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. 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.

Transforming Atrial Fibrillation Research to Integrate Social Determinants of Health

“…A contributing factor is that many of the groups disproportionately experiencing SDOH are underrepresented in existing clinical trials. Specifically, the underreporting of race and ethnicity and lack of representation in AF clinical trials of American Indian or Alaska Native, Asian, Black, Hispanic/Latino, and Native Hawaiian or Other Pacific Islander individuals, older individuals, and lower income individuals are well established. Similarly, most AF clinical trials do not report on participants’ educational attainment or health literacy level.…”

“…Multiple gaps are highlighted in the area of race, ethnicity, and AF (eFigure 1 in the Supplement). Despite global efforts to improve representation of UREG individuals in research, American Indian or Alaska Native, Asian, Black, Hispanic/Latino, and Native Hawaiian or Other Pacific Islander individuals remain poorly represented in genetic studies, registries, and clinical trials of AF, particularly novel therapies and procedural interventions . Underrepresentation contributes to the tendency for individuals from UREG to be treated as monolithic entities, despite substantial subgroup variation in SDOH, management, and outcomes.…”

Global Burden of Atrial Fibrillation and Flutter by National Income: Results From the Global Burden of Disease 2019 Database

“… 28 In large AF clinical trials, which are mostly located in high‐income countries, non‐White ethnicities are often underrepresented compared with the entire countries' population or ethnicity is not reported. 29 , 30 , 31 In the ASSERT trial (Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial), participants with European ethnicity had a higher risk of AF compared with Black Africans, Chinese, and Japanese participants. 32 Differences in clinical complications between ethnicities have been observed, such as a higher stroke risk in Asians even at a low CHA 2 DS 2 ‐VASc score 33 or higher rates of heart failure in Africans.…”

Association of Women Authors With Women Enrollment in Clinical Trials of Atrial Fibrillation

“…The study search, selection, and data abstraction process have been reported previously. 3 Briefly, we searched MEDLINE and ClinicalTrials.gov from January 1985 to April 2019 using search terms (*Atrial fibrillation OR *AF) AND (*Rate control therapy OR *Rhythm control therapy OR *Ablation OR *Cardioversion OR *Anticoagulation OR *Treatment) to identify randomized controlled trials of AF with a follow‐up duration of ≥3 months. We extracted the number of women participants in the trials, the total number of women authors, and women in the first or senior (ie, last) author position.…”