15250-m-cuypers

137 Regret and information satisfaction at one-year follow-up 7 consistency was good (Cronbach’s alphas 0.87-0.91). To control for any changes in the overall patient-doctor relation over time, we included this variable with a single item (‘How would you rate your relationship (trust) with your doctor?’) at all time points, answered on a 5-point scale, ranging from 1–poorly to 5–excellent (29). The patient- doctor relation can also be a component of treatment satisfaction (44), however, in case of Pca treatment, the clinician responsible for the execution of treatment, could be different from the urologist with whom patients have their regular consultations with. Therefore, we chose to assess this variable separately from treatment satisfaction. Statistical analysis Intention-to-treat analysis included all patients from both arms. Descriptive statistics are presented as means (and SDs) for continuous variables and frequencies (and percentages) for categorical variables. Differences in characteristics between trials arms, and between responders and non-responders were compared with t-tests for continuous variables and chi-square tests for categorical variables. To assess determinants of clinically relevant levels of regret and information satisfaction, scores were dichotomized with a score >25 indicating regret and <75 indicating dissatisfaction. These new variables each served as outcome variable in a multivariable logistic regression that included age, education, marital status, received treatment, trial arm, perceived role during decision-making, anxious and depressive symptoms, and the perceived patient-doctor relation as covariates. The association between these factors and the outcome variable are presented as odds ratios (with 95% confidence intervals). Statistical analyses were conducted using SPSS 22.0 (Statistical Package for Social Sciences, Chicago, IL). Tests were two-sided and considered statistically significant if p <.05. RESULTS In total, 384 patients were enrolled in this study (DA: n=273, control: n=111) and received the initial questionnaire after treatment decision-making (T1, response rate 88%). Follow-up questionnaires after 6 months (T2) were sent to 336 patients (DA: 235, control: 101, response rate 92%), and to 308 patients after 12 months (T3, DA: 214, control: 94, response rate 95%). Completion rates were comparable across participants from all hospitals. Men without a partner and men with low education were more often lost to follow-up (Table 1).