Return of individual research results: What do participants prefer and expect?

Abstract

Newer data platforms offer increased opportunity to share multidimensional health data with research participants, but the preferences of participants for which data to receive and how is evolving. Our objective is to describe the preferences and expectations of participants for the return of individual research results within Project Baseline Health Study (PBHS). The PBHS is an ongoing, multicenter, longitudinal cohort study with data from four initial enrollment sites. PBHS participants are recruited from the general population along with groups enriched for heart disease and cancer disease risk. Cross-sectional data on return of results were collected in 2017–2018 from an (1) in-person enrollment survey (n = 1,890), (2) benchmark online survey (n = 1,059), and (3) participant interviews (n = 21). The main outcomes included (1) preferences for type of information to be added next to returned results, (2) participant plans for sharing returned results with a non-study clinician, and (3) choice to opt-out of receiving genetic results. Results were compared by sociodemographic characteristics. Enrollment and benchmark survey respondents were 57.1% and 53.5% female, and 60.0% and 66.2% white, respectively. Participants preferred the following data types be added to returned results in the future: genetics (29.9%), heart imaging, (16.4%), study watch (15.8%), and microbiome (13.3%). Older adults (OR 0.60, 95% CI: 0.41–0.87) were less likely to want their genetic results returned next. Forty percent of participants reported that they would not share all returned results with their non–study clinicians. Black (OR 0.64, 95% CI 0.43–0.95) and Asian (OR 0.47, 95% CI 0.30–0.73) participants were less likely, and older participants more likely (OR 1.45–1.61), to plan to share all results with their clinician than their counterparts. At enrollment, 5.8% of participants opted out of receiving their genetics results. The study showed that substantial heterogeneity existed in participant’s preferences and expectations for return of results, and variations were related to sociodemographic characteristics.

Multi-dimensional characterization of prediabetes in the Project Baseline Health Study

“…At the initial in-person visit, participants underwent a broad array of testing and biospecimen collections, some of which were repeated at annual follow-up visits [ 5 ]. For this analysis, we used data from a range of PBHS assessments: self-reported demographics, medical history, and medications; clinical assessments, including vital signs and anthropometric measurements; physical performance testing; lung assessments, including pulmonary function tests and chest radiograph; cardiovascular assessments, including electrocardiograms; ankle-brachial index measurements, coronary calcium scan, echocardiogram, and stress echocardiogram; eye assessments, including optical coherence tomography and retinal photography; laboratory values measured from blood and urine biospecimens; psychological screening assessments collected either in-person or online; and step and sleep data collected via a Verily Study Watch.…”

“…The Project Baseline Health Study (PBHS) (ClinicalTrials.gov NCT03154346) is a unique, multicenter, prospective cohort harnessing advanced technological and digital capabilities for recruitment and data collection [ 4 , 5 ]. The PBHS study performed deep phenotyping at in-person study visits, including medical history, physical function measures, imaging and biospecimen collection, as well as longitudinal digital health data, survey data, and annual follow-up.…”

Ethical Considerations in Clinical Trials for Disorders of Consciousness

“…Determination of whether, when and how to disclose research results demands case-by-case consideration, given the plurality of factors that might bear on these decisions and their potential impact on participants, surrogates and research data integrity. These questions should be proactively discussed during the study design phase and written into the protocol and consent procedure [147][148][149][150][151]…”

“…The determination of whether, when, and how to disclose research results requires case-by-case consideration, given the plurality of factors that might bear on these decisions and their potential impact on participants, surrogates, and research-data integrity. These questions should be proactively discussed during the study design phase and written into the protocol and consent procedure [ 147 , 148 , 149 , 150 , 151 ]. Consensus has been growing among ethicists, legal scholars, and regulators in favor of more regular return of research results, where appropriate [ 152 ], and a 2018 Consensus Study Report of the National Academies of Sciences, Engineering, and Medicine (NASEM) details a vision for “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm” [ 149 ].…”

Lingering Impacts on Sleep Following the Daylight Savings Time Transition

“…BHS has a communitydwelling cohort which participates in a variety of study-related activities, and the study features a variety of engagement mechanisms, including return of results efforts. [21] Even in this context, the opt-in rate of 69.1% is very high compared to traditional uptake of studies offered in remote circumstances, for which participation may range between 11% and 47.4% in disease speci c registry studies between one day and three months long. [22] [23] That said, not all participants who opted in contributed enough data to meet minimum thresholds for analysis, and this may well have affected power to detect changes related to sleep.…”