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First consultation of developing the methodological guideline for case-control study in traditional Chinese medicine based on Delphi method
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DOI   10.11656/j.issn.1672-1519.2015.10.03
Key Words   traditional Chinese medicine;case-control study;Delphi method;expert consultation;methodological guideline
Author NameAffiliationE-mail
ZHOU Li Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China  
HU Xiao-yi Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China  
ZHONG Ying Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China  
WEN Ze-huai Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
National Center for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, Guangzhou 510405, China 
wenzh@gzucm.edu.cn 
Abstract
    [Objective] To evaluate the items by consulting experts, and then form the second round items to be questioned for developing the methodological guideline. [Methods] We evaluated the importance of items by using the general international Delphi method, and adopted the way of expert consultation for the first round consultation. Meanwhile, the experts could raise their opinions and suggestions about the items. Finally, confirming the included items according to the results of expert consultation and providing the draft for the second round consultation. [Results] According to the results of systematic literature search, complying with the STROBE guideline of observational studies and other procedures of methodological guidelines, we formulated the questionnaire including 45 items. The recovery rate of the questionnaire (specialist active coefficient) was 81.8%. The concentration indexes, including mean, mode and sum scores calculated from experts' opinion were consistency, which indicated a good degree of concentration among experts' opinion. All coefficient of variation (CV) were < 0.3, suggesting coordination degree of experts was better. The results showed that mean scores of 36 items were greater than or equal to 4 points,and 9 items were greater than or equal to 3 points and less than 4 points. The identification about time point of traditional Chinese medicine (TCM) syndrome and constitution classification in TCM were questioned more. [Conclusion] The 36 items were included in the second round survey,and 9 items had the possibility to be included. It showed that there were some particularity in case-control studies for TCM, especially TCM syndrome and constitution classification fields.

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