Department of Neurorehabilitation, Traumatic Brain Injury, Copenhagen University Hospital - Rigshospitalet, Kettegård Alle 30, 2650, Hvidovre, Denmark.
Department of Neuroanaesthesiology, Neuroscience Centre, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Syst Rev. 2022 Jun 4;11(1):114. doi: 10.1186/s13643-022-01987-4.
Adequately conducted systematic reviews with meta-analyses are considered the highest level of evidence and thus directly defines many clinical guidelines. However, the risks of type I and II errors in meta-analyses are substantial. Trial Sequential Analysis is a method for controlling these risks. Erroneous use of the method might lead to research waste or misleading conclusions.
The current protocol describes a systematic review aimed to identify common and major mistakes and errors in the use of Trial Sequential Analysis by evaluating published systematic reviews and meta-analyses that include this method. We plan to include all studies using Trial Sequential Analysis published from January 2018 to January 2022, an estimated 400 to 600 publications. We will search Medical Literature Analysis and Retrieval System Online and the Cochrane Database of Systematic Reviews, including studies with all types of participants, interventions, and outcomes. Two independent reviewers will screen titles and abstracts, include relevant full text articles, extract data from the studies into a predefined checklist, and evaluate the methodological quality of the study using the AMSTAR 2, assessing the methodological quality of the systematic reviews.
This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). The identified mistakes and errors will be published in peer reviewed articles and form the basis of a reviewed guideline for the use of Trial Sequential Analysis. Appropriately controlling for type I and II errors might reduce research waste and improve quality and precision of the evidence that clinical guidelines are based upon.
充分进行的系统评价和荟萃分析被认为是最高级别的证据，因此直接定义了许多临床指南。然而，荟萃分析中 I 类和 II 类错误的风险是很大的。试验序贯分析是一种控制这些风险的方法。错误地使用该方法可能导致研究浪费或产生误导性的结论。
本方案旨在通过评估包含该方法的已发表系统评价和荟萃分析，确定试验序贯分析使用中的常见和主要错误。我们计划纳入 2018 年 1 月至 2022 年 1 月期间发表的所有使用试验序贯分析的研究，预计有 400 至 600 篇出版物。我们将检索医学文献分析与检索系统在线和 Cochrane 系统评价数据库，包括所有类型参与者、干预措施和结局的研究。两名独立的审查员将筛选标题和摘要，纳入相关的全文文章，将研究数据提取到预定义的检查表中，并使用 AMSTAR 2 评估研究的方法学质量，评估系统评价的方法学质量。
本方案遵循系统评价和荟萃分析报告的首选条目（PRISMA-P）。确定的错误和误差将发表在同行评议的文章中，并为试验序贯分析的使用制定审查指南提供基础。适当控制 I 类和 II 类错误可能会减少研究浪费，并提高临床指南所依据的证据的质量和精度。
