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Randomized controlled trials in pediatric urology: room for improvement
Blayne Welk1, Kourosh Afshar, Andrew E MacNeily
1Department of Surgery, Division of Pediatric Urology, University of British Columbia, Vancouver, BC, Canada.
The Journal of Urology
|June 7, 2006
Summary
Randomized controlled trials (RCTs) are rare in pediatric urology literature, making up less than 1% of published studies. The quality of these few RCTs is generally low, indicating a need for more well-designed research in the field.
Area of Science:
- Pediatric Urology Research
- Clinical Trial Methodology
Background:
- The body of published literature in pediatric urology is extensive.
- Randomized controlled trials (RCTs) are considered the gold standard for clinical research.
- The representation and quality of RCTs in pediatric urology are not well-defined.
Purpose of the Study:
- To determine the proportion of pediatric urology literature that comprises RCTs.
- To assess the methodological quality of identified RCTs in pediatric urology.
Main Methods:
- Systematic searches of MEDLINE and EMBASE databases (1966–2004) were performed.
- Identified RCTs were reviewed for demographic, methodological, and statistical characteristics.
- Trial quality was evaluated using the Jadad scale.
Main Results:
- Only 77 RCTs were identified, representing 0.4%–0.9% of the pediatric urology literature.
- The majority of RCTs originated from Europe (40%) and North America (26%).
- Trials were generally of low to fair quality (median Jadad score 3), with no significant improvement over time. Higher quality was associated with European/North American origin and negative results.
Conclusions:
- RCTs form a small fraction of the pediatric urology literature.
- High-quality RCTs in this field are infrequent.
- There is a need to increase the number and quality of well-designed RCTs in pediatric urology.