Aims: Determine effectiveness of cardiovascular patient decision aids (PtDAs), assess consideration for sex and/or gender in included trials, and report whether PtDAs included sex/gender information in personal cardiovascular risk calculations, benefits or harms.
Methods and results: Systematic review with meta-analysis. Independent reviewers screened 209 trials in the 2024 Cochrane Review of PtDAs for eligible cardiovascular trials with updated search to February 2025. Primary outcomes: attributes of the decision quality and decision-making process. We conducted meta-analysis for similarly measured outcomes. We assessed sex/gender considerations according to International Committee of Medical Journal Editors' recommendations.Thirty-two trials evaluated PtDAs versus usual care on cardiovascular screening (n=3 trials; 9.4%), prevention (n=4; 12.5%), and treatment (25; 78.1%) decisions. There was no difference between groups on decision quality (2 trials). Patients exposed to PtDAs had significantly improved decision-making process outcomes: 12% greater knowledge (20 trials), 127% more accurate risk perceptions (7 trials), 10% feel less uninformed (12 trials), 8% less unclear values (12 trials), and 31% less clinician-controlled decision-making. There were no harms. All 32 trials reported sex or gender with 15 (47%) using appropriate terms. One trial reported outcomes separately by sex, but not by study arm. Six (19%) discussed influence of sex/gender on trial findings. Fourteen (43.8%) PtDAs included sex/gender personalized cardiovascular risk scores. supp.
Conclusion: Cardiovascular PtDAs improve quality of the decision-making process. Less than half of trials used appropriate sex/gender terms and only one reported findings separately by sex/gender. Future PtDA research must improve sex and gender-based reporting and analysis.
© The Author(s) 2025. Published by Oxford University Press on behalf of the European Society of Cardiology.