The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions
The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions
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DOI：
10.1136/jech.52.6.377
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发表时间：
1998-06-01
影响因子：
6.3
通讯作者：
Black, N
中科院分区：
文献类型：
--
作者：
Downs, SH;Black, N
测试创建具有以下特征的有效和可靠的检查表的可行性：适用于评估随机和非随机研究;提供研究质量的总体评分和评分概况，不仅包括报告质量、内部效度设计-首先根据流行病学原理，综述，和现有的随机研究检查表。由三位经验丰富的评审员评估表面和内容效度，并使用两名评估员评估10项随机和10项非随机研究来确定可靠性。使用不同的评分员，检查表进行了修订和测试的内部一致性（库德-理查森20），重测和评分员间的信度（斯皮尔曼相关系数和符号秩检验; K统计;），标准效度，和responderburn.Main结果的性能的检查表的试点版本修订后大大提高。质量指数有很高的内部一致性（KR-20：0.89），除了外部效度（KR-20：0.54）的分量表。质量指标的重测信度（r0.88）和评分员间信度（r0.75）良好。各分量表的信度从好（偏倚）到差（外部效度）不等。质量指数与评估随机研究的现有既定工具高度相关（r 0.90）。非随机化和随机化研究的性能几乎没有差异。评分员花了大约20分钟来评估每一个文件（范围10至45分钟）。结论-这项研究表明，它是可行的，以开发一个检查表，可用于评估的方法学质量，不仅是随机对照试验，但也非随机研究。它还表明，有可能编制一份清单，提供文件概况，提醒审查人员注意其特定的方法优势和劣势。需要进一步开展工作，以改进检查表和外部效度评估方面的评分员培训。
Objective-To test the feasibility of creating a valid and reliable checklist with the following features: appropriate for assessing both randomised and non-randomised studies; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting, internal validity (bias and confounding) and power, but also for external validity.Design-A pilot version was first developed, based on epidemiological principles, reviews, and existing checklists for randomised studies. Face and content validity were assessed by three experienced reviewers and reliability was determined using two raters assessing 10 randomised and 10 non-randomised studies. Using different raters, the checklist was revised and tested for internal consistency (Kuder-Richardson 20), test-retest and inter-rater reliability (Spearman correlation coefficient and sign rank test; K statistics;), criterion validity, and respondent burden.Main results-The performance of the checklist improved considerably after revision of a pilot version. The Quality Index had high internal consistency (KR-20: 0.89) as did the subscales apart from external validity (KR-20: 0.54). Test-retest (r 0.88) and inter-rater (r 0.75) reliability of the Quality Index were good. Reliability of the subscales varied from good (bias) to poor (external validity). The Quality Index correlated highly with an existing, established instrument for assessing randomised studies (r 0.90). There was little difference between its performance with non-randomised and with randomised studies. Raters took about 20 minutes to assess each paper (range 10 to 45 minutes).Conclusions-This study has shown r;hat it is feasible to develop a checklist that can be used to assess the methodological quality not only of randomised controlled trials but also non-randomised studies. It has also shown that it is possible to produce a checklist that provides a profile of the paper, alerting reviewers to its particular methodological strengths and weaknesses. Further work is required to improve the checklist and the training of raters in the assessment of external validity.