TY - JOUR
T1 - Consensus definition of a radiologically healed fistula on magnetic resonance imaging in perianal Crohn's disease
T2 - an international Delphi study
AU - Anand, Easan
AU - Devi, Jalpa
AU - Joshi, Shivani
AU - Antoniou, Anna
AU - Doering, Michelle
AU - Stoker, Jaap
AU - Lung, Phillip
AU - Hart, Ailsa L.
AU - Ballard, David H.
AU - Deepak, Parakkal
AU - Tozer, Phil
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/11/18
Y1 - 2024/11/18
N2 - INTRODUCTION: Perianal fistulising Crohn's disease (pfCD) is a distinct and debilitating phenotype seen in around one-third of patients with CD. Clinical trials in pfCD are increasingly using magnetic resonance imaging (MRI) criteria as a primary endpoint, but there is heterogeneity in the radiological definition of a healed perianal fistula that currently limits our ability to perform meaningful meta-analyses of studies. Our aim is to standardise outcomes through the generation of an international consensus definition of a radiologically healed fistula. METHODS AND ANALYSIS: This international Delphi consensus study employs a two-part strategy.The first is a systematic review to identify a longlist of variables used to define radiological healing in pfCD. MRI-based indices used to score fistula severity and healing will be assessed for their methodological quality using Consensus-based Standards for the selection of health Measurement Instruments (COSMIN). The systematic review protocol will be conducted using COSMIN methodology and reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses.The second part will be an online Delphi consensus, guided by the results of the systematic review. Radiologists, gastroenterologists and colorectal surgeons with expertise in the management of pfCD will be invited to take part in two to three rounds of online surveys. Once an a priori threshold of >80% agreement is reached on individual radiological components used to define 'healing' and 'healed', a final meeting of key stakeholders will be organised to generate a consensus definition of a healed fistula. ETHICS AND DISSEMINATION: The study has been deemed exempt from a formal Research Ethics Committee review as no patients will participate directly in the consensus process, given the technical nature of the research question. The study is registered with the local R&D department (Reference RD24/007). Publication of this study will help standardise radiological endpoint measurement in clinical trials of pfCD and improve the synthesis and meta-analysis of comparative studies. PROSPERO REGISTRATION NUMBER: CRD42024504334.
AB - INTRODUCTION: Perianal fistulising Crohn's disease (pfCD) is a distinct and debilitating phenotype seen in around one-third of patients with CD. Clinical trials in pfCD are increasingly using magnetic resonance imaging (MRI) criteria as a primary endpoint, but there is heterogeneity in the radiological definition of a healed perianal fistula that currently limits our ability to perform meaningful meta-analyses of studies. Our aim is to standardise outcomes through the generation of an international consensus definition of a radiologically healed fistula. METHODS AND ANALYSIS: This international Delphi consensus study employs a two-part strategy.The first is a systematic review to identify a longlist of variables used to define radiological healing in pfCD. MRI-based indices used to score fistula severity and healing will be assessed for their methodological quality using Consensus-based Standards for the selection of health Measurement Instruments (COSMIN). The systematic review protocol will be conducted using COSMIN methodology and reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses.The second part will be an online Delphi consensus, guided by the results of the systematic review. Radiologists, gastroenterologists and colorectal surgeons with expertise in the management of pfCD will be invited to take part in two to three rounds of online surveys. Once an a priori threshold of >80% agreement is reached on individual radiological components used to define 'healing' and 'healed', a final meeting of key stakeholders will be organised to generate a consensus definition of a healed fistula. ETHICS AND DISSEMINATION: The study has been deemed exempt from a formal Research Ethics Committee review as no patients will participate directly in the consensus process, given the technical nature of the research question. The study is registered with the local R&D department (Reference RD24/007). Publication of this study will help standardise radiological endpoint measurement in clinical trials of pfCD and improve the synthesis and meta-analysis of comparative studies. PROSPERO REGISTRATION NUMBER: CRD42024504334.
KW - Colorectal surgery
KW - Gastrointestinal imaging
KW - Inflammatory bowel disease
UR - http://www.scopus.com/inward/record.url?scp=85210047955&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2024-087919
DO - 10.1136/bmjopen-2024-087919
M3 - Article
C2 - 39557555
AN - SCOPUS:85210047955
SN - 2044-6055
VL - 14
SP - e087919
JO - BMJ Open
JF - BMJ Open
IS - 11
ER -