The development of a faecal incontinence core outcome set: an international Delphi study protocol.

The development of a faecal incontinence core outcome set: an international Delphi study protocol. Assmann, Sadé; Keszthelyi, Daniel; Kleijnen, Jos; Kimman, Merel; Anastasiou, Foteini; Bradshaw, Elissa; Carrington, Emma; Chiarioni, Giuseppe; Maeda, Yasuko; Muris, Jean; Pohl, Daniel; Rydningen, Mona; Vaizey, Carolynne; Breukink, Stephanie Purpose: Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI. Methods: Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS. Discussion: This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care.