2022
DOI: 10.1016/j.jacadv.2022.100079
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A Systematic Review of Sex-Specific Reporting in Heart Failure Clinical Trials

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Cited by 12 publications
(8 citation statements)
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“…Selection, recruitment, and retention bias mean that data representing white men may become the norm against which women’s health and disease are benchmarked. In the case of heart failure, for instance, underenrolment of women in trials relative to disease prevalence means that estimates from data on male participants unduly informs treatment practices and assumptions about the safety of interventions 8. In the Systolic Blood Pressure Intervention Trial (Sprint), only 35% of participants in the intensive or standard arms were women, despite the planned enrolment target of 50% 25.…”
Section: Recruitment and Retention Biasmentioning
confidence: 99%
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“…Selection, recruitment, and retention bias mean that data representing white men may become the norm against which women’s health and disease are benchmarked. In the case of heart failure, for instance, underenrolment of women in trials relative to disease prevalence means that estimates from data on male participants unduly informs treatment practices and assumptions about the safety of interventions 8. In the Systolic Blood Pressure Intervention Trial (Sprint), only 35% of participants in the intensive or standard arms were women, despite the planned enrolment target of 50% 25.…”
Section: Recruitment and Retention Biasmentioning
confidence: 99%
“…A systematic review of 224 cardiovascular trials published between 2000 and 2020, in which 28.2% of participants were female, found that only 33% of studies reported sex disaggregated subgroup analyses and 28% reported interactions between sex and treatment effect. No trial reported sex disaggregated screening, consent, or withdrawal rates, and only two trials reported sex disaggregated losses to follow-up 8…”
Section: Paucity Of Sex Disaggregated Datamentioning
confidence: 99%
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“…The resulting gaps in clinical knowledge and outcomes have been documented in various areas of medicine (3). In cardiovascular medicine, unsurprisingly, the substantial improvements in care and outcomes among men failed to translate to the female population (4), ( 5), (6). Restrictive enrollment and failures to utilize appropriate methodology have, ultimately, led to incomplete and poorly generalizable knowledge that created significant disparities.…”
Section: Introductionmentioning
confidence: 99%
“…Regulatory and funding agencies have highlighted the importance of adequate inclusion of women and female participants in research studies, and have implemented policies requiring sex- and gender-specific analyses but little progress has been made in this regard. 4 , 6 There remain large knowledge gaps in (1) unique CV conditions that affecting only female individuals (2) CV conditions that affect primarily women and female individuals; (3) CV treatments in pregnant or lactating women; and (4) CV conditions that present, progress, or respond to treatment differently in women and female patients. Individuals who have the potential to become pregnant or who are pregnant or lactating remain largely excluded from research because of outdated protection by exclusion ideologies.…”
mentioning
confidence: 99%