| BackgroundTraditional Chinese medicine(TCM)is an individualized model with the syndrome differentiation and treatment as the main body.Although its clinical efficacy has been verified for a long time,it lacks scientific and objective evidence.The current group research methods dominated by evidence-based medicine and clinical epidemiology have been applied in the evaluation of the effectiveness of TCM.Although the output of clinical evidence has been standardized,it has brought about the problem of the lack of characteristics of syndrome differentiation and treatment,and it is difficult to meet the needs of individualized practice and analysis.There is still a gap with the objective evaluation of the true curative effect of TCM.Constructing an individualized curative effect evaluation method that meets the characteristics of syndrome differentiation and treatment has become a research problem that needs to be solved urgently.ObjectiveBy combing the time and space characteristics of syndrome differentiation and treatment,aiming at the complicated evaluation problems caused by individual differences of patients in the dynamic change of time,the individualized Long-term efficacy evaluation method of traditional Chinese medicine is proposed.On this basis,the research framework and implementation steps are formed,and the demonstration construction,system development,and clinical verification of the evaluation method are carried out in combination with specific diseases.This paper hopes to establish a complete method research and practice system,realizing the objective dynamic evaluation and long-term prediction guidance of individualized efficacy of traditional Chinese medicine,assisting the improvement and innovation of individualized efficacy evaluation method of traditional Chinese medicine,and optimizing the output and application of clinical evidence of traditional Chinese medicine.Methods1.Proposal of the individualized Long-term efficacy evaluation methods of TCMClearing up the characteristics of time-space for syndrome differentiation and treatment,analyzing the limitations of current grouped evaluation methods that applied to the evaluation of individualized efficacy evaluation of TCM,and summarizing the scientific question;Proposing the individualized Long-term efficacy evaluation method of TCM based on the working foundation of the team,and making clear its connotation and main body;Analyzing the speculative process of individualized diagnosis and treatment and evaluation for TCM with reference to PICO model from the perspective of structured construction of research issues,the research framework and implementation strategy of the individualized Long-term efficacy evaluation method of TCM are formulated to fit the connotation and improve the main body of Long-term evaluation method.2.Demonstration and construction of the individualized Long-term efficacy evaluation method of TCMThe Long-term evaluation method is demonstrated and constructed based on the research framework and implementation steps:1)Take non-ST-segment elevation acute coronary syndrome as a disease example,systematic reviews combined with expert brainstorming and analysis of clustering and factor to form a summary list of individual outcome indicators;2)Take non-ST-segment elevation acute coronary syndrome as a disease example,network meta-analysis is used to form a summary list about the rank of efficacy for fixed interventions among different indicators;3)Bibliometrics method is used to summarize the individualized research results of TCM,arranging and forming the summary list about the individualized comparison methods;4)Bibliometric method is used to summarize multi-disciplinary longitudinal data models,arranging and forming the summary list about the individual data analysis methods.3.Exploration and development of the individualized Long-term efficacy evaluation system for TCMBased on the summary list from the demonstration and construction of the Long-term method,an personalized selection module is formed by the support of the lists about the rank of efficacy for fixed interventions among different indicators and individual outcome indicators;a logic analysis module is formed by "the comparison of curative effect before and after individualized treatment" that selected from the list of individualized comparison methods;an external calling analysis module is formed by "the nonlinear latent variable growth curve model" that selected from the list of the longitudinal data models.The Eclipse+JDK+SDK+ADT is used as the integrated development platform built by the Android mobile client system and the MySQL+Java Web+Tomcat is used as the development platform of the system background server based on the guidance of the three-layer architecture.The individualized Long-term efficacy evaluation system for TCM is designed and constructed,optimizing the Long-term evaluation method based on the information model.4.Clinical application of the individualized Long-term efficacy evaluation methods of TCMBased on the individualized long-term efficacy evaluation methods of TCM,100 patients with non-ST-segment elevation acute coronary syndrome are included through a combination of retrospective and prospective registry study design.The evidence-based goal achievement assessment provides dynamic follow-up and observation of patients,quantitatively evaluates the individualized curative effect of TCM before and after treatment.The nonlinear latent variable growth curve model is combined to analyze curative effect differences,changing trends,and influencing factors from the individual level.Time series analysis is combined to forecast the trend of individualized Long-term efficacy from the patient level and give individualized guidance in combination with curative effect factors.Results1.Proposal of the individualized Long-term efficacy evaluation methods of TCMThe temporal and spatial characteristics of syndrome differentiation and treatment are individual differences and dynamic changes.The scientific problem of the thesis is to explore and solve the complicated evaluation problems caused by the dynamic changes of individual differences in diagnosis and treatment based on syndrome differentiation.Making clear that TCM needs to redefine the overall state of patients through evaluation as time goes by,and its process and practice is the individualized Long-term efficacy evaluation method of TCM.Its connotation is the complete collection of data for individualized diagnosis and treatment of TCM,multi-time point dynamic analysis and quantitative evaluation of individualized efficacy for TCM,long-term prediction and guidance of individualized efficacy for TCM.Its major body is primary selected the evidence-based goal attainment scale method.The PICO model is referenced,and its four components are transformed as follows:the optimization of individualized outcome indicators,individualized intervention evaluation methods,individualized compared methods,and individualized data analysis methods,forming the research framework and implementation steps about the Long-term evaluation method of individualized TCM.2.Construction of the individualized Long-term efficacy evaluation method of TCM1)In view of the optimization of individualized outcome indicators,a total of 130 randomized controlled trials were included to form a list of 125 outcome indicators and 7 types of indicator criteria.After the indicators were combined and optimized,24 outcome indicators were obtained,making the indicators stand out based on a comprehensive and reasonable list.2)In view of the optimization of individualized intervention evaluation methods,166 randomized controlled trials are included,including 69 fixed interventions of Chinese patent medicines.Network meta-analysis indicates a total of 44 Chinese patent medicines of the top 10 curative effects among the 7 evaluation indicators,showing the rank of the efficacy of the same Chinese patent medicine in different indicators.3)In view of the optimzation of individualized compared methods,a total of 74 individualized research results of TCM were included,and 5 comparison models were summarized and sorted out:comparison of individualized efficacy before and after the intervention,comparison of individualized efficacy and recognized efficacy evaluation standards,individual efficacy and group comparison of curative effect,comparison of the individual index and multiple index linear trend,comparison of the individual index and multiple index weight systems.4)In view of the optimization of individualized data analysis methods,a total of 115 articles and 34 longitudinal data models are included.The main subject of the model is mathematics,and the hot research field is medicine.Models are mainly divided into five categories:linear models,mixed-effects models,joint models,data envelopment analysis models,and time series models.It clears up and presents the corresponding characteristics of the model and the connotation of the method.The demonstration and construction above provide the support and improvement about the personalized formulation of outcome indictors,the optimized selection of individualized treatment methods,the selection of quantitative efficacy comparison methods,and individualized dynamic analysis and long-term prediction.3.Exploration and development of the individualized Long-term efficacy evaluation system for TCMThe individualized Long-term efficacy evaluation system for TCM is established by two areas(client areas and background management areas)and three-tier architecture(interface layer,business logic layer,and data access layer).The client area is composed of three modules:researcher login,project manager login,and system administrator.The background management area is composed of six modules:research center management,trial management,disease management,subject management,system authority management,and statistical analysis.Based on the information module formed by the demonstration of the Long-term evaluation method,the individualized data collection,input and operation analysis with the Android system client and back-end server,preliminary realized the optimization of the Long-term evaluation method.4.Clinical application of the individualized Long-term efficacy evaluation methods of TCMAfter the clinical application of the individualized Long-term efficacy evaluation system for TCM,the results of repeated measures analysis of variance for the long-term evaluation method shows that the scores of evidence-based goal attainment scale are on the rise,and there are statistical differences in the scores at different times(P<0.05),the scores of final evaluation were significantly higher than the baseline,the difference has the statistically significant(P<0.05),suggesting that the comparison of individualized efficacy of TCM before and after the treatment is significant.The mean,variance,and correlation of intercept,slope,and quadratic slope for the nonlinear latent variable growth curve model show as follows.Firstly,the retrospective study of individualized TCM efficacy illustrates nonlinear changes and there are individual differences(P<0.05),suggesting that different individuals had different feedback on efficacy in the past.There are individuals with rapid response and improvement.Secondly,the prospective study also illustrates nonlinear changes and there are individual differences of individualized efficacy in the initial level(P<0.05),suggesting that there are individuals with different efficacy feedback in the initial stage of treatment.The covariate results of the model suggest that the influencing factor of the initial level and dynamic change of the efficacy in the retrospective study is the previous medical history,and the influencing factor of the initial efficacy is the syndrome;In the prospective study,the influencing factor of the initial efficacy is the pulse condition.The factors of the later stage are age,deficiency and excess of syndromes,and pulse condition(P<0.05).Taking a prospective research patient as an example,time series analysis predicts that its Long-term individualized efficacy of TCM is better,and individualized guidance reminds patients that he needs to pay attention to the burden of chronic diseases that may increase the risk with age.He also needs to pay attention to tonifying Qi and activating blood based on influence factors of syndrome and pulse deficiency.The content above verified the clinical feasibility of the Long-term evaluation method.ConclusionThis paper closely focuses on the temporal and spatial characteristics of the individual differences and dynamic changes in syndrome differentiation and treatment of TCM,exploring and establishing the individualized Long-term evaluation method and application system of TCM,which is oriented by the difficult clinical evaluation problems,driven by the construction of Long-term evaluation methods,and combined with electrical system development and clinical application,dynamically evaluating the individualized efficacy of TCM and provide long-term prediction and guidance for individuals,helping the improvement and innovation of TCM efficacy evaluation methods,and assisting and optimizing the output and application of TCM clinical evidence. |
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