Abstract: TH-PO767
Sex and Gender Considerations in Randomized Controlled Trials in Adults Receiving Chronic Dialysis: A Meta-Epidemiologic Study
Session Information
- Sex and Reproductive Factors in Kidney Health
November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Women's Health and Kidney Diseases
- 2100 Women's Health and Kidney Diseases
Authors
- Collister, David Thomas, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada
- Pyne, Lonnie, McMaster University, Hamilton, Ontario, Canada
- Bhasin, Arrti A., McMaster University, Hamilton, Ontario, Canada
- Ahmed, Sofia B., University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
- Smyth, Brendan, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia
- Herrington, William G., University of Oxford, Oxford, Oxfordshire, United Kingdom
- Jardine, Meg, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia
- Walsh, Michael, McMaster University, Hamilton, Ontario, Canada
Background
How sex and gender concepts are incorporated in randomized controlled trials (RCTs) in adults with kidney failure receiving chronic dialysis is unknown.
Methods
Meta-epidemiologic study of RCTs in chronic dialysis from the highest impact journals from 2000 to 2020. Meta-regression was performed to identify trial characteristics independently associated with the proportion of female/women participants.
Results
Of 561 included RCTs, 69.7% were parallel and 28.0% were crossover in design. 80.6% were in the hemodialysis population. 1/4 were placebo controlled, 1/4 were compared to usual care and 1/2 were compared to an active therapy. 37.6% of RCTs were blinded. The median (IQR) size was 60 participants (26, 151) and the median (IQR) follow-up was 154 days (42, 365). The mean (SD) proportion of female/women participants was 0.40 (0.13). 39.0% of trials reported sex and 26.6% reported gender of participants. 56.2% referred to participants as females, 25.3% referred to participants as women and 15.5% referred to both females and women. No trial characteristic other than region (Asia, ß 0.062 95% CI 0.007-0.117) was associated with the proportion of female/women participants. Considering trial design and conduct, 2.7% used male/female sex and/or man/woman gender as an inclusion criteria, 26.6% as exclusion criteria (e.g. related to pregnancy, contraception, lactation), 4.5% for randomization, 4.8% for subgroup analyses and 15.7% for covariate adjustment.
Conclusion
RCTs in dialysis are representative of the general dialysis population with regards to sex/gender but rarely report both sex and gender separately and often do not include either in their reporting or analysis.