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Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study
Neha Pagidipati1, Brooke Heidenfelder2, Lydia Coulter Kwee3
1Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, N.C.
American Journal of Medicine Open
|April 1, 2025
Summary
Returning urgent health results to research participants is ethically vital. A new process successfully communicated important findings, though it demanded significant staff resources.
Area of Science:
- Clinical research ethics
- Health informatics
- Medical diagnostics
Background:
- Returning research results to participants is an ethical imperative.
- Best practices for communicating urgent or emergent findings are not well-established.
Purpose of the Study:
- To describe the development and implementation of a process for returning urgent or emergent results to participants in the Project Baseline Health Study (PBHS).
Main Methods:
- A prospective observational cohort study involving 2502 participants (2017-2023).
- Urgent or emergent results from vital signs, lab tests, and imaging were returned.
- The process focused on findings from ocular, cardiovascular, and pulmonary assessments.
Main Results:
- Among 2002 participants, 39.7% had at least one urgent/emergent finding returned (1159 results over 3 years).
- Common findings included eye issues (246), pulmonary nodules (159), and cardiac abnormalities (123 stress echocardiograms, 74 bradycardia).
- Participants with findings were older and had more comorbidities.
Conclusions:
- This study details one of the first systematic processes for returning urgent/emergent results in a research cohort.
- The process successfully returned clinically significant results.
- Significant time and effort were required from study staff.
Keywords:
Cardiovascular diseaseDiabetesIncidental findingsLung diseaseProspective studiesReturn of resultsMore Related Videos
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