非随机对照研究方法学评价指标(Methodological Index for Non-randomized Studies, MINORS)

发布于 2024年6月28日 星期五 11:54:48 浏览:57
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非随机对照研究方法学评价指标(Methodological index for non-randomized studies,MINORS)是由法国外科医师Slim等在2007年提出的,特别适用于外科非随机对照干预性研究(Non-randomized surgical studies)质量的评价。本文重点讲述MINORS的使用方法。

关键词:非随机对照干预性研究; 非随机对照试验; MINORS

一、MINORS的使用方法

MINORS采用计分方式评价研究质量,共包含12个评价条目,每个条目0-2分,0分表示完全没有报道;1分表示有报道但信息不全;2分表示有报道且信息充分。前8个条目适用于无对照组的研究,满分为16分;加上后4个条目可针对有对照组的研究进行质量评价,满分为24分。

二、MINORS的评估清单

The revised and validated version of MINORS
MINORS的修订和验证版本
Number序号Evaluation index评价指标Evaluation criteria评价标准
1A clearly stated aimThe question addressed should be precise and relevant in the light of available literature
有明确的研究目的提出的问题应该精确并且有文献支持
2Inclusion of consecutive patientsAll patients potentially fit for inclusion (satisfying the criteria for inclusion) have been included in the study during the study period (no exclusion or details about the reasons for exclusion)
连续纳入患者所有的潜在患者(符合纳入标准)在研究期间均被纳入(未排除或给出了排除理由)
3Prospective collection of dataData were collected according to a protocol established before the beginning of the study
前瞻性收集数据按照研究开始前已建立好的计划进行数据收集
4Endpoints appropriate to the aim of the studyUnambiguous explanation of the criteria used to evaluate the main outcome which should be in accordance with the question addressed by the study. Also, the endpoints should be assessed on an intention-to-treat basis
适合研究目的的结局指标明确解释用于评价主要结局的标准,这些标准应与研究所提出的问题相一致。此外,应在意向性治疗基础上评估结局指标
5Unbiased assessment of the study endpointBlind evaluation of objective endpoints and double-blind evaluation of subjective endpoints. Otherwise the reasons for not blinding should be stated
客观评价研究结局应采用评价者单盲法评价客观结局指标,采用双盲法评价主观结局指标。否则,需给出未设盲的理由
6Follow-up period appropriate to the aim of the studyThe follow-up should be sufficiently long to allow the assessment of the main endpoint and possible adverse events
随访期应与研究目的相符随访时间需足够长以便评估主要终点指标和可能的不良事件
7Loss to follow up less than 5%All patients should be included in the follow up. Otherwise, the proportion lost to follow up should not exceed the proportion experiencing the major endpoint.
失访率低于5%所有患者均应被纳入随访。否则,失访的比例不应超过发生主要终点的患者比例
8Prospective calculation of the study sizeInformation of the size of detectable difference of interest with a calculation of 95% confidence interval, according to the expected incidence of the outcome event, and information about the level for statistical significance and estimates of power when comparing the outcomes.
样本量的前瞻性计算样本量的计算需要考虑:预期结局事件的发生率,差异大小及95%置信区间,显著性水平和把握度
Additional criteria in the case of comparative study
译文:设立对照组研究的补充评价标准
9An adequate control groupHaving a gold standard diagnostic test or therapeutic intervention recognized as the optimal intervention according to the available published data.
对照组选择是否恰当对照组应该是目前已发表文献中,行业公认的诊断“金标准”或最佳干预措施
10Contemporary groupsControl and studied group should be managed during the same time period (no historical comparison).
对照组与实验组是否同步对照组与实验组应是同期进行的(非历史对照)
11Baseline equivalence of groupsThe groups should be similar regarding the criteria other than the studied endpoints. Absence of confounding factors that could bias the interpretation of the results.
组间基线可比性除研究终点外,对照组与试验组基线资料应相似可比。没有使结果解释产生偏倚的混杂因素
12Adequate statistical analysesWhether the statistics were in accordance with the type of study with calculation of confidence intervals or relative risk.
恰当的统计学分析统计分析方法是否适合研究类型,应计算置信区间或相对危险度

注:本文内容是参考相关文献后对非随机对照研究方法学评价指标(Methodological index for non-randomized studies,MINORS)的概述,仅代表本网站观点。关于MINORS的更多内容详见论文Methodological index for non-randomized studies (minors): development and validation of a new instrument

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