Representation of Women, Older Patients, Ethnic and Racial Minorities in
Trials of Atrial Fibrillation
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.