http://journals.sagepub.com/doi/full/10.1177/1747493017711813
Abstract
Finding,
testing and demonstrating efficacy of new treatments for stroke
recovery is a multifaceted challenge. We believe that to advance the
field, neurorehabilitation trials need a conceptually rigorous starting
framework. An essential first step is to agree on definitions of
sensorimotor recovery and on measures consistent with these definitions.
Such standardization would allow pooling of participant data across
studies and institutions aiding meta-analyses of completed trials, more
detailed exploration of recovery profiles of our patients and the
generation of new hypotheses. Here, we present the results of a
consensus meeting about measurement standards and patient
characteristics that we suggest should be collected in all future stroke
recovery trials. Recommendations are made considering time post stroke
and are aligned with the international classification of functioning and
disability. A strong case is made for addition of kinematic and kinetic
movement quantification. Further work is being undertaken by our group
to form consensus on clinical predictors and pre-stroke clinical data
that should be collected, as well as recommendations for additional
outcome measurement tools. To improve stroke recovery trials, we urge
the research community to consider adopting our recommendations in their
trial design.
Introduction
We must challenge the common assumption that most sensorimotor therapies are universally applicable and will achieve the same benefit for all people with stroke. The magnitude of change and likelihood of achieving clinically meaningful improvement in response to specific therapies will depend on age, stroke severity, and other factors including pre-existing comorbid conditions (e.g. diabetes, cognitive impairment, depression)5 and pre-stroke lifestyle factors (e.g. social engagement, exercise).6 The respective contributions of these factors have yet to be fully understood. Going forward, we need to identify the determinants that may help predict responders and non-responders to interventions.
The measurement working group of the Stroke Recovery and Rehabilitation Roundtable (SRRR)7 was established to develop recommendations for standardized assessment time points and measures to be included in all adult trials of sensorimotor recovery after stroke. Given the current lack of standards for data collection and heterogeneous reports in stroke recovery trials, our expert group also considered pre-stroke clinical, demographic and stroke-related data that should be collected to improve clinical prediction of recovery and characterization of patient cohorts.
The decision to focus on sensorimotor recovery reflects the volume of existing trials in this area, the range of outcomes currently in use across these trials, and the gap in current research that known international initiatives has not addressed (e.g. Core Outcome Measures in Effectiveness Trials Initiative (COMET), National Institute of Neurological Disorders and Stroke Common Data Elements (NINDS CDE), The International Consortium for Health Outcomes Measurement (ICHOM),8 Improving Research Outcome Measurement in Aphasia (ROMA)9 and Standardization of Measures in Arm Rehabilitation Trials after Stroke (SMART), Supplementary Table 1). Acknowledging that clinical measures cannot distinguish between true neurological repair (behavioral restitution) and use of compensatory strategies,10 a second objective was to consider whether we could recommend specific kinetic and/or kinematic outcomes that reflect quality of motor performance in order to better understand the neurophysiological changes that occur when patients improve.11,12 Our overall objective of the roundtable was to provide recommendations that, if applied, could improve the methodology of rehabilitation and recovery trials, help build our understanding of the trajectory of stroke recovery and aid discovery of new and more targeted treatments.
Methods
Development of core measurement set
Over five stages (Figure 1), our expert group developed the core measurement set. A ‘core’ measure was considered one that should be included in all stroke rehabilitation and recovery trials.
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