Development Of A Quality Evaluation Scale For Traditional Chinese Medicine Case Report

Objective: To explore the characteristics of TCM case reports,develop a TCM case report quality evaluation scale,and provide ideas and methods for evaluating TCM case reports.Methods: 1.Literature study of TCM case report quality evaluation.Through searching multiple literature databases,literature related to the standardization of TCM medical records was screened,and entries related to TCM case reports were sorted out,including general information,chief complaint,current medical history,four diagnostic information,TCM diagnosis,evidence analysis,treatment rules,prescription medication,medical advice,diagnosis and treatment process,medical case interpretation,informed consent,etc.,to form a pool of TCM case report standardized entries.2.Selection of normative items based on Delphi questionnaire method.Based on the results of the literature study,we developed an expert questionnaire for evaluating the quality of TCM case reports,and after two rounds of Delphi expert questionnaire,we statistically analyzed the mean,insignificant percentage,rank sum,coefficient of variation to determine the importance of different entries of TCM case reports,and determined the entries to be retained and rejected,and formed a preliminary quality evaluation scale of TCM case reports;and based on the statistical results of the data,the weights and scores of different entries were determined,the quality evaluation grade criteria of TCM case reports were formulated.3.Consistency test of the Quality Evaluation Scale of TCM Case Reports.Twenty TCM case reports were selected to test the quality evaluation scale,and the case reports were obtained from the Journal of Traditional Chinese Medicine,Chinese Journal of Traditional Chinese Medicine and Pharmacy,Journal of Jinan University and other journals.Two evaluators scored 20 medical cases and 6 evaluators scored 5 medical cases to verify the practicability and evaluation consistency of the scale.Results: 1.A database of TCM case report quality evaluation entries was established.A total of9513 documents were retrieved from the literature study,25 documents containing TCM case report specification entries were finally included after screening.A total of 96 entries in 7 sections of preface,general information,diagnostic information,treatment information,outcome and follow-up,discussion and interpretation,and other information were extracted,and duplicate contents were eliminated to form the expert questionnaire of "TCM Case Report Quality Evaluation Scale".2.Establishing the entries of "TCM Case Report Quality Evaluation Scale".Based on two rounds of Delphi expert questionnaire,the positive coefficients of experts were 100%and 94.1%,the authority coefficient was 0.917,the Kendall harmony coefficients were 0.12 and0.358 in the first and second rounds,respectively,(p < 0.05).And the Cronbach coefficients were0.72 and 0.96,respectively,with a strong internal consistency.After the first round of questionnaires,11 entries with lower scores and 7 entries added by experts entered the second round of questionnaires,and the remaining entries were directly included because of their high degree of importance and highly consistent scores;14 entries with lower scores were deleted from the second round of expert questionnaires,resulting in a scale consisting of 27 normative TCM case report entries,which were grouped into 10 panels,namely: 1.normative title and abstract;2. informed consent;3.complete medical history description;4.TCM diagnosis and rationale;5.Western medicine diagnosis and rationale;6.therapeutic intervention;7.efficacy evaluation;8.follow-up consultation and follow-up;9.medical case interpretation;10.normative evaluation.The weight coefficients were calculated according to the weighted average method,and the results of the weight assignment of each evaluation index were expanded by 10 times and taken as relatively neat values,and the values of the above 10 evaluation indexes were: 12,3,15,12,3,15,8,10,16,6,with a total score of 100 points.Case reports with scores of 80 and above were classified as high quality medical cases,case reports with scores of 60-80 were classified as moderate quality medical cases,and case reports with scores below 60 were classified as low quality medical cases.3.Validation of the TCM Case Report Quality Evaluation Scale with a high degree of consistency.Twenty case reports were rated,of which 2 were high quality case reports,13 were moderate quality case reports,2 were low quality case reports,and the remaining 2 had varying evaluation grades.The evaluation grades of the 20 case reports by the 2 raters’ Kappa value was 0.663 > 0.4;6 raters rated 5 of the medical cases,and the Kendall’s harmony coefficient of the evaluation results was 0.845 > 0.8,indicating a high consistency of the rating results;among the 20 case reports evaluated,the higher the quality case reports,the higher the consistency of the raters’ ratings(SD=3.54);the moderate quality case reports,the greater the difference(SD=6.89).Of the 10 evaluations,the highest scores were for entry 6 therapeutic intervention(88.6%)and entry 3 complete history description(88%),and the lowest scores were for entry 2 informed consent(0%)and entry 1 normative title and abstract(51.4%);the entry had the highest consistency(SD=0)due to the lack of informed consent in all case reports;entry 9 medical case interpretation had the lowest consistency(SD=5.34),followed by the entry 1 normatives title and abstract(SD=4.68).Conclusion: 1.In this study,the content of TCM case reports was used as the starting point to establish a literature base of standardized TCM case report entries,form a pool of TCM case report quality evaluation entries,evaluate each entry of TCM case reports using the Delphi questionnaire,objectively and comprehensively analyze the importance of each entry,and form a quality evaluation scale for TCM case reports,including 27 entries in 10 panels,and the weight assignment of each entry.The evaluation indexes and weights of the scale were set according to the characteristics of TCM case reports,and the scale was able to quantify and grade the evidence of TCM case reports,and the reliability test proved that the internal consistency of the scale was good.2.The results of scoring case reports using the quality evaluation scale showed strong consistency,which is innovative and practical,and proposed a feasible solution for determining the grade of case reports,and provided ideas and methods for improving the objectivity,standardization,authenticity and scientificity of TCM case reports.