Trial reportThe British journal of surgery2025
Effectiveness of a patient decision aid for women considering post-mastectomy breast reconstruction: randomized controlled trial.
Trial report in The British journal of surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPost-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.
methodsIn 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.
resultsA 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.
conclusionIn 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. TRIAL REGISTRATION NUMBER: NL-OMON28003 (NTR), NL7939 (NTR-new).
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