Completeness of Reporting in Randomized Controlled Trials of 3 Vaccines

Abstract

Clear reporting of randomized controlled trials (RCTs) of vaccines is important for understanding results and assessing their validity. The CONsolidated Standards of Reporting Trials (CONSORT) statement provides guidance to help authors reporting RCTs. The objective was to assess the completeness of reporting of RCTs of vaccines based on the CONSORT 2010 checklist. We collected data about items required by the CONSORT checklist or specific to trials of vaccines. We used publications of RCTs identified in 3 systematic reviews of pneumococcal polysaccharide, pneumococcal conjugate and rotavirus vaccines. We included the first journal publication that reported clinical, carriage or immunological data for each trial and summarized results descriptively. We included 70 publications from 19 journals. Of these, 14 publications (20%) stated in the title that the trial was randomized and 26 publications (37%) nominated at least 1 primary outcome. The method for generating the random allocation sequence was fully reported in 24 publications (34%), the method of allocation concealment in 9 publications (13%) and 30 publications (43%) included a flow diagram. Trial registration numbers were reported in all articles published in 2010 to 2011. Actual age at vaccination was reported in 20% of trials of childhood schedules. Eleven of 19 journals endorsed the CONSORT statement. The reporting of RCTs of vaccines is incomplete, with important methodological details missing from most reports. Journals could play a leading role in implementing changes. Improved reporting would make publications of vaccine trials easier to find, the findings easier to interpret and aid the incorporation of findings into policy.