Methodological Issues in Rehabilitation Research: A Scoping Review.

OBJECTIVE: To identify, synthesize, and categorize the methodological issues faced by the rehabilitation field. DATA SOURCES: A scoping review was conducted using studies identified in MEDLINE, the Cochrane Library, EMBASE, Web of Science, Scopus, Physiotherapy Evidence Database, and Google Scholar up to August 2018. STUDY SELECTION: We included all type of publications describing methodological issues in rehabilitation research where rehabilitation is described as a multimodal process. The methodological issues have been categorized and classified. DATA EXTRACTION: The synthesis included qualitative and quantitative analysis. To focus the attention on rehabilitation, we post hoc divided in "specific issues" (highly related to, even if not exclusive of, rehabilitation research) and "generic issues" (common in biomedical research). DATA SYNTHESIS: Seventy-one publications were included: 68% were narrative reviews, 15% systematic reviews, 7% editorials, 4% meta-epidemiologic studies, and 5% others. Specific methodological issues include the following: problematic application of randomized controlled trials (32%), absent definition of core outcome sets (28%), poor interventions description (22%), weak methodological (conducting) and reporting quality (21%), scarce clinical practice applicability (14%), lack of blinding assessor (10%), inadequate randomization methods or inadequate allocation concealment (8%), and inadequate participants description and recruitment (8%). "Generic" issues included the following: data and statistical description (31%), authors' methodological training (7%), peer review process (6%, n=4), funding declaration (6%), ethical statement (3%), protocol registration (3%), and conflict of interest declaration (1%). CONCLUSIONS: Methodological and reporting issues might influence the quality of the evidence produced in rehabilitation research. The next steps to move forward in the field of rehabilitation could be to evaluate the influence of all these issues on the validity of trial results through meta-epidemiologic studies and to develop specific checklists to provide guidance to authors to improve the reporting and conduct of trials in this field.

Tools to Assess the Risk of Bias and Reporting Quality of Randomized Controlled Trials in Rehabilitation.

OBJECTIVES: (1) To determine whether new tools and items have been developed to evaluate the risk of bias (RoB) and reporting of randomized controlled trials (RCTs) in rehabilitation; (2) to determine which items are included in the existing reporting guidelines, and to create a matrix of items to report and conduct trials in rehabilitation as the first step for a starting a rigorous validation process. DATA SOURCES: Searches were conducted in MEDLINE, EMBASE, and Cumulative Index to Nursing and Allied Health databases. STUDY SELECTION: Studies should describe a newly developed tool to evaluate the RoB or quality of reporting for RCTs in the area of rehabilitation. DATA EXTRACTION: (1) First, we extracted items from new tools identified by the electronic search strategies and then (2) we looked at the items provided by the Consolidated Standards of Reporting Trials statement and its relevant extensions. We determined whether these items were already included in our matrix of items. Items were classified based on methodological domains they accomplish, biases they were able to target, and whether they guide reporting or conduct. DATA SYNTHESIS: Among the 1596 citations found, 23 articles were potentially relevant. From these, only 3 new scales (National Institute for Complementary Medicine Acupuncture Network, Quality of reports on spa and balneotherapy [SPAC], Assessment of Study Quality and Reporting in Exercise) were found. In addition, the newly updated Cochrane RoB tool (RoB 2.0) was included. Our matrix contained 122 unique items for any rehabilitation area, 46 items (37.7%) were related to conduct, and 58 (47.5%) were related to the reporting; 18 (14.8%) were related to both. Overall, 76 new items were added among all domains. CONCLUSIONS: Many individual and diverse items have been used to guide the reporting and conduct of rehabilitation trials. This indicates a great variability in number of items and an apparent lack of consensus on a core set of items to be used in rehabilitation. Future research should look into developing a core set of items for the rehabilitation field.

Criteria to Evaluate the Quality of Outcome Reporting in Randomized Controlled Trials of Rehabilitation Interventions.

ABSTRACT: No standardized guideline for the reporting of outcomes measures in randomized controlled trials of rehabilitation interventions is currently available. This study includes four phases to identify, synthesize, and make recommendations for potential attributes of reporting criteria of outcome measures in rehabilitation randomized controlled trials. First, we surveyed the author instructions for rehabilitation journals to determine how journals require authors to report outcomes. Second, we reviewed all consolidated standards of reporting trials extensions to determine how other speciality groups require reporting of outcomes in randomized controlled trials. Third, we conducted a focused scoping review to examine the nature and variations of criteria used to evaluate the quality of outcome measures in randomized controlled trials. Finally, we synthesized the information from phases 1-3 and propose four criteria specific to the reporting of outcomes in randomized controlled trials of rehabilitation interventions: (1) clearly describe the construct to be measured as outcome(s); (2) justify the selection of outcome measures by mapping to World Health Organization International Classification of Function, Disability, and Health (International Classification of Functioning) framework; justify the psychometric properties (relevance, validity, reliability) of the selected measurement tool; (3) clearly describe the timing of outcome measurement, with consideration of the health condition, the course of disease, and hypothesized effect of intervention; and (4) complete and unselective reporting of outcome data.

Recommendations for Reporting on Rehabilitation Interventions.

ABSTRACT: Clear reporting on rehabilitation treatments is critical for interpreting and replicating study results and for translating treatment research into clinical practice. This article reports the recommendations of a working group on improved reporting on rehabilitation treatments. These recommendations are intended to be combined with the efforts of other working groups, through a consensus process, to arrive at a reporting guideline for randomized controlled trials in physical medicine and rehabilitation (Randomized Controlled Trials Rehabilitation Checklist). The work group conducted a scoping review of 156 diverse guidelines for randomized controlled trial reporting, to identify themes that might be usefully applied to the field of rehabilitation. Themes were developed by identifying content that might improve or enhance existing items from the Template for Intervention Description and Replication. Guidelines addressing broad research domains tended to define reporting items generally, from the investigator's perspective of relevance, whereas those addressing more circumscribed domains provided more specific and operationalized items. Rehabilitation is a diverse field, but a clear description of the treatment's separable components, along with distinct treatment theories for each, can improve reporting of relevant information. Over time, expert consensus groups should develop more specific guideline extensions for circumscribed research domains, around coalescing bodies of treatment theory.

The Structure of Research Questions in Randomized Controlled Trials in the Rehabilitation Field: A Methodological Study.

OBJECTIVE: The aim of this study is to assess whether and how the PICO (Population, Intervention, Comparator, and Outcomes) format is described to frame research questions in randomized controlled trials looking at effectiveness of rehabilitation interventions. DESIGN: A methodological study was conducted. Randomized controlled trials in the rehabilitation field, published between July 1, 2019, and December 31, 2019, were included. The framing of the primary research question from each trial was evaluated. RESULTS: A total of 97 randomized controlled trials were included in the analysis. The most frequent framing of the primary research question was as an "objective" statement (55%), and in 33% of the articles, this was stated as an "objective" together with a "hypothesis" description. All PICO elements were present in 55% of research questions, but only 49% have used the statement suggested by Cochrane. CONCLUSION: The findings of this study suggest that a specific item about the "research question" and the rationale that drove the proposed design following the form suggested by Cochrane should be included in the RCT Rehabilitation Checklist.

Reporting of patients' characteristics in rehabilitation trials: an analysis of publications of RCTs in major clinical rehabilitation journals.

BACKGROUND: The reporting of patients' characteristics in randomized-controlled trials (RCTs) is one important dimension to improve the clinical replicability or transferability of study results into clinical practice. AIM: Based on a previously developed framework for reporting on patient characteristics, the aim of this study was to determine whether and how patients' characteristics are presented in RCTs of major rehabilitation journals. DESIGN: A literature search in eight high-impact medical rehabilitation journals was conducted. SETTING: Any setting. POPULATION: A rehabilitation patient group. METHODS: Papers were included if they presented results on a RCT on rehabilitation patients. We excluded pilot or feasibility studies. We extracted information related to the description of personal, clinical and diagnosis-specific characteristics, comorbidities, and functioning according to the ICF (body functions and structures, activities and participation and context personal/environmental factors). RESULTS: From a total of 129 papers initially identified we finally included 100 papers. Patient groups were almost exclusively defined by clinical diagnostic groups. Age and gender were the most prominent persons' characteristics (100% / 99% reported), followed by marital (22%), educational (15%) and occupational status (14%). Clinical characteristics usually relate to the respective diagnosis; general characteristics were reported on the duration of illness or symptoms (62%), to a lesser degree on BMI (45%) and/or weight (32%) and height (27%). One out of five papers report on comorbidities of the patients (20%). Information of body functions were present in almost every paper (98%), and nearly two third reported at least some aspect of activities and participation at baseline (63%). CONCLUSIONS: The present analysis shows that there is a need to further the development of appropriate standards for the reporting of patient characteristics in rehabilitation trials. CLINICAL REHABILITATION IMPACT: In future it should help rehabilitation practitioners to decide whether the patients in a study and their own patients share features similar enough to allow for transferability of results.

Attrition, missing data, compliance, and related biases in randomized controlled trials of rehabilitation interventions: towards improving reporting and conduct.

INTRODUCTION: Attrition, missing data, compliance, and related biases can influence the magnitude of treatment effects in randomized controlled trials (RCTs). It is unclear which items should be considered when reporting and evaluating the influence of these biases in trial reports in the rehabilitation field. The aim was to describe which individual items considering attrition, missing data, compliance, and related biases are included in quality tools used in rehabilitation research. In addition, we aimed to determine whether the existing reporting guidelines, such as the CONSORT and its extensions include all relevant items related to these biases when reporting RCTs in the area of rehabilitation. EVIDENCE ACQUISITION: Comprehensive literature searches and a systematic approach to identify tools and items looking at attrition, missing data, compliance and related biases in rehabilitation were performed. We extracted individual items linked to these biases from all quality tools. We calculated the frequency of quality items used across tools and compared them to those found in the CONSORT statement and its extensions. A list of items to be potentially added to the CONSORT statement was generated. EVIDENCE SYNTHESIS: Three new tools to assess the conduct and reporting of trials in the rehabilitation field were found. From these tools, 28 items were used to evaluate the reporting as well as the conduct of trials considering attrition, missing data, compliance, and related biases in the rehabilitation field. However, our team found that some of these items lack specificity in the information required and therefore more research is needed to determine a core set of items used for reporting as well as assessing the risk of bias (RoB) of RCT in the rehabilitation field. CONCLUSIONS: Although many items have been described by existing tools and the CONSORT statement (and its extensions) that deal with attrition, missing data, compliance, and related biases, several gaps in reporting were identified. It is crucial that future research investigate a core set of items to be used in the field of rehabilitation to facilitate the reporting as well as the conduct of RCTs.

Influence of attrition, missing data, compliance, and related biases and analyses strategies on treatment effects in randomized controlled trials in rehabilitation: a methodological review.

INTRODUCTION: Attrition, missing data, compliance, and related biases are three interrelated concepts. Previous research has found that these biases can affect the treatment estimates of randomized trials (RCTs). The extent to which the effects of attrition, missing data, compliance and related biases influence effect size estimates in rehabilitation as well as the effect of analytic strategies to mitigate these biases is unknown. EVIDENCE ACQUISITION: To compile and synthetize the empirical evidence regarding the effects of attrition and compliance related biases on treatment effect estimates in rehabilitation RCTs. Electronic searches were conducted. Studies were included if they investigated the effects of attrition, missing data, compliance and related biases on treatment estimates. The seven studies meeting inclusion criteria were coded for type of biases and summarized using a narrative and/or quantitative approach when appropriate. EVIDENCE SYNTHESIS: Findings demonstrated that trials reporting higher levels of attrition (differences in ES: 0.18 [95%CI: 0.15, 0.22 ]), exclusion of participants from analyses (differences in ES: 0.13 [95% CI: -0.03, 0.29]), lack of good control of incomplete outcome data (differences in ES: 0.14 [95%CI: -0.02, 0.30]) and analysis by "as treated"(differences in ES:-0.39 [95%CI: -0.99, 0.2]) or "per protocol" (differences in ES:-0.46 [95%CI: -0.92, 0]) analyses were more likely to have higher effects than those that did not. CONCLUSIONS: These findings suggest that attrition, missing data, compliance, and related biases have an influence in treatment effect estimates in rehabilitation trials. Therefore, these results should be taken into consideration when designing, conducting and reporting trials in the rehabilitation field.

Randomized controlled trials in non-pharmacological rehabilitation research: a scoping review of the reporting of sample size calculation, randomization procedure, and statistical analyses.

INTRODUCTION: The randomized controlled trials (RCTs) are often considered as the gold standard for clinical trials and researchers argue that the quality of RCT reports should be of the highest standards due to their clinical significance. To review the quality of reporting of the sample size calculation methods, and randomization procedures, and assess whether the statistical analyses correlate as reported in the trials' Evidence acquisition and Evidence synthesis sections in non-pharmacological, physiological rehabilitation RCT interventions. EVIDENCE ACQUISITION: A systematic electronic search was conducted in Cochrane Central from 1 January 2019 to 16 December 2019. Titles and abstracts were analyzed for inclusion independently by two authors, and disagreements were resolved by a third reader. Studies were included if they met the following criteria: 1) assessed and reported a type of non-pharmacological rehabilitation RCT (e.g. physiotherapy); 2) randomized intervention to patients with a disease comparing to healthy or patients without intervention as the comparison group; 3) published in an indexed journal; and 4) original research, available full text, human study, published in 2019, and written in English. The following information was extracted from the included articles: journal impact factor (JIF), sample size calculation methods (SS), randomization procedure (RND), and statistical analyses (STAT) reported. Analyzing the full text, whether SS and RND were reported or not and whether the STAT correlated with the Methods and Results sections. The prevalence of each statistical method was derived from the Methods section of the report and compared if it was reported in the Results section. The continuous variable of JIF was tested for normality and used for independent t-test for equality of means between categories. In addition, using Downs and Black checklist the methodological quality of the articles was assessed and categorized to be poor, fair, good, and excellent based on the checklist's score. Finally, the association between the assessed quality (categorical variable) of the articles and the reporting variables (categorical variables) was analyzed utilizing the Pearson χ2. EVIDENCE SYNTHESIS: One hundred and nighty-four articles were retrieved from the systematic search out of which 99 (51%) were included for data extraction and further analyses. About one in five (20.2%) and two in five (37.4%) did not properly and adequately report the SS and RND while one in five (19.2%) there was at least one mismatch in STAT. The JIF was not significantly associated to the quality of reporting of SS (t=1.974, P=0.051), RND (t=0.309, P=0.758), and STAT (t=-0.275, P=0.784). This finding could indicate that the quality of the journal did not assure the quality of the reporting these methods. However, there was a significant association between the assessed quality of the article measured with the Down's and Black checklist and the reporting of SS (χ2=29.149, DF=2, P<0.0001), RND (χ2=55.079, df=2, P<0.0001) and STAT (χ2=25.778, df=2, P<0.0001). CONCLUSIONS: Recent reporting quality of non-pharmacological rehabilitation RCTs was investigated. We found that the quality of the article but not the quality of the journal in which it is published in may be associated to the quality of reporting in sample size methods, randomization processes, and statistical analyses reporting. The quality of study reporting may be enhanced utilizing a guideline that addresses the required information in sample size calculation, randomization of individuals, and proper statistical analyses used and reported.

Research priorities for rehabilitation and aging with HIV: a framework from the Canada-International HIV and Rehabilitation Research Collaborative (CIHRRC).

BACKGROUND: People living with HIV are living longer, and can experience physical, mental and social health challenges associated with aging and multimorbidity. Rehabilitation is well positioned to address disability and maximize healthy aging. An international collaborative network, called the Canada-International HIV and Rehabilitation Research Collaborative (CIHRRC), works to guide this emerging field. In this article, we report findings from CIHRRC's aim to identify emerging research priorities in HIV, aging and rehabilitation from the perspectives of people living with HIV, clinicians, researchers, representatives from community organizations and policy stakeholders. METHODS: We conducted a multi-stakeholder multi-method international consultation with people living with HIV, researchers, clinicians and representatives of community-based organizations to identify research priorities in HIV, aging and rehabilitation. Stakeholders identified research priorities during a one-day International Forum comprised of presentations and facilitated discussion. We collated and analyzed data using content analytical techniques, resulting in a framework of research priorities. RESULTS: Sixty-nine stakeholders from countries including Canada (n = 62; 90%), the United Kingdom (n = 5; 7%), United States (n = 1; 1%) and Australia (n = 1; 1%) attended the International Forum on HIV, Aging and Rehabilitation Research. Stakeholders represented community-based organizations (n = 20; 29%), academic institutions (n = 18; 26%), community or institutional healthcare organizations (n = 11; 16%), research or knowledge production organizations (n = 10; 14%), and organizations representing government or industry (n = 10; 14%). The Framework of Research Priorities in HIV, Aging and Rehabilitation includes seven research priorities: (1) nature, extent and impact of disability, concurrent health conditions and chronic inflammation with HIV; (2) prevalence, severity and impact of frailty; (3) community and social participation aging with HIV; (4) strategies for chronic disease management and healthy aging with HIV; (5) facilitators and barriers to access and engagement in, rehabilitation; (6) effectiveness of rehabilitation interventions for healthy aging with HIV; and (7) advancing development and use of patient reported outcome measures in HIV and aging. The Framework highlights methodological considerations to approach the priorities and the importance of knowledge translation and exchange to apply research knowledge into practice, programs and policy. CONCLUSIONS: These priorities offer a foundation for collaboration among international and multidisciplinary teams to advance the field of HIV, aging and rehabilitation in order to promote healthy aging with HIV.

Novel Effect Size Interpretation Guidelines and an Evaluation of Statistical Power in Rehabilitation Research.

OBJECTIVE: First, to establish empirically-based effect size interpretation guidelines for rehabilitation treatment effects. Second, to evaluate statistical power in rehabilitation research. DATA SOURCES: The Cochrane Database of Systematic Reviews was searched through June 2019. STUDY SELECTION: Meta-analyses included in the Cochrane Database of Systematic Reviews with "rehabilitation" as a keyword and clearly evaluated a rehabilitation intervention. DATA EXTRACTION: We extracted Cohen's d effect sizes and associated sample sizes for treatment and comparison groups. Two independent investigators classified the interventions into 4 categories using the Rehabilitation Treatment Specification System. The 25th, 50th, and 75th percentile values within the effect size distribution were used to establish interpretation guidelines for small, medium, and large effects, respectively. A priori power analyses established sample sizes needed to detect the empirically-based values for small, medium, and large effects. Post-hoc power analyses using median sample sizes revealed whether the "typical" rehabilitation study was sufficiently powered to detect the empirically-based values. Post hoc power analyses established the statistical power of each test based on the sample size and reported effect size. DATA SYNTHESIS: We analyzed 3381 effect sizes extracted from 99 meta-analyses. Interpretation guidelines for small effects ranged from 0.08 to 0.15; medium effects ranged from 0.19 to 0.36; and large effects ranged from 0.41 to 0.67. We present sample sizes needed to detect these values based on a priori power analyses. Post hoc power analyses revealed that a "typical" rehabilitation study lacks sufficient power to detect the empirically-based values. Post hoc power analyses using reported sample sizes and effects indicated the studies were underpowered, with median power ranging from 0.14 to 0.23. CONCLUSIONS: This study presented novel and empirically-based interpretation guidelines for small, medium, and large rehabilitation treatment effects. The observed effect size distributions differed across intervention categories, indicating that researchers should use category-specific guidelines. Furthermore, many published rehabilitation studies are underpowered.

INTERnational Project for the Evaluation of "activE Rehabilitation" (inter-PEER) - a protocol for a prospective cohort study of community peer-based training programmes for people with spinal cord injury.

BACKGROUND: Active Rehabilitation (AR) is a community peer-based concept for people with spinal cord injury (SCI) that is primarily delivered through brief residential training programmes. Despite a plethora of positive anecdotal evidence of AR programmes as life-changing experiences, the effects of AR-programmes have not been evaluated scientifically. Here, we present the protocol of the INTERnational Project for the Evaluation of "activE Rehabilitation" (inter-PEER) aiming to evaluate the effects of AR training programmes on community-dwelling individuals with SCI. METHODS: International prospective cohort study that recruits consecutive participants in AR training programmes. Evaluation is conducted through a web-based survey at 3 time-points: at the commencement and completion of the training programme, and 3 months after the end of the training programme. Evaluation also includes a practical wheelchair skills test at the first two time-points. The primary outcome measures are the Spinal Cord Independence Measure Self-report (SCIM-SR), the Queensland Evaluation of Wheelchair Skills test (QEWS), the Wheelchair Skills Test Questionnaire (WST-Q) and the Moorong Self-Efficacy Scale (MSES). The secondary outcome measures are the 11-item Life Satisfaction Questionnaire (LiSat-11), the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-Participation), the Leisure Time Physical Activity Questionnaire for people with SCI (LTPAQ-SCI) and the 10-item Connor-Davidson Resilience Scale (CD-RISC-10). We piloted the implementation of the protocol in Sweden in 7 participants with diverse SCI and sociodemographic characteristics and collected feedback from participants and peer-mentors about study procedures through interviews, a workshop and field observations. DISCUSSION: Inter-PEER is the first initiative to propose a systematic evaluation of the effects of AR training programmes among individuals with SCI. The project is a collaborative work of multiple stakeholders, including researchers, clinicians, peer mentors with SCI, and administrators of organisations providing AR programmes. The inter-PEER uses standardised outcome measures relevant to the AR context, it will facilitate quality evaluations of community peer-based programmes, stimulate international collaborations, and inform the design of randomised controlled trials on the effects of AR training programmes.

An overview of outcome measures used in neuropsychological rehabilitation research on adults with acquired brain injury.

Outcome measurement is the cornerstone of evidence-based health care including neuropsychological rehabilitation. A complicating factor for outcome measurement in neuropsychological rehabilitation is the enormous number of measures available and the lack of a standard set of outcome measures. As a first step towards such a set, we reviewed intervention evaluation studies of the last 20 years to get an overview of instruments used for measuring outcome. The instruments were divided into two main categories: neuropsychological tests (International Classification of Functioning (ICF) level of functions) and other instruments (all other ICF domains). We considered the most common cognitive domains: memory, attention, executive functions, neglect, perception, apraxia, language/communication and awareness. Instruments used most for measuring outcome were neuropsychological tests (n = 215) in the domains of working memory, reaction times, neglect and aphasia. In the second category (n = 166) the multi-domain instruments were most represented. Several steps can be taken to select a standard set of outcome measures for future use. Next to evaluation of quality and feasibility of the instruments, expert opinion and consensus procedures can be applied.

Intervention development and treatment success in UK health technology assessment funded trials of physical rehabilitation: a mixed methods analysis.

OBJECTIVES: Physical rehabilitation is a complex process, and trials of rehabilitation interventions are increasing in number but often report null results. This study aimed to establish treatment success rates in physical rehabilitation trials funded by the National Institute of Health Research Health Technology Assessment (NIHR HTA) programme and examine any relationship between treatment success and the quality of intervention development work undertaken. DESIGN: This is a mixed methods study. SETTING: This study was conducted in the UK. METHODS: The NIHR HTA portfolio was searched for all completed definitive randomised controlled trials of physical rehabilitation interventions from inception to July 2016. Treatment success was categorised according to criteria developed by Djulbegovic and colleagues. Detailed textual data regarding any intervention development work were extracted from trial reports and supporting publications and informed the development of quality ratings. Mixed methods integrative analysis was undertaken to explore the relationship between quantitative and qualitative data using joint displays. RESULTS: Fifteen trials were included in the review. Five reported a definitive finding, four of which were in favour of the 'new' intervention. Eight trials reported a true negative (no difference) outcome. Integrative analysis indicated those with lower quality intervention development work were less likely to report treatment success. CONCLUSIONS: Despite much effort and funding, most physical rehabilitation trials report equivocal findings. Greater focus on high quality intervention development may reduce the likelihood of a null result in the definitive trial, alongside high quality trial methods and conduct.

Beyond current research practice: Methodological considerations in MS rehabilitation research (is designing the perfect rehabilitation trial the Holy Grail or a Gordian knot?).

Rehabilitation is an essential aspect of symptomatic and supportive treatment for people with multiple sclerosis (MS). The number of randomised controlled trials (RCTs) for rehabilitation interventions in MS has increased over the last two decades. The design, conduct and reporting quality of some of these trials could be improved. There are, however, some specific challenges that researchers face in conducting RCTs of rehabilitation interventions, which are often 'complex interventions'. This paper explores some of the challenges of undertaking robust clinical trials in rehabilitation. We focus on issues related to (1) participant selection and sample size, (2) interventions - the 'dose', content, active ingredients, targeting, fidelity of delivery and treatment adherence, (3) control groups and (4) outcomes - choosing the right type, number, timing of outcomes, and the importance of defining a primary outcome and clinically important difference between groups. We believe that by following internationally accepted RCT guidelines, by developing a critical mass of MS rehabilitation 'trialists' through international collaboration and by continuing to critique, challenge, and develop RCT designs, we can exploit the potential of RCTs to answer important questions related to the effectiveness of rehabilitation interventions.

Setting the scene for the Second Stroke Recovery and Rehabilitation Roundtable.

The Stroke Recovery and Rehabilitation Roundtable (SRRR) meetings bring together an international group of preclinical and clinical researchers along with statisticians, methodologists, funders and consumers, working to accelerate the development of effective treatments for stroke recovery and to support best-evidence uptake in rehabilitation practice. The first meeting (2016) focused on four recommendation areas: translation of preclinical evidence into human discovery trials; recovery biomarkers to provide knowledge of therapeutic targets and prognosis in human stroke; intervention development, monitoring, and reporting standards; and standardized measurement in motor recovery trials. The impact of SRRR is growing, with uptake of recommendations emerging, and funders exploring ways to incorporate research targets and recommendations. At our second meeting (SRRR2, 2018), we worked on new priority areas: (1) cognitive impairment, (2) standardizing metrics for measuring quality of movement, (3) improving development of recovery trials, and (4) moving evidence-based treatments into practice. To accelerate progress towards breakthrough treatments, formation of an International Stroke Recovery and Rehabilitation Alliance is our next step, where working groups will take recommendations and build partnerships needed to achieve our goals.

How to use the International Classification of Functioning, Disability and Health as a reference system for comparative evaluation and standardized reporting of rehabilitation interventions.

Rehabilitation aims to optimize functioning of persons experiencing functioning limitations. As such the comparative evaluation of rehabilitation interventions relies on the analysis of the differences between the change in patient functioning after a specific rehabilitation intervention versus the change following another intervention. A robust health information reference system that can facilitate the comparative evaluation of changes in functioning in rehabilitation studies and the standardized reporting of rehabilitation interventions is the International Classification of Functioning, Disability and Health (ICF). The objective of this paper is to present recommendations that Cochrane Rehabilitation could adopt for using the ICF in rehabilitation studies by: 1) defining the functioning categories to be included in a rehabilitation study; 2) specifying selected functioning categories and selecting suitable data collection instruments; 3) examining aspects of functioning that have been documented in a study; 4) reporting functioning data collected with various data collection instruments; and 5) communicating results in an accessible, meaningful and easily understandable way. The authors provide examples of concrete studies that underscore these recommendations, whereby also emphasizing the need for future research on the implementation of specific recommendations, e.g. in meta-analysis in systematic literature reviews. Furthermore, the paper outlines how the ICF can complement or be integrated in established Cochrane and rehabilitation research structures and methods, e.g. use of standard mean difference to compare cross-study data collected using different measures, in developing core outcome sets for rehabilitation, and the use of the PICO model.