| Defining the clinical value of traditional Chinese medicines(TCMs)is one of the main goals of their post-market research and evaluation.During the process of TCM inheritance and development,measuring,evaluating,and optimizing the full lifecycle value of TCMs has become a hot topic.In recent years,the market for TCMs in China has been continuously expanding,with an increasing number of varieties,but quite a few products have similar formulations,similar indications,and unclear clinical positioning,making it difficult to meet the growing health needs of the people for healthcare services.Therefore,how to scientifically screen high-clinical-value TCMs has become a difficult problem for healthcare decision-makers.Evaluation models are important tools for measuring the clinical value of drugs,and are also important reference points for healthcare decision-makers when making complex decisions related to healthcare services and treatments.Foreign researchers have started to evaluate the value of drugs at an earlier stage and systematically developed various drug value evaluation frameworks for different scenarios.Due to the commonality between TCMs and chemical drugs as well as the uniqueness of TCMs,existing international drug value evaluation frameworks and indicators cannot be directly applied to the clinical value evaluation of TCMs.Therefore,targeted research is needed to develop models suitable for the clinical value evaluation of TCMs.Research perspectives are key elements in drug value assessment,and differences in the value structure factors covered may lead to differences in evaluation results under different perspectives,affecting drug decision-making.Therefore,this study aims to explore a multi-perspective evaluation model suitable for the clinical value evaluation of TCMs,providing theoretical basis and practical reference for the study of the clinical value evaluation of TCMs.Objective1.Comparing the characteristics of multiple frameworks of the existing drug value evaluation frameworks in the world,using Chinese patent medicine to conduct empirical evaluation of the preliminarily selected frameworks,and screening the superior framework suitable for evaluating the clinical value of Chinese patent medicine;2.Based on the advantage framework construct the clinical value evaluation framework of Chinese patent medicine from the perspective of the whole society,the perspective of the health system and the perspective of patients.3.To carry out multi-level empirical evaluation of the implementation effect of the clinical value evaluation framework of Chinese patent medicine to prove the applicability and universality of the framework.Methods1.In terms of framework screening,the existing drug value evaluation frameworks in the world were searched by computer,the characteristics,applicable conditions,components and measurement methods of the value frameworks were sorted out,the common characteristics and differences between the frameworks were compared and analyzed,and the frameworks that may be suitable for the value evaluation of Chinese patent drugs were screened out.Qilong capsule was taken as an example to screen out different drug value evaluation frameworks for empirical evaluation of the clinical value of Chinese patent drugs,analyze the advantages and disadvantages of different frameworks,and screen out the advantage framework suitable for evaluating the clinical value of Chinese patent drugs.2.In terms of framework construction,following the formulation principles of index difference,quantification,hierarchy,compatibility and independence,based on the value measurement indicators in the drug value evaluation framework,combined with the clinical value characteristics of Chinese patent medicine,the pool of candidate indicators for clinical value evaluation of Chinese patent medicine was established through group expert discussion.The modified Delphi method was used to construct the evaluation index system of clinical value of Chinese patent medicine from the perspective of the whole society,the perspective of the health system and the perspective of patients.The analytic hierarchy process was used to determine the weight of the evaluation index of clinical value of Chinese patent medicine,and the multi-perspective evaluation framework of clinical value of Chinese patent medicine was established.3.In terms of framework evaluation,the clinical value of Qilong capsule was evaluated by the established clinical value evaluation framework of Chinese patent medicine,and the evaluation results were compared with the previous drug value evaluation frameworks.Secondly,based on the same perspective,the clinical value evaluation framework of Chinese patent medicine was used to evaluate the clinical value of three different Chinese patent drugs(Qilong capsule,Naoxintong capsule,ginkgolide injection),and the evaluation results were compared and analyzed.Finally,the clinical value evaluation framework of Qilong capsule was constructed from different perspectives,and the evaluation results were compared and analyzed.The applicability and universality of the framework were verified from different levels.Results1.A total of 43 international drug value assessment frameworks were retrieved.Based on the range of application,perspective and evaluation indicators of the frameworks,ICER,NICE,IQWiG,PPVF,MCDA and EVIDEM6 value assessment frameworks that could evaluate Chinese patent medicines were preliminatively screened based on the value characteristics of Chinese patent medicines.Qilong Capsule was used to evaluate the empirical value of 6 advantage frameworks.The results showed that ICER,NICE and IQWiG frameworks included few indicators,which only reflected the clinical effect of Chinese patent medicine and the clinical value of health economics.The PPVF framework reflects the effectiveness,safety and health outcomes,cost and quality of evidence from the perspective of patients,but does not consider the accessibility of Chinese patent medicine.The MCDA and EVIDEM frameworks reflect the value of proprietary Chinese medicine in terms of disease burden,effectiveness,safety,economy and innovation,which are relatively comprehensive.However,the accessibility of drugs and TCM characteristic elements of proprietary Chinese medicine are not included,so their clinical value cannot be fully demonstrated.2.In terms of framework construction,it follows the construction principle of clinical value evaluation index system of Chinese patent medicine,integrates,classifies and summarizes relevant evaluation indexes in the drug value evaluation framework of previous literature retrieval,and adopts the proposed index screening criteria according to two rounds of improved Delphi expert questionnaire consultation.The index system of clinical value evaluation of Chinese patent medicine was constructed from the perspective of patients,health system and society.The evaluation index system of clinical value of Chinese patent drugs based on the perspective of patients included 6 first-level indexes,10 second-level indexes and 16 third-level indexes,including effectiveness,safety,economy,innovation,suitability and accessibility.The evaluation index system of clinical value of Chinese patent medicine from the perspective of health system and society included 6 first-level indexes,12 second-level indexes and 23 third-level indexes,including effectiveness,safety,economy,innovation,suitability and accessibility.Ahp was used to determine the weight and combination weight of evaluation indicators in each index system from the perspective of patients,health system and the whole society.The weights of primary indexes in the clinical value evaluation index system of Chinese patent medicines from the perspective of patients were effectiveness(28.7%),safety(18.6%),economy(14.0%),innovation(10.4%),suitability(12.5%)and accessibility(15.8%).From the perspective of health system and the perspective of the whole society,the weights of primary indexes in the evaluation index system of clinical value of Chinese patent drugs were effectiveness(38.3%),safety(26.3%),economy(12.2%),innovation(9.1%),suitability(7.3%)and accessibility(6.8%),respectively.In order to ensure that each index of clinical value of Chinese patent medicine is measurable and comprehensive in its overall value,corresponding evaluation methods and standards were formulated for effectiveness,safety,economy,innovation,suitability and accessibility as well as integrated evaluation of all indexes.3.In terms of framework verification,based on the perspective of health system,CVAF-CPM framework was applied to reevaluate the clinical value of Qilong Capsule,the classic famous prescription.The results showed that the effectiveness,safety,economy,innovation,suitability and accessibility of the Chinese patent medicine could be fully reflected in this framework,which has feasibility and superiority compared with previous frameworks.Based on the perspective of health system technology,three different Chinese patent medicines,namely Qilong Capsule,Naoxintong Capsule and ginkgolide injection,were selected to verify the CVAF-CPM framework.The results showed that the clinical value evaluation results of the three Chinese patent medicines were 0.8035,0.7605 and 0.8398 points,respectively.Can reflect the applicability of its framework.The CVAF-CPM framework evaluated the clinical value of Qilong Capsule from the perspective of patients,health system and the whole society.The results showed that Qilong capsule scored 0.7825 points,0.8035 points and 0.8035 points,indicating that CVAF-CPM can better reflect the clinical value of Chinese patent medicine.It has certain universality.Conclusion1.There are differences in the scope of application,intended use,research perspective,index content and other characteristics of the existing drug value evaluation models in the world,and the universal drug value evaluation model cannot fully reflect the clinical value of Chinese patent medicine.Based on the multi-criteria decision analysis model,the clinical value evaluation model of Chinese patent medicine was constructed,which was divided into CVAF-CPM model from the perspective of the whole society and the health system,and CVAF-CPM model from the perspective of patients.3.After different levels of verification and evaluation,CVAF-CPM has good superiority,universality and applicability,and the model reflects the clinical value factors of Chinese patent medicine,TCM syndromes,and Chinese medicinal materials.Highlights of innovation1.This study constructed a multi-perspective evaluation model for the clinical value of Chinese patent drugs(CVAF-CPM),which reflects the unique elements of traditional Chinese medicine(TCM)such as TCM syndromes and herbal resources.2.This study innovatively developed a set of evaluation methods for various indicators of the clinical value of Chinese patent drugs and a comprehensive evaluation method,providing practical basis and theoretical foundation for future research on the clinical value assessment of Chinese patent drugs. |
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