The First Clinical Medical College of Lanzhou University, Lanzhou 730000, China; Evidence-Based Medicine Center, School of Basic Medical Sciences of Lanzhou University, Lanzhou 730000, China; Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, China.
Evidence-Based Medicine Center, School of Basic Medical Sciences of Lanzhou University, Lanzhou 730000, China; Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, China.
J Clin Epidemiol. 2018 Jan;93:45-55. doi: 10.1016/j.jclinepi.2017.10.012. Epub 2017 Oct 31.
The aim of this study was to investigate the differences in main characteristics, reporting and methodological quality between prospectively registered and nonregistered systematic reviews.
PubMed was searched to identify systematic reviews of randomized controlled trials published in 2015 in English. After title and abstract screening, potentially relevant reviews were divided into three groups: registered non-Cochrane reviews, Cochrane reviews, and nonregistered reviews. For each group, random number tables were generated in Microsoft Excel, and the first 50 eligible studies from each group were randomly selected. Data of interest from systematic reviews were extracted. Regression analyses were conducted to explore the association between total Revised Assessment of Multiple Systematic Review (R-AMSTAR) or Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) scores and the selected characteristics of systematic reviews.
The conducting and reporting of literature search in registered reviews were superior to nonregistered reviews. Differences in 9 of the 11 R-AMSTAR items were statistically significant between registered and nonregistered reviews. The total R-AMSTAR score of registered reviews was higher than nonregistered reviews [mean difference (MD) = 4.82, 95% confidence interval (CI): 3.70, 5.94]. Sensitivity analysis by excluding the registration-related item presented similar result (MD = 4.34, 95% CI: 3.28, 5.40). Total PRISMA scores of registered reviews were significantly higher than nonregistered reviews (all reviews: MD = 1.47, 95% CI: 0.64-2.30; non-Cochrane reviews: MD = 1.49, 95% CI: 0.56-2.42). However, the difference in the total PRISMA score was no longer statistically significant after excluding the item related to registration (item 5). Regression analyses showed similar results.
Prospective registration may at least indirectly improve the overall methodological quality of systematic reviews, although its impact on the overall reporting quality was not significant.
本研究旨在探讨预先注册和未注册的系统评价在主要特征、报告和方法学质量方面的差异。
在 PubMed 上搜索 2015 年发表的以英文撰写的随机对照试验系统评价。在标题和摘要筛选后，将潜在相关的综述分为三组：注册非 Cochrane 综述、Cochrane 综述和未注册综述。对于每组，在 Microsoft Excel 中生成随机数表，并从每组中随机选择前 50 项合格研究。从系统评价中提取感兴趣的数据。回归分析用于探索总修订评估多个系统评价（R-AMSTAR）或系统评价和荟萃分析报告的首选项目（PRISMA）评分与系统评价的选择特征之间的关联。
注册综述在文献检索的进行和报告方面优于未注册综述。在 11 项 R-AMSTAR 项目中有 9 项在注册和未注册综述之间存在统计学差异。注册综述的总 R-AMSTAR 评分高于未注册综述[平均差异（MD）=4.82，95%置信区间（CI）：3.70，5.94]。排除与注册相关的项目的敏感性分析得出了类似的结果（MD=4.34，95%CI：3.28，5.40）。注册综述的总 PRISMA 评分明显高于未注册综述（所有综述：MD=1.47，95%CI：0.64-2.30；非 Cochrane 综述：MD=1.49，95%CI：0.56-2.42）。然而，在排除与注册相关的项目（项目 5）后，总 PRISMA 评分的差异不再具有统计学意义。回归分析显示了类似的结果。
前瞻性注册至少可以间接提高系统评价的整体方法学质量，尽管其对整体报告质量的影响并不显著。
