The Study On Developing Methodological Guideline For Case-control Study In Chinese Medicine Based On Expert Consensus Method

Objective1.Literature researchBy systematically searching the Case-control studies for traditional Chinese medicine(TCM)from 2014.1-2018.12,conducting methodological quality evaluation and report quality evaluation,identifying methodological problems,and formulating an item pool for survey problem evaluation.2.Expert consultationThe first round of evaluation of the survey question items is conducted through expert consultation.Based on the results of the first round,the importance and scientific of question items are comprehensively analyzed,the different opinions are revised and feedbacked.Expert consultation entry.The questionnaire was sent in the second round,repeat the statistical analysis results of the method.After the third round of questionnaires,the existing problems were discussed to determine the final version.In the end,a sample of Case-control research technical specifications in the field of traditional Chinese medicine with a certain consensus was formed.Methods1.Literature research6 databases were systematically searched from inception to December 31,2018 by used of combination of manual search and computer search.The included Case-control studies were evaluated in the methodological quality and report quality by the Newcastle-Ottawa Scale(NOS)and Strengthening the Reporting of Observational Studies in Epidemiology(STROBE statement)checklist(Introduction and Method section),respectively.The characteristics of studies were described by applying the methods of qualitative description,and offering the materials for establishing an expert survey questionnaire entry pool.2.Expert consultationThe Delphi Method,which is commonly used to conduct the first round of consultation surveys in the form of expert consultations,evaluate the importance of the items in the survey,and determine the items to be included based on the results of the consultation based on the expert’s recommendations.The second round of consultations discussed issues with large differences of opinion and formed the third round of questionnaires.The third round of consultations discussed the problems.After completing three rounds of Delphi investigations,write an investigation report.Results1.methodological quality of the literature and the quality of the report289 articles were finally included.CM syndromes,symptoms,constitution and genetic testing were the core topics of Case-control studies in CM.The results of the methodological quality showed that low-quality literatures(3-4 points)accounted for 17.0%(49 articles),medium-quality literatures(5-6 points)accounted for 59.8%(173 articles),and high-quality literatures(7-8 points)accounted for 23.2%(67 articles).In addition,most of the literatures didn’t report complete information required by the STROBE checklist.The application of matching,bias and quality control were lack of necessary details,but the reporting of study object and statistical analysis were explicit.Correlation Analysis found that the methodological quality of the literature was weakly correlated with the quality of the report(rs,=0.246,P<0.001).Offered the valuable materials for establishing the item pool of questionnaire.2.the investigation resultsAccording to the results of the literature research,with reference to the process of formulating technical specifications internationally,46 items were finally developed in the design and reporting phases of the Case-control study.(1)Positive coefficient of experts:For this study,44 experts were selected for three rounds of questionnaire surveys from the country.The questionnaire recovery rates were:73.3%,86.4%,and 86.8%,indicating that the consensus of expert entry level is good,and ensured the credibility of the survey results.(2)Expert authority coefficient:The three rounds of questionnaire experts’ conversion coefficients are:0.82,0.85,0.86.(3)Expert opinion coordination coefficient:The three rounds of questionnaire survey coefficients of variation are:0.2229,0.1043,and 0.0801.The three rounds of expert opinion coordination coefficients are:0.356,0.349,0.422.The chi-square test p-values of the coordination coefficients were all less than 0.001,indicating that the expert evaluation opinions were coordinated.The identification of TCM syndromes and physiques and the selection of new cases are the most questionable items from experts.Conclusion1.The methodological quality was weakly correlated with the quality of the report.The overall quality of the Case-control studies on Chinese Medicine was acceptable,but the high-quality literature was relatively less.Most of the studies published were still have problems in reporting of matching and quality control.Both methodological and reporting quality should be further improved.2.The survey results show that Case-control studies in the field of traditional Chinese medicine should pay more attention on the characteristics of traditional Chinese medicine.The draft of technical specification involves the study design and reporting phases,which can improve the methodological quality and reporting quality of Case-control studies.