| For the past few years, government increase support for TCM, set up multitier national grade scientific research item, traditional Chinese medicine projects resource allocation gradually increasing, therefore project found、research process execute and evaluate will profound influence for TCM.Quality control is activity and operation technique that achieve quality requirements. In the field of TCM clinical research, quality control is necessary measurement for guarantee the scientificalness of study design and rationality of ethics research record and research authentic. Therefore, conducting quality control of TCM clinical research to guarantee the authenticity and standardization, is particularly important and receives increasing concerns from the government and the public. Ministry of Science and Technology set up a "Scheme Optimization and Quality Control for TCM Clinical Research" project, in the "Prevention and Treatment of Difficult and Complicated Disease of TCM " plan of the "11th Five-year National Key Technology R&D Program" for the first time, to implement the project optimization and process quality management for TCM clinical research, through the establishment of four-level quality control and quality assurance system.Based on quality monitoring results, we analyzed the quality management level in accordance with the scheduled target, and predicted the development trend. The final intention of quality control evaluation of TCM clinical research is to solve the problems, then adjust or correct the execution process in time.Objective:1.Based on mid-term and process evaluation indictors, to establish indicators of final quality control evaluation.2. To evaluate the reliability and validity of indicators, and explore the application value in final quality control evaluation for TCM clinical research.3. Utilize imaging combine quality control checking information to evaluate the quality of TCM clinical research. 4. Explore to set up a trends model of TCM clinical research to observe and analysis the changeness of quality of research.Methods:1. established a set of index system for quality. Secondly the expert investigation method was used to determine the12remained core indicators’ subjective weighting, according to which the quality control evaluation score of a project was calculated. And the reliability and validity of the indicators were evaluated through structural equation model (SEM). Considering data’s skewed distribution, partial least squares (PLS) estimation method was used to calculate the objective weighting, according to which the score and the ranking of a project was computed. Finally to compare and analyze the three scores, we discussed the application of quantitative indicators in TCM clinical research. Utilize flashing lightning chart for observing the difference of final evaluation indictor mean score.2. Try to take the radar chart for imaging of the quality control information and records to evaluate the final quality of TCM clinical research.3. Explore to set up a Markov model of TCM clinical research to observe and analysis the changeless of research quality.Results:1. The indicators of final quality control evaluation for TCM clinical research consisted of4essential factors (trials design, quality of record, electronic data management, ethics and quality control) and12indicators (random trials of designing, blindly trials of designing, integrity of medical records, integrity of CRF records, unreasonable alternation of CRF records, recording of Adverse Event reporting, take the appoint database, accuracy and integrity of indicators between CRF and database, tracing back of CRF, signatures of informed consent, primary examination and secondary inspection).2. Results of the reliability indicated:the combination reliabilities of all latent variables were over0.7, demonstrating that latent variables could be effectively measured by corresponding observation variable indicators. Most average variance extracted (AVE) values of latent variables were higher than0.5, which illustrated that majority variation of latent variables are from real variation, and the measurable variables could strongly explain the variation of latent variable. Results of the validity analysis showed:by bootstrap, Visual PLS Explore the routine、load, indicating good model fitting effect. According to the scores calculated respectively on the subjective weighting and objective weighting, it was favorable to distinguish projects on the four extremities, the coincidence rate was80%. For those projects in the middle (the second quartile and third quartile), the calculated scores based on subjective weighting and objective weighting respectively differed greatly and the coincidence rate was higher than60%, the first quartile and third quartile coincidence was higher than90%, and the other quartile is simply to them. Analysis the three methods by Kendall’s tau, results indicated:subjective and objective related coefficients is0.74, score and objective related coefficients is0.731, score and objective related coefficients is0.967.Utilize flashing lightning chart observe that average score is lower in the indictors of "tracing back of CRF"、"primary examination"、"blinding"; average score is higher in the indictors of "recording of Adverse Event reporting"^"integrity of CRF records"、" take the appoint database"、"signatures of informed consent", the other indictors present the otherness form higher to lower.2. From the analysis reasults indicate:almost quality transfer is positive, for example:①the powder from the class"excellent"to "fine" is1.106; the powder of transfer "medium" and "discrepancy" are0.0356and0.117;②the powder from the class "fine" to "medium" or to "excellen"are almost same, there are0.8724and0.9082, the powder of transferring to "discrepancy" is0.5892;③for "medium" projects, the powder of transferring to "excellent" or "fine" is relative higher, to " discrepancy" is relative lower;④for "discrepancy" class powder of transferring to" fine" is0.6843, to "excellent" or "medium" is lower, these results above show the positive tendency is obvious.Conclusion:1. Final quality control evaluation indicators on the basis of quantitative indicators of mid-term and process of evaluation.The results of reliability and validity analysis were within acceptable range, which indicated close internal relationship between the index construction and final quality control evaluation, this set of indicators is an effective tool to measure the level of final quality, is also important work connect to mid-term and process of evaluation.2. Ranking the projects on scores calculated by subjective weighting of expert opinion and objective weighting of mathematical characteristics (PLS), could better distinguish quality projects (the first quartile to fourth quartile).The calculated scores based on subjective weighting and objective weighting respectively differed greatly and the coincidence rate is higher than60%, three methods’ consistency relatively high.3. Utilize the radar chart for imaging of the quality control information and records is a feasible tool for evaluating the final quality of TCM clinical research.4. Utilize flashing lightning chart can observe the difference of one class project in all indictors, can also observe the difference of all classes projects in one indictor, which analysis the difference of the quality in projects.5. Markov model of TCM clinical research indicate every class projects quality positive transfer, which state the quality control can improve the quality of projects, also show that dynamic variation of quality of projects.6. The third party quality control inspection and administration section provide the guarantee for42disease projects in quality control. Feedback the results on time that make the clearly problem which be solved, can improve the quality of the research. |
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