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.

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.

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.

To estimate the association between maternal COVID-19 vaccination during pregnancy and adverse neonatal and maternal outcomes.

Population-based retrospective cohort study using a hospitalisation database linked with other health administrative databases.

Province of Quebec, Canada, from 1 May 2021 to 30 June 2023.

All singleton pregnancies resulting in a live birth or stillbirth at ≥20 weeks of gestation, excluding those with a conception date

We used robust Poisson regression models to estimate adjusted risk ratios (aRRs) for chorioamnionitis, postpartum haemorrhage, caesarean delivery, preterm birth, very preterm birth, small for gestational age (SGA), maternal and neonatal admission to intensive care unit (ICU, NICU) and severe neonatal morbidity. We used a Cox regression model with a time-varying exposure variable to estimate adjusted HRs (aHRs) for stillbirth. Propensity score weighting was used to adjust for potential confounding.

Among 140 073 singleton pregnancies resulting in live birth or stillbirth, 61 282 individuals (43.8%) received at least one dose of messenger RNA COVID-19 vaccine during pregnancy. Vaccination during pregnancy was not associated with an increased risk of chorioamnionitis (aRR 0.99, 95% CI 0.95 to 1.04), postpartum haemorrhage (aRR 1.03, 95% CI 0.99 to 1.06), very preterm birth (aRR 1.04, 95% CI 0.89 to 1.21) and stillbirth (aHR 1.14, 95% CI 0.94 to 1.39). Vaccination during pregnancy was significantly associated with a reduced risk of caesarean delivery (aRR 0.94, 95% CI 0.92 to 0.96), maternal ICU admission (aRR 0.80, 95% CI 0.65 to 0.98), SGA (aRR 0.94, 95% CI 0.91 to 0.98), NICU admission (aRR 0.91, 95% CI 0.85 to 0.96), preterm birth (aRR 0.94, 95% CI 0.90 to 0.99) and severe neonatal morbidity (aRR 0.91, 95% CI 0.85 to 0.98).

Our findings suggest that COVID-19 vaccination during pregnancy was not associated with an increased risk of adverse outcomes. Ongoing surveillance of the safety of maternal COVID-19 vaccination is essential as doses continue to be recommended for this group.