Selection and Uses of Outcome Measures i

7/25/2019 Selection and Uses of Outcome Measures i

1/33

Selection and Uses of OutcomeMeasures in Stroke Rehabilitation

Research & Practice

BYAshiru Hamza MuhammadPT, MMedPH,MNSP, MMPHC.

PhD Research Student

Center for Population Health

Dept. of Social & Preventive MedicineFaculty of Medicine

niversity of Malaya, Malaysia


2/33

Topics

Issues Incorporating the concept of ICF

Psychometric Properties

Type of Outcome Measures

Purpose of Measurement

Methods of Data Acquisition

Most commonly used tro!e Outcome

Measures "ses of Outcome Measures


3/33

Issues tro!e is a ma#or Pu$lic %ealth issue

&ndcommonest cause of death and the ma#or cause of chronic

disa$ility Impact can $e de'astating( lea'ing a person )ith residual

impairment of physical( psychological( and social functions

*ength of time to reco'ery depends on stro!e se'erity

Assessment of reco'ery in indi'iduals after stro!e is important for

$oth clinical practice and research But selecting outcome measures is a di+cult process

Due to the 'arious aetiologies of stro!e( heterogeneity of symptoms('aria$ility in se'erity( and the possi$ility of spontaneous reco'ery

after stro!e

Despite comple,ities( se'eral strategies can facilitate the selectionin clinical trial research and practice-

American Heart Association. 2001 heart and stroke statistical update. Dallas, TX, 2000.

Carod-Artal J and et al (2000. !"ualit# o$ %i$e Amon& 'troke 'uriors )aluated 1 *ear A$ter 'troke + )perience o$ a 'troke nit.!

Journal o$ the American Heart Association ('troke !"+ 2/-000.oerts %, Counsell C. Assessment o$ clinical outcomes in acute stroke trials. 'troke 1342+35 61


4/33

The IC!International Classi"cation of unctionin#$ Health &

%isabilit'

Body Functions Activity Participation

Health Condition

(disorder / disease)

Environmental factors Personal factors

& Structure


5/33

De.nitions

In the conte,t of health/

Im(airments are pro$lems in $odyfunction or structure such as a signi.cant

de'iation or loss

Acti)it limitations are di+culties anindi'idual may ha'e in e,ecuting acti'ities

Partici(ation restrictions are pro$lemsan indi'idual may e,perience inin'ol'ement in life situations-


6/33

%isabilit &

Rehabilitation

Body Functions Activity Participation

Health Condition

(disorder / disease)

Environmental factors Personal factors

& Structure

Rehabilitation

optimising

Physiotherapyurgery

0ducation!ills training0mpo)erment

Ad'ocacyBuilding rampsA)areness raisingChanging attitudes


7/33

Psychometric properties Critical to the selection of any outcome measure

The essential psychometric properties are relia$ility('alidity( responsi'eness( and sensi$ility-

1alidity 1alidity is the a$ility of an instrument to measure )hat it

is intended to and presumed to measure-

Many types of 'alidity are referred to in the literature(such as face( content( discriminati'e( con'ergent(predicti'e( and criterion-

Of these( the most important are criterion and predicti'e

'alidity- Criterion alidit#refers to the performance of the

instrument against an e,ternal gold standard or theactual outcome that the test )as de'eloped to assess-

Heit7mann CA, 8aplan 9. Assessment o$ methods $or measurin& social support. Health :s#chol 134;+;/610.

'alter 8, Jutai JC, ?itensk# J. @ssues $or selection o$ outcome measures in stroke rehailitation+ @C= od#$unctions. Disail ehail 200/42;+11620;


8/33

Cont2d

:redictie alidit#is a form of criterion 'alidity and isthe degree to )hich a test can predict ho) )ell anindi'idual )ill do in a future situation-

Reliabilit This is the e,tent to )hich a score is free of random

error such that measurements for the same indi'idualon independent occasions or $y di3erent o$ser'ersproduce compara$le or appro,imate results

There are three $asic )ays to e'aluate the relia$ilityof a gi'en instrument/ internal consistency( interraterrelia$ility( and test4retest relia$ility

'alter 8, Jutai JC, ?itensk# J, ?a#le# 9. @ssues $or selection o$ outcome measures in strokerehailitation+ @C= participation. Disail ehail 200/42;+/0;6/23.

'alter 8, Jutai JC, ?itensk# J, ?a#le# 9. @ssues $or selection o$ outcome measures in strokerehailitation+ @C= actiit#. Disail ehail 200/42;+1/60.


9/33

Cont2d

test-retest reliailit# is the measure ofcorrespondence $et)een scores achie'ed $y the

same person on t)o di3erent times A suggested minimum test4retest relia$ility of 5-65

is proposed to e'aluate the on7going progress of anindi'idual in a treatment condition

The pro$lem is in ascertaining )hether o$ser'edchanges are due to chance( impro'ement ordeterioration o'er time

Turner . ehailitation+ issues in $unctional assessment. @n+ 'pilker ?, editor. "ualit# o$ li$e and pharmacoeconomics in clinicaltrials. :hiladelphia+ %ippincott-aen :ulishers4 15. p. 363/1.


10/33

Cont2d

inter-rater reliailit# pertains to the e,tent of correlationo$tained $et)een t)o or more o$ser'ers that assess samerespondent-

8enerally( 95: agreement $et)een o$ser'ers is the leastrequired

@nternal consistenc# reliailit#is the most commonly usedestimate of the relia$ility of an outcome measure-

It is the a'erage degree of association among the items ona test-

Cron$ach2s coe+cient ;alpha2 is used to e'aluate thee,tent of equi'alence and association $et)een responsesto items


11/33

Cont2d

>esponsi'eness >esponsi'eness is sensiti'ity to changes )ithin

patients o'er time( )hich may $e indicati'e oftherapeutic e3ects-

Most commonly e'aluated through correlation )ithother scores( e3ect si?es( standardi?ed response

means( relati'e e+ciency and sensiti'ity andspeci.city of change scores-

0-g-( )hen e,amining sensiti'ity to change in ane,pected direction( the standardi?ed e3ect methodcategori?es 5-@ as small( 5-@4 5-9 as moderate( and5-9 as large-

'alter 8, Jutai JC, ?itensk# J. @ssues $or selection o$ outcome measures in stroke rehailitation+ @C= od# $unctions.Disail ehail 200/42;+11620;.

'alter 8, Jutai JC, ?itensk# J, ?a#le# 9. @ssues $or selection o$ outcome measures in stroke rehailitation+ @C=participation. Disail ehail 200/42;+/0;6/23.


12/33

Cont2d

ensi$ility ensi$ility refers to the o'erall appropriateness( importance(

and ease of use of an instrument

It is a ma#or factor determining the success or failure of aclinical measure-

The primary consideration in choosing an outcome measure isthe correspondence $et)een the dimensions of the measureimpairment( acti'ity( or participation and the goals of theinter'ention and the study-

0-g-( if the goal of the inter'ention is to impro'e upper e,tremitymotor reco'ery( select measures that reect upper e,tremitymotor function-

In addition( the measures that are selected must not $e$urdensome for the patient( yet should capture the range oftheir a$ilities-

Duncan :e *ork+ =utura :ulishin&4 13. p. 22/620.


13/33

%as the measure $een used )ithin the stro!epopulation

An important factor to consider )hen e'aluating outcome measures2

psychometric properties is )hether or not the measure has pre'iously $eenused )ithin the stro!e population-

>elia$ility and 'alidity are not .,ed qualities of measures-

They should $e regarded as relati'e indicators of ho) )ell the instrumentmight function )ithin a gi'en sample or for a gi'en purpose-

ensiti'ity to change may li!e)ise $e condition7 or purpose speci.c-

0-g-( Barthel Inde, has a ceiling e3ect in stro!e patients )ith mild de.cits(

yet it may $e one of the most sensiti'e measures in patients )ith morese'ere impairments-

It is important for a measure to ha'e $een tested for use in the population)ithin )hich it )ill $e used

Ehen considering the use of an outcome measure or the time of

assessment( natural history of stro!e and stro!e se'erity should $econsidered-

%orent7


14/33

8eneric and Disease7peci.c Outcomemeasures

8eneric instruments Proposed to $e applica$le to e'eryone including

)ide range inter'entions

Allo) for comparisons $et)een groups )ith 'arious!inds of illnesses

They cannot address the pro$lem associated )ith aspeci.c diseased condition and may not $eresponsi'e to signi.cant ad#ustment in O*

8eneric measures are similar to intelligence test and

are of t)o essential categories pro.le andpreference7$ased-

?uck D and et al (2000. !)aluation o$ 9easures sed to Assess "ualit# o$ %i$e A$ter 'troke.! 'troke!"+ 200-2010.


15/33

Cont2d

%ealth pro.le e,plains %>o* in numerousdimensions including physical( functional(

psychological and social health and isstrategi?ed to produce scores on numerousdynamics of o*

Preference7$ased are utility measurements that

are designed to yield single summary 'aluenormally ranging from 5 for dead to G forcomplete health that co'er se'eral domains of

o*

In generic measures( some domains areapplica$le to all groups of patients $ut aspectse,ceptional to a particular condition may $e

lac!ing

Do#le :. J (2002. !9easurin& Health utcomes in 'troke 'uriors.! Arch :h#s 9ed ehail #!(2+ '-'.


16/33

Cont2d

0-g- ( Medical Outcomes hort7Form %ealth ur'eyF7H( IP 4 ic!ness Impact Pro.le IP(

Jottingham %ealth Pro.le J%P( 0uroqol 7D The hort Form7H F7H is the e,tensi'ely used

generic measure of %>o* tool that assessesphysical( psychological( and social functions

But )as disco'ered to su3er high oor and ceilinge3ects in some domains and there$y diminishing itscapa$ility to detect ad#ustment )ith regards to ol

Due to the limitations associated )ith the generic

measures( tro!e speci.c measures )ere de'elopedto deal )ith elements peculiar to tro!e patients

9ar&areth B. % and et al (200. !@mpact o$ chronic disease on Eualit# o$ li$e amon& the elderl# in the state o$ 'Fo :aulo, ?ra7il+ apopulation-ased stud#.! e :anam 'alud :ulicaG:an Am J :ulic Health

$%(+ 1-21.


17/33

Cont2d

Disease7speci.c instruments Measure o* only for distinct su$populations

In tro!e trials( they )ere de'eloped to deal )ith the items)hich are most pertinent to stro!e patients

Because of the greater a$ility to pinpoint signi.cantchanges( they are li!ely to $ecome the more suita$lemeasurement of post tro!e O*

Eea!ness stems from the fact that these scales are stillrelati'ely ne) and there are still not enough data a'aila$lefrom clinical trials

0-g- The tro!e Impact cale I( The tro!e peci.c

uality of *ife Measure 7O*( The tro!e Adaptedic!ness Impact Pro.le A7IPH5 -

Daina 8 and Daia (2005. !9easurement o$ Eualit# o$ li$e in stroke patients.! 9edicina (8aunas%$(+ ;0-;15.

8urcay 0 and et al &556- K%ealth >elated uality of *ife in .rst7e'er tro!e patients-K Ann audi Med*+G/ H7L5-


18/33

Purpose of Measurement Discriminati'e scales

"sed in $et)een7su$#ects e,perimental design Distinguished $et)een indi'iduals or groups )ith

respect to underlying dimension )hen no e,ternalcriterion or gold standard is a'aila$le for 'alidating

these measures 0-g( if one had t)o groups of patients )ith stro!e

and )anted to e,amine the di3erences $et)een thet)o groups in AD*s( one )ould require adiscriminati'e scale-

Bu#att BH, Jaeschke , =een# DH, :atrick D%. 9easurements inclinical trials+ choosin& the ri&ht approach. @n+ 'pilker ?,editor. "ualit# o$ li$e and pharmacoeconomics in clinical trials. :hiladelphia+ %ippincott-aen :ulishers4 15. p.16.


19/33

Cont2d

Predicti'e scales

"sed to classify indi'iduals in to a set ofprede.ned measurement categories )hen a goldstandard is a'aila$le

8old standard is later used to determine )hether

indi'iduals ha'e $een classi.ed correctly- 0-g-( an in'estigator had de'eloped a mo$ility

instrument that too! G hour to administer-Because an hour represents a rather long test( it)ould $e desira$le to ha'e a shorter 'ersion-One might choose a su$sample from the originaltest and e,amine the performance of the ne)(shorter instrument using the original as a goldstandard-


20/33

Cont2d

0'aluati'e scales

"sed to measure the e,tent of longitudinal changein an indi'idual or group )ithin su$#ectse,perimental design

Compare treatment e3ects $y loo!ing at changes inperformance )ithin each participant acrosstreatments-

Thus( for an e'aluati'e scale( )e might as! )hethera particular change in a patient2s AD* scorerepresents a tri'ial( small $ut important( moderate(

or large impro'ement or deterioration-

Bu#att BH, =een# DH, :atrick D%. 9easurin& health-related Eualit# o$ li$e. Ann @ntern 9ed 14113+5226 52-


21/33

0+cacy and 03ecti'eness trials 0+cacy trials

The goal of e+cacy trials is to optimi?e the chance ofdetecting a $iological e3ect )ith as fe) patients aspossi$le-

Because impairment scales may $e the mostsensiti'e to change and ha'e the greatest capacityto di3erentiate $et)een treatment groups( they are

particularly useful for e+cacy studies-

Thus( the study endpoint )ill most li!ely reect theimpairment the treatment is attempting to minimi?e-

9arch J', 'ila 'B, Compton ', 'hapiro 9, Cali , 8rishnan . The case $or practical clinical trials in ps#chiatr#. Am J :s#chiatr#200/4152+35635.

Deu#st B, ?o&ousslask# J. ecent pro&ress in dru& treatment $or acute stroke. J >eurol >eurosur& :s#chiatr# 145;+206 2/.

'troke Therap# Academic @ndustr# oundtale @@. ecommendations $or clinical trial ealuation o$ acute stroke therapies. 'troke200142+1/3 61505.


22/33

Cont2d

Duration of follo)7up for clinical endpoints

functional outcome does not need to e,ceed Hmonths in typical e+cacy studiesN shorter periodsmay $e possi$le-

A shorter time period )ill li!ely reduce 'ariation in

clinical outcome due to su$sequent e'entsunrelated to the study-

=uhrer 9J. erie o$ clinical trials in medical rehailitation+ impetuses, challen&es, and needed $uture directions. Am J :h#s 9edehail 200432+'3 6'1/.


23/33

Cont2d

03ecti'eness Trials The aim of e3ecti'eness trials is to determine )hether

inter'entions ha'e $ene.cial results )hen they areadministrated in the conte,t of ordinary clinical practice-

Principally concerned )ith the e,ternal 'alidity oftreatment outcomes-

tudies that focus on e3ecti'eness are $roadlyconceptuali?ed( use heterogeneous samples that arerecruited in a 'ariety of practice settings(

And are assessed not only for primary outcomes $ut alsofor a )ide range of outcomes rele'ant to pu$lic health(

such as co7mor$idity( quality of life( and coste3ecti'eness-

=uhrer 9J. erie o$ clinical trials in medical rehailitation+ mpetuses, challen&es, and needed $uture directions. Am J :h#s 9edehail 200432+'3 6'1/.


24/33

Cont2d

Participants tend to $e follo)ed for a longerduration( and data analysis can place greater

emphasis on di3erences among su$groups- 0nhance the generali?a$ility of a study( $ut

they may also introduce possi$le confounds

that allo) the results to $e attri$uted tofactors other than the inter'ention itself-

In e3ecti'eness studies( the most clinicallyrele'ant outcome must $e assessed- For the

most part( these )ill include acti'ities andparticipation measures-

'choenald '8, Hoa&ood 8. )ectieness, transportailit#, and dissemination o$ interentions+ hat matters henI

:s#chiatr 'er 20014/2+110 611;.


25/33

Cont2d

The most commonly used outcome measure ine3ecti'eness studies ha'e $een the Barthel Inde, andthe modi.ed >an!in scale

The tro!e Impact cale I has $een de'eloped to $e amore comprehensi'e measure of health outcomes forstro!e populations-

The I incorporates meaningful dimensions of function

and health7related quality of life into one self7reportquestionnaire-

The I 'ersion H includes @6 items and assesses eightdomains strength( hand function( AD* and IAD*( mo$ility(communication( emotion( memory and thin!ing( and

participation or role function-

?urns ?J. Children and eidence-ased practice. :s#chiatr Clin >orth Am 200425+//6;0


26/33

Methods of Data Acquisition

Inter'ie)er Administered Inter'ie)s

elf Administered uestionnaires

O$ser'ational Assessments

Telephone Administered

Assessments )ith patients or )ith pro,y

Face7face Method or Computeri?ed


27/33

Most commonly used tro!e Outcome Measures

Body tructure Impairments

Jeurological scales Jational Institutes of %ealth tro!e cale

Motor function

Fugl4Meyer Assessment Modi.ed Ash)orth

Cogniti'e scales Jeuro$eha'ioral Cognition tatus 0,am

Mini Mental tate 0,amination

peech and language functions Boston Diagnostic Aphasia 0,amination

Eestern Aphasia Battery

1isual perception

Motor7free 1isual Perception Test


28/33


Depression scales Bec! Depression In'entory Centre for 0pidemiologic tudies

Depression

8eriatric Depression cale

Acti'ities Acti'ities of Daily *i'ing

Barthel Inde,

Functional Independence Measure

Balance Berg Balance cale


29/33


Mo$ility and motor function Timed "p7and78o

G5 Meter )al!

Minutes )al!

Eolf Motor Function Test

Motor Assessment cale >i'ermead Motor Assessment

Motricity Inde,

Chedo!e McMaster tro!e Assessment cale

Modi.ed >an!in %andicap cale

Instrumental Acti'ities of Daily *i'ing Frenchay Acti'ities Inde,

Older Americans >esources and er'ices


30/33


Participation

%ealth status and quality of life Medical Outcomes tudy hort Form

tro!e peci.c uality of life

0uroo*7@D

tro!e Impact cale

ic!ness Impact Pro.le stro!e7adapted'ersion

Family Family assessment de'ice

Multidimensional cale of Percei'ed ocialupport


31/33

"ses of tro!e Outcome Measures Pro'ide 'alua$le information and strategies to $e utili?ed

$y health care pro'iders and professionals in their attemptto impro'e the quality of life of tro!e patients


32/33

"ses of tro!e Outcome Measures er'es to inform policy ma!ersN

7 >esource allocation7 Policy formulation in a resource poor country

Planning of reha$ilitation ser'ices as )ell as speci.ctherapeutics-

7 Indi'idual as )ell as macro le'el health careplanning and decision ma!ing

7 useful in the assessment of the e3ecti'eness( cost7$ene.t and cost7utility of 'arious old and emergingprophylactic( therapeutic and reha$ilitati'einter'entions

O'erseeing disease period( and for healtheconomics and planners2 designing ne) ideas andsolutions to the disclosed pro$lems


33/33

T%AJ YO"T%AJ YO"

This is not the end.'t is not even the(e)innin) of the end.*ut it is, perhaps, the endof the (e)innin)+

-inston Churchill

%o)e'er( Coming together is a$eginningN !eeping togetheris progressN )or!ing together issuccessQ Ford%-

Date post:	24-Feb-2018
Category:	Documents
Upload:	gursangeet-kaur
View:	216 times
Download:	0 times

Selection and Uses of Outcome Measures i

Documents