| ObjectiveTo make the best use of TCM unique diagnostic and therapeutic technologies, standardized guidelines are needed for screening and evaluating these technologies. The study is to develop Evaluation guidelines on TCM unique diagnostic and therapeutic technologies to improve quality of related studies.ContentExploring TCM diagnostic and therapeutic technologies characteristics and connotation; Analyzing related literature to formulate the basic framework of guidelines; Consensus approaches such as expert interview, questionnaires and consult are used to form guidelines draft; we take Edged acupuncture treatment for lumbar disc herniation as an example to test the practicability of the guidelines.Method1. Documentary researches:A large number of related literatures were collected to be combed and classified. Consensus method in developing latest TCM clinical guidelines were summarized and analyzed to lay a foundation of my studies.2. Research Framework:Core groups including professionals were set to make related questionnaires. Consensus method from experts contributed to be the pillar of guidelines3. Item details:On the basis of the framework, focus group discussions were used to polish the details of my studies, to refine the guidelines draft.4. Guidelines draft research stage:Modified Delphi method were applied and further feedbacks were collected from experts to perfect the draft.5. Preliminary verification stages of the Guidelines:Practices serve for testing the truth. To test the feasibility and practicality of the guidelines, we selected Edged needles in treating prolapse of lumbar intervertebral disc as an example to do a retrospective analysis. We not only proved the efficacy of this micro-surgery therapy, but also verified the applicability of the Guidelines.The verification even provided data to support perspective study.ResultIn the process of establishing guidelines, experts consensus approaches were applied for many times. After building the basic framework of the guidelines,10 chapters with 38 summaries were formed.When it came to item details, TCM authorities and professionals were further consulted, we adopted their advices and draft came out. In the preliminary process, modified Delphi method acted as a method of consensus, we chose experts for consultation nation-widely. Related questionnaires were developed, we distributed and recollected them. By analyzing the data of questionnaires, the response rate was 100 percent, the effective rate was 97%, expert active coefficient was 100%.Experts gave feedbacks for nine chapters with a total of 45 items, full marks rate were greater than 70%, full marks rate for each item was greater than 80%. We concluded that each item was of significance.Diverse opinions aggregated from panelists were highly centralized, CV<0.300, Kenders harmonious coefficient was 0.9, which indicated that the consultation had high credibility.In the practice stage of the guidelines, we had done substantial work to evaluate a variety of unique diagnostic and therapeutic techniques. In this study, a retrospective study, edged needles in treating prolapse of lumbar intervertebral disc, was selected as an example to refine the guidelines.We tested eight chapters with thirty five items in the guidelines, including organization management, registration management, personnel allocation, research flow and design, patients’ rights and interests protection, quality control, research reports.Conclusions1. Guidelines on TCM unique diagnostic and therapeutic technologies experienced a process of literature researches, expert consultation and field surveys, the guidelines included nine Chapters.2. Guidelines on TCM unique diagnostic and therapeutic technologies evaluation were put into practice for Edged needles in treating prolapse of lumbar intervertebral disc, the guidelines’ practicability was enhanced after some amendments.3. Guidelines on TCM unique diagnostic and therapeutic technologies evaluation are to be further improved in practice. |
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