The Investigation On The Design And Feasibility Of Protocols In Clinical Researches On The Non-communicable Diseases With TCM Intervention

ObjectiveThrough developing the the research implementers evaluation questionnaire to evaluate the scientific nature and feasibility of the TCM Non-communicable diseases research demonstration project,understand the basic situation of NCDS research program,explore the common methodology issues of the TCM Non-communicable diseases research demonstration project to provide reference for the traditional Chinese medicine NCDS clinical research plan design.MethodTo develop the questionnaire for research implementers to investigate the scientific nature and feasibility of demonstration project design relying on traditional Chinese medicine NCDS from the perspective of clinical research implementers, following the production methods of scale and with the principles of design of clinical epidemiology.The specific methods are as follows:●Establishing the working group, and making the concept clear that the questionnaire measures as the scientific nature and feasibility of demonstration project design;●Literature study, expert consultation, focus group discussing,research implementers interviews, were comprehensive used to develop items pool, making the research implementers evaluation questionnaire;●Choice2or more slow disease group centers,respondents identified as involved in carrying out research,complete the questionnaire distribution and recovery work, quality control during the investigation, and further perfect the questionnaire, perform a statistical analysis of survey data, submit the scientific nature and feasibility investigation report of NCDS of traditional Chinese medicine research demonstration project.Result●The basic situation of TCM Non-communicable diseases research demonstration projectThe19NCDS of traditional Chinese medicine research plan in2011Special NCDS of traditional Chinese medicine industry are borne by the medical college and its affiliated hospitals. More than half of the large number of center to participate in the project implementation are more than10branch.Involved belong to the exploratory research, clinical research and sample size is larger and most plan design are randomized controlled trial study, using multi-index comprehensive evaluation of outcome.17in intervention plan use a complex intervention,13of the method as a way to combine traditional Chinese and western medicine treatment; On the screening of interference elements,12accord to the previous clinical research evidence,8on the basis of systematic review of clinical trials;In the scheme of complex intervention only14articles related on the basis of explanation; more than half of the article lack the discussion with the various interference factors of the interaction relationship;The advantage of combined intervention is not detailed described in most design plan.Most plans does not cover the research hypothesis; In17randomplan only nine describe randomized sequence,8plan use allocation concealment,all achieve basically blinded.For intervention plans to extension only four have carried on the detailed description and the others are not covered.The scientific nature and feasibility investigation results of TCM Non-communicable diseases research demonstration projectThrough investigating the11NCDS of traditional Chinese medicine research19plan,the questionnaire survey to382study partic pants in the survey perpetrators are female predominance, focused on the age40, with a master’s degree in most,be given priority to with the attending physician and resident, accounted for more than half of that does not participate in the plan to discuss that can objectively reflect the quality of the project design, GCP training staff ratio of83%, very familiar with GCP staff ratio of48.7%, the majority in survey research practitioners are trained in relevant clinical scientific research subject and have the good scientific quality.The scientific score is higher than the feasibility score in382questionnaires, as same as19research plan, including bleeding in the brain to the intervention research plan is the highest scientific score, TCM treatment of chronic nephritis albuminuria research is the highest feasibility score, diabetic microvascular complications of intervention research plan is the lowest scientific and feasible score.From382questionnaires of scientific article grade distribution, the majority people choose "bi jiao xx" and "fei chang xx", explain scientific article grade is generally reasonable, but4.2%of the perpetrators think target population doesn’t meet the needs of the research.2.6%of perpetrators believe into exclusion standard setting, course setting and research cycle settings is not very reasonable. The proportion of the perpetrators who think about the level of expected curative effect in solution, expected target and promotion is not able to achieve the expected results is2.9%,5.5%and2.9%respectively.The distribution of feasible article grade is relatively scattered, the perpetrators select’ji ben xx" and "bi jiao xx" are in the majority, most of the practitioners think the protocol that they participate in is feasible, but74.9%consider the study cost is in general and on the high side.On19protocols of scientific analysis in four aspects, scientific score generally higher concentration in the design of the "research plan", explain that the scientific study of protocol design is reasonable, score is generally low concentrated in the "expected outcomes and promotion", show that the expected results and promote scientific is not very reasonable.The generally high feasibility score of19protocols on the five aspects of feasibility is concentrated in the "design process", manifest the feasibility of design process is better and the generally lower score concentrate on the terms of "compliance", explain the feasibility in terms of compliance situation is not very good. On9diseases of scientific analysis in four aspects, scientific score generally higher concentration in the design of the "research plan", explain that the scientific study of protocol design is reasonable, score is generally low concentrated in the "expected outcomes and promotion", show that the expected results and promote scientific is not very reasonable. The generally high feasibility score of9diseases on the five aspects of feasibility is concentrated in the "design process", manifest the feasibility of design process is better and the generally lower score concentrate on the terms of "compliance", explain the feasibility in terms of compliance situation is not very good. By the scientific nature and feasibility analysis of9kinds of disease, data shows the scientific nature and feasibility of kidney diseases score is higher, the scientific nature and feasibility of diabetes rating is lower.ConclusionThis study adopts the method of making the standard questionnaire and scale, developed the research implementers evaluation questionnaire and carried out a survey of11longitudinal subject19solutions involved in implementation of382scientific research personnel,describe the present situation of the Special NCDS of traditional Chinese medicine industryand explore the evaluation methods in view of the research implementers evaluating the scientific nature and feasibility of the project plan,discovering the feasibility under scientific-common technical problems in the design and implementation of the NCDS protocols, analyzed the reasons and proposed should pay more attention to the feasibility of the protocol design, ensure the scientific nature and feasibility of balance,so as to provide guidance for the future of traditional Chinese medicine industry clinical trials specification design.