{
  "abstract": "Introduction The UK National Heart Failure Audit (England and Wales) reports 43% of patients hospitalised with heart failure (HF) were female (2639 of 6170) in 2008-2009; this has not changed over time (44% in most recent report). A more recent community-based HF prevalence study (Northwest London) reports 56% are female (19,463 amongst 34,651 patients), 31% (10,793) are white, 26% (8905) are Asian, 7% (2412) are black, 9% (3087) are mixed, and 27% are unknown.A systematic review published in 2022 showed only 26% of patients randomised in HF trials are female.Objectives We have here sought to test whether the gender selection bias has improved since 2022. In addition, we assess ethnic diversity represented in HF trials.Methods We performed a Pubmed search for peer-reviewed randomised control trials in heart failure (any subtype) by publication date: 2021- 2022 vs 2023-2020; excluding protocol papers and secondary analyses (See search strategy in table 1; PRISMA diagram, figure 1).Statistical analysis- Descriptive statistics are presented as median [IQR] and are compared using the Mann-Whitney Test.Results 388 trials were identified, including 136,574 patients with HF randomised (160 trials in 2021-2022, and 228 trials in 2023-20). Overall, 53,314 women were randomised (40%).In our aggregate analysis, 10214/24775 (41%) patients randomised in 2021 are women compared with 15576/39471 (40%) patients in 2022, 5816/16705 (35%) in 2023, 9241/23341 (40%) in 2024, and 12467/32282 (39%) in 2020.On a per trial level, a median 39% [27, 50] of patients with heart failure randomised are women in trials reported in 2021-2022, compared with 35% [20, 47] in 2023-20 (p=0.11).Ethnicity information was extracted from 120 trials (64 in 2021-22, 61 in 2023-20). 81% [61, 90] randomised are white in 2021-22, in comparison to 75% [65, 90] in 2023-20 (p=0.79). As for black participants, the median is 12% [2, 23] for 2021-22, in comparison to 14% [4, 28] in 2023-20 (p=0.3). Only 2% [0.4, 6] in 2021-22, and 1% [0, 8] in 2023-20 are Asian [table 2].Patient Public Involvement (PPI) coauthor comments: Ensuring clinical trials are representative of all patients is very important because if, for example, women are not adequately represented in studies, the results might not be applicable to women. Future HF trials might consider randomising more patients from ethnic minority background by making patient information sheets available in more diverse languages with the help of videos.Conclusions Women are still less likely to be randomised in Heart Failure clinical trials. Our systematic review highlights the need for future randomised trials to randomise more women, as well as more patients from diverse ethnic background. These Equality, Diversity and Inclusivity (EDI) objectives should align with the NIHR EDI strategy and the INCLUDE framework, recognising inclusive research is essential to reducing health inequalities and improving outcomes for all people living with HF.Conflict of Interest KW is Chief Investigator and the EDI lead of Safe@Home-HF -a large multicentre randomised trial in heart failure (NIHR HSDR grant application 2026).Abstract 268 Figure 1Reporting items for systematic reviews and meta-analyses (PRISMA) diagram. Outline of inclusion and exclusion pathwayAbstract 268 Table 1Search strategyAbstract 268 Table 2Selection bias in heart failure randomised trails",
  "authors": [
    {
      "affiliations": [
        "Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Lancashire, United Kingdom"
      ],
      "name": "Lana Robinson"
    },
    {
      "affiliations": [
        "Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Lancashire, United Kingdom"
      ],
      "name": "Hilda Yuson"
    },
    {
      "affiliations": [
        "Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Lancashire, United Kingdom"
      ],
      "name": "Mohamed Elhenedy"
    },
    {
      "affiliations": [
        "Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Lancashire, United Kingdom"
      ],
      "name": "Layan Abu-Khalaf"
    },
    {
      "affiliations": [
        "Lancashire Cardiac Centre Patient Public Involvement Group, Blackpool Teaching Hospitals NHS Foundation Trust, Lancashire, United Kingdom"
      ],
      "name": "Grace Wong"
    },
    {
      "affiliations": [
        "Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Lancashire, United Kingdom",
        "Liverpool Centre for Cardiovascular Science, UK Honorary Senior Clinical Lecturer in Cardiology, University of Liverpool, Liverpool, United Kingdom"
      ],
      "name": "Kenneth Y-K Wong"
    }
  ],
  "title": "268 Are female patients less likely to be randomised in heart failure trials? - A systematic review to impact equality, diversity and inclusivity for future trial design",
  "uid": "d3373e9e-bdb1-5d5d-92d8-e791091ce1f6"
}