TY - JOUR
T1 - AFCOS
T2 - The Development of a Cryptoglandular Anal Fistula Core Outcome Set
AU - Iqbal, Nusrat
AU - Machielsen, Astrid J H M
AU - Kimman, Merel L
AU - Kane, Gillian
AU - Woodcock, Rebecca
AU - Grossi, Ugo
AU - Tozer, Phil J
AU - Breukink, Stéphanie O
AU - AFCOS Consensus Meeting Collaborators
N1 - Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.
PY - 2023/5
Y1 - 2023/5
N2 - OBJECTIVE: To develop a cryptoglandular Anal Fistula Core Outcome Set: a minimum set of outcomes that should be measured in all studies of cryptoglandular anal fistula treatment.BACKGROUND: Variability in the outcomes that are reported in studies of cryptoglandular anal fistula treatment hampers systematic evidence synthesis to identify the best treatment.METHODS: This study followed guidance from the Core Outcome Measures in Effectiveness Trials initiative and consisted of three stages: (1) generation of candidate outcomes through systematic review of the literature and qualitative patient interviews; (2) prioritization of outcomes by key stakeholders, including patients, surgeons, gastroenterologists, and radiologists in an online Delphi consensus process; and (3) determination of the final Core Outcome Set (COS) in a consensus meeting attended by patients and clinicians.RESULTS: Sixty-four outcomes were presented in the first Delphi survey round. A total of 191 participants from over 30 countries ranked these outcomes according to their importance in defining treatment success (57.6% surgeons and gastroenterologists, 8.9% radiologists, and 33.5% patients). After two rounds, 53 outcomes were identified as important and discussed in the consensus meeting attended by 10 patients and 12 clinicians. A final 10 outcomes were voted into the COS: clinical fistula healing, radiological healing, recurrence, development of additional fistulas, fistula symptoms, incontinence, psychological impact of treatment, complications and reinterventions, patient satisfaction, and quality of life.CONCLUSION: The final COS represents an international, multidisciplinary, patient-centered attempt to establish consistency in fistula research, with a substantial focus on patient priorities for treatment.
AB - OBJECTIVE: To develop a cryptoglandular Anal Fistula Core Outcome Set: a minimum set of outcomes that should be measured in all studies of cryptoglandular anal fistula treatment.BACKGROUND: Variability in the outcomes that are reported in studies of cryptoglandular anal fistula treatment hampers systematic evidence synthesis to identify the best treatment.METHODS: This study followed guidance from the Core Outcome Measures in Effectiveness Trials initiative and consisted of three stages: (1) generation of candidate outcomes through systematic review of the literature and qualitative patient interviews; (2) prioritization of outcomes by key stakeholders, including patients, surgeons, gastroenterologists, and radiologists in an online Delphi consensus process; and (3) determination of the final Core Outcome Set (COS) in a consensus meeting attended by patients and clinicians.RESULTS: Sixty-four outcomes were presented in the first Delphi survey round. A total of 191 participants from over 30 countries ranked these outcomes according to their importance in defining treatment success (57.6% surgeons and gastroenterologists, 8.9% radiologists, and 33.5% patients). After two rounds, 53 outcomes were identified as important and discussed in the consensus meeting attended by 10 patients and 12 clinicians. A final 10 outcomes were voted into the COS: clinical fistula healing, radiological healing, recurrence, development of additional fistulas, fistula symptoms, incontinence, psychological impact of treatment, complications and reinterventions, patient satisfaction, and quality of life.CONCLUSION: The final COS represents an international, multidisciplinary, patient-centered attempt to establish consistency in fistula research, with a substantial focus on patient priorities for treatment.
KW - Core Outcome Set
KW - Delphi consensus
KW - Anal fistula
KW - Outcomes
U2 - 10.1097/SLA.0000000000005462
DO - 10.1097/SLA.0000000000005462
M3 - Article
C2 - 35815887
SN - 0003-4932
VL - 277
SP - E1045-E1050
JO - Annals of Surgery
JF - Annals of Surgery
IS - 5
ER -