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Effectiveness of a web-based, individually tailored decision aid for depression or acute low back pain: a randomized controlled trial [with consumer summary]
Simon D, Kriston L, von Wolff A, Buchholz A, Vietor C, Hecke T, Loh A, Zenker M, Weiss M, Harter M
Patient Education and Counseling 2012 Jun;87(3):360-368
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate the effectiveness of a web-based, individually tailored decision aid (Patient Dialogue) on depression or acute low back pain for insurees of a German sickness fund. METHODS: Patient Dialogue (PD) was compared to the non-tailored static patient information (SPI) in an online randomized controlled trial (RCT). The primary outcome was decisional conflict; secondary outcomes included knowledge, preparation for decision-making, preference for participation, involvement in decision-making, decision regret, and adherence. RESULTS: Out of 2,480 randomized participants, 657 (26.5%) provided analyzable data immediately after using the system. Three months later, data from 131 (5.3%) participants could be included in the analysis. The PD group reported a significantly lower overall decisional conflict than the SPI group (38.7 versus 45.1; p = 0.028 via multiple imputation estimator). The largest standardized effect (Cohen's d 0.56) resulted from the preparation for decision-making (PD 59.4 versus SPI 46.8; p < 0.001). CONCLUSION: PD may be an effective tool to reduce decisional conflict and prepare participants for treatment decision-making. However, the large dropout rate needs to be taken into account. PRACTICE IMPLICATIONS: This study shows how a health insurance fund can support shared decision-making and how a decision aid can be evaluated in a RCT under routine care conditions.
With permission from Excerpta Medica Inc.

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