Outcome Measures In Stroke - EBRSR

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EBRSR[Evidence-Based Review of Stroke Rehabilitation]20Outcome Measures in StrokeRehabilitationKatherine Salter PhD (cand.), Nerissa Campbell PhD, Marina Richardson MSc, Swati Mehta PhD (cand.),Jeffrey Jutai PhD, Laura Zettler MSc, Matthew Moses BA, Andrew McClure MSc, Rachel Mays BSc (cand.),Norine Foley MSc, Robert Teasell MDLast Updated: September 2013AbstractTo enhance the clinical meaningfulness of the SREBR, the present review provides the best availableinformation on how outcome measures might be classified and selected for use, based upon theirmeasurement qualities. For this purpose, we have selected for review some of the most commonly-usedmeasures in stroke rehabilitation. The ICF conceptual framework is used to classify measures in strokerehabilitation and aspects of measurement theory pertinent for evaluating measures are discussed.Each measure reviewed in this chapter was evaluated in terms of appropriateness, reliability, validity,responsiveness, precision, interpretability, applicability and feasibility. All measures were assessed forthe thoroughness with which its reliability, validity and responsiveness have been reported. The presentdocument contains summary reviews of 38 assessment tools used in the evaluation of Body Structure(14 tools), Activity (15 tools) and Participation (9 tools) outcomes.20. Outcome Measures in Stroke Rehabilitationpg. 1 of 141www.ebrsr.com

Table of ContentsAbstract . 1Table of Contents. 220.1 Introduction. 420.1.1 Domains of Stroke Rehabilitation.420.1.2 Evaluation Criteria for Outcome Measures.620.1.3 Has the Measure Been Used in a Stroke Population? .820.1.4 Has the Measure Been Tested for Use with Proxy Assessment?.820.1.5 What is the Recommended Timeframe for Measurement? .920.2 Body Structure/Impairment Outcome Measures . 920.2.1 Beck Depression Inventory (BDI) .1020.2.2 Behavioral Inattention Test (BIT) .1120.2.3 Canadian Neurological Scale (CNS) .1520.2.4 Clock Drawing Test (CDT) .1620.2.5 Frenchay Aphasia Screening Test (FAST).1820.2.6 Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) .2020.2.7 General Health Questionnaire – 28 (GHQ-28) .2220.2.8 Geriatric Depression Scale (GDS).2420.2.9 Hospital Anxiety and Depression Scale (HADS) .2620.2.10 Line Bisection Test (LBT) .2820.2.11 Mini-Mental State Examination (MMSE).2920.2.12 Modified Ashworth Scale (MAS) .3120.2.13 Montreal Cognitive Assessment (MoCA).3320.2.14 Motor-free Visual Perception Test (MVPT) .3520.2.15 National Institutes of Health Stroke Scale (NIHSS) .3620.2.16 Orpington Prognostic Scale (OPS).3820.2.17 Stroke Rehabilitation Assessment of Movement (STREAM) .4020.3 Activity/Disability Outcome Measures . 4220.3.1 Action Research Arm Test (ARAT) .4220.3.2 Barthel Index (BI).4320.3.3 Berg Balance Scale (BBS) .4620.3.4 Box and Block Test (BBT).4820.3.5 Chedoke-McMaster Stroke Assessment Scale (CMSA) .4920.3.6 Chedoke Arm and Hand Activity Inventory (CAHAI).5020.3.7 Clinical Outcome Variables (COVS) .5220.3.8 Functional Ambulation Categories (FAC) .5320.3.9 Functional Independence Measure (FIM).5420.3.9.1 Barthel Index vs. the Functional Independence Measure .5620.3.9.2 CIHI - National Rehabilitation Reporting System .5720.3.10 Frenchay Activities Index (FAI) .5720.3.11 Modified Rankin Handicap Scale (MRS) .6020.3.12 Motor Assessment Scale (MAS).6220.3.13 Nine-hole Peg Test (NHPT) .6420.3.14 Rivermead Mobility Index (RMI) .6620.3.15 Rivermead Motor Assessment (RMA).6720.3.16 Six-Minute Walk Test (6MWT) .6820. Outcome Measures in Stroke Rehabilitationpg. 2 of 141www.ebrsr.com

20.3.17 Timed “Up & Go” Test (TUG) .7120.3.18 Wolf Motor Function Test .7320.4 Participation/Handicap Outcome Measures. 7620.4.1 Canadian Occupational Performance Measure (COPM) .7620.4.2 EuroQol Quality of Life Scale (EQ5D) .7920.4.3 LIFE-H (Assessment of Life Habits) .8120.4.4 London Handicap Scale (LHS) .8320.4.5 Medical Outcomes Study Short Form 36 (SF-36).8520.4.6 Nottingham Health Profile (NHP) .8720.4.7 Reintegration to Normal Living Index (RNLI) .8920.4.8 Stroke-Adapted Sickness Impact Profile (SA-SIP-30).9120.4.9 Stroke Impact Scale (SIS) .9320.4.10 Stroke Specific Quality of Life Scale (SSQOL) .9420.5 Conclusions and Recommendations . 9520.5.1 Evaluation Summaries by ICF Category .96References . 10020. Outcome Measures in Stroke Rehabilitationpg. 3 of 141www.ebrsr.com

20.1 IntroductionMeasuring the effectiveness of interventions is accepted as being central to good practice. Van derPutten et al. (1999) pointed out that measuring the outcome of health care is a “central component ofdetermining therapeutic effectiveness and, therefore, the provision of evidence-based healthcare,” (vander Putten et al. 1999).The Stroke Rehabilitation Evidence-Based Review (SREBR) is a landmark achievement in consolidatingthe best-available scientific evidence for the effectiveness of stroke rehabilitation. But, there arelimitations to successfully transferring the research results to clinical practice and service delivery. Someare imposed by the current state of outcome measurement in stroke rehabilitation. Limitations includethe lack of consensus on the selection of measures to best address and balance the needs and values ofstakeholders in stroke rehabilitation, including patients and their caregivers, practitioners, and healthcare decision makers. Ultimately, the comparison of size and direction of statistical results across areasof stroke rehabilitation covered within the SREBR will be most meaningfully interpreted when it is clearthat comparable approaches to outcome measurement have been used (Jutai & Teasell 2003). Toenhance the clinical meaningfulness of the SREBR, we present the best available information on howoutcome measures might be classified and selected for use, based upon their measurement qualities.For this purpose, we have selected for review only some of the more commonly used measures in strokerehabilitation. We do not intend this to be a comprehensive compendium of stroke outcome measures.In this chapter, we attempt to describe how the ICF (WHO 2001, 2002) conceptual framework can beused for classifying outcome measures in stroke rehabilitation, and summarize aspects of measurementtheory that are pertinent for evaluating measures. We also give a template presentation on thecharacteristics, application, reliability, validity, and other clinimetric qualities of commonly usedmeasures in a format for easy reference. For a more extensive discussion of outcome measurementtheory and properties in rehabilitation, we refer the reader to the book authored by Finch et al. (2002).This chapter will present only the information most relevant for stroke rehabilitation.20.1.1 Domains of Stroke RehabilitationOutcomes research requires a systematic approach to describing outcomes and classifying themmeaningfully. The study and assessment of stroke rehabilitation has sparked the development ofnumerous outcome measures applicable to one or more of its many dimensions. In attempting todiscuss some of the commonly used measures available for use within the field of stroke rehabilitation,it is useful to have guidelines available for classifying these tools. The WHO International Classification ofFunctioning, Disability and Health (ICF: WHO, 2001, 2002) provides a multi-dimensional framework forhealth and disability suited to the classification of outcome instruments.Originally published in 1980, the WHO framework has undergone several revisions. In the most recentversion, the ICF framework (2001, 2002) identifies three primary levels of human functioning – the bodyor body part, the whole person and the whole person in relation to his/her social context. Outcomesmay be measured at any of these levels -- Body functions/structure (impairment); Activities (refers tothe whole person – formerly conceived as disability in the old ICIDH framework) and Participation(formerly referred to as handicap). Activity and participation are affected by environmental andpersonal factors (referred to as contextual factors within the ICF).Table 20.1.1 ICF Definitions20. Outcome Measures in Stroke Rehabilitationpg. 4 of 141www.ebrsr.com

Old TerminologyNew TerminologyImpairmentBody ipationDefinition-Physiological functions of body systems includingpsychological. Structures are anatomical parts or regions oftheir bodies and their components. Impairments areproblems in body function or structure.-The execution of a task by an individual. Limitations inactivity are defined as difficulties an individual mightexperience in completing a given activity.-Involvement of an individual in a life situation. Restrictions toparticipation describe difficulties experienced by theindividual in a life situation or role.Outcome measures can also be conceived of as falling along a continuum of measurement moving frommeasurements at the level of body function or structure to those focused on participation and lifesatisfaction. The number of other, non-treatment, variables external to healthcare present that couldaccount for change increases as one moves away from body structure toward life satisfaction, makingoutcomes much more difficult to define and assess (Brenner et al. 1995; Roberts & Counsell 1998).If a classification is to be useful for scientific research, the basic categories and concepts within it needto be measurable, and their boundaries clear and distinct. It is not yet clear from the research evidencethat the three ICF categories completely fulfill these criteria. Nonetheless, when applied to outcomeassessment in stroke rehabilitation the ICF conceptual framework can be used to place outcomemeasures into one of the three categories depending upon what it is they purport to measure. However,outcome measures rarely fit neatly into a single category. More often, they assess elements belongingto more than one domain. For the purposes of this discussion, measures have been classified accordingto the level of assessment they include furthest along a continuum from body function, through activity,to participation. The instruments appearing in the Participation domain, for instance, assess elementsfrom all domains including those reflective of participation in life situations such as social functioning orroles. While these measures have been used to assess health-related quality of life, it is not our intent todefine such a construct or its assessment here.Table 20.1.2 Classification of Outcome Measures*Body structure (impairments)Activities (limitations to activity–disability)Beck Depression InventoryAction Research Arm TestBehavioral Inattention TestBarthel IndexCanadian Neurological ScaleBerg Balance ScaleClock Drawing TestBox and Block TestFrenchay Aphasia Screening TestChedoke McMaster Stroke AssessmentFugl-Meyer AssessmentScaleGeneral Health Questionnaire -28Chedoke Arm and Hand Activity InventoryGeriatric Depression ScaleClinical Outcome Variables ScaleHospital Anxiety and Depression ScaleFunctional Ambulation CategoriesLine Bisection TestFunctional Independence MeasureMini Mental State ExaminationFrenchay Activities IndexModified Ashworth ScaleMotor Assessment ScaleMontreal Cognitive AssessmentNine-hole Peg TestMotor-free Visual Perception TestRankin Handicap ScaleNational Institutes of Health StrokeRivermead Mobility ScaleScaleRivermead Motor Assessment20. Outcome Measures in Stroke RehabilitationParticipation (barriers to participation-handicap)Canadian Occupational PerformanceMeasureEuroQol Quality of Life ScaleLIFE-HLondon Handicap ScaleMedical Outcomes Study Short- Form36Nottingham Health ProfileReintegration to Normal Living IndexStroke Adapted Sickness Impact ProfileStroke Impact ScaleStroke Specific Quality of Lifepg. 5 of 141www.ebrsr.com

Orpington Prognostic ScaleStroke Rehabiliation Assessment ofMovementSix Minute Walk TestTimed Up and GoWolf Motor Function Test*Based on tables presented in Roberts & Counsell (1998) and Duncan et al. (2000).20.1.2 Evaluation Criteria for Outcome MeasuresWhile it is useful to have this framework within which to classify levels of outcomes measures, it isnecessary to have a set of criteria to guide the selection of outcomes measures. Reliability, validity andresponsiveness have widespread usage and are discussed as being essential to the evaluation ofoutcome measures (Duncan et al. 2002; Law & MacDermid 2002; Roberts & Counsell 1998; van derPutten et al. 1999). Finch et al. provide a good tutorial on issues for outcome measure selection (Finchet al. 2002).The Health Technology Assessment (HTA) programme (Fitzpatrick et al. 1998) examined 413 articlesfocusing on methodological aspects of the use and development of patient-based outcome measures. Intheir report, they recommend the use of 8 evaluation criteria. Table 20.1.2.1 lists the criteria and gives adefinition for each one. It also identifies a recommended standard for quantifying (rating) each criterion,where applicable, and how the ratings should be interpreted. The table, including some additionalconsiderations described below, was applied to each of the outcome measures reviewed in this chapter.Table 20.1.2.1 Evaluation Criteria and tyDefinitionStandardThe match of the instrument to thepurpose/question under study. One mustdetermine what information is required and whatuse will be made of the information gathered(Wade 1992)- Refers to the reproducibility and internalconsistency of the instrument.- Reproducibility addresses the degree to whichthe score is free from random error. Test re-test& inter-observer reliability both focus on thisaspect of reliability and are commonly evaluatedusing correlation statistics including ICC,Pearson’s or Spearman’s coefficients and kappacoefficients (weighted or unweighted).- Internal consistency assesses the homogeneityof the scale items. It is generally examined usingsplit-half reliability or Cronbach’s alpha statistics.Item-to-item and item-to scale correlations arealso accepted methods.Depends upon the specific purpose for which themeasurement is intended.Test-retest or interobserver reliability (ICC; kappastatistics): 1Excellent: 0.75;Adequate: 0.4 – 0.74;Poor: 0.40Note: Fitzpatrick et al. (1998) recommend aminimum test-retest reliability of 0.90 if themeasure is to be used to evaluate the ongoingprogress of an individual in a treatment situation.Internal consistency (split-half or Cronbach’s statistics):Excellent: 0.80;Adequate: 0.70 – 0.79;Poor 0.70 2Note: Fitzpatrick et al. (1998) caution values inexcess of 0.90 may indicate redundancy.Inter-item & item-to-scale correlation coefficients:-Adequate levels -- inter-item: between 0.3 and 0.9;item-to-scale: between 0.2 and 0.9 3Does the instrument measure what it purports to Construct/convergent and concurrent correlations:measure? Forms of validity include face, content, Excellent: 0.60, Adequate: 0.31 - 0.59, Poor: 20. Outcome Measures in Stroke Rehabilitationpg. 6 of 141www.ebrsr.com

tyFeasibilityconstruct, and criterion. Concurrent, convergentor discriminative, and predictive validity are allconsidered to be forms of criterion validity.However, concurrent, convergent anddiscriminative validity all depend on the existenceof a “gold standard” to provide a basis forcomparison. If no gold standard exists, theyrepresent a form of construct validity in whichthe relationship to another measure ishypothesized (Finch et al. 2002).Sensitivity to changes within patients over time(which might be indicative of therapeutic effects).Responsiveness is most commonly evaluatedthrough correlation with other change scores,effect sizes, standardized response means,relative efficiency, sensitivity & specificity ofchange scores and ROC analysis.Assessment of possible floor and ceiling effects isincluded as they indicate limits to the range ofdetectable change beyond which no furtherimprovement or deterioration can be noted.Number of gradations or distinctions within themeasurement. E.g. Yes/no response vs. a 7-pointLikert response setHow meaningful are the scores? Are thereconsistent definitions and classifications forresults? Are there norms available forcomparison?How acceptable the scale is in terms ofcompletion by the patient – does it represent aburden? Can the assessment be completed byproxy, if necessary?Extent of effort, burden, expense & disruption tostaff/clinical care arising from the administrationof the instrument.0.304ROC analysis – AUC: Excellent: 0.90, Adequate:0.70 – 0.89, Poor: 0.70 5There are no agreed on standards by which to judgesensitivity and specificity as a validity index (Riddle& Stratford, 1999)Sensitivity to change:Excellent:Evidence of change in expected direction usingmethods such as standardized effect sizes: 0.5 small;0.5 – 0.8 moderate 0.8 large)Also, by way of standardized response means, ROCanalysis of change scores (area under the curve –see above) or relative efficiency.Adequate:Evidence of moderate/less change than expected;conflicting evidence.Poor:Weak evidence based solely on p-values (statisticalsignificance) 6Floor/Ceiling Effects:Excellent: No floor or ceiling effectsAdequate: floor and ceiling effects 20% of patientswho attain either the minimum (floor) or maximum(ceiling) score.Poor: 20%. 7Depends on the precision required for the purposeof the measurement (e.g., classification, evaluation,prediction).Jutai & Teasell (2003) point out these practicalissues should not be separated from considerationof the values that underscore the selection ofoutcome measures. A brief assessment ofpracticality will accompany each summaryevaluation.Unless otherwise noted within the table, criteria and definitions: Fitzpatrick et al. (1998); McDowell & Newell (1996). Sources for evaluationstandards: 1Andresen (2000); Hseuh et al. (2001); Wolfe et al. (1991); 2Andresen (2000);3Hobart et al. (2001); Fitzpatrick et al. (1998);4,6Andresen (2000); McDowell & Newell (1996); Fitzpatrick et al. (1998); Cohen et al. 2000; 5McDowell & Newell (1996); 7Hobart et al. (2001).Each measure reviewed in this chapter was also assessed for the thoroughness with which its reliability,validity and responsiveness have been reported in the literature. Standards for evaluation of rigor wereadapted from McDowell & Newell (1996) and Anderson (2000).20. Outcome Measures in Stroke Rehabilitationpg. 7 of 141www.ebrsr.com

Table 20.1.2.2 Evaluation Standards – RigorThoroughness or Rigorof testingExcellent – most major forms of testing reported.Adequate – several studies and/or several types of testing reportedPoor – minimal information is reported and/or few studies (other than author’s)N/a – no information availableAssessments of rigor using the above standards are given along with evaluation ratings for reliability,validity and responsiveness for each measure (see Table 20.1.2.3, below).Table 20.1.2.3 Evaluation RigorResponsivenessResultsFloor/ceilingNOTE: Excellent; Adequate; Poor; n/a insufficient information; TR Test re-test; IC internal consistency; IO Interobserver; varied(re. floor/ceiling effects; mixed results)Ratings of (excellent), (adequate) and (poor) are assigned based on the criteria and evidencepresented in the standards column of Table 20.3. For example, If a rating of “ ” or excellent is givenfor validity, it means that evidence has been presented demonstrating excellent construct validity basedon the standards provided and in various forms including convergent and discriminant validity.In addition to the criteria outlined above, 3 additional issues were considered:Has the measure been used in a stroke population?Has the measure been tested for use with proxy assessment?What is the recommended time frame for measurement?20.1.3 Has the Measure Been Used in a Stroke Population?Reliability and validity are not fixed qualities of measures. They should be regarded as relative indicatorsof how well the instrument might function within a given sample or for a given purpose (Fitzpatrick et al.1998; Lorentz et al. 2002). Responsiveness, too, may be condition or purpose specific. Van der Putten etal., (1999) for example, found the Barthel Index and the FIM exhibited greater effect sizes among strokepatients than among MS patients concluding that responsiveness of instruments seems disease- orcondition- dependent. Therefore, it is important for a measure to have been tested for use in thepopulation within which it will be used.Measures developed for generic use cannot focus on the problems associated with any one conditionand, therefore, may not be sensitive to problems inherent in the stroke population (Buck et al. 2000). Ina discussion of health-related quality of life measurement, Williams et al. (1999) point out that genericmeasures may not include particular assessments of importance in stroke (such as arm and hand orlanguage assessments).20.1.4 Has the Measure Been Tested for Use with Proxy Assessment?When assessment is conducted in such a way as to require a form of self-report (e.g. interview orquestionnaire – in person, by telephone or by mail), stroke survivors who have experienced significantcognitive or speech and language deficits may not be able to complete such measures and therefore,20. Outcome Measures in Stroke Rehabilitationpg. 8 of 141www.ebrsr.com

may be excluded from assessment. In such cases, the use of a proxy respondent becomes an importantalternative source of information. However, the use of proxy respondents should be approached with adegree of caution.In studies of proxy assessments, a tendency has been reported for family members or significant othersto assess the patient as more disabled than they appear on other measures of functional disability,including self-reported methods. This discrepancy becomes more pronounced among patients withmore impaired levels of functioning (Hachisuka et al. 1997; Segal et al. 1996; Sneeuw et al. 1997).Hachisuka et al. (1997) suggested that this discrepancy could be explained by a difference ininterpretation. Proxy respondents may be rating actual, observable performance, while patients mayrate their perceived capability – what they think they are capable of doing rather than what theyactually do.Unfortunately, use of a healthcare professional as a substitute for the family member or significantother as proxy does not solve the problem of reliability. A similar discrepancy has been noted in ratingswhen using healthcare professionals as proxy respondents though in the opposite direction. They maytend to rate patients higher than the patients themselves would (McGinnis et al. 1986; Sneeuw et al.1997). It has been suggested that, in this case, the discrepancy is due to a difference in frame ofreference. A healthcare professional may use a different, more disabled group, as a reference normwhereas the patient would only compare him/herself to pre-stroke conditions (McGinnis et al. 1986).20.1.5 What is the Recommended Timeframe for Measurement?The natural history of stroke presents problems in assessment in that the rate and extent of change inoutcomes varies across the different levels of ICF classification (Duncan et al. 2000). The further onemoves along the outcome continuum from body structure t

Barthel Index Berg Balance Scale Box and Block Test Chedoke McMaster Stroke Assessment Scale Chedoke Arm and Hand Activity Inventory Clinical Outcome Variables Scale Functional Ambulation Categories Functional Independence Measure Frenchay Activities Index Motor Assessment Scale Nine-hole Peg Test Rankin Handicap Scale Rivermead Mobility Scale

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