Alina Vrieling

Mar 27, 2023 | bmjopen.bmj.com | Ellen Kampman |Alina Vrieling

Data collection and managementQuestionnairesParticipants are asked to complete self-administered web-based or paper-and-pencil-based questionnaires at 3 months, 1 year and 2 years after treatment (figure 1, table 1). Web-based questionnaires are collected using Castor EDC. Follow-up telephone calls are made to non-responding participants and to respondents whose questionnaires have missing items.

Mar 8, 2023 | bmjopen.bmj.com | Maike G. Sweegers |Alina Vrieling |Helene Rundqvist |Emine Akdemir

Methods and analysisThe ENHANCE study is a multicentre, open label, two-arm randomised controlled trial. Patient inclusion and data collection started in August 2022. Ethical approval, extending to all participating centres, was granted by the Medical Ethical Committee NedMec (Amsterdam, The Netherlands), under reference number 22–595/NL78792.031.22. The trial is prospectively registered in Clinical Trials on 29 July 2022.