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Abstract Background Wearable activity trackers may facilitate walking for chronic pain management. Objective We assessed the acceptability of a commercially available tracker and three alternative modes of reporting daily steps among older adults in a low-income, urban community. We examined whether using the tracker (Fitbit ZipTM) was associated with improvements in functioning and activity. Design Randomized controlled pilot and feasibility trial. Subjects Fifty-one African American adults in Detroit, Michigan, aged 60 to 85 years, with chronic musculoskeletal pain (28 in the intervention group, 23 controls). Methods Participants completed telephone surveys at baseline and eight weeks. Intervention participants wore trackers for six weeks, alternately reporting daily step counts via text messages, automated telephone calls, and syncing (two weeks each). We used multimethods to assess satisfaction with trackers and reporting modalities. Adherence was indicated by the proportion of expected days on which valid step counts were reported. We assessed changes in pain interference, physical function, social participation, walking frequency, and walking duration. Results More than 90% of participants rated trackers as easy to use, but some had technical or dexterity-related difficulties. Text reporting yielded 79% reporting adherence vs 69% each for automated calls and syncing. Intervention participants did not show greater improvement in functioning or walking than controls. Conclusions With appropriate support, wearable activity trackers and mHealth reporting for chronic pain self-care are feasible for use by vulnerable older adults. Future research should test whether the effects of trackers on pain-related outcomes can be enhanced by incorporating behavior change strategies and training in evidence-based cognitive-behavioral techniques.

•Our study explored basic methodological standards in COVID-19 guideline development.•Only 4% of the guidelines were classified as the highest methodological quality.•Insufficient methodological standards could lead to harmful actions for patients. The number of published clinical practice guidelines related to COVID-19 has rapidly increased. This study explored if basic methodological standards of guideline development have been met in the published clinical practice guidelines related to COVID-19. Rapid systematic review from February 1 until April 27, 2020 using MEDLINE [PubMed], CINAHL [Ebsco], Trip and manual search, including all types of healthcare workers providing any kind of healthcare to any patient population in any setting. There were 1342 titles screened and 188 guidelines included. The highest average AGREE II domain score was 89% for scope and purpose, the lowest for rigor of development (25%). Only eight guidelines (4%) were based on a systematic literature search and a structured consensus process by representative experts (classified as the highest methodological quality). The majority (156; 83%) was solely built on an informal expert consensus. A process for regular updates was described in 27 guidelines (14%). Patients were included in the development of only one guideline. Despite clear scope, most publications fell short of basic methodological standards of guideline development. Clinicians should use guidelines that include up-to-date information, were informed by stakeholder involvement, and employed rigorous methodologies. [Display omitted]

Background Older adults in disadvantaged urban communities contend with chronic psychosocial and environmental stressors that contribute to high levels of chronic pain-related disability. African American older adults are especially at risk due to the health-damaging effects of structural racism. The purpose of this study is to test the efficacy of a chronic pain self-management intervention tailored for this context. STEPS (Seniors using Technology to Engage in Pain Self-management) is a community health worker (CHW)-led chronic pain self-management program designed for older adults living in underserved communities. It is a 7-week intervention that includes (a) brief videos presenting pain self-management skills; (b) weekly telephone calls with a CHW to support the practice of new skills and goal setting; and (c) tracking daily step counts using a wearable activity tracker. CHWs also screen for social needs and make appropriate community referrals. Methods We will randomly assign 414 participants to the STEPS intervention or a control condition in a 1:1 ratio, stratifying by gender and age group. We hypothesize that participants in the STEPS intervention will have greater improvements in pain interference and pain intensity, and a more positive Global Impression of Change immediately following the intervention and at 12 months from baseline. Control group members are invited to attend a workshop covering key intervention content after the final data collection point. Discussion Growing evidence supports the effectiveness of CHWs as culturally sensitive liaisons between healthcare systems and underserved communities. If the STEPS program is shown to significantly improve pain-related outcomes, STEPS could be integrated into healthcare systems to more comprehensively treat chronic pain while reducing barriers to care and promoting non-pharmacological pain management strategies. Trial registration ClinicalTrials.gov, NCT05278234. Registered on March 3, 2022.

Objectives/Goals: To tailor support for behavioral and social science research (BSSR), it is helpful to understand this broad category. As a first step to characterizing BSSR at University of Michigan (UM), our goal is to use a large language model (LLM) to identify health-related BSSR from a database of funded studies. Methods/Study Population: We are using a private, secure version of Open AI ChatGPT-4.1 LLM to evaluate whether studies are health-related BSSR or not based on the study team’s (1) abstract, (2) objectives, and (3) key words entered into UM’s internal research proposal system for all studies funded over the last 10 years (i.e., 2014 – 2024). The model included a prompt with the National Institutes of Health (NIH) definition of BSSR and was instructed to categorize the research as being BSSR, not BSSR, or possibly BSSR. Results from the LLM were compared for consistency with assessments made by human-made decision rules. Results/Anticipated Results: Preliminary results from a pilot sample of 150 studies funded in 2024 (~5%) reviewed by ChatGPT for BSSR status revealed: 6 false positives, 128 true negatives, 14 true positives, and 2 false negatives. Accuracy = 95%, precision = 70%, recall (sensitivity) = 88%, specificity = 96%, and F1 Score = 0.78. ChatGPT and human-based decisions differed primarily on cognition and vehicle technology studies and studies for which information was sparse. Further refinements to the prompt are being made and applied to the remaining studies funded in 2024 before expanding to the entire sample of studies from the last 10 years. Discussion/Significance of Impact: It is time and cost prohibitive for a human to review and classify all funded studies at UM as BSSR or not. Using LLMs offers the potential to make this classification work feasible with limited resources, which is a necessary step toward understanding the state of BSSR.

A high‐quality protocol document is essential for the successful and efficient implementation of clinical trials, but there is no consensus on how clinical trial protocol document quality should be evaluated. We used a modified Delphi approach and cognitive interviews to develop a new protocol document quality assessment tool, the Protocol Quality Rating Tool (PQRT). We compiled a checklist of elements that should be included in a high‐quality trial protocol document and asked experts to rate the importance of each element. We developed the PQRT by describing the expected content of each element and identified essential vs. additional (bonus) content to differentiate high‐ versus low‐quality protocol documents and then organized the elements into 18 sections. We revised the PQRT based on feedback from and cognitive interviews with our protocol quality rating team. We then tested the PQRT using ten protocol documents previously approved by the Institutional Review Board. All the protocol quality raters found the tool easy to use and their scores were highly concordant for eight of ten protocol documents. We have developed and tested a simple tool to measure clinical trial protocol document quality and encourage other researchers to evaluate and validate it.

OBJECTIVE. This study assessed the feasibility and preliminary efficacy of an online-assisted, occupational therapist–delivered, cognitive–behavioral therapy intervention to promote physical function in patients with knee osteoarthritis (KOA). METHOD. Fifty-seven participants with KOA were randomized 2:1 to the Engage program (eight clinic-based sessions supported by online modules) or usual care. Using analysis of covariance, we estimated Engage’s effect on physical function (Western Ontario and McMaster Universities Osteoarthritis Index’s Physical Function subscale [WOMAC–PF]) at 6 mo. RESULTS. Data were analyzed on 46 completers. Engage was associated with a small effect (η2 = 0.01) on the WOMAC–PF. More Engage participants than controls reported much or very much improvement (45% vs. 13%; p = .03). Satisfaction was high, and 30 of 31 participants attended six sessions or more. CONCLUSION. An online-supported cognitive–behavioral program for people with KOA delivered by occupational therapists is feasible and may contribute to improved physical function.

OBJECTIVE. Fear of falling can lead to restricted activity, but little is known about how this fear affects different aspects of people’s lives. This study examined the relationship between fall-related efficacy (i.e., confidence or belief in one’s ability to perform activities without losing balance or falling) and activity and participation. METHOD. We conducted a meta-analysis of studies comparing community-dwelling older adults’ fall-related efficacy to measures of activity or participation. RESULTS. An examination of 20 cross-sectional and prospective studies found a strong positive relationship between fall-related efficacy and activity (r = .53; 95% CI [.47, .58]). An insufficient number of studies examining fall-related efficacy and participation were available for analysis. CONCLUSION. Low fall-related efficacy may be an important barrier to occupational engagement for many older adults and warrants careful consideration by occupational therapists. Future research should explore interventions that target fall-related efficacy and examine their effects on activity performance and engagement.

Community-engaged research is an approach that helps foster partnerships between community members and researchers by incorporating community members across multiple stages of the research study. In doing so, researchers can gain a deeper understanding of the insider perspective. One area that has received limited attention is the process of engaging community members in qualitative data analysis. To overcome this limitation, we outline how we implemented and adapted the Rigorous and Accelerated Data Reduction (RADaR) technique to explore learners’ perceptions and experiences of a tailored research best practices training for community health workers and promotoras. We reflect on the strengths and challenges of using the RADaR technique in community-engaged research and provide a list of considerations for researchers engaging in a similar process. We also incorporate the community partner’s perspectives on engaging in qualitative data analysis. This article provides a step-by-step approach for engaging community partners in the qualitative data analysis process, particularly using the RADaR technique, as a strategy for enhancing research quality and mitigating the power imbalance between researchers and communities.

Objectives/Goals: To support the growing number of clinical research professionals (CRP) working in behavioral and social science contexts, relevant formative assessments of research skills are needed. This study examines the development of an objective formative assessment designed to assess skills relevant to conducting social and behavioral research. Methods/Study Population: A multidisciplinary group at the University of Michigan was convened to develop the assessment. Case studies depicting clinical and translational research conducted in behavioral and social science contexts were used to measure proficiency in seven of the eight ECRPTQ competencies: Scientific Concepts & Research Design, Ethical & Participant Safety Concerns, Clinical Trial Operations (Good Clinical Practice), Study & Site Management, Data Management & Informatics, Leadership & Professionalism, Communication, and Teamwork & Team Science. Three difficulty levels of questions were developed: basic, intermediate, and advanced. To reinforce knowledge and skill development, the assessment was designed to give respondents formative feedback after responding to each question. Results/Anticipated Results: A preliminary “pre-pilot” test was conducted with three postdoctoral scholars to ensure that the assessment items were understandable. The assessment was then pilot tested with a larger group of 40 clinical research professionals (CRP) to test for the clarity and difficulty level of the items. A smaller group of 20 of these CRPs agreed to participate in focus groups to obtain feedback on their user experience. Data regarding years of experience as a CRP, types of studies engaged with, and information regarding professional certification were collected and used in the analyses. Demographic data collected were not connected to user responses. Results of the pilot test and focus groups were used to revise the questions on the final version of the assessment. Discussion/Significance of Impact: To our knowledge, this is the first objective assessment of research skills for CRP working in behavioral and social science contexts. We will discuss how other institutions can use this instrument to evaluate the training needs of their social and behavioral research workforce.

Objectives/Goals: We evaluated the implementation of a peer-facilitated research best practices training for Community Health Workers and Promotoras (CHW/Ps) at four new partner sites to increase the capacity and capability of a workforce increasingly involved in community-engaged research. Methods/Study Population: Staff were trained using a train-the-trainer model, and materials were disseminated to partners at three academic institutions and one community-based organization. Each site delivered the training virtually or in-person in English and/or Spanish. CHW/P learners at all sites completed online evaluation surveys about the impact of the training on their knowledge and skills for participating in research-related work, and two CHW/Ps from each site participated in follow-up interviews to gather feedback about their experiences. Staff completed fidelity monitoring, follow-up interviews, and three brief surveys regarding feasibility, acceptability, and appropriateness of implementing the training. Results/Anticipated Results: The four sites conducted six trainings with a total of 42 CHW/Ps. Two sites each conducted one in-person training in English while the other two sites each conducted two virtual trainings, one in English and one in Spanish. Staff noted facilitators to successful implementation, including providing a facilitator guide and course materials in both languages and tips sheets for navigating REDCap; using the train-the-trainer model; and compensating CHW/P learners for attendance. The primary barrier noted was not having a budget for in-person trainings (e.g., refreshments, printed materials). CHW/P learners reported positive experiences with few suggestions for improving the training. Discussion/Significance of Impact: Preliminary results suggest the research best practices training for CHW/Ps is feasible, acceptable, and appropriate for implementation by partners at academic institutions and community-based organizations, regardless of language (i.e., English or Spanish) or delivery (i.e., virtual or in-person).