Clinical–alimentary tractDevelopment, Validation, and Evaluation of a Pediatric Ulcerative Colitis Activity Index: A Prospective Multicenter Study
Section snippets
Study Design and Overview
A Delphi group of pediatric IBD experts was established to aid with item generation, reduction, and gradation. A Delphi technique involves an iterative, multistep process to reach a consensus for a specified question, when the experts are not physically together. The responses of all members of the Delphi group are summarized by an expert panel, processed, and resent to the group for further comments until consensus is reached. Between November 2005 and November 2006, 2 separate prospective
Item Generation, Reduction, and Grading
Of the 48 pediatric IBD experts contacted, 36 responded and served as the Delphi group. A list of 21 potential items was generated by the expert panel, and the Delphi group added another 20. Eleven variables, which were ranked significantly higher than the others, were graded by the Delphi group from 1, important, to 11, least important (Table 1). One item, “rectal urgency,” was removed because of perceived difficulties in applying this variable to young children. C-reactive protein (CRP),
Discussion
We have developed a novel multiitem UC activity index for pediatric patients. The large Delphi group and the multicenter enrollment serve to enhance its content and face validity. The use of the PGA as the outcome measure39 judged by multiple pediatric IBD experts provided a good average estimate of disease activity for the weighting. There are multiple precedents for utilizing the PGA in this way. It has been used to weight the items of the widely accepted CDAI3 and to validate the Pediatric
References (56)
Specificities of inflammatory bowel disease in childhood
Best Pract Res Clin Gastroenterol
(2004)- et al.
Development of a Crohn’s disease activity indexNational Cooperative Crohn’s Disease Study
Gastroenterology
(1976) - et al.
Preliminary report: cyclosporin in treatment of severe active ulcerative colitis
Lancet
(1990) - et al.
A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis
Gastroenterology
(2007) - et al.
A methodological framework for assessing health indices
J Chronic Dis
(1985) - et al.
Definitions of inflammatory bowel disease of unknown etiology
Gastroenterology
(1975) - et al.
Clinimetric and psychometric strategies for development of a health measurement scale
J Clin Epidemiol
(1999) - et al.
How should importance and severity ratings be combined for item reduction in the development of health status instruments?
J Clin Epidemiol
(1999) - et al.
A comparative contrast of clinimetric and psychometric methods for constructing indexes and rating scales
J Clin Epidemiol
(1992) - et al.
Responsiveness and validity in health status measurement: a clarification
J Clin Epidemiol
(1989)
A critical look at transition ratings
J Clin Epidemiol
Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance
J Chronic Dis
Measuring change over time: assessing the usefulness of evaluative instruments
J Chronic Dis
Correlation between endoscopic severity and the clinical activity index in ulcerative colitis
Am J Gastroenterol
Relative responsiveness of condition-specific and generic health status measures in degenerative lumbar spinal stenosis
J Clin Epidemiol
A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn’s disease
Gastroenterology
Optimal Crohn’s Disease Activity Index (CDAI) response criteria is defined by decrease >100 points (abstr)
Gastroenterology
Severe colitis in children and adolescents: diagnosis: course and treatment
Gastroenterology
Biological therapies for ulcerative colitis
Acta Gastroenterol Belg
An index of disease activity in patients with ulcerative colitis
Am J Gastroenterol
Cortisone in ulcerative colitis; final report on a therapeutic trial
Br Med J
Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial
BMJ
Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitisA randomized study
N Engl J Med
A comparison of oral prednisolone given as single or multiple daily doses for active proctocolitis
Scand J Gastroenterol
A simple clinical colitis activity index
Gut
Proposal of a new clinical index predictive of endoscopic severity in ulcerative colitis
Dig Dis Sci
Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: Report of a Working Party of the 2005 Montreal World Congress of Gastroenterology
Can J Gastroenterol
Endoscopic assessment of the colonic response to corticosteroids in children with ulcerative colitis
J Pediatr Gastroenterol Nutr
Cited by (0)
Supported by a research fellowship stipend (to D.T.) from the Canadian Institute of Health Research/Canadian Association of Gastroenterology/Crohn’s and Colitis Foundation of Canada.
The authors thank the pediatric IBD experts who participated in the Delphi process.
Conflict of interest: None.
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D.T. is the recipient of a postgraduate award, University of Toronto.