PDF(Pubmed)
Abstract：
Evidence synthesis serves an important role to promote informed decision-making in healthcare practice. A key issue of evidence synthesis is the approach to deal with rare adverse events and the methods to address bias of harm effects. Empirical data is essential to help methodologists and statisticians to solve the issues in evidence synthesis of adverse events. For this reason, we have established SMART Safety dataset, the largest empirical dataset of meta-analyses of adverse events. The dataset contains 151 systematic reviews with 629 meta-analyses on safety outcomes, which covers more than 2,300 randomized controlled trials and 362 harm outcomes, with 10,069 rows and 45 columns of trial level information. All information was double- or even quadra-checked and further verified by referring the original source (e.g., the full-text of the included randomized trials) to ensure high validity of the data.
摘要：
证据综合在促进医疗保健实践中的明智决策方面发挥着重要作用。证据综合的一个关键问题是处理罕见不良事件的方法和解决伤害影响偏差的方法。经验数据对于帮助方法学家和统计学家解决不良事件证据综合问题至关重要。出于这个原因,我们建立了智能安全数据集，不良事件荟萃分析的最大经验数据集。该数据集包含151个系统评价和629个关于安全性结果的荟萃分析，涵盖超过2300项随机对照试验和362项危害结果，包含10069行和45列的试用级别信息。所有信息都经过双重甚至四度检查，并通过引用原始来源进一步验证(例如，纳入的随机试验的全文），以确保数据的高有效性。
