Returning individual research results to clinical study participants has not historically been the norm, even for participants with abnormal findings. The paradigm, though, is shifting, with return of results becoming not only a scientific responsibility but also an ethical imperative. However, best practices haven’t been established yet.
A team of Duke researchers led by Svati H. Shah, MD, MS, Ursula Geller Distinguished Professor of Research in Cardiovascular Diseases, and Neha Pagidipati, MD, MPH, associate professor of medicine, have developed a model using the Project Baseline Health Study (PBHS) for how to effectively communicate results to patients and help empower them towards their health and medical choices. The study also detailed the large number of abnormal results that were returned to participants, highlighting the need to consider these processes early in study design. Results were published in the American Journal of Medicine Open.
As scientific research shifts to emphasize transparency, participant empowerment, and the democratization of data, this model demonstrates the feasibility and value of a comprehensive, systematic approach to returning clinically significant findings in a research context.
Project Baseline launched in 2017 to create a comprehensive reference point, or “baseline,” of good health and to build a robust data platform for studying how health transitions to disease. Over 2,500 participants across three sites, including Duke and Stanford, enrolled and completed assessments conducted by the study team that included a wide range of health data, like clinical, genetic, behavioral, and environmental information, through baseline eye, heart and lung imaging and annual visits, wearable devices, surveys, and biospecimen collection.
Among the 2,002 participants analyzed, nearly 40% would receive at least one result that required immediate or urgent attention. In some cases, individuals received as many as eight separate findings, again highlighting the need to return results to study participants to help them manage and be in control of their health choices. The participants had abnormal results returned to them for a variety of conditions, including vital signs, clinical laboratory testing, chest CT scans and X-rays, electrocardiograms, echocardiograms, and ophthalmologic assessments.
To accomplish this task, a Return of Results (RoR) Committee was established early in the study to oversee the return of findings. They developed a systematic, ethical, and clinically informed process for returning individual-level urgent and emergent results to participants and detailed determination for what types of results should be returned and within what time period.
Some results were more pertinent to get to participants faster than others, given potential clinical implications of the abnormal findings, so the team developed a color-coded flag system to prioritize and categorize results:
- Red flag: Emergent, requiring immediate clinical attention
- Orange flag: Urgent, but less time-sensitive
- Yellow flag: Actionable or uncertain results
- Green flag: Within expected clinical range
Participants had their results returned to them by site principal investigators — practicing physicians — or their designees.
However, with that many results to return, there is also a strong need for a streamlined process to alleviate the burden placed on health care professionals. So, the Project Baseline team also developed a predictive model using widely available clinical and demographic variables, like age, sex, body mass index, blood pressure, smoking status, and history of chronic conditions, which helped identify which participants were most likely to have actionable results.
As the research community continues to evolve its approach to participant engagement, the Project Baseline study offers a robust framework for returning results ethically and effectively. It also raises important questions for future studies, such as how to define "urgent" findings and how to balance return policies with participant preferences, and the need to consider design and funding for return of results prior to study initiation.
Project Baseline is a groundbreaking initiative between Duke University, Stanford University and Verily Life Sciences. The Duke Clinical Research Institute serves as the coordinating center.