摘要
探讨中国心脏健康膳食研究中营养饲食临床试验的设盲和盲法评价方法,报告盲法实施细节,进行盲态调查,计算两种BI指数(blinding index,BI),即Jame’s BI和Bang’s BI。中国心脏健康膳食研究盲法评价的Jame’s BI为0.683(95%CI:0.593~0.772),干预组Bang’s BI为0.340(95%CI:0.199~0.481),对照组Bang’s BI为0.086(95%CI:-0.060~0.231)。中国心脏健康膳食研究盲法实施总体较为成功,但干预组的受试者可能在一定程度上推测出自己的组别。对营养饲食临床试验应报告设盲细节并考虑进行盲法评价。
DECIDE-Diet trial was taken as a case to introduce the methods of blinding and blinding assessment for feeding trials,report the details of blinding,conduct a blinding survey and calculate Jame's BI and Bang's BI.Jame's BI was 0.683(95%CI:0.593~0.772).The Bang's BI for the intervention group was 0.340(95%CI:0.199~0.481),and for the control group was 0.086(95%CI:-0.060~0.231).The blinding of the DECIDE-Diet was generally successful,but the intervention group may infer their group to a certain extent.Feeding trials should report the details of blinding and consider blinding assessment.
作者
陈夏燕
王燕芳
武阳丰
黎淑仪
赵燕芳
缪珂
冯琳
李会娟
Chen Xiayan;Wang Yanfang;Wu Yangfeng;Li Shuyi;Zhao Yanfang;Miao Ke;Feng Lin;Li Huijuan(Peking University Clinical Research Institute,Beijing 100191,China;School of Public Health,Sun Yat-Sen University,Guangzhou 510080,China;Huadong Hospital Affiliated to Fudan University,Shanghai 200040,China)
出处
《中华临床营养杂志》
CAS
CSCD
2022年第1期49-52,共4页
Chinese Journal of Clinical Nutrition
基金
“十三五”国家重点研发计划重点专项(2016YFC1300200)。
关键词
盲法
盲法评价
盲法指数
饲食试验
营养学
Blinding
Blinding assessment
Blinding index
Feeding trial
Nutrition
