• Dtsch Arztebl Int · Jun 2024

    Randomized Controlled Trial

    An Online Decision Aid for Patients With Metastatic Melanoma—Results of the Randomized Controlled Trial "PEF-Immun".

    • Pia Grabbe, Milena S Borchers, Kathrin M Gschwendtner, Sophia Strobel, Beate Wild, Marietta Kirchner, Katharina Kälber, Adriana Rendon, Julian Steininger, Friedegund Meier, Jessica C Hassel, and Christiane Bieber.
    • Dtsch Arztebl Int. 2024 Jun 14 (Forthcoming).

    BackgroundTreatment decisions in metastatic melanoma (MM) depend on patient preferences and require the patients' involvement in the decision-making process. Patients often feel overwhelmed by the complexity of treatment options with their individual advantages and disadvantages. We developed an online patient decision aid (PtDA) to facilitate shared decision making (SDM).MethodsWe conducted a two-center, two-armed, prospective, open randomized controlled trial with MM patients who were facing a decision about first-line treatment. They were randomly allotted (1:1) to the use or non-use of the PtDA before discussing the choice of treatment with a physician (intervention group [IG] and control group [CG], respectively). The primary endpoint of the study was patient knowledge about first-line treatment options (multiple-choice test, 10 items, range 0-40 points). The secondary endpoints were the degree of SDM (ratings of audio recordings of the patient-physician discussions by third-party observers) and satisfaction with the decision that was taken on later follow-up.Results120 of the 128 randomized patients completed the baseline questionnaire and were included in the analysis (59% male, median age 66 years). The primary endpoint, i.e., the mean difference in knowledge after discussion with a physician, was significantly higher in the intervention group (mean difference -3.22, 95% CI [-6.32;-0.12], p = 0.042). No difference was found in either of the secondary endpoints (SDM and satisfaction with the decision). The patients in the intervention group rated the PtDA as very useful.ConclusionPtDA improved MM patients' knowledge about their options for treatment. Both patients who used it and patients who did not were highly satisfied with their treatment decisions. Additional physician training seems necessary to promote SDM.

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