Institute of Musculoskeletal Health and Arthritis

Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete. Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances. Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders. Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses. Conclusions and Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.

Background: Research objectives should be focused toward advancing knowledge that has meaningful impact on health. However, research agendas are mostly driven by the health care community, with limited input from patients.Aims: In this study, prioirities of uncertainties for the management of fibromyalgia (FM) that could propel future research were identified by a defined process using the James Lind Alliance Priority Setting Partnership (JLA-PSP) methodology.Methods: As a first step, a survey was distributed across Canada that engaged patients, caregivers, and health care professionals to provide narrative input to eight open-ended questions regarding FM care. Responses were thematically condensed and synthesized into an initial list of 43 uncertainties used to guide a comprehensive literature search. Questions already effectively addressed in the literature were excluded, leaving 25 uncertainties that were ranked during a one-day consensus workshop.Results: Three broad themes emerged: the value of personalized targeted treatment and subgrouping of patients; the efficacy of various self-management strategies and educational initiatives; and identification of the ideal health care setting to provide FM care. Opioids and cannabinoids were the only specific pharmacologic interventions ranked as needing further research.Conclusions: The prioritized questions highlight the importance of recognizing the heterogeneity of FM symptoms, the need for a personalized treatment approach, and a better understanding of the value of self-management strategies. This is the first study that uses an established and transparent methodology to engage all FM stakeholders to help inform researchers and funding bodies of clinically relevant research priorities.

BACKGROUND: The Lancet Low Back Pain (LBP) Series highlighted the lack of LBP data from low- and middle-income countries (LMICs). The study aimed to describe (1) what LBP care is currently delivered in LMICs and (2) how that care is delivered. DESIGN: An online mixed-methods study. METHODS: A Consortium for LBP in LMICs (n = 65) was developed with an expert panel of leading LBP researchers (>2 publications on LBP) and multidisciplinary clinicians and patient partners with 5 years of clinical/lived LBP experience in LMICs. Quantitative data were analyzed using descriptive statistics. Two researchers independently analyzed qualitative data using inductive and deductive coding and developed a thematic framework. RESULTS: Forty-seven (85%) of 55 invited panel members representing 32 LMICs completed the survey (38% women, 62% men). The panel included clinicians (34%), researchers (28%), educators (6%), and people with lived experience (4%). Pharmacotherapies and electrophysiological agents were the most used LBP treatments. The thematic framework comprised 8 themes: (1) self-management is ubiquitous, (2) medicines are the cornerstone, (3) traditional therapies have a place, (4) society plays an important role, (5) imaging use is very common, (6) reliance on passive approaches, (7) social determinants influence LBP care pathway, and (8) health systems are ill-prepared to address LBP burden. CONCLUSION: LBP care in LMICs did not consistently align with the best available evidence. Findings will help research prioritization in LMICs and guide global LBP clinical guidelines. J Orthop Sports Phys Ther 2024;54(8):560-572. Epub 11 April 2024. doi:10.2519/jospt.2024.12406

In a time-division broadcast positioning system (TDBPS), localizing mobile targets using classical time difference of arrival (TDOA) methods poses significant challenges. Concurrent TDOA measurements are infeasible because targets receive signals from different anchors and extract their transmission times at different reception times, as well as at varying positions. Traditional TDOA estimation schemes implicitly assume that the target remains stationary during the measurement period, which is impractical for mobile targets exhibiting high dynamics. Existing methods for mobile target localization are mostly specialized and rely on motion modeling and do not rely on the concurrent TDOA measurements. This issue limits their direct use of the well-established classical TDOA-based localization methods and complicating the entire localization process. In this article, to obtain concurrent TDOA estimates at any instant out of the sequential measurements for direct use of existing TDOA-based localization methods, we propose a novel TDOA estimation method, termed parameterized TDOA (P-TDOA). By approximating the time-varying TDOA as a polynomial function over a short period, we transform the TDOA estimation problem into a model parameter estimation problem and derive the desired TDOA estimates thereafter. Theoretical analysis shows that, under certain conditions, the proposed P-TDOA method closely approaches the Cramér–Rao Lower Bound (CRLB) for TDOA estimation in concurrent measurement scenarios, despite measurements being obtained sequentially. Extensive numerical simulations validate our theoretical analysis and demonstrate the effectiveness of the proposed method, highlighting substantial improvements over existing approaches across various scenarios.

The Canadian Institutes of Health Research (CIHR) commenced a Quality Assurance Program in 2019 to monitor the quality of peer review in its Project Grant Competition Peer Review Committees. Our primary aim was to describe the performance of CIHR grant peer reviewers, based on the assessments made by CIHR peer review leaders during the first 3 years of the Research Quality Assurance Program. All Peer Review Committee Chairs and (or) Scientific Officers who led peer review for CIHR in 2019, 2020, and 2021 completed Reviewer Quality Feedback forms immediately following Peer Review Committee meetings. The form assessed Performance, Future potential, Review quality, Participation, and Responsiveness. We summarised and descriptively synthesised data from assessments conducted after each of the four grant competitions. The performance of peer reviewers on 4438 occasions was rated by Chairs and Scientific Officers. Approximately one in three peer reviewers submitted outstanding reviews or discussed additional applications and one in 10 demonstrated potential as a future Peer Review Committee leader. At most, one in 20 peer reviewers was considered to have not performed adequately with respect to review quality, participation, or responsiveness. There is a need for more research on the processes involved in allocating research grant funding.

INTRODUCTION: The intersection of sexism with racism and xenophobia disproportionately exposes visible minority women to gender-based violence (GBV) at the community and systemic levels. This study aims to understand the knowledge strengths and gaps on GBV against visible minority women with an intersectional lens, revealing systemic barriers to accessing support and how these barriers intensify GBV and its effects. It will also identify effective and ineffective policies and practices in the literature to develop strategies addressing the root causes of GBV and supporting survivors. METHODS AND ANALYSIS: We will conduct a mixed-methods systematic review using a convergent integrated approach to examine current literature on community- and systemic-level GBV against visible minority women. We will follow Joanna Briggs Institute's guidelines to converge data from both qualitative and quantitative studies to obtain an integrated qualitative synthesis on GBV in five countries: Canada, the USA, the UK, Australia and New Zealand. This analysis will be conducted following Thomas and Harden's thematic synthesis guidelines. Community members with lived experience of GBV will actively contribute to improving the relevance and interpretation of results, following a community-engaged research approach. Themes are expected to unveil various aspects of community- and systemic-level GBV due to the intersection of racism, xenophobia and sexism, alongside barriers in addressing GBV and research gaps. ETHICS AND DISSEMINATION: Since this study does not involve primary data collection or the use of identifiable human data, no ethical approval will be needed. Results will be disseminated through integrated knowledge translation, involving collaboration with participants who have lived experience of GBV. The findings will be used to identify specific areas of policy intervention, including adopting culturally sensitive approaches, improving school and workplace policies and promoting rights of visible minority women.

<sec> <title>BACKGROUND</title> Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. </sec> <sec> <title>OBJECTIVE</title> The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. </sec> <sec> <title>METHODS</title> The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ≤7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. </sec> <sec> <title>RESULTS</title> Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. </sec> <sec> <title>CONCLUSIONS</title> The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/16799 </sec>

<sec> <title>BACKGROUND</title> Strong evidence supports beginning stroke rehabilitation as soon as the patient’s medical status has stabilized and continuing following discharge from acute care. However, adherence to rehabilitation treatments over the rehabilitation phase has been shown to be suboptimal. </sec> <sec> <title>OBJECTIVE</title> The aim of this study is to assess the impact of a telerehabilitation platform on stroke patients’ adherence to a rehabilitation plan and on their level of reintegration into normal social activities, in comparison with usual care. The primary outcome is patient adherence to stroke rehabilitation (up to 12 weeks), which is hypothesized to influence reintegration into normal living. Secondary outcomes for patients include functional recovery and independence, depression, adverse events related to telerehabilitation, use of services (up to 6 months), perception of interprofessional shared decision making, and quality of services received. Interprofessional collaboration as well as quality of interprofessional shared decision making will be measured with clinicians. </sec> <sec> <title>METHODS</title> In this interrupted time series with a convergent qualitative component, rehabilitation teams will be trained to develop rehabilitation treatment plans that engage the patient and family, while taking advantage of a telerehabilitation platform to deliver the treatment. The intervention will be comprised of 220 patients who will take part in stroke telerehabilitation with an interdisciplinary group of clinicians (telerehabilitation group) versus face-to-face standard of care (control group: n=110 patients). </sec> <sec> <title>RESULTS</title> Our Research Ethics Board approved the study in June 2020. Data collection for the control group is underway, with another year planned before we begin the intervention phase. </sec> <sec> <title>CONCLUSIONS</title> This study will contribute to the minimization of both knowledge and practice gaps, while producing robust, in-depth data on the factors related to the effectiveness of telerehabilitation in a stroke rehabilitation continuum. Findings will inform best practice guidelines regarding telecare services and the provision of telerehabilitation, including recommendations for effective interdisciplinary collaboration regarding stroke rehabilitation. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT04440215; https://clinicaltrials.gov/ct2/show/NCT04440215 </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/32134 </sec>