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112 Chapter 6 International Patient Decision Aid Standards (IPDAS), mostly because of missing DA development information or unbalanced presentation of treatment benefits and risk. Furthermore, they lacked a user-centered design or were not specifically aimed at facilitating SDM in the patient-doctor encounter 27-30 . In the absence of a Dutch Pca treatment DA that included a values clarification method, a novel web-based DA was developed with a specific user-centered focus on facilitating SDM 31 . A cluster randomized controlled trial (RCT) that compared DA counseling to a control armwith standard counselingwas set up. The primary finding that the DA helped patients align treatment choices to their personal preferences was published previously 32 . The current study investigated patient reported outcomes related to the decision making process, directly following treatment decision-making. We hypothesized that with the DA decisional conflict (primary outcome) would be lower and patient involvement, Pca knowledge and information satisfaction (secondary outcomes) would be better, compared to the control group 18 . Moreover, we were interested in individual differences (DA format preference, anxiety and depression symptoms) among DA users to explain potential differences in outcomes within the trial’s DA arm. METHODS Participants and recruitment All patients from participating hospitals, who were newly diagnosed with localized Pca (PSA <20, Gleason <8) between August 1, 2014 and July 1, 2016, had at least two treatment options and nomental or cognitive impairments, were suitable for enrollment in this trial. Patients were recruited at diagnosis by their urologist or by an (oncology) nurse immediately following diagnosis and were given a study package containing an information letter, informed consent form, leaflet and a pre-stamped envelope. To agree with participation, the informed consent form had to be returned using the pre- stamped envelope. On the informed consent form patients indicated the date of their next consultation, which usually was two or three weeks following diagnosis and the moment to discuss treatment choice. A questionnaire was sent within one week after this indicated date by email (paper version on request) 18 . Design Eighteen Dutch hospitals were randomized to the intervention or control arm. All hospitals were general hospitals, except for one academic hospital in the control arm. Patients in the control arm received information and counseling as usual, patients from hospitals in the intervention arm received access to the online DA in addition to

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