We sought to (1) identify the outcome measures currently used across stroke arm rehabilitation randomized trials, (2) identify and compare outcomes important to stroke survivors, carers and clinicians and (3) describe where existing research outcome measures capture outcomes that matter the most to stroke survivors, carers and clinicians and where there may be discrepancies.
First, we systematically identified and extracted data on outcome measures used in trials within a Cochrane overview of arm rehabilitation interventions. Second, we conducted 16 focus groups with stroke survivors, carers and clinicians using nominal group technique, supplemented with eight semi-structured interviews, to identify these stakeholders’ most important outcomes following post-stroke arm impairment. Finally, we described the constructs of each outcome measure and indicated where stakeholders’ important outcomes were captured by each measure.
We extracted 144 outcome measures from 243 post-stroke arm rehabilitation trials. The Fugl-Meyer Assessment Upper Extremity section (used in 79/243 trials; 33%), Action Research Arm Test (56/243; 23%), and modified Ashworth Scale (53/243; 22%) were most frequently used. Stroke survivors (n = 43), carers (n = 10) and clinicians (n = 58) identified 66 unique, important outcomes related to arm impairment following stroke. Between one and three outcomes considered important by the stakeholders were captured by the three most commonly used assessments in research.
Up to 77% of stroke survivors experience upper limb (arm) impairment,1 which affects function2 and reduces health-related quality of life.3 Rehabilitation strategies, including those for the arm after stroke, should be based on research evidence. However, only moderate-quality evidence supports the use of interventions to rehabilitate the arm in current clinical practice.4 There is a demand from stroke survivors, carers, clinicians and researchers for research into interventions to improve arm function after stroke.5,6
Efficacy of interventions should be demonstrated using measures that accurately and consistently capture change following treatment.7 Researchers currently use a wide range of measures to assess the efficacy of arm interventions after stroke within randomized controlled trials; recent work has identified at least 48 arm-related measures,8 indicating heterogeneity in what is in current use, as well as the wide range of possible targets for arm interventions including specific impairments, spasticity, pain or task-specific function. The measures in current use are highly varied in their focus and methods, impacting on researchers’ ability to compare and aggregate data from different studies to examine overall efficacy. Consensus on appropriate measures would enhance our ability to detect efficacy of interventions through pooled analysis.9 It has been acknowledged that selection of measures for use in trials should capture domains of importance to patients, carers and clinicians, consider the psychometric properties of measures, and feasibility for use in clinical and research settings.10,11
There is a need for consensus on measure use in post-stroke arm rehabilitation trials.8 The Core Outcome Measures in Effectiveness Trials (COMET) initiative10,12 provides guidance on development of consensus recommendations, highlighting the importance of targeting outcomes that are important and relevant to patients and clinicians.
Considering the views of stroke survivors, clinicians and researchers, the National Institute for Neurological Disorders and Stroke-Common Data Element13 recommends items for inclusion as part of standardized data collection across all stroke trials, and the International Consortium for Health Outcomes Measurement recommends measures for standardized data collection in stroke clinical practice.14 Other recommendations exist for general stroke outcomes and reflect physicians’ opinions on important outcomes according to the World Health Organization International Classification of Functioning, Disability and Health framework.15
The Stroke Recovery and Rehabilitation Round Table, consisting of researchers and clinicians, has generated consensus recommendations for core data collection across sensorimotor stroke rehabilitation trials, including a recommendation to use the Action Research Arm Test for measurement of arm activity limitation across trials.16 In addition, work has been completed to describe the psychometric properties of 53 available arm measures17 in order to inform selection. However, due to the wide-ranging impact of stroke on people’s lives,18 arm-specific measures are unlikely to capture all important outcomes.
To date, there is no clear consensus recommendation for the selection of measures in post-stroke arm rehabilitation randomized trials. Furthermore, there is a lack of information about which outcomes are most meaningful to stroke survivors, carers and clinicians. With a view to inform recommendations for selecting measures in future trials, we sought to investigate (1) existing measures used in post-stroke arm rehabilitation research studies, (2) outcomes important to stroke survivors, their carers and practising clinicians and (3) where important outcomes are captured by existing measures.[…]
Continue —-> Outcome measures in post-stroke arm rehabilitation trials: do existing measures capture outcomes that are important to stroke survivors, carers, and clinicians? – Julie Duncan Millar, Frederike van Wijck, Alex Pollock, Myzoon Ali, 2019