Mickenautsch Steffen, Rupf Stefan, Yengopal Veerasamy
Faculty of Dentistry, University of the Western Cape, Cape Town, South Africa.
Department of Community Dentistry, School of Oral Health Sciences, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Front Med (Lausanne). 2023 Jun 28;10:1201951. doi: 10.3389/fmed.2023.1201951. eCollection 2023.
Systematic reviews of prospective controlled clinical therapy trials are one of the most important sources of information in modern medicine. Besides the systematic search for and statistical pooling of current clinical trial data for a particular type of therapy, systematic reviews also have the task of appraising the quality of trial results. The quality of trial results may be diminished by low internal trial validity, due to systematic error (bias). A high risk of bias may likely cause the reported trial results to be diverted from the actual true therapeutic effect and thus render it unsuitable for clinical guidance. According to the Cochrane Collaboration, the risk of bias in clinical therapy trials should be assessed using its Risk of Bias tool, Version 2 (RoB 2). However, the tool has been established to have poor inter-rater reliability, with a limited empirical evidence base and described as complex and demanding. Against this background, the composite quality score (CQS) has been developed as a possible alternative trial appraisal tool, characterised by high epistemic rigour, empirical evidence base, inter-rater reliability and ease of use. This article presents the current evidence of the CQS and its limitations.
前瞻性对照临床治疗试验的系统评价是现代医学中最重要的信息来源之一。除了系统检索和统计汇总特定类型治疗的当前临床试验数据外，系统评价还承担着评估试验结果质量的任务。由于系统误差（偏倚）导致试验内部效度较低，可能会降低试验结果的质量。高偏倚风险可能会使报告的试验结果偏离实际的真实治疗效果，从而使其不适用于临床指导。根据Cochrane协作网的说法，应使用其偏倚风险工具第2版（RoB 2）评估临床治疗试验中的偏倚风险。然而，该工具已被证实具有评分者间信度较差、实证证据基础有限的问题，且被描述为复杂且要求较高。在此背景下，综合质量评分（CQS）已被开发出来，作为一种可能的替代试验评估工具，其特点是具有高度的认知严谨性、实证证据基础、评分者间信度和易用性。本文介绍了CQS的当前证据及其局限性。
