Annelotte van Bommel

121 Information provision of immediate breast reconstruction outcome measures (PROMs) from cancer survivors. 32 Paper questionnaires were provided on request. Invitations were sent out to selected patients from January 8th to May 29th , 2015; responses were collected until July 30 th , 2015. Respondents gave consent for processing their completed questionnaires and to merge them with the clinical data available in the NCR and NBCA. According to the Central Committee on Research involving Human Subjects (CCMO), this type of study does not require approval from an ethics committee in the Netherlands. This study was approved by the Privacy Review Board of the NCR. Questionnaire The questionnaire was specifically developed for this study and included items on patient characteristics, general health, breast cancer treatment, and breast reconstruction ( Supplementary Appendix 2 ). In addition, questions about SDM were categorized according to the definition of SDM: acknowledging a decision is required by knowing that IBR is an option, understanding and weighing all available information about the treatment options, and incorporating the patients’ preferences in the final decision. 18 The questionnaire was tested for readability and comprehensibility by a panel of former breast cancer patients (members of the Dutch Breast Cancer Patient Association, “Borstkankervereniging Nederland”) before deployment. Analysis Patients who reported they had had DBR were excluded. Statistical analyses were performed in three steps. First, characteristics of respondents with IBR versus without IBR were compared using Pearson Chi-square tests. Second, patient responses regarding information provision and decision-making items were described and compared using Chi-square tests. In the third step, a multivariate logistic regression analysis was performed to determine the effect of being informed about IBR on receiving IBR, controlled for patient, tumor, and treatment characteristics that appeared to have a statistically significant relation with IBR in univariate analyses (relaxed significance level p<0.10); the significance level within the multivariate analyses was p<0.05. The following variables were included in the univariate analysis: age, body mass index (BMI), number of comorbidities, highest 7