Patient Selection

ImportancePrevious work found that 25% to 30% of randomized clinical trials (RCTs) with protocols approved in 2012 or between 2000 and 2003 were discontinued prematurely, most commonly due to inadequate participant recruitment. To minimize research waste, RCTs should be registered and their results made available.ObjectivesTo assess the fate of RCTs approved by ethics committees in 2016 in terms of nonregistration, discontinuation, and nonpublication, and to examine RCT characteristics associated with discontinuation due to poor recruitment and nonpublication of RCT results.Evidence reviewAs a prespecified project of the Adherence to SPIRIT Recommendations (ASPIRE) study, this systematic review had access to 347 RCT protocols approved in 2016 by research ethics committees in the UK, Switzerland, Germany, and Canada. Eligible RCTs were defined as prospective studies randomly assigning participants to interventions to study effects on health outcomes. RCTs were excluded that never started, were ongoing at time of follow-up, were duplicates, or were labeled as pilot, feasibility, or phase 1 trials. Key trial characteristics were extracted from the approved trial protocols. In July 2024, pairs of reviewers systematically searched for trial registrations and results publications. When the status of either was unclear, the corresponding ethics committee or the principal investigator was contacted for clarification.FindingsOf 347 included RCTs, 20 (5.8%) were unregistered, 108 (31.1%) were discontinued, most often due to poor recruitment (49 [45.4%]), and 276 (79.5%) made their results publicly available. Results from industry-sponsored trials were more often available than non-industry-sponsored trials (166 of 181 [92.3%] vs 110 of 166 [66.3%]). This difference was attributable to a higher prevalence of industry-sponsored trials that reported results in trial registries (153 of 181 [84.5%]) vs nonindustry RCTs (17 of 166 [10.2%]). Multivariable logistic regression indicated that industry-sponsored trials were less frequently discontinued due to poor recruitment than non-industry-sponsored RCTs (adjusted odds ratio, 0.32 [95% CI, 0.15-0.71]).Conclusions and relevanceFindings from this systematic review indicated that nonregistration, premature discontinuation due to poor recruitment, and nonpublication of RCT results remained major challenges, especially for non-industry-sponsored trials. To mitigate these challenges, requirements enforced by funders and ethics committees also taking into account legal obligations should be considered and empirically evaluated.

Functional near-infrared spectroscopy (fNIRS) is a popular optical neuroimaging method; however, participants with Afro-textured (i.e., dark, coarse, curly) hair are often excluded due to difficulty obtaining sensor-scalp contact. Grounded in lived experience and sociocultural literature, we aimed to develop and evaluate culturally responsive best practices for participant interaction and hair preparation to increase Black participant inclusion in fNIRS research. First, we developed an intake survey, guidelines for researcher staffing and training, and a suite of customizable hair preparation techniques that prioritize participant comfort and hair integrity. We then evaluated these techniques with 19 Black participants (11 adults, eight children) with varying hair types/styles; methods included braiding cornrows around the intended optode montage, using gels and clips to part hair, and various ways of increasing tension to promote sensor-scalp contact. On average, signal quality improved by 50%, with the greatest improvements in anterior regions. While signal quality was not perfect, it was generally improved to the point of acceptability and inclusion in a racially/ethnically diverse dataset (with hair type/color as covariates). We conclude with recommendations for increasing awareness of racial bias in neuroimaging, greater diversity in research teams, and a more inclusive approach for working with diverse populations.

IntroductionThe New York University Caregiver Intervention plus Enhanced Support Project is a randomized controlled trial of a family-based psychosocial intervention to enhance social support and reduce cardiometabolic risk for Chinese and Korean American dementia caregivers, using culturally tailored recruitment strategies.MethodsWe reviewed reflections from research staff, weekly meeting minutes, debriefing sessions, and progress reports, to identify key challenges and approaches to engaging participants.ResultsKey challenges included reluctance to involve family members, dementia stigma, and resistance to involving family. In response, we engaged online communities, partnered with local organizations, participated in events, and adapted recruitment messages to cultural norms. For the Chinese community, we focused on practical skills while for the Korean community, we emphasized caregiving strategies and the personal/social benefits of participation, reducing rejection rates.DiscussionOur findings underscore the importance of culturally tailored recruitment strategies in dementia research. Respectful, sensitive, and culturally informed approaches can significantly enhance engagement and participation.HighlightsCulturally adapted recruitment strategies improve study engagement with Chinese and Korean American dementia caregivers. Community partnerships with local social services agencies are essential for recruitment success. Culturally relevant social media applications were integrated to increase accessibility for study participants. This study uniquely targets and recruits Chinese and Korean American dementia caregivers with metabolic syndrome-related symptoms, incorporating a psychological intervention alongside biomarker data collection. The iterative adaptation of recruitment methods and tailored messaging to specific ethnic groups ensure the intervention is culturally aligned, enhancing both participation and relevance to the caregivers' unique health and caregiving contexts.