Faculty of Dentistry, University of the Western Cape, Tygerberg, Cape Town, South Africa.
Department of Community Dentistry, School of Oral Health Sciences, Faculty of Health Sciences, University of the Witwatersrand, Parktown, Johannesburg, South Africa.
PLoS One. 2022 Dec 30;17(12):e0279645. doi: 10.1371/journal.pone.0279645. eCollection 2022.
To conduct a survey of current meta-epidemiological studies to identify additional trial design characteristics that may be associated with significant over- or underestimation of the treatment effect and to use such identified characteristics as a basis for the formulation of new CQS appraisal criteria.
We retrieved eligible studies from two systematic reviews on this topic (latest search May 2015) and searched the databases PubMed and Embase for further studies from June 2015 -March 2022. All data were extracted by one author and verified by another. Sufficiently homogeneous estimates from single studies were pooled using random-effects meta-analysis. Trial design characteristics associated with statistically significant estimates from single datasets (which could not be pooled) and meta-analyses were used as a basis to formulate new or amend existing CQS criteria.
A total of 38 meta-epidemiological studies were identified. From these, seven trial design characteristics associated with statistically significant over- or underestimation of the true therapeutic effect were found.
One new criterion concerning double-blinding was added to the CQS, and the original criteria for concealing the random allocation sequence and for minimum sample size were amended.
对当前的荟萃流行病学研究进行调查，以确定可能与治疗效果过高或过低估计相关的其他试验设计特征，并将这些确定的特征作为制定新的 CQS 评估标准的基础。
我们从关于这个主题的两项系统评价中检索了合格的研究（最新检索日期为 2015 年 5 月），并从 2015 年 6 月至 2022 年 3 月在 PubMed 和 Embase 数据库中搜索了其他研究。所有数据均由一名作者提取，另一名作者进行验证。来自单个研究的足够同质的估计值使用随机效应荟萃分析进行了汇总。将与单个数据集（无法汇总）和荟萃分析的统计学显著估计值相关的试验设计特征作为制定新的或修订现有的 CQS 标准的基础。
共确定了 38 项荟萃流行病学研究。从中发现了 7 个与治疗效果的真实估计过高或过低显著相关的试验设计特征。
在 CQS 中增加了一个关于双盲的新标准，并修订了原始的随机分组序列隐藏和最小样本量标准。
