Chinese Evidence-based Medicine Center and Cochrane China Center, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.
NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China.
BMC Med Res Methodol. 2022 Jan 7;22(1):6. doi: 10.1186/s12874-021-01482-9.
In recent years, studies that used routinely collected data (RCD), such as electronic medical records and administrative claims, for exploring drug treatment effects, including effectiveness and safety, have been increasingly published. Abstracts of such studies represent a highly attended source for busy clinicians or policy-makers, and are important for indexing by literature database. If less clearly presented, they may mislead decisions or indexing. We thus conducted a cross-sectional survey to systematically examine how the abstracts of such studies were reported.
We searched PubMed to identify all observational studies published in 2018 that used RCD for assessing drug treatment effects. Teams of methods-trained collected data from eligible studies using pilot-tested, standardized forms that were developed and expanded from "The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology" (RECORD-PE) statement. We used descriptive analyses to examine how authors reported data source, study design, data analysis, and interpretation of findings.
A total of 222 studies were included, of which 118 (53.2%) reported type of database used, 17 (7.7%) clearly reported database linkage, and 140 (63.1%) reported coverage of data source. Only 44 (19.8%) studies stated a predefined hypothesis, 127 (57.2%) reported study design, 140 (63.1%) reported statistical models used, 142 (77.6%) reported adjusted estimates, 33 (14.9%) mentioned sensitivity analyses, and 39 (17.6%) made a strong claim about treatment effect. Studies published in top 5 general medicine journals were more likely to report the name of data source (94.7% vs. 67.0%) and study design (100% vs. 53.2%) than those in other journals.
The under-reporting of key methodological features in abstracts of RCD studies was common, which would substantially compromise the indexing of this type of literature and prevent the effective use of study findings. Substantial efforts to improve the reporting of abstracts in these studies are highly warranted.
近年来，越来越多的研究使用常规收集数据（RCD），如电子病历和行政索赔，来探索药物治疗效果，包括有效性和安全性。此类研究的摘要代表了忙碌的临床医生或决策者高度关注的来源，对于文献数据库的索引也很重要。如果呈现得不够清晰，可能会误导决策或索引。因此，我们进行了一项横断面调查，系统地检查了这些研究摘要的报告方式。
我们在 PubMed 中搜索了 2018 年发表的所有使用 RCD 评估药物治疗效果的观察性研究。经过培训的方法团队使用经过试验验证、标准化的表格从“用于药物流行病学的观察性常规收集健康数据研究报告声明（RECORD-PE）”中收集合格研究的数据。我们使用描述性分析来检查作者如何报告数据来源、研究设计、数据分析和结果解释。
共纳入 222 项研究，其中 118 项（53.2%）报告了使用的数据库类型，17 项（7.7%）明确报告了数据库链接，140 项（63.1%）报告了数据源的覆盖范围。只有 44 项（19.8%）研究陈述了预设假设，127 项（57.2%）报告了研究设计，140 项（63.1%）报告了使用的统计模型，142 项（77.6%）报告了调整后的估计值，33 项（14.9%）提到了敏感性分析，39 项（17.6%）对治疗效果做出了强烈的结论。发表在顶级 5 本普通医学期刊上的研究比发表在其他期刊上的研究更有可能报告数据源名称（94.7% vs. 67.0%）和研究设计（100% vs. 53.2%）。
RCD 研究摘要中关键方法学特征的报告不足较为常见，这将极大地影响此类文献的索引，并阻碍研究结果的有效利用。非常有必要大力改进这类研究摘要的报告。
