Objective Lack of standardised outcomes hampers effective analysis and comparison of data when comparing treatments in fistulising perianal Crohn’s disease (pCD). Development of a standardised set of outcomes would resolve these issues. This study provides the definitive core outcome set (COS) for fistulising pCD.
Design Candidate outcomes were generated through a systematic review and patient interviews. Consensus was established via a three-round Delphi process using a 9-point Likert scale based on how important they felt it was in determining treatment success culminating in a final consensus meeting. Stakeholders were recruited nationally and grouped into three panels (surgeons and radiologists, gastroenterologists and IBD specialist nurses, and patients). Participants received feedback from their panel (in the second round) and all participants (in the third round) to allow refinement of their scores.
Results A total of 295 outcomes were identified from systematic reviews and interviews that were categorised into 92 domains. 187 stakeholders (response rate 78.5%) prioritised 49 outcomes through a three-round Delphi study. The final consensus meeting of 41 experts and patients generated agreement on an eight domain COS. The COS comprised three patient-reported outcome domains (quality of life, incontinence and a combined score of patient priorities) and five clinician-reported outcome domains (perianal disease activity, development of new perianal abscess/sepsis, new/recurrent fistula, unplanned surgery and faecal diversion).
Conclusion A fistulising pCD COS has been produced by all key stakeholders. Application of the COS will reduce heterogeneity in outcome reporting, thereby facilitating more meaningful comparisons between treatments, data synthesis and ultimately benefit patient care.
- crohn’s disease
- clinical trials
- anal sepsis
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Contributors All authors were involved in the design and delivery of the project. The manuscript was written by KS, PJT, SOA, AGKM, ALH and NSF. All authors reviewed and critically appraised the manuscript before submission.
Funding KS is supported by a Royal College of Surgeons of England Research Scholarship. AGKM is supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The study was supported by the Bowel Disease Research Foundation (BDRF), the Royal College of Surgeons, of England (RCS) and the Association of Coloproctologists of Great Britain and Ireland (ACPGBI).
Disclaimer The views expressed are those of the authors and not necessarily those of the UK National Health Service, National Institute for Health Research or Department of Health.
Competing interests KS and SOA have received honoraria from Takeda for sitting on an advisory board. PJT has received honoraria from Takeda for sitting on an advisory board and for speaking at a symposium. AJL is an advisory board member or received lecture fees from Takeda Pharma, AbbVie, Vifor Pharma, Dr Falk and Shield Therapeutics. ALH has served as a consultant, advisory board member or speaker for AbbVie, Atlantic, Bristol-Myers Squibb, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire and Takeda. She also serves on the Global Steering Committee for Genentech. NSF has received travel grants from Obsidian Health and Strategen to deliver invited lectures.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Additional supplementary data are available online. All other data are available on request.
Collaborators Abercrombie John; Acheson Austin; Anderson Simon; Armstrong Aidan; Arthur James; Ashton Katherine; Babu Sathish; Beales Ian; Bhatnagar Gauraang; Bloom Stuart; Blunt Dominic; Brown Matthew; Burling David; Butterworth Jeffrey; Calvert Christopher; Cooney Rachel; Coyne Peter; Creed Thomas; Cuming Tamzin; Dennis Robert; Douie Walter; Dunkley Irene; Eaden Jayne; Epstein Jonathan; Evans Martyn; Fallis Simon; Fieldsend Beverley; Fraser Catherine; Goodhand James; Grierson Catherine; Griffiths Ben; Gupta Arun; Gupta Sanjay; Guy Richard; Hall Alex; Hall Diane; Hall Nigel; Halligan Steve; Hancock Laura; Harbord Marcus; Hargest Rachel; Hawthorne Barney; Hayee Bu; Helbren Emma; Henderson Paul; Hoare Tim; Holtham Stephen; Ilangovan Rajapandian; Johnson Matthew; Kemp Cheryl; Nicholas Kennedy A; Kiparissi Fevronia; Knowles Charles; Lee Bee; Lewis Wendy; Limdi Jimmy; Lovegrove Richard; MacLean Peter; Maginnis Janis; Mann Steven; Mansfield John; Marshall Michele; Maxwell-Armstrong Charles; McNair Alistair; Nahal Jasbir; Pallan Arvind; Parkes Gareth; Patel Rajan; Patel Uday; Pee Leon; Phillis Kathryn; Pinkney Thomas; Planche Katie; Pollok Richard; Power Niall; Puckett Mark; Razack Abdul; Robinson Kerry; Rogers Dan; Richard Russell K; Rutter Mathew; Ryan Suzanne; Salaman Judith; Saunders John; Selinger Christian; Shaikh Irshad; Shaw Ian; Singh Baljit; Sitchon Ederis; Smart Christopher; Smart Neil; Stearns Adam; Stubbs Ben; Stuart Taylor A; Teare Julian; Tony Tham C; Thomas Pradeep; Todd John; Torkington Jared; Travis Simon; Tremelling Mark; Tyrrell Tracey; Tzivinikos Christos; Vaizey Carolynne; Warren Oliver; Warusavitarne Janindra; Wesley Emma; West Debbie; Whitehead Emma; Williams Graham; Wills Mark; Wilson Graeme; Wood Eleanor; Yarrow Hannah; Younge Lisa
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