title: Systematic review of randomized controlled trial quality in pediatric kidney transplantation.
abstract: Limited pediatric-specific research can lead to sub-standard evidence for clinical decision making in children. We sought to systematically evaluate the methodological quality and the reporting standards of randomized controlled trials (RCTs) of transplantation trials in children. We included RCTs of kidney transplant recipients that had enrolled at least one child (aged 17 years or less) and that were reported in English language, peer reviewed journals from 2000 onward in the Cochrane Renal Group's specialized register. Trial reports were assessed against the 22 item checklist of the CONsolidated Standards Of Reporting Trials (CONSORT) statement. Twenty-seven RCTs were included. The reporting of the essential components of the methods, results and discussion domains was unsatisfactory. Mean CONSORT criteria score for the pediatric trials was 67% and 66% for trials including both adults and children (p value for the difference = 1.00). Trial reporting quality in pediatric transplantation trials is not different from trials involving adults. It is evident that the reporting standards of RCTs in both adult and pediatric transplantation require major improvements. This work bench-marks current standards for future quality improvement.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Brooks
authors.forename: Gail Y
authors.initials: GY
authors.lastname: Higgins
authors.forename: Angela C
authors.initials: AC
authors.lastname: Webster
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D019317:Evidence-Based Medicine; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007223:Infant; D016030:Kidney Transplantation; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents