Outcome measurement in stroke: a scale selection strategy.

BACKGROUND AND PURPOSE Evaluating the impact of new treatments requires the use of reliable, valid, and responsive outcome measures. However, given the wide range of instruments currently available, it is not always straightforward for healthcare professionals to select the most appropriate tool. In this review, we propose a potential approach to scale selection. METHODS In designing a new study of the impact of a robotic device in stroke rehabilitation, we developed a three-stage scale selection strategy. First, two guidance documents (Medical Outcome Trust and Food and Drug Administration PRO Guidance) were reviewed to identify key scale assessment criteria. Second, consideration was given at a theoretical level of the concepts and domains relevant to the goals our study. Third, a comprehensive literature search strategy and review were developed in conjunction with healthcare professionals and psychometricians. Identified scales were appraised regarding their psychometric properties and clinical content. RESULTS Forty-five measures were initially identified and appraised. From a clinical content perspective, none of the measures were considered to be sufficient on their own to capture all the important outcome domains in this study. However, 3 measures were identified that best met our review criteria: Stroke Rehabilitation Assessment of Movement, Chedoke Arm and Hand Inventory, and ABILHAND. After the final stage of scale appraisal, two further upper limb scales (Fugl-Meyer and Action Research Arm Test) were included based on clinical content and study design issues. CONCLUSIONS Our three-stage review process appears to be a potentially useful approach for evidence-based scale selection in stroke rehabilitation studies.