eprintid: 10179371 rev_number: 13 eprint_status: archive userid: 699 dir: disk0/10/17/93/71 datestamp: 2023-10-23 14:28:16 lastmod: 2024-08-01 10:46:03 status_changed: 2023-10-23 14:28:16 type: article metadata_visibility: show sword_depositor: 699 creators_name: Crowley, Eileen creators_name: Ma, Christopher creators_name: Guizzetti, Leonard creators_name: Zou, Guangyong creators_name: Lewindon, Peter J creators_name: Gee, Michael S creators_name: Hyams, Jeffrey S creators_name: Rosen, Michael J creators_name: von Allmen, Daniel creators_name: de Buck van Overstraeten, Anthony creators_name: Shackelton, Lisa M creators_name: Remillard, Julie creators_name: Schleicher, Lauren creators_name: Dillman, Jonathan R creators_name: Rimola, Jordi creators_name: Taylor, Stuart A creators_name: Fletcher, Joel G creators_name: Church, Peter C creators_name: Feagan, Brian G creators_name: Griffiths, Anne M creators_name: Jairath, Vipul creators_name: Greer, Mary-Louise C title: Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn's Disease Clinical Trials ispublished: pub divisions: UCL divisions: B02 divisions: C10 divisions: D17 divisions: FI6 keywords: Clinical trial, Crohn’s disease, pediatric, pelvic MRI, perianal fistula note: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. abstract: BACKGROUND: Perianal fistulas and abscesses occur commonly as complications of pediatric Crohn's disease (CD). A validated imaging assessment tool for quantification of perianal disease severity and activity is needed to evaluate treatment response. We aimed to identify magnetic resonance imaging (MRI)-based measures of perianal fistulizing disease activity and study design features appropriate for pediatric patients. METHODS: Seventy-nine statements relevant to MRI-based assessment of pediatric perianal fistulizing CD activity and clinical trial design were generated from literature review and expert opinion. Statement appropriateness was rated by a panel (N = 15) of gastroenterologists, radiologists, and surgeons using modified RAND/University of California Los Angeles appropriateness methodology. RESULTS: The modified Van Assche Index (mVAI) and the Magnetic Resonance Novel Index for Fistula Imaging in CD (MAGNIFI-CD) were considered appropriate instruments for use in pediatric perianal fistulizing disease clinical trials. Although there was concern regarding the use of intravascular contrast material in pediatric patients, its use in clinical trials was considered appropriate. A clinically evident fistula tract and radiologic disease defined as at least 1 fistula or abscess on pelvic MRI were considered appropriate trial inclusion criteria. A coprimary clinical and radiologic end point and inclusion of a patient-reported outcome were also considered appropriate. CONCLUSION: Outcomes of treatment of perianal fistulizing disease in children must include MRI. Existing multi-item measures, specifically the mVAI and MAGNIFI-CD, can be adapted and used for children. Further research to assess the operating properties of the indices when used in a pediatric patient population is ongoing. date: 2024-03 date_type: published publisher: Wiley-Blackwell official_url: https://doi.org/10.1093/ibd/izad134 oa_status: green full_text_type: other language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 2044075 doi: 10.1093/ibd/izad134 medium: Print-Electronic pii: 7234320 lyricists_name: Taylor, Stuart lyricists_id: STAYL70 actors_name: Taylor, Stuart actors_id: STAYL70 actors_role: owner full_text_status: public publication: Inflammatory Bowel Diseases volume: 30 number: 3 pagerange: 357-369 pages: 13 event_location: England citation: Crowley, Eileen; Ma, Christopher; Guizzetti, Leonard; Zou, Guangyong; Lewindon, Peter J; Gee, Michael S; Hyams, Jeffrey S; ... Greer, Mary-Louise C; + view all <#> Crowley, Eileen; Ma, Christopher; Guizzetti, Leonard; Zou, Guangyong; Lewindon, Peter J; Gee, Michael S; Hyams, Jeffrey S; Rosen, Michael J; von Allmen, Daniel; de Buck van Overstraeten, Anthony; Shackelton, Lisa M; Remillard, Julie; Schleicher, Lauren; Dillman, Jonathan R; Rimola, Jordi; Taylor, Stuart A; Fletcher, Joel G; Church, Peter C; Feagan, Brian G; Griffiths, Anne M; Jairath, Vipul; Greer, Mary-Louise C; - view fewer <#> (2024) Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn's Disease Clinical Trials. Inflammatory Bowel Diseases , 30 (3) pp. 357-369. 10.1093/ibd/izad134 <https://doi.org/10.1093/ibd%2Fizad134>. Green open access document_url: https://discovery-pp.ucl.ac.uk/id/eprint/10179371/1/Taylor_RCT01331%20MANUSCRIPT%20MAGNIFI%20PEDS%20RAND%20.pdf