循证医学数据库信息模型中证据强度模块的构建及验证

Development of evidence level module for information model of evidence-based medicine database and its verification

目的:建立循证医学数据库信息模型中证据强度模块并进行验证。方法:通过随机对照试验报告质量标准CONSORT 2010及CEBM、CASP、JBI、SIGN等评价标准,提取该模块应具备的数据元,最后通过著录和评价DynaMed数据库中的文献验证该模块的可行性。结果:提取出PICO、顺序产生、分配隐蔽机制、盲法、样本一致、干预一致、失访比例、ITT分析、置信区间、结果、样本量、流程图等数据元构成证据强度模块,并选出9个数据元进行相应的满足度计算,作为随机对照试验证据强度的主要排序依据。通过著录验证,该模型对证据的评价等级与DynaMed基本一致。结论:该证据强度模块是有效可行的,可作为循证医学数据库信息模型的一个重要组成部分,为初步评价证据打下基础。

Objective To develop and verify the evidence level module for information model of evidence-based medicine(EBM)database.Methods The data elements of the evidence level module were extracted according to the CONSORT 2010 and CEBM,CASP,JBI and SIGN.The evidence level module was verified by describing and reviewing the literature in DynaMed.Results The evidence level module is consisted of the extracted data elements:PICO,sequence generation,allocation concealment mechanism,blinding,sample conformity,intervention conformity,follow-up loss rate,ITT analysis,confidence interval,results,sample size and flow diagram.The satisfaction of 9 data elements selected from the above extracted data elements was calculated,which was used as a ranking index for the evidence level in randomized control trials.The evidence evaluation level in evidence level module was consistent with that in DynaMed,which was verified by the description.Conclusion The evidence level module can be used as an important part of information model of EBM database,thus laying a foundation for the primary data assessment.