Study On Establishment And Application Of Evaluation Indicators Of Internal Control For Traditional Chinese Medicine Clinical Research

Traditional chinese medicine(TCM)clinical research quality control evaluation,as a form of scientific and technological assessment,can scientifically and objectively reflect whether the implementation of the research in accordance with the clinical research protocol and its implementation level,then find problems of implementation in the study in order to facilitate timely correction and adjust to ensure the quality of the study.Based on the 11th Five-Year National Science and Technology Support Program Difficult and Complicated disease Prevention and Treatment of TCM project and the 12th Five-Year National Chinese Medicine Administration of Chinese medicine research Prevention and Ttreatment of Chronic Disease Clinical Research of TCM project,constructed third-party quality control evaluation indicators(external control evaluation indicators)suitable for TCM clinical research.But the scope of its application has relevance.It has been proved that the above evaluation indicators significantly guaranteed the quality of TCM clinical research.However,the use of independent third-party quality control(external control),needed cost a lot of manpower,material and financial resources.For some TCM clinical research,if not set up special funds for quality control,would lead to the lack of supervision,resulting in the quality of clinical research could not be guaranteed.As the clinical research administors of the Chinese medicine hospital management department,it was needed to strengthen scientific research management and quality control from inside the hospital,to ensure the result of TCM clinical research scientific and reliable.Therefore,it was needed to construct quality control system(internal control management)for TCM hospital.After the literature search,there was no quantitative internal control evaluation indicator for TCM clinical research and scientific research management department.The internal control management of the scientific research management department had the characteristics of scientific research management and quality control,and the quantitative evaluation indicators constructed by the third party quality control were not applicable for it.Therefore,it was necessary to constructe the interal control management indicators for the quality of TCM clinical research.1 Objective1.1 On the basis of the external evaluation indicators for TCM clinical research in the early stage,this paper constructed the internal control evaluation indicators for TCM clinical research quality according to the characteristics of internal control management of scientific research management department,to achieve the quantitative evaluation of TCM clinical research quality,and provide new methods for internal control management of scientific research management department.1.2 Taking into account the reality of scientific research management needs,develop a quality control and quantitative evaluation related functions as the core of network quality control supervision and management platform to achieve quality control of remote,real-time monitoring,and improve quality control efficiency.1.3 Put the final internal control indicators into the construction of quality control supervision and management platform,through the examples applied the indictors in order to prove the scientific and practical of the evaluation indicators and the quality control management platform.2 Methods2.1 Based on the previous study,combined with the literature research on the characteristics of internal control research management,using core group discussions,the composition of the elements and indicators of the internal control evaluation indicator were initially determined.But it was not determined which indicators were included in each element.2.2 After the first round of expert surveys,the opinion of the experts of the scientific research management department on the atttribution of the indicators to elements was summarized.By the frequency advantage method to choose the experts opinion(at least 50%of the scientific research management department experts agreed indicators attributed to the element as a basic selected condition),the internal control indicators of TCM clinical research(multidimensional structure model)was initially constructed.2.3 Inspected the quality of studies of project of Prevention and Ttreatment of Chronic Disease Clinical Research of TCM,the modeling data which was used to select and validate the indicators was acquired.2.4 After collecting the modeling data needed,using the multidimensional generalized partial credit model(MGPCM)of multidimensional item response theory(MIRT),internal control indicators was selected by the discrimination parameter of entirety and each elements.Then the structure and composition was adjusted once again,and the internal control theoretical evaluation model was determined.2.5 The theoretical model of the inernal control evaluation indicators was assessed and confirmed by reliability and validity based on the Classical Test Theory(CTT).The reliability evaluation indicator depended on Cronbach's alpha(Cronbach ? coefficient);the construct validity was evaluated by Structural Equation Model Second-order Latent Variable Model(SEM-SLVM).Using Partial Least Square(PLS)with bootstrap method,significance of parameter estimation was tested to assess the reasonableness of the internal evaluation indicators.The fitting condition of data and internal control model was also analyzed.2.6 The internal control evaluation indicators,which were tested by reliability and validity,were feedbacked to experts of the research management department,and conducted the second round of expert surveys to finalize the internal control evaluation indicators model and its subjective weight.2.7 Put the final internal control evaluation indicators into the evaluation of the quality of 13 clinical studies of Xiyuan Hospital of China Academy of Chinese Medical Science,and construction of traditional Chinese medicine clinical quality control supervision and management platform.According to the subjective weight weighted sum method,all studies quality score were calculated.According to the quantitative evaluation results,the results of quality control of 13 subjects were analyzed.3 Results3.1 After the core group discussion,the internal control evaluation indicators of clinical studies quality of TCM were initially constructed,including a target(internal control evaluation of TCM clinical research),4 elements(research program compliance quality assessment,research data records quality assessment,subject rights protection quality assessment and internal management of the study group quality assessment),13 indicators(the implementation of the study design method,compliance of subjects inclusion and exclusion,intervention measures consistent with the program,integrity and accuracy of intervention records,the integrity,accuracy and normalization of case report form(CRF),the record and analysis of the adverse events(AE)/serious adverse events(SAE),the ethical review,signatures of informed consent,appearance rate,the progress of the research,the quality control,the reasonable use of research funds,the authenticity of the subjects verified).3.2 The 13 indicators have been ascertained by the first round of expert consultation,and according to scientific research management expert opinions on selecting indicators for elements.In the end,there were eight multi-dimensional internal control evaluation indicators attributed to two different elements such as compliance of subjects inclusion and exclusion,the record and analysis of AE/SAE,the ethical review,signatures of informed consent,appearance rate,the progress of the research,the quality control,the authenticity of the subjects verified.And based on this,internal control evaluation professional model(multi-dimensional internal control evaluation model)appeared.3.3 The collection of modeling data in this study involved 28 TCM clinical studies of Prevention and Ttreatment of Chronic Disease Clinical Research of TCM project.Internal control experts scored the quality of each clinical study according to the Internal Control Evaluation Form of TCM Clinical Research Quality,and finally obtained 168 data.3.4 The authenticity of subjects of all studies have been verified,the indicator subjects authenticity verification was well implemented.Through the core group discussion,the indicator was not carried out quantitative evaluation in the futhure,only as a prerequisite for internal control quantitative evaluation.Only on the basis of authenticity verification,the inernal quality control quantitative evaluation could be carried out.Then MIRT was used to evaluate the remaining 12 indicators of the internal control evaluation multidimensional structure model.The entirety structure and each element level of the internal control indicators were selected by the discrimination parameter.Finally,two internal control evaluation models were found.3.5 Application of Cronbach a and SEM-SLVM,two theoretical models were valided from the aspects of internal consistency and strucrural validity of the indicators.The results of the reliability test showed that the overall reliability coefficients of the 12 internal control models was 0.6,which could be accepted in the practice.Eliminate one model which Cronbach a value for element was negative.Finally,another model was preserved,because the internal consistency of the element was positive.The structural validity test results also showed that the loading coefficient between the evaluation indicators and the elements and the path coefficient between the elements and the target layer were all significant.Further more,Goodness Fit Index(GFI)was 0.812,close to 0.9,Incremental Fit Index(IFI)and Comparative Fit Index(CFI)were close to 0.6.Though they were not so perfect,it could be considered that the model fit index was acceptable in practical applications.3.6 By consulting the second round experts' opinions,the structure and subjective weight of the internal control evaluation indicators model were confirmed.At this point,the internal control evaluation indicators for TCM clinical research were finally ascertained.It contained 1 target(internal control evaluation of clinical studies quality),4 elements and 12 indicators.Among them,element of research program compliance quality assessment contained 3 indicators(the implementation of the study design method,compliance of subjects inclusion and exclusion,intervention measures consistent with the program);element of research data records quality assessment contained 4 indicdors(integrity and accuracy of intervention records,the integrity,accuracy and normalization of CRF,signatures of informed consent,quality control);element of subject rights protection quality assessment contained 2 indicators(the ethical review,the record and analysis of AE/SAE);element of internal management of the study group quality assessment contained 3 indicators(appearance rate,the progress of the research,the reasonable use of research funds).3.7 The use of internal control evaluation indicators and quality control supervision and management platform,the quality of 13 studies were quantified.And the results could be showed through the quality control supervision and management platform.And the platform has achieved the functions that loaded the quality control list and quality control report,making the future quality control more standardized;provided electronic management of research materials;achieved the progress of research,achieved quality control of the studies of remote real-time mointoring.4 Conclusions4.1 The method of selection of internal control evaluation indicators was combination of the professional selection and MIRT selection.The entirety structure and each element level of the internal control indicators were selected by the discrimination parameter of MIRT.And this provided a new idea and method for the construction of quality evaluation indicators for TCM clinical research.4.2 Based on external control evaluation indicators for the previous TCM clinical research and the characteristics of the internal control management of the scientific research management department,combined with professional selection and MIRT selection,after the scientific verification of the validity and the reliability,constructed internal control evaluation indicators for scientific research management department to evaluate the quality of TCM clinical research.The indicators further enriched and developed the clinical research quality evaluation indicator system.4.3 Through the application of the internal control evaluation indicators,the internal control evaluation indicators for TCM clinical research could reflect the quality of the implementation of the studies well;achieve the objective comparison of the different studies and the implementation of different indicators;intuitively show the key factors that affected the quality level.And this provided a basis for scientific research management decision-making.4.4 This study constructed quality control supervision and management platform for TCM clinical research,which has achieved the basic objective of the original design purposes.And by quality inspection of the Chinese Academy of Traditional Chinese Medicine Xiyuan Hospital 13 studies tested the platform and the internal control evaluation indicators.Overall,the scientific and practicability of TCM internal control evaluation indicators and quality control supervision and management platform were scientific and validated.And the quality control efficiency has been already improved.