| BackgroundSince the 1990s,consensus methods have been extensively used in the formulation of clinical practice guidelines(CPGs),and the rational use of the consensus methods is a vital foundation for the scientific guidance provided by CPGs.Like western medical CPGs,acupuncture-moxibustion CPGs are often confronted with the dilemma of "insufficient evidence" or "low-quality evidence" during the formulation.Moreover,as an operational therapy,factors influencing the efficacy of acupuncture-moxibustion are complex.In order to strengthen its guidance function in clinical practice,the treatment protocols of acupuncture-moxibustion are included in recommendations based on comprehensive considerations of the recommended intervention from the aspects of theory,method,acupoint and operation to improve the application value of acupuncture-moxibustion CPGs.Therefore,when there is no reliable evidence available or has different guidance for diagnosis and treatment in the evidence body,knowledge and experience from experts can be deeply excavated through consensus methods to increase the reliability and validity of recommendations and recommended treatment protocols.However,the application of consensus methods in acupuncture-moxibustion CPGs often has the risk of irrational use,such as the representativeness of consensus participants and the standardization of consensus process,and the reporting quality of the consensus in acupuncture-moxibustion CPGs is also uneven.Adverse reporting on the consensus will not only reduce the confidence of the recommendations and recommended treatment protocols from users,but also affect the reproducibility of the consensus process.In order to ensure the reasonable application of consensus methods during the formulation of acupuncture-moxibustion CPGs,especially the consensus process of forming recommended treatment protocols,and the full reflection of the core parts of consensus,it is necessary to research on how to scientifically implement and report consensus method in acupuncture-moxibustion CPGs.PurposeThis study intends to analyze the application and reporting status of consensus methods in acupuncture-moxibustion CPGs comprehensively,explore the factors influencing the consensus-reaching during the formulation of acupuncture-moxibustion CPGs systematically,and put forward methodological suggestions for the planning,implementation and reporting of consensus methods in acupuncture-moxibustion CPGs.Content and MethodContent 1:Characteristic analysis of application and reporting status of consensus methods in acupuncture-moxibustion CPGs.(1)This study reviews the published disease-related acupuncture-moxibustion CPGs systematically,formulates data extraction tables,sorts out relevant information of consensus methods,consensus participants,consensus process and consensus results from the included CPGs.(2)This study summarizes basic elements of consensus,and analyzes the relevant content and data by descriptive statistics based on the basic elements.(3)This study summarizes the main problems in the application and reporting of consensus methods in acupuncture-moxibustion CPGs.Content 2:Analysis of influencing factors of consensus-reaching in acupuncture-moxibustion CPGs based on the theory of implementation science.(1)Based on the guidance of implementation science and the analysis of the reporting status of consensus methods in acupuncture-moxibustion CPGs,this study preliminarily constructs the conceptual framework about influencing factors of consensus-reaching in acupuncture-moxibustion CPGs.(2)By observing the consensus process of five CPGs developed by the World Federation of Acupuncture-Moxibustion Societies,this study optimizes the framework of influencing factors.(3)The framework of influencing factors is applied to the consensus process of an acupuncture-moxibustion CPG to improve the content of factors and the framework structure.(4)Based on the framework of influencing factors,this study puts forward methodological suggestions on the planning and implementation of consensus methods in acupuncture-moxibustion CPGs.Content 3:Research on the recommended checklist of reporting the consensus process in CPGs.(1)By systematically searching the methodological documents of CPGs,analyzing the content that can be reported in the framework of influencing factors and the content which have been reported from acupuncture-moxibustion CPGs,this study extracts the requirements related to the reporting of consensus in acupuncture-moxibustion CPGs and forms the initial recommended reporting items pool.(2)According to the framework of influencing factors,this study eliminates,merges and classifies the initial items,and forms the initial checklist.(3)This study invites guiding experts to reach a consensus on the checklist.(4)This study invites reviewing experts to make a final decision on the checklist.(5)This study explores the applicability of the checklist in acupuncture-moxibustion CPGs and proposes methodological suggestions on the report of consensus methods in acupuncture-moxibustion CPGs.RESULT1 Characteristic analysis of application and reporting status of consensus methods in acupuncture-moxibustion CPGs.This study includes 36 acupuncture-moxibustion CPGs,and they report consensus process most detailed in step of the recommendation formulation,details as follows.(1)In terms of consensus participants:89%(32)CPGs report basic information of the participants,including the total number,their name,professional composition,geographical distribution,organization,authority,etc.;11%(4)CPGs report that the participants come from the expert group of the CPGs;42%(15)CPGs report the selection criteria of participants,mainly in terms of field,geography,positional title,etc.;14%(5)CPGs report the people and the method that determine the selection criteria of participants;3%(1)CPGs report on the selection process of participants;and 33%(12)CPGs report on the participants’ participation.(2)In terms of the consensus method and the criteria for reaching/ending consensus:97%(35)CPGs report the consensus method they used,but 56%(20)CPGs describe the consensus method in non-standard way,such as the usage of"argument","questionnaire" and "discussion";28%(10)CPGs report their different criteria for reaching/ending consensus,but no CPG reports the reasons why they choose the criteria.(3)In terms of the consensus content and materials:33%(12)CPGs report these.(4)In terms of the consensus process,no CPG reports whether it has conducted a pre-test of the consensus process;11%(4)CPGs report that it has conducted a pre-review of consensus content/materials;81%(29)CPGs describe the consensus implementation process;and 58%(21)CPGs report the consensus rounds;50%(18)CPGs reports the occurred differences during the consensus process and the process of how to deal with them.(5)In terms of consensus results:97%(35)CPGs report the final consensus results and the interpretation of the results,such as the consideration process of core influencing factors.(6)In terms of conflict of interest:42%(15)CPGs describe the conflict of interest of the members who participated in the formulation of the CPG,and all of them indicate that they have no conflict of interest.2 Analysis of influencing factors of consensus-reaching in acupuncture-moxibustion CPGs based on the theory of implementation science.Based on the comprehensive framework for implementation science(CFIR),a framework of influencing factors is initially constructed,which contains 5 dimensions and 17 elements,including consensus participants,consensus methods,process,internal and external factors.Through the observation research,the"content"dimension is added to the influencing factors framework,the "external factors" and"internal factors" are merged into the "environment" dimension,and the influencing factors included in the "consensus participants" and "process" dimensions are supplemented.Through the empirical research,the theoretical framework of influencing factors,which includes 5 dimensions and 27 elements,is finally improved and determined,including the following aspects.(1)Characteristics of consensus participants include the views and knowledge of the disease,confidence in implementing the intervention,acceptance of the formulation of acupuncture-moxibustion CPGs,familiarity with the consensus procedure,familiarity and understanding of the consensus content and materials,conflict of interest and other individual factors.(2)Characteristics of the consensus method include the degree of how the consensus method match the consensus purpose,characteristics of core elements,trialability and complexity.(3)Characteristics of the consensus content include source,classification types and formulation process of consensus content,scope,quantity,consensus background and evaluation perspective,considerations,and readability and credibility of supporting materials.(4)Environmental characteristics include stability of the group,professional diversity,collaboration and communication within the team,implementation climate,policies and values of the organization,and the urgency of the formulation of CPGs.(5)Process characteristics include planning,engaging,executing,reflecting and evaluating.3 Research on the recommended checklist of reporting the consensus process in CPGs.Through the literature research,137 initial items are included,of which 12 items come from acupuncture-moxibustion CPGs,14 items come from the influencing factors framework,94 items come from the formulation of CPGs methodological documents,and 17 items come from the consensus methodological documents.After sorting and summarizing all the items according to the influencing factors framework,the initial recommended reporting checklist finally contains 7 dimensions and 20 items.Then,this study forms an expert group including 11 multidisciplinary experts.After two rounds of voting on the initial checklist,the recommended checklist of reporting the consensus process is finally formed,containing 7 dimensions and 18 items,and has already been examined by 23 reviewers.Conclusion1 There are several suggestions which need to be taken into account when consensus planning and implementation of acupuncture and moxibustion CPGs:clarifying the consensus content and factors to be considered during consensus-making in related step;paying attention to the core effective factors of the intervention in the treatment of target diseases;carrying out the whole process management of the consensus method and attaching importance to the preliminary planning;comprehensively considering the views of all stakeholders and strengthening methodological guidance;improving the quality control and evaluation feedback mechanism of the consensus process;and making detailed records of the implementation process.2 In reporting the consensus process of acupuncture-moxibustion CPGs,there are certain suggested aspects under purpose and content,participant,method and standard,material and background,process,result,and conflict of interest.Emphasis is placed on the selection criteria and selection process of participants,the core elements and characteristics of the consensus method,and the major differences in the consensus process and their causes in reporting.CPGs may consider publishing additional methodological literature to transparently report on the consensus process.Highlight of innovation1.This study analyzes existing methodological problems of the consensus process in acupuncture-moxibustion CPGs from two dimensions,which are the consensus stages and the structural elements of the consensus.2.Based on CFIR,this study explores the influencing factors of consensus-reaching in acupuncture-moxibustion CPGs,constructs the framework of the influencing factors of consensus-reaching,and put forwards methodological suggestions about planning and implementation of the consensus method in acupuncture-moxibustion CPGs after a comprehensive analysis of the influencing factors.3.According to the formulation method from the international health reporting guidelines,combined several qualitative methodologies,based on the influencing factors of consensus-reaching in acupuncture-moxibustion CPGs and the content related to consensus reporting in formulation methodology documents of CPGs,this study forms a recommended checklist of reporting the consensus process in CPGs,explores the application of the checklist in acupuncture-moxibustion CPGs,and proposes methodological suggestions for the consensus reporting in acupuncture-moxibustion CPGs. |
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