Sex and Gender Reporting in Trials Evaluating Patient Decision Aids: A Secondary Analysis

01 Apr 20264 min read0 viewsJournal Feed

GIST

Objectives Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Design Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022.

Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review.

We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate.

Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Clinical Editorial

Scope and purpose

The article presents a secondary analysis of a Cochrane review evaluating patient decision aids (PtDAs) in randomized controlled trials (RCTs) involving adults facing treatment or screening decisions.
Its aim is to examine how sex and gender are reported and whether trial results differ by sex or gender.

Study design and data sources

This work reuses the primary data from a prior systematic review that searched MEDLINE, Embase, PsychINFO, and EBSCO from inception through March 2022.
Two investigators independently screened studies, extracted data, and assessed risk of bias.
For this analysis, only primary outcomes from the original review were considered.
The evaluation included descriptive synthesis and meta-analysis when two or more RCTs provided compatible outcome measures for females/women or males/men.

Terminology and methodological rigor

The authors assessed the accuracy of sex terminology (biological attribute) and gender terminology (social construct), noting inaccuracies when terms were used interchangeably.
They evaluated whether trials disaggregated results by sex or gender and whether appropriate terminology was applied.

Study population and reporting patterns

Among 209 RCTs in the original review, 206 reported sex and/or gender data.
Only 35 of these (17%) used accurate terminology.
Demographic reporting patterns included 70 trials with females/women only, 27 with males/men only, 12 analyzed by sex/gender, and 97 that did not disaggregate results by sex or gender.

Primary and secondary outcomes examined

Outcomes focused on informed values-choice congruence and aspects of decision-making quality, such as knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, and undecided status.
Adverse-event-related outcomes included decision regret and emotional distress, evaluated by sex and gender where data permitted.

Key findings and quantitative signals

In meta-analytic comparisons, trials evaluating PtDAs for females/women versus usual care yielded a knowledge score difference of 10.84 (out of 100), while those for males/men showed a difference of 9.38 (out of 100); the between-group difference was not statistically significant (p = 0.44).
For participation in decision making, males/men demonstrated a notably higher self-reported engagement compared with usual care, whereas females/women did not show a corresponding increase (reported as a ratio of 3.16 for males vs 0.95 for females), with statistical interpretation constrained by the data presentation.

Limitations and uncertainties

The analysis highlights a pervasive limitation: only a minority of PtDA RCTs disaggregated data by sex or gender, and terminology accuracy was limited (only 17% with precise usage).