Appraisal of the pediatric crohn's disease activity index on four prospectively collected datasets

Recommended cutoff values and clinimetric properties

Dan Turner, Anne M. Griffiths, Thomas D. Walters, Tong Seah, James Markowitz, Marian Pfefferkorn, David Keljo, Anthony Otley, Neal S. Leleiko, David MacK, Jeffrey Hyams, Arie Levine

Research output: Contribution to journalArticle

65 Citations (Scopus)

Abstract

Objectives: The Pediatric Crohn's Disease Activity Index (PCDAI) is the outcome measure of choice in clinical trials of pediatric Crohn's disease. The aim of this study was to provide knowledge on its performance and accuracy of different cutoff scores. Methods: Longitudinal data prospectively generated from four sources were used, including the REACH and budesonide trials, a North-American inflammatory bowel diseases (IBD) registry, and a cohort aimed at evaluating growth. Cutoff values of disease activity were determined by physician global assessment from the pooled cohort using serial receiver operator characteristic curves and area under the curve (AUC) as well as comparing the overall accuracy. Test-retest reliability and responsiveness were ascertained by comparing the baseline and follow-up scores, using an external anchor. Results: A total of 437 children were included (268 (61%) males, mean age 12.92.6 years). To define remission, a composite definition of 10 points or 7.5 points without the height item had the highest accuracy; this addressed the limitation that height is not a responsive item. The best cutoff of 10-27.5 was determined for mild disease, 30-37.5 for moderate disease, 40-100 for severe disease, and a change of 12.5 points for response (AUC 0.8-0.9; P>0.001). Ninety children whose disease remained unchanged showed fair test-retest reliability (intraclass correlation coefficient0.74-0.8; P>0.001). The PCDAI showed good responsiveness, as reflected from the correlational (r0.7; P>0.001), distributional (Guyatt's responsiveness statistics0.9), and diagnostic utility analysis (AUC 0.85 (95% confidence interval 0.81-0.88). Conclusions: The clinimetric properties of the PCDAI are sufficient to support its use in clinical research. Cutoff values suggested by this study differ slightly from those previously published on much smaller cohorts.

Original languageEnglish
Pages (from-to)2085-2092
Number of pages8
JournalAmerican Journal of Gastroenterology
Volume105
Issue number9
DOIs
StatePublished - Sep 2010

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Area Under Curve
Reproducibility of Results
Budesonide
Inflammatory Bowel Diseases
Registries
Outcome Assessment (Health Care)
Pediatric Crohn's disease
Datasets
Clinical Trials
Confidence Intervals
Physicians
Growth
Research

ASJC Scopus subject areas

  • Gastroenterology
  • Medicine(all)

Cite this

Appraisal of the pediatric crohn's disease activity index on four prospectively collected datasets : Recommended cutoff values and clinimetric properties. / Turner, Dan; Griffiths, Anne M.; Walters, Thomas D.; Seah, Tong; Markowitz, James; Pfefferkorn, Marian; Keljo, David; Otley, Anthony; Leleiko, Neal S.; MacK, David; Hyams, Jeffrey; Levine, Arie.

In: American Journal of Gastroenterology, Vol. 105, No. 9, 09.2010, p. 2085-2092.

Research output: Contribution to journalArticle

Turner, D, Griffiths, AM, Walters, TD, Seah, T, Markowitz, J, Pfefferkorn, M, Keljo, D, Otley, A, Leleiko, NS, MacK, D, Hyams, J & Levine, A 2010, 'Appraisal of the pediatric crohn's disease activity index on four prospectively collected datasets: Recommended cutoff values and clinimetric properties', American Journal of Gastroenterology, vol. 105, no. 9, pp. 2085-2092. https://doi.org/10.1038/ajg.2010.143
Turner, Dan ; Griffiths, Anne M. ; Walters, Thomas D. ; Seah, Tong ; Markowitz, James ; Pfefferkorn, Marian ; Keljo, David ; Otley, Anthony ; Leleiko, Neal S. ; MacK, David ; Hyams, Jeffrey ; Levine, Arie. / Appraisal of the pediatric crohn's disease activity index on four prospectively collected datasets : Recommended cutoff values and clinimetric properties. In: American Journal of Gastroenterology. 2010 ; Vol. 105, No. 9. pp. 2085-2092.
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abstract = "Objectives: The Pediatric Crohn's Disease Activity Index (PCDAI) is the outcome measure of choice in clinical trials of pediatric Crohn's disease. The aim of this study was to provide knowledge on its performance and accuracy of different cutoff scores. Methods: Longitudinal data prospectively generated from four sources were used, including the REACH and budesonide trials, a North-American inflammatory bowel diseases (IBD) registry, and a cohort aimed at evaluating growth. Cutoff values of disease activity were determined by physician global assessment from the pooled cohort using serial receiver operator characteristic curves and area under the curve (AUC) as well as comparing the overall accuracy. Test-retest reliability and responsiveness were ascertained by comparing the baseline and follow-up scores, using an external anchor. Results: A total of 437 children were included (268 (61{\%}) males, mean age 12.92.6 years). To define remission, a composite definition of 10 points or 7.5 points without the height item had the highest accuracy; this addressed the limitation that height is not a responsive item. The best cutoff of 10-27.5 was determined for mild disease, 30-37.5 for moderate disease, 40-100 for severe disease, and a change of 12.5 points for response (AUC 0.8-0.9; P>0.001). Ninety children whose disease remained unchanged showed fair test-retest reliability (intraclass correlation coefficient0.74-0.8; P>0.001). The PCDAI showed good responsiveness, as reflected from the correlational (r0.7; P>0.001), distributional (Guyatt's responsiveness statistics0.9), and diagnostic utility analysis (AUC 0.85 (95{\%} confidence interval 0.81-0.88). Conclusions: The clinimetric properties of the PCDAI are sufficient to support its use in clinical research. Cutoff values suggested by this study differ slightly from those previously published on much smaller cohorts.",
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AU - Markowitz, James

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