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Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn's
Eileen Crowley1,2, Christopher Ma2,3,4, Leonard Guizzetti2
1Department of Pediatrics, Division of Pediatric Gastroenterology, Children's Hospital Western Ontario, Western University, London Health Sciences Centre, London, Ontario, Canada.
Insights
Magnetic resonance imaging (MRI) measures like the mVAI and MAGNIFI-CD are suitable for assessing pediatric Crohn's disease perianal fistulas. These tools, along with specific trial designs, can help evaluate treatment effectiveness in children.
Area of Science:
- Pediatric Gastroenterology
- Medical Imaging
- Clinical Trial Design
Background:
- Perianal fistulas and abscesses are common in pediatric Crohn's disease (CD).
- A validated imaging tool is needed to quantify perianal disease severity and activity for treatment response evaluation.
- This study aimed to identify MRI-based measures for perianal fistulizing disease activity and appropriate study designs for pediatric patients.
Approach:
- Seventy-nine statements regarding MRI assessment of pediatric perianal fistulizing CD and clinical trial design were generated.
- A panel of 15 gastroenterologists, radiologists, and surgeons rated statement appropriateness using a modified RAND/UCLA methodology.
Key Points:
- The modified Van Assche Index (mVAI) and MAGNIFI-CD were deemed appropriate for pediatric perianal fistulizing disease clinical trials.
- Use of intravascular contrast material in pediatric patients was considered appropriate for clinical trials.
- Appropriate trial inclusion criteria included clinically evident fistula tracts and radiologic disease (fistula/abscess on pelvic MRI).
- A coprimary clinical and radiologic endpoint and patient-reported outcomes were also considered appropriate.
Conclusions:
- MRI is essential for evaluating treatment outcomes in pediatric perianal fistulizing disease.
- Existing measures (mVAI, MAGNIFI-CD) can be adapted for pediatric use.
- Ongoing research is assessing the performance of these indices in pediatric populations.
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.
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