The Research On Traditional Chinese Medicine Clinical Practice Guideline:Treatment Of Clavicle Fracture,Evidence-Based Guideline,Revised Edition

ObjectiveTo establish traditional Chinese medicine clinical guideline for treatment of clavicle fracture scientifically and canonically, through evidence-based medical study, classification standard of TCM literature, Delphi expert consensus, argumentation of expert meeting and peer evaluation.Methods1. Evidence-base medicine study:literature searching, study identifying, quality assessment and evidence recommendationPubMed, Embase, the Cochrane Library, CNKI, WANGFANG, VIP, TCMDB, CDMD, Disease diagnosis and treatment database, Disease diagnosis and treatment of TCM standard database, Clinical trials registry in China and America, Clinical guideline databases include NGC, NICE and SIGN were searched in June 2015 comprehensively. The included studies were identified by inclusion and exclusion criteria strictly.The methodological quality was assessed initially and criterion score was set to be quoted as guide evidence (Randomized controlled trials:Cochrane risk of bias tool, Jadad scale score greater than or equal to 3 points; Non-randomized clinical trial:MINORS, item score greater than or equal to 13 points; Meta analysis:AMSTAR scale score greater than or equal to 3 points; respectively).The clinical studies which met the foregoing criterion were graded and recommended based on the classification standard of TCM literature.2. Delphi expert consensus, argumentation of expert meeting and peer evaluation.Based on evidence-base medicine study and principle of Delphi expert consensus, the Delphi expert questionnaire was underwent by email for forty experts in two rounds’ surveys. The recycling questionnaires were analysed from the aspect of based characteristics of experts, participation index and various indexes of experts’ opinion. The guideline graft was drafted and revised according the Delphi expert consensus. Expert meeting was convened in Guangdong Provincial Hospital of Chinese Medicine on August 14,2015, invited TCM orthopedics specialist to examine and verify the guideline graft and then drafted the guideline evaluation draft. The methodological quality of guideline evaluation draft was assessed on the aspect of scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability and editorial independence by The Appraisal of Guidelines for Research & Evaluation (AGREE)Ⅱ.200 case questionnaires of consistency evaluation was designed and used among the 10 medical institutions. The revised guideline was improved and updated by summary of the peer evaluation.ResultsThrough evidence-base medicine study, two rounds of Delphi expert survey and one time of expert meeting, TCM clinical guideline graft for treatment of clavicle fracture (revised edition) was initially drafted. Based on AGREE Ⅱ, The scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability and editorial independence of the guideline evaluation draft were evaluated high consistency. The clinical consistency of the revised guideline was resulted more than 70% in 200 case questionnaires among the 10 medical institutions. TCM clinical practice guideline for treatment of clavicle fracture (revised edition) was established scientifically and canonically in the improvement and update of scope, term and definition, diagnosis, syndrome differentiation, treatment and functional training.ConclusionThis is the first attempt in TCM orthopedics evidence-based guideline to establish TCM clinical guideline for treatment of clavicle fracture (revised edition) through evidence-based medical study, classification standard of TCM literature, Delphi expert consensus, argumentation of expert meeting and peer evaluation. This guideline was of great importance in TCM standard and canonical clinical practice for treatment of clavicle fracture. However some possible limitations and future research directions were pointed out in the aspect of high quality evidence, multidisciplinary of working group, clinical consistency of one-year case survey、evidence recommendation system in this guideline. That should be improved and updated in the future guideline revision to ensure the scientificity and advancement of the guideline research.