Establishment Of Methods For Setting Priority Areas Of Clinical Research In Traditional Chinese Medicine

BackgroundClinical research requires a great deal of resources,and so is the Chinese medicine(CM)clinical research with an increasing number.However,a large amount of CM clinical researches are in low-quality and the research evidence is too scattered to use.To improve the level of research and the quality of evidence,and to reduce the avoidable waste and aimless research,it is urgent to sort out and focus on priority research areas and problems.Establishing research priority setting method for CM clinical research is of great significance for improving the research efficiency and for helping researchers determine the prior research themes.In the 1980s and 1990s,some developed countries took the lead in exploring and practicing the health research priority setting methods,and formed several multi-step research models,such as CHNRI(The Child Health and Nutrition Research Initiative)and JLAPSP(James Lind Alliance Priority Setting Partnership).However,it is still rare in China to do researches in this field.Besides,there is no priority setting method for CM clinical research at present.Objective1.To systematically review the research and application progress of health research priority setting methods.2.To propose the framework and elements for setting CM clinical research priority areas,based on the current priority setting problems and CM clinical research charateristics.3.To verify the feasibility of CM clinical research priority setting method,in the case of setting the research priorities of CM therapies for myocardial infarction(MI)prevention and treatment.4.To evaluate the application effect of CM clinical research priority setting method in a randomized controlled trial.Methods1.Literature reviewWe systematically searched the PubMed,EMbase,Web of Science databases,and screened for the original researches related to health research priorities.The content and application areas of the health research priority setting methods were compared between the years of 2015-2018 and before 2014.The publication trend,application areas,participant distribution,number of participants,participant identity were described.Different prioity setting patterns,research list generation methods,consensus achievement methods,and prioritization methods were analyzed.2.Method constructionFirstly,the main contents of CM clinical research were defined.Then we summarized the needs of CM clinical research priority setting methods under the current research circumstances.Finally,we proposed the main elements and the framework of CM clinical research priority setting method.3.Verification researchWe used the establised method to set the research priorities of CM therapies for MI prevention and treatment.The process was divided into five steps,including setting a research plan,semi-structured interview of MI patients/caregivers,research themes collection,evidence map for scoping the research field,modified nominal group technique to identify the research priorities.Setting the research plan included identifying the research purpose,research initiators,research funding,time period,research scope,the task of core working group and broad participants,research list generation method,priority evaluation criteria,priority determination method,as well as setting the publication,reevaluation and update plan.Semi-structured interview understood the needs of MI patients or caregivers for the prevention and treatment of MI with CM.E-survey of multi-stakeholder groups to collect the MI research emphasis and the research themes on CM therapies optimization.This is a step to provide the optional research themes for setting the research priorities of CM therapies for MI prevention and treatment.Then,an evidence map was made to scope the clinical research field of CM therapies for MI prevention and treatment.Finally,the top ten research priorities were identified from the research list by the core working group experts using modified nominal group technique.The priority order was set according to the patients' needs,the evidence map and the priority criteria.4.Application effect evaluationTaking the research priority of CM therapies for MI prevention and treatment as an example,we randomly divided the different stakeholders into three groups.Two groups used a modified nominal group technique combining with patients'opinion,evidence map and priority criteria.One group used a conventional consensus meeting method.Then we compared the similarities and differences of the research priorities identified by the three groups.After the meeting,the participants were surveyed to evaluate their satisfaction of the results,the level of participation,the gains from the research process,as well as the problems for improvement.Results1.In the literature review of the health research priority setting articles,2244 articles published between the years of 2015-2018 were retrieved.After removing the duplicates,1076 articles were screened for eligibility,and 147 articles were included in the analysis.Compared with the number of articles published before 2014,a continuously increasing trend was observed.Priority setting methods are most commonly applied in researches of cancer,nursing care,and health of neonatal,child,adolescent.Most of the research participants came from different regions and countries with the total number of 500 or less.The participants were mainly experts in the certain fields,medical staff,patients and caregivers.The most commonly used research models were JLAPSP and CHNRI.The priority research topics were mostly collected from the wide public or groups of experts.The Delphi method was frequently used for reaching consensus,and the priorities were often ranked by voting.2.To establish the CM clinical research priority setting method,we put forward three main factors and a five-step framework.The three main factors were scoping the field to evaluate the research problems,incorporating multi-stakeholders' opinions to improve translational efficiency,taking CM characteristics into account when setting the priority criteria.The five-step framework was defining the research scope and plan,determining the tasks of the core working group and broad participants,scoping the research field,collecting the research topics and determining the priorities,making publication,reevaluation and update.3.In the verification study,the research priorities of the CM therapies for MI prevention and treatment were identified in a few steps.The semi-structured interview included 8 MI patients and 2 caregivers,with 5 CM therapies optimization suggestions and 6 MI research opinions collected.The electronic questionnaire survey collected 337 valid questionnaires,and finally included 316 questionnaires with 405 opinions.Among them,150 were optimization suggestions for the CM therapies of MI prevention and treatment,and 255 expressed the MI research focuses.The analysis found that the most recommended CM research areas was the development of treatments and therapeutic interventions.The most concerned areas of MI research were the development of treatments and therapeutic interventions,prevention of disease and conditions,and promotion of well-being.The development of treatments and therapeutic interventions was most concerned by medical staff and researchers.The public concerned about prevention of disease and conditions,and promotion of well-being,as well as the development of treatments and therapeutic interventions.At last,30refined research themes of CM therapies for MI prevention and treatment were listed.To make an evidence map on the clinical research field of CM therapies for MI prevention and treatment,6 Chinese and English databases were searched,with 1664 articles included for analysis(1615 clinical studies,31 systematic reviews,and 18 guidelines or clinical pathway studies).14 experts(6 MI clinical research experts,4 clinicians in cardiology,2 CM clinical research methodology experts,and 2 policy makers/managers)participated in the final meeting to identify the research prioities with modified nominal group technique.The top ten clinical research priorities were:?Research on CM therapies for MI driven heart failure;?Research on Chinese patent medicine for MI emergency treatment;?Research on CM exercise therapies for MI prevention(such as Tai Chi,Eight Trigrams Boxing);?Standardization study on MI syndrome differentiation system;?Research on CM therapies for MI driven hypotension;?Research on CM etiology and pathogenesis of MI(such as stasis poison pathogenesis);? Research on CM syndrome/constitution identification of MI high-risk population;?Study of CM effects on cardiac function after MI;?Research on CM treatment combined with MI coronary revascularization;?Safety study of CM blood-activating drugs on MI prevention and treatment(such as dose-effect study).4.In the application effect evaluation study,21 stakeholder representatives(9 MI clinical research experts,6 clinicians in cardiology,3 CM clinical research methodology experts,and 3 policy makers/managers)were randomly assigned to three groups(Group A,Group B,and Group C)in a 1:1:1 ratio.Group A and Group B applied the modified nominal group tech nique combining with patients'opinions,evidence map and priority criteria.Group C adopted the general consensus conference method.Finally,18 priority research topics were identified in Group A,11 in group B,and 14 in group C.The five common research topics were:research on CM etiology and pathogenesis of MI;standardization study on MI syndrome differentiation system;research on Chinese patent medicine for MI emergency treatment;research on CM therapies for MI driven heart failure;study of CM effects on cardiac function after MI and research on CM treatment combined with MI coronary revascularization.There were 6 overlapping research themes between Group A and B,Group B and C respectively.Group A and C had 10 overlapping research themes.The top three priority research themes in Groups A and B were similar,but did not coincide with Group C.From the results of consensus and process evaluation,Group A all agreed with the research results very much,fully participated and gained much in the process.Group B and Group C had a few feedback of general identification and general participation.Group C was not as good as the first two groups in terms of the gains from the participation process.To a certain extent,the modified nominal group method was better than the current expert consensus meeting,in terms of result recognition,research participation and benefit.However,there were still some aspects to be improved,such as classify the research themes;make compact meeting process;prolong the Ththinking time;inform the meeting process in advance;and optimize the survey scales.ConclusionseCM clinical research priority setting method was proposed systematicly and scientificly,based on the current priority setting methods,CM clinical research problems and characteristics.With verification research and application effect evaluation,the method is practical and reasonable to be used to determine the priority funding areas and priority research themes of CM clinical research.