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Developing a core outcome set for fistulising perianal Crohn's disease

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Developing a core outcome set for fistulising perianal Crohn's disease. / ENiGMA collaborators.

In: Gut, Vol. 68, No. 2, 01.02.2019, p. 226-238.

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ENiGMA collaborators. / Developing a core outcome set for fistulising perianal Crohn's disease. In: Gut. 2019 ; Vol. 68, No. 2. pp. 226-238.

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@article{7c89f56609054a239f9daf250468cf04,
title = "Developing a core outcome set for fistulising perianal Crohn's disease",
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.",
keywords = "Consensus Development Conferences as Topic, Crohn Disease/pathology, Delphi Technique, Disease Progression, Fecal Incontinence/etiology, Humans, Interviews as Topic, Outcome Assessment (Health Care), Patient Reported Outcome Measures, Quality of Life, Rectal Fistula/pathology, Research Design, Risk Factors, Systematic Reviews as Topic",
author = "Kapil Sahnan and Tozer, {Phil J} and Adegbola, {Samuel O} and Lee, {Matthew J} and Nick Heywood and McNair, {Angus G K} and Daniel Hind and Nuha Yassin and Lobo, {Alan J} and Brown, {Steven R} and Shaji Sebastian and Phillips, {Robin K S} and Lung, {Phillip F C} and Faiz, {Omar D} and Kay Crook and Sue Blackwell and Azmina Verjee and Hart, {Ailsa L} and Fearnhead, {Nicola S} and {ENiGMA collaborators}",
note = "{\circledC} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.",
year = "2019",
month = "2",
day = "1",
doi = "10.1136/gutjnl-2017-315503",
language = "English",
volume = "68",
pages = "226--238",
journal = "Gut",
issn = "0017-5749",
number = "2",

}

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TY - JOUR

T1 - Developing a core outcome set for fistulising perianal Crohn's disease

AU - Sahnan, Kapil

AU - Tozer, Phil J

AU - Adegbola, Samuel O

AU - Lee, Matthew J

AU - Heywood, Nick

AU - McNair, Angus G K

AU - Hind, Daniel

AU - Yassin, Nuha

AU - Lobo, Alan J

AU - Brown, Steven R

AU - Sebastian, Shaji

AU - Phillips, Robin K S

AU - Lung, Phillip F C

AU - Faiz, Omar D

AU - Crook, Kay

AU - Blackwell, Sue

AU - Verjee, Azmina

AU - Hart, Ailsa L

AU - Fearnhead, Nicola S

AU - ENiGMA collaborators

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2019/2/1

Y1 - 2019/2/1

N2 - 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.

AB - 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.

KW - Consensus Development Conferences as Topic

KW - Crohn Disease/pathology

KW - Delphi Technique

KW - Disease Progression

KW - Fecal Incontinence/etiology

KW - Humans

KW - Interviews as Topic

KW - Outcome Assessment (Health Care)

KW - Patient Reported Outcome Measures

KW - Quality of Life

KW - Rectal Fistula/pathology

KW - Research Design

KW - Risk Factors

KW - Systematic Reviews as Topic

UR - http://www.scopus.com/inward/record.url?scp=85045407042&partnerID=8YFLogxK

U2 - 10.1136/gutjnl-2017-315503

DO - 10.1136/gutjnl-2017-315503

M3 - Article

VL - 68

SP - 226

EP - 238

JO - Gut

T2 - Gut

JF - Gut

SN - 0017-5749

IS - 2

ER -