Integrating sex and gender in studies of cardiac resynchronization therapy: a systematic review

Abstract

Aims To examine the prevalence, temporal changes, and impact of the National Institute of Health (NIH) Sex as a Biological Variable (SABV) policy on sex and gender reporting and analysis in cardiac resynchronization therapy (CRT) cohort studies. Methods and results We searched MEDLINE, EMBASE, and Web of Science for cohort studies reporting the effectiveness and safety of CRT in heart failure patients from January 2000 to June 2020, with no language restrictions. Segmented regression analysis was used for policy analysis. We included 253 studies. Fourteen per cent considered sex in the study design. Outcome data disaggregated by sex were only reported in 17% of the studies. Of the studies with statistical models (n = 173), 57% were adjusted for sex. Sixty‐eight per cent of those reported an effect size for sex on the outcome. Sex‐stratified analyses were conducted in 13% of the studies. Temporal analysis shows an increase in sex reporting in background, statistical models, study design, and discussion. Besides statistical models, NIH SABV policy analysis showed no significant change in the reporting of sex in study sections. Gender was not reported or analysed in any study. Conclusions There is a need to improve the study design, analysis, and completeness of reporting of sex in CRT cohort studies. Inadequate sex integration in study design and analysis may potentially hinder progress in understanding sex disparities in CRT. Deficiencies in the integration of sex in studies could be overcome by implementing guidance that already exists.

Equity Considerations in COVID‐19 Vaccination Studies of Individuals With Autoimmune Inflammatory Rheumatic Diseases

“…Further, the majority of studies were conducted in high‐income countries, thus applicability to low‐ and middle‐income countries might be limited. Our findings accord with previous evidence of poor reporting for dimensions of inequities in observational studies ( 39 ).…”

“…Further, the majority of studies were conducted in high-income countries, thus applicability to low-and middle-income countries might be limited. Our findings accord with previous evidence of poor reporting for dimensions of inequities in observational studies (39). Transparent reporting of equity characteristics allows individuals to judge whether evidence applies to themselves, clinicians to assess whether evidence applies to their population of care, and policymakers to make informed decisions that take into account the entire population that they serve.…”

Reporting of equity in observational epidemiology: A methodological review

“…A broader analysis of studies could reveal less equity reporting. For instance, in 253 cardiac resynchronisation device studies [ 26 ], only 16% considered sex in the study design, and 26% reported sex-related effect sizes. Similarly, in 103 psychiatric studies using routinely collected health data [ 43 ], only 14% defined the target population by social determinants and assessed effect modification.…”

Improving equity, diversity, and inclusion in academia

“…Reporting guidelines may improve the reporting of research and should be used by researchers [ 64 – 67 ]. Although guidelines such as the SAGER guidelines have recommended sex-specific analyses to obtain more equitable evidence [ 68 ], and several funders have mandated their analyses, such mandates may be insufficient to change reporting practices [ 69 ]. Researchers must demonstrate their commitment to improving equity in research by adhering to equity reporting guidelines such as the extensions of the CONSORT (Consolidated Standards of Reporting Trials) [ 70 ] and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) [ 71 ] more work is needed to assess their impact on reporting.…”