Rosati Paola, Porzsolt Franz, Ricciotti Gabriella, Testa Giuseppina, Inglese Rita, Giustini Ferruccio, Fiscarelli Ersilia, Zazza Marco, Carlino Cecilia, Balassone Valerio, Fiorito Roberto, D'Amico Roberto
G.A.L.I.L.E.O. Gruppo per l'Apprezzamento della Letteratura e l'Implementazione dei Livelli di Evidenza in Ospedale, Bambino Gesù Children's Hospital IRCCS, Rome, 00165, Italy.
Unit of Clinical Epidemiology, Bambino Gesù Children's Hospital IRCCS, Rome, 00165, Italy.
Trials. 2016 Sep 23;17(1):430. doi: 10.1186/s13063-016-1551-6.
Whether information from clinical trial registries (CTRs) and published randomised controlled trial (RCTs) differs remains unknown. Knowing more about discrepancies should alert those who rely on RCTs for medical decision-making to possible dissemination or reporting bias. To provide help in critically appraising research relevant for clinical practice we sought possible discrepancies between what CTRs record and paediatric RCTs actually publish. For this purpose, after identifying six reporting domains including funding, design, and outcomes, we collected data from 20 consecutive RCTs published in a widely read peer-reviewed paediatric journal and cross-checked reported features with those in the corresponding CTRs.
We collected data for 20 unselected, consecutive paediatric RCTs published in a widely read peer-reviewed journal from July to November 2013. To assess discrepancies, two reviewers identified and scored six reporting domains: funding and conflict of interests; sample size, inclusion and exclusion criteria or crossover; primary and secondary outcomes, early study completion, and main outcome reporting. After applying the Critical Appraisal Skills Programme (CASP) checklist, five reviewer pairs cross-checked CTRs and matching RCTs, then mapped and coded the reporting domains and scored combined discrepancy as low, medium and high.
The 20 RCTs were registered in five different CTRs. Even though the 20 RCTs fulfilled the CASP general criteria for assessing internal validity, 19 clinical trials had medium or high combined discrepancy scores for what the 20 RCTs reported and the matched five CTRs stated. All 20 RCTs selectively reported or failed to report main outcomes, 9 had discrepancies in declaring sponsorship, 8 discrepancies in the sample size, 9 failed to respect inclusion or exclusion criteria, 11 downgraded or modified primary outcome or upgraded secondary outcomes, and 13 completed early without justification. The CTRs for seven trials failed to index automatically the URL address or the RCT reference, and for 12 recorded RCT details, but the authors failed to report the results.
Major discrepancies between what CTRs record and paediatric RCTs publish raise concern about what clinical trials conclude. Our findings should make clinicians, who rely on RCT results for medical decision-making, aware of dissemination or reporting bias. Trialists need to bring CTR data and reported protocols into line with published data.
临床试验注册机构（CTRs）提供的信息与已发表的随机对照试验（RCTs）的信息是否存在差异尚不清楚。更多地了解这些差异应能提醒那些依靠RCTs进行医疗决策的人注意可能存在的传播或报告偏倚。为了帮助严格评估与临床实践相关的研究，我们探寻了CTRs记录的内容与儿科RCTs实际发表的内容之间可能存在的差异。为此，在确定了包括资金、设计和结果等六个报告领域后，我们从一份广泛阅读的同行评审儿科期刊上连续发表的20项RCTs中收集了数据，并将报告的特征与相应CTRs中的特征进行了交叉核对。
我们收集了2013年7月至11月在一份广泛阅读的同行评审期刊上发表的20项未经挑选的连续儿科RCTs的数据。为了评估差异，两名评审员确定并对六个报告领域进行了评分：资金和利益冲突；样本量、纳入和排除标准或交叉设计；主要和次要结果、提前完成研究以及主要结果报告。在应用关键评估技能计划（CASP）清单后，五对评审员对CTRs和匹配的RCTs进行了交叉核对，然后对报告领域进行了映射和编码，并将综合差异评为低、中、高。
这20项RCTs在五个不同的CTRs中注册。尽管这20项RCTs符合CASP评估内部有效性的一般标准，但对于这20项RCTs报告的内容与匹配的五个CTRs陈述的内容，19项临床试验的综合差异得分处于中等或较高水平。所有20项RCTs都选择性地报告或未报告主要结果，9项在声明赞助方面存在差异，8项在样本量方面存在差异，9项未遵守纳入或排除标准，11项降低或修改了主要结果或提升了次要结果，13项未经正当理由提前完成。七项试验的CTRs未能自动索引URL地址或RCT参考文献，12项记录了RCT细节，但作者未报告结果。
CTRs记录的内容与儿科RCTs发表的内容之间的重大差异引发了对临床试验结论的担忧。我们的研究结果应使依靠RCT结果进行医疗决策的临床医生意识到传播或报告偏倚。试验者需要使CTR数据和报告的方案与发表的数据保持一致。
