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Abstract Introduction: Engaging patients, caregivers, and other stakeholders to help guide the research process is a cornerstone of patient-centered research. Lived expertise may help ensure the relevance of research questions, promote practices that are satisfactory to research participants, improve transparency, and assist with disseminating findings. Methods: Traditionally engagement has been conducted face-to-face in the local communities in which research operates. Decentralized platform trials pose new challenges for the practice of engagement. We used a remote model for stakeholder engagement, relying on Zoom meetings and blog communications. Results: Here we describe the approach used for research partnership with patients, caregivers, and clinicians in the planning and oversight of the ACTIV-6 trial and the impact of this work. We also present suggestions for future remote engagement. Conclusions: The ACTIV-6 experience may inform proposed strategies for future engagement in decentralized trials.

Abstract Background The supplementation of electronic health records data with administrative claims data may be used to capture outcome events more comprehensively in longitudinal observational studies. This study investigated the utility of administrative claims data to identify outcomes across health systems using a comparative effectiveness study of different types of bariatric surgery as a model. Methods This observational cohort study identified patients who had bariatric surgery between 2007 and 2015 within the HealthCore Anthem Research Network (HCARN) database in the National Patient-Centered Clinical Research Network (PCORnet) common data model. Patients whose procedures were performed in a member facility affiliated with PCORnet Clinical Research Networks (CRNs) were selected. The outcomes included a 30-day composite adverse event (including venous thromboembolism, percutaneous/operative intervention, failure to discharge and death), and all-cause hospitalization, abdominal operation or intervention, and in-hospital death up to 5 years after the procedure. Outcomes were classified as occurring within or outside PCORnet CRN health systems using facility identifiers. Results We identified 4899 patients who had bariatric surgery in one of the PCORnet CRN health systems. For 30-day composite adverse event, the inclusion of HCARN multi-site claims data marginally increased the incidence rate based only on HCARN single-site claims data for PCORnet CRNs from 3.9 to 4.2%. During the 5-year follow-up period, 56.8% of all-cause hospitalizations, 31.2% abdominal operations or interventions, and 32.3% of in-hospital deaths occurred outside PCORnet CRNs. Incidence rates (events per 100 patient-years) were significantly lower when based on claims from a single PCORnet CRN only compared to using claims from all health systems in the HCARN: all-cause hospitalization, 11.0 (95% Confidence Internal [CI]: 10.4, 11.6) to 25.3 (95% CI: 24.4, 26.3); abdominal operations or interventions, 4.2 (95% CI: 3.9, 4.6) to 6.1 (95% CI: 5.7, 6.6); in-hospital death, 0.2 (95% CI: 0.11, 0.27) to 0.3 (95% CI: 0.19, 0.38). Conclusions Short-term inclusion of multi-site claims data only marginally increased the incidence rate computed from single-site claims data alone. Longer-term follow up captured a notable number of events outside of PCORnet CRNs. The findings suggest that supplementing claims data improves the outcome ascertainment in longitudinal observational comparative effectiveness studies.

Abstract Introduction: Shared decision-making (SDM) is a critical component of delivering patient-centered care. Members of vulnerable populations may play a passive role in clinical decision-making; therefore, understanding their prior decision-making experiences is a key step to engaging them in SDM. Objective: To understand the previous healthcare experiences and current expectations of vulnerable populations on clinical decision-making regarding therapeutic options. Methods: Clients of a local food bank were recruited to participate in focus groups. Participants were asked to share prior health decision experiences, explain difficulties they faced when making a therapeutic decision, describe features of previous satisfactory decision-making processes, share factors under consideration when choosing between treatment options, and suggest tools that would help them to communicate with healthcare providers. We used the inductive content analysis to interpret data gathered from the focus groups. Results: Twenty-six food bank clients participated in four focus groups. All participants lived in areas of socioeconomic disadvantage. Four themes emerged: prior negative clinical decision-making experience with providers, patients preparing to engage in SDM, challenges encountered during the decision-making process, and patients’ expectations of decision aids. Participants also reported they were unable to discuss therapeutic options at the time of decision-making. They also expressed financial concerns and the need for sufficiently detailed information to evaluate risks. Conclusion: Our findings suggest the necessity of developing decision aids that would improve the engagement of vulnerable populations in the SDM process, including consideration of affordability, use of patient-friendly language, and incorporation of drug–drug and drug–food interactions information.