Research On Methods For Formulating And Reporting Norms Of Clinical Experts In Traditional Chinese Medicine

The release of traditional Chinese medicine(TCM)standardization documents has been promoting the formulation of standards in TCM industry,which include clinical practice guidelines(CPGs)and clinical expert consensus.However,due to the problems of"insufficient evidence "or"very low quality" in the field of TCM,the development of CPGs is always faced with difficulties.Meanwhile,because of the research cycle,the lack of high-quality clinical evidence cannot be solved in a short time.In order not to affect the effective implementation of clinical decisions,it is necessary to formulate scientific and normative documents that can help to guide clinical decisions.Based on international experience,we find that the clinical expert consensus is suitable to provide guidance and help for clinical practice in the absence of clinical evidence or high-quality clinical evidence.However,different from the CPGs,researchers in the field of TCM still have insufficient understanding of the development method of clinical expert consensus.In order to deepen researchers' understanding of clinical expert consensus,this study explored the development process and reporting guideline of clinical expert consensus.It is hoped that this study can help to promote the development of clinical expert consensus,and solve the current situation of consensus development in the field of TCM.Objectives1 Systematized search the international consensus statement documents,and summarize the process of consensus formulation.Then combine with the domestic situation and the characteristics of TCM,supplement and adapt it to form the consensus formulation process of clinical expert consensus of Chinese patent medicine.2 Systematized search the international consensus statement documents,extract and summarize the report items.Then combine with the domestic situation and the characteristics of TCM,supplement and improve them to form the reporting checklist for the clinical expert consensus of TCM.MethodsThis study was divided into several parts including retrieval,screening,extraction,evaluation and modification.(1)Literature related to consensus was obtained through PubMed and CNKI,and the search terms included "consensus statement","expert panel","consensus document ","consensus reports "and "consensus guidelines",etc.(2)Firstly screening out the institutions which have developed consensus statements more than others,and the relevant methodology reports.Then the consensus development manuals of each institution were collected by searching the official websites of the institutions.By looking at the separately released consensus documents,the consensus documents clearly describing the development process were screened out.(3)Extract the items and important topics in the development manuals and methodology reports to form the initial lists.Establish the table of initial list,extract the data of the original consensus documents,check the items of the initial lists and record the new items which are not included in the initial lists,and form the items pool.(4)The working group discusses the corresponding relationship between the items in the items pool and between the items and the topics,and forms the first draft.Methodological experts with exp erience in consensus formulation were invited to give several rounds of feedback on the first draft.At last the final draft and explanatory documents of the manual and reporting guideline were formed according to the revision opinions.ResultsBy searching the consensus documents published over the years,this study sorted out a number of institutions and societies which have formulated high-level consensus statements in the world,including National Institutes of Health(NIH),American College of Cardiology(ACC),American Academy of Otolaryngology-Head and Neck Surgery(AAO-HNS),American Society of Clinical Oncology(ASCO),and American College of Chest Physicians(CHEST).The development manuals and report guidelines of these institutions are summarized.Learning from the manuals and report guidelines,combined with other excellent consensus document,and considered the problems may be faced when formulating and reporting clinical expert consensus of TCM,the development manual of clinical expert consensus of Chinese patent medicine called "ten steps" and reporting checklist of clinical expert consensus of TCM was formed after repeated discussions and modification.The manual can be divided into ten steps,including project team formulation,questionnaire investigation,clinical problems determination,literature retrieval,screening and analysis,evidence evaluation,formulating consensus recommendations or consensus advice,writing draft,opinion request,peer review,review and release.There are 30 terms in the reporting checklist,including basic information(1-5),background(6-10),methods(11-14),consensus(15-17),discussion(18-20),review and feedback revision(21-23),funding and conflict of interest(24-25),and annex(26-30).The manual and reporting checklist have also been included in the compilation statement by the Standardization Department of China Association of Chinese Medicine.Conclusions1 As for the current research status of TCM,it is unrealistic to blindly pursue high-quality CPGs.Instead,we can follow the evidence-based medicine,formulate clinical expert consensus in line with the national conditions to provide guidance and help for clinical practice.2 Learning from the international scientific consensus development process and reporting methods,combined with the characteristics of TCM,and considering the domestic research environment,the development manual of clinical expert consensus of Chinese patent medicine and the reporting checklist for clinical expert consensus of TCM can be formed preliminarily.