Research On The Evaluative Criteria Of Practical Experience About New Medications Based On Ancient Chinese Classic Practical Prescription

Objective:This study will use bibliometrics to study various elements of existing human experience literature,further clarify the concept of human experience,and analyze its research hotspots.The human experience evaluation items were drafted and revised by combining qualitative and quantitative methods,and the human experience data of TCM new drugs were further refined and explored,in order to provide reference and grading evaluation of data from all dimensions for new drug applicants who need the support of human experience evidence.Methods:Based on bibliometrics literature research,relevant literature retrieval was carried out in three Major Chinese and English databases,CNKI,Wanfang and PubMed.The literatures that directly discussed the sources,collection methods,research and development ideas and evaluation criteria of human experience data were included,and the literatures that only mentioned nouns,repeated literatures between databases,news,newspaper news,advertisements,and literatures with unclear explanations were excluded.The literature retrieved by the above developed retrieval strategy was de-weighed,screened,collated and extracted by an independent researcher and examined by another independent researcher.In case of disagreement,the decision is made by a third researcher who is more authoritative in the field.Use Excel basic characteristics(2016)to collect literature,as far as possible to collect all the relevant people with experience in all the earth basic information,including but not limited to people with experience category,people with experience basic requirements,data source,content collection,collection methods,people with empirical evidence type/design method,people with experience in the research and development of traditional Chinese medicine common problems and solution,the research key point.Classify the basic information and manually screen the frequency index.According to the bibliometrics literature research results,a research group was set up to select the pre-selected items,initially build the item pool,and optimize the first-level classification framework of item construction and list based on expert consultation.This study using a modified Delphi method,the existing research as the basis of the first round,each entry in the form of Likert5 level evaluation method combined with open questions formulated questionnaire,solicit opinions from the team about the importance of the effectiveness of the entry or,in the second round of the expert consultation on controversial entry in the last round of the open questions,Likert5 grading method is proposed for expert "familiarity".In each round of expert questionnaire,indicators such as reliability,validity,differentiation and expert authority are evaluated to form the final item list.Results:(1)29 literatures related to TCM human experience were obtained from cnki,22 of which were directly related;Wanfang search results showed 395 literatures,including 19 literatures related to human experience of TCM,16 literatures directly related;406 articles were retrieved from PubMed,including 8 articles related to human experience in TCM,4 articles directly related,and 4 articles overlaps on CNKI.After coarse screening,weight removal and screening according to the criteria of acceptance and arrangement,23 articles were finally included.Among them,5 articles described the categories or basic requirements of human experience,accounting for 21.7%of the total literature.Eleven articles,accounting for 47.8%of the total number of literatures,were analyzed in the aspects of human experience data collection,collection methods and content.Six articles discussed the transformation of empirical evidence for human use,accounting for about 26%of the total number of literatures.Eleven articles,accounting for 47.8%of the total number,analyzed the key points,research design and research ideas of human experience research.Eight articles,accounting for 34.8%of the total,discussed the evaluation method of human experience.In the past,the concept of human experience is unclear,data sources are not unified,classification is not clear,and the expression and system are different,so it is difficult to give researchers the role of self-evaluation and reference.This study described and sorted out the system framework in a unified way,and classified and counted the characteristics of various points of human experience in various literatures from five aspects and dimensions:applicability evaluation,data source,collection content,problems in evidence transformation,and human experience evaluation.(2)According to the summary results of all dimensions of bibliometrics research,Applicability evaluation item listing 1 "men with experience" contains "theory elements","in fact","clinical application of" 3 evaluation field and "source","medicinal clarity" and "sufficiency of evidence","sexual history","application universality" and"consistency","experience validity" and "drug safety" eight key points of evaluation;In Listing 2,"Items for Evaluation of Human Experience Data Grade",three data grades are further subdivided for each evaluation point in Listing 1,and the preliminary theoretical conceptual framework of individual qualitative evaluation is given for each point.Through the first round of expert consultation,22 questionnaires were sent out and 19 were returned,with a response rate of 86.36%.About 84.21%of experts proposed additional modification suggestions,and Cronbach’s a coefficient was 0.823.According to experts’ suggestions,we carried out targeted expert consultation to modify the items,deleted 2 judgment basis items and their classification,and modified 7 judgment basis items and their classification.The item description was optimized through the second round of expert consultation and interview,and the final item list was formed.Conclusions:In this study,the empirical data for human use of TCM new drugs were further refined and explored in a unified expression and systematic framework,providing a reference basis for the hierarchical evaluation of data from all dimensions for new drug applicants who need to use empirical evidence for human use.Due to the limitations of research methods,the results of item analysis are biased to some extent,and the practical application of the scale cannot be realized due to the limitations of time and conditions.Therefore,the item list can be further modified and improved in practice in the future.