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Representation of Women, Older Patients, Ethnic and Racial Minorities in Trials of Atrial Fibrillation
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  • Muhammad Khan,
  • Muhammad Bilal Munir,
  • Safi Khan ,
  • Charumathi Subramanian,
  • Muhammad Khan,
  • Zain Ul Abideen Asad,
  • Swapna Talluri,
  • Aarthi Madhanakumar,
  • Ahmad Lone,
  • Muhammad Khan,
  • Erin Michos,
  • Mohamad Alkhouli
Muhammad Khan
West Virginia University Hospitals
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Muhammad Bilal Munir
West Virginia University School of Medicine
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Safi Khan
Guthrie Robert Packer Hospital
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Charumathi Subramanian
Washington Hospital Healthcare System
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Muhammad Khan
West Virginia University Hospitals
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Zain Ul Abideen Asad
University of Oklahoma Health Sciences Center
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Swapna Talluri
Guthrie Healthcare System
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Aarthi Madhanakumar
Allegheny Health Network
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Ahmad Lone
West Virginia University
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Muhammad Khan
John H Stroger Hospital of Cook County
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Erin Michos
Johns Hopkins University
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Mohamad Alkhouli
Mayo Clinic
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Abstract

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. In RCTs, proportions of women, Hispanics, Blacks, American Indian/Alaskan patients, Asians, native Hawaiian/Pacific Islanders and non-Whites were 35.2%, 11.9%, 1.2%, 0.2%, 14.2%, 0.05%, and 19.5%, respectively. The corresponding proportions in general population were 35.1%, 5.2%, 5.7%, 0.2%, 2.4%, 0.1%, 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. In nearly all studied RCTs, the reporting of racial demographics did not start until later part of last decade.

Peer review status:UNDER REVIEW

23 Aug 2020Submitted to Journal of Cardiovascular Electrophysiology
24 Aug 2020Assigned to Editor
24 Aug 2020Submission Checks Completed
28 Aug 2020Reviewer(s) Assigned