15250-m-cuypers

99 PCPCC study protocol 5 Potentially confounding variables (for example, personality, health skills, and age) will be explored for their impact on the primary and secondary outcomes. Missing data and drop-outs will be described. Ethical considerations The research protocol was examined by the accredited regional Medical Research Ethics Committee ‘METC Brabant’, and concluded that participants are not subjected to any procedure or imposed to perform any behavior. With this conclusion the obligation to fulfill the specific requirements of the Dutch law for Medical Research involving Human Subjects (WMO) was waived (reference: NW2014-03). The science committee of the initiating hospital has approved the study protocol (reference: WB/mt/14.030). All participating patients will sign an informed consent form. DISCUSSION This study investigates the effect of an interactive, web-based, treatment decision aid for early-stage prostate cancer. It compares impact on the decision-making process and patient reported outcomes from an intervention group with a control group. Included patients will be followed for 12 months to investigate long term consequences from the intervention on regret, treatment satisfaction and quality of life. Randomization will take place at the hospital level, meaning that once included, all patients within in one hospital receive the same treatment. Compared to randomization on the level of the patient, this design is less prone to contamination bias. The strength of this study is the initial involvement of 19 participating hospitals. With this large number, a proper variation of local circumstances can be taken into account that might affect structural adaptation of the DA in clinical practice. The large number of participating hospitals also requires careful management by the researchers during the trial period. Motivating all involved doctors, nurses and assistants requires careful monitoring of inclusion progress per location, and adaptation to specific circumstances. Another challenge is to take the treatment variation per hospital into account. If past-year treatment characteristics appear to be imbalanced between both arms, we may decide to adjust for past year treatment, based on hospital-specific treatment profiles obtained from the Netherlands Cancer Registry. Although we are aware of the fact that individual differences between clinicians could also affect decision outcomes, there are some considerations that justify taking the institution as the unit of analysis. First, diagnosis and offered treatment plans are often the result of multi-disciplinary consideration (for example, urologists, radiotherapists,