Impact of an in-consult patient decision aid on treatment choices and outcomes of management for patients with an endoscopically resected malignant colorectal polyp: a study protocol for a non-randomised clinical phase II study

This study protocol describes our clinical multi-institutional, non-randomised, interventional phase II study at Danish surgical departments planned to commence in the second quarter of 2024. The aim of this study is to examine whether shared decision-making and using a patient decision aid in consultations affect patients’ choice of management, comparing with retrospective data. The secondary aim is to investigate patients’ experiences, perceived involvement, satisfaction, decision conflict and other outcomes using questionnaire feedback directly from the patients. Ethics and dissemination There are no conflicts of interest for principal or local investigators in any of the study sites. All results will be published at Danish and international meetings, and in English language scientific peer-reviewed journals. Our study underwent evaluation by the Regional Committees on Health Research Ethics for Southern Denmark (file number 20232000-47), concluding that formal approval was not required for this kind of research. Trial registration number NCT05776381.
Source: BMJ Open - Category: General Medicine Authors: Tags: Open access, Surgery Source Type: research