Quality of reporting of pediatric randomized control trials: The effectiveness of the consort guidelines
Methods: A cross-sectional study on a random sample of 63 pediatric RCTs published in English in 2009 was conducted. Articles included neonatal and older age trials, and parallel, crossover, cluster, and factorial studies. The main outcome measured was the proportion of studies including each of 11 items taken from the CONSORT statement. The quality of reporting was compared across age groups, trial type, funding source, and whether articles were published in CONSORT endorsing journals.
Results: Interventions most often tested were medications (23/63), followed by lifestyle/counseling (20/63); 52 of the trials were conducted in children older than neonates. There were 46 parallel studies, and 17 were crossover, cluster, or factorial. Quality of reporting was poor: 8 out of the 11 CONSORT items assessed had reporting rates below 50%, with lowest rate being availability of trial protocol. There were no significant differences in quality of reporting by age group or trial type. Studies that report the source of funding were more likely to have higher quality in other aspects of reporting. Articles published in journals that endorsed the CONSORT statement had significantly higher rates of reporting for 5/11 CONSORT items, including randomized in the title, intent to treat analysis, method of random sequence generation, including a participant flow diagram, and trial registration.
Conclusions: Reporting of RCTs in pediatrics in 2009 is of low quality. Articles published in CONSORT endorsing journals are of consistently higher quality; these findings emphasize the need to endorse the CONSORT guidelines to improve reporting of pediatric RCTs.
Learning Areas:Basic medical science applied in public health
Clinical medicine applied in public health
Communication and informatics
Ethics, professional and legal requirements
Planning of health education strategies, interventions, and programs
Provision of health care to the public
Assess the quality of reporting of Randomized Control Trials (RCTs) in pediatrics, and the actual effect the CONSORT statement has had on the quality of reporting of trials in pediatrics. Describe the CONSORT guidelines for reporting Randomized Control Trials
Keyword(s): Pediatrics, Quality Assurance
Qualified on the content I am responsible for because: I have participated in multiple research endeavors at the Florida International University Herbert Wertheim College of Medicine as a principal or co-principal investigator. Among my research interest are community-based participatory research and applied biostatistics.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.