Assessment of the current state of the consideration of specific features of time-to-event analyses in meta-analyses: re-analysis of systematic reviews and implementation of guidance

评估荟萃分析中考虑事件时间分析具体特征的现状：系统评价的重新分析和指南的实施

• 批准号: 437030575
• 负责人: Professorin Dr. Nicole Skoetz
• 金额: --
• 依托单位: Institut für Öffentliches Gesundheitswesen
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2020
• 资助国家: 德国
• 起止时间: 2019-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/437030575?language=en
• 关键词: Assessment; current; state; consideration; specific

The measurement and comparison of event times in clinical research is done by means of time-to-event analysis, so for example in the assessment of overall survival. These analyses are challenging and contain specific methodical features. Their results are therefore not always straight forward to interpret and evaluate. While extensive guidance on time-to-event analysis at the study level and in presence of individual patient data is available, guidance for meta-analyses based on aggregated data, which are increasingly used in systematic reviews and guidelines, is lacking. Moreover, existing guidance is primarily focused on recovering result data to pool effect estimates while leaving the certainty in the included estimators largely untouched. Due to the particular difficulties and features of time-to-event analyses, however, the absence of guidance introduces a considerable threat to the quality of reviews when existing uncertainties are not taken into account or reported adequately. The main objective of this project is to improve the application and reporting of time-to-event meta-analyses sustainably. Therefore, this project includes an assessment of systematic reviews and their included studies to elicit how review authors currently deal with existing problems in primary studies when conducting time-to-event meta-analyses and deriving conclusions. This will then form a basis for future improvement efforts. For this purpose, the effect estimates and characteristics of time-to-event analyses from primary studies included in time-to-event meta-analyses of eligible systematic reviews will be examined. This then allows to evaluate whether and how the review authors consider methodological features and existing problems in their systematic reviews. The assessment will include, amongst other things, a re-analysis of the included time-to-event meta-analyses. In order to actively improve the quality of systematic reviews and to avoid future mistakes, the results of the systematic assessment will then be used to inform the development of targeted guidance materials. To enhance the user friendly design of the guidance, the development process will include multiple consultation rounds with review authors and guideline developers. The findings of this project are intended to provide a foundation for future initiatives that aim to improve and strengthen the quality of systematic reviews and guidelines which include time-to-event meta-analyses.

在临床研究中，事件时间的测量和比较是通过时间到事件的分析来完成的，例如在评估总生存率时。这些分析具有挑战性，并包含具体的方法特征。因此，他们的结果并不总是直截了当的解释和评估。虽然在研究水平和存在个体患者数据的情况下，对事件时间分析的广泛指导是可用的，但在系统评价和指南中越来越多地使用的基于汇总数据的荟萃分析的指导是缺乏的。此外，现有的指导主要侧重于恢复结果数据以汇集效应估计，而在很大程度上不影响所包括估计器的确定性。但是，由于时间对事件分析的特殊困难和特点，当没有充分考虑或报告现有的不确定性时，缺乏指导会对审查的质量造成相当大的威胁。该项目的主要目标是可持续地改进时间-事件荟萃分析的应用和报告。因此，本项目包括对系统综述及其纳入的研究的评估，以引出综述作者在进行事件时间荟萃分析和得出结论时如何处理主要研究中存在的问题。这将为今后的改进工作奠定基础。为此目的，将对纳入符合条件的系统评价的事件发生时间荟萃分析的主要研究的效应估计和事件发生时间分析的特征进行检查。这样就可以评估综述作者是否以及如何在他们的系统综述中考虑方法学特征和存在的问题。除其他事项外，评估将包括对所包括的事件时间元分析的重新分析。为了积极提高系统评估的质量，避免未来的错误，系统评估的结果将被用于有针对性的指导材料的制定。为了加强指南的用户友好设计，开发过程将包括与评审作者和指南开发者进行多轮咨询。本项目的研究结果旨在为未来旨在改善和加强包括事件时间元分析在内的系统审查和指南质量的举措提供基础。