基于CDISC框架对中外病例报告表要素缺陷的分析  

An integrity analysis of case report forms in China and foreign countries based on standards of CDISC

作　　者：舒婧娴 蒲冰瑶 徐娜娜[1] 陈瑞芳[1] 温改艳 戴海将 项玉霞[1] 黄志军[1] 袁洪[1] 陆瑶[1] 

机构地区：[1]中南大学湘雅三医院临床药理中心,长沙410013 [2]中南大学药学院,长沙410013

出　　处：《中国新药杂志》2016年第8期893-898,共6页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2012ZX09303014001);国家自然科学基金(81273594);十二五国家科技支撑计划课题(2012BAI37B05)

摘　　要：目的:基于临床数据交换标准协会(CDISC)标准比较中外病例报告表(CRF)各要素的缺陷情况。方法:从湘雅三医院伦理委员会近6年受理的595份CRF中挑选109份中国和65份国外CRF,比较中外CRF各要素的出现率。结果:国内CRF在用药史(79.8%vs 93.8%,P=0.012)、疗效评价(27.5%vs64.6%,P=0.000)等13个要素方面的缺失明显高于国外,中外CRF在依从性评价(24.8%vs 33.8%,P=0.198)、人口学资料中婚姻状况记录(11.9%vs 20%,P=0.148)等7个要素方面缺失明显。结论:与国外临床研究相比,国内设计CRF时需重视用药史记录、疗效评价等方面内容的完整性。国内外均需加强CRF中的依从性评价、人口学资料中婚姻状况记录等7个要素的记录。Objective： To compare the defect situation of elements in the case report form（ CRF） in China and foreign countries based on the standards of Clinical Data Interchange Standards Association（ CDISC）. Methods： We collected 109 Chinese and 65 foreign CRFs from the Ethics Committee of the Third Xiangya Hospital in the past six years. The CRF integrity questionnaire was designed according to the Study Data Tabulation Model of CDISC to analyze the difference of defect situation in domestic and foreign CRFs. Results： The recording ratios of medical history（ 79. 8% vs 93. 8%,P = 0. 012）,efficacy evaluation（ 27. 5% vs 64. 6%,P = 0. 000） and other eleven elements in domestic CRFs were significantly lower than those in foreign CRFs. The recording ratios of compliance evaluation form（ 24. 8% vs 33. 8%,P = 0. 198）,marital status（ 11. 9% vs 20%,P = 0. 148） and other five elements in both domestic and foreign CRFs were very low. Conclusion： Compared with foreign CRFs,the integrity of medical history and efficacy evaluation are overlooked in domestic CRFs. The integrity of compliance evaluation form,marital status and other five elements in domestic and foreign CRFs should be improved.

关 键 词：病例报告表 药物临床试验 缺陷 要素 完整性 

分 类 号：R969[医药卫生—药理学]