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7/25/2019 DISSERTATION Critical Review Assignment 1.docx
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HonoursProject MHB913252 S1218907
School of Health and
Social Care
Session 2015-2016
Student Matriculation Number: S1218907
P P di t
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Diabetic hot spots: can they bepredicted using temperature
monitoring tools andsubsequently prevent footulceration?
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ContentsAbstract.................................................................................................................
!ntroduction........................................................................................................... "
#ethodology.......................................................................................................... $
%indings............................................................................................................... 1
Discussion............................................................................................................2$
&onclusion........................................................................................................... '2
Ac(no)ledgements..............................................................................................''
*eference +ist...................................................................................................... '
Appendices..........................................................................................................'
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Abstract
Background
Diabetes affects 1 in 11 eo!e and t"is figure is rising raid!# $ t"e !e%e! of diabetic foot
u!ceration &a# a!so increase !acing "uge burdens on "ea!t"care and indi%idua!s' (reat
e&"asis is !aced on se!f$re%ention ractices) *it" te&erature &onitoring t"e ne*strateg# arising' +"e t"eor# is u!ceration is receded b# inf!a&&ation *"ic" cou!d be
&onitored using infrared t"er&o&eters to estab!is" areas of i&ending breakdo*n) gi%ing t"e
indi%idua! re&onition !ike o*ers regarding t"eir foot "ea!t" status' Ho*e%er e%en t"oug"
te&erature &onitoring is uti!ised in ot"er asects of diabetes care) it is not t"e case *it"
diabetic foot u!ceration current!#) *"ereb# no guide!ines are a%ai!ab!e'
,i&
+"erefore t"e ai& of t"is !iterature re%ie* is to assess *"et"er te&erature &onitoring is
fitting for foot ractice b# critica!!# araising current e%idence regarding *"et"er se!f$
te&erature &onitoringtoo!s suc" as infrared t"er&o&eters are effecti%e in redicting and
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onc!usion
4%era!! t"is critica! re%ie* "ig"!ig"ted t"at te&erature &onitoring is a ro&ising ad%ancing
tec"no!og# in "ea!t"care and "as "ad &ain!# ositi%e resu!ts regarding t"e re%ention of
diabetic foot u!ceration an area of increasing focus' Ho*e%er furt"er robust studies need to
take t"e net ste to suort t"ese current findings before suc" too!s are i&!e&ented in
ractice'
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Introduction
Diabetes) according to (a!e and ,nderson 62012 is a co&&on &etabo!ic condition
c"aracterised b# c"ronic "#erg!#cae&ia eit"er fro& a co&!ete !ack of insu!in kno*n as
t#e 1 or re!ati%e !ack of insu!in and increasing insu!in resistance t#e 2' t is a gro*ing
g!oba! issue *or!d*ide affecting a staggering 15 &i!!ion adu!ts 6nternationa! Diabetes
-ederation) 2015' Ho*e%er) t"is is redicted to rise to .2 &i!!ion b# 200' :it"in (reat
Britain) Diabetes ;< 62015 reorted 3'9 &i!!ion eo!e !i%e *it" diabetes *"ic" is redicted
to rise to 5 &i!!ion *it"in t"e decade' -urt"er&ore in Scot!and t"ere are 27.)30 eo!e *it"
diabetes $5'2= of t"e ou!ation> and .1)8.9 reside in (!asgo* 6Mc
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13)7. of t"e diabetic ou!ation "a%e reorted "a%ing a foot u!cer figures fro& (!asgo*
reresent roug"!# a /uarter of t"is tota! at 3)0.5 6Mc "ea!t"care "as s"ifted to Fre%ention is t"e best cureC as art of
"ea!t" ro&otion !ans' +"e &ain current re%entati%e strategies insta!!ed inc!ude atient
education) se!f$insection) regu!ar foot screenings and risk stratification) odiatr# and MD+
inter%ention) /ua!it# aroriate foot*ear and ort"oses 6("os" and o!!ier) 2012'
, stud# b# ,r&strong and Ea%er# 61997 in%estigated t"e effecti%eness of te&erature too!s
i it i i d " !i f t" di b ti f t !i ti " " t
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Methodology
4ctober 2015 brainstor&ing surrounding D-; e&"asised t"e i&act on indi%idua!s)
odiatrists) t"e "ea!t" ser%ice and otentia! ser%ice i&ro%e&ents regarding indicati%e
re%entati%e &easures 6figure 1' +"is faci!itated concetua!isation of t"e researc" toic'
nitia! bro*sing ensued to ea&ine re!i&inar# !iterature 6tab!e 1' , researc" /uestion *ast"en estab!is"ed ,%e#ard 62010 states researc" /uestions focus an initia! "#ot"esis) *"ic"
once ans*ered s"ou!d i&ro%e atient care t"roug" infor&ed reco&&endations and suerior
understanding of t"e subject area o*ing to e%idence based ractice 6BP' +"e P4 too!
de%e!oed t"e researc" /uestion does t"e use of se!f$te&erature &onitoring too!s suc" as
infrared t"er&o&eters 6inter%ention) effecti%e!# redict and subse/uent!# re%ent t"e
de%e!o&ent of foot u!cers 6outco&e in diabetic atients 6ou!ation co&ared to eisting
standard re%entati%e &easures 6co&arison +"e P4 design i&ro%es detection of "ig"
/ua!it# e%idence) faci!itates structured researc" and breakdo*n of t"e /uestion into four
easi!# identifiab!e asects for efficient recise searc"ing 6,s!a& A &&anue!) 2010'
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-igure 1 nitia! Brainstor& Mind&a 6eferences can be found in ,endi 1
Page | 0
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+ab!e 1 nitia! Bro*se
Research Topic Initial Terms Site Papers Returned;ti!ising
te&erature
&onitoring as a
diagnostic
re%entati%e too!
for diabetic foot
u!ceration'
Ite&erature
&onitoringJ
,D
Idiabetic foot
u!cerationJ
a'(; Disco%er a. )082
b.28)000 Kie!ded too &an# non$acade&ic
and irre!e%ant resu!ts
c.19)00
b'(oog!e
c'(oog!e
Sc"o!ar
S( (uide!ines
62013
(uide!ine 11. Manage&ent of Diabetes
Mini&a! guidance on re%entati%e &easures for u!ceration)
on!# foot*ear and ort"oses &entioned'
Patient education is reco&&ended'
+"er&o&etr# can be used to identif# "arcot) and t"en can be
used to &onitor ost diagnosis "arcot disease acti%it#treat&ent as tota! contact casting of affected !i&b s"ou!dcoincide *it" te&erature reduction'
$!acking guidance in re%enting and diagnosing areas of foot
u!ceration'
(uide!ines
62015
( 19 Diabetic -oot Prob!e&s re%ention and &anage&ent
(uidance surrounding re%enting diabetic foot rob!e&s b#
i t" f t ! ! f t" 6 i t !
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, !iterature searc" 6tab!e 2 *as undertaken ear!# o%e&ber 2015 insecting funda&enta!
acade&ic databases> ,MD) ,HE) MDE and Hea!t" Source *ere a!! searc"edsi&u!taneous!# %ia BS4 Host *it" du!icates re&o%ed' oc"rane Eibrar#) ProOuest and
:eb of Science *ere searc"ed searate!# 6,endi 2' Main searc" ter&s inc!uded
Ite&erature &onitoringJ) I"and"e!dJ) IredictingJ) Ire%entingJ) Idiabetic foot u!cerationJ
and suitab!e s#non#&s' Boo!ean oerators and truncation #ie!ded focused roducti%e resu!ts'
efine&ent inc!uded !i&iting ub!ication dates to *it"in 200$2015 $ it *as noted during
initia! researc" &u!ti!e studies *ere conducted broad!# on t"is subject fie!d o%er 1980s$
1990s) succeeded b# a !iterature ga unti! &id$2000s *"en interest sarked again' +"erefore
t"e decision *as &ade to generate t"e &ost recent) udated !iterature for araisa!> "oefu!!#
attaining &ore re!e%ant conc!usions'
Searc" resu!ts *ere e%a!uated and studies inc!uded if t"e# &et redefined e!igibi!it# criteria
6tab!e 3' +"ereafter four studies resided) &anua! searc"ing of references *as undertaken
ensuring otentia! re!e%ant artic!es *ere not o%er!ooked' +"is re%ea!ed su!e&entar# studies>
"o*e%er t"ese *ere t"en discarded after a!#ing suc" criteria'
Eiterature araisa! t"e S( 62015a a!gorit"& for c!assif#ing stud# design for /uestions of
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+ab!e 2 Eiterature Searc" Strateg#
Searchterms
temperature monitoring OR thermometry OR skin temperature OR temperature ttemperature regulation ORinfrared thermometry
AND
selfmonitoring OR selfassessment OR home monitoring OR handheld
AND
dia!etic foot ulceration OR D"# OR foot ulcer OR foot complication OR dia
ulcers OR dia!etic $ound ANDpre%ention OR prediction
Data!ases
searched
,MD) ,HE) oc"rane Eibrar#) MDE) Hea!t" Source ursingN,cade&ic dition) ProOuest
Hea!t" and Medica! o&!ete) ProOuest ursing and ,!!ied Hea!t" Source) :eb of Science
Part of&ournals
searched
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+ab!e 3 e%ie* !igibi!it# riteria
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Findings
Eiterature (at"ering esu!ts
Succeeding t"e !iterature searc") o%er four "undred artic!es *ere gat"ered for screening and
aers di&inis"ed unti! t"e fina! four artic!es re&ained as in figure 2' +"oroug" !iterature
re%ie* tab!es can be found in ,endi ' ,!! four studies 6Ea%er# et a!) 200> Ea%er# et a!)
2007> ,r&strong et a!) 2007> Skafje!d et a!) 2015 *ere rando&ised contro!!ed tria!s 6+s'
,ccording to Sto!berg) or&an and +ro 6200) +s are regarded as t"e strongest t#e of
e%idence> t"e# are designed to "a%e a !o* robabi!it# of bias and !ess &et"odo!ogica! errors
6Burns) o"ric" and "ung) 2011'
Stud# esu!ts
+ab!e 3 dis!a#s secific stud# resu!ts' +"ree studies 6Ea%er# et a! 200> Ea%er# et a! 2007>
,r&strong et a! 2007 found statistica!!# significant reduced u!cer incidence rates in t"e
inter%ention co&ared to contro!s indicating se!fassess&ent infrared t"er&o&eters
secifica!!# +e&+ouc" 6figure 3 aears to be an effecti%e co&!e&entar# too! to standard
D-; H " fi ! d d fi di 6Sk fj !d !
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-igure 2 PSM, -!o* Diagra&
ecords identified t"roug"
database searc"ing
,MD) ,HE) Hea!t" Source)MDE 6n 78
oc"rane Eibrar# 6n
ProOuest Hea!t" $ ursing and,!!ied Hea!t" 6n 28
:eb of Science 6n .3
,dditiona! records identifiedt"roug" ot"er sources
6n10
$eference Eists
ation
Overall Total
= 439
ecords ec!uded after screeningtit!e andNor abstract
6n205
on +s 698
Eetters to t"e aut"or or eert
co&&entaries 61.
NM i i !
ning
ecords after du!icates re&o%ed
6n 393
d d
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+ab!e Studies esu!ts
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-igure 3 +e&+ouc" De%ice
Ea%er# 62007
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,rtic!es *i!! be t"e&atica!!# discussed to ro%ide a concise) s#nt"esised re%ie* of stud#
features' +"e&es *ere identified as areas of notab!e discussion b# t"e re%ie*er> "o*e%er t"is
is b# no &eans abso!ute'
Pri&ar# 4utco&e Measure
Positi%e!#) a!! four studies &easured t"e sa&e ri&ar# c!inica! outco&e foot u!cer incidence $articiants eit"er did or did not de%e!o a D-; 6dic"oto&ous outco&e t"roug"out t"e stud#
course' Ho*e%er) %ariation occurred regarding &et"ods of &easuring u!ceration) *"ic" !i&its
direct co&arison bet*een t"e studies 6Eiberati et a!) 2009' :"i!st) 62015 e&"asise
ractitioners s"ou!d use a standardised diagnostic s#ste& to ensure neutra!it#> t*o studies
6Ea%er# et a!) 200> ,r&strong et a!) 2007 used no or unsecific criteria for u!cerc!assification oor objecti%it#' ncouraging!# t"e re&aining t*o studies 6Ea%er# et a!)
2007> Skafje!d et a!) 2015 uti!ised uni%ersa!!# estab!is"ed *ound grading s#ste&s +"e
;ni%ersit# of +eas :ound !assification 6;+ and :agner ;!cer !assification 6:
resecti%e!#' Mu!ti!e studies 64#ibo et a!) 2001> (u! et a!) 200. coå t"e t*o s#ste&s
f d b " i ! ! i id f " i d " i f i ki i
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reduce genera!isabi!it# of t"e findings'n t"ree aers 6Ea%er# et a!) 200> ,r&strong et a!)
2007> Skafje!d et a!) 2015) articiants "ad to be eit"er risk grou 2Q or 3 according to t"e
nternationa! :orking (rou on t"e Diabetic -oot c!assification too! 6tab!e 5' t is i&ortant
to note t"an in one stud# 6Skafje!d et a!) 2015> articiants "ad to be eager to &onitor foot
skin te&erature) t"erefore introducing a sa&!e se!ection bias and reducing t"e eterna!
%a!idit# of t"is tria! 6Po!gar A +"o&as) 2013'
+ab!e 5 nternationa! :orking (rou on Diabetic -oot isk !assification S#ste& 6Bus et a!
62015
Risk +roup ,lassification Risk "actors Present
0 o eri"era! neuroat"#
1 Peri"era! neuroat"#
2 Peri"era! neuroat"# *it" eri"era! arteria! disease 6P,DQ andNor a foot
defor&it#
3 Peri"era! neuroat"# and a "istor# of foot u!ceration or !o*er etre&it#
a&utation
,!! studies ec!uded acti%e u!ceration) infection and "arcot art"roat"# as *e!! as oen
i i "i " !d i ki " i i
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Stud# Met"ods
Sample Size, Justification, and Drop-out:
t is i&ractica! and cost!# to stud# entire target ou!ations $ researc"ers in%estigate
reresentati%e sa&!es and atte&t to genera!ise t"e findings' +"erefore se!ecting an
aroriate sa&!e si?e is i&ortant> in "ea!t" researc" it is i&!ied t"ere is no oti&a!
nu&ber 6Po!gar A +"o&as) 2013' ,!t"oug" genera!!#) !arger sa&!e si?es roduce &ore
accurate resu!ts and ac"ie%es "ig"er o*er' Sa&!e si?es *ere di%erse> t*o studies 6Skafje!d
et a!) 2015 and Ea%er# et a!) 200 "ad notab!# fe*er articiants of 1 and 85) *"i!st t"e
re&aining studies 6Ea%er# et a!) 2007 and ,r&strong et a!) 2007 "ad 173 and 225
resecti%e!# cu&u!ating to 52' 4n!# t"e t*o !arger studies ro%ided justification of
deter&ined sa&!e si?e and increases robustness of t"ese tria!s 6Ea%er# et a! A ,r&strong et
a! 2007' +"e for&er c"ose a o*er of 80= to #ie!d .0 subjects er grou *it" t"e ai& t"at
55 *ou!d co&!ete t"e stud# after accounting for an eected 10= dro out rate' Ho*e%er
t"is target *as not &et eac" treat&ent ar& a!!ocated fe*er t"an .0 articiants and o%era!!
t"e stud# droout rate *as 12'71=) *it" indi%idua! grou droout rates ca!cu!ated "ig"er
t"an anticiated suggesting t"e stud# &a# be s!ig"t!# undero*ered to detect a significant
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-igure Droout Statistics and Rustifications
12',
"/$0
1
a!ery et al "200#$
%ro& 'ut (ercentage ")$
-ustifications and "igures +roup
n%o!untar# :it"dra*a! o!untar# :it"dra*a!
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,
1
1,
2
(a%ery et al 178865
Drop Out Percentage 19 5
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,
11,
S*af+eld et al "2015$
%ro& 'ut (ercentage ")$
-ustifications and "igures +roup
Total
n%o!untar# :it"dra*a! o!untar# :it"dra*a!
o secified reasons
Droout !!ness
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Randomisation, roup !llocation, "oncealment and #lindin$:
,!! studies stated rando&isation *as erfor&ed> "o*e%er Ea%er# et a! 6200 ro%ided no
furt"er infor&ation) t"us t"e reader cannot be certain t"is *as tru!# undertaken' 4ne stud#
Skafje!d et a! 62015 erfor&ed b!ock rando&isation and in addition) atients *it" re%ious
"arcot art"roat"# *ere stratified' +"e re&aining studies erfor&ed si&!e rando&isation
6,r&strong et a!) 2007 A Ea%er# et a!) 2007 b# generated rando&ised !ists> secifica!!# %ia
t"e stud# biostatistician *"o se/uentia!!# assigned atients and co&uter generated
resecti%e!# t"e !atter t"erefore reduces t"e risk of "u&an error and bias' ,dditiona!!# t"is
*as t"e on!# stud# to address rando&isation concea!&ent *"ereb# a!!ocation *as sea!ed in
oa/ue en%e!oes) t"is is a ositi%e asect as a!!ocation concea!&ent is critica! and inf!uences
success of rando&isation 6iera and Bangdi*a!a) 2007) as its absence can !ead to se!ection
bias' ,s Doig and Si&son 62005 "ig"!ig"ted) %ague or unsatisfactor# concea!&ent &et"ods
can roduce 0= greater biased esti&ates of treat&ent effect' egarding grou a!!ocation)
articiants *ere rando&ised e/ua!!#' Ho*e%er) ,r&strong et a! 62007 did not disc!ose
grou sa&!e figures) t"erefore it is unkno*n "o* &an# subjects *ere in eac" grou or if
t"ere *as a ossib!e a!!ocation bias 6as t"is *as t"e stud# rando&ised %ia t"e stud#
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studies is foot u!cer incidence *"ic" is infre/uent and transient) !onger fo!!o* u eriods 6@ 1
#ear *ou!d be referred and is ac"ie%ed b# t"ree studies'
Stud# Design
#aseline "(aracteristics
Positi%e!# a!! four studies resented tab!es according to t"e &et"odo!ogica! guide!ines
4S4+ 2010 State&ent ) *"ic" "ig"!ig"ted stud# treat&ent grous *ere co&arab!e in
base!ine c"aracteristics) *it" Ea%er# et a! 62007 and Skafje!d et a 62015 ro%iding &ore
etensi%e infor&ation' +"ree studies 6Ea%er# et a!) 200> ,r&strong et a!) 2007> Skafje!d et a!
2015 carried out significance testing of base!ine de&ogra"ics desite t"is being ad%ised
against b# t"e 4S4+ grou as being inessentia! and decei%ing dissi&i!arit# regarding
base!ine c"aracteristics are a conse/uence of c"ance rat"er t"an bias 6Mo"er et a!) 2010'
"ontrol "lassification
ac" stud# can be c!assified as acti%e 6ositi%e contro!!ed tria!s consisting of eisting
standard re%entati%e t"era#' ,ccording to Mi!!er and Brod# 62002 and S( 6201 t"is is
fa%ourab!e and ensures studies are &ora!!# sound> if ro%en effecti%e standard t"era# eists
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4utco&e Statistics and ,na!#sis
-or ana!#ses) a!! studies used significance !e%e!s e/ua! to 0'05 or !ess and ro&inent!#
reorted $%a!ues in t"eir resu!ts' :"i!st P %a!ues eress *"et"er an effect eists> it does not
identif# t"e &agnitude of suc" effect' +"erefore in /uantitati%e studies) *"i!st %a!ues
6statistica! significance re&ain essentia!) t"e effect si?e 6substanti%e significance s"ou!d be
t"e funda&enta! finding 6Su!!i%an A -einn) 2012' +"ree studies 6Ea%er# et a! 200> Ea%er#
et a! 2007> ,r&strong et a! 2007 used an indirect &easure of effect si?e kno*n as odds ratios
64 regarding u!cer incidence> a!t"oug" t"is *as not e!icit!# stated 6tab!e .' 4s are
effecti%e *"en outco&es are dic"oto&ous as in t"is case) but genera!!# are uti!ised in case
contro! studies' e%ert"e!ess !iterature 6
"o*e%er 4s can inf!ate effect si?es and are difficu!t to interret b# t"e ub!ic) ractitioners
and e%en researc"ers) t"erefore s"ou!d on!# be reorted if acco&anied b# accurate
c!arification of i&!ication *"ic" *as not t"e case "ere t"us s"ou!d be interreted *it"
caution'
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+ab!e . ffect Si?es
Stud# Statistica! ,na!#sis nterretation
Ea%er# et a!
6200
n"anced t"era# %ersus standard t"era# odds of
de%e!oing foot co&!ication
4 10'3 !arge effect si?e
onfidence inter%a! 61'2$85'3 :idt" 8'1
n"anced t"era# ten ti&es !ess !ike!# to u!cerate co&ared to
standard t"era#'
,s t"e confidence inter%a! does not contain t"e %a!ue of no
effect 64 1) t"en it can be conc!uded t"ere is a statistica!!#
significant corre!ation'
S&a!!er studies usua!!# "a%e *ider confidence inter%a!s and t"is
is t"e s&a!!est of t"e t"ree studies'
Ho*e%er) *ide confidence inter%a! indicates t"e recision of
effect is actua!!# unkno*n and &ore infor&ation is re/uired
e%en t"oug" t"e odds ratio suggests itCs a !arge effect'
Ea%er# et a!
62007
n"anced t"era# %ersus standard t"era# odds of
de%e!oing foot u!ceration
4 '8 &ediu& effect si?e
onfidence inter%a! 61'53$13'1
:idt" 11'.1n"anced t"era# %ersus structured t"era# odds of
de%e!oing foot u!ceration
4 '71 &ediu& effect si?e
onfidence inter%a! 61'.0$13'85
:idt" 12'25
ti&es !ess !ike!# of u!cerating in t"e en"anced t"era# t"an
bot" standard t"era# and structured t"era#'
,s t"e confidence inter%a! does not contain t"e %a!ue of no
effect 64 1) t"en it can be conc!uded t"ere is a statistica!!#
significant corre!ation'
,r&strong n"anced t"era# %ersus standard t"era# odds of n"anced t"era# grou are t"ree ti&es !ess !ike!# to u!cerate
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:"ereas t"e fina! fourt" stud# conducted b# a!ternate aut"ors did not identif# an# statistica!
significance in foot u!cer occurrence bet*een grous'
%iscussion
+"ese resu!ts "a%e etended e%idence) ackno*!edging an interesting !ink regarding raised
te&eratures being indicati%e of i&ending u!ceration and t"at statistica!!# confident
corre!ations &a# eist bet*een uti!ising infrared t"er&o&eters and reduced u!cer incidence)
suorting its use as an ad%antageous adjuncti%e t"era# to eisting t"eraies' e%ert"e!ess)
suboti&a! reorting of %ita! infor&ation or &et"odo!ogica! rocedures a&ong t"e studies
*as a consistent issue' ;nderstandab!# t"is rendered t"e re%ie*er uncertain of bias reducing
asects *"ic" *ere dee&ed to "a%e occurred oor!# or not at a!! i&!#ing reduced interna!
%a!idit#' Ho*e%er) a stud# b# De%ereau et a! 6200 e%a!uated !e%e!s of non$reorted
rocedures to actua! rocedure occurrence !e%e!s in +s and conc!uded readers s"ou!d not
&ake assu&tions regarding non$reorted content' +"is cou!d be a !i&itation of t"e
researc"er) s"o*casing "aste and ineerience' egard!ess c!inicians re!# on ab!# conducted
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"o&e> it *ou!d be beneficia! and uti!ised dai!#' ,!t"oug" t"is cannot be direct!# transferab!e
to +e&+ouc") it reresents initia! inc!ination t"is is an area atients are eager to see
de%e!oed'
(a!e and ,nderson 62012 "ig"!ig"ted &an# s#c"osocia! i&!ications of DM> &ost eo!e
undergo fee!ings of !earned se!f$"e!!essness) o*er!essness or condition consu&tion at
stages and &a# suffer fro& &enta! i!! "ea!t" $ diabetes is !inked to increased risk of
deression' +"is is often associated *it" oorer "#sica! outco&es and &a# create resistance
to or i&act a ersonCs abi!it# to se!f$&anage' F4n t"e ot"er footC) t"is too! "as an oortunit#
if i&!e&ented *it" t"e rig"t rofessiona! suort to integrate &enta! and "#sica! "ea!t" b#
ro&oting se!f$care and atient e&o*er&ent as Diabetes Scot!and 62015 noted) eo!e
need to fee! &enta!!# e&o*ered to go%ern t"eir "#sica! diabetes'
!inica! &!ications
*odiatr+ and ulti-*rofessional "ontet
+*o inc!uded studies "ig"!ig"ted atients using +e&+ouc" contacted stud# ersonne! &ore
fre/uent!# regarding increased te&eratures) c!inica!!# t"is cou!d transfer to increased
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T U.$.. &i!!ion
HonoursProject MHB913252 S1218907
Hb,1c scores' t &a# a!so be usefu! in inatient settings *"ere !ess t"an "a!f of ad&issions
recei%e foot screening and 1'= of diabetic inatients de%e!o ne* foot !esions 6Hea!t" and
Socia! are nfor&ation entre) 201' urses cou!d &onitor atientCs te&erature for
i&ending u!ceration furt"er i&ro%ing foot c"ecks as art of t"e nationa! inatient
initiati%e of t"e FP for -eetC ca&aign b# t"e Scottis" Diabetes -oot ,ction (rou 6+"e
Scottis" (o%ern&ent) 201'
"ost "onsiderations
egarding "ea!t" econo&ics) +e&+ouc" roug"!# costs V150 or U103 according to Mcurd#
62008' t genera!!# aears to be a !o* cost diagnostic re%entati%e de%ice t"at cou!d be used
as an adjunct *it" standard re%entati%e &easures a%ai!ab!e at t"e HSCs disosa!) co&ared
to t"e eense of u!ceration and a&utation 6-igure '
-igure ,%erage HS osts of Diabetic -oot o&!ications
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&essaging *i!! reduce D-;s and i&ro%e co&!iance' esu!ts of t"ese tria!s are due to be
ub!is"ed in 2018 and 2017 resecti%e!#' t is e%ident t"is is an ad%ancing researc" area *it"
oortunit# for de%e!o&ent and in%est&ent'
%uture )nnovations
+"e Scottis" (o%ern&ent 6201 "ig"!ig"ted its riorit# to i&ro%e de%e!o&ent of
inno%ati%e too!s for diabetes care' 4ne roosa! cou!d be for t"e concets of t*o different
t#es of te&erature &onitoring to &erge de%ices enco&assing E+ t"er&ogra"s) *"ere
atients stand on a t"er&a! !ates or sensors in s"oes to generate fu!! foot genera! %isua!
i&ages) fo!!o*ed b# &ore recise t"er&o&etr# of "ot sots *"ere actua! te&erature figures
are &easured to ro%ide &ore co&re"ensi%e &onitoring'
urrent e%ie* Ei&itations
,ccess to certain journa!s *as restricted) t"erefore fu!! scoe of !iterature *as una%ai!ab!e>
cannot be sure a!! re!e%ant e%idence *as inc!uded' -urt"er&ore) !iterature *as !i&ited to
ng!is" !anguage due to t"e uni!ingua! interreter' e%ie*er ineerience in researc" and
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Conclusion
urrent!# t"ere are no guide!ines surrounding te&erature &onitoring for diabetic foot
u!ceration t"erefore it is not used routine!# b# atients or t"e HS> "o*e%er t"is re%ie*
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Ac*no,ledgeents
*ou!d !ike to eress gratitude to suer%isor Professor Stuart Baird for "is guidance)
ad%ice) inte!!ectua! discussions) reassurance and atience regarding t"is roject' *ou!d a!so
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,MS+4() D'(' et a!') 1997' nfrared Der&a! +"er&o&etr# for t"e Hig"$isk Diabetic
-oot'*(+sical T(erap+Won!ineX' 6662) ' 1.9$175' W%ie*ed 12 Ranuar# 201.X' ,%ai!ab!e
fro& "ttNNtjourna!'ata'orgNcontentN77N2N1.9'!ong
,MS+4() D'(' et a!') 200' ariabi!it# in ,cti%it# Ma# Precede Diabetic -oot
;!ceration'Dia.etes "areWon!ineX' 7668) ' 1980$198' W%ie*ed 21 -ebruar# 201.X'
,%ai!ab!e fro& "ttNNcare'diabetesjourna!s'orgNcontentN27N8N1980'fu!!
,MS+4() D'(' et a!') 2007' Skin +e&erature Monitoring educes t"e isk for
Diabetic -oot ;!ceration in Hig"$isk Patients' T(e !merican Journal of edicineWon!ineX'
;7862) ' 102$10.' W%ie*ed 10 o%e&ber 2015X' ,%ai!ab!e fro&
"ttNN***'a&j&ed'co&Nartic!eNS0002$93360700739$5Ndf
,MS+4() D'(' A E,K) E',' 1997' Monitoring "ea!ing of acute "arcotCs
art"roat"# *it" infrared der&a! t"er&o&etr#'Journal of Re(a.ilitation Researc( and
DevelopmentWon!ineX' ./63) ' 317$321' W%ie*ed 12 Ranuar# 201.X' ,%ai!ab!e fro&
"ttNN***'re"ab'researc"'%a'go%NjourN97N3N3NdfNar&strong'df
,MS+4() D'(') E,K) E',' A H,
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W%ie*ed 12 Ranuar# 201.X' ,%ai!ab!e fro&
"ttNNcare'diabetesjourna!s'orgNcontentN17N8N835'abstract
B4;E+4) ,'R'M' et a!') 2005' +"e g!oba! burden of diabetic foot disease' +"e Eancet
Won!ineX' 3.. 6998) ' 1719$172' W%ie*ed 1 Ranuar# 201.X' ,%ai!ab!e fro&
"ttNN***'sciencedirect'co&NscienceNartic!eNiiNS010.73.05.7.982
B;S) P'B') 4HH) 'R' A H;()
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D4() ('S' A SMPS4) -' 2005' ando&i?ation and a!!ocation concea!&ent a ractica!
guide for researc"ers'Journal of "ritical "areWon!ineX' 7862) ' 187$191' W%ie*ed 30
Ranuar# 201.X' ,%ai!ab!e fro&
"ttNN***'sciencedirect'co&NscienceNartic!eNiiNS0883910500020
D;() +' A :,D) () 2008' Managing !inica! Prob!e&s in Diabetes' 4ford
B!ack*e!! Pub!is"ing'
DM4DS) M'' A -4S+) ,''M') 201'ana$in$ t(e Dia.etic %oot' 3rded' :est
Susse Ro"n :i!e# A Sons Etd'
-,D) ,'S') SM,E],DH) M' A E,R,) B' 2007' ,ssess&ent and +reat&ent of
Diabetic -oot ;!cer')nternational Journal of "linical *racticeWon!ineX'
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(,E) ','M') A ,DS4) R'') 2012' Diabetes &e!!itus and ot"er disorders of
&etabo!is&' n
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201.X' ,%ai!ab!e fro& "ttNN***'consort$
state&ent'orgNMediaNDefau!tNDo*n!oadsN4S4+=202010=20!anation=20and
=20!aboration=206BMR'df
M4E,) -'R') H;++4) B' A -(;SS4) D' 2008' Does ana!#sis using I!ast
obser%ation carried for*ardJ introduce bias in de&entia researc" "anadian edicine
!ssociation JournalWon!ineX' ;6=68) ' 751$753' W%ie*ed -ebruar# 201.X' ,%ai!ab!e
fro& "ttNN***'ncbi'n!&'ni"'go%N&cNartic!esNPM2553855N
,+4,E S++;+ -4 H,E+H ,D , EE WX) 2015'
Dia.etic %oot *ro.lems: prevention and mana$ementWon!ineX' ationa! nstitute for Hea!t"
and are ce!!ence' W%ie*ed 21 Dece&ber 2015X' ,%ai!ab!e fro&
"ttNN***'nice'org'ukNguidanceNng19Nc"aterNintroduction
,+4,E S++;S 4- H,E+H) 1999'Researc( )nvolvin$ )ndividuals &it(
>uestiona.le "apacit+ to "onsent: *oints to "onsiderWon!ineX' ationa! nstitutes of Hea!t"'
W%ie*ed 30 Ranuar# 201.X' ,%ai!ab!e fro&
"ttNNgrants'ni"'go%NgrantsNo!ic#N/uestionab!ecaacit#'"t&
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P4E(,) S' A +H4M,S) S',') 2013')ntroduction to Researc( in t(e 1ealt( Sciences
Won!ineX' .t"ed' dinburg" "urc"i!! Ei%ingston' W%ie*ed 17 Ranuar# 201.X' ,%ai!ab!e fro&
"ttsNN***'da*sonera'co&Nreadon!ineN97807020..98
P,+4) R' et a!') 2011' ffecti%eness of inso!es used for t"e re%ention of u!ceration in t"e
neuroat"ic diabetic foot a s#ste&atic re%ie*'Journal of Dia.etes and its "omplications
Won!ineX' 7461) ' 52$.2' W%ie*ed 7 -ebruar# 201.X' ,%ai!ab!e fro&
"ttNN***'sciencedirect'co&NscienceNartic!eNiiNS105.872709000932
P4S++) R' A -,
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nterco!!egiate (uide!ines et*ork' W%ie*ed 7 Dece&ber 2015X' ,%ai!ab!e fro&
"ttNN***'sign'ac'ukNdfNsign11.'df
S4++SH +4EE(,+ (;DES +:4< WS(X) 201' S)5 7: !
$uideline developer;s (and.ooWon!ineX' dinburg" Scottis" nterco!!egiate (uide!ines
et*ork' W%ie*ed 1 -ebruar# 201.X' ,%ai!ab!e fro& "ttNN***'sign'ac'ukNdfNsign50'df
S4++SH +4EE(,+ (;DES +:4< WS(X) 2015a'
et(odolo$ical *rinciplesWon!ineX' Scottis" nterco!!egiate (uide!ines et*ork' W%ie*ed 1.
Dece&ber 2015X' ,%ai!ab!e fro& "ttNN***'sign'ac'ukN&et"odo!og#Ninde'"t&!
S4++SH +4EE(,+ (;DES +:4< WS(X) 2015b' "ritical
!ppraisal: 5otes and "(eclistsWon!ineX' Scottis" nterco!!egiate (uide!ines et*ork'
W%ie*ed 1. Dece&ber 2015X' ,%ai!ab!e fro&"ttNN***'sign'ac'ukN&et"odo!og#Nc"eck!ists'"t&!
S4++SH +4EE(,+ (;DES +:4< WS(X) 2015c' S)5
radin$ S+stem 8999-6786Won!ineX' Scottis" nterco!!egiate (uide!ines et*ork' W%ie*ed 1.
Dece&ber 2015X' ,%ai!ab!e fro&
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S+SS) 'M' et a!') 198.' ;se of !i/uid cr#sta! t"er&ogra"# in t"e e%a!uation of t"e diabetic
foot'Dia.etes "areWon!ineX' =63) ' 2.7$272' W%ie*ed 12 Ranuar# 201.X' ,%ai!ab!e fro&
"ttNNcare'diabetesjourna!s'orgNcontentN9N3N2.7'abstract
S+4EB() H'4') 4M,) (' A +4P) ' 200' ando&i?ed ontro!!ed +ria!s' T(e
!merican Journal of Roent$enolo$+Won!ineX' ;3.6.) ' 1539$15' W%ie*ed 17 Dece&ber
2015X' ,%ai!ab!e fro& "ttNN***'ajron!ine'orgNdoiNdfN10'221Najr'183'.'01831539
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noug"'Journal of raduate edical ducationWon!ineX' /63) ' 279$282' W%ie*ed 1
-ebruar# 201.X' ,%ai!ab!e fro& doi
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"ttNN***'go%'scotNPub!icationsN201N11N.72N3
,) ,'R' A B,(D:,E,) S'' 2007' !i&inating Bias in ando&i?ed ontro!!ed
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62) ' 132$137' W%ie*ed 30 Ranuar# 201.X' ,%ai!ab!e fro&
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e $ S( Met"odo!ogica! ,raisa! of ,!! Studies "eck!ist and %idence (rading
Appendi* /0Eiterature e%ie* +ab!es
Appendi* 404S4+ 2010 "eck!ist
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63' :4;DS +,+4,E) 2013')nternational #est *ractice uidelines: 2ound
ana$ement in Dia.etic %oot 'lcersWon!ineX' :ounds nternationa!' W%ie*ed 22 4ctober
2015X' ,%ai!ab!e fro&
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6' (EP) H' A E,(,)
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=20inde=3,=20a=20=22roof=20of=20concet=22=20stud#=20to=20assess
=20*ound=20"ea!ing=20trajector#'Asage773Aages773$
9AsidBS4MDEAauB"arara=20M
611' E,K) E',' A ,MS+4() D'(' 2007' +e&erature Monitoring to ,ssess)
Predict and Pre%ent Diabetic -oot o&!ications' "urrent Dia.etes ReportsWon!ineX' 66.)
' 1.$19' W%ie*ed 22 4ctober 2015X' ,%ai!ab!e fro&
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=20&onitoring=20to=20assess=2=20redict=2=20and=20re%ent=20diabetic
=20foot=20co&!ications'Asage1.Aages1.$
9AsidBS4MDEAauEa%er#=20E,
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Appendi* 70%idence of Databases Searc"ed W,MD) ,HE) Hea!t" Source) MDEX
Page | 0
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Page | ,
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Appendi* 7 cont0 Woc"rane Eibrar#X
Page | ,1
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Page | ,2
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Appendi* 7 cont0 WProOuestX
Page | ,'
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Appendi* 7 cont0 W:eb of ScienceX
Page | ,
H j 9132 2 S121890
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Appendi* .a0S( !assif#ing Stud# Design for Met"odo!ogica! ,raisa! 6S() 2015a
Page | ,,
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Appendi* .!0S( Met"odo!ogica! ,raisa! "eck!ist for +s6S() 2015b
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Appendi* .c0S( (uidance otes for Met"odo!ogica! ,raisa! "eck!ist for +s
6S() 2015b
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Appendi* .d0S( (rading S#ste&6S() 2015c
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Appendi* .e0S( Met"odo!ogica! ,raisa! of ,!! Studies "eck!ist Wadated fro& aendi 3bX
Stud+ )dentification 0aver+ et al B6774C 0aver+ et al B677
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1'10 :"ere t"e stud# is carried out at &ore t"an
one site) resu!ts are co&arab!e for a!! sites
annot sa# annot sa# annot sa# ot a!icab!e
Section 2 4%era!! ,ssess&ent of t"e Studies
2'1 +aking into accountc!inica!
considerations)
#our e%a!uations of
t"e &et"odo!og#
used) and t"e
statistica! o*er of
t"e stud#) are #ou
certain t"e o%era!!
effect is due to t"e
stud# inter%ention
;ncertain oor&et"odo!ogica! rigour and
reorting of i&ortant asects'
S&a!! sa&!e si?e *it" no
justification ossib!# &a# be
undero*ered' Ho*e%er t"is
stud# "as an etre&e!# ositi%e
asect *"ic" differentiates it
co&ared to t"e ot"er studies'
(ra"s "ig"!ig"ting te&erature
differences bet*een t"e on!#subject *"o u!cerated and a
subject *"o did not u!cerate
*ere ro%ided' t can c!ear!# be
seen t"at t"e atient *"o
u!cerated) te&erature
differences bet*een rig"t and
!eft sites *ere &ore erratic and
continua!!# resented *it"
"ig"er te&eratures o%er a
eriod of ti&e at t"e site of
u!ceration "ig"!ig"ts
redicti%e asect of stud#'
Kes $ good &et"odo!ogica!rigour and &ost in$det"
reorting of stud# infor&ation'
Earge sa&!e si?e and
justification gi%en &a# "a%e
good o*er' !inica!!#)
inter%entions t"oroug"!# detai!ed
good grounds for reeatabi!it#'
,ddition of t"ird treat&ent ar&
did not i&act t"e resu!ts
significant!#) *as si&i!ar to t"econtro! and t"erefore strengt"ens
t"e difference identified bet*een
t"e inter%ention and contro!
grous'
o oor &et"odo!ogica! rigourand aut"or reorting of i&ortant
asects of t"e stud#) ossib!e bias
&ore e%ident' Eargest sa&!e si?e
is a ositi%e asect) grounds for
good o*er 225 subjects *ere
rando&ised) "o*e%er no
infor&ation regarding a!!ocation
grou si?e or dro outs' So&e
sa&!e si?e justification $ suggested
a sa&!e si?e of 70 er groua!t"oug" 225 subjects *ere
rando&ised nterretation of t"is
stud# is confusing and difficu!t
*"en ana!#sing stud# resu!ts'
nter%ention rotoco!s &ost si&i!ar
to Ea%er# et a! 6200 and as suc"
t"ese studies are &ore co&arab!e'
;ncertain ,ut"or reorti&et"odo!ogica! rigour *as
ade/uate) e%idence of ossi
!o* bias' S&a!!est sa&!e s
no justification suggests st
be undero*ered) a!t"oug"
a i!ot' n addition of t"eor
counse!!ing a!ongside infra
t"er&o&etr# in t"e inter%e
&akes it difficu!t to disting
resu!ts' ou!d t"e t"eor# bacounse!!ing actua!!# "a%e i
t"e resu!ts negati%e!# ,s t
t"e on!# stud# not to s"o*
statistica!!# suorti%e resu
regarding te&erature &on
,!so t"is asect &akes t"e
!ess co&arab!e to t"e ot"e
studies'
2'2 ,re t"e resu!ts of Patient (rou +argeted Patient (rou +argeted Patient (rou +argeted Patient (rou +argeted
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t"e stud# direct!#
a!icab!e to t"e
atient grou
targeted
Diabetics at "ig" risk of
!o*er etre&it#co&!ications
Kes) subjects recruited fro&
a "ig" risk c!inic
Diabetics c!assified as "ig" risk
for !o*er etre&it#co&!ications
Kes
Diabetics c!assified as "ig" risk for
!o*er etre&it# co&!ications o) !i&ited genera!isabi!it# $ a!!
articiants *ere recruited fro&a %eteranCs "ea!t" centret"erefore on!# ;S eterans
inc!uded' +"is ou!ation &a#be of oorer "ea!t" or "a%esignificant &enta! i!! "ea!t" e'g'increased incidence of ost$trau&atic stress disorder orderession'
Hig" risk diabetic atie
uroean aucasian et"origin
Kes) a!! atients studied
aucasian and recruitedc!inics and 1 odiatrist i
or*a#'
2'3 Su&&arise t"e
aut"orsC
conc!usions' ,dd
an# co&&ents of
o*n assess&ent
and an# areas of
uncertaint#'
,ut"orCs onc!usions
nter%ention grou 6infrared
t"er&o&etr# \ standard t"era#
eerienced significant!# fe*er
diabetic foot co&!ications
co&ared to contro! to contro!6standard t"era#' esu!ts
suggest te&erature &onitoring
&a# be an effecti%e too! to
re%ent diabetic foot u!ceration
,ut"orCs onc!usions
nter%ention grou 6infrared
t"er&o&etr# \ standard t"era#
"ad significant!# fe*er u!cers
t"an bot" structured grou
6structured foot ea& \ standardt"era# and contro! grou
6standard t"era#' esu!ts s"o*
infrared t"er&o&etr# can ser%e
as an eas# to use adjuncti%e ear!#
*arning s#ste& to re%ent
diabetic foot u!ceration'
,ut"orCs onc!usions nter%ention
grou 6infrared t"er&o&etr# \
standard t"era# eerienced
statistica!!# significant fe*er u!cers
t"an t"e contro! grou 6standard
t"era#' ncreased te&eraturessee& to redict areas of u!ceration
and se!f$te&erature &onitoring
&a# reduce t"e risk of diabetic foot
u!ceration'
,ut"orCs onc!usions nte
grou 6infrared t"er&o&etr
t"eor# based counse!!ing \
t"era# did not s"o* statis
significant resu!ts co&are
contro! grou 6standard t"e
2' 1o& &ell &as t(e
stud+ done to
minimise .ias
0o& >ualit+ B8-C
$(i$( ris of .ias
1i$( >ualit+ B8EEC
-ver+ lo& ris of .ias
0o& >ualit+ B8-C
$(i$( ris of .ias
!ccepta.le >ualit+ B
$lo& ris of .ias
S((rading
eco&&endation 4ffer te&erature &onitoring de%ices suc" as infraredt"er&o&eters *"en reco&&ending and creating &anage&ent !ans to re%ent
u!ceration'
#
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Qote nitia!!# t"is araisa! c"eck!ist *as conducted *it"out t"e acco&an#ing notes 6aendi 3c> ans*ers *ere inconsistent and based so!e!# on t"e assu&tions of set
standard /uestions and set ans*ers *it" !itt!e c!arit# $ as suc" so&e different resu!ts *ere obtained *"ereb# t*o of t"e studies *ere graded a "ig"er /ua!it# 6Ea%er# et a!) 200 and
,r&strong et a!) 2007' -o!!o*ing identification of t"e assistant notes) t"e c"eck!ist *as reeated and found different 6t"e current outco&es' Ea%er# et a! 62007 and Skafje!d et a!
62015 *ere unc"anged fro& t"e first ti&e 6"ig" /ua!it# and accetab!e /ua!it# resecti%e!#> "o*e%er t"e ot"er t*o studies *"ic" *ere re%ious!# of accetab!e /ua!it# *ere
do*ngraded to !o* /ua!it#' +"is *i!! i&act t"e re%ie* outco&e'
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Appendi* /0Eiterature e%ie* +ab!es
1/ibliogra&hiccitationand itle
Studyty&e
uber of(atients
(atientcharacteris
tics
Inter!ention Study Methods engthof
follo,u&
'utcoeeasures
StatisticalAnalysis
(a%ery> (? A?>@iggins> ? R?>
(anctot> D? R?>
,onstantinides>
+? P?> Bamorano>
R? +?> Armstrong>
D? +?> et al? 788/?
@ome
monitoring of foot
skin temperature
to pre%ent
ulceration
+ $,
Standard
+"era#
63 dro
outs 1
co&!eted
stud#'
n"anced
+"era#
1 6 dro
outs 37
co&!eted
stud#'
Particiants adu!ts618$80'
Mean %a!ues
Standard +"era#
,ge 5'8
= Men 52'3
Diabetes duration
12'7 #ears
,&utation Histor#
1 isk categor# &ean
2'1
n"anced
+"era#
2 +reat&ent (rous
(rou 1 Standard +"era# $
i'i' +"eraeutic foot*ear
ii' Diabetic foot education
iii' %er# 10$12 *eeks recei%ed a foot e%a!uation
conducted b# a odiatrist'
(rou 2 n"anced +"era#
Standard t"era# 6i)ii)iii
Pre stud# neuro!ogica! assess&ent
conducted using %ibrator# ercetion
t"res"o!d 6P+ to identif# sensor#
neuroat"#' P+ @25 defined resence
of neuroat"#'
Pre stud# %ascu!ar assess&ent inc!uded
a!ation of eda! u!ses) bot" dorsa!is
edis and osterior tibia!' f one or bot"
u!ses *ere not a!ab!e t"en t"e subject
*as ec!uded'
Patients *ere enro!!ed if t"e# "ad
$ Diabetes 6does not state t#e of
diabetes inc!uded or ='
$&et t"e "ig" risk rofi!e for t"e
. &ont"s
Measure&ent
s e%a!uated at
base!ine and
again at t"e
end of t"e
stud#'
Pri&ar# 4utco&e 2foot complications
e'g' incidence of
foot ulceration?
nfection) c"arcot
foot and a&utation
6additiona! but not
riorit# outco&es'
Secondar# 4utco&e
"unctional
impairment
&easured %ia s"ort
for& "ea!t" sur%e#
6S-$3. re and
ost stud#'
-or a!! ana!#sis a
significance !e%e! of
^ 0'05 6intention to
treat basis'
,na!#sis of ariance
6,4, *as used
to e%a!uate
continuous %ariab!es
bet*een t"e treat&ent
grous'
-is"erCs eact test
*as used to e%a!uate
dic"oto&ous%ariab!es an odds
ratio of 95=
confidence inter%a!
6'
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,ge 55
= Men 8'8
Diabetes duration
1'8
,&utation "istor#
1
isk categor# &ean
2'1
\
n"anced +"era# $ Pro%ided *it" a "and"e!d
infrared skin t"er&o&eter 6+e&+ouc"
recorded in a !og book'
$+e&erature &onitoring of bot" feet on plantar
aspect at . sites 6"a!!u) 1st) 3rdA 5t"&et "eads)
centra! &id foot and "ee!
$, difference of 2'2 degrees ce!cius bet*een one
foot and t"e contra!atera! foot indicated subjects
"as to contact a stud# nurse and reduce nu&ber of
stoes carried out unti! t"e te&erature difference
*as reduced'
$Monitoring of foot in t"e &orning and e%ening
$f an area "ad been a&utated t"en an adjacent
area *as used for &easure&ent
$f a site "ad ca!!us it *as sti!! used as a site for
&onitoring'
de%e!o&ent of a diabetic foot u!cer'
Hig" risk *as defined as "a%ing diabetes)
a "istor# of foot u!ceration or !o*er !i&b
a&utation) resence of eri"era!
sensor# neuroat"# *it" !oss of
rotecti%e sensation) e%idence of a foot
defor&it# t"is is re%ious!# identified
risk factors for foot u!cersNa&utations'
nc!usion riteria
$:or!d Hea!t" 4rganisation 6:H4
criteria for diagnosis of Diabetes'
$Must be ab!e to gi%e infor&ed consent
$,du!ts aged 18$80'
$Diabetic foot risk c!assification s#ste&
deter&ined b# nternationa! Diabetic
:orking (rou articiants &ust be
grou 2 or 3'
c!usion riteria
$Presence of oen *ounds
$4en a&utation sites
$,cti%e c"arcot ,rt"roat"#
$Peri"era! %ascu!ar disease
$acti%e foot infection
$de&entia
$i&aired cogniti%e function
$"istor# of a!co"o! or drug abuse *it"in
t"e re%ious #ear'
General comments:
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j
Aim0 )%aluate ho$ effecti%e an at home infrared temperature tool $as to impro%e clinical outcome and functional status of dia!etics $ith high risk feet and $hether it $as a useful early $arning tool of
inflammation and tissue in&ury possi!ly leading foot complications?
Results0 enhanced therapy group had fe$er dia!etic complications 1; ulcer5 compared to 6 ulcers> 7 incidents of charcot foot and 7 incidents of foot infection $hich reCuired amputation in the standard therapy
group this $as statistically significant P28?8;? Patients in standard therapy group $ere more likely to de%elop a foot complication compared to the enhanced therapy group !y ;8?.9 1=49 ,I ;?73?.5?
Secondary outcome of functional status 1measured !y S". infection and charcot arthropathy no mention as to definitionGclassification of ulceration e?g? a foot ulcer as measured !y
HagnerGTe*as classification therefore $hat they classify as an ulcer> other studies may not? Appro%al from ethics committee not mentioned? +ood use of %isual graph sho$ing daily temperature measurements
in a patient that did not ulcerate compared to a patient $ho did? (imitations of study mentioned e?g? longer follo$ up $ould !e preferred and that the outcomes sho$n may !e as a result of increased %igilanceG
increased foot inspection in those using the physical temperature monitoring de%ice? Suggestions regarding future studies made e?g? consider randomising to a . rdpatient group in%ol%ing acti%e screening?
Inter%ention Detail0 standard therapy procedure not e*plained in detail $hat did the dia!etic foot education consist of Hhat type of foot$ear and insoles $ere issued did each participant recei%e standardfoot$earGinsoles or $ere they customised Did patients record ho$ long they $ore shoes for daily Inter%entions of foot$ear> dia!etic foot education and use of temperature monitoring tool relies on patient
compliance? Recording of measurements in log!ook relies on participant honesty? )*planation of ho$ temperature monitoring tool $orks not gi%en?
2/ibliogra&hic
citationand itle
Studyty&e
uberof
(atients
(atientcharacteristics
Inter!ention StudyMethods
ength of
follo,u&
'utcoeeasures
StatisAnal
(a%ery> (? A?>
@iggins> ? R?>
(anctot> D? R?>,onstantinides>
+? P?> Bamorano>
R? +?>
Athanasiou> ?
A?> et al? 7886?
+ 173
Standard
+"era# 58
$ 52
co&!eted
stud#
. dros outs
Particiants adu!ts 618$
80
Mean %a!ues
Standard +"era#
,ge .5
= Men 53'
3 +reat&ent (rous
, edo&eter *as issued to a!! stud# articiants to
record t"eir dai!# acti%it# in a !og book'
(rou 1 Standard +"era#
i'Eo*er !i&b ea&ination e%er# 8 *eeks
euro!ogica!
assess&ent
conducted using
P+ and 10g
&onofi!a&ent
testing nu&ber
of sites *it"
reduced sensation
out of 10'
15 &ont"s Pri&ar# 4utco&e
resence of foot
u!ceration used
re$estab!is"ed
criteria to &easure
t"is'
Secondar# 4utco&e
dai!# use of
-or a!! ana!#ses
!e%e! of ^ 0'0
obser%ation car
6E4- *as us
intent to treat b
,na!#sis of ar
6,4, for i
sa&!es *as us
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j
Pre%enting
dia!etic foot
ulcer recurrence
in high risk
patients
$3 fro&
ad%erse
e%ents
$3 %o!untar#
dro out
Structured
-oot
a&ination
+"era# 5.
50
co&!eted
stud#
. dro outs
$ fro&
ad%erse
e%ents
$2 %o!untar#
dro outs
n"anced
+"era# 59
9
co&!eted
stud#
10 dro outs
$ fro&
ad%erse
e%ents
$. %o!untar#dro outs
+#e 2 Diabetes 5.
Diabetes duration 13'7
,&utation "istor# 18
Structured -oot
a&ination
,ge .'2
= Men 51'7
+#e 2 diabetes 53
Diabetes duration 13'8
,&utation "istor# 1
n"anced +"era#
,ge .5'
= Men 55'9
+#e 2 diabetes 55
Diabetes duration 13'7
,&utation "istor# 13
ii'Patient education rogra& %ia %ideotae addressing
aetio!og# of diabetic foot u!cers) t"e risk factors) safe
se!f$care ractices and *"at ear!# *arning signs to !ook
for'
iii' +"eraeutic inso!es and foot*ear *"ic" *ere
regu!ar!# e%a!uated b# a odiatrist to assess *"et"er an#
needed to be re!acedNreaired'
egu!ar foot insection *as ad%ised and if an# areas of
concern *ere identified t"en t"e# *ere to contact t"e
stud# nurse *"o contacted t"e in%estigator *it"out
re%ea!ing treat&ent grou assign&ent'
(rou 2 Structured -oot a&ination
Standard +"era# 6i)ii)iii
\
Structured -oot a&ination trained to be ab!e to
carr# out a foot ea&ination t*ice dai!# using a &irror
to %isua!ise difficu!t %ie*ing areas of t"e foot e'g'
!antar asect'
4bjecti%e *as to identif# an# redness) disco!ouration)
$armth !y palpation'
ecording of nor&a! and abnor&a! obser%ations *as
conducted in a !og book 6to ro%ide a rotoco! for
e%a!uation *it" t"e additiona! of icture
reresentations'
, se!f$ea&ination c"eck!ist "ad to be co&!eted toensure a!! e!e&ents of t"e foot ea&ination *ere
conducted'
,d%ised to contact stud# nurse of an# abnor&a!
obser%ations'
ascu!ar
assess&ent
inc!uded
a!ation of eda!
u!ses) using t"e
Do!er and
,BP'
nc!usion
riteria
$Diagnosis of
diabetes
$,bi!it# to
ro%ide infor&ed
consent
$,du!ts aged 18$
80$, "istor# of foot
u!ceration
$,BP @ 0'70
c!usion
riteria
$4en *ound
$4en a&utation
$,cti%e c"arcot
art"roat"#
$Se%ere
eri"era! arteria!
disease
$-oot infection
$De&entia
rescribed s"oes
and inso!es
&easured using a
se!f$reorted
/uestionnaire at t"e
end of t"e stud#
ordina! sca!e to
identif# !e%e! of use
e'g' L "ours dai!#
etc'
bet*een$grou
on continuous t
%ariab!es'
$an odds ratio
o&arison of
de%e!o a foot
re!ation to treat
a
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j
(rou 3 n"anced +"era#
Standard t"era# 6i)ii)iii
\
n"anced +"era# trained to use a digita! infrared
t"er&o&eter 6+e&+ouc"' , standardised %ideotae
*as used to train eac" articiant) fo!!o*ed b#
articiant de&onstration back to t"e stud# nurse on
"o* to use t"e t"er&o&eter correct!#' ecorded foot
te&eratures in a !ogbook *it" ictoria! reresentations'
$+e&erature &onitoring of bot" feet on t"e plantar
aspectat . sites 6Ha!!u) 1st) 3rdA 5t"&et "eads) &idfoot
and t"e "ee!
$ f an area "ad been a&utated t"en an adjacent area
*as used for &easure&ent'
, difference of 2'2 degrees ce!cius fro& one footco&ared *it" t"e sa&e site on t"e ot"er foot for @2
da#s t"en articiants "ad to contact t"e stud# nurse and
decrease acti%it# unti! t"e te&eratures returned to
nor&a!'
General comments:
Aim0 )%aluate the effecti%eness of an at home temperature monitoring tool to help high risk dia!etics identify inflammation and areas of their feet $hich are prone to ulceration !efore an ulcer actuall
Results0 the enhanced therapy group had significantly fe$er incidences of ulceration> J/ fold decrease risk of ulcers 13?495 4 ulcers? In comparison to standard therapy 17=?.95 and structured thera
!oth had ;6 ulcerations each essentially identical? aplan:eier sur%i%al analysis sho$ed that the enhanced therapy e*pressed a longer mean time to de%elop an ulcer 1/7=?4 days5 compared to stan
therapy 1.63?4 days5 and structured therapy 1.66?. days5 the o%erall difference !et$een time to de%elop ulcers !y treatment groups $as statistically significant using log rank test 1P28?8;;5? @o$e%er
no difference !et$een the standard and structured therapy for time to ulcerate 1P28?=;85? The enhanced therapy group $as statistically different from !oth the standard therapy 1P28?884=5 and struct
therapy 1P28?88445 in time to ulceration? The test for trend found the enhanced therapy group to !e superior and had a statistically significant trend of sur%i%al compared to standard or structured the
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1P28?8;865? Selfreported daily use of prescri!ed shoes and insoles sho$ed good compliance in all . treatment groups no statistical difference in participants $ho $ore the shoes and insoles for at leas
per day among treatment groups 1standard therapy 3=?49> structured foot therapy 6.?79 and enhanced therapy 3.?895> PJ8?86;?Participants in the enhanced therapy$ho $ere compliant$ith asse
recording foot temperatures 489 of the time $ere less likely to ulcerate 1OR 48?8> PK8?88;5 $hich $as statistically significant? Of those $ho de%eloped an ulcer in the enhanced therapy> 389 did not co
temperature monitoring and participants $ho did not de%elop an ulcer> =79 assessed and recorded their foot temperatures at least 489 of the time? In the structured therapy there $as no statistical d
compliance of recording daily foot assessments in those $ho ulcerated 1/6?;95 and those $ho did not ulcerate 1/.? on a%erage> !ased on pedometer acti%ity> $hene%er an ele%ated tempe
identified there $as a 4;?79 decrease in physical acti%ity?
Study :ethods0 Patient characteristics $ere similar at !aseline 1not statistically significant5? +oodGlarge sample siEe 1;6.5 ;4; completed study total of 77 drop outs $hich $ere e*plained as either %
$ith reasons gi%en e?g? too much to do or due to ad%erse e%ents $ith reasons gi%en e?g? foot trauma :I etc? -ustification of sample siEe $as gi%en and e*plained $as calculated on the !asis of the amo
su!&ects e*pected to ulcerate o%er ;4 months? Planned to ha%e allocation of participants to groups $as then sealed in opaCue en%elopes
concealment? Single !lind study physician !linded 1unfeasi!le to !lind participants due to manual use of temp monitoring tool etc5 participants $ere instructed not to discuss their group allocation
help maintain !linding? +ood length of follo$ up 1;4 months5?Study $as appro%ed !y hospital re%ie$ !oard? Recruitment of participants not mentioned $here $ere they recruited from mentions i
multicentre trial !ut doesnLt gi%en any more details? Inclusion and e*clusion criteria mentioned a!ility to pro%ide informed consent $as mentioned as a prereCuisite for inclusion ho$e%er there $as n
mention if informed consent $as actually o!tained? Primary outcome of foot ulceration $hich $as defined using pre%iously esta!lished criteria #ni%ersity of Te*as Hound ,lassification? No strengths
limitations of the study addressed? No suggestions a!out impro%ing future studies in this research area?
Inter%ention detail0 Standard Therapy0 no e*planation of ho$ lo$er e*tremity e%aluation $as carried outG$hat it consisted of? Patient education program e*plained in further detail %ideotape used t
standardisation? Therapeutic foot$ear and insoles mentioned did each participant recei%e standard foot$earGinsoles Here they customised or prefa!ricated +ood that they e%aluated ho$ long p
foot$ear for daily? Hhen patients inspected their feet did they record findings in a log!ook Daily acti%ity $as monitored !y a pedometer to pro%ide figures on ho$ much people $alked recorded in l
Structured "oot )*am Therapy0 trained to conduct a structured foot e*amination o!ser%ational only> ho$ $as this e*plained to participants Did they each recei%e the same standard training Reco
log!ook $ith pictures for help and had to complete a checklist of elements included in selfe*amination? Purpose of log!ook $as to pro%ide structured e%aluation and to %erify that the e*amination $as
)nhanced therapy0 trained use of temperature monitoring tool $as standardised !y use of a %ideotape to teach participants ho$ to correctly use it follo$ed !y study nurse e%aluating if they used it c
Information of ho$ the temperature monitoring tool $orks $as gi%en? Inter%entions of patient education> therapeutic foot$earGinsoles> foot inspection> structured foot e*amination and use of temperat
reCuires patient compliance? Recording of measurements in log!ook relies on participant honesty?
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3/ibliogra&hiccitationand itle
Studyty&e
uber of&atients
(atientcharacteristics Inter!ention StudyMethods ength offollo, u&
'utcoeeasures Statistical
Armstrong> D?
+?> @oltE
Neiderer> ?>
Hendel> ?>
:ohler> -?>
im!riel> @? R?>
M (a%ery> (? A?
7886?
Skin
temperature
monitoring
reduces the risk
for dia!etic foot
ulceration in high
risk patients
+ 225 Particiants adu!t
%eterans618$80
Mean a!ues
Standard +"era#
,ge .9'7
Se = 9'7 6is t"is &a!eor fe&a!e
Diabetes duration 12'.
#ears
Hb,1c = 7'
euroat"# \ !oss of
sensation 100=
etinoat"# 3'2=
n"anced +"era#
,ge .8'2
Se = 98'2 6is t"is &a!e
or fe&a!e Diabetes duration 13'.
#ears
Hb,1c = 8'1
euroat"# \ !oss of
sensation 100=
2 +reat&ent (rous
(rou 1 Standard +"era# 6ontro!
i'+"eraeutic foot*ear
ii'Diabetic foot education
iii'egu!ar foot care
i%' , structured foot assess&ent *as to be
conducted dai!# and findings recorded in a!ogbook' f an# abnor&a!ities *ere detected
t"en t"e# *ere to contact t"e stud# co$
ordinator as soon as ossib!e'
(rou 2 Der&a! +"er&o&etr#
6n"anced +"era#
Standard t"era# 6i)ii)iii)i%
\
n"anced t"era# using an infrared skint"er&o&eter 6+e&+ouc"
$+e&erature &onitoring of bot" feet at . sites
6not stated) t*ice dai!#'
nc!usion riteria
$+#e 2 diabetes
6recei%ing foot care at
t"e Sout"ern ,ri?ona ,
Hea!t" are S#ste&
$,ges 18$80
$isk ategor# 2or 3 of
t"e nternationa! -oot
isk !assification
S#ste&
c!usion riteria
$,cti%e oen u!cers
$,&utation sites
$-oot infection
$,cti%e c"arcot
,rt"roat"#
$Se%ere eri"era!
%ascu!ar disease 6non$
a!ab!e eda! u!ses or
,BP L0'8 on eit"er
foot
$De&entia or i&aired
18
&ont"s
$
Pri&ar#
&easure
s *ere
obtained
atbase!ine
$-o!!o*
u at 3)
.)9)12
and 18
&ont"s'
Pri&ar# 4utco&e
-oot u!cer
incidence
6roortion of
articiants to
de%e!o an# t#e of
foot u!cer' $,n
u!cer *as defined as
t"e full thicknessloss of the
epidermis or
dermis $ith or
$ithout
in%ol%ement of the
deeper structures
$Pri&ar# endoint
*as nu&ber of
atients in t"e
grous de%e!oing
an# kind of foot
u!cer'
4bjecti%e to
e%a!uate "o*
effecti%e a se!f$
ad&inistered
-or a!! ana!#ses a sta
significance of ^ 5
-or e%a!uation of de
outco&e differences
grous e'g' ti&e to in
u!ceration roducing
contro!!ing for co%ar
Hb,1c) "istor# of aco roortiona! "a?
used'
Ste*ise &ode!!ing
used to se!ect co%ari
b# i!ot stud# e%iden
!iterature
%a!uation of otenti
dic"oto&ous associa
s/uared test *as use
%a!uation of skin te
differences 6co&are
oosite foot at t"e
u!ceration in t"e *ee
an# reu!ceration and
a 1 *eek sa&!e of 5
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etinoat"# 23'=
$, te&erature difference of @2'2 degrees
ce!cius bet*een rig"t and !eft foot indicated
atients to contact t"e stud# co$ordinator and
*ere ad%ised to reduce t"eir acti%it# unti! t"e
te&eratures returned to nor&a!'
$e!ained an abso!ute Inor&a!J skin
te&erature !e%e! *ou!d be difficu!t to identif#
due to diabetic disease rocesses'
cogniti%e function
$,cti%e drug or a!co"o!
abuse *it"in !ast #ear
$&aired sig"t 6unab!e
to read t"e big 2'5c&
screen on t"e digita!
t"er&o&eter
$;nab!e to *a!k *it"out
assistance of *"ee!c"air
or crutc"es
te&erature
&onitoring too! to
reduce incidence of
diabetic foot u!cers'
Secondar#
objecti%es t"e
effect of
inter%ention on
u!cer t#e) "ea!t"
re!ated /ua!it# of
!ife) se!f$efficac#)
care satisfaction and
acti%it# &odu!ation'
sa&!ed subjects t"a
u!ceration a Mann$
*as used'
General comments:
Aim0 )%aluate ho$ effecti%e an at home infrared temperature monitoring tool $as in reducing the incidence of foot complications in high risk dia!etic patients at risk of foot ulceration? Study tested h
home temperature monitoring $ould reduce ulcer incidence and positi%ely influence Cuality of life related to health> selfefficacy> care satisfaction and acti%ity modification not addressed in results> to
in future studies
Results0 in total there $ere ;= ulcers o%er the ;3 months 2 3?/9? @o$e%er in the enhanced therapy group had fe$er incidences of ulceration 14 /?695 compared to the standard therapy group 1;/ ;
.?8> ,I ;?83?4> P28?8.3? In addition> the enhanced therapy group $as associated $ith a longer time to ulceration compared to standard therapy group> 1P28?8/5? In addition> proportional standards re
indicated that age> ele%ated foot ulcer classification 1risk category .5 and minority status $ere associated $ith Cuicker time to ulceration than enhanced therapy group> these $as statistically significan
P28?8;> P28?;5 respecti%ely? Of patients that did ulcerate> there $as a temperature difference !et$een the affected foot and contralateral lim! of a /?3 increase at the site of ulceration ; $eek !efore the
de%eloped than in a random 6 consecuti%e day sample of 48 su!&ects $ho did not ulcerate 1P28?88;5?
Study :ethods0 Patient characteristics $ere similar at !aseline 1not statistically significant> PJ8?845? Participants $ere all %eterans $ith dia!etes specific population group states they are a potentia
risk population group does this limit generaliEa!ility +oodGlarge sample siEe 774 largest out of all the studies? No mention of ho$ many completed the study as drop outs $ere not mentioned? )*
sample siEe $as gi%en> calculated on the !ases that $ithin ; year> up to 689 of patients $ith foot ulcer history reulcerate? Felie%ed incidence of ulceration $ould !e 689 in standard therapy and !et$e
enhanced therapy? In this study for an estimated sample siEe of 68 per group 12total 7;8 participants 774 in study5> a log rank test for eCuality of sur%i%al cur%es $ould ==9 po$er to detect /89 dif
po$er for a .89 difference and 3.9 po$er for 749 difference? Interim analyses not performed? No esta!lishment of stopping rules? Randomisation mentioned to the allocation of the 7 groups0 no nu
regarding allocation of randomisation? Process of randomisation gi%en patients $ere consented then randomisation generated %ia a randomised assignment list !y !iostatistician? ,oncealment of ran
not mentioned? Single !linding physician !linded 1unfeasi!le to !lind participants due to manual use of temp monitoring tool etc?5 participants $ere instructed not to discuss their group allocation i
help maintain !linding? During diagnostic e%aluation> the treating physician ne%er conducted temperature monitoring? +ood length of follo$ up 1;3 months longest compared to other studies5? Recru
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mentioned from Southern AriEona A @ealth ,are system single centre trial? :entions that patients $ere consented? No mention of ethics appro%al? Inclusion and e*clusion criteria mentioned0 li
inclusion criteria? Patients $ith sight impairment 1una!le to read thermometer screen5 $ere mentioned as an e*clusion criterion ho$e%er in patient characteristics it states that 7.9 and ./9 of partici
enhanced and structured therapy groups respecti%ely had retinopathy? Outcome measurements0 study definition of $hat they percei%e to !e an ulcer gi%en no use of Hagner classification $hich also i
infectionGischaemia? Some limitations of study addressed e?g? underestimated the sample siEe reCuired? Suggestions for future studies mentioned multicentre trial o%er a longer time period and studies
Cuality of life> functional status> selfefficacy> care satisfaction and cost as this $as not addressed in current study?
Inter%ention Detail0 Standard therapy procedures not e*plained in detail no e*planation as to $hat type of therapeutic foot$ear $as issued> standardised for e%ery patient or customised Did patient
long they $ore shoes for daily No e*planation as to ho$ patients recei%ed dia!etic foot education or process of regular foot care? Participants $ere instructed to perform a structured foot e*aminatio
findings in a log!ook ho$ $as this e*plained to participants to !e carried out Information of ho$ the temperature monitoring tool $orks $as gi%en? Inter%entions reCuire patient compliance? Recor
log!ook relies on patient honesty?
#/ibliogra&hic
citationAnd itle
Studyty&e
uberof
&atients
(atientcharacterist
ics
Inter!ention StudyMethods
ength offollo, u&
'utcoeeasures
Statistical
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Skaf&eld> A?>
I%ersen> :? :?>
@olme> I?> Ri!u>
(?> @%aal> ?> M
ilho%d> F? ?
78;4?
A pilot study
testing the
feasi!ility of skin
temperature
monitoring to
reduce recurrent
foot ulcers in
patients $ith
dia!etes a
feasi!ility study4
+ 1
Standard
+"era# 20
20
co&!eted
stud#
6no dro outs
n"anced
+"era# 21
18
co&!eted
stud#
63 %o!untar#
dro outs
Particiants adu!ts
618$80
,!! articiants
aucasian
Mean a!ues
Standard +"era#
,ge 59'
= Men 75
Diabetes duration
19'5
+#e 1+#e 2
3070
Hb,1c = 7'9
BM 31'1
etinoat"# = 7
Mu!ti!e u!cer"istor# 6= 85
n"anced +"era#
,ge 57'1
= Men 8.
Diabetes duration
17
+#e 1+#e 2
2971
Hb,1c = 8'3
BM 31'
etinoat"# = 0
Mu!ti!e u!cer
"istor# 6= .5
2 +reat&ent (rous
(rou 1 Standard
+"era#6contro!
i'Dai!# foot insection 6!antar) dorsu&
and interdigita! record in a !og book and
contact stud# nurse of an# c"anges)
inc!uding ne* u!cer' ,d"erence to foot
insection *as recorded as a = of da#s
*it" a c"eck indicating foot insection'
ii'usto&ised foot*ear ad%ised to
a!*a#s *ear it
-or genera! &edica! and diabetes care) t"e#
*ere sti!! ab!e to contact t"eir genera!
ractitioners did (Ps kno* t"e# *ere
art of a stud#
(rou 2 n"anced +"era#
6inter%ention
Standard +"era# 6i)ii
\
n"anced t"era# using digita! infrared
t"er&o&eter 6+e&+ouc" &onitoring foot
te&erature' +"e stud# nurse e!ained t"e
urose of t"e t"er&o&eter and "o* to use
it'
$+e&erature &onitoring of !antar asect
of bot" feet at . sites 6not stated
recorded in a !og book dai!#' ,d"erence to
te&erature &onitoring *as recorded as a
nc!usion
riteria:
$Diagnosis of
t#e 1 or t#e
2 diabetes
$,ges 18$80$isk categor#
grou 3 of
Diabetes -oot
isk
!assification
S#ste&
6re%ious
"istor# of foot
u!cer and
eri"era!
neuroat"#
$Must becaab!e of
ro%iding
infor&ed
consent
$Must be
caab!e of
co&!eting a
*ritten
/uestionnaire
$Had to be
*i!!ing to
erfor& foot
skin
te&erature if
assigned to
suc" grou
ossib!e
1 #ear
$!inica! ea&inations
erfor&ed b# ort"oaedic
surgeon and
endocrino!ogist at base!ine
and end of t"e stud# 6:aist
circu&ference) bod#
*eig"t) "eig"t base!ine
on!# to ca!cu!ate BM and
an etensi%e foot
ea&ination *as
conducted a!ation of
u!ses' ,BP) bone) feet
skin and nai! c"anges)
neuro!ogica! assess&ent
6P+ and &onofi!a&ent'
$%a!uation at base!ine and
fo!!o* u %isits e%er# 3&ont"s
:"ere assess&ent of
subjectCs readiness to
record skin foot
te&eratures took !ace
according to ++M stages'
-o!!o*ed b#
$+ai!or stage based
counse!!ing'
5 stages
1' ot using t"et"er&o&eter and does not
intend to'
2' +"inking about using it)
but not in t"e near future'
Pri&ar# outco&e
foot u!cer
occurrence
c!assification b#
t"e Hagner "oot
System? +"is *as
a!so t"e stud#
endoint
articiants
sta#ed in t"e
stud# unti! t"e#
u!cerated or unti!
t"e end of t"e
stud#'
$,t base!ine and
end of stud#)
articiants
co&!eted
/uestionnairesinc!uding
infor&ation on
socio$
de&ogra"ic
%ariab!es 6age)
se) !i%ing
conditions)
education)
e&!o#&ent
status) !ifest#!e
6s&oker)
diabetes re!atedinfor&ation 6t#e
and duration of
diabetes)
associated "ea!t"
rob!e&s) "istor#
-or a!! ana!#ses a sta
significance of t*o$s
ntention to treat basi
Monitoring of foot sk
te&erature *as di%i
L80= or @80=
-or grou co&ariso
continuous %ariab!es
BM) *aist circu&fe
Hb,1c) duration of d
,BP $ indeendent s
tests *ere used'
-or araisa! of t"e e
inter%ention on t"e n
subjects *it" a foot u
eact test *as used'
o&arison of t"e t
regarding foot u!cer
ti&e
7/25/2019 DISSERTATION Critical Review Assignment 1.docx
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= of da#s *it" foot te&erature
&easure&ents recorded in !ogbook'
$, te&erature difference of @2'0 degrees
ce!cius fro& one foot to t"e oosite at t"e
sa&e site for t*o consecuti%e da#s t"en
t"e# *ere ad%ised to contact stud# nurse
and to &ini&ise "#sica! acti%it# unti!
te&eratures L2'0'
$ecord dai!# "#sica! acti%it# using a
Ste$ounter in a !ogbook during first
*eek
\
+"eor# based counse!!ing suorting t"e
te&erature &onitoring e%er# 3 &ont"s
inc!usion of
bias
c!usion
riteria
$4en u!cers$,cti%e c"arcot
art"roat"#
$,cti%e
osteoe!itis
$sc"ae&ia
6non$a!ab!e
eda! u!ses or
,BP L0'7
3':i!! begin to use it
' Started to use it) but not
on a regu!ar basis 6L80=
of t"e ti&e'
5' ;sing t"er&o&eter
regu!ar!# 6@80= of t"e
ti&e'
of foot u!ceration)
"istor# of
a&utation and
c"arcot
art"roat"#'
$4n co&!etion
of stud#) subjects
a!so co&!eted a
/uestionnaire
regarding use of
custo&ised
foot*ear'
General comments:
Aim0 Test the feasi!ility of foot temperature monitoring in com!ination $ith theory !ased counselling to standard foot care to reduce or pre%ent dia!etic foot ulcer recurrence?
Results0 Throughout the study> the enhanced therapy group e*perienced fe$er incidences of foot ulceration 16 ulcers .=95 compared to standard therapy group 1;8 ulcers 4895> ho$e%er this $as
statistically significant P28?4.7?Also the time to de%elop a foot ulcer did not differ significantly !et$een the t$o groups 1P28?/86> chisCuared at 8? ;/ su!&ects 1 ;/ su!&ects 16895 also recorded foot o!ser%ations J389 of the time? In the enhanced therapy group there $as no as
!et$een temperature monitoring J389 of the time compared to K389 of the time and foot ulcer occurrence time? In the enhanced therapy group> 3 su!&ects e*perienced increased foot temperatures
su!&ects 14895 contacted the study nurse $ith these concerns? and in the standard therapy group> ;7 su!&ects o!ser%ed foot changes of $hich / 1..95 contacted the study nurse? None of these partici
e*perienced foot ulceration? In the enhanced therapy group> 4 su!&ects 17/95 $ore customised foot$ear for J;7h per day compared to 6 su!&ects 1.495 in the standard therapy> ho$e%er this $as not s
significant 1P28?3435?
Study :ethods0 Patient characteristics $ere e*tensi%e and similar at !aseline the only statistically significant difference !et$een groups $as in the urinary al!uminGcreatinine ratio 1789 and as they ha%e an a
increased risk of recurrence? No mention ho$ concealment of randomisation $as carried out? All study procedures $ere performed in the same setting Dia!etes clinic at Oslo uni%ersity hospital? Sing
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study physician !linded 1unfeasi!le to !lind participants due to manual use of temp monitoring tool etc5 ho$ $as !linding maintained No mention that su!&ects $ere instructed not to discuss their
allocation? +ood length of follo$ up 1; year5? Recruitment mentioned < dia!etic outpatient centres and ; podiatrist in Oslo? Study states patients recei%ed full confidentiality and all participants ga%e
$ritten consent? )thics appro%al $as gained? Inclusion and e*clusion criteria mentioned0 slight !ias as patients had to !e $illing to measure foot temperature if they $ere randomised to that group to !
@a%ing ischaemia $as an e*clusion criterion measured !y nonpalpa!le pulses and AFPI K8?6> ho$e%er to !e categorised as ischaemic AFPI is usually K8?4 possi!ly e*cluded non ischaemic patients
measure of foot ulceration $as classified using Hagner scale standardised method that is uni%ersally used therefore can !e generalised? (imitations of study mentioned e?g underpo$ered and it is not
comparison due to use of thermometer and theory !ased counselling? Suggestions of future studies to conduct large scale inter%entions in this area to impro%e patient !eha%iour and foot ulcer recurren
Inter%ention Detail0 Standard therapy0 in foot inspection> no information gi%en on $hat patients $ere told to !e looking for e?g? colour> foot temperature palpation etc Did the nurse use %isual aids or
sho$ them typical $arning signs of foot ulceration Participants $ere ad%ised to $ear customised foot$ear $ere these made as part of the inter%ention and therefore standardised to each su!&ect of t
had participants already !een issued $ith foot$ear pre%iously If so> ho$ old $ere these Some participantLs foot$ear may ha%e !een in !etter condition than others? In the enhanced therapy su!&ects
trained to use thermometer and to conduct daily selfmonitoring of skin temperatures ho$ $as this conducted> %er!ally or %ia standardised %ideotape :inimal information gi%en regarding ho$ the
temperature monitoring tool $orks? No recording of daily acti%ity therefore $hen temperatures ele%ated> ho$ can in%estigators !e sure su!&ects reduced their acti%ity !y half? Inter%entions reCuire pa
compliance? Recording %ia log!ook relies on patient honesty?
Appendi* 404S4+ 2010 ;sed to &ro%e eorting of ando&ised ontro!!ed +ria!s and to ,ssist eaders in ritica! ,raisa!
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