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德尔菲清单:一份通过德尔菲共识制定的用于系统评价的随机临床试验质量评估标准清单。

The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus.

作者信息

Verhagen A P, de Vet H C, de Bie R A, Kessels A G, Boers M, Bouter L M, Knipschild P G

机构信息

Department of Epidemiology, Maastricht University, The Netherlands.

出版信息

J Clin Epidemiol. 1998 Dec;51(12):1235-41. doi: 10.1016/s0895-4356(98)00131-0.

Abstract

Most systematic reviews rely substantially on the assessment of the methodological quality of the individual trials. The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of randomized clinical trials (RCTs). The invited participants were experts in the field of quality assessment of RCTs. The initial item pool contained all items from existing criteria lists. Subsequently, we reduced the number of items by using the Delphi consensus technique. Each Delphi round comprised a questionnaire, an analysis, and a feedback report. The feedback report included staff team decisions made on the basis of the analysis and their justification. A total of 33 international experts agreed to participate, of whom 21 completed all questionnaires. The initial item pool of 206 items was reduced to 9 items in three Delphi rounds. The final criteria list (the Delphi list) was satisfactory to all participants. It is a starting point on the way to a minimum reference standard for RCTs on many different research topics. This list is not intended to replace, but rather to be used alongside, existing criteria lists.

摘要

大多数系统评价在很大程度上依赖于对各个试验方法学质量的评估。本研究的目的是就一组用于随机临床试验(RCT)质量评估的通用核心条目达成专家共识。受邀参与者为RCT质量评估领域的专家。初始条目库包含现有标准列表中的所有条目。随后,我们采用德尔菲共识技术减少了条目数量。每一轮德尔菲法都包括一份问卷、一次分析和一份反馈报告。反馈报告包括基于分析做出的工作人员团队决策及其理由。共有33位国际专家同意参与,其中21位完成了所有问卷。经过三轮德尔菲法,206个条目的初始条目库减少到了9个条目。最终的标准列表(德尔菲列表)令所有参与者满意。它是迈向许多不同研究主题RCT最低参考标准的起点。该列表并非旨在取代现有标准列表,而是要与现有标准列表一起使用。

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