Representation of women, older patients, ethnic, and racial minorities in trials of atrial fibrillation.

Autor: Khan MZ; Department of Medicine, West Virginia University, Morgantown, West Virginia, USA., Munir MB; Section of Electrophysiology, Division of Cardiovascular Medicine, University of California San Diego, La Jolla, California, USA., Khan SU; Department of Medicine, West Virginia University, Morgantown, West Virginia, USA., Subramanian CR; Department of Medicine, Washington Hospital Health Care System, Fremont, California, USA., Khan MU; Department of Medicine, West Virginia University, Morgantown, West Virginia, USA., Asad ZUA; Cardiovascular Disease Section, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA., Talluri S; Department of Medicine, Guthrie Health System/Robert Packer Hospital, Sayre, Pennsylvania, USA., Madhanakumar A; Department of Cardiovascular Medicine, Allegheny General hospital, Pittsburgh, Pennsylvania, USA., Lone AN; Department of Medicine, West Virginia University, Morgantown, West Virginia, USA., Khan MS; Department of Medicine, John H. Stroger Cook County Hospital, Chicago, Illinois, USA., Michos ED; Division of Cardiology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA., Alkhouli M; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Jazyk: angličtina
Zdroj: Pacing and clinical electrophysiology : PACE [Pacing Clin Electrophysiol] 2021 Mar; Vol. 44 (3), pp. 423-431. Date of Electronic Publication: 2021 Feb 03.
DOI: 10.1111/pace.14178
Abstrakt: Background: Representation trends of women, older adults, and ethnic/racial minorities in randomized controlled trials (RCTs) of atrial fibrillation (AF) are uncertain.
Methods: We systematically reviewed 134 AF related RCTs (phase II and III) encompassing 149,162 participants using Medline and ClinicalTrials.gov through April 2019 to determine representation trends of women, older patients (≥75 years), and ethnic/racial minorities. Weighted data on the prevalence of AF from epidemiological studies were used to compare the representation of the studied groups of interest in AF RCTs to their expected burden of the disease.
Results: Only 18.7% of the RCTs reported proportion of older patients, and 12.7% RCTs reported ethnic/racial minorities. The proportions of women in RCTs versus general population were 35.2% and 35.1%, of Hispanics were 11.9% and 5.2%, of Blacks were 1.2% and 5.7%, of American Indian/Alaskans were 0.2% and 0.2%, of Asians were 14.2% and 2.4%, of native Hawaiian/Pacific Islanders were 0.05% and 0.1% and of non-Whites were 19.5% and 22.5%, respectively. The weighted mean age (SD) across the trials was 65.3 (3.2) years which was less than the corresponding weighted mean age of 71.1 (4.5) years in the comparative epidemiological data.
Conclusion: The reporting of older patients and ethnic/racial minorities was poor in RCTs of AF. The representation of women and American Indian/Alaskan natives matched their expected population share of disease burden. Hispanics and Asians were over-represented and Blacks, native Hawaiian/Pacific Islanders and non-Whites were under-represented in RCTs of AF.
(© 2021 Wiley Periodicals LLC.)
Databáze: MEDLINE
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