Effectiveness of a patient decision aid for women considering post-mastectomy breast reconstruction: Randomized controlled trial

Abstract

Background Post-mastectomy breast reconstruction (PMBR) improves quality of life, yet decisions regarding type and timing are complex, requiring careful consideration of risks, benefits, and personal preferences. Shared decision-making enhances satisfaction with reconstructive decisions, but some women experience difficulty participating effectively. This study evaluated the effectiveness of a PMBR-specific patient decision aid (pDA) compared with high-quality standard care. Methods In this single-centre RCT, women eligible for PMBR were assigned in a 1:1 ratio to either standard care alone (control) or standard care and a pDA (intervention). Questionnaires were completed at baseline, after reconstructive decision, and at 1-year post-surgery. The primary outcome was decisional conflict after the decision. Secondary outcomes included measures for the decision-making process, patient-reported, and surgical outcomes. Between-group differences were analysed using t-tests, Mann-Whitney U tests, and chi-square tests. Mean differences (MD) with 95% confidence intervals quantified outcomes, while effect sizes were determined by Cohen's d. Results A total of 134 patients were enrolled (66 intervention, 68 control). Both groups reported consistently low decisional conflict (17 and 20 respectively). No significant differences were found in the primary (MD -2.8, 95% c.i., -8.4 to 2.8, Cohen's d -0.18) or secondary outcomes immediately after reconstructive decision or 1-year post-surgery. Conclusion In a population with access to high-quality multidisciplinary care, an online pDA for PMBR did not provide additional benefits over standard care. Both approaches effectively supported reconstructive decision-making, resulting in consistently low levels of decisional conflict.