ABSTRACT
OBJECTIVE: Summaries of health research can be a complementary way to return value to participants. We assess how research participants engage with summaries via email communication and how this can be improved. MATERIALS AND METHODS: We look at correlations between demographic subgroups and engagement in a longitudinal dataset of 305 626 participants (77% are classified as underrepresented in biomedical research) from the All of Us Research Program. We compare this against engagement with other program communications and use impact evaluations (N = 421 510) to measure the effect of tailoring communication by (1) eliciting content preferences, (2) Spanish focused content, (3) informational videos, and (4) article content in the email subject line. RESULTS: Between March 2020 and October 2021, research summaries reached 67% of enrolled participants, outperforming other program communication (60%) and return of results (31%), which have a high uptake rate but have been extended to a subset of eligible participants. While all demographic subgroups engage with research summaries, participants with higher income, educational attainment, White, and older than 45 years open and click content most often. Surfacing article content in the email subject line and Spanish focused content had negative effects on engagement. Video and social media content and eliciting preferences led to a small directional increase in clicks. DISCUSSION: Further individualization of tailoring efforts may be needed to drive larger engagement effects (eg, delivering multiple articles in line with stated preferences, expanding preference options). Our findings are likely a conservative representation of engagement effects, given the coarseness of our click rate measure. CONCLUSIONS: Health research summaries show promise as a way to return value to research participants, especially if individual-level results cannot be returned. Personalization of communication requires testing to determine whether efforts are having the expected effect.
ABSTRACT
BACKGROUND: Early identification of an acute respiratory infection is important for reducing transmission and enabling earlier therapeutic intervention. We aimed to prospectively evaluate the feasibility of home-based diagnostic self-testing of viral pathogens in individuals prompted to do so on the basis of self-reported symptoms or individual changes in physiological parameters detected via a wearable sensor. METHODS: DETECT-AHEAD was a prospective, decentralised, randomised controlled trial carried out in a subpopulation of an existing cohort (DETECT) of individuals enrolled in a digital-only observational study in the USA. Participants aged 18 years or older were randomly assigned (1:1:1) with a block randomisation scheme stratified by under-represented in biomedical research status. All participants were offered a wearable sensor (Fitbit Sense smartwatch). Participants in groups 1 and 2 received an at-home self-test kit (Alveo be.well) for two acute respiratory viral pathogens: SARS-CoV-2 and respiratory syncytial virus. Participants in group 1 could be alerted through the DETECT study app to take the at-home test on the basis of changes in their physiological data (as detected by our algorithm) or due to self-reported symptoms; those in group 2 were prompted via the app to self-test only due to symptoms. Group 3 served as the control group, without alerts or home testing capability. The primary endpoints, assessed on an intention-to-treat basis, were the number of acute respiratory infections presented (self-reported) and diagnosed (electronic health record), and the number of participants using at-home testing in groups 1 and 2. This trial is registered with ClinicalTrials.gov, NCT04336020. FINDINGS: Between Sept 28 and Dec 30, 2021, 450 participants were recruited and randomly assigned to group 1 (n=149), group 2 (n=151), or group 3 (n=150). 179 (40%) participants were male, 264 (59%) were female, and seven (2%) identified as other. 232 (52%) were from populations historically under-represented in biomedical research. 118 (39%) of the 300 participants in groups 1 and 2 were prompted to self-test, with 61 (52%) successfully completing self-testing. Participants were prompted to home-test more frequently due to symptoms (41 [28%] in group 1 and 51 [34%] in group 2) than due to detected physiological changes (26 [17%] in group 1). Significantly more participants in group 1 received alerts to test than did those in group 2 (67 [45%] vs 51 [34%]; p=0·047). Of the 61 individuals who were prompted to test and successfully did so, 19 (31%) tested positive for a viral pathogen-all for SARS-CoV-2. The individuals diagnosed as positive for SARS-CoV-2 in the electronic health record were eight (5%) in group 1, four (3%) in group 2, and two (1%) in group 3, but it was difficult to confirm if they were tied to symptomatic episodes documented in the trial. There were no adverse events. INTERPRETATION: In this direct-to-participant trial, we showed early feasibility of a decentralised programme to prompt individuals to use a viral pathogen diagnostic test based on symptoms tracked in the study app or physiological changes detected using a wearable sensor. Barriers to adequate participation and performance were also identified, which would need to be addressed before large-scale implementation. FUNDING: Janssen Pharmaceuticals.