Evaluation Of The Applicability Of Traditional Chinese Medicine Clinical Guidelines

The clinical guidelines of Traditional Chinese Medicine(TCM)are based on the systematic evaluation of evidence,incorporating the characteristics of Chinese medicine,balancing the advantages and disadvantages of different interventions,and forming recommendations for providing patients with the best medical and health services.By providing standardized treatment measures,TCM clinical guidelines help to reduce unnecessary differences in clinical practice between different regions and hospitals in China.At present,the number of clinical guidelines is still growing rapidly,and nearly one-third of the guidelines are related to Chinese medicine.Although,more and more institutions and individuals have conducted various aspects of evaluation of TCM clinical guidelines,the evaluation is often aimed at a single guide,which cannot fully reflect the current status of clinical application of clinical guidelines in Chinese medicine.In addition,AGREE,an internationally used guide evaluation tool,cannot objectively reflect the dialectical treatment of clinical guidelines for TCM.Therefore,this study uses the "Questionnaire on the Applicability of Guidelines for Clinical Treatment on Traditional Chinese Medicine" to investigate clinicians.The items investigated in this questionnaire are the subjective judgments of doctors on the guidelines and are used to understand the applicability of clinical guidelines in clinical practice.The aim of the research is to evaluate the current status of the application of guidelines in clinical practice by questionnaire,which including evaluating the current situation of clinical doctor’s familiarity and using of the guidelines.It also related to the quality level,application and the doctor’s suggestions to the guidelines.1.Objective of studyBy understanding the current status of the applicability of the clinical guidelines for TCM,as well as the clinicians’ familiarity with and use of the guidelines,the quality,the application situation,the clinicians’ opinions and suggestions to the guidelines,to discover the problems existing in the current clinical guidelines for TCM and also provide suggestions for the future development and implementation of clinical guidelines for TCM.2.Research Contents and Methods2.1 Evaluation of Reliability and validity to the "Questionnaire on the Applicability of Guidelines for Clinical Treatment on Traditional Chinese Medicine"2.1.1 Sources of the "Questionnaire on the Applicability of Clinical Guidelines for Traditional Chinese Medicine”The evaluation project for clinical diagnosis and treatment guidelines for traditional Chinese medicine was set up by the Public Health Project Funding of Ministry of Finance.According to the requirements of this project,the project group designed the "Questionnaire on the Applicability of Guidelines for Clinical Treatment on Traditional Chinese Medicine"(see Appendix I).There are 4 dimensions and 28 entries in the questionnaire.The 4 dimensions are basic information,quality level,application status,and suggestions.2.1.2 Selection of guidelinesIn 2008,the China Association of Chinese Medicine published guidelines on chronic gastritis,gastroesophageal reflux disease,Behcet syndrome,bronchiectasis,allergic rhinitis,colon cancer,hypothyroidism,hypochondriac pain,and Guan Ge.2.1.3 Investigative ProcedureDuring the period from November to December 2013,the disease Department of Xiyuan Hospital of the Chinese Academy of Traditional Chinese Medicine assumed the evaluation of the guideline.Each disease entities of the guideline evaluation investigates at least the following personnel:no less than 4 chief physicians and deputy chief physicians,and no less than 6 attending physicians and residents in this department.200 questionnaires were issued and 180 valid questionnaires were recovered.The feasibility,reliability,and validity of the questionnaires were analyzed,and the reliability and rationality of the questionnaires were initially verified.2.1.4 Research Methods2.1.4.1 Questionnaire Survey MethodUse the questionnaire method.The clinicians at all levels finish the"Questionnaire on the Applicability of Guidelines for Clinical Treatment on Traditional Chinese Medicine",collect the questionnaires,and conduct data collation and analysis on the effective questionnaires.2.1.4.2 Statistical MethodUsing EpiData 3.1 to establish a database,the data entry method is independently entered by two machines.After checking and verifying correctly,the psych package in R software is used for statistical analysis,that is,the feasibility,reliability,and validity of the questionnaire are evaluated.2.2 Evaluation of the Applicability of TCM Clinical Guidelines2.2.1 Selection of GuidelinesIn 2008,11 disciplines such as Internal Medicine,Gynecology,Pediatrics,Ophthalmology,Otolaryngology,Oncology,and Orthopedics were issued by the China Association of Chinese Medicine,and 76 diseases evaluated the applicability.2.2.2 Time and place of investigationFrom December 2013 to January 2014,the evaluation of the applicability of clinical guidelines for traditional Chinese medicine diagnosis and treatment throughout 38 Chinese medicine hospitals in China.2.2.3 Evaluation Process and Method2.2.3.1 Methods of EvaluationUse the questionnaire method.The clinicians at all levels finish the"Questionnaire on the Applicability of Guidelines for Clinical Treatment on Traditional Chinese Medicine",collect the questionnaires,and conduct data collation and analysis on the effective questionnaires.2.2.3.2 EvaluatorsIt is suggested that more than five organization from different territory to participate in the evaluation.The number of evaluators is generally around 50(about 10 from each organization),or can be determined based on actual demand.Each disease entities of the guideline evaluation investigates at least the following personnel:no less than 4 chief physicians and deputy chief physicians,and no less than 6 attending physicians and residents in this department.All the materials are arranged by the hospitals construction units,and have a dedicated staff to serve as the investigators,who are responsible for organizing the distribution,guiding the completion and the reclaiming of questionnaires.2.2.4 Evaluation Process2.2.4.1 Questionnaire Completion:The evaluator completed the questionnaire,and the relevant management department are responsible for the electronic data entry of the questionnaire and the reclaiming of the paper questionnaire.There are 3,642 questionnaires were collected.2.2.4.2 Statistical Methodology:Establishing a database by using the Epi3.1,the data was entered separately by two computers.After checking and verifying of the data,using SPSS 16.0 software to evaluate the applicable content with descriptive statistical analysis and comprehensive factor analysis.2.2.5 Evaluation contentThe evaluation of the Guidelines for Clinical Treatment on Traditional Chinese Medicine includes 4 aspects:whether the clinician uses the guidelines and familiar with it,the clinician’s evaluation of the quality and level,application and the suggestions of the guidelines.The clinician’s evaluation of the quality and level of the guidelines includes:whether the scope of application of the guidelines is clear,the terms and diagnostic key points are accurate;the symptom classification,the treatment principle,the formula,the medication,the other treatment methods,the adjustment and prevention are reasonable;The clinician’s evaluation of the application to the guidelines includes:the harmonizing and supporting of the relevant standards(guidelines);the reasonability and integrity rationality of the contents and structure;guidance and the unit’s general practice.Level comparison between diagnosis and treatment routinely,key disciplines,specialized diagnosis and treatment program,the latest clinical research achievements,expert diagnosis and treatment experience;the efficacy,safety and simplicity of the clinical application and the economical efficiency of the treatment program,and its impact to standardize medical management and ensure the quality of medical services.The suggestions to the guidelines from clinicians include:the areas need to be improved,the results need to absorb and the advice on evaluation.3.Research results3.1 Reliability and Validity Analysis of the "Questionnaire on the Applicability of Guidelines for Clinical Treatment on Traditional Chinese Medicine"The results of the reliability study of the "Questionnaire on the Applicability of Guidelines for Clinical Treatment on Traditional Chinese Medicine" shows that:the quality and level of guidelines+application,the quality and level of guidelines,and the Crowns Bach a-coefficient of the guide application were all greater than 0.8,indicating that the consistency between the scale entries is high.The reliability coefficient of "Guideline quality and level+application" is 0.971,and the consistency of the integrated dimension is the best.It shows that the reliability coefficient of the questionnaire is good and the consistency between the items is high.The validity test results of the questionnaire are as follows:KMO value=0.936,Bartlett value=2192.036,test p value=0.From the Bartlett test,it can be seen that the assumption that deny each variable is independent,that is,there is a strong correlation between the variables,indicating that the "Questionnaire on the Applicability of Guidelines for Clinical Treatment on Traditional Chinese Medicine" has a good validity.The results show that the questionnaire has good reliability and validity,with the external and internal consistency.3.2 Evaluation of the Applicability of Clinical Guidelines for TCM3.2.1 Evaluation of the degree of familiarity and use condition to the guidelines by Physicians:The number of persons familiar with the guideline was 3,317(91.1%);The number of persons using the guidelines was 2,856(78.4%).3.2.2 With regard to the evaluation of the quality level of the guidelines,the scope of application,the ratio of the terms explicitly used is 90.3%and 93.33%respectively..Among the options related to dialectical treatment,the proportion of diagnostic key points,syndrome classification,treatment,formula and drug use is 90.96%,83.96%,88.41%,86.49%,and 86.3%respectively;The more explicit proportions of other treatment and adjustment prevention were 79.41%and 65.76%respectively.3.2.3 In the evaluation of the application of the guidelines,the coordination and matching of the content,the reasonability and completeness of the content,the reasonability and completeness of the structure,the proportions are 85.58%,83.44%,83.72%,and 84.68%The comparison between diagnosis and treatment routinely,key disciplines,specialized diagnosis and treatment program,the latest clinical research achievements,expert diagnosis and treatment experience,the ratio are 81.82%,81.93%,75.12%,and 78.36%.The "efficacy","safety","economic efficiency","simplicity" and"impact to standardize medical management and ensure the quality of medical services" proportions of 79.49%,91.68%,87.92%,85.48%and 82.51%respectively.3.2.4 In the view of physicians,the most need to be improved in the guidelines are:to improve the overall level,quality and applicability of the guidelines are 35.5%,18.62%and 42.56%.Physicians believe that the most important results to be absorbed by the guidelines are:the proportion of select "national famous old Chinese medicine diagnosis and treatment programs","special scientific research achievements in the industry,national scientific and technological support research achievements,and hospital characteristic diagnosis and treatment programs are 43.82%,23.23%,9.56%,and 23.39%respectively.In terms of physicians" suggestion to the evaluation of the guidelines,choose the "abolish the guidelines","update the guidelines in time","provide the designing method of guidelines to increase doctors’ trust",and"expand the promotion of the guidelines" are 0.52%,58.68%,28.36%,and 12.44%respectively.3.2.5 From the analysis of the relevancy of the familiarity and usage,and the quality and applicability of the guideline,it is demonstrated that the applicability evaluation is relevant to the familiarity and usage of the guideline,and which shows a positive correlation.4.Research Conclusions4.1 The general familiarity and usage of the clinical guidelines of TCM are good.There is a certain correlation between the doctors ’usage of the guidelines and their professional titles.The attending physicians would use the guidelines more frequently 4.2 The general quality level and application of the clinical guidelines of TCM are relatively good.Differences still exist in the content of the guidelines and in the treatment of syndrome differentiation,and attention should be paid to other levels of treatment and prevention when revising of the guidelines in future.In the application of the guidelines,attention should be paid to the latest clinical research results and the unit’s expert experience level to improve the clinical application of the guidelines.4.3 The applicability of the guidelines in the clinical context is related to the level of familiarity and usage of the guidelines by physicians.In the future application and promotion of the guidelines,attention should be paid to improving the applicability of the guidelines in the clinical context,updating the guidelines in time and increasing the trust of doctors.