15250-m-cuypers

123 Decision process parameters 6 DISCUSSION In this pragmatic cluster randomized controlled trial among patients with localized Pca, adding an online DA to standard counseling did not lead to different levels of patient involvement or decisional conflict in comparison to standard counseling. Patients who used the DA did feel more knowledgeable about Pca treatments but scored equally well as participants from the control group on a knowledge test. Small negative effects of the DA were found on the scales for preparation for decision-making and information satisfaction, in particular for DA users with medium or high anxiety and depression symptoms or who would preferred the DA to be in print. With the DA, patients were providedwith structured information about Pca and possible treatments. Treatment advantages and disadvantages were presented in a balanced manner, and VCMs were included to help patients establish a treatment preference based on personal values 31 . An earlier investigation into treatment choices within this trial revealed that with the current DA, the treatment decisions were more often in line with the patient’s preference instead of the doctor’s preference 32 . However, this did not translate into an effect on decisional conflict in the current study, with previous Pca DA studies also finding mixed results on this outcome 27 . Possibly, this is because of the nature of the concept of decisional conflict. Despite the wide use of decisional conflict as an outcome measure in DA evaluations, it has been debated whether lowering decisional conflict should actually be the desired outcome of a DA intervention 26, 27, 43, 44 . Careful consideration of all available treatment options, including weighing pros and cons against personal preferences, could evoke conflict and the perceived decision difficulty, regardless of interventions to support the decision making process. If ultimately, the final decision has a better patient-treatment fit, existence or even increase of decisional conflict could also be the expense of a thorough decision-making process 45, 46 . Follow-up evaluation of our trial participants is planned to determine if patients are more satisfied with the selected treatment and experience less regret, after treatment is completed, compared to patients from the control group. Next to finding no effect on decisional conflict, the effects from the DA on the secondary outcomes, preparation for decision-making and information satisfaction, were small but opposite from what was expected and overall findings in DA studies 18, 26 . Although patients were unaware of randomization at hospital level and were not informed that the DA was the subject of this study, care providers were aware that the purpose of the study was to compare the DA to usual information routines. During counseling, the novelty of the DA might have been over-emphasized, increasing patients’ expectations and leading to a more critical evaluation of the DA in the questionnaire. An indication