PMID- 37524088
OWN - NLM
STAT- MEDLINE
DCOM- 20240304
LR  - 20240312
IS  - 1536-4844 (Electronic)
IS  - 1078-0998 (Linking)
VI  - 30
IP  - 3
DP  - 2024 Mar 1
TI  - Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing 
      Disease Activity in Pediatric Crohn's Disease Clinical Trials.
PG  - 357-369
LID - 10.1093/ibd/izad134 [doi]
AB  - 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.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & 
      Colitis Foundation. All rights reserved. For permissions, please e-mail: 
      journals.permissions@oup.com.
FAU - Crowley, Eileen
AU  - Crowley E
AUID- ORCID: 0000-0002-9545-4384
AD  - Department of Pediatrics, Division of Pediatric Gastroenterology, Children's 
      Hospital Western Ontario, Western University, London Health Sciences Centre, 
      London, Ontario, Canada.
AD  - Alimentiv Inc, London, ON, Canada.
FAU - Ma, Christopher
AU  - Ma C
AUID- ORCID: 0000-0002-4698-9948
AD  - Alimentiv Inc, London, ON, Canada.
AD  - Division of Gastroenterology and Hepatology, Department of Medicine, University 
      of Calgary, Calgary, AB, Canada.
AD  - Department of Community Health Sciences, Cumming School of Medicine, University 
      of Calgary, Calgary, AB, Canada.
FAU - Guizzetti, Leonard
AU  - Guizzetti L
AD  - Alimentiv Inc, London, ON, Canada.
FAU - Zou, Guangyong
AU  - Zou G
AD  - Alimentiv Inc, London, ON, Canada.
AD  - Department of Epidemiology and Biostatistics, Western University, London, 
      Ontario, Canada.
FAU - Lewindon, Peter J
AU  - Lewindon PJ
AD  - Department of Gastroenterology, Queensland Children's Hospital, University of 
      Queensland, Brisbane, Queensland, Australia.
AD  - Children's Medical Research Institute, University of Queensland, Brisbane, 
      Queensland, Australia.
FAU - Gee, Michael S
AU  - Gee MS
AD  - Department of Radiology, Massachusetts General Hospital Boston, MA, USA.
AD  - Department of Radiology, Harvard Medical School, Boston, MA, USA.
FAU - Hyams, Jeffrey S
AU  - Hyams JS
AUID- ORCID: 0000-0002-9769-236X
AD  - Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children's 
      Medical Center, Hartford, CT, USA.
FAU - Rosen, Michael J
AU  - Rosen MJ
AD  - Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of 
      Pediatrics, Stanford Medicine, Stanford, CA, USA.
FAU - von Allmen, Daniel
AU  - von Allmen D
AD  - Department of Pediatric Surgery and Surgical Services, Cincinnati Children's 
      Hospital Medical Center, Cincinnati, OH, USA.
AD  - Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, 
      OH, USA.
FAU - de Buck van Overstraeten, Anthony
AU  - de Buck van Overstraeten A
AD  - Department of Surgery, Mount Sinai Hospital, University of Toronto, Toronto, ON, 
      Canada.
FAU - Shackelton, Lisa M
AU  - Shackelton LM
AUID- ORCID: 0000-0002-1788-475X
AD  - Alimentiv Inc, London, ON, Canada.
FAU - Remillard, Julie
AU  - Remillard J
AD  - Alimentiv Inc, London, ON, Canada.
FAU - Schleicher, Lauren
AU  - Schleicher L
AD  - Alimentiv Inc, London, ON, Canada.
FAU - Dillman, Jonathan R
AU  - Dillman JR
AD  - Department of Radiology, Cincinnati Children's Hospital Medical Center, 
      Cincinnati, OH, USA.
AD  - Department of Radiology, University of Cincinnati College of Medicine, 
      Cincinnati, OH, USA.
FAU - Rimola, Jordi
AU  - Rimola J
AUID- ORCID: 0000-0002-1814-4198
AD  - IBD Unit, Radiology Department, Hospital Clinic Barcelona, IDIBAPS, Spain.
FAU - Taylor, Stuart A
AU  - Taylor SA
AD  - Centre for Medical Imaging, Charles Bell House, University College London, 
      London, UK.
FAU - Fletcher, Joel G
AU  - Fletcher JG
AD  - Department of Radiology, Mayo Clinic, Rochester, MN, USA.
FAU - Church, Peter C
AU  - Church PC
AD  - Division of Gastroenterology, Hepatology & Nutrition, Department of Paediatrics 
      and IBD Centre, The Hospital for Sick Children, University of Toronto, Toronto, 
      ON, Canada.
AD  - Institute of Health Policy, Management and Evaluation, University of Toronto, 
      Toronto, ON, Canada.
FAU - Feagan, Brian G
AU  - Feagan BG
AD  - Alimentiv Inc, London, ON, Canada.
AD  - Department of Epidemiology and Biostatistics, Western University, London, 
      Ontario, Canada.
AD  - Department of Medicine, Division of Gastroenterology, Western University, London, 
      ON, Canada.
FAU - Griffiths, Anne M
AU  - Griffiths AM
AD  - Division of Gastroenterology, Hepatology & Nutrition, Department of Paediatrics 
      and IBD Centre, The Hospital for Sick Children, University of Toronto, Toronto, 
      ON, Canada.
FAU - Jairath, Vipul
AU  - Jairath V
AD  - Alimentiv Inc, London, ON, Canada.
AD  - Department of Epidemiology and Biostatistics, Western University, London, 
      Ontario, Canada.
AD  - Department of Medicine, Division of Gastroenterology, Western University, London, 
      ON, Canada.
FAU - Greer, Mary-Louise C
AU  - Greer MC
AD  - Department of Diagnostic Imaging, The Hospital for Sick Children, Department of 
      Medical Imaging, University of Toronto, Toronto, ON, Canada.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Inflamm Bowel Dis
JT  - Inflammatory bowel diseases
JID - 9508162
RN  - Pediatric Crohn's disease
SB  - IM
MH  - Child
MH  - Humans
MH  - Abscess
MH  - *Crohn Disease/complications/diagnostic imaging
MH  - *Fistula
MH  - Magnetic Resonance Imaging
MH  - Clinical Trials as Topic
OTO - NOTNLM
OT  - Crohn's disease
OT  - clinical trial
OT  - pediatric
OT  - pelvic MRI
OT  - perianal fistula
EDAT- 2023/08/01 01:08
MHDA- 2024/03/04 06:47
CRDT- 2023/07/31 18:43
PHST- 2022/09/16 00:00 [received]
PHST- 2024/03/04 06:47 [medline]
PHST- 2023/08/01 01:08 [pubmed]
PHST- 2023/07/31 18:43 [entrez]
AID - 7234320 [pii]
AID - 10.1093/ibd/izad134 [doi]
PST - ppublish
SO  - Inflamm Bowel Dis. 2024 Mar 1;30(3):357-369. doi: 10.1093/ibd/izad134.