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      Consensus-Based Core Set of Outcome Measures for Clinical Motor Rehabilitation After Stroke—A Delphi Study

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          Abstract

          Introduction: Outcome measures are key to tailor rehabilitation goals to the stroke patient's individual needs and to monitor poststroke recovery. The large number of available outcome measures leads to high variability in clinical use. Currently, an internationally agreed core set of motor outcome measures for clinical application is lacking. Therefore, the goal was to develop such a set to serve as a quality standard in clinical motor rehabilitation poststroke.

          Methods: Outcome measures for the upper and lower extremities, and activities of daily living (ADL)/stroke-specific outcomes were identified and presented to stroke rehabilitation experts in an electronic Delphi study. In round 1, clinical feasibility and relevance of the outcome measures were rated on a 7-point Likert scale. In round 2, those rated at least as “relevant” and “feasible” were ranked within the body functions, activities, and participation domains of the International Classification of Functioning, Disability, and Health ( ICF). Furthermore, measurement time points poststroke were indicated. In round 3, answers were reviewed in reference to overall results to reach final consensus.

          Results: In total, 119 outcome measures were presented to 33 experts from 18 countries. The recommended core set includes the Fugl–Meyer Motor Assessment and Action Research Arm Test for the upper extremity section; the Fugl–Meyer Motor Assessment, 10-m Walk Test, Timed-Up-and-Go, and Berg Balance Scale for the lower extremity section; and the National Institutes of Health Stroke Scale, and Barthel Index or Functional Independence Measure for the ADL/stroke-specific section. The Stroke Impact Scale was recommended spanning all ICF domains. Recommended measurement time points are days 2 ± 1 and 7; weeks 2, 4, and 12; 6 months poststroke and every following 6th month.

          Discussion and Conclusion: Agreement was found upon a set of nine outcome measures for application in clinical motor rehabilitation poststroke, with seven measurement time points following the stages of poststroke recovery. This core set was specifically developed for clinical practice and distinguishes itself from initiatives for stroke rehabilitation research. The next challenge is to implement this clinical core set across the full stroke care continuum with the aim to improve the transparency, comparability, and quality of stroke rehabilitation at a regional, national, and international level.

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          Most cited references29

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          The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument

          Background: COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. Method: In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. Conclusions: In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments.
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            Standardized measurement of sensorimotor recovery in stroke trials: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.

            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.
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              Fugl-Meyer assessment of sensorimotor function after stroke: standardized training procedure for clinical practice and clinical trials.

              Outcome measurement fidelity within and between sites of multi-site, randomized, clinical trials is an essential element to meaningful trial outcomes. As important are the methods developed for randomized, clinical trials that can have practical utility for clinical practice. A standardized measurement method and rater training program were developed for the total Fugl-Meyer motor and sensory assessments; inter-rater reliability was used to test program effectiveness. Fifteen individuals with hemiparetic stroke, 17 trained physical therapists across 5 regional clinical sites, and an expert rater participated in an inter-rater reliability study of the Fugl-Meyer motor (total, upper extremity, and lower extremity subscores) and sensory (total, light touch, and proprioception subscores) assessments. Intra-rater reliability for the expert rater was high for the motor and sensory scores (range, 0.95-1.0). Inter-rater agreement (intraclass correlation coefficient, 2, 1) between expert and therapist raters was high for the motor scores (total, 0.98; upper extremity, 0.99; lower extremity, 0.91) and sensory scores (total, 0.93; light touch, 0.87; proprioception, 0.96). Standardized measurement methods and training of therapist assessors for a multi-site, rehabilitation, randomized, clinical trial resulted in high inter-rater reliability for the Fugl-Meyer motor and sensory assessments. Poststroke sensorimotor impairment severity can be reliably assessed for clinical practice or rehabilitation research with these methods.
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                Author and article information

                Contributors
                Journal
                Front Neurol
                Front Neurol
                Front. Neurol.
                Frontiers in Neurology
                Frontiers Media S.A.
                1664-2295
                02 September 2020
                2020
                : 11
                : 875
                Affiliations
                [1] 1Department of Neurology, University of Zurich and University Hospital Zurich , Zurich, Switzerland
                [2] 2Department of Rehabilitation Sciences, KU Leuven—University of Leuven , Leuven, Belgium
                [3] 3Institute of Neuroscience and Physiology, Clinical Neuroscience, University of Gothenburg , Gothenburg, Sweden
                [4] 4Department of Neurology and Department of Clinical Research, University of Basel , Basel, Switzerland
                [5] 5Neurorehabilitation Unit and University Center for Medicine of Aging and Rehabilitation, Felix Platter Hospital, University of Basel , Basel, Switzerland
                [6] 6Department of Neurology, University of Greifswald , Greifswald, Germany
                [7] 7German Center for Neurodegenerative Diseases , Greifswald, Germany
                [8] 8TECNALIA, Basque Research and Technology Alliance (BRTA), Neurorehabilitation Area at the Health Division , Donostia-San Sebastian, Spain
                [9] 9Department of Rehabilitation Medicine, Amsterdam Neuroscience and Amsterdam Movement Sciences, Amsterdam University Medical Centre , Amsterdam, Netherlands
                [10] 10Department Non-acquired-brain Injuries, Amsterdam Rehabilitation Centre Reade , Amsterdam, Netherlands
                [11] 11Gerontechnology and Rehabilitation Group, University of Bern , Bern, Switzerland
                [12] 12Artorg, Center for Biomedical Engineering Research, University of Bern , Bern, Switzerland
                [13] 13Department of Movement and Clinical Neuroscience, UCL Queen Square Institute of Neurology , London, United Kingdom
                [14] 14The National Hospital for Neurology and Neurosurgery, Queen Square , London, United Kingdom
                [15] 15cereneo, Center for Neurology and Rehabilitation , Vitznau, Switzerland
                Author notes

                Edited by: Stefano Tamburin, University of Verona, Italy

                Reviewed by: Ning Cao, Moss Rehabilitation Hospital, United States; Alessandro Giustini, Istituto di Riabilitazione Santo Stefano, Italy; Catherine E. Lang, Santo Stefano Rehabilitation Group, Italy

                *Correspondence: Janne Marieke Veerbeek janne.veerbeek@ 123456usz.ch

                This article was submitted to Neurorehabilitation, a section of the journal Frontiers in Neurology

                Article
                10.3389/fneur.2020.00875
                7496361
                33013624
                6089de57-7a43-463e-8bcb-1bb2f02e1e2a
                Copyright © 2020 Pohl, Held, Verheyden, Alt Murphy, Engelter, Flöel, Keller, Kwakkel, Nef, Ward, Luft and Veerbeek.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 17 January 2020
                : 09 July 2020
                Page count
                Figures: 2, Tables: 3, Equations: 0, References: 44, Pages: 9, Words: 6271
                Categories
                Neurology
                Original Research

                Neurology
                stroke,motor rehabilitation,clinical,outcome measures,delphi study
                Neurology
                stroke, motor rehabilitation, clinical, outcome measures, delphi study

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