Effectiveness of evidence-based decision aids for women with pathogenic BRCA1 or BRCA2 variants in the german health care context: results from a randomized controlled trial

Autor: Sibylle Kautz-Freimuth, Marcus Redaèlli, Arim Shukri, Hannah Kentenich, Dusan Simic, Vanessa Mildenberger, Rita Schmutzler, Kerstin Rhiem, Stephanie Stock
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMC Medical Informatics and Decision Making, Vol 23, Iss 1, Pp 1-13 (2023)
Druh dokumentu: article
ISSN: 1472-6947
DOI: 10.1186/s12911-023-02327-9
Popis: Abstract Background Women with pathogenic BRCA1 or BRCA2 variants are at high risk for breast and ovarian cancer. Preventive options include risk-reducing breast and ovarian surgeries and intensified breast surveillance. However, individual decision-making is often associated with decisional conflicts. Two evidence-based decision aids have recently been developed for these women (healthy or with unilateral breast cancer) for the German context to support them in their decision-making process. This study evaluated their effectiveness. Methods In a randomized controlled study, women (aged 18–70 years) with pathogenic BRCA1 or BRCA2 variants were randomly assigned 1:1 to the intervention (IG, n = 230) or control (CG, n = 220) group. All participants received usual care. After baseline survey (t0), IG participants additionally received the DAs. Follow-up surveys were at three (t1) and six (t2) months. Primary outcome was decisional conflict at t1. Secondary analyses included decision status, decision regret, knowledge on risks and preventive options, self-reported psychological symptoms, acceptability of DAs, and preparation for decision-making. Results Of 450 women recruited, 417 completed t0, 398 completed t1 and 386 completed t2. Compared to CG, IG participants had lower decisional conflict scores at t1 (p = 0.049) and t2 (p = 0.006) and higher scores for knowledge (p = 0.004), acceptability (p = 0.000), and preparation for decision-making (p
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