Abstract
Background & Aims: Cross-sectional imaging is important in the assessment of transmural inflammation in Crohn's disease (CD). Small bowel involvement is often more extensive in pediatric CD, requiring a panentering measuring tool. We undertook to develop a magnetic resonance enterography (MRE)-based index that would measure inflammation in all segments of the intestine, without rectal contrast. Methods: Children with CD underwent ileocolonoscopy and MRE and half were prospectively followed for 18 months when MRE was repeated. Item generation and reduction were performed by a Delphi panel of pediatric radiologists, a systematic literature review, a cross-sectional study of 48 MREs, and a steering committee. Formatting and weighting were performed using multivariate modeling adjusted by a steering committee. MREs were read locally and centrally. Reliability, validity, and responsiveness were determined using several clinimetric and psychometric approaches. Results: Thirty items were initially generated and reduced to 5 using regression analysis on 159 MREs: wall thickness, wall diffusion weighted imaging, ulcerations, mesenteric edema, and comb sign. In the validation cohort of 81 MREs, the weighted global PICMI correlated well with the radiologist global assessment (r = 0.85; P < .001) and with the simple endoscopic score in a subsample with ileocolonic disease (r = 0.63; P < .001). Interobserver and test-retest reliability were high (interclass correlation coefficients, 0.84; 95% confidence interval [CI], 0.79–0.87; and 0.81, 95% CI, 0.65–0.90, respectively; both P < .001). Excellent responsiveness was found at repeated visits (n = 116 MREs; area under the receiver operating characteristic curve 0.96; 95% CI, 0.93–0.99). Transmural healing was defined as PICMI ≤10 and response as a change of >20 points with excellent discriminative validity (area under the receiver operating characteristic curve = 0.96; 95% CI, 0.93–0.99). Conclusions: The PICMI is a valid, reliable, and responsive index for assessing transmural inflammation in pediatric CD. It scores the entire bowel length and does not require intravenous contrast or rectal enema and, therefore, is suitable for use in children. (ClinicalTrials.gov, Number: NCT01881490.)
| Original language | American English |
|---|---|
| Pages (from-to) | 1306-1320 |
| Number of pages | 15 |
| Journal | Gastroenterology |
| Volume | 163 |
| Issue number | 5 |
| DOIs | |
| State | Published - Nov 2022 |
Bibliographical note
Funding Information:Funding The ImageKids study was supported by an educational grant from AbbVie, which was not involved in any part of the study including protocol preparation, data acquisition, analyses, or manuscript preparation. CRediT Authorship Contributions Gili Focht, MSc, MBA (Data curation: Equal; Formal analysis: Equal; Methodology: Supporting; Project administration: Lead; Writing – original draft: Lead; Writing – review & editing: Lead). Ruth Cytter-Kuint, MD (Investigation: Equal; Writing – review & editing: Supporting; Central Reading: Equal). Mary-Louise C. Greer, MD (Conceptualization: Equal; Investigation: Equal; Writing – review & editing: Equal; Central Reading: Equal). Li-Tal Pratt, MD (Investigation: Supporting; Central Reading: Equal). Denise A. Castro, MD (Investigation: Supporting; Central Reading: Equal). Peter C. Church, MD (Data curation: Supporting; Formal analysis: Supporting; Investigation: Supporting; Writing – review & editing: Supporting). Thomas D. Walters, MD (Conceptualization: Supporting; Data curation: Supporting; Investigation: Supporting; Software: Lead). Jeffrey Hyams, MD (Data curation: Supporting; Investigation: Supporting; Writing – review & editing: Supporting). Dan Navon, MSc (Formal analysis: Supporting). Javier Martin de Carpi, MD (Data curation: Supporting; Investigation: Supporting; Writing – review & editing: Supporting). Frank Ruemmele, MD (Data curation: Supporting; Investigation: Supporting; Writing – review & editing: Supporting). Richard K. Russell, MD (Data curation: Supporting; Investigation: Supporting; Writing – review & editing: Supporting). Matan Gavish, PhD (Formal analysis: Equal). Anne M. Griffiths, MD (Conceptualization: Equal; Data curation: Equal; Investigation: Equal; Methodology: Equal; Supervision: Equal; Writing – review & editing: Equal). Dan Turner, MD, PhD (Data curation: Equal; Formal analysis: Equal; Formal analysis: Equal; Funding acquisition: Lead; Funding acquisition: Lead; Investigation: Lead; Investigation: Lead; Methodology: Lead; Methodology: Lead; Supervision: Lead; Supervision: Lead; Writing – original draft: Lead; Writing – original draft: Lead; Writing – review & editing: Lead; Writing – review & editing: Lead). Conflicts of interest G.F. received in the past 3 years consultation fees from Abbvie and Lilly. M.L.G. received in the past 3 years AbbVie investigator-initiated research grant and honoraria and Samsung honoraria. P.C. received in the past 3 years speaker fees, consultant fees, or grants from Abbvie, Amgen, Janssen, and Takeda. R.K.R. received in the past 3 years consultation fees, research grants, royalties, or honorarium from Janssen, Pfizer, Nestlé Health Sciences, Ferring, Abbvie, Takeda, Celltrion, Lilly, Pharmacosmos, and Tillots. Also, R.K.R. was supported by a National Health Service Research Scotland Career Researcher Clinician award. A.M.G. received in the past 3 years consultant fees from Abbvie, Amgen, Bristol Myers Squibb, Lilly, Janssen, Merck, and Pfizer; speaker fees from Abbvie, Janssen, and Nestlé; and an investigator-initiated research grant from Abbvie. D.T. received in the last 3 years consultation fees, research grants, royalties, or honorarium from Janssen, Pfizer, Hospital for Sick Children, Ferring, Abbvie, Takeda, Atlantic Health, Shire, Celgene, Lilly, Roche, ThermoFisher, and BMS. All other authors disclose no conflicts.
Funding Information:
Conflicts of interest G.F. received in the past 3 years consultation fees from Abbvie and Lilly. M.L.G. received in the past 3 years AbbVie investigator-initiated research grant and honoraria and Samsung honoraria. P.C. received in the past 3 years speaker fees, consultant fees, or grants from Abbvie, Amgen, Janssen, and Takeda. R.K.R. received in the past 3 years consultation fees, research grants, royalties, or honorarium from Janssen, Pfizer, Nestlé Health Sciences, Ferring, Abbvie, Takeda, Celltrion, Lilly, Pharmacosmos, and Tillots. Also, R.K.R. was supported by a National Health Service Research Scotland Career Researcher Clinician award. A.M.G. received in the past 3 years consultant fees from Abbvie, Amgen, Bristol Myers Squibb, Lilly, Janssen, Merck, and Pfizer; speaker fees from Abbvie, Janssen, and Nestlé; and an investigator-initiated research grant from Abbvie. D.T. received in the last 3 years consultation fees, research grants, royalties, or honorarium from Janssen, Pfizer, Hospital for Sick Children, Ferring, Abbvie, Takeda, Atlantic Health, Shire, Celgene, Lilly, Roche, ThermoFisher, and BMS. All other authors disclose no conflicts.
Publisher Copyright:
© 2022 AGA Institute
Keywords
- Inflammation
- Magnetic Resonance Enterography
- Pediatric Crohn's disease