Institute for Laboratory Animal Science, Hannover Medical School, Carl Neubergstrasse 1, 30625, Hannover, Germany.
Department of Animals in Science and Society, Utrecht University, Yalelaan 2, Utrecht, 3584 CM, the Netherlands.
Syst Rev. 2024 Sep 7;13(1):230. doi: 10.1186/s13643-024-02650-w.
While undisputedly important, and part of any systematic review (SR) by definition, evaluation of the risk of bias within the included studies is one of the most time-consuming parts of performing an SR. In this paper, we describe a case study comprising an extensive analysis of risk of bias (RoB) and reporting quality (RQ) assessment from a previously published review (CRD42021236047). It included both animal and human studies, and the included studies compared baseline diseased subjects with controls, assessed the effects of investigational treatments, or both. We compared RoB and RQ between the different types of included primary studies. We also assessed the "informative value" of each of the separate elements for meta-researchers, based on the notion that variation in reporting may be more interesting for the meta-researcher than consistently high/low or reported/non-reported scores. In general, reporting of experimental details was low. This resulted in frequent unclear risk-of-bias scores. We observed this both for animal and for human studies and both for disease-control comparisons and investigations of experimental treatments. Plots and explorative chi-square tests showed that reporting was slightly better for human studies of investigational treatments than for the other study types. With the evidence reported as is, risk-of-bias assessments for systematic reviews have low informative value other than repeatedly showing that reporting of experimental details needs to improve in all kinds of in vivo research. Particularly for reviews that do not directly inform treatment decisions, it could be efficient to perform a thorough but partial assessment of the quality of the included studies, either of a random subset of the included publications or of a subset of relatively informative elements, comprising, e.g. ethics evaluation, conflicts of interest statements, study limitations, baseline characteristics, and the unit of analysis. This publication suggests several potential procedures.
虽然评价纳入研究的偏倚风险无疑很重要,且属于任何系统评价(SR)的定义部分,但这也是执行 SR 时最耗时的部分之一。在本文中,我们描述了一个案例研究,该研究对之前发表的一篇综述(CRD42021236047)进行了广泛的偏倚风险(RoB)和报告质量(RQ)评估分析。该综述纳入了动物和人类研究,纳入的研究比较了基础疾病患者与对照组、评估了研究性治疗的效果,或同时比较了两者。我们比较了不同类型的主要研究的 RoB 和 RQ。我们还根据报告中的差异可能对元研究人员更具研究价值的观点,基于单独元素对元研究人员的“信息价值”进行了评估,而不是一贯的高/低或报告/未报告评分。一般来说,实验细节的报告都很低。这导致了频繁出现不明确的偏倚风险评分。我们观察到这种情况在动物和人类研究中都存在,无论是疾病对照比较还是实验治疗的研究。图和探索性卡方检验表明,与其他研究类型相比,研究性治疗的人类研究的报告情况稍好。按照现有证据报告,除了反复表明所有类型的体内研究都需要改进实验细节的报告外,系统评价的偏倚风险评估信息价值较低。对于那些不直接影响治疗决策的综述,对纳入研究的质量进行全面但部分评估可能是有效的,无论是对纳入出版物的随机子集进行评估,还是对相对有信息价值的子集进行评估,这些子集可以包括伦理评估、利益冲突声明、研究局限性、基线特征和分析单位等。本文提出了几种潜在的方法。