Methodological index for non-randomized studies (MINORS):: Development and validation of a new instrument
Methodological index for non-randomized studies (MINORS):: Development and validation of a new instrument
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DOI：
10.1046/j.1445-2197.2003.02748.x
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发表时间：
2003-09-01
影响因子：
1.7
通讯作者：
Chipponi, J
中科院分区：
文献类型：
--
作者：
Slim, K;Nini, E;Chipponi, J
背景：由于进行随机试验的特殊方法学困难，外科研究仍然主要依赖于观察性或非随机研究。无论是从读者的角度还是为了荟萃分析的目的，几乎没有有效的工具来确定这类研究的方法学质量。本研究的目的是开发和验证这种工具。方法：在非随机研究方法学指数(Minor)的初始概念化阶段之后，12个潜在项目的清单被发送给来自不同外科专业的100名专家进行评估，并由10名临床方法学专家进行评估。随后的测试包括评审员间一致性、2个月时的重测信度、内部一致性信度和外部效度。结果：《未成年人问卷》包含12个条目，前8个条目专门用于非比较研究。信度建立在评价者之间良好的一致性、卡帕系数的高重测信度和高的克朗巴赫α系数的良好内部一致性的基础上。外部效度是根据未成年人识别优秀试验的能力建立的。结论：未成年人是一种有效的工具，用于评估非随机外科研究的方法学质量，无论是比较还是非比较。下一步将是确定其在大量研究中使用时的外部效度，并将其与其他现有工具进行比较。
Background: Because of specific methodological difficulties in conducting randomized trials, surgical research remains dependent predominantly on observational or non-randomized studies. Few validated instruments are available to determine the methodological quality of such studies either from the reader's perspective or for the purpose of meta-analysis. The aim of the present study was to develop and validate such an instrument.Methods: After an initial conceptualization phase of a methodological index for non-randomized studies ( MINORS), a list of 12 potential items was sent to 100 experts from different surgical specialities for evaluation and was also assessed by 10 clinical methodologists. Subsequent testing involved the assessment of inter-reviewer agreement, test-retest reliability at 2 months, internal consistency reliability and external validity.Results: The final version of MINORS contained 12 items, the first eight being specifically for non-comparative studies. Reliability was established on the basis of good inter-reviewer agreement, high test-retest reliability by the kappa-coefficient and good internal consistency by a high Cronbach's alpha-coefficient. External validity was established in terms of the ability of MINORS to identify excellent trials.Conclusions: MINORS is a valid instrument designed to assess the methodological quality of non-randomized surgical studies, whether comparative or non-comparative. The next step will be to determine its external validity when used in a large number of studies and to compare it with other existing instruments.