figure2)
Three independent studies that met the inclusion criteriawere identified (Table 1) The studieswere published between2004 and2016 andwere conducted in Sweden (n=1) and theUK (n=2)
emspensp emsp | emsp1089LUMLEY Et aL
31emsp|emspQuality assessment
The overall quality of the included studies was high with posi‐tive responses formost items on the CASP checklist (AppendixS7) Positive responses indicate that the paper hasmet the rel‐evantCASPcriteriaforcredibilityandrigourHowevertwoofthethreestudiesdidnotfullyconsidertherelationshipbetweentheresearcherandstudyparticipantsthereforepotentiallyintroduc‐ingbias into the researchprocessStudieswerenotexcludedorweightedbasedonquality
4emsp |emspTHEMES
FiveoverarchingthemeswereidentifiedphysicalimpactofVVpsy‐chologicalimpactsocialimpactadaptingtoVVandreasonsforseeking
treatmentWithinthesemainthemesfurthersubthemeswereidenti‐fiedsymptomssymptommanagementphysicalfunctionworryanxi‐etyappearancesocialrestrictionsandrelationships(Table2)
41emsp|emspPhysical impact
ThephysicalimpactofVVwasevidentacrossallthreeincludedpa‐persaswere thesubthemesof symptomsmanagementof symp‐tomsandphysicalfunction
411emsp|emspSymptoms
Descriptionsofpainheavinessanditchingwerecommontopar‐ticipants in all three studieswith swelling reported in only twopapers Cramps tingling and numbness were also reported astroublesomesymptoms(FranzampWann‐Hansson2015)reflecting
F I G U R E 1 emspApplicationofframeworksynthesis[Colourfigurecanbeviewedatwileyonlinelibrarycom]
Familiarisation
Comparison of PROMs including identification and
interpretation of itemsdomains
Development of provisional framework of themes and
subthemes for use in analysis of included studies
Systematic identification of qualitative research studies
examining the experiences of people living with VV
Provisional framework for analysis entered into NVIVO
Reviewers familiarize themselves with included studies and upload
papers as sources into NVIVO
Iterative process of line-by-line coding of included studies in NVIVO with categorisation to
putative themes including addition of and categorisation to
new emergent themes
Continuous re-examination of analysed studies as new themes
emerge and the thematic framework develops to ensure a comprehensive and consistent analysis has been conducted
Thematic framework finalised facilitating a coherent synthesis
presentation and discussion of the impact of VV on QoL with reference
to itemsdomains in PROMs used with VV populations
Familiarisation with PROMs validated in populations
with VV
1090emsp |emsp emspensp LUMLEY Et aL
thebroadrangeofphysicalsymptomsdescribedacrossthethreepapers The symptomsoftenhad an impact onother aspects oflifesuchassleepresulting inparticipantsfeelingtiredThedis‐tressassociatedwithsymptomsisclearlydescribedbysomestudyparticipantswhilstforothersthesymptomswerelesstroubling
They drive me mad absolutely mad with the itching Ill scratch them and scratch them thatmuch that ImakethemlikeyouknowscratchmarksImakethembleedwiththescratchmarks Participant13mdashPalfreymanetal
ItusedtoaffecteverythingIwoulddoeverydayhellipitwas really awfulhellipmy legswere so soreanduncom‐fortable Patient14mdashHudsonetal
TheywerentpainfulexactlybutermattheendofthedayIwouldbeconsciousofthemliketheywereachyyouknownotpainful Patient9mdashHudsonetal
412emsp|emspManagement of symptoms
Allthreepaperscontaineddescriptionsofhowparticipantsuseddif‐ferentstrategiestomanagetheimpactoftheirsymptomsThemaincoping strategies employedwere elevationof legs and theuseofcreamsointmentsandcompressionhosieryHoweverwherethesestrategieswereineffectiveorinappropriateindividualscalledupontheir own internal resources
Theuseofcompressionhosierywasvieweddifferently inthetwostudiesthatcommentFranzandWannHansenwhilstacknowledgingthedifficultiesinvolvedinwearingcompressionhosieryreportbenefitsin reducing swelling and suggest and that for some individuals the use of stockingsiscrucialtogettingeverydayworkdoneIncontrastPalfreymanetalreportawidespreaddissatisfactionwiththeuseofcompressionho‐sierybypatientswhichtosomeextentseemedtobesharedbyclinicians
The doctor (at the outpatient clinic) asked if I usedstockingsIsaidtheyreawasteoftimeHesaysldquoYouthinksoIminclinedtoagreewirsquothatrdquo Participant1mdashPalfreymanetal
Palfreymanetalalsonotedtheuseofanalgesiatomanagepainanddiscomfortwithoneparticipantdescribingtheuseofarangeofnonsteroidal anti‐inflammatories (NSAIDs) with varying effects andanotherparticipantusingparacetamolcodeinecombinations
Themanagement of symptoms theme is directly linked to theldquoAdaptingtoVVrdquothemeasallthreepapersreporthowparticipantsmakelifeadaptationsaswellaspracticalonestorelievesymptomsinanefforttocopewithalifewithVV
ThelastfewdaysIliterallycrawledthroughthedoorandhadtositdownwithmyfeetuphightogetthebloodandswellingdown Patient14mdashHudsonetal
I put creamon you know soothing cream like cala‐mine and stuff like that and that voltarol gel thatsquitegood Participant5ndashPalfreymanetal
F I G U R E 2 emspPRISMA2009flowdiagram
Records idenfied through database searching
(n = 1804)
Addional records idenfied through other sources
(n = 0)
Records aer duplicates removed (n = 1318)
Records screened (n = 1318)
Records excluded (n = 1262)
Full-text articles assessed for eligibility
(n = 56)
Full-text arcles excluded with reasons
(n = 53)
Studies included in qualitave synthesis
(n = 3)
emspensp emsp | emsp1091LUMLEY Et aL
IfeelthatthelegbecomesalittlemoreswollenwhenI dont have the stockings on especially downherewherethesocksenditmaybemorepronouncedifIdonthavethecompressionstockingson Informant4mdashFranzandWann‐Hansson
SoItriedthemuptokneelikepopsocksandwhenyou had them on for a bit well they give you some right pain you knowwhere the veins swellWhenyouvehademonabittheyresotightstockingsyourgladtogethomeandgetemoff Participant1mdashPalfreymanetal
413emsp|emspPhysical function
None of the papers identified that VV prevented specific activi‐tiesofdaily living suchaspersonal careorhouseworkhoweverthey clearly showed that participants experienced limitations intheir daily lives for instance being able to participate in leisureactivitieswalkingdistancesorexerciseTheserestrictionssome‐times resulted fromphysical problemswhenundertaking certainactivitieshoweversomeindividualswhilstphysicallyableplaced
limitationsontheiractivitiesduetotheappearanceoftheVVthisdemonstratesaclosecrossoverbetweenthephysicalandpsycho‐logical themes The consequences of the physical impact of VVwerebestdescribedasldquonotbeingabletolivelifefullyrdquo(FranzandWann‐Hansson)
Twopapers(PalfreymanetalFranzandWann‐Hansson)identi‐fiedthatVVcouldaffecttheworklivesofparticipantsbothduetophysicalandpsychologicalfactorsFranzandWann‐Hanssonfoundboth those that were still working and those that were now retired spokeof the struggleof copingwith symptomsand trying to findrelief at work
Ifoundthatthey(mylegs)getverytiredandheavyifIamonmyfeetfortoolongorIhavetowalktoofarso it was always at the back of my mind that my legs weretoosoreifIdidtoomuchhellipPatient20mdashHudsonet al
42emsp|emspPsychological impact
Psychological impactencompassedsubthemesofworryoranxietyandappearance
TA B L E 1 emsp Includedstudies
Author and year Country Research design Sample Main findings
FranzandWann‐Hansson(2015)
Sweden Exploratoryqualitativestudywithphenomenologicalapproach
12(purposivesample) TheessencemeantadaptingtoalifewithVVrelieving discomfort from legs with an unfavorableappearance
Phenomenologicalreduction Age56(mean)range32ndash72) Gender (42male) (512)
Copingwithdiscomfortinvolveddealingwiththe disease emotionally and finding strategiesthathelpedtorelievesymptomshoweverlivingwithldquorepulsiverdquolegswasseen as embarrassing and many found the need to hide their condition
HudsonOgdenandWhiteley(2015)
UK Qualitativesemi‐structuredinterviews(qualitativesectionofamixed‐methodsstudyincludinganRCT)
20 (four from each arm of thewiderRCT)
Fourthemescaptured (1)Negativeemotionsassociatedwithsymptoms (2)Unpreparednessforthesurgicalprocess (3)Feelingcaredfor (4)Improvementsinwell‐being
Thematic analysis Age(mean)508years Gender (30male) (620)
Anoverarchingthemeofrelationshipswasidentified VVhadadetrimentalimpactonQoLpriortosurgerypostsurgeryQoLimproved
PalfreymanDrewery‐CarterRigbyMichaelsandTod(2004)
UK Qualitativeusingsemi‐ structured interviews
16(purposivesample) ParticipantsattributedawiderangeofsymptomstotheirVVandwereactivelyseekingtreatmentwiththeexpectationthattheywouldgainsymptomrelief
Framework analysis Age(mean) 51years(range20ndash75) Gender (19male) (316)
ThesymptomsattributedtoVVhadasignificantnegativeimpactonQoLandlifestyle Improvingthecosmeticappearanceoftheir legs was seen as a secondary benefit
1092emsp |emsp emspensp LUMLEY Et aL
421emsp|emspWorry or anxiety
InallstudiesparticipantsexpressedworriesaboutdeteriorationofVVandtheriskoffutureproblemssuchasVLUordeepveinthrom‐bosis (DVT)Thisanxietywassometimes rooted inexperiencesoffamily or friends
Wellthenthethoughtscamethatitcouldbesome‐thinglikethat(ulcers)whichisstarting Informant4mdashFranzandWann‐Hansson
InoticedascratchandIwasveryworriedaboutopen‐ingsomeskinorsomethingyouknowandpossiblygettinganulcer Patient10mdashHudsonetal
Therewasalsoafeelingamongsttheparticipantsthatif they had surgical treatment itwould prevent anyfurtherdeteriorationhellip AuthorsmdashPalfreymanetal
422emsp|emspAppearance
ThepsychologicaleffectofVVwasalsorelatedtoappearancethiswasreportedinallthreepapersandincludedpersonalfeelingsofembarrass‐mentdisgustandfeelingself‐consciousTherewasalsotheimpactofthereactionsofothersortheworryaboutapotentialnegativereaction
Iwas just veryaware thatmy legs shouldntbe likethis and that if they were more normal and less ugly
TA B L E 2 emspThemesidentifiedfromincludedpapers
Main theme SubthemePalfreyman et al (2004)
Hudson et al (2015)
Franz amp Wann‐Hansson (2015)
1Physicalimpact Symptoms
Heaviness
Itching
Pain
Swelling times
Othersymptoms(phlebitistiredness)
Sleep times
Management of symptoms
Copingstrategies
Compression times
Analgesia times times
Elevation
Physical function
Limitations
Work times
2Psychologicalimpact Worryanxiety
Futurehealthproblems
Deterioration
Appearance
Personalfeelings(embarrass‐mentself‐consciousdisgust)
Reactions of others
Self‐imageself‐esteem times times
3Impactonsocialfunctioning Restrictions
Relationships
4Reasonsforseekingtreatment Symptomrelief times
Cosmeticconcerns times
Preventfutureproblems times
5AdaptingtoVV Lifeadaptations
Clothingadaptations
emspensp emsp | emsp1093LUMLEY Et aL
andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal
hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal
ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson
These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming
I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal
Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson
Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions
She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal
43emsp|emspSocial impact
Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships
431emsp|emspRestrictions
Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise
ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo
ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson
If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal
ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them
432emsp|emspRelationships
TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships
One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal
IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal
44emsp|emspReasons for seeking treatment
Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact
More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal
OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
1088emsp |emsp emspensp LUMLEY Et aL
2emsp |emspMETHODS
This systematic review was conducted using explicit systematicmethods to reduce the riskofbias andprovide reliable findings inaccordancewithpublishedguidelines(HigginsampGreen2011)spe‐cifically a thematic synthesis was conducted as this is a recognised methodusedinsystematicreviewsofqualitativeresearchwhichpre‐servesanexplicitandtransparent linkbetweenreviewconclusionsand the primary researchThomas andHarden (2008) This reviewfollows the design established in a prepublished protocol (Duncanetal2016)titledldquoUnderstandingtheexperienceandimpactofliv‐ingwithavascularconditionfromthepatientsrsquoperspectiverdquoandisreported according to the ldquoEnhancing Transparency in ReportingtheSynthesisofQualitativeResearchrdquo (ENTREQ) statement (TongFlemmingMcInnesOliverampCraig 2012) The ENTREQ checklistcanbeseeninsupplementaryFileS1
21emsp|emspStudy identification and selection
Studies were included if they were primary qualitative researchstudies including populations of adults with VV and published inEnglishMixed‐methods studies where details of data collectionanalysesandresultsofthequalitativeportionofthestudywerere‐portedseparatelywereincludedAppendixS2showstheeligibilitycriteria
SearcheswereconductedinCinahlEmbaseMedlinePsycINFOScience Citation Index and the Social Science Citation Index andProQuest dissertations and theses No language or date restric‐tionswereappliedasan initialscopingsearchhad identifieda lackof available literature in this subject area Additionally reference lists of included studies and related reviews were scrutinised and cita‐tionsearcheswereconducted(seeAppendixS3forfulldetailsofthesearchstrategy)
Tworeviewers(ELandPP)independentlyscreenedthetitleandabstract of all studies identified by the searches with reference to theinclusionandexclusioncriteriainthepublishedprotocolAllpo‐tentialfull‐textpaperswerereadanddiscussionwasusedtoresolveanydifferenceofopinionAthirdresearcher(AA)wasavailableforconsultation if consensus could not be reached
22emsp|emspData extraction and quality assessment
Dataextractionwasconductedusingastudy‐specificdataextrac‐tion form details of author date country research design method ofanalysisaimsandobjectivessampleincludingageandgenderdiagnosisandeligibilitycriteriawerecollected (AppendixS4)TheCritical Appraisal Skills Programme (CASP) qualitative researchchecklistwasemployedtoassessthemethodologicalqualityoftheincluded papers including trustworthiness and relevance (CASP2014)TheCASPchecklistwaschosenas itassessesboththeap‐propriatenessandqualityofreportingandiscommonlyusedinqual‐itative reviews of evidence (CarrollampBooth 2014) The checklistcomprisesoftenquestionsaboutthequalitativemethodologyand
areansweredeitherldquoyesrdquoldquonordquoorldquounclearrdquoQualityassessmentwasconductedindependentlybytworesearchers(ELandPP)andanydiscrepancieswereresolvedthroughdiscussionfollowingtheCASPcriteria
23emsp|emspData analysis
Eachfull‐textpaperwasuploadedelectronicallyintoNVIVO10(QSRInternational Burlington USA) the reviewers read through eachof thepapers to familiarise themselveswith thestudyand resultsthe results sections were then analysed using thematic synthesis (ThomasampHarden2008)
Interobserveragreementofcodingwascheckedandconsensuswashighshowingsubstantialalmostperfectorperfectagreementwithkappacoefficientratingcommonlybetween061and1(VieraampGarrett2005)
Aprovisionalthematicframework(AppendixS5)wasdevelopedusingconceptualdomainsfromPROMsvalidatedforusewithVVpa‐tients(AppendixS6)thatwereidentifiedinaseparatereview(Aberetal2017)
InitialcodingofthetextwasconductedindependentlylinebylinewithrelevantsectionsandquotationshighlightedandassignedtothespecificnodesoftheprovisionalthematicframeworkTherewasthepotentialtoconstrainorlimitthedeductionofnewthemesbyusingapreliminaryframeworkhoweveritdidnotpredeterminethefinalthemes
Comparisons were made across the three included studiesmatching emergent themes to those already established in the frameworkWherenewconceptswereidentifiedadditionalthemeswerecreatedandpreviouslycodedpaperswerere‐visitedtoestab‐lishwhetheranyaspectsoftheirfindingsmatchedthenewlycreatedthemeTheclassificationoftextaccordingtoexistingandemergentthemesiscomparabletothedevelopmentofdescriptivethemesinthematicanalysis (ThomasampHarden2008)wherethemesremainldquoclose to theprimary studyrdquo Figure1demonstrates the synthesisprocess
3emsp |emspRESULTS
A total of 1804 referenceswere identified following the removalof duplicates 1318 citations were screened of these 56 full‐textarticleswereretrievedandscreenedforeligibilityofthese53wereexcludedReasonsforexclusionwereasfollowsThepaperwasnotavailable in English the study populationwas not clearly definedsolelyasVVor thestudywasnotqualitative researchordidnotdetail data collection or analysis methods Study selection is detailed in thePRISMAflowdiagram (MoherLiberatiTeetzlaffampAltman2009)(Figure2)
Three independent studies that met the inclusion criteriawere identified (Table 1) The studieswere published between2004 and2016 andwere conducted in Sweden (n=1) and theUK (n=2)
emspensp emsp | emsp1089LUMLEY Et aL
31emsp|emspQuality assessment
The overall quality of the included studies was high with posi‐tive responses formost items on the CASP checklist (AppendixS7) Positive responses indicate that the paper hasmet the rel‐evantCASPcriteriaforcredibilityandrigourHowevertwoofthethreestudiesdidnotfullyconsidertherelationshipbetweentheresearcherandstudyparticipantsthereforepotentiallyintroduc‐ingbias into the researchprocessStudieswerenotexcludedorweightedbasedonquality
4emsp |emspTHEMES
FiveoverarchingthemeswereidentifiedphysicalimpactofVVpsy‐chologicalimpactsocialimpactadaptingtoVVandreasonsforseeking
treatmentWithinthesemainthemesfurthersubthemeswereidenti‐fiedsymptomssymptommanagementphysicalfunctionworryanxi‐etyappearancesocialrestrictionsandrelationships(Table2)
41emsp|emspPhysical impact
ThephysicalimpactofVVwasevidentacrossallthreeincludedpa‐persaswere thesubthemesof symptomsmanagementof symp‐tomsandphysicalfunction
411emsp|emspSymptoms
Descriptionsofpainheavinessanditchingwerecommontopar‐ticipants in all three studieswith swelling reported in only twopapers Cramps tingling and numbness were also reported astroublesomesymptoms(FranzampWann‐Hansson2015)reflecting
F I G U R E 1 emspApplicationofframeworksynthesis[Colourfigurecanbeviewedatwileyonlinelibrarycom]
Familiarisation
Comparison of PROMs including identification and
interpretation of itemsdomains
Development of provisional framework of themes and
subthemes for use in analysis of included studies
Systematic identification of qualitative research studies
examining the experiences of people living with VV
Provisional framework for analysis entered into NVIVO
Reviewers familiarize themselves with included studies and upload
papers as sources into NVIVO
Iterative process of line-by-line coding of included studies in NVIVO with categorisation to
putative themes including addition of and categorisation to
new emergent themes
Continuous re-examination of analysed studies as new themes
emerge and the thematic framework develops to ensure a comprehensive and consistent analysis has been conducted
Thematic framework finalised facilitating a coherent synthesis
presentation and discussion of the impact of VV on QoL with reference
to itemsdomains in PROMs used with VV populations
Familiarisation with PROMs validated in populations
with VV
1090emsp |emsp emspensp LUMLEY Et aL
thebroadrangeofphysicalsymptomsdescribedacrossthethreepapers The symptomsoftenhad an impact onother aspects oflifesuchassleepresulting inparticipantsfeelingtiredThedis‐tressassociatedwithsymptomsisclearlydescribedbysomestudyparticipantswhilstforothersthesymptomswerelesstroubling
They drive me mad absolutely mad with the itching Ill scratch them and scratch them thatmuch that ImakethemlikeyouknowscratchmarksImakethembleedwiththescratchmarks Participant13mdashPalfreymanetal
ItusedtoaffecteverythingIwoulddoeverydayhellipitwas really awfulhellipmy legswere so soreanduncom‐fortable Patient14mdashHudsonetal
TheywerentpainfulexactlybutermattheendofthedayIwouldbeconsciousofthemliketheywereachyyouknownotpainful Patient9mdashHudsonetal
412emsp|emspManagement of symptoms
Allthreepaperscontaineddescriptionsofhowparticipantsuseddif‐ferentstrategiestomanagetheimpactoftheirsymptomsThemaincoping strategies employedwere elevationof legs and theuseofcreamsointmentsandcompressionhosieryHoweverwherethesestrategieswereineffectiveorinappropriateindividualscalledupontheir own internal resources
Theuseofcompressionhosierywasvieweddifferently inthetwostudiesthatcommentFranzandWannHansenwhilstacknowledgingthedifficultiesinvolvedinwearingcompressionhosieryreportbenefitsin reducing swelling and suggest and that for some individuals the use of stockingsiscrucialtogettingeverydayworkdoneIncontrastPalfreymanetalreportawidespreaddissatisfactionwiththeuseofcompressionho‐sierybypatientswhichtosomeextentseemedtobesharedbyclinicians
The doctor (at the outpatient clinic) asked if I usedstockingsIsaidtheyreawasteoftimeHesaysldquoYouthinksoIminclinedtoagreewirsquothatrdquo Participant1mdashPalfreymanetal
Palfreymanetalalsonotedtheuseofanalgesiatomanagepainanddiscomfortwithoneparticipantdescribingtheuseofarangeofnonsteroidal anti‐inflammatories (NSAIDs) with varying effects andanotherparticipantusingparacetamolcodeinecombinations
Themanagement of symptoms theme is directly linked to theldquoAdaptingtoVVrdquothemeasallthreepapersreporthowparticipantsmakelifeadaptationsaswellaspracticalonestorelievesymptomsinanefforttocopewithalifewithVV
ThelastfewdaysIliterallycrawledthroughthedoorandhadtositdownwithmyfeetuphightogetthebloodandswellingdown Patient14mdashHudsonetal
I put creamon you know soothing cream like cala‐mine and stuff like that and that voltarol gel thatsquitegood Participant5ndashPalfreymanetal
F I G U R E 2 emspPRISMA2009flowdiagram
Records idenfied through database searching
(n = 1804)
Addional records idenfied through other sources
(n = 0)
Records aer duplicates removed (n = 1318)
Records screened (n = 1318)
Records excluded (n = 1262)
Full-text articles assessed for eligibility
(n = 56)
Full-text arcles excluded with reasons
(n = 53)
Studies included in qualitave synthesis
(n = 3)
emspensp emsp | emsp1091LUMLEY Et aL
IfeelthatthelegbecomesalittlemoreswollenwhenI dont have the stockings on especially downherewherethesocksenditmaybemorepronouncedifIdonthavethecompressionstockingson Informant4mdashFranzandWann‐Hansson
SoItriedthemuptokneelikepopsocksandwhenyou had them on for a bit well they give you some right pain you knowwhere the veins swellWhenyouvehademonabittheyresotightstockingsyourgladtogethomeandgetemoff Participant1mdashPalfreymanetal
413emsp|emspPhysical function
None of the papers identified that VV prevented specific activi‐tiesofdaily living suchaspersonal careorhouseworkhoweverthey clearly showed that participants experienced limitations intheir daily lives for instance being able to participate in leisureactivitieswalkingdistancesorexerciseTheserestrictionssome‐times resulted fromphysical problemswhenundertaking certainactivitieshoweversomeindividualswhilstphysicallyableplaced
limitationsontheiractivitiesduetotheappearanceoftheVVthisdemonstratesaclosecrossoverbetweenthephysicalandpsycho‐logical themes The consequences of the physical impact of VVwerebestdescribedasldquonotbeingabletolivelifefullyrdquo(FranzandWann‐Hansson)
Twopapers(PalfreymanetalFranzandWann‐Hansson)identi‐fiedthatVVcouldaffecttheworklivesofparticipantsbothduetophysicalandpsychologicalfactorsFranzandWann‐Hanssonfoundboth those that were still working and those that were now retired spokeof the struggleof copingwith symptomsand trying to findrelief at work
Ifoundthatthey(mylegs)getverytiredandheavyifIamonmyfeetfortoolongorIhavetowalktoofarso it was always at the back of my mind that my legs weretoosoreifIdidtoomuchhellipPatient20mdashHudsonet al
42emsp|emspPsychological impact
Psychological impactencompassedsubthemesofworryoranxietyandappearance
TA B L E 1 emsp Includedstudies
Author and year Country Research design Sample Main findings
FranzandWann‐Hansson(2015)
Sweden Exploratoryqualitativestudywithphenomenologicalapproach
12(purposivesample) TheessencemeantadaptingtoalifewithVVrelieving discomfort from legs with an unfavorableappearance
Phenomenologicalreduction Age56(mean)range32ndash72) Gender (42male) (512)
Copingwithdiscomfortinvolveddealingwiththe disease emotionally and finding strategiesthathelpedtorelievesymptomshoweverlivingwithldquorepulsiverdquolegswasseen as embarrassing and many found the need to hide their condition
HudsonOgdenandWhiteley(2015)
UK Qualitativesemi‐structuredinterviews(qualitativesectionofamixed‐methodsstudyincludinganRCT)
20 (four from each arm of thewiderRCT)
Fourthemescaptured (1)Negativeemotionsassociatedwithsymptoms (2)Unpreparednessforthesurgicalprocess (3)Feelingcaredfor (4)Improvementsinwell‐being
Thematic analysis Age(mean)508years Gender (30male) (620)
Anoverarchingthemeofrelationshipswasidentified VVhadadetrimentalimpactonQoLpriortosurgerypostsurgeryQoLimproved
PalfreymanDrewery‐CarterRigbyMichaelsandTod(2004)
UK Qualitativeusingsemi‐ structured interviews
16(purposivesample) ParticipantsattributedawiderangeofsymptomstotheirVVandwereactivelyseekingtreatmentwiththeexpectationthattheywouldgainsymptomrelief
Framework analysis Age(mean) 51years(range20ndash75) Gender (19male) (316)
ThesymptomsattributedtoVVhadasignificantnegativeimpactonQoLandlifestyle Improvingthecosmeticappearanceoftheir legs was seen as a secondary benefit
1092emsp |emsp emspensp LUMLEY Et aL
421emsp|emspWorry or anxiety
InallstudiesparticipantsexpressedworriesaboutdeteriorationofVVandtheriskoffutureproblemssuchasVLUordeepveinthrom‐bosis (DVT)Thisanxietywassometimes rooted inexperiencesoffamily or friends
Wellthenthethoughtscamethatitcouldbesome‐thinglikethat(ulcers)whichisstarting Informant4mdashFranzandWann‐Hansson
InoticedascratchandIwasveryworriedaboutopen‐ingsomeskinorsomethingyouknowandpossiblygettinganulcer Patient10mdashHudsonetal
Therewasalsoafeelingamongsttheparticipantsthatif they had surgical treatment itwould prevent anyfurtherdeteriorationhellip AuthorsmdashPalfreymanetal
422emsp|emspAppearance
ThepsychologicaleffectofVVwasalsorelatedtoappearancethiswasreportedinallthreepapersandincludedpersonalfeelingsofembarrass‐mentdisgustandfeelingself‐consciousTherewasalsotheimpactofthereactionsofothersortheworryaboutapotentialnegativereaction
Iwas just veryaware thatmy legs shouldntbe likethis and that if they were more normal and less ugly
TA B L E 2 emspThemesidentifiedfromincludedpapers
Main theme SubthemePalfreyman et al (2004)
Hudson et al (2015)
Franz amp Wann‐Hansson (2015)
1Physicalimpact Symptoms
Heaviness
Itching
Pain
Swelling times
Othersymptoms(phlebitistiredness)
Sleep times
Management of symptoms
Copingstrategies
Compression times
Analgesia times times
Elevation
Physical function
Limitations
Work times
2Psychologicalimpact Worryanxiety
Futurehealthproblems
Deterioration
Appearance
Personalfeelings(embarrass‐mentself‐consciousdisgust)
Reactions of others
Self‐imageself‐esteem times times
3Impactonsocialfunctioning Restrictions
Relationships
4Reasonsforseekingtreatment Symptomrelief times
Cosmeticconcerns times
Preventfutureproblems times
5AdaptingtoVV Lifeadaptations
Clothingadaptations
emspensp emsp | emsp1093LUMLEY Et aL
andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal
hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal
ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson
These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming
I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal
Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson
Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions
She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal
43emsp|emspSocial impact
Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships
431emsp|emspRestrictions
Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise
ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo
ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson
If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal
ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them
432emsp|emspRelationships
TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships
One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal
IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal
44emsp|emspReasons for seeking treatment
Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact
More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal
OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
emspensp emsp | emsp1089LUMLEY Et aL
31emsp|emspQuality assessment
The overall quality of the included studies was high with posi‐tive responses formost items on the CASP checklist (AppendixS7) Positive responses indicate that the paper hasmet the rel‐evantCASPcriteriaforcredibilityandrigourHowevertwoofthethreestudiesdidnotfullyconsidertherelationshipbetweentheresearcherandstudyparticipantsthereforepotentiallyintroduc‐ingbias into the researchprocessStudieswerenotexcludedorweightedbasedonquality
4emsp |emspTHEMES
FiveoverarchingthemeswereidentifiedphysicalimpactofVVpsy‐chologicalimpactsocialimpactadaptingtoVVandreasonsforseeking
treatmentWithinthesemainthemesfurthersubthemeswereidenti‐fiedsymptomssymptommanagementphysicalfunctionworryanxi‐etyappearancesocialrestrictionsandrelationships(Table2)
41emsp|emspPhysical impact
ThephysicalimpactofVVwasevidentacrossallthreeincludedpa‐persaswere thesubthemesof symptomsmanagementof symp‐tomsandphysicalfunction
411emsp|emspSymptoms
Descriptionsofpainheavinessanditchingwerecommontopar‐ticipants in all three studieswith swelling reported in only twopapers Cramps tingling and numbness were also reported astroublesomesymptoms(FranzampWann‐Hansson2015)reflecting
F I G U R E 1 emspApplicationofframeworksynthesis[Colourfigurecanbeviewedatwileyonlinelibrarycom]
Familiarisation
Comparison of PROMs including identification and
interpretation of itemsdomains
Development of provisional framework of themes and
subthemes for use in analysis of included studies
Systematic identification of qualitative research studies
examining the experiences of people living with VV
Provisional framework for analysis entered into NVIVO
Reviewers familiarize themselves with included studies and upload
papers as sources into NVIVO
Iterative process of line-by-line coding of included studies in NVIVO with categorisation to
putative themes including addition of and categorisation to
new emergent themes
Continuous re-examination of analysed studies as new themes
emerge and the thematic framework develops to ensure a comprehensive and consistent analysis has been conducted
Thematic framework finalised facilitating a coherent synthesis
presentation and discussion of the impact of VV on QoL with reference
to itemsdomains in PROMs used with VV populations
Familiarisation with PROMs validated in populations
with VV
1090emsp |emsp emspensp LUMLEY Et aL
thebroadrangeofphysicalsymptomsdescribedacrossthethreepapers The symptomsoftenhad an impact onother aspects oflifesuchassleepresulting inparticipantsfeelingtiredThedis‐tressassociatedwithsymptomsisclearlydescribedbysomestudyparticipantswhilstforothersthesymptomswerelesstroubling
They drive me mad absolutely mad with the itching Ill scratch them and scratch them thatmuch that ImakethemlikeyouknowscratchmarksImakethembleedwiththescratchmarks Participant13mdashPalfreymanetal
ItusedtoaffecteverythingIwoulddoeverydayhellipitwas really awfulhellipmy legswere so soreanduncom‐fortable Patient14mdashHudsonetal
TheywerentpainfulexactlybutermattheendofthedayIwouldbeconsciousofthemliketheywereachyyouknownotpainful Patient9mdashHudsonetal
412emsp|emspManagement of symptoms
Allthreepaperscontaineddescriptionsofhowparticipantsuseddif‐ferentstrategiestomanagetheimpactoftheirsymptomsThemaincoping strategies employedwere elevationof legs and theuseofcreamsointmentsandcompressionhosieryHoweverwherethesestrategieswereineffectiveorinappropriateindividualscalledupontheir own internal resources
Theuseofcompressionhosierywasvieweddifferently inthetwostudiesthatcommentFranzandWannHansenwhilstacknowledgingthedifficultiesinvolvedinwearingcompressionhosieryreportbenefitsin reducing swelling and suggest and that for some individuals the use of stockingsiscrucialtogettingeverydayworkdoneIncontrastPalfreymanetalreportawidespreaddissatisfactionwiththeuseofcompressionho‐sierybypatientswhichtosomeextentseemedtobesharedbyclinicians
The doctor (at the outpatient clinic) asked if I usedstockingsIsaidtheyreawasteoftimeHesaysldquoYouthinksoIminclinedtoagreewirsquothatrdquo Participant1mdashPalfreymanetal
Palfreymanetalalsonotedtheuseofanalgesiatomanagepainanddiscomfortwithoneparticipantdescribingtheuseofarangeofnonsteroidal anti‐inflammatories (NSAIDs) with varying effects andanotherparticipantusingparacetamolcodeinecombinations
Themanagement of symptoms theme is directly linked to theldquoAdaptingtoVVrdquothemeasallthreepapersreporthowparticipantsmakelifeadaptationsaswellaspracticalonestorelievesymptomsinanefforttocopewithalifewithVV
ThelastfewdaysIliterallycrawledthroughthedoorandhadtositdownwithmyfeetuphightogetthebloodandswellingdown Patient14mdashHudsonetal
I put creamon you know soothing cream like cala‐mine and stuff like that and that voltarol gel thatsquitegood Participant5ndashPalfreymanetal
F I G U R E 2 emspPRISMA2009flowdiagram
Records idenfied through database searching
(n = 1804)
Addional records idenfied through other sources
(n = 0)
Records aer duplicates removed (n = 1318)
Records screened (n = 1318)
Records excluded (n = 1262)
Full-text articles assessed for eligibility
(n = 56)
Full-text arcles excluded with reasons
(n = 53)
Studies included in qualitave synthesis
(n = 3)
emspensp emsp | emsp1091LUMLEY Et aL
IfeelthatthelegbecomesalittlemoreswollenwhenI dont have the stockings on especially downherewherethesocksenditmaybemorepronouncedifIdonthavethecompressionstockingson Informant4mdashFranzandWann‐Hansson
SoItriedthemuptokneelikepopsocksandwhenyou had them on for a bit well they give you some right pain you knowwhere the veins swellWhenyouvehademonabittheyresotightstockingsyourgladtogethomeandgetemoff Participant1mdashPalfreymanetal
413emsp|emspPhysical function
None of the papers identified that VV prevented specific activi‐tiesofdaily living suchaspersonal careorhouseworkhoweverthey clearly showed that participants experienced limitations intheir daily lives for instance being able to participate in leisureactivitieswalkingdistancesorexerciseTheserestrictionssome‐times resulted fromphysical problemswhenundertaking certainactivitieshoweversomeindividualswhilstphysicallyableplaced
limitationsontheiractivitiesduetotheappearanceoftheVVthisdemonstratesaclosecrossoverbetweenthephysicalandpsycho‐logical themes The consequences of the physical impact of VVwerebestdescribedasldquonotbeingabletolivelifefullyrdquo(FranzandWann‐Hansson)
Twopapers(PalfreymanetalFranzandWann‐Hansson)identi‐fiedthatVVcouldaffecttheworklivesofparticipantsbothduetophysicalandpsychologicalfactorsFranzandWann‐Hanssonfoundboth those that were still working and those that were now retired spokeof the struggleof copingwith symptomsand trying to findrelief at work
Ifoundthatthey(mylegs)getverytiredandheavyifIamonmyfeetfortoolongorIhavetowalktoofarso it was always at the back of my mind that my legs weretoosoreifIdidtoomuchhellipPatient20mdashHudsonet al
42emsp|emspPsychological impact
Psychological impactencompassedsubthemesofworryoranxietyandappearance
TA B L E 1 emsp Includedstudies
Author and year Country Research design Sample Main findings
FranzandWann‐Hansson(2015)
Sweden Exploratoryqualitativestudywithphenomenologicalapproach
12(purposivesample) TheessencemeantadaptingtoalifewithVVrelieving discomfort from legs with an unfavorableappearance
Phenomenologicalreduction Age56(mean)range32ndash72) Gender (42male) (512)
Copingwithdiscomfortinvolveddealingwiththe disease emotionally and finding strategiesthathelpedtorelievesymptomshoweverlivingwithldquorepulsiverdquolegswasseen as embarrassing and many found the need to hide their condition
HudsonOgdenandWhiteley(2015)
UK Qualitativesemi‐structuredinterviews(qualitativesectionofamixed‐methodsstudyincludinganRCT)
20 (four from each arm of thewiderRCT)
Fourthemescaptured (1)Negativeemotionsassociatedwithsymptoms (2)Unpreparednessforthesurgicalprocess (3)Feelingcaredfor (4)Improvementsinwell‐being
Thematic analysis Age(mean)508years Gender (30male) (620)
Anoverarchingthemeofrelationshipswasidentified VVhadadetrimentalimpactonQoLpriortosurgerypostsurgeryQoLimproved
PalfreymanDrewery‐CarterRigbyMichaelsandTod(2004)
UK Qualitativeusingsemi‐ structured interviews
16(purposivesample) ParticipantsattributedawiderangeofsymptomstotheirVVandwereactivelyseekingtreatmentwiththeexpectationthattheywouldgainsymptomrelief
Framework analysis Age(mean) 51years(range20ndash75) Gender (19male) (316)
ThesymptomsattributedtoVVhadasignificantnegativeimpactonQoLandlifestyle Improvingthecosmeticappearanceoftheir legs was seen as a secondary benefit
1092emsp |emsp emspensp LUMLEY Et aL
421emsp|emspWorry or anxiety
InallstudiesparticipantsexpressedworriesaboutdeteriorationofVVandtheriskoffutureproblemssuchasVLUordeepveinthrom‐bosis (DVT)Thisanxietywassometimes rooted inexperiencesoffamily or friends
Wellthenthethoughtscamethatitcouldbesome‐thinglikethat(ulcers)whichisstarting Informant4mdashFranzandWann‐Hansson
InoticedascratchandIwasveryworriedaboutopen‐ingsomeskinorsomethingyouknowandpossiblygettinganulcer Patient10mdashHudsonetal
Therewasalsoafeelingamongsttheparticipantsthatif they had surgical treatment itwould prevent anyfurtherdeteriorationhellip AuthorsmdashPalfreymanetal
422emsp|emspAppearance
ThepsychologicaleffectofVVwasalsorelatedtoappearancethiswasreportedinallthreepapersandincludedpersonalfeelingsofembarrass‐mentdisgustandfeelingself‐consciousTherewasalsotheimpactofthereactionsofothersortheworryaboutapotentialnegativereaction
Iwas just veryaware thatmy legs shouldntbe likethis and that if they were more normal and less ugly
TA B L E 2 emspThemesidentifiedfromincludedpapers
Main theme SubthemePalfreyman et al (2004)
Hudson et al (2015)
Franz amp Wann‐Hansson (2015)
1Physicalimpact Symptoms
Heaviness
Itching
Pain
Swelling times
Othersymptoms(phlebitistiredness)
Sleep times
Management of symptoms
Copingstrategies
Compression times
Analgesia times times
Elevation
Physical function
Limitations
Work times
2Psychologicalimpact Worryanxiety
Futurehealthproblems
Deterioration
Appearance
Personalfeelings(embarrass‐mentself‐consciousdisgust)
Reactions of others
Self‐imageself‐esteem times times
3Impactonsocialfunctioning Restrictions
Relationships
4Reasonsforseekingtreatment Symptomrelief times
Cosmeticconcerns times
Preventfutureproblems times
5AdaptingtoVV Lifeadaptations
Clothingadaptations
emspensp emsp | emsp1093LUMLEY Et aL
andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal
hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal
ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson
These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming
I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal
Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson
Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions
She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal
43emsp|emspSocial impact
Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships
431emsp|emspRestrictions
Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise
ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo
ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson
If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal
ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them
432emsp|emspRelationships
TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships
One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal
IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal
44emsp|emspReasons for seeking treatment
Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact
More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal
OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
1090emsp |emsp emspensp LUMLEY Et aL
thebroadrangeofphysicalsymptomsdescribedacrossthethreepapers The symptomsoftenhad an impact onother aspects oflifesuchassleepresulting inparticipantsfeelingtiredThedis‐tressassociatedwithsymptomsisclearlydescribedbysomestudyparticipantswhilstforothersthesymptomswerelesstroubling
They drive me mad absolutely mad with the itching Ill scratch them and scratch them thatmuch that ImakethemlikeyouknowscratchmarksImakethembleedwiththescratchmarks Participant13mdashPalfreymanetal
ItusedtoaffecteverythingIwoulddoeverydayhellipitwas really awfulhellipmy legswere so soreanduncom‐fortable Patient14mdashHudsonetal
TheywerentpainfulexactlybutermattheendofthedayIwouldbeconsciousofthemliketheywereachyyouknownotpainful Patient9mdashHudsonetal
412emsp|emspManagement of symptoms
Allthreepaperscontaineddescriptionsofhowparticipantsuseddif‐ferentstrategiestomanagetheimpactoftheirsymptomsThemaincoping strategies employedwere elevationof legs and theuseofcreamsointmentsandcompressionhosieryHoweverwherethesestrategieswereineffectiveorinappropriateindividualscalledupontheir own internal resources
Theuseofcompressionhosierywasvieweddifferently inthetwostudiesthatcommentFranzandWannHansenwhilstacknowledgingthedifficultiesinvolvedinwearingcompressionhosieryreportbenefitsin reducing swelling and suggest and that for some individuals the use of stockingsiscrucialtogettingeverydayworkdoneIncontrastPalfreymanetalreportawidespreaddissatisfactionwiththeuseofcompressionho‐sierybypatientswhichtosomeextentseemedtobesharedbyclinicians
The doctor (at the outpatient clinic) asked if I usedstockingsIsaidtheyreawasteoftimeHesaysldquoYouthinksoIminclinedtoagreewirsquothatrdquo Participant1mdashPalfreymanetal
Palfreymanetalalsonotedtheuseofanalgesiatomanagepainanddiscomfortwithoneparticipantdescribingtheuseofarangeofnonsteroidal anti‐inflammatories (NSAIDs) with varying effects andanotherparticipantusingparacetamolcodeinecombinations
Themanagement of symptoms theme is directly linked to theldquoAdaptingtoVVrdquothemeasallthreepapersreporthowparticipantsmakelifeadaptationsaswellaspracticalonestorelievesymptomsinanefforttocopewithalifewithVV
ThelastfewdaysIliterallycrawledthroughthedoorandhadtositdownwithmyfeetuphightogetthebloodandswellingdown Patient14mdashHudsonetal
I put creamon you know soothing cream like cala‐mine and stuff like that and that voltarol gel thatsquitegood Participant5ndashPalfreymanetal
F I G U R E 2 emspPRISMA2009flowdiagram
Records idenfied through database searching
(n = 1804)
Addional records idenfied through other sources
(n = 0)
Records aer duplicates removed (n = 1318)
Records screened (n = 1318)
Records excluded (n = 1262)
Full-text articles assessed for eligibility
(n = 56)
Full-text arcles excluded with reasons
(n = 53)
Studies included in qualitave synthesis
(n = 3)
emspensp emsp | emsp1091LUMLEY Et aL
IfeelthatthelegbecomesalittlemoreswollenwhenI dont have the stockings on especially downherewherethesocksenditmaybemorepronouncedifIdonthavethecompressionstockingson Informant4mdashFranzandWann‐Hansson
SoItriedthemuptokneelikepopsocksandwhenyou had them on for a bit well they give you some right pain you knowwhere the veins swellWhenyouvehademonabittheyresotightstockingsyourgladtogethomeandgetemoff Participant1mdashPalfreymanetal
413emsp|emspPhysical function
None of the papers identified that VV prevented specific activi‐tiesofdaily living suchaspersonal careorhouseworkhoweverthey clearly showed that participants experienced limitations intheir daily lives for instance being able to participate in leisureactivitieswalkingdistancesorexerciseTheserestrictionssome‐times resulted fromphysical problemswhenundertaking certainactivitieshoweversomeindividualswhilstphysicallyableplaced
limitationsontheiractivitiesduetotheappearanceoftheVVthisdemonstratesaclosecrossoverbetweenthephysicalandpsycho‐logical themes The consequences of the physical impact of VVwerebestdescribedasldquonotbeingabletolivelifefullyrdquo(FranzandWann‐Hansson)
Twopapers(PalfreymanetalFranzandWann‐Hansson)identi‐fiedthatVVcouldaffecttheworklivesofparticipantsbothduetophysicalandpsychologicalfactorsFranzandWann‐Hanssonfoundboth those that were still working and those that were now retired spokeof the struggleof copingwith symptomsand trying to findrelief at work
Ifoundthatthey(mylegs)getverytiredandheavyifIamonmyfeetfortoolongorIhavetowalktoofarso it was always at the back of my mind that my legs weretoosoreifIdidtoomuchhellipPatient20mdashHudsonet al
42emsp|emspPsychological impact
Psychological impactencompassedsubthemesofworryoranxietyandappearance
TA B L E 1 emsp Includedstudies
Author and year Country Research design Sample Main findings
FranzandWann‐Hansson(2015)
Sweden Exploratoryqualitativestudywithphenomenologicalapproach
12(purposivesample) TheessencemeantadaptingtoalifewithVVrelieving discomfort from legs with an unfavorableappearance
Phenomenologicalreduction Age56(mean)range32ndash72) Gender (42male) (512)
Copingwithdiscomfortinvolveddealingwiththe disease emotionally and finding strategiesthathelpedtorelievesymptomshoweverlivingwithldquorepulsiverdquolegswasseen as embarrassing and many found the need to hide their condition
HudsonOgdenandWhiteley(2015)
UK Qualitativesemi‐structuredinterviews(qualitativesectionofamixed‐methodsstudyincludinganRCT)
20 (four from each arm of thewiderRCT)
Fourthemescaptured (1)Negativeemotionsassociatedwithsymptoms (2)Unpreparednessforthesurgicalprocess (3)Feelingcaredfor (4)Improvementsinwell‐being
Thematic analysis Age(mean)508years Gender (30male) (620)
Anoverarchingthemeofrelationshipswasidentified VVhadadetrimentalimpactonQoLpriortosurgerypostsurgeryQoLimproved
PalfreymanDrewery‐CarterRigbyMichaelsandTod(2004)
UK Qualitativeusingsemi‐ structured interviews
16(purposivesample) ParticipantsattributedawiderangeofsymptomstotheirVVandwereactivelyseekingtreatmentwiththeexpectationthattheywouldgainsymptomrelief
Framework analysis Age(mean) 51years(range20ndash75) Gender (19male) (316)
ThesymptomsattributedtoVVhadasignificantnegativeimpactonQoLandlifestyle Improvingthecosmeticappearanceoftheir legs was seen as a secondary benefit
1092emsp |emsp emspensp LUMLEY Et aL
421emsp|emspWorry or anxiety
InallstudiesparticipantsexpressedworriesaboutdeteriorationofVVandtheriskoffutureproblemssuchasVLUordeepveinthrom‐bosis (DVT)Thisanxietywassometimes rooted inexperiencesoffamily or friends
Wellthenthethoughtscamethatitcouldbesome‐thinglikethat(ulcers)whichisstarting Informant4mdashFranzandWann‐Hansson
InoticedascratchandIwasveryworriedaboutopen‐ingsomeskinorsomethingyouknowandpossiblygettinganulcer Patient10mdashHudsonetal
Therewasalsoafeelingamongsttheparticipantsthatif they had surgical treatment itwould prevent anyfurtherdeteriorationhellip AuthorsmdashPalfreymanetal
422emsp|emspAppearance
ThepsychologicaleffectofVVwasalsorelatedtoappearancethiswasreportedinallthreepapersandincludedpersonalfeelingsofembarrass‐mentdisgustandfeelingself‐consciousTherewasalsotheimpactofthereactionsofothersortheworryaboutapotentialnegativereaction
Iwas just veryaware thatmy legs shouldntbe likethis and that if they were more normal and less ugly
TA B L E 2 emspThemesidentifiedfromincludedpapers
Main theme SubthemePalfreyman et al (2004)
Hudson et al (2015)
Franz amp Wann‐Hansson (2015)
1Physicalimpact Symptoms
Heaviness
Itching
Pain
Swelling times
Othersymptoms(phlebitistiredness)
Sleep times
Management of symptoms
Copingstrategies
Compression times
Analgesia times times
Elevation
Physical function
Limitations
Work times
2Psychologicalimpact Worryanxiety
Futurehealthproblems
Deterioration
Appearance
Personalfeelings(embarrass‐mentself‐consciousdisgust)
Reactions of others
Self‐imageself‐esteem times times
3Impactonsocialfunctioning Restrictions
Relationships
4Reasonsforseekingtreatment Symptomrelief times
Cosmeticconcerns times
Preventfutureproblems times
5AdaptingtoVV Lifeadaptations
Clothingadaptations
emspensp emsp | emsp1093LUMLEY Et aL
andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal
hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal
ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson
These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming
I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal
Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson
Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions
She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal
43emsp|emspSocial impact
Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships
431emsp|emspRestrictions
Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise
ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo
ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson
If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal
ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them
432emsp|emspRelationships
TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships
One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal
IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal
44emsp|emspReasons for seeking treatment
Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact
More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal
OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
emspensp emsp | emsp1091LUMLEY Et aL
IfeelthatthelegbecomesalittlemoreswollenwhenI dont have the stockings on especially downherewherethesocksenditmaybemorepronouncedifIdonthavethecompressionstockingson Informant4mdashFranzandWann‐Hansson
SoItriedthemuptokneelikepopsocksandwhenyou had them on for a bit well they give you some right pain you knowwhere the veins swellWhenyouvehademonabittheyresotightstockingsyourgladtogethomeandgetemoff Participant1mdashPalfreymanetal
413emsp|emspPhysical function
None of the papers identified that VV prevented specific activi‐tiesofdaily living suchaspersonal careorhouseworkhoweverthey clearly showed that participants experienced limitations intheir daily lives for instance being able to participate in leisureactivitieswalkingdistancesorexerciseTheserestrictionssome‐times resulted fromphysical problemswhenundertaking certainactivitieshoweversomeindividualswhilstphysicallyableplaced
limitationsontheiractivitiesduetotheappearanceoftheVVthisdemonstratesaclosecrossoverbetweenthephysicalandpsycho‐logical themes The consequences of the physical impact of VVwerebestdescribedasldquonotbeingabletolivelifefullyrdquo(FranzandWann‐Hansson)
Twopapers(PalfreymanetalFranzandWann‐Hansson)identi‐fiedthatVVcouldaffecttheworklivesofparticipantsbothduetophysicalandpsychologicalfactorsFranzandWann‐Hanssonfoundboth those that were still working and those that were now retired spokeof the struggleof copingwith symptomsand trying to findrelief at work
Ifoundthatthey(mylegs)getverytiredandheavyifIamonmyfeetfortoolongorIhavetowalktoofarso it was always at the back of my mind that my legs weretoosoreifIdidtoomuchhellipPatient20mdashHudsonet al
42emsp|emspPsychological impact
Psychological impactencompassedsubthemesofworryoranxietyandappearance
TA B L E 1 emsp Includedstudies
Author and year Country Research design Sample Main findings
FranzandWann‐Hansson(2015)
Sweden Exploratoryqualitativestudywithphenomenologicalapproach
12(purposivesample) TheessencemeantadaptingtoalifewithVVrelieving discomfort from legs with an unfavorableappearance
Phenomenologicalreduction Age56(mean)range32ndash72) Gender (42male) (512)
Copingwithdiscomfortinvolveddealingwiththe disease emotionally and finding strategiesthathelpedtorelievesymptomshoweverlivingwithldquorepulsiverdquolegswasseen as embarrassing and many found the need to hide their condition
HudsonOgdenandWhiteley(2015)
UK Qualitativesemi‐structuredinterviews(qualitativesectionofamixed‐methodsstudyincludinganRCT)
20 (four from each arm of thewiderRCT)
Fourthemescaptured (1)Negativeemotionsassociatedwithsymptoms (2)Unpreparednessforthesurgicalprocess (3)Feelingcaredfor (4)Improvementsinwell‐being
Thematic analysis Age(mean)508years Gender (30male) (620)
Anoverarchingthemeofrelationshipswasidentified VVhadadetrimentalimpactonQoLpriortosurgerypostsurgeryQoLimproved
PalfreymanDrewery‐CarterRigbyMichaelsandTod(2004)
UK Qualitativeusingsemi‐ structured interviews
16(purposivesample) ParticipantsattributedawiderangeofsymptomstotheirVVandwereactivelyseekingtreatmentwiththeexpectationthattheywouldgainsymptomrelief
Framework analysis Age(mean) 51years(range20ndash75) Gender (19male) (316)
ThesymptomsattributedtoVVhadasignificantnegativeimpactonQoLandlifestyle Improvingthecosmeticappearanceoftheir legs was seen as a secondary benefit
1092emsp |emsp emspensp LUMLEY Et aL
421emsp|emspWorry or anxiety
InallstudiesparticipantsexpressedworriesaboutdeteriorationofVVandtheriskoffutureproblemssuchasVLUordeepveinthrom‐bosis (DVT)Thisanxietywassometimes rooted inexperiencesoffamily or friends
Wellthenthethoughtscamethatitcouldbesome‐thinglikethat(ulcers)whichisstarting Informant4mdashFranzandWann‐Hansson
InoticedascratchandIwasveryworriedaboutopen‐ingsomeskinorsomethingyouknowandpossiblygettinganulcer Patient10mdashHudsonetal
Therewasalsoafeelingamongsttheparticipantsthatif they had surgical treatment itwould prevent anyfurtherdeteriorationhellip AuthorsmdashPalfreymanetal
422emsp|emspAppearance
ThepsychologicaleffectofVVwasalsorelatedtoappearancethiswasreportedinallthreepapersandincludedpersonalfeelingsofembarrass‐mentdisgustandfeelingself‐consciousTherewasalsotheimpactofthereactionsofothersortheworryaboutapotentialnegativereaction
Iwas just veryaware thatmy legs shouldntbe likethis and that if they were more normal and less ugly
TA B L E 2 emspThemesidentifiedfromincludedpapers
Main theme SubthemePalfreyman et al (2004)
Hudson et al (2015)
Franz amp Wann‐Hansson (2015)
1Physicalimpact Symptoms
Heaviness
Itching
Pain
Swelling times
Othersymptoms(phlebitistiredness)
Sleep times
Management of symptoms
Copingstrategies
Compression times
Analgesia times times
Elevation
Physical function
Limitations
Work times
2Psychologicalimpact Worryanxiety
Futurehealthproblems
Deterioration
Appearance
Personalfeelings(embarrass‐mentself‐consciousdisgust)
Reactions of others
Self‐imageself‐esteem times times
3Impactonsocialfunctioning Restrictions
Relationships
4Reasonsforseekingtreatment Symptomrelief times
Cosmeticconcerns times
Preventfutureproblems times
5AdaptingtoVV Lifeadaptations
Clothingadaptations
emspensp emsp | emsp1093LUMLEY Et aL
andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal
hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal
ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson
These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming
I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal
Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson
Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions
She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal
43emsp|emspSocial impact
Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships
431emsp|emspRestrictions
Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise
ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo
ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson
If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal
ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them
432emsp|emspRelationships
TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships
One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal
IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal
44emsp|emspReasons for seeking treatment
Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact
More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal
OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
1092emsp |emsp emspensp LUMLEY Et aL
421emsp|emspWorry or anxiety
InallstudiesparticipantsexpressedworriesaboutdeteriorationofVVandtheriskoffutureproblemssuchasVLUordeepveinthrom‐bosis (DVT)Thisanxietywassometimes rooted inexperiencesoffamily or friends
Wellthenthethoughtscamethatitcouldbesome‐thinglikethat(ulcers)whichisstarting Informant4mdashFranzandWann‐Hansson
InoticedascratchandIwasveryworriedaboutopen‐ingsomeskinorsomethingyouknowandpossiblygettinganulcer Patient10mdashHudsonetal
Therewasalsoafeelingamongsttheparticipantsthatif they had surgical treatment itwould prevent anyfurtherdeteriorationhellip AuthorsmdashPalfreymanetal
422emsp|emspAppearance
ThepsychologicaleffectofVVwasalsorelatedtoappearancethiswasreportedinallthreepapersandincludedpersonalfeelingsofembarrass‐mentdisgustandfeelingself‐consciousTherewasalsotheimpactofthereactionsofothersortheworryaboutapotentialnegativereaction
Iwas just veryaware thatmy legs shouldntbe likethis and that if they were more normal and less ugly
TA B L E 2 emspThemesidentifiedfromincludedpapers
Main theme SubthemePalfreyman et al (2004)
Hudson et al (2015)
Franz amp Wann‐Hansson (2015)
1Physicalimpact Symptoms
Heaviness
Itching
Pain
Swelling times
Othersymptoms(phlebitistiredness)
Sleep times
Management of symptoms
Copingstrategies
Compression times
Analgesia times times
Elevation
Physical function
Limitations
Work times
2Psychologicalimpact Worryanxiety
Futurehealthproblems
Deterioration
Appearance
Personalfeelings(embarrass‐mentself‐consciousdisgust)
Reactions of others
Self‐imageself‐esteem times times
3Impactonsocialfunctioning Restrictions
Relationships
4Reasonsforseekingtreatment Symptomrelief times
Cosmeticconcerns times
Preventfutureproblems times
5AdaptingtoVV Lifeadaptations
Clothingadaptations
emspensp emsp | emsp1093LUMLEY Et aL
andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal
hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal
ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson
These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming
I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal
Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson
Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions
She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal
43emsp|emspSocial impact
Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships
431emsp|emspRestrictions
Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise
ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo
ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson
If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal
ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them
432emsp|emspRelationships
TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships
One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal
IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal
44emsp|emspReasons for seeking treatment
Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact
More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal
OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
emspensp emsp | emsp1093LUMLEY Et aL
andswollenthenIwouldfeelabithappier Patient2mdashHudsonetal
hellipbecause I dont like being stared at and laughedat for something that I cant particularly help Andtheyveupsetmemanya timewhen IwasyoungerThey called me a freak and things for having them And a lot of peoplewould stare at them andmakenoisesatme Participant11mdashPalfreymanetal
ItsmorepsychologicalthatIthinkpeoplearestaringatmyknees Informant12mdashFranzandWann‐Hansson
These issues contributed to negative self‐image and self‐es‐teemforparticipantsbothmaleandfemaleAgainthereisalinktothethemeofadaptationasthecosmetic impactofVV ledtopeopleadaptingclothingtoensuretheycoveredtheirVV inad‐dition they also altered the activities they tookpart in such assportsandswimming
I was very conscious of them and wouldnt wearshortsorskirtsforalongtimehellipIguesstheywerentthatobvious tootherpeople but tome theyweredisgustingand I just feltmorecomfortable in trou‐sershelliporatleastthicktightsPatient2mdashHudsonetal
Youdonotwant towalk amongpeoplehellipand showyourlegs Informant3mdashFranzandWann‐Hansson
Palfreymanreportedemploymentwasaffectedforafemalepartic‐ipantduetoherconcernsabouttheappearanceofherVVandassoci‐ated clothing restrictions
She felt that any job that did not allow her to wear trousersmeantthatshewouldbeunabletotakeupanyjoboffer AuthorsmdashPalfreymanetal
43emsp|emspSocial impact
Impactonsocialfunctioningconsistedofthesubthemesofrestric‐tionsandrelationships
431emsp|emspRestrictions
Allpapershighlightedthatparticipantshadfacedrestrictionsintheirsocial lives For some this had led to a degree of social isolation due to being unable or unwilling to participate in leisure activities orexercise
ButeveryoneImeetsays ldquoCanyoucomeandexer‐cisewithusItrsquosmorefunwhenwearemorepeoplerdquo
ButIcanrsquotIrsquovetriedtwiceIhaveseveralfriendswhoexercisetwiceaweek Informant2mdashFranzandWann‐Hansson
If any activity meant that they (participants) wouldhavetoexposetheir legs topublicviewtheywouldceasetobeinvolved AuthorsmdashPalfreymanetal
ThesocialimpactofVVisfurtherillustratedbyHudsonetalwhodescribestudyparticipants reporting thepositiveeffectsofsurgeryin terms of the removal of restrictions allowing full engagement once more with life and others around them
432emsp|emspRelationships
TherewasalsodiscussionoftheimpactonrelationshipsAllpapersreported that thenegativeemotionsparticipantshadexperiencedduetotheappearanceoftheirVVdirectlyinfluencedhowtheyper‐ceivedandinteractedwithothersbothwithinawidersocialcontextHudsonetalalsonotedanimpactonclosepersonalrelationships
One participant reported that her symptoms influ‐enced her interactions with her husband leading to tensionsintheirrelationshipAuthorsmdashHudsonetal
IdontfeelcomfortableIfeellikealotofpeoplestareatthemorfeelrepulsedbythem Participant11mdashPalfreymanetal
44emsp|emspReasons for seeking treatment
Thisthemewascommontotwopapers(PalfreymanetalHudsonetal)howeveritshouldbenotedthatexplorationofreasonswhypeo‐pleseektreatmentwasaspecificobjectiveofPalfreymanetalBothpapers identified that the primary reasons for seeking treatmentweresymptomreliefor topreventworseningof theirVVandthepossibilityofothercomplicationsExpectationsfortheeffectivenessoftreatmentwereoftenfoundtobeunrealistic(Palfreymanetal)Amelioratingthecosmeticappearancewasasecondaryconsidera‐tiondespitetheappearanceofVVbeingcommonlyreportedacrossthepapersashavingadistressingpsychologicalandsocialimpact
More than anything is that itwont be as it is nowsothatthepainfactortheheavinesseverythingthatgoeswithithopefullywillhavegone Participant14mdashPalfreymanetal
OneofmyfriendsrsquomothershadalotofproblemswithherveinsIthinkshehadanulcerandIrememberallthetroublethatcausedIdidntwantsomethinglikethat happened tome so that spurredmeon to gettreated Patient12mdashHudsonetal
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
1094emsp |emsp emspensp LUMLEY Et aL
45emsp|emspAdaptation
Adaptationwasacommonthemeacrossallpaperswithmanydif‐ferentkindsofadaptationsdescribedItisimportanttonotethatthe coping strategies employed tomanage symptoms thatwerepreviouslydiscussedshouldbedifferentiatedfromthelifeadap‐tationsconsideredatthispointFranzandWann‐Hanssonidenti‐fiedthatthetwoconceptsthoughoutwardlydifferentwerealsointertwined
Strategies for relief were not only instrumental mea‐suressuchastheuseofcompressionstockingsoint‐ments elevation of the leg and proper shoeshellipbutalsowereinherentinthepowerofthoughtsaswasdescribed in learning to live with discomfort and ac‐ceptanceofthedisease AuthorsmdashFranzandWann‐Hansson
Overwhelminglythesewerelifeadaptationssuchaschangingac‐tivitiesduetotheimpactonphysicalfunctionorcopingstrategiestodealwithsymptomsandadaptingworksituations
WellIhavebeenthinkingabouttheworksituationhellipifitispossibletoperhapschangethelengthofthepe‐riodandthelengthofworkinghoursduringthedayhellip Informant9mdashFranzandWann‐Hansson
Whenitcametointerestsinvolvingphysicalactivityandexercisetheinformantstriedtofindalternativeactivities that they could do despite their leg prob‐lems AuthorsmdashFranzandWann‐Hansson
Adaptationalsoappearsinrelationtothethemeofpsychologicalimpact as in all papers therewasmention of participants adaptingwhatclothingtheyworetodisguisetheappearanceofhavingVVandthesubsequentnegativeemotionsthiscaused
Many participants reported shame regarding theirlegs and took measures to avoid exposing them inpublicoftenatcosttotheircomfort AuthorsmdashHudson et al
ThosewhohadbeenlivingwithVVsymptomsforalong time had different methods to conceal their un‐attractive legs For example covering the legswithlongpantsorasaronginthesummerwasonewayofhidingthem AuthorsmdashFranzandWann‐Hansson
Inadditiontotheimpactontheiractivitiesthecos‐metic appearance of their legs also influenced thetypeofclothingwornbyparticipants AuthorsmdashPalfreymanetal
5emsp |emspDISCUSSION AND SYNTHESIS OF EMERGENT THEMES
The findings of the review have been discussed with reference to thedomainsusedinPROMsthathaveundergonesomeformofpub‐lishedvalidationinpopulationswithVVThisapproachwastakenasPROMsareregularlyusedtoassesstheimpactofVVonpatientstomeasuretreatmentresultsandtosupportclinicaldecision‐making
The final thematic framework was closely related to the initial frameworkwhichemerged fromanalysis and synthesisofPROMsusedandvalidatedwithaVVpopulation(Aberetal2017)thismayleadtosuggestionsthatadeductiveratherthaninductiveapproachwasusedHoweverthemessuchasadaptationdidemergeasare‐sult of the analysis and syntheses which are novel and to date not widelydescribed in theexisting literature reflecting the inductivenature of the analysis
Inour synthesiswe identifyphysical psychological and socialimpact in addition to reasons for seeking treatment and adapta‐tions as the five key themes that should be addressed in the de‐signoffuturePROMsandintheprovisionofcaretopatientswithVVTable3demonstrateswhichPROMsvalidatedforusewithVVpatients have domains or items that correspondwith the themesidentified inthisreview itshouldbenotedthattheVVSymQwasdevelopedsolelyasasymptomreportquestionnaire
Therangeofphysicalsymptomsreportedacrossthethreepaperswasvaried forexample swelling isnotmentionedbyPalfreymanyetappearsstronglyintheothertwoincludedpapers inadditionswelling is also adomain in all of theVV‐specificPROMs (AVVQVVSymQandSQOR‐V)
ThedegreetowhichpeoplewerebotheredbysymptomsofVVsuchaspainalsovariedwidelybothwithinandacrossthepapersForsomethesymptomsappearedtomaketheparticipantsldquoawarerdquooftheirVVwhilstforothersthepaincouldbedebilitatingresult‐ing in restrictions in their lives and requiring the need for activemanagement
Thediversityand impactofthesymptomsreportedacrossthethree papers demonstrated that there is no definitive list of VVsymptomsand thatnotall symptomsaffecteveryone in thesameway
Thesubjectivenatureof symptomexperiencehas implicationsfor theuseofPROMs as specific symptomsmaynotbe includedinthePROMforexampleworriesabouttheappearanceofVVortheremaybesymptomssuchasitchingthatareincludedbutthatarenottypical toallpatientsTherearealso implicationsforclini‐caldecision‐makingduetothedifficultyinmeasuringsymptomsofVVasNICE(2013)guidanceforthemanagementofVVstatesldquoQoLmeasures are unlikely to reflect severity of disease because of varia‐tionsinperceptionofsymptomsrdquo
The variety of descriptions of practical day‐to‐day symptommanagementacrossthepapershighlightedthevarietyofmethodsthatVVpatients employed Thismaydemonstrate a deficit of in‐formationavailable topatientsabout themosteffectivemeansof
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
emspensp emsp | emsp1095LUMLEY Et aL
symptomcontrolandtheimportanceofadherencetorecommendedmanagementoptions
Thisreviewalsofoundinconsistencyintheuseofcompressionhosiery as the two papers that covered it offered contradictorypoints The participants in Franz andWann‐Hansson appeared tohave more positive experiences of the use of compression thanthoseofPafreymanWhatisnotcleariswhetherthisdifferentiationcouldbeduetopooradherencelackofunderstandingofthebene‐fitsofcompressionorusingincorrectlyfittedcompressionhosiery
Thesubthemeofphysicalfunctionrelatedmoretophysicallim‐itationsratherthananabsoluteinabilitytocarryoutphysicaltasksThelackofclearphysicalimpactmaybeacontributingfactorinthereluctanceofsomeNHStrustsintheUKtofundVVsurgeryiftheassumption is that lack of measurable restriction does not meritcostly and not necessarily fully effective intervention
Recurrence of VV after conventional surgical treatment is a common costly and complex problem which accounts for over
20ofpatients requiringvenoussurgery (vanGroenendaeletal2009)GadSaberampHokkam (2012)noted reoccurrence ratesof60 after 5years injection sclerotherapywas suggested to haveahigherthan20reoccurrencerate(SheffieldTeachingHospitalsNHSFoundationTrust2011)
ThegenericPROMsusedintheVVpopulationandthespecificinstrumentAVVQbothhaveldquophysicalfunctionrdquodomainshoweverbasedonthefindingsreportedintheincludedstudiesaPROMdo‐mainrelatedmoretoldquophysicallimitationsrdquosuchasthatintheSF‐36isperhapsmoreapplicableTheSQOR‐VincludesquestionsaskingtowhatextentVVaffectsactivitiessuchasstandingsittingwalkingandusingthestairsthisemphasisonextentoflimitationratherthanpreventionofcarryingoutanactivityisperhapsmorerelevant
Thepsychological impactof livingwithVVappearsstrongly inthisreviewwithallthreepapersdemonstratingasignificantimpactFearsoffurtherdeteriorationandfutureproblemssuchasdevelop‐ingVLUorDVTwerecommoninmanypatientsacrossallpapers
TA B L E 3 emspPROMsitemsandcorrespondingqualitativereviewthemes
Qualitative review analysis themes
PROM
PROM item or domainPROM originSF‐361 AVVQ2 SQOR‐V3 VSymQ4
Physicalimpact Adaptation
times Physicalfunction1 Physicallimitations1 Physicalfunctionactivities2 Restriction of movement3
Socialimpact Adaptation
times Social activities1 Leisuresocial activities2 Restriction of activities3mdashincludingsocialsportorleisureactivitychoice
Psychologicalimpact Adaptation
times times Mentalhealth1 Emotional health1 Emotional distress3mdashincludingworryworseningcomplications
Physicalimpact Adaptation
Pain1 Painache2 Paindiscomfort3 Achiness4
Psychologicalimpact times times Healthperceptions1 Riskthreat to health3
Psychologicalimpact Adaptation
times times Appearance2mdashincludingclothingchoice Appearanceattractiveness3mdashincludingclothing choice
Physicalimpact times times times Progression3
NA times times times Vitality1
Physicalimpact Adaptation
times Symptoms234 Swelling234 Itching234 Heaviness34 Throbbing4 Skin2mdashdiscolourationrashulcer Sensation3mdashwarmburningtinglingstingingstabbing Restless legs3 Nightcramps3 Worsewithheatimproveswithcold3
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
1096emsp |emsp emspensp LUMLEY Et aL
thiscommonanxietyhasbeendescribedasanldquoexaggeratedsenseofriskfromVVrdquobyNICE(2013)ThereappearstobelittlereliableevidenceabouttheproportionofVVthatprogresstoVLUwithper‐hapsonlyanestimated3ndash6ofpeoplewithVVaffected(Nelzen2008)EnsuringpatientsarewellinformedabouttheirVVconditionandabouttheriskofothercomplicationsmaygosomewaytomiti‐gatingunnecessaryworryandanxiety
OnlyoneVV‐specificPROMtheSQOR‐VincludesdomainsthatwouldenablepatientstoreportpsychologicalemotionalormentalimpactsrelevanttotheanxietyandworryreportedinthisreviewTheSF‐36also includesdomains thatcapturebothemotionalandmental health
ThesignificanceofthecosmeticappearanceofVVhasperhapshistoricallybeentrivialisedincomparisonwiththeimpactofsymp‐tomshoweverthisreviewfoundthatappearancewasasignificantpsychologicalissueforpatientsAllthreepapershighlightedfeelingsofdistress andembarrassment felt bypatientsdue to the lookoftheirVV Thiswas due to both their personal perception and thereactions of others
IntheNICEvascularreferralguidelinesldquobody‐imageconcernsrdquoisincludedasanimportantmeasurableoutcomeofpatient‐assessedsymptomsandldquoappearancerdquo is includedasadomain intheAVVQandtheSQOR‐VhoweveritwouldnotbespecificallycapturedbyeithertheVVSymQorgenericPROMs
Social functionwas clearly found to be affected in all papersoften leading tovaryingdegreesof social isolationThe impactofsomeVVsymptoms resulted insomeparticipantsbeingunable toundertake usual leisure activities and hobbies For others it was downtoavoidanceduetoareluctancetoexposetheirVV
Inbothcasestheoutcomeofsocialisolationpreventedpeoplefrom living their lives fully andoftenhad implication for personalrelationshipswithpartnersfriendsandfamilyItwouldappearthatthere is potentially a close link between social and psychologicalimpactwith social isolation contributing to feelingsof lowmoodImpact of VV on social activities is measured by the SF‐36 theSQOR‐VandtheAVVQ
Symptomreliefratherthanthecosmeticappearancewasthepri‐maryreasonforseekingtreatmentinthetwopapersthatexploredthis theme
Existingliteraturedemonstratesthatimprovementinsymptomsis a common yet potentially unrealistic expectationDillon CarrFeeley and Tierney (2005) reported that 75 of participants ex‐pectedVVtreatmenttoimprovetheirsymptomswhilstDarvalletal(2009)foundthat100oftheirparticipantshadexpectedsomeimprovementfollowingtreatmentyet20hadunmetexpectations
Ifpatientsfeelthattheirtreatmenthasnotmettheirexpecta‐tionsthisislikelytohaveanimpactontheirQoLHealthcarepro‐fessionalsneedtoensurethatallpatientsarefullyinformedaboutpotentialbenefitsandrisksoftreatmentincludingthefactthattheymight need more than one treatment they may have a reoccurrence andtheymaydevelopnewVVinthefuture
Current PROMsdonot include a clear process for patients tohighlight their reasons for seeking treatment therefore healthcare
professionalsmayfindthemselvesunableto judgewhetherornotpatientshaverealistictreatmentexpectations
Participantsadoptedawiderangeofadaptationsinordertoen‐ablethemtocontinuetolivetheirlivesasfullyaspossibleThiswasnotableinallaspectspertainingtotheimpactofVVonQoLphysi‐callypsychologicallyandsocially
Someadaptationsmaybecharacterisedaspassiveforinstancewhen an individual stops doing something becauseof pain or ap‐pearancewhereasotheradaptationsmayberegardedaspositivemdashratherthanstoppingexercisebecauseofappearanceordiscomfortanewformofexerciseisadopted
TheabilityofVVpatientstopositivelyadapttotheirconditionand make the adjustments necessary to continue working and otherwise safeguard theirhealthandwell‐being isone suggestedreason for theperceptionofVVas a cosmetic condition (FranzampWann‐Hansson2015)
Anexpectationofsuccessfultreatmentforpatientsmaybethattheywouldnolongerhaveaneedtoadopttheseadaptationsthusleadingtoaresumptionofldquonormalrdquolife
NoavailablePROMvalidatedforVVpopulationscurrentlyex‐iststhatwouldfullycapturehowpatientsadapttheirlivestotheirconditionTheAVVQand theSQOR‐Vbothaskwhether clothingchoice isaffectedbyVVandtheSQOR‐Vaskswhetherchoiceofactivities is influenced by VV however this does not fully cover how patientsldquoadaptrdquooremployldquocopingstrategiesrdquotolivetheirlivesfully
51emsp|emspFurther researchmdashconstruction of PROMs
The content validity of a PROMcan be determined by examiningtherelevancetopatientsoftheitemsincludedThiscanbeassessedbyconsideringwhetherornotitemsweredevelopedthroughquali‐tativestudieswithpatientsand incorporatingqualitativeevidencefrom the literature
Acceptedguidancesuggests thatPROMsshouldbedevelopedusingpatient‐generated information (FDA2009)This informationisbestgeneratedusingqualitativeresearchmethodseitherthroughconductingaprimaryqualitativestudyorsystematicreviewsofex‐istingqualitativeliteraturebothofthesemethodsoffergreaterin‐sightintopatientexperiences
Of thethreecondition‐specificPROMs identified in thispaperonlyonetheVVSymQincorporatedqualitativepatient‐basedfind‐ings into development The AVVQ itemswere based on commonclinicalassessmentquestionsofVVpatientsandtheSQOR‐Vusedacommitteeofldquoexpertsrdquotoreviewexistingquestionnairesandanal‐yse relevant literature
AnidentifiedaimofthedevelopersoftheSQOR‐Vwasinfacttodevelopaquestionnairethatconsideredthepatientsrsquomainconcernsyetitappearsthattheydidnotconsultpatientsabouttheconstruc‐tionof items They also concluded that ldquocontent validity couldbeinferredasquestionswerecreatedforclarityandcompletenessbyagroupofexpertsinthefieldrdquo(Guexetal2007)ithardtounder‐standhowanyonecouldhavemoreinsightthanthepersonwholiveswith the condition
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
emspensp emsp | emsp1097LUMLEY Et aL
Familiarity with the findings of existing qualitative literaturethroughqualitativereviewsoremploymentofqualitativeresearchmethodssuchas interviewsenablesanin‐depthunderstandingoftherangeandseverityofsymptomsandresultingimpactonQoLexperiencedbypatientsQualitativemethodsshouldbeusedinthedevelopmentofPROMstoensurethat theyreflect themost rele‐vant issuespatientsface thereforeenhancingthecontentvalidityof such measures
The findings from this reviewhavebeenused in the develop‐mentofanewelectronicPROM(e‐PAQ‐VAS)whichisintendedtobeusedwithpatientswitha rangeofvascularconditions It com‐plements similar reviews that have been conductedwith patientswhohaveabdominalaorticaneurysmsperipheralarterialdiseasecarotid arterial disease andVLU and the findings from a primaryqualitativeresearchstudy
6emsp |emspCONCLUSION
Health‐related QoL patient‐assessed symptoms (including paindiscomfort body image concerns swelling aching and heaviness)andprogressionhavebeencitedas themost importantoutcomestoidentifywhichpeoplewouldbenefitfromareferraltoavascularservice(NICE2013)
The use of PROMs to gather such information is well estab‐lishedhoweverasthisreviewhasshownthosePROMscurrentlyvalidated for usewithpatientswithVV both generic and condi‐tion‐specificmaynotcapturethefullextentoftheimpactofVVonpatientsQoL
Healthcare professionals involved in the assessment and careof patientswithVV and those involved in planning vascular ser‐viceprovisionneedtobeasfamiliaraspossiblewiththelivedex‐perienceof such individuals inorder toprovideapatient‐centredservice
61emsp|emspRelevance to clinical practice
bull PROMsdataarecollectedpre‐andpost‐VVsurgerysohealthcareprofessionals should be familiarwith the instruments used andhaveawarenessthatthequestionscontainedwithintheseinstru‐mentsmaynotaccurately reflectpatientsrsquoexperiencesof livingwithVVAsVVhaveadiverserangeofsymptomsandtheimpactcanbewidereachingonmanydifferentaspectsofQoLthiscanbedifficulttocapture
bull The various adaptations patients employ in order to copewiththeirVVmaymaskthefullimpactoftheircondition
bull HealthcareprofessionalshavearesponsibilitytoensurepatientsareawareofboththemosteffectivemeansofsymptomcontrolandtheimportanceofadherencetorecommendedmanagementoptionsHealthcareprofessionalsshouldalsobeproperlytrainedinthefittingofcompressionhosieryinorderforpatientstopo‐tentially receive benefit from them
bull PatientswithVVmayhaveunfoundedfearsoffutureproblemssuchasdevelopingVLUorDVThealthcareprofessionalsshouldensurepatientsarewellinformedabouttheirconditionandtherisk of other complications in order to mitigate unnecessaryworryandanxiety
bull Healthcare professionals need to ensure that all patients haverealistictreatmentexpectationsincludingpotentialrisksoftreat‐ment such as the fact that they might need more than one treat‐menttheymayhaveareoccurrenceandtheymaydevelopnewVV in future
7emsp |emspLIMITATIONS
Thispaperissubjecttolimitationsduetoboththeageofoneoftheincluded studies and the small number of studies included overall Inclusionofapaper14yearsoldmaylimittherelevanceofitsresultsandthereforethefindingsofthisreviewOnlythreestudieswerein‐cludedinthisreviewpotentiallyaffectingtherepresentativenessofthe thematic findings and therefore the conclusions reached in this paperAswithprimaryqualitative researchwhere relatively smallsamplesarethenormbutselectivesamplingcancontinueuntildatasaturation has been achieved qualitative evidence syntheses canbenefitfrominclusionofandaccesstomultiplestudiessothattheexperienceoflivingwithVVcanbeunderstoodindifferentcontextsandcircumstancesThelackofavailablequalitativeliteratureonthissubject could suggest that this condition is often overlooked and that thesubjectwouldbenefitfromfurtherin‐depthqualitativeresearch
ACKNOWLEDG EMENTS
The authors would like to acknowledge Irene Mabbott PracticeDevelopment Co‐ordinator at Sheffield Teaching Hospitals NHSFoundationTrustforproof‐readingandreviewinganearlyversionofthepaperandtheadministrativemanagementandsupportpro‐vided by Dr EmmaWilson Programme GrantManager and KathWilsonProgrammeAdministrator
CONFLIC TS OF INTERE S T
Noconflictofinteresthasbeendeclaredbytheauthors
AUTHOR CONTRIBUTION
AllauthorscontributedtotheconceptionanddesignofthereviewELPPandAAwereinvolvedinacquisitionanalysisandinterpreta‐tion of data All authors were involved in drafting the article or revis‐ingitcriticallyforimportantintellectualcontent
ORCID
Elizabeth Lumley httpsorcidorg0000‐0002‐8962‐7568
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
1098emsp |emsp emspensp LUMLEY Et aL
R E FE R E N C E S
AberAPokuEPhillipsPEssatMBuckley‐WoodsHPalfreymanShellipMichaelsJ(2017)Systematicreviewofpatient‐reportedout‐comes measures in patients with varicose veins British Journal of Surgery 104(11)1424ndash1432
BlackN(2013)Patientreportedoutcomemeasurescouldhelptrans‐form healthcare BMJ 346f167httpsdoiorg101136bmjf167
CarrAJampHigginsonIJ(2001)MeasuringqualityoflifeArequalityoflifemeasurespatientcentredBritish Medical Journal 322(7298)1357httpsdoiorg101136bmj32272981357
Carroll C amp Booth A (2014) Quality assessment of qualitative evi‐denceforsystematicreviewandsynthesisIsitmeaningfulandifsohowshoulditbeperformedResearch Synthesis Methods 6149ndash154httpsdoiorg101002jrsm1128
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists OxfordCASPhttpwwwcasp‐uknetchecklists
DarvallKABateGR SamRCAdamD J Silverman SHampBradburyAW(2009)Patientsexpectationsbeforeandsatisfac‐tionafterultrasoundguidedfoamsclerotherapyforvaricoseveinsEuropean Journal of Vascular and Endovascular Surgery 38(5) 642ndash647httpsdoiorg101016jejvs200907014
DarvallKABateGRAdamDJampBradburyAW(2012)Generichealth relatedqualityof life issignificantlyworse invaricoseveinpatientswith lower limb symptoms independent of CEAP clinicalgrade European Journal of Vascular and Endovascular Surgery 44 341ndash344
DevlinN J ampAppleby J (2010)TheKingrsquos Fund (2010)Getting themost out of proms Putting health outcomes at the heart ofNHSdecision‐makingmdashISBN9781857175912wwwkingsfundorgukpublications
DillonM F CarrC J Feeley TMampTierney S (2005) Impact oftheinformedconsentprocessonpatientsunderstandingofvaricoseveins and their treatment Irish Journal of Medical Science 174(3)23ndash27httpsdoiorg101007BF03169143
Duncan R Booth A Woods H Essat M Phillips P Poku EhellipMichaels J (2016)Understanding theexperienceand impactofliving with a vascular condition from the patients perspective Aqualitative evidence synthesis protocol Available athttpeprintswhiteroseacuk963256DP_16_05pdf
EuroQoLGroup (1990)EuroQoLAnewfacility for themeasurementofhealth‐relatedqualityof lifeHealth Policy 16199ndash208httpsdoiorg1010160168‐8510(90)90421‐9 Availabe at httpwwweuroqolorgeq‐5deq‐5d‐versionseq‐5d‐languagesavailable‐ver‐sionshtml
EvansCJLeeAJAllanPLRuckleyCVampFowkesFG(2014)Incidence and risk factors for venous reflux in the general pop‐ulation Edinburgh Vein Study European Journal of Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
Food and Drug Administration (FDA) (2009) Guidance for IndustryUse inMedical ProductDevelopment to Support LabellingClaimsGuidance for Industry (December) 1ndash39 httpswwwfdagovDrugsGuidanceComplianceRegulatoryInformationGuidancesde‐faulthtm
FranzAampWann‐HanssonC(2015)Patientsrsquoexperiencesoflivingwithvaricose veins and management of the disease in daily life Journal of Clinical Nursing 25(5ndash6)733ndash741
GadMASaberAampHokkamEN(2012)Assessmentofcausesandpatterns of recurrent varicose veins after surgeryNorth American Journal of Medicine amp Science 4(1) 45ndash48 httpsdoiorg1041032F1947‐2714929051041031947‐271492905
GarrattAMMacdonaldLMRutaDARussellITBuckinghamJKampKrukowskiZH(1993)TowardsmeasurementofoutcomesforpatientswithvaricoseveinsQual Health Care 2 5ndash10
GuexJJZimmetSEBoussettaSNguyenCampTaiebC(2007)Construction and validation of a patient‐reported outcome dedi‐catedtochronicvenousdisordersSQOR‐V (specificqualityof lifeand outcome responsemdashvenous) Journal Des Maladies Vasculaires 32(3)135ndash147
Health and Social Care Information Centre (HSCIC) (2016) SpecialTopic A study on varicose vein treatments Patient ReportedOutcome Measures (PROMs) in England httpcontentdigi‐tal nhsukcataloguePUB19984proms‐spec‐topi‐vari‐vein‐trtm‐2009‐15pdf
HealthQualityOntario(HQO)(2011)Endovascularradiofrequencyab‐lationforvaricoseveinsAnevidence‐basedanalysisOntario Health Technology Assessment Series 11(1)1ndash93
Higgins J P T amp Green S (2011) (Eds) Cochrane Handbook for Systematic Reviews of Interventions Version 510 [updated March2011]TheCochraneCollaborationAvailablefromwwwhandbookcochraneorg
HudsonBFOgdenJampWhiteleyMS(2015)Athematicanalysisofexperiencesofvaricoseveinsandminimallyinvasivesurgeryunderlocal anaesthesia Journal of Clinical Nursing 24(11‐12)1502ndash1512httpsdoiorg101111jocn12719
KahnSRMLanCELampingDLKurzXBeacuterardAAbenhaimLAfortheVEINESStudyGroup(2004)Relationshipbetweenclinicalclassificationofchronicvenousdiseaseandpatient‐reportedqualityof life results from an international cohort study Journal of Vascular Surgery 39823ndash828
LeeA JRobertson LABoghossian SMAllanP LRuckleyCV Fowkes F G amp Evans C J (2015) Progression of varicoseveinsandchronicvenousinsufficiencyinthegeneralpopulationinthe Edinburgh Vein Study Journal of Vascular Surgery Venous and Lymphatic DisordersJan313(1)18ndash26
Lim C S Gohel M S Shepherd A C amp Davies A H (2010)SecondarycaretreatmentofpatientswithvaricoseveinsinNationalHealth Service England at least how it appeared on a NationalHealth Service website Phlebology 25(4) 184ndash189 httpsdoiorg101258phleb2009009035
Marsden G Perry M Kelley K amp Davies A H amp GuidelineDevelopment Group (2013) Diagnosis and management of vari‐coseveinsinthelegssummaryofNICEguidanceBMJ 347f4279httpsdoiorg101136bmjf4279
MoherD LiberatiA Teetzlaff JampAltmanDG (2009)Preferredreporting items for systematic reviews and meta‐analyses ThePRISMA statement Journal of Clinical Epidemiology 62(10) 1006ndash1012httpsdoiorg101016jjclinepi200906005
NationalInstituteforHealthandCareExcellence(NICE)(2013)Varicose veins in the legs The diagnosis and management of varicose veins LondonNICEwwwniceorgukCG168
NelzenO(2008)PrevalenceofvenouslegulcerTheimportanceofthedata collection method Phlebolymphology 15(4)143ndash150
PalfreymanSJDrewery‐CarterKRigbyKMichaelsJAampTodAM(2004)VaricoseveinsAqualitativestudytoexploreexpectationsand reasons for seeking treatment Journal of Clinical Nursing 13(3)332ndash340httpsdoiorg101046j1365‐2702200300840x
PalfreymanSJampMichaelsJA(2009)Asystematicreviewofcom‐pressionhosieryforuncomplicatedvaricoseveinsPhlebology 24(1_suppl)13ndash33httpsdoiorg101258phleb200909s003
Paty J Turner‐Bowker D M Elash C A ampWright D (2016) TheVVSymQreg instrument Use of a new patient‐reported outcomemeasureforassessmentofvaricoseveinsymptomsPhlebology 31 481ndash488httpsdoiorg1011770268355515595193
Robertson L A Evans C J Lee A J Allan P L Ruckley C V ampFowkesFGR(2016)Incidenceandriskfactorsforvenousrefluxin the general population Edinburgh vein study European Journal for Vascular and Endovascular Surgery 48(2) 208ndash214 httpsdoiorg101016jejvs201405017
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720
emspensp emsp | emsp1099LUMLEY Et aL
SheffieldTeachingHospitalsNHSFoundationTrust(2011)InformationforpatientsndashrecurrentvaricoseveinsRetrievedfromhttpswwwsthnhsukclientfilesFilepd2958_RecurrentVaricoseVeinspdf
Shingler S Robertson L Boghossian S amp Stewart M (2013)Compression stockings for the initial treatment of varicose veinsin patients without venous ulceration Cochrane Database of Systematic Reviews Issue 12 Art No CD008819 httpsdoiorg10100214651858CD008819pub3
ThomasJampHardenA(2008)Methodsforthethematicsynthesisofqualitative research in systematic reviews BMC Medical Research Methodology 8(1)45httpsdoiorg1011861471‐2288‐8‐45
Tong A Flemming K McInnes E Oliver S amp Craig J (2012)Enhancing transparency in reporting the synthesis of qualitativeresearch ENTREQ BMC Medical Research Methodology 12 181 httpsdoiorg1011861471‐2288‐12‐181
vanGroenendaelLJvanderVlietJAFlinkenfloumlgelLRooversEAvanSterkenburgSMMampReijnenM(2009)Treatmentof recurrent varicose veins of the great saphenous vein by con‐ventional surgery and endovenous laser ablation Journal of Vascular Surgery 50(5) 1106ndash1113 httpsdoiorg101016jjvs200906057
VascularDiseaseFoundation(2005)KeepinginCirculation5(2)1ndash2athttpwwwvasculardiseaseorgfilesv05‐n02‐kicpdf
VieraAJampGarrettJM(2005)Understandinginterobserveragree‐mentThekappastatisticFamily Medicine 37(5)360ndash363
Ware J EampSherbourneCD (1992) TheMOS36‐item short‐formhealthsurvey(SF‐36)IConceptualframeworkanditemselectionMedical Care 30473ndash483
Williams K Sansoni J Morris D Grootemaat P amp Thompson C(2016)Patient-reported outcome measures Literature review Sydney AustraliaACSQHC
Wong Y T (2016) Venous disease An Australian perspective In ADardik (Ed)Vascular surgery A global perspectiveNewHavenCTSpringer
SUPPORTING INFORMATION
Additional supporting information may be found online in theSupportingInformationsectionattheendofthearticle
How to cite this articleLumleyEPhillipsPAberABuckley‐WoodsHJonesGLMichaelsJAExperiencesoflivingwithvaricoseveinsAsystematicreviewofqualitativeresearchJ Clin Nurs 2019281085ndash1099 httpsdoiorg101111jocn14720