Objective The basic terms of the technical specifications for case-control studies in the field of traditional Chinese medicine (TCM) are formed by expert consensus methods, in order to develop detailed texts of the technical specifications. Methods According to the process of international guidelines, a total of 44 experts participated in the Delphi survey. Results The three rounds of questionnaire response rates were 73.3%, 86.4%, and 86.8%, respectively. The experts' authority coefficients were 0.82, 0.85, and 0.86, respectively; and the expert opinion coordination coefficients were 0.356, 0.349, and 0.422, respectively. Expert enthusiasm, authority, opinion centralization, and degree of coordination were relatively high. There were many opinions raised in the expert consensuses on how to measure TCM syndrome, TCM constitution, the time point of measurement and the selection of new cases. Conclusion The case-control studies in TCM field should pay more attention to the characteristics of TCM. The draft of technical specification involves the study design and reporting, which can improve the methodological and reporting quality of case-control studies.
ObjectiveTo investigate the current situation of domestic registry studies, and to provide basis for future research.MethodsWorld Health Organization (WHO) registration platform, ClinicalTrials.gov registration platform and other registration platforms were searched to collect the registered registration studies in Mainland China from inception to July 31st, 2018. Two researchers collected and collated data, analyzed by descriptive statistical methods, and then python-igraph package in Python 3.5 was used to draw the network diagram.ResultsA total of 247 studies were retrieved, mainly for disease registry and pharmaceutical product registry. Cohort and case-series were the principally study design. The research focused on chronic diseases such as cardiovascular and cerebrovascular diseases, and research sites were based on the economically developed area, for example, Beijing, Shanghai and Guangdong. The network diagram of study design and disease system shows that cohort research design is widely used in the nervous system and circulatory system; the network diagram of the research sites and disease system found that Beijing mainly studied circulatory and nervous system diseases, Shanghai mainly studied circulatory system diseases, and Guangdong relatively studied more on nervous system and urinary system diseases.ConclusionThe increasing number of registry studies in China reflects the importance of long-term outcome assessment of diseases.