NICOLE STADNICK
University of California San Diego

In response to the alarming health disparities experienced by underserved communities related to the COVID-19 pandemic, the National Institutes of Health (NIH) heavily invested in community engagement research efforts to eliminate disparities in testing, clinical trial participation, access to care, and vaccination. We describe the use of a Theory of Change process to meaningfully engage community members from or supporting underserved communities in two NIH-funded implementation science projects aimed at promoting equitable access to COVID-19 prevention and care services.

Both projects focused on underserved Latinx, Black, and immigrant and refugee communities in South/Central San Diego and/or individuals accessing care at a federally qualified health center (FQHC) near the US/Mexico border.

A Community Advisory Board (CAB) was established for each project with 11 and 22 members. CAB members included community organizers, promotores, FQHC providers and administrators, and public health researchers. The Global Action Research Center (ARC) led the recruitment of CAB members and facilitated each meeting. The Global ARC is a non-profit social change organization committed to bridging academic and community conversations to support community-driven solutions to public health priorities. The CABs were guided through a six-session Theory of Change, focused on identifying necessary conditions that must exist for a community-identified issues of concern along with specified actions to create those conditions and a blueprint for assessing the efficacy of those actions. Each session lasted two hours hosted over Zoom and was augmented by interactive web-based activities. Each CAB member was offered $100 for their participation in each meeting. There was a live interpreter who facilitated participation of Spanish-speaking CAB members.

A Theory of Change for each project was completed in approximately four months. A total of nine necessary conditions were identified across both projects. Cross-cutting conditions related to 1) accessible and available resources and services, 2) culturally and linguistically competent programming and materials, 3) investment in trusted community and faith leaders to convey accurate information, 4) social safety net to provide ancillary resources/services to support families. Corresponding actions to create these conditions were operationalized by the CAB members along with measures to indicate success in creating these necessary conditions.

We used a CAB-led Theory of Change process facilitated by our community partner, the Global ARC, to comprehensively assess and co-create necessary conditions, actions, and measures to eliminate disparities in COVID-19 prevention and intervention. While resource-intensive, these methods yielded a rich opportunity to equitably engage diverse groups that typically are not invited to inform these processes.

SHELLEY VANDERHOUT, PhD, RD
University of Ottawa

Patient-reported outcomes (PROs) are subjective measures of health and well-being that come directly from patients and commonly used to measure patient experience, quality of life, and symptoms. Given that pragmatic trials aim to provide evidence to inform clinical care decision making, PROs seem well suited to pragmatic trials; however, their use and reporting in pragmatic trials have not been described. We sought to review pragmatic trials to describe (1) the prevalence and types of PROs used; (2) whether the use of PROs varied across trial characteristics; and (3) how sample sizes and target differences were determined for trials with PROs.

An electronic search filter in MEDLINE was used to identify primary reports of pragmatic randomized controlled trials in health research published 2014-2019, that were registered in ClinicalTrials.gov and self-identified as pragmatic. Trial descriptors were downloaded from ClinicalTrials.gov; information about PROs and sample size calculations were extracted from each report. Data were summarized descriptively. Chi-squared, Cochran-Armitage and Wilcoxon rank-sum tests were used to examine associations between trial characteristics and use of PROs.

Of 415 trials which met inclusion criteria, 235 (57%) measured PROs (144 (35%) at least as primary/co-primary and 91 (22%) as only secondary outcomes). Primary PROs were symptoms (64; 44%), health behaviours (36; 25%), quality of life (8; 13%), functional status (16; 11%), and patient experience (10; 7%). Studies published in higher impact journals or funded by industry were less likely to use PROs as primary/co-primary outcomes, whereas individually (vs. cluster) randomized studies, those conducted in Europe, and those which tested dietary or behavioural interventions were more likely to use PROs as primary/co-primary outcomes. Patient engagement was not associated with use PROs as primary/co-primary outcomes. For the 144 trials with a PRO as primary or co-primary outcome, 126 (88%) reported a sample size calculation for that outcome. No justification was provided for the target difference in 53 (42%); patient or stakeholder opinion was rarely used to justify the target difference (8, 6%).

PROs are not routinely selected as outcomes in pragmatic trials, and patient and stakeholder engagement in determining target differences and sample sizes is rare. Institutions, funding bodies, and scientific journals can encourage the use of PROs in pragmatic trials by creating incentives, providing methodological support, and establishing policies for pragmatic trialists.