A quality assessment of randomized clinical trials in pediatric orthopaedics.

The promotion and practice of evidence-based medicine necessitates a critical evaluation of medical literature, including the criterion standard of randomized clinical trials (RCTs). Recent studies have examined the quality of RCTs in various surgical specialties, but no study has focused on pediatric orthopaedics. The purpose of this study was to assess and describe the quality of RCTs published in the last 10 years in journals with high clinical impact in pediatric orthopaedics. All of the RCTs in pediatric orthopaedics published in 5 well-recognized journals between 1995 and 2005 were reviewed using the Detsky Quality Assessment Scale. The mean percentage score on the Detsky scale was 53% (95% confidence interval, 46%-60%). Only 7 (19%) of the articles satisfied the threshold for a satisfactory level of methodological quality (Detsky >75%). Most RCTs in pediatric orthopaedics that are published in well-recognized peer-reviewed journals demonstrate substantial deficiencies in methodological quality. Particular areas of weakness include inadequate rigor and reporting of randomization methods, use of inappropriate or poorly described outcome measures, inadequate description of inclusion and exclusion criteria, and inappropriate statistical analysis. Further efforts are necessary to improve the conduct and reporting of clinical trials in this field to avoid inadvertent misinformation of the clinical community.