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US estimates of hospitalized pediatric patients with ulcerative colitis: implications for multicenter clinical
Stephen L Guthery1, Lydia Dong, J Michael Dean
1Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA. Stephen.Guthery@hsc.utah.edu
Insights
Half of hospitalized pediatric ulcerative colitis (UC) patients are treated at high-volume centers. Approximately 5 such centers are sufficient for clinical trials in refractory UC.
Area of Science:
- Pediatric Gastroenterology
- Clinical Research Epidemiology
Background:
- Optimal clinical management for pediatric ulcerative colitis (UC) is evolving.
- Limited data exists on the number of US children hospitalized with UC.
- The Kids' Inpatient Database (KID) was analyzed to address this gap.
Purpose of the Study:
- To estimate the distribution of hospitalized pediatric UC patients in the US.
- To determine the number of high-volume hospitals treating these patients.
- To assess sample sizes for clinical research in pediatric UC.
Main Methods:
- Analysis of the 2003 Kids' Inpatient Database (KID).
- Inclusion of subjects under 18 years old with ICD-9 codes for UC (556.0-556.9).
- Colectomy defined by procedure code 45.8; weighted estimates generated; simulation studies performed.
Main Results:
- 2311 UC cases identified; mean age 13.1 years; 9% underwent colectomy.
- 1008 UC cases treated at high-volume hospitals, primarily children's hospitals.
- Simulations indicated ~5 high-volume hospitals needed for refractory UC pilot trials.
Conclusions:
- Nearly half of hospitalized pediatric UC patients are treated at a few high-volume centers.
- Approximately 5 high-volume centers are adequate for pilot clinical trials in hospitalized refractory UC patients.
Background:
The optimal clinical management of children hospitalized with ulcerative colitis (UC) is evolving. There are limited data quantifying the number of pediatric patients with UC admitted to hospitals in the United States. We analyzed the Kids' Inpatient Database (KID, 2003), to estimate the distribution of hospitalized children with UC and estimate sample sizes available for clinical research.
Methods:
We limited our analysis to subjects age less than 18 years. We defined cases of UC as discharge records associated with an ICD-9 code of 556.0-556.9 in the first position. We defined colectomy as principal procedure code of 45.8. We generated weighted estimates for these analyses. To estimate the relationship between number of patients and number of hospitals necessary for clinical trials, we generated 1000 simulated datasets.
Results:
A total of 2311 UC cases were identified. The mean age at admission was 13.1 (standard error [SE] 0.1) years, and 9% (SE 0.9%) underwent colectomy during their hospitalization. 1008 UC cases were treated at high-volume hospitals; the majority of these children were treated at children's hospitals. Simulation studies suggest that approximately 5 high-volume hospitals would be necessary to generate sample sizes necessary for a pilot clinical trial of refractory UC.
Conclusions:
Approximately half of all young patients hospitalized with UC in the US were treated at a limited number of high-volume hospitals, and approximately 5 such centers would be adequate for pilot clinical trials of hospitalized patients with refractory UC.
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