Randomized Controlled Trials in Pediatric Urology: Room for Improvement

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Abstract
The primary purpose of this study was to ascertain what proportion of the body of published literature in pediatric urology is represented by randomized controlled trials. The secondary purpose was to assess the quality of these trials. Using a predefined strategy, we conducted systematic computerized searches of the MEDLINE (years 1966 to 2004) and EMBASE (1980 to 2004) databases to identify all English language randomized controlled trials related to pediatric urology. Full text versions of identified studies were reviewed in blinded fashion for key demographic, methodological and statistical characteristics. Trial quality was assessed with the previously validated Jadad tool. The 77 identified randomized controlled trials represented only 0.4% to 0.9% of the indexed pediatric urology literature. The origins of these trials were Europe (40%), North America (26%) and a variety of other geographic centers (34%). A primarily surgical focus was present in 43% of the studies. Trials with negative results represented only 19% of the total randomized controlled trials. Generally, the trials were of low to fair quality (median Jadad score 3), with substandard methodological reporting and planning. There was not a significant trend toward improved quality in recent years. Trials from North America and Europe had higher quality (p = 0.007), as did those reporting negative results (p = 0.0001). Randomized controlled trials in pediatric urology constitute only a small proportion of the body of published literature in the field. High quality studies are uncommon. Efforts should be made to increase the number of well designed, randomized controlled trials in pediatric urology.