ICON Health Economics and Epidemiology, ICON Health Economics, Abingdon, UK.
J Eval Clin Pract. 2019 Feb;25(1):44-52. doi: 10.1111/jep.12889. Epub 2018 Feb 27.
RATIONALE, AIMS, AND OBJECTIVES: When randomized controlled trial data are limited or unavailable, or to supplement randomized controlled trial evidence, health technology assessment (HTA) agencies may rely on systematic reviews of nonrandomized studies (NRSs) for evidence of the effectiveness of health care interventions. NRS designs may introduce considerable bias into systematic reviews, and several methodologies by which to evaluate this risk of bias are available. This study aimed to identify tools commonly used to assess bias in NRS and determine those recommended by HTA bodies.
Appraisal tools used in NRS were identified through a targeted search of systematic reviews (January 2013-March 2017; MEDLINE and EMBASE [OVID SP]). Recommendations for the critical appraisal of NRS by expert review groups and HTA bodies were reviewed.
From the 686 studies included in the narrative synthesis, 48 critical appraisal tools were identified. Commonly used tools included the Newcastle-Ottawa Scale, the methodological index for NRS, and bespoke appraisal tools. Neither the Cochrane Handbook nor the Centre for Reviews and Dissemination recommends a particular instrument for the assessment of risk of bias in NRS, although Cochrane has recently developed their own NRS critical appraisal tool. Among HTA bodies, only the Canadian Agency for Drugs and Technologies in Health recommends use of a specific critical appraisal tool-SIGN 50 (for cohort or case-control studies). Several criteria including reporting, external validity, confounding, and power were examined.
There is no consensus between HTA groups on the preferred appraisal tool. Reviewers should select from a suite of tools on the basis of the design of studies included in their review.
背景、目的和目标：当随机对照试验数据有限或不可用时，或者为了补充随机对照试验证据，卫生技术评估（HTA）机构可能依赖于非随机研究（NRS）的系统评价来获取卫生保健干预措施有效性的证据。NRS 设计可能会给系统评价带来相当大的偏倚，并且有几种评估这种偏倚风险的方法。本研究旨在确定常用于评估 NRS 偏倚的工具，并确定 HTA 机构推荐的工具。
通过对系统评价（2013 年 1 月至 2017 年 3 月；MEDLINE 和 EMBASE [OVID SP]）的有针对性搜索，确定用于 NRS 的评价工具。审查了专家审查小组和 HTA 机构对 NRS 批判性评估的建议。
从叙述性综合中纳入的 686 项研究中，确定了 48 种批判性评价工具。常用的工具包括纽卡斯尔-渥太华量表、NRS 方法学指数和定制的评价工具。Cochrane 手册和中心评价和传播都没有推荐用于评估 NRS 偏倚的特定工具，尽管 Cochrane 最近开发了自己的 NRS 批判性评价工具。在 HTA 机构中，只有加拿大药物和技术评估机构建议使用特定的批判性评价工具-SIGN 50（用于队列或病例对照研究）。检查了包括报告、外部有效性、混杂和功效在内的几个标准。
HTA 团体之间在首选评价工具方面没有达成共识。审查员应根据其审查中纳入的研究设计，从一系列工具中进行选择。
