Dos and don'ts for conducting mediation analysis: A commentary with practical tips to avoid common problems.

Purpose: Mediation analyses allow for exploration of causal mechanisms that explain how a predictor is related to an outcome. Tests of mediation are fundamental to addressing some of the most consequential questions in rehabilitation science. In recent decades, the development of easy-to-use analytical tools has made conducting statistical tests of mediation more accessible to researchers. Unfortunately, there are persistent problems in the conceptual underpinning of many tests of mediation. Even in cases where the statistical analyses are correctly run, problems with the underlying rationale for the mediational analysis will render the results inconsequential, in the best case, or misleading, in the worst case. Method: In this commentary, I summarize the uses of mediation analysis and through a series of six main types of errors provide practical, plain language guidance ("Dos and Don'ts") for conducting a conceptually robust mediation analysis. Results: The "Dos and Don'ts" laid out in this commentary highlight that there are persistent issues with lack of understanding of mediation, confusion about the differences between moderation, mediation, and covariates, lack of strong theoretical justification for mediation, and lack of attention to methodological issues (e.g., measurement) in many mediation analyses. Conclusions: Promoting the use of mediation analysis in rehabilitation research will advance theory and effective practice in our field. Researchers undertaking mediation analysis are encouraged to prioritize developing a strong theoretical framework that justifies use of mediation analysis, ensuring study methodology supports and enables tests of mediation, as well emphasizing a strong statistical approach to conducting the test of mediation. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Introducing JOSPT Methods: A Journal Focused on Advancing the Research Methods Applied to the Musculoskeletal Rehabilitation Field.

SYNOPSIS: In 2025, JOSPT will continue its mission to enhance research in the field of musculoskeletal rehabilitation. JOSPT aims to support authors who are working to advance the research methods applied to answer clinical questions in the musculoskeletal rehabilitation field. Using the most robust methods helps authors ensure their studies can have immediate impact on health policies and clinical practice. With this editorial, we introduce a new gold open-access journal, JOSPT Methods, where research will be available to read for free, immediately upon publication. J Orthop Sports Phys Ther 2024;54(10):1-3. doi:10.2519/jospt.2024.12972.

Psychometric network analysis in rehabilitation research: A methodological demonstration in depression symptoms of veterans and service members at 1 and 2 years after traumatic brain injury.

PURPOSE/OBJECTIVE: Psychometric network analysis (PNA) is an application of dynamic systems theory that can inform measurement of complex rehabilitation phenomena such as depressive symptom patterns in veterans and service members (V/SMs) after traumatic brain injury (TBI). This study applied PNA to the Patient Health Questionnaire-9 (PHQ-9), a common measure of depressive symptoms, in a sample of V/SMs with TBI at Years 1 and 2 (Y1-2) postinjury. RESEARCH METHOD/DESIGN: A sample of 808 V/SMs with TBI participated, 594 contributing PHQ-9 data at Y1 and 585 at Y2. Participants were recruited while or after receiving inpatient postacute rehabilitation from one of five Veterans Affairs Polytrauma Rehabilitation Centers. RESULTS: The networks were stable and invariant over time. At both times, network structure revealed the cardinal depressive symptom "feeling down, depressed, or hopeless," as evidenced by its strength centrality. In the Y1 network, the suicidal ideation node was connected exclusively to the network through the guilt node, and in the Y2 network, the suicidal ideation node formed a second connection through the low mood node. The guilt node was the second most influential node at Y1 but was replaced by anhedonia node at Y2. CONCLUSIONS/IMPLICATIONS: This study demonstrated the potential of PNA in rehabilitation research and identified the primacy of feeling down, depressed, and hopeless after TBI at both Y1 and Y2, with guilt being the second most influential symptom at Y1, but replaced by anhedonia at Y2, providing supportive evidence that the relationships among depressive symptoms after TBI are dynamic over time. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

[Quality Criteria of Qualitative Studies in Rehabilitation Research]. / Qualitätskriterien qualitativer Studien in der Rehabilitationsforschung.

Considering the variety of research questions, perspectives, and disciplines involved, qualitative studies have become an integral part of rehabilitation sciences. To ensure and estimate their quality and thus the significance of their results, criteria are needed for both researchers and recipients. Due to the specific nature and the heterogeneity of qualitative research approaches, there is still disagreement regarding appropriate universally valid quality criteria. In this article, core criteria that can be used to plan, conduct and receive qualitative studies are presented and discussed with reference to national rehabilitation research. For this purpose, the specific characteristics of rehabilitation research are taken into account and the application of quality criteria is illustrated using concrete examples from the research practice of rehabilitation sciences.

Historical technology transfer activities and productivity of NIDLRR grantees.

This paper analyzes the technology-related outputs from The National Institute of Disability, Independent Living, and Rehabilitation Research (NIDILRR). We seek to answer the questions: What are the types and frequency of assistive technology (AT) technology transfer (ATTT) outputs from NIDILRR grants? How does NIDILRR's ATTT generation compare to other granting organizations? What types of ATTT outputs occur, how, and what is the relative productivity of the most frequently funded universities and small businesses performing with funding by NIDILRR grants? An online search was conducted for indications of ATTT from grants funded from 1983-2021 through publicly available databases, the National Rehabilitation Information Center (NARIC), and the internet. This data was then categorized across relevant output types and analyzed. NIDILRR funded 662 organizations and 951 different investigators from 1983 to 2021. The NIDILRR-funded portfolio includes 6,996 papers, 438 informational websites, 163 patents, 120 software products, and 29 hardware products. Compared to the National Institutes of Health (NIH), NIDILRR produced slightly more products per dollar. Our results highlight the substantial portfolio of technology-related outputs generated with NIDILRR funding and demonstrate how productivity measures can be calculated to guide future funding strategies.

Assessment of Rehabilitation Journal Requirements for the Use of Reporting Guidelines and Clinical Trial Registration.

OBJECTIVE: To assess reporting guideline and clinical trial registration requirements in rehabilitation journals. DESIGN: We examined rehabilitation journals with 5-year impact factors exceeding 1.00 from the 2021 Scopus CiteScore tool, alongside the 28 journals included in the 2014 rehabilitation and disability quality improvement initiative. Journals outside the traditional rehabilitation scope were excluded. SETTING: A publicly-funded academic health center in the United States. PARTICIPANTS AND INTERVENTIONS: N/A. MAIN OUTCOME MEASURE(S): The proportion of journals requiring/recommending reporting guideline use and clinical trial registration. RESULTS: Over 90% (57/63) of journals required/recommended clinical trial reporting guidelines, while 68% (39/57) specified guideline requirements for systematic review/meta-analysis protocols. The 2014 collaborative initiative journals demonstrated higher rates of requiring/recommending reporting guidelines for clinical trials (24/26; 92.3%), systematic reviews/meta-analyses (23/26; 88.5%), observational studies in epidemiology (22/25; 88%), and diagnostic accuracy studies (20/24; 83.3%). Conversely, the 2021 Scopus CiteScore journals displayed higher rates for the remaining study designs. Overall, 52/63 (82.5%) journals required/recommended trial registration. Trial registration policies were comparable, with a slight advantage favoring the 2021 Scopus CiteScore journals. CONCLUSION: Rehabilitation journals variably promoted reporting guideline use and clinical trial registration. Common study designs like clinical trials, observational studies in epidemiology, and diagnostic accuracy studies demonstrated robust requirement/recommendation rates, while less common designs like economic evaluations and animal research had suboptimal rates. Journals can enhance reporting guideline use and trial registration by directing authors to the EQUATOR Network, requiring adherence to registration and reporting standards, and clarifying language in author instructions.

[Introduction to qualitative evidence synthesis - Variants and application]. / Einführung in die qualitative Evidenzsynthese ­ Varianten und Anwendung.

Qualitative evidence syntheses (QES) are still uncommon in German rehabilitation research, although robust syntheses of qualitative evidence may lead to more strongly scientifically based decisions in health care. This article introduces the topic of qualitative evidence synthesis by describing three different synthesis methods - thematic synthesis, meta-ethnography, and grounded theory synthesis - and illustrating them with examples from rehabilitation research. This is followed by guidance on selecting the appropriate QES-method and reflections on the challenges of QES that are associated with the literature search and quality assessment of the studies to be included in the synthesis. Likewise considerations on quality criteria and their application are taken into account. GRADE-CERQual provides guidance for assessing confidence of findings from QES. Finally the value of QES for rehabilitation research is discussed.

Relevance and use of health policy, health systems and health services research for strengthening rehabilitation in real-life settings: methodological considerations.

Research on health policy, systems, and services (HPSSR) has seen significant growth in recent decades and received increasing attention in the field of rehabilitation. This growth is driven by the imperative to effectively address real-life challenges in complex healthcare settings. A recent resolution on 'Strengthening rehabilitation in health systems' adopted by the World Health Assembly emphasizes the need to support societal health goals related to rehabilitation, particularly to promote high-quality rehabilitation research, including HPSSR. This conceptual paper, discussed with the participants in the 5th Cochrane Rehabilitation Methodological Meeting held in Milan on September 2023, outlines study designs at diverse levels at which HPSSR studies can be conducted: the macro, meso, and micro levels. It categorizes research questions into four types: those framed from the perspective of policies, healthcare delivery organizations or systems, defined patient or provider populations, and important data sources or research methods. Illustrative examples of appropriate methodologies are provided for each type of research question, demonstrating the potential of HPSSR in shaping policies, improving healthcare delivery, and addressing patient and provider perspectives. The paper concludes by discussing the applicability, usefulness, and implementation of HPSSR findings, and the importance of knowledge translation strategies, drawing insights from implementation science. The goal is to facilitate the integration of research findings into everyday clinical practice to bridge the gap between research and practice in rehabilitation.

International survey on the implementation of the European and American guidelines on disorders of consciousness.

Diagnostic, prognostic, and therapeutic procedures for patients with prolonged disorders of consciousness (pDoCs) vary significantly across countries and clinical settings, likely due to organizational factors (e.g., research vs. non-academic hospitals), expertise and availability of resources (e.g., financial and human). Two international guidelines, one from the European Academy of Neurology (EAN) and one from the American Academy of Neurology (AAN) in collaboration with the American Congress of Rehabilitation Medicine (ACRM) and the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR), were developed to facilitate consistent practice among professionals working with this challenging patient population. While the recommendations of both guidelines agree in principle, it remains an open issue how to implement them into clinical practice in the care pathway for patients with pDoCs. We conducted an online survey to explore health professional clinical practices related to the management of patients with pDoCs, and compare said practices with selected recommendations from both the guidelines. The survey revealed that while some recommendations are being followed, others are not and/or may require more honing/specificity to enhance their clinical utility. Particular attention should be given to the implementation of a multimodal assessment of residual consciousness, to the detection and treatment of pain, and to the impact of restrictions imposed by COVID-19 pandemics on the involvement of patients' families/representatives.

A roadmap for research in post-stroke fatigue: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.

RATIONALE: Fatigue affects almost half of all people living with stroke. Stroke survivors rank understanding fatigue and how to reduce it as one of the highest research priorities. METHODS: We convened an interdisciplinary, international group of clinical and pre-clinical researchers and lived experience experts. We identified four priority areas: (1) best measurement tools for research, (2) clinical identification of fatigue and potentially modifiable causes, (3) promising interventions and recommendations for future trials, and (4) possible biological mechanisms of fatigue. Cross-cutting themes were aphasia and the voice of people with lived experience. Working parties were formed and structured consensus building processes were followed. RESULTS: We present 20 recommendations covering outcome measures for research, development, and testing of new interventions and priority areas for future research on the biology of post-stroke fatigue. We developed and recommend the use of the Stroke Fatigue Clinical Assessment Tool. CONCLUSIONS: By synthesizing current knowledge in post-stroke fatigue across clinical and pre-clinical fields, our work provides a roadmap for future research into post-stroke fatigue.

Control intervention design for preclinical and clinical trials: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.

Control comparator selection is a critical trial design issue. Preclinical and clinical investigators who are doing trials of stroke recovery and rehabilitation interventions must carefully consider the appropriateness and relevance of their chosen control comparator as the benefit of an experimental intervention is established relative to a comparator. Establishing a strong rationale for a selected comparator improves the integrity of the trial and validity of its findings. This Stroke Recovery and Rehabilitation Roundtable (SRRR) taskforce used a graph theory voting system to rank the importance and ease of addressing challenges during control comparator design. "Identifying appropriate type of control" was ranked easy to address and very important, "variability in usual care" was ranked hard to address and of low importance, and "understanding the content of the control and how it differs from the experimental intervention" was ranked very important but not easy to address. The CONtrol DeSIGN (CONSIGN) decision support tool was developed to address the identified challenges and enhance comparator selection, description, and reporting. CONSIGN is a web-based tool inclusive of seven steps that guide the user through control comparator design. The tool was refined through multiple rounds of pilot testing that included more than 130 people working in neurorehabilitation research. Four hypothetical exemplar trials, which span preclinical, mood, aphasia, and motor recovery, demonstrate how the tool can be applied in practice. Six consensus recommendations are defined that span research domains, professional disciplines, and international borders.

Control intervention design for preclinical and clinical trials: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.

Control comparator selection is a critical trial design issue. Preclinical and clinical investigators who are doing trials of stroke recovery and rehabilitation interventions must carefully consider the appropriateness and relevance of their chosen control comparator as the benefit of an experimental intervention is established relative to a comparator. Establishing a strong rationale for a selected comparator improves the integrity of the trial and validity of its findings. This Stroke Recovery and Rehabilitation Roundtable (SRRR) taskforce used a graph theory voting system to rank the importance and ease of addressing challenges during control comparator design. "Identifying appropriate type of control" was ranked easy to address and very important, "variability in usual care" was ranked hard to address and of low importance, and "understanding the content of the control and how it differs from the experimental intervention" was ranked very important but not easy to address. The CONtrol DeSIGN (CONSIGN) decision support tool was developed to address the identified challenges and enhance comparator selection, description, and reporting. CONSIGN is a web-based tool inclusive of seven steps that guide the user through control comparator design. The tool was refined through multiple rounds of pilot testing that included more than 130 people working in neurorehabilitation research. Four hypothetical exemplar trials, which span preclinical, mood, aphasia, and motor recovery, demonstrate how the tool can be applied in practice. Six consensus recommendations are defined that span research domains, professional disciplines, and international borders.

Description of an interdisciplinary, holistic cognitive rehabilitation program for adults with mild to moderate cognitive impairment after acquired brain injury.

PURPOSE: Cognitive rehabilitation research has progressed slowly, in part due to incomplete reporting of intervention content and delivery and the difficulties this produces for discerning program effectiveness. This knowledge gap can be reduced by providing detailed intervention descriptions. We document the content/ingredients and therapeutic targets of a cognitive rehabilitation program for adults with mild-to-moderate cognitive impairment. METHODS: The documentation process used a method of participatory/collaborative research. Discussions with the clinical team identified session content/ingredients and therapeutic targets, which were then described using Body Functions, and Activities & Participation domains from the International Classification of Function, Disability and Health (ICF). Domains most frequently targeted by each clinician were identified as Primary Targets. RESULTS: Each clinician produced a detailed description of session content, implementation, and ICF-coded therapeutic targets. This revealed that the whole program targets 29 ICF domains, seven of which were identified as Primary Targets: Higher-level Cognitive; Attention; Memory; Emotional; Global Psychosocial, Temperament and Personality, and Conversation. CONCLUSIONS: Documentation of treatment targets enabled identification of appropriate outcome measures which are now being used to investigate program efficacy. This step-by-step explanation of the documentation process could serve as a guide for other teams wanting to document their rehabilitation interventions and/or establish similar programs.IMPLICATIONS FOR REHABILITATIONIncomplete reporting of intervention content and delivery contributes to difficulties in discerning the effectiveness of complex rehabilitation programs.Current recommendations for rehabilitation intervention reporting suggest that these difficulties can be partially overcome by providing detailed descriptions of intervention content/ingredients and treatment targets.Human and physical resources differ widely from one clinical setting to another and the existence of clear program descriptions can guide clinicians who wish to create similar programs.Detailed descriptions of rehabilitation interventions are necessary to accurately measure patient outcomes and generate testable hypotheses about proposed mechanisms of action.Program descriptions are needed for the development of treatment theories and the advancement of evidence-based practice in rehabilitation.

A roadmap for research in post-stroke fatigue: Consensus-based core recommendations from the third Stroke Recovery and Rehabilitation Roundtable.

RATIONALE: Fatigue affects almost half of all people living with stroke. Stroke survivors rank understanding fatigue and how to reduce it as one of the highest research priorities. METHODS: We convened an interdisciplinary, international group of clinical and pre-clinical researchers and lived experience experts. We identified four priority areas: (1) best measurement tools for research, (2) clinical identification of fatigue and potentially modifiable causes, (3) promising interventions and recommendations for future trials, and (4) possible biological mechanisms of fatigue. Cross-cutting themes were aphasia and the voice of people with lived experience. Working parties were formed and structured consensus building processes were followed. RESULTS: We present 20 recommendations covering outcome measures for research, development, and testing of new interventions and priority areas for future research on the biology of post-stroke fatigue. We developed and recommend the use of the Stroke Fatigue Clinical Assessment Tool. CONCLUSIONS: By synthesizing current knowledge in post-stroke fatigue across clinical and pre-clinical fields, our work provides a roadmap for future research into post-stroke fatigue.

Factors Influencing Physical Medicine and Rehabilitation Trainee Research Engagement.

ABSTRACT: Research engagement during physical medicine and rehabilitation residency and fellowship training is essential for advancing evidence-based medicine and fostering the development of clinician-scientists. Current Accreditation Council for Graduate Medical Education guidelines regarding research requirements during physical medicine and rehabilitation training are ambiguous, and it is unknown whether physical medicine and rehabilitation trainees receive adequate support to pursue research at the level they desire. This anonymous survey study aimed to identify perceived barriers and facilitators to research engagement among US physical medicine and rehabilitation residents and fellows. Our findings suggest that physical medicine and rehabilitation trainees value research engagement. However, research productivity during physical medicine and rehabilitation residency is limited, with many trainees reporting inadequate support and time to participate in research in a meaningful way. Additional support from residency and fellowship programs, including protected time for research, as well as research-specific education and mentorship should be considered to enhance physical medicine and rehabilitation trainee research engagement.

Research priorities in HIV, aging and rehabilitation: building on a framework with the Canada-International HIV and Rehabilitation Research Collaborative.

BACKGROUND: In 2016, the Canada-International HIV and Rehabilitation Research Collaborative established a framework of research priorities in HIV, aging and rehabilitation. Our aim was to review and identify any new emerging priorities from the perspectives of people living with HIV, clinicians, researchers, and representatives from community organizations. METHODS: We conducted a multi-stakeholder international consultation with people living with HIV, researchers, clinicians and representatives of community-based organizations. Stakeholders convened for a one-day Forum in Manchester, United Kingdom (UK) to discuss research priorities via a web-based questionnaire and facilitated discussions. We analyzed data using conventional content analytical techniques and mapped emerging priorities onto the foundational framework. RESULTS: Thirty-five stakeholders from the UK(n = 29), Canada(n = 5) and Ireland(n = 1) attended the Forum, representing persons living with HIV or representatives from community-based organizations(n = 12;34%), researchers or academics(n = 10;28%), service providers(n = 6;17%), clinicians(n = 4;11%); and trainees(n = 4;11%). Five priorities mapped onto the Framework of Research Priorities across three content areas: A-Episodic Health and Disability Aging with HIV (disability, frailty, social participation), B-Rehabilitation Interventions for Healthy Aging across the Lifespan (role, implementation and impact of digital and web-based rehabilitation interventions) and C-Outcome Measurement in HIV and Aging (digital and web-based rehabilitation health technology to measure physical activity). Stakeholders indicated methodological considerations for implementing digital and web-based rehabilitation interventions into research and practice and the importance of knowledge transfer and exchange among the broader community. CONCLUSION: Results highlight the sustained importance of the Framework of Research Priorities and provide further depth and areas of inquiry related to digital and web-based rehabilitation interventions and technology aging with HIV.

Improving Rehabilitation Research to Optimize Care and Outcomes for People with Chronic Primary Low Back Pain: Methodological and Reporting Recommendations from a WHO Systematic Review Series.

Chronic primary low back pain (CPLBP) is a prevalent and disabling condition that often requires rehabilitation interventions to improve function and alleviate pain. This paper aims to advance future research, including systematic reviews and randomized controlled trials (RCTs), on CPLBP management. We provide methodological and reporting recommendations derived from our conducted systematic reviews, offering practical guidance for conducting robust research on the effectiveness of rehabilitation interventions for CPLBP. Our systematic reviews contributed to the development of a WHO clinical guideline for CPLBP. Based on our experience, we have identified methodological issues and recommendations, which are compiled in a comprehensive table and discussed systematically within established frameworks for reporting and critically appraising RCTs. In conclusion, embracing the complexity of CPLBP involves recognizing its multifactorial nature and diverse contexts and planning for varying treatment responses. By embracing this complexity and emphasizing methodological rigor, research in the field can be improved, potentially leading to better care and outcomes for individuals with CPLBP.

Reasons for missing evidence in rehabilitation meta-analyses: a cross-sectional meta-research study.

BACKGROUND: Systematic reviews of randomized controlled trials are the best evidence for informing on intervention effectiveness. Their results, however, can be biased due to omitted evidence in the quantitative analyses. We aimed to assess the proportion of randomized controlled trials omitted from meta-analyses in the rehabilitation field and explore related reasons. METHODS: This is a cross-sectional meta-research study. For each systematic review included in a published selected sample in the rehabilitation field, we identified an index meta-analysis on the primary outcome and the main comparison. We then looked at all the studies considered eligible for the chosen comparison in the systematic review and identified those trials that have been omitted (i.e., not included) from each index meta-analysis. Reasons for omission were collected based on an eight-reason classification. We used descriptive statistics to describe the proportion of omitted trials overall and according to each reason. RESULTS: Starting from a cohort of 827 systematic reviews, 131 index meta-analyses comprising a total of 1761 eligible trials were selected. Only 16 index meta-analyses included all eligible studies while 15 omitted studies without providing references. From the remaining 100 index meta-analyses, 717 trials (40,7%) were omitted overall. Specific reasons for omission were: "unable to distinguish between selective reporting and inadequate planning" (39,3%, N = 282), "inadequate planning" (17%, N = 122), "justified to be not included" (15,1%, N = 108), "incomplete reporting" (8,4%, N = 60), "selective reporting" (3,3%, N = 24) and other situations (e.g., outcome present but no motivation for omission) (5,2%, N = 37). The 11,7% (N = 84) of omitted trials were not assessed due to non-English language or full text not available. CONCLUSIONS: Almost half of the eligible trials were omitted from their index meta-analyses. Better reporting, protocol registration, definition and adoption of core outcome sets are needed to prevent omission of evidence in systematic reviews.

Understanding implementation of a complex intervention in a stroke rehabilitation research trial: A qualitative evaluation using Normalisation Process Theory.

BACKGROUND: The Implicit Learning in Stroke study was a pilot cluster randomised controlled trial, investigating the use of different motor learning strategies in acute stroke rehabilitation. Participating Stroke Units (n = 8) were from the South East/West regions of the UK, with the experimental intervention (implicit learning) being delivered by clinical teams. It required therapists to change how they gave instructions and feedback to patients during rehabilitation. This paper reports the processes underpinning implementation of the implicit learning intervention. The evaluation aimed to i) understand how therapists made sense of, engaged with and interpreted the effects of the intervention; ii) compare this to the experience reported by patients; iii) extrapolate learning of broader relevance to the design and conduct of research involving complex interventions in stroke rehabilitation. METHODS: Qualitative evaluation, with data collected through focus groups with clinical staff (n = 20) and semi structured interviews with people with stroke (n = 19). Mixed inductive and theory driven analysis, underpinned by Normalisation Process Theory. RESULTS: How therapists made sense of and experienced the intervention impacted how it was implemented. The intervention was delivered by individual therapists, and was influenced by their individual values, beliefs and concerns. However, how teams worked together to build a shared (team) understanding, also played a key role. Teams with a more "flexible" interpretation, reported the view that the intervention could have benefits in a wide range of scenarios. Those with a more fixed, "rule based" interpretation, found it harder to implement, and perceived the benefits to be more limited. Therapists' concerns that the intervention may impair therapeutic relationships and patient learning were not reflected in how patients experienced it. CONCLUSIONS: Changing practice, whether in a research study or in the "real world", is complex. Understanding the process of implementation is crucial to effective research delivery. Implementation frameworks facilitate understanding, and subsequently the systematic and iterative development of strategies for this to be addressed. How teams (rather than individuals) work together is central to how complex interventions are understood and implemented. It is possible that new complex interventions work best in contexts where there are 'flexible' cultures. Researchers should consider, and potentially measure this, before they can effectively implement and evaluate an intervention. TRIAL REGISTRATION: Clinical Trials - NCT03792126.

ReDWINE: A clinical datamart with text analytical capabilities to facilitate rehabilitation research.

Rehabilitation research focuses on determining the components of a treatment intervention, the mechanism of how these components lead to recovery and rehabilitation, and ultimately the optimal intervention strategies to maximize patients' physical, psychologic, and social functioning. Traditional randomized clinical trials that study and establish new interventions face challenges, such as high cost and time commitment. Observational studies that use existing clinical data to observe the effect of an intervention have shown several advantages over RCTs. Electronic Health Records (EHRs) have become an increasingly important resource for conducting observational studies. To support these studies, we developed a clinical research datamart, called ReDWINE (Rehabilitation Datamart With Informatics iNfrastructure for rEsearch), that transforms the rehabilitation-related EHR data collected from the UPMC health care system to the Observational Health Data Sciences and Informatics (OHDSI) Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) to facilitate rehabilitation research. The standardized EHR data stored in ReDWINE will further reduce the time and effort required by investigators to pool, harmonize, clean, and analyze data from multiple sources, leading to more robust and comprehensive research findings. ReDWINE also includes deployment of data visualization and data analytics tools to facilitate cohort definition and clinical data analysis. These include among others the Open Health Natural Language Processing (OHNLP) toolkit, a high-throughput NLP pipeline, to provide text analytical capabilities at scale in ReDWINE. Using this comprehensive representation of patient data in ReDWINE for rehabilitation research will facilitate real-world evidence for health interventions and outcomes.