Cardiovascular disease (CVD) is a major threat to human health, and its prevention and treatment largely depend on evidence-based and rational medical decision-making. With the development of the shared decision-making (SDM) model, patient decision aids (PDAs) have increasingly been used to facilitate clinician-patient communication and enhance patient engagement in decision-making. However, the quality of cardiovascular PDAs varies considerably and lacks standardized regulation. The International Patient Decision Aid Standards (IPDAS 4.0) provide an evidence-based framework for the design and evaluation of PDAs. This study systematically evaluated PDAs in the cardiovascular field using the IPDAS 4.0 framework to provide evidence for clinical practice.

To evaluate the effectiveness of PDAs in SDM among CVD patients.

A systematic search was conducted in PubMed, Embase, Web of Science, Cochrane Library, CNKI, VIP, CBM, and Wanfang Data, covering publications up to October 31, 2023. Randomized controlled trials (RCTs) evaluating the effects of PDAs in patients with CVD were included. Two researchers independently screened the studies, extracted data, and assessed methodological quality. Intervention groups received PDAs in any format, while control groups received routine treatment or care. The quality of PDAs development was assessed using IPDAS 4.0, and meta-analysis was performed with RevMan 5.4.

A total of 16 RCTs involving 4 861 patients were included. According to IPDAS 4.0, the top three scoring domains were disclosure, information and values, while the lowest three were test, plain language, and decision support technology evaluation. Meta-analysis indicated that PDAs significantly improved patients' knowledge (SMD=0.88, 95%CI=0.52-1.24, P<0.001) and reduced decisional conflict (SMD=-0.21, 95%CI=-0.40--0.03, P<0.001). Reductions in decisional conflict were observed across the informed (SMD=-0.36, 95%CI=-0.48--0.25, P<0.001), values clarity (SMD=-0.24, 95%CI=-0.35--0.13, P<0.001), support (SMD=-0.19, 95%CI=-0.31--0.08, P<0.001), and effective decision (SMD=-0.20, 95%CI=-0.31--0.08, P<0.001) subscales.

PDAs interventions are effective in improving knowledge, decisional satisfaction, and reducing decisional conflict among CVD patients, though their impact on decision regret requires further investigation. Future studies should integrate China's healthcare context to develop PDAs tailored to CVD patients based on the IPDAS 4.0 framework, thereby promoting the implementation of SDM in clinical practice.