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Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform  ( SCI-EXPANDED收录)   被引量:6

文献类型:期刊文献

英文题名:Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform

作者:Gu, Jing[1,2];Wang, Qi[1];Wang, Xiaogang[1];Li, Hailong[2];Gu, Mei[3];Ming, Haixia[2];Dong, Xiaoli[2];Yang, Kehu[1];Wu, Hongyan[2]

第一作者:顾静;Gu, Jing

通信作者:Yang, KH[1]

机构:[1]Lanzhou Univ, Inst Integrated Tradit Chinese & Western Med, Sch Basic Med Sci, Evidence Based Med Ctr, Lanzhou 730000, Gansu, Peoples R China;[2]Gansu Univ Tradit Chinese Med, New Prod Dev Chinese Med Engn Lab, Lanzhou 730000, Gansu, Peoples R China;[3]Xiaoman Middle Sch, Zhangye 730000, Gansu, Peoples R China

第一机构:Lanzhou Univ, Inst Integrated Tradit Chinese & Western Med, Sch Basic Med Sci, Evidence Based Med Ctr, Lanzhou 730000, Gansu, Peoples R China

通信机构:[1]corresponding author), Lanzhou Univ, Inst Integrated Tradit Chinese & Western Med, Sch Basic Med Sci, Evidence Based Med Ctr, Donggang West Rd, Lanzhou 730000, Gansu, Peoples R China.

年份:2014

卷号:2014

外文期刊名:EVIDENCE-BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE

收录:;Scopus(收录号:2-s2.0-84896072174);WOS:【SCI-EXPANDED(收录号:WOS:000331765500001)】;

基金:The authors thank LetPub for its linguistic assistance during the preparation of this paper. The work is supported by the Gansu Province Science and Technology Program for Livelihood of the People (Finance Department and Education Department of Gansu Province (2012), Grant no. 254).

语种:英文

摘要:Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration.

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