| Background:Proprietary Chinese medicine in Chinese medicine clinical application is more and more big,the proportion of the study more and more,organizations and institutions have carried out a comprehensive evaluation and research of the proprietary Chinese medicine,the normative research method,has not been formed because of the result in various organizations and institutions to develop proprietary Chinese medicine comprehensive evaluation report one-sided evaluation content,evaluation quality is differ,disorderly evaluation form.Report guidelines are formulated using specific research methods and characterized by a high degree of consensus reached by experts.They are used to guide researchers’ reports,such as checklists,flow charts or structured texts.Standardized comprehensive evaluation reports of Proprietary Chinese medicines can effectively meet researchers’ research needs and clinical application needs.Objective:Of this study was to develop proprietary Chinese medicine comprehensive evaluation report in the specification list,a system,comprehensive,high elastic checklist,you can to provide for the establishment of the late proprietary Chinese medicine comprehensive evaluation Report guideline main reference material,also can satisfy researchers,clinicians,pharmaceutical production enterprises,the comprehensive evaluation report,reasonable standard written proprietary Chinese medicine,Standardize the selection of proprietary Chinese medicine,so that patients can understand the relevant information of proprietary Chinese medicine.Methods:In the first stage,high-quality evidences were collected by searching databases,websites and other means to determine the necessity of carrying out research.In the second stage,the EQUATOR should refer to the reporting specification formulation steps recommended by the EQUATOR Collaboration,carry out the improved Delphi method and carry out expert consensus according to the characteristics of Traditional Chinese Medicine,and preliminarily formulate the checklist and explanatory text.In the third stage,an empirical study and optimization of the checklist and explanatory text were carried out by using the two-person back-to-back evaluation method.Results:(1)Collect high-quality evidence of the formulation of the comprehensive evaluation report standard of Chinese patent medicines by searching EQUATOR Collaborative network,CNKI database,Wanfang Database,VIP Database,Cochrane Library.Pubmed and other online and offline channels;Currently EQUATOR has not yet included EQUATOR comprehensive evaluation report norm of Chinese patent medicine and there is no standard EQUATOR comprehensive evaluation report norm of Chinese patent medicine in all major databases.The compilation of EQUATOR comprehensive evaluation checklist is conducive to EQUATOR research.According to the development steps of EQUATOR report norm recommended by EQUATOR,The requirements and research methods of reporting standards are determined.(2)After collecting high-quality evidence,the list item pool of comprehensive evaluation report of Chinese patent medicine was established according to the improved Delphi method;(3)Formulate the expert questionnaire according to the item pool of the checklist,determine the principle of expert selection and invite members of the expert group to conduct the first round of questionnaire survey on the members of the expert group;(4)The experts’ scores and opinions collected in the first round of questionnaire survey were summarized and analyzed,and the second round of expert questionnaire survey was carried out after the questionnaire items were modified;(5)Analyze and summarize the results of two rounds of expert questionnaires,and preliminarily draw up the list and text description of comprehensive evaluation report of Chinese patent medicine;(6)Two research team members were selected for training,and the existing comprehensive evaluation reports of Proprietary Chinese medicines were collected from major databases at home and abroad to conduct backto-back empirical research on the checklist.If the verification results were inconsistent,a third party was introduced for discussion.(7)After summarizing the conclusions of the two researchers,input them into EXCEL and analyze the results.The two researchers filled in the feedback form.The research group optimized the items in the checklist and the explanatory text of the checklist centering on the opinions and analysis results of empirical researchers.Conclusion:In this study,the list of comprehensive evaluation reports of Proprietary Chinese medicines was preliminarily developed by retrieving high-quality evidence and expert consensus of Delphi method,and the list of reports and explanatory texts were adjusted and optimized based on the two-person back-to-back empirical study.However,the current work is only a part of a complete Report guideline,and it is hoped that the checklist and explanatory text produced by this study can provide more sufficient research support for the study of the comprehensive evaluation Report guideline of Chinese patent medicine in the future. |
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