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Feasibility and validity of the pediatric ulcerative colitis activity index in routine clinical practice
Jennifer L Dotson1, Wallace V Crandall, Peixin Zhang
1*Division of Pediatric Gastroenterology, Hepatology and Nutrition, Nationwide Children's Hospital, Columbus, OH †The Children's Hospital of Philadelphia, Philadelphia, PA ‡Department of Pediatrics, University of Vermont, Burlington §Department of Pediatrics, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill.
Insights
The Pediatric Ulcerative Colitis Activity Index (PUCAI) is feasible for routine use in pediatric gastroenterology. This validated and responsive tool effectively monitors ulcerative colitis activity in children.
Area of Science:
- Pediatric Gastroenterology
- Clinical Trial Endpoints
- Disease Activity Indices
Background:
- The Pediatric Ulcerative Colitis Activity Index (PUCAI) was initially developed for clinical trials.
- Recent guidelines suggest PUCAI for routine pediatric ulcerative colitis care.
Purpose of the Study:
- To assess the feasibility, validity, and responsiveness of the PUCAI in diverse pediatric gastroenterology practices.
- To evaluate PUCAI's utility beyond clinical trials.
Main Methods:
- Data from 2503 pediatric ulcerative colitis patients in the ImproveCareNow registry were analyzed.
- Feasibility assessed by completion rates; validity by correlation with Physician Global Assessment (PGA).
- Responsiveness evaluated by correlating changes in PUCAI and PGA scores.
Main Results:
- PUCAI completion rate was 96%, demonstrating high feasibility.
- PUCAI showed good correlation with PGA (r=0.76) and strong test-retest reliability (ICC=0.72).
- The index demonstrated good responsiveness to changes in disease activity (Guyatt statistic=1.18).
Conclusions:
- The PUCAI is a feasible tool for routine clinical monitoring of pediatric ulcerative colitis.
- Its demonstrated validity and responsiveness support its use in clinical practice.
- PUCAI aids in tracking disease activity for children with ulcerative colitis.
Objectives:
The Pediatric Ulcerative Colitis Activity Index (PUCAI) is a noninvasive disease activity index developed as a clinical trial endpoint. More recently, practice guidelines have recommended the use of PUCAI in routine clinical care. We therefore sought to evaluate the feasibility, validity, and responsiveness of PUCAI in a large, diverse collection of pediatric gastroenterology practices.
Methods:
We extracted data from the 2 most recent encounters for patients with ulcerative colitis in the ImproveCareNow registry. Feasibility was determined by the percentage of patients for whom all PUCAI components were recorded, validity by correlation of PUCAI scores across physician global assessment (PGA) categories, and responsiveness to change by the correlation between the change in PUCAI and PGA scores between visits.
Results:
A total of 2503 patients were included (49.5% boys, age 15.2 ± 4.1 years, disease duration 3.7 ± 3.2 years). All items in the PUCAI were completed for 96% of visits. PUCAI demonstrated excellent discriminatory ability between remission, mild, and moderate disease; discrimination between moderate and severe disease was less robust. There was good correlation with PGA (r = 0.76 [P < 0.001] and weighted kappa κ = 0.73 [P < 0.001]). The PUCAI change scores correlated well with PGA change scores (P < 0.001). Test-retest reliability of the PUCAI was good (intraclass correlation coefficient 0.72 [95% confidence interval 0.70-0.75], P < 0.001). Guyatt responsiveness statistic was 1.18, and the correlation of ΔPUCAI with ΔPGA was 0.69 (P < 0.001).
Conclusions:
The PUCAI is feasible to use in routine clinical settings. Evidence of its validity and responsiveness supports its use as a clinical tool for monitoring disease activity for patients with ulcerative colitis.
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