Formulation Of The Classification Standards For Recommendations In The Clinical Guidelines/consensus Of Traditional Chinese Medicine

Objectives:In the domain of clinical practice guidelines(CPGs)of Traditional Chinese Medicine(TCM),developing and grading high-quality,clear,transparent and operable recommendations is an important approach to promote the translation from research evidence into clinical practice.At present,recommendations in TCM CPGs or expert consensuses are ungraded or evaluated by different grading standards.Moreover,the reporting of those recommendations is usually ambiguous,insufficient or not standardized.Thus,developing unified,standardized grading system of recommendation in TCM field could not only instruct forming and implementation process of scientific clinical recommendations,but also promote the evaluation and research of TCM CPGs and expert consensuses.Hence,we decided to explore and make the rating criteria of strength for recommendations in clinical practice guidelines of Chinese medicine.Methods:This study consists of two parts.The first part is literature study,which included 33 TCM CPGs,covering internal medicine,acupuncture and other special diseases,and 32 guideline developing handbooks released by different representative guideline developing institutions.Information related to developing,grading,and reporting recommendations was extracted.The second part is expert consensus which is divide into questionnaire survey and consensus meeting,The questionnaire survey was conducted by "Wenjuanxing" website based on the literatures research.Then,according to the results of questionnaire survey,we held an expert consensus meeting in order to demonstrate every item in the criteria.Lastly,the rating criteria of strength for recommendations in clinical practice guidelines of Chinese medicine was generated.Results:Firstly,in the part of literature research,nine parts of information were extracted from TCM CPGs including basic information,grading of evidence quality and recommendations,summary of recommendations,main body recommendation,reporting items of recommendation,target population,interventions,formula/Chinese patent/acupuncture/moxibustion/cupping/tuina/external therapy,explanations,etc.Three parts of data consisting of basic information,method of rating evidence quality and strength of recommendation,reporting form of recommendations was detected in guideline handbooks.Secondly,we made initial items on the basis of previous work,and invited 36 experts conducting a questionnaire survey by "Wenjuanxing" website,who maj or in integrated medicine,Chinese medicine,evidence-based medicine,journal editing,etc.As a result,a total of 30 valid survey were collected.Lastly,we held an expert consensus meeting coving 14 researchers who expert in relevant field in order to discuss and modify each item based on previous survey.Finally,we summarized above results and generated the rating criteria of strength for recommendations in clinical practice guidelines of Chinese medicine including of report principles for the developing of recommendations,factors affecting recommendations,rating and expression of recommendations and content report of recommendations.Conclusion:The feature of TCM should be fully considered in the development of CPGs.When generating recommendations,different factors such as the evidence of clinical research,ancient literatures evidence,experts experience,etc.,should be taken into fully consideration.Moreover,formal consensus methods should be used to form and rate the grading of recommendation,and the process should be clearly reported.In the main body of guidelines,core content of recommendations should also be reported specifically.