Divisions of Clinical Epidemiology and Biostatistics and International and Environmental Health, Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.
Pediatr Infect Dis J. 2012 Dec;31(12):1286-94. doi: 10.1097/INF.0b013e31827032bb.
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.
清晰报告疫苗的随机对照试验（RCT）对于理解结果和评估其有效性非常重要。CONsolidated Standards of Reporting Trials（CONSORT）声明提供了帮助作者报告 RCT 的指导。目的是根据 CONSORT 2010 清单评估疫苗 RCT 的报告完整性。
我们收集了 CONSORT 清单要求的项目或专门针对疫苗试验的项目的数据。我们使用了 3 项关于肺炎球菌多糖、肺炎球菌结合疫苗和轮状病毒疫苗的系统评价中确定的 RCT 出版物。我们纳入了报告每个试验的临床、携带或免疫数据的首个期刊出版物，并进行了描述性总结。
我们纳入了来自 19 种期刊的 70 篇出版物。其中，14 篇出版物（20%）在标题中说明试验是随机的，26 篇出版物（37%）至少提名了 1 个主要结局。24 篇出版物（34%）全面报告了随机分配序列的生成方法，9 篇出版物（13%）报告了分配隐藏方法，30 篇出版物（43%）包含了流程图。2010 年至 2011 年发表的所有文章都报告了试验注册号码。儿童接种计划中有 20%的试验报告了实际接种年龄。19 种期刊中有 11 种支持 CONSORT 声明。
疫苗 RCT 的报告不完整，大多数报告都缺少重要的方法学细节。期刊可以在实施变革方面发挥主导作用。改进报告将使疫苗试验的出版物更容易找到，发现更容易解释，并有助于将发现纳入政策。
