Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews

Two systematic reviews conducted to build the evidence base for the development of pediatric reporting guideline extensions: 1) SPIRIT-Children (SPIRIT-C) for pediatric trial protocols and 2) CONSORT-Children (CONSORT-C) for pediatric trial reports. MEDLINE, the Cochrane Methodology Register, and reference lists of the included studies were searched. Publications of any type were eligible if they included explicit recommendations or empirical evidence for the reporting of potential items in a pediatric protocol (for the SPIRIT-C systematic review) or trial report (for the CONSORT-C systematic review). Recommendations, evidence, and additional characteristics were extracted. Themes in the recommendations and evidence were synthesized. All steps were conducted by two reviewers with discrepancies resolved by a third reviewer.