Developing a core outcome set for fistulising perianal Crohn's disease. Issue 2 (3rd February 2018)

• Record Type: Journal Article
• Authors: Sahnan, Kapil; Tozer, Phil J; Adegbola, Samuel O; Lee, Matthew J; Heywood, Nick; McNair, Angus G K; Hind, Daniel; Yassin, Nuha; Lobo, Alan J; Brown, Steven R; Sebastian, Shaji; Phillips, Robin K S; Lung, Phillip F C; Faiz, Omar D; Crook, Kay; Blackwell, Sue; Verjee, Azmina; Hart, Ailsa L; Fearnhead, Nicola S
• Other Names: author non-byline.; Abercrombie John author non-byline.; Acheson Austin author non-byline.; Anderson Simon author non-byline.; Armstrong Aidan author non-byline.; Arthur James author non-byline.; Ashton Katherine author non-byline.; Babu Sathish author non-byline.; Beales Ian author non-byline.; Bhatnagar Gauraang author non-byline.; Bloom Stuart author non-byline.; Blunt Dominic author non-byline.; Brown Matthew author non-byline.; Burling David author non-byline.; Butterworth Jeffrey author non-byline.; Calvert Christopher author non-byline.; Cooney Rachel author non-byline.; Coyne Peter author non-byline.; Creed Thomas author non-byline.; Cuming Tamzin author non-byline.; Dennis Robert author non-byline.; Douie Walter author non-byline.; Dunkley Irene author non-byline.; Eaden Jayne author non-byline.; Epstein Jonathan author non-byline.; Evans Martyn author non-byline.; Fallis Simon author non-byline.; Fieldsend Beverley author non-byline.; Fraser Catherine author non-byline.; Goodhand James author non-byline.; Grierson Catherine author non-byline.; Griffiths Ben author non-byline.; Gupta Arun author non-byline.; Gupta Sanjay author non-byline.; Guy Richard author non-byline.; Hall Alex author non-byline.; Hall Diane author non-byline.; Hall Nigel author non-byline.; Halligan Steve author non-byline.; Hancock Laura author non-byline.; Harbord Marcus author non-byline.; Hargest Rachel author non-byline.; Hawthorne Barney author non-byline.; Hayee Bu author non-byline.; Helbren Emma author non-byline.; Henderson Paul author non-byline.; Hoare Tim author non-byline.; Holtham Stephen author non-byline.; Ilangovan Rajapandian author non-byline.; Johnson Matthew author non-byline.; Kemp Cheryl author non-byline.; Kennedy Nicholas A author non-byline.; Kiparissi Fevronia author non-byline.; Knowles Charles author non-byline.; Lee Bee author non-byline.; Lewis Wendy author non-byline.; Limdi Jimmy author non-byline.; Lovegrove Richard author non-byline.; Maclean Peter author non-byline.; Maginnis Janis author non-byline.; Mann Steven author non-byline.; Mansfield John author non-byline.; Marshall Michele author non-byline.; Maxwell-armstrong Charles author non-byline.; Mcnair Alistair author non-byline.; Nahal Jasbir author non-byline.; Pallan Arvind author non-byline.; Parkes Gareth author non-byline.; Patel Rajan author non-byline.; Patel Uday author non-byline.; Pee Leon author non-byline.; Phillis Kathryn author non-byline.; Pinkney Thomas author non-byline.; Planche Katie author non-byline.; Pollok Richard author non-byline.; Power Niall author non-byline.; Puckett Mark author non-byline.; Razack Abdul author non-byline.; Robinson Kerry author non-byline.; Rogers Dan author non-byline.; Russell Richard K author non-byline.; Rutter Mathew author non-byline.; Ryan Suzanne author non-byline.; Salaman Judith author non-byline.; Saunders John author non-byline.; Selinger Christian author non-byline.; Shaikh Irshad author non-byline.; Shaw Ian author non-byline.; Singh Baljit author non-byline.; Sitchon Ederis author non-byline.; Smart Christopher author non-byline.; Smart Neil author non-byline.; Stearns Adam author non-byline.; Stubbs Ben author non-byline.; Taylor Stuart A author non-byline.; Teare Julian author non-byline.; Tham Tony C author non-byline.; Thomas Pradeep author non-byline.; Todd John author non-byline.; Torkington Jared author non-byline.; Travis Simon author non-byline.; Tremelling Mark author non-byline.; Tyrrell Tracey author non-byline.; Tzivinikos Christos author non-byline.; Vaizey Carolynne author non-byline.; Warren Oliver author non-byline.; Warusavitarne Janindra author non-byline.; Wesley Emma author non-byline.; West Debbie author non-byline.; Whitehead Emma author non-byline.; Williams Graham author non-byline.; Wills Mark author non-byline.; Wilson Graeme author non-byline.; Wood Eleanor author non-byline.; Yarrow Hannah author non-byline.; Younge Lisa author non-byline.;
• Is Part Of: Gut. Volume 68:Issue 2(2019)
• Page Start: 226
• Page End: 238
• Publication Date: 2018-02-03
• Subjects: ibd -- crohn's disease -- clinical trials -- anal sepsis; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2017-315503
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : 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.