Gulab, Asma, Essa, Hani, Lo, Kevin Bryan, Sankaranarayanan, Rajiv 
ORCID: 0000-0003-2355-2011 and Rangaswami, Janani
(2022)
Gender Distribution in Randomized Controlled Trials among Patients with Heart Failure with Reduced Ejection Fraction: A Systematic Review.
GLOBAL HEART, 17 (1).
8-.
Abstract
BACKGROUND Heart failure (HF) is a major cause of morbidity and mortality at a global level, affecting 64 million people worldwide with about 40–50% of the hospitalized heart failure patients being female [1]. Despite high disease burden of HF in women, HF trials have consistently underrepresented women in enrollment [2]. The objective of this study was to determine the trends in the representation of women in randomized controlled trials (RCTs) for therapies for heart failure with reduced ejection fraction (HFrEF). METHODS This systematic review looked at the patterns and rates of inclusion of women in RCTs among patients with HFrEF. We utilized PubMed to extract RCTs conducted between January 1, 2010, and December 1, 2020. The medical subject headings (MeSH) terms used for extraction were heart failure OR heart failure, congestive OR heart failure with reduced ejection fraction. Terms like left sided heart failure OR systolic heart failure were not included to keep the search strategy easily replicable and clear. Studies were reviewed individually and screened by title and abstract. Sub-studies or post-hoc analyses were excluded. Trials looking at heart failure with preserved ejection fraction were excluded. Data are presented using descriptive statistics frequencies and percentages. Mean and standard deviation were used while median interquartile range was used for skewed variables. The percentage of females included in studies with studies per year was log transformed and fitted into a time regression model by year. The Mann Whitney U test was used to compare the median percentages of females according to study size (more than 100 samples included and less than 100 samples). A p-value of 0.05 was considered statistically significant. FINDINGS A total of 3052 studies were reviewed, and 706 studies met criteria for inclusion. Thirty-seven percent of studies involved pharmacologic interventions, while 10% of studies looked at device therapy (implantable cardioverter and defibrillator/cardiac resynchronization therapy). The rest of the studies included a combination of exercise, community programs, surgical, procedural and laboratory testing. The pooled study sample age ranged from 42 to 85 years. Only 26% (17–36) of the participants were women. There were no significant differences in representation of women (%) across the nature of interventions (pharmacotherapy, device, other interventions). The median percentage of females included in trials of HFrEF over the past 10 years was less than 50% per year, but with a gradual increasing trend towards the later part of the decade p < 0.001 for linear trend, as shown in Figure 1.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Heart Failure, Gender disparaties, Randomized Controlled trials, Heatlh disparities, Heart Failure with Reduced EF |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences Faculty of Health and Life Sciences > Clinical Directorate |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 23 Jan 2023 10:13 |
| Last Modified: | 23 Jan 2023 10:13 |
| DOI: | 10.5334/gh.1093 |
| Open Access URL: | http://doi.org/10.5334/gh.1093 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3167788 |
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