Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study Experience
Background: Returning results to research participants is increasingly recognized as an ethical mandate, yet little is known about best practices to optimally communicate urgent or emergent results. Methods: We describe the development of and experience with a process to return results to participan...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-06-01
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| Series: | American Journal of Medicine Open |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2667036425000068 |
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| author | Neha Pagidipati Brooke Heidenfelder Lydia Coulter Kwee Fatima Rodriguez Ranee Chatterjee Kishan S. Parikh Michel G. Khouri Jennifer Stiller Julie Eckstrand P. Kelly Marcom Priyatham S. Mettu Glenn J. Jaffe Sumana Shashidhar Susan Swope Susan Spielman Elizabeth Fraulo L. Kristin Newby Pamela Douglas Charlene Wong Robert Green Scarlet Shore Jessica Mega Adrian Hernandez Paul Campbell Kenneth W. Mahaffey Svati H. Shah |
| author_facet | Neha Pagidipati Brooke Heidenfelder Lydia Coulter Kwee Fatima Rodriguez Ranee Chatterjee Kishan S. Parikh Michel G. Khouri Jennifer Stiller Julie Eckstrand P. Kelly Marcom Priyatham S. Mettu Glenn J. Jaffe Sumana Shashidhar Susan Swope Susan Spielman Elizabeth Fraulo L. Kristin Newby Pamela Douglas Charlene Wong Robert Green Scarlet Shore Jessica Mega Adrian Hernandez Paul Campbell Kenneth W. Mahaffey Svati H. Shah |
| author_sort | Neha Pagidipati |
| collection | DOAJ |
| description | Background: Returning results to research participants is increasingly recognized as an ethical mandate, yet little is known about best practices to optimally communicate urgent or emergent results. Methods: We describe the development of and experience with a process to return results to participants in the Project Baseline Health Study (PBHS), which was a prospective observational cohort study of 2502 participants enrolled from 2017 to 2019 and followed through 2023. Urgent or emergent results were returned during or after the baseline visit from vital signs; clinical laboratory testing; and ocular, cardiovascular, and pulmonary imaging. Results: Among 2002 participants in this analysis, 39.7% had at least one urgent or emergent finding returned, representing a total of 1159 results returned over 3 years. The most commonly returned results were eye findings (n = 246), pulmonary nodules (n = 159), abnormal stress echocardiograms (n = 123), abnormal rest electrocardiograms (bradycardia) (n = 74), and lung parenchyma findings (n = 55). Participants with urgent or emergent incidental findings were older (mean [SD] 58.0 [16.2] years vs 48.0 [16.6] years) with a greater burden of cardiovascular, metabolic, or cancer comorbidities than those without urgent or emergent incidental findings. Conclusions: This report from the PBHS study is one of the first to describe a process to systematically return urgent or emergent results to research participants. This process led to the successful return of clinically important results to participants but also required significant time and effort from study clinicians and staff. |
| format | Article |
| id | doaj-art-314ef8ac2b814856a33ae50078eb22dc |
| institution | DOAJ |
| issn | 2667-0364 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | American Journal of Medicine Open |
| spelling | doaj-art-314ef8ac2b814856a33ae50078eb22dc2025-08-20T03:10:25ZengElsevierAmerican Journal of Medicine Open2667-03642025-06-011310009210.1016/j.ajmo.2025.100092Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study ExperienceNeha Pagidipati0Brooke Heidenfelder1Lydia Coulter Kwee2Fatima Rodriguez3Ranee Chatterjee4Kishan S. Parikh5Michel G. Khouri6Jennifer Stiller7Julie Eckstrand8P. Kelly Marcom9Priyatham S. Mettu10Glenn J. Jaffe11Sumana Shashidhar12Susan Swope13Susan Spielman14Elizabeth Fraulo15L. Kristin Newby16Pamela Douglas17Charlene Wong18Robert Green19Scarlet Shore20Jessica Mega21Adrian Hernandez22Paul Campbell23Kenneth W. Mahaffey24Svati H. Shah25Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, N.C.Duke Clinical and Translational Science Institute, Duke University School of Medicine, Durham, N.C.Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, N.C.Department of Medicine, Division of Cardiovascular Medicine, and the Cardiovascular Institute, Stanford University School of Medicine, Stanford, CalifDepartment of Medicine, Division of General Internal Medicine, Duke University School of Medicine, Durham, N.C.Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, N.C.; WakeMed, Raleigh, N.C.Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, N.C.Duke Clinical and Translational Science Institute, Duke University School of Medicine, Kannapolis, N.C.Duke Clinical and Translational Science Institute, Duke University School of Medicine, Durham, N.C.Duke Cancer Institute, Duke University School of Medicine, Durham, N.C.Department of Ophthalmology, Duke University School of Medicine, Durham, N.C.Department of Ophthalmology, Duke University School of Medicine, Durham, N.C.Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CalifStanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CalifStanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CalifDuke Clinical Research Institute, Duke University School of Medicine, Durham, N.C.Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, N.C.; Duke Clinical Research Institute, Duke University School of Medicine, Durham, N.C.Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, N.C.; Duke Clinical Research Institute, Duke University School of Medicine, Durham, N.C.Department of Pediatrics, Duke University School of Medicine, Durham, N.C.Mass General Brigham, Broad Institute, Ariadne Labs and Harvard Medical School, Boston, MassVerily Life Sciences, Inc., South San Francisco, CalifVerily Life Sciences, Inc., South San Francisco, CalifDepartment of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, N.C.; Duke Clinical Research Institute, Duke University School of Medicine, Durham, N.C.Sanger Heart & Vascular Institute Concord, Concord, N.C.Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, Calif; Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CalifDepartment of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, N.C.; Duke Clinical and Translational Science Institute, Duke University School of Medicine, Durham, N.C.; Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, N.C.; Duke Clinical and Translational Science Institute, Duke University School of Medicine, Kannapolis, N.C.; Duke Clinical Research Institute, Duke University School of Medicine, Durham, N.C.; Requests for reprints should be addressed to Svati H. Shah, MD, MPH, Duke University School of Medicine, 300 N. Duke Street, Durham, NC 27701.Background: Returning results to research participants is increasingly recognized as an ethical mandate, yet little is known about best practices to optimally communicate urgent or emergent results. Methods: We describe the development of and experience with a process to return results to participants in the Project Baseline Health Study (PBHS), which was a prospective observational cohort study of 2502 participants enrolled from 2017 to 2019 and followed through 2023. Urgent or emergent results were returned during or after the baseline visit from vital signs; clinical laboratory testing; and ocular, cardiovascular, and pulmonary imaging. Results: Among 2002 participants in this analysis, 39.7% had at least one urgent or emergent finding returned, representing a total of 1159 results returned over 3 years. The most commonly returned results were eye findings (n = 246), pulmonary nodules (n = 159), abnormal stress echocardiograms (n = 123), abnormal rest electrocardiograms (bradycardia) (n = 74), and lung parenchyma findings (n = 55). Participants with urgent or emergent incidental findings were older (mean [SD] 58.0 [16.2] years vs 48.0 [16.6] years) with a greater burden of cardiovascular, metabolic, or cancer comorbidities than those without urgent or emergent incidental findings. Conclusions: This report from the PBHS study is one of the first to describe a process to systematically return urgent or emergent results to research participants. This process led to the successful return of clinically important results to participants but also required significant time and effort from study clinicians and staff.http://www.sciencedirect.com/science/article/pii/S2667036425000068Cardiovascular diseaseDiabetesIncidental findingsLung diseaseProspective studiesReturn of results |
| spellingShingle | Neha Pagidipati Brooke Heidenfelder Lydia Coulter Kwee Fatima Rodriguez Ranee Chatterjee Kishan S. Parikh Michel G. Khouri Jennifer Stiller Julie Eckstrand P. Kelly Marcom Priyatham S. Mettu Glenn J. Jaffe Sumana Shashidhar Susan Swope Susan Spielman Elizabeth Fraulo L. Kristin Newby Pamela Douglas Charlene Wong Robert Green Scarlet Shore Jessica Mega Adrian Hernandez Paul Campbell Kenneth W. Mahaffey Svati H. Shah Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study Experience American Journal of Medicine Open Cardiovascular disease Diabetes Incidental findings Lung disease Prospective studies Return of results |
| title | Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study Experience |
| title_full | Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study Experience |
| title_fullStr | Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study Experience |
| title_full_unstemmed | Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study Experience |
| title_short | Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study Experience |
| title_sort | returning individual level urgent or emergent research results to participants the project baseline health study experience |
| topic | Cardiovascular disease Diabetes Incidental findings Lung disease Prospective studies Return of results |
| url | http://www.sciencedirect.com/science/article/pii/S2667036425000068 |
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