Sadé Assmann1,2,3, Daniel Keszthelyi4,5, Jos Kleijnen6, Merel Kimman7, Foteini Anastasiou8, Elissa Bradshaw9, Emma Carrington10, Giuseppe Chiarioni11,12, Yasuko Maeda13, Jean Muris14, Daniel Pohl15, Mona Rydningen16,17, Carolynne Vaizey18, Stephanie Breukink19,5,6. 1. Department of Surgery and Colorectal Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands. s.assmann@maastrichtuniversity.nl. 2. Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands. s.assmann@maastrichtuniversity.nl. 3. School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, The Netherlands. s.assmann@maastrichtuniversity.nl. 4. Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands. 5. School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, The Netherlands. 6. School for Oncology and Developmental Biology (GROW), Maastricht University, Maastricht, The Netherlands. 7. Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands. 8. 4rth TOMY - Academic Primary Care Unit Clinic of Social and Family Medicine, University of Crete, Heraklion, Greece. 9. Community Gastroenterology Specialist Nurse, Royal Free Hospital, London, England. 10. Surgical Professorial Unit, Department of Colorectal Surgery, St Vincent's University Hospital, Dublin, Ireland. 11. Division of Gastroenterology of the University of Verona, AOUI Verona, Verona, Italy. 12. Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. 13. Department of Surgery and Colorectal Surgery, Western General Hospital, Edinburgh, UK. 14. Department of General Practice, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands. 15. Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich, Switzerland. 16. Department of Gastrointestinal Surgery, University Hospital of North Norway, Tromsø, Norway. 17. Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, Tromsø, Norway. 18. St Mark's Hospital, The National Bowel Hospital, London, UK. 19. Department of Surgery and Colorectal Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Abstract
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. TRIAL REGISTRATION: This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554 . The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336 .
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. TRIAL REGISTRATION: This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554 . The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336 .
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Authors: Sadé L Assmann; Daniel Keszthelyi; Jos Kleijnen; Foteini Anastasiou; Elissa Bradshaw; Ann E Brannigan; Emma V Carrington; Giuseppe Chiarioni; Liora D A Ebben; Marc A Gladman; Yasuko Maeda; Jarno Melenhorst; Giovanni Milito; Jean W M Muris; Julius Orhalmi; Daniel Pohl; Yvonne Tillotson; Mona Rydningen; Saulius Svagzdys; Carolynne J Vaizey; Stephanie O Breukink Journal: United European Gastroenterol J Date: 2022-03-18 Impact factor: 6.866