15250-m-cuypers

192 Chapter 10 PATIENTS AND METHODS The three decision aids Each of the three DAs involved was developed according to the International Patient DecisionAids Standards (IPDAS) and contained informationabout thedisease, treatment options, and (dis)advantages of all options based on (inter)national guidelines and international literature 23 . Patients, urologists and radiation oncologists were involved in the development and review process of the DAs 24-26 . In each DA, the same choice options were presented: surgery, brachytherapy, and external beam radiotherapy, as well as the option of active surveillance. The DAs varied in their format and length. DA1 was a concise booklet (14 pages), DA2 was an even more concise (in diagram style with short explanations) booklet or online DA (by patient choice), and DA3 was an elaborate online DA with values clarification exercises (VCEs). The DA format coincided with the intended moment of use. DA1 and DA2 aimed to be used within consultations, while DA3’s intended use was outside consultation. The characteristics of the DAs are presented in Table 1. Detailed descriptions of the separate trials investigating the DA effects have been published earlier 24-27 . Setting and participants Thirty-three hospitals (out of a total of 90 hospitals inTheNetherlands) implementedone of the three DAs in treatment counseling. Each DA was implemented in a specific region of The Netherlands (DA1 – East; 8 hospitals; DA2 – North-West: 16 hospitals; DA3 – South: 9 hospitals). Per DA, hospitals were recruited to participate based on convenience (e.g., distance), allocation of DAs to hospitals was not randomized. The DAs were handed out to patients newly diagnosed with localized Pca. For all 3 DAs, patients were eligible to participate if they had the possibility to choose between at least two treatments covered by the DA. Assessment of whether the DA was applicable (e.g. eligibility for at least two treatments covered by the DA) was done by the patient’s urologist. Actual distribution of the DA was done by either the urologist or a specialized nurse, depending on what best fitted with existing local care pathways. After the treatment decision was made, but before treatment started, patients received a questionnaire to evaluate receipt and usage of the DA. All data were collected between July 2013 and June 2016. Research protocols from each DA group were reviewed by their respective local institutional ethics committees, which each provided a waiver for further ethical assessment.