Author + information
- Received January 25, 2019
- Revision received March 7, 2019
- Accepted March 14, 2019
- Published online May 1, 2019.
- Benjamin A. Steinberg, MD, MHSa,∗ (, )
- Paul Dorian, MDb,
- Kevin J. Anstrom, PhDc,
- Rachel Hess, MD, MSa,
- Daniel B. Mark, MDc,
- Peter A. Noseworthy, MDd,
- John A. Spertus, MD, MPHe and
- Jonathan P. Piccini, MD, MHSc
- aDepartment of Medicine, University of Utah Health Sciences Center, Salt Lake City, Utah
- bDivision of Cardiology, University of Toronto, St. Michael's Hospital, Toronto, Ontario, Canada
- cDuke Clinical Research Institute, Durham, North Carolina
- dDepartment of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- eCardiovascular Research, Department of Biomedical and Health Informatics, Saint Luke's Mid-America Heart Institute, Kansas City, Missouri
- ↵∗Address for correspondence:
Dr. Benjamin A. Steinberg, Division of Cardiovascular Medicine, University of Utah Health Sciences Center, 30 North 1900 East, Room 4A100, Salt Lake City, Utah 84132.
Objectives This study sought to determine how frequently patient-reported outcomes (PROs) are collected in registered clinical studies of atrial fibrillation (AF).
Background Improving symptom burden and quality of life are important goals in the treatment of AF and are best measured with PROs.
Methods Data from Clincaltrials.gov were studied to identify PROs in AF studies. All studies reporting AF as the disease condition were included, and PROs were identified by search terms within the outcome measures field. Generic and AF-specific PROs were identified and assessed by study type and year. Clinicaltrials.gov reporting was compared with published reports of linked studies in PubMed.
Results From 1999 to 2018, 1,709 studies including AF patients were posted; 238 studies (14%) included PROs. Collection of PROs was reported in 22% of trials (n = 83 of 386) studying procedural interventions and 11% of all Phase 3 studies (n = 18 of 168). Among the 238 studies with PROs, most described “quality of life” (n = 194 [82%]), and most (n = 198 [83%]) included only generic (not AF-specific) PROs. Only 17% of studies (n = 40) reporting PROs specified a previously published AF-specific tool, most commonly the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) form (n = 20 [8.4%]). Among the available PubMed citations of 391 studies, 74 studies (19%) described collecting a specific PRO tool (n = 29 [7.4%]) for an AF-specific PRO.
Conclusions Despite increased emphasis on the importance of PROs in AF, a minority of registered clinical trials reported collecting PROs, with very few using validated, AF-specific PROs. Improving outcomes that are most important to patients will necessitate increased emphasis on these PROs in pivotal clinical studies.
Supported by U.S. National Institutes of Health/National Heart, Lung, and Blood Institute award K23HL143156 to Dr. Steinberg. The content is the sole responsibility of the authors and does not necessarily represent the official views of the NIH. Dr. Piccini has received research funding from Abbott, Boston Scientific, and Gilead; and he is a consultant for Abbott, Allergan, ARCA Biopharma, Biotronik, Johnson & Johnson, LivaNova, Medtronic, Sanofi, and Phillip. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received January 25, 2019.
- Revision received March 7, 2019.
- Accepted March 14, 2019.
- 2019 American College of Cardiology Foundation
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