TY - JOUR
T1 - AFCOS: The Development of a Cryptoglandular Anal Fistula Core Outcome Set
AU - Iqbal, Nusrat
AU - Astrid, Machielsen J.H.M.
AU - Merel L, Kimman
AU - Gillian, Kane
AU - Rebecca, Woodcock
AU - Ugo, Grossi
AU - Tozer, Phil J.
AU - Stéphanie O, Breukink
AU - Cordero, Estefania Guzman
AU - Gardiner, Neil
AU - Gecim, Ibrahim Ethem
AU - Gottesman, Lester
AU - Han, Ingrid
AU - Keizers, Piet
AU - Keller, Deborah
AU - Leventi, Aikaterini
AU - Lundby, Lilli
AU - Lung, Phillip
AU - Marshall, Gary
AU - Mulrenan, Catherine
AU - Pugh, K.
AU - Ratto, Carlo
AU - Whitehead, Heather
AU - Zimmerman, David
PY - 2023
Y1 - 2023
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
KW - Core Outcome Set
KW - Delphi consensus
KW - anal fistula
KW - outcomes
UR - http://hdl.handle.net/10807/236057
U2 - 10.1097/SLA.0000000000005462
DO - 10.1097/SLA.0000000000005462
M3 - Article
SN - 0003-4932
VL - 277
SP - E1045-E1050
JO - Annals of Surgery
JF - Annals of Surgery
ER -