Underrepresentation of Women in Late-Breaking Cardiovascular Clinical Trials

Holtzman, Jessica N.; Kaur, Gurleen; Power, Juliette E; Barkhordarian, Maryam; Mares, Adriana; Goyal, Amit; Gulati, Martha

doi:10.1089/jwh.2022.0536

Cited by 5 publications

(2 citation statements)

References 26 publications

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“…RECOVERY participants were also less frequently female (37% vs 45%), but it is not possible to identify the underlying reasons for this in the available data. However, this is similar to results found in other trials and may be due to under-recruitment of older patients (who are more frequently women) [ 23 , 24 ]. Of note, we found important differences in recruitment across different geographical regions, with the recruitment ratio (the number of individuals included in RECOVERY divided by the number of individuals in the reference population) ranging from 7.4 to 16.4%.…”

Section: Discussionsupporting

confidence: 88%

Clinical trial results in context: comparison of baseline characteristics and outcomes of 38,510 RECOVERY trial participants versus a reference population of 346,271 people hospitalised with COVID-19 in England

Pessoa-Amorim,

Goldacre,

Crichton

et al. 2024

Trials

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Background Randomised trials are essential to reliably assess medical interventions. Nevertheless, interpretation of such studies, particularly when considering absolute effects, is enhanced by understanding how the trial population may differ from the populations it aims to represent. Methods We compared baseline characteristics and mortality of RECOVERY participants recruited in England (n = 38,510) with a reference population hospitalised with COVID-19 in England (n = 346,271) from March 2020 to November 2021. We used linked hospitalisation and mortality data for both cohorts to extract demographics, comorbidity/frailty scores, and crude and age- and sex-adjusted 28-day all-cause mortality. Results Demographics of RECOVERY participants were broadly similar to the reference population, but RECOVERY participants were younger (mean age [standard deviation]: RECOVERY 62.6 [15.3] vs reference 65.7 [18.5] years) and less frequently female (37% vs 45%). Comorbidity and frailty scores were lower in RECOVERY, but differences were attenuated after age stratification. Age- and sex-adjusted 28-day mortality declined over time but was similar between cohorts across the study period (RECOVERY 23.7% [95% confidence interval: 23.3–24.1%]; vs reference 24.8% [24.6–25.0%]), except during the first pandemic wave in the UK (March–May 2020) when adjusted mortality was lower in RECOVERY. Conclusions Adjusted 28-day mortality in RECOVERY was similar to a nationwide reference population of patients admitted with COVID-19 in England during the same period but varied substantially over time in both cohorts. Therefore, the absolute effect estimates from RECOVERY were broadly applicable to the target population at the time but should be interpreted in the light of current mortality estimates. Trial registration ISRCTN50189673- Feb. 04, 2020, NCT04381936- May 11, 2020.

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Section: Discussionsupporting

confidence: 88%

Clinical trial results in context: comparison of baseline characteristics and outcomes of 38,510 RECOVERY trial participants versus a reference population of 346,271 people hospitalised with COVID-19 in England

Pessoa-Amorim,

Goldacre,

Crichton

et al. 2024

Trials

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“…Individuals identifying as female patients remain underrepresented in cardiovascular clinical trials relative to their percentage of the population and disease burden. [29][30][31] The urgency of these trends is amplified by the fact that chronic hypertension is a condition that increases more rapidly during the reproductive years with worse morbidity in female patients compared with male patients. 32 Compared with male patients, female patients are diagnosed later and are less likely to receive guideline-concordant care, and the overall quality of care is significantly lower.…”

Section: Discussionmentioning

confidence: 99%

Blood Pressure Trajectories Through the First Year Postpartum in Overweight or Obese Individuals Following a Hypertensive Disorder of Pregnancy

Hauspurg,

Bryan,

Jeyabalan

et al. 2024

Hypertension

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Background: Hypertensive disorders of pregnancy are associated with cardiovascular disease; however, patterns of blood pressure (BP) recovery are understudied. We compared pregnancy and postpartum BP trajectories among individuals with hypertensive disorders of pregnancy who developed persistent hypertension at 1-year postpartum compared with individuals with normalization of BP. Methods: We used data from a randomized clinical trial of individuals with overweight, obesity, and hypertensive disorders of pregnancy conducted in the first year after delivery. Pregnancy BPs were obtained during prenatal visits; postpartum BPs were prospectively obtained through home monitoring. Demographic characteristics and trajectories were compared by hypertensive status (systolic BP ≥130 mm Hg, diastolic BP ≥80 mm Hg, or use of antihypertensive medications) at 1 year. We used repeated BP measures to fit separate mixed-effects linear regression models for pregnancy and postpartum using restricted cubic splines. Results: We included 129 individuals; 75 (58%) individuals progressed to hypertension by 1-year postpartum. Individuals with hypertension were older, delivered at earlier gestational ages, and had higher body mass index at 1-year postpartum compared with those with normalization. Individuals with hypertension had similar BP trajectories during pregnancy to those with BP normalization but a significantly different BP trajectory ( P <0.01 for systolic and diastolic BPs) in the first year postpartum. These differences persisted in multivariable models after adjustment for early pregnancy body mass index, age, and severity of hypertensive disorder of pregnancy ( P <0.01 for systolic and diastolic BPs). Conclusions: BP trajectories in the first year postpartum, but not during pregnancy, may provide important information for risk stratification after a hypertensive disorder of pregnancy. REGISTRATION: URL: https://clinicaltrials.gov ; Unique identifier: NCT03749746.

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Sex distribution in clinical trials of radiologic contrast agents: A 27-year review

McEvoy,

Abu-Omar,

Hussain

et al. 2024

Clinical Imaging

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Underrepresentation of Women in Late-Breaking Cardiovascular Clinical Trials

Cited by 5 publications

References 26 publications

Clinical trial results in context: comparison of baseline characteristics and outcomes of 38,510 RECOVERY trial participants versus a reference population of 346,271 people hospitalised with COVID-19 in England

Clinical trial results in context: comparison of baseline characteristics and outcomes of 38,510 RECOVERY trial participants versus a reference population of 346,271 people hospitalised with COVID-19 in England

Blood Pressure Trajectories Through the First Year Postpartum in Overweight or Obese Individuals Following a Hypertensive Disorder of Pregnancy

Sex distribution in clinical trials of radiologic contrast agents: A 27-year review

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