Methodological Study For Prioritizing Clinical Questions Of Traditional Chinese Medicine Guidelines

BackgroundTraditional Chinese medicine(TCM)guidelines refer to the systematic development of TCM clinical diagnosis and treatment recommendations,which can help doctors and patients make appropriate and reasonable decisions and judgments for specific clinical questions.The development of clinical questions is the key part of guideline development process,which determine the content of guidelines.Clinical questions also reflect the scope and type of clinical practice guidelines and are the basis for follow-up evidence retrieval,systematic review and recommendation formation.The development of a guideline often takes 2-3 years,due to the limitation of time,human and material resources,the guideline cannot solve all clinical questions,so it is necessary to judge the priority of the guideline questions,select the most important and urgent clinical questions in current clinical context to solve,in order to maximize the guiding significance of the guidelines to clinical practice.At present,the selection of clinical questions in TCM guidelines mainly adopts the method of expert experience scoring,and experts score the importance of clinical questions of the guidelines based on personal experience.Due to the lack of clear scoring principles and items,and the different experts’ understanding of the importance,the interpretability and credibility of the evaluation results are affected.Based on above,it is necessary to develop a list of priority selection items for clinical questions in TCM guidelines to increase the transparency and objectivity of the selection process of clinical issues in the guidelines,assist clinical guideline makers to select and development the most important and urgent clinical questions,and enhance the application value of TCM guidelines.Methods1)We searched the domestic and foreign guideline development manual systematically,conducted a methodological systematic review of the construction and selection of clinical questions.We analyzed and discuss methodological content about the number of clinical questions selected,the type of questions,the selection of evaluators,and the selection methods through the methods of comparative induction,qualitative and quantitative combination.2)The relevant literature on the priority selection of domestic and foreign guidelines and the relevant literature on the advantages of TCM in TCM guidelines were systematically searched.The priority selection and evaluation items of TCM guidelines for clinical questions were extracted by literature content analysis to form a list of items.The method of cognitive interview was used to supplement and optimize the items and interpretations.Clinical experts and methodological experts with experience in developing TCM guidelines were selected to conduct two rounds of Delphi expert questionnaires to evaluate the importance and readability of the items.Items of the TCM guidelines clinical questions were screened and determined the priority selection and evaluation through the importance score and coefficient of variation.Combined with content about the number of selections,applicable questions types,method users,etc.in the second part of the study,the priority selection and evaluation tool of clinical questions in the TCM guidelines was formed.A pilot test was used to test whether the items of the tool were feasible,whether the evaluation time was acceptable,and whether the evaluation results were ranked.And we would revised items and the evaluation rules.Results1)A total of 38 domestic and foreign guideline development manuals were included.Fifteen manuals mentioned the source of clinical questions,including literature,clinical expert consultation,and scene reproduction.The eight manuals referred to the types of clinical questions,which were mainly divided into background questions and foreground questions.The background questions included questions about the definition of the disease and the burden of epidemics.Foreground questions included questions about treatment,diagnosis,prognosis,environment,genetics,and other exposure factors.Clinical questions structures were mentioned in 27 manuals,and PICO(Population,Intervention,Comparison,Outcome)structures were recommended in 21 articles.12 manuals reported the recommendation about the number of clinical questions,which recommended to consider the size of the guideline scope,guideline development time and resource constraints.The maximum number of recommended questions in the existing guideline manuals was 20.Ten manuals mentioned that the evaluators for the selection of clinical questions are mainly guideline development groups or guideline consensus committees which include clinical experts,guideline technicians,patient representatives,health economists,pharmacists,etc.Eleven manuals mentioned the selection methods for clinical problems,mainly including the consensus method,the ranking method,and the establishment of standard selection method.Twelve guidelines referred to the selection of clinical outcomes,which were mainly scored into three categories:’key outcomes’,’important outcomes’,and ’outcomes of low or low importance’.Through the systematic analysis of the methodological part of the construction and selection of clinical questions in the guideline development manual,the guidance and reference are provided for the selection of clinical problem selection methods,applicable problem types,method users,selection and evaluation items of TCM guidelines.2)A total of 6285 articles were retrieved,47 articles were finally included,256 items were extracted,17 items were identified after collation and summary.We conducted cognitive interview with three guideline researchers.One item was deleted,one item was merged,and the items and interpretations were optimized through interview.Through the Delphi questionnaire,18 methodological experts and clinical experts with experience in developing TCM guidelines scored the importance and readability of 15 items.After the first round of questionnaires,15 items were readable.According to the importance score and expert advice,we deleted 1 item,merged one item.Ten items had high importance scores and small coefficient of variation.Three items had high importance score and large coefficient of variation,which were revised according to the recommendations and entered the second round of scoring.Through the second round of importance scoring and group discussion,13 items were finally included,and the methods and tools for the priority selection and evaluation of clinical questions in TCM guidelines were formed.The evaluation methods and tools were tested to verify the feasibility of the items,the acceptability of the evaluation time,and the rank and explainability of the evaluation results.And we revised items and the evaluation rules.ConclusionsThis study explored the items that may affect the selection priority of clinical questions in the TCM guidelines through literature research,cognitive interviews and Delphi expert questionnaires.Thirteen items were identified in four dimensions:disease,diagnosis and treatment,outcome,and evidence.The priority selection evaluation items for the clinical questions of the guideline improved the problem of lacking objectivity and interpretability in the selection of clinical questions in the current TCM guidelines,and strengthened the transparency of the selection process.At the same time,it is hoped that the preliminary exploration of the selection method of clinical questions in TCM guidelines in this study can promote the follow-up related methodological research,and provide a reference for further optimizing the selection of clinical questions in TCM guidelines.