Evidence-based Evaluation And Implementation Of Integrated TCM Intervention In Smoking Cessation Clinics: A Scientific Methodology Stud

Background Smoking is harmful to health,and the "Health China 2030" plan outlines the need to promote and strengthen smoking cessation services in China.Smoking cessation is the only and most effective way to avoid the harmful effects of smoking.Traditional Chinese medicine(TCM)has a wealth of research evidence on smoking cessation and has unique advantages in the smoking cessation relative symptoms,but smoking cessation clinics are not fully utilized or even unable to provide TCM services,resulting in the evidence on smoking cessation in Chinese medicine not being translated and applied.The emerging interdisciplinary discipline of Implementation Science aims to improve the quality and effectiveness of health services by systematically researching,designing and evaluating"implementation strategy" to facilitate the translation of medical interventions into clinical practice and medical decision-making,but its methods and techniques have not yet been introduced into the field of TCM.Objective The aim of this doctoral project was to develop a methodological framework and identify core elements for the implementation science of TCM.Based on the proposed methodological framework,and to evaluate the current status of the core elements of smoking cessation studies by various evidence-based medical(EBM)evaluation methods.The feasibility of the framework was verified by an implementation research of integrative TCM intervention for smoking cessation in the context of smoking cessation clinic.Method This doctoral project included five chapters,the first chapter was a methodological study of implementation science,and the second to fifth chapter was a validation of the implementation study.The first chapter:introducing the multidisciplinary concepts and methods reflected in implementation science,drawing on the structured questions of evidence-based medicine(i.e.participants,interventions,control,outcome,PICO),constructing ideas and methods for the design of implementation research on integrative TCM intervention,and forming an implementation science methodological framework for integrative TCM intervention led by core elements.The second to fifth chapter:based on the methodological framework of the previous chapter,multiple EBM evaluation approaches and qualitative research methods were used to evaluate the smoking cessation studies separately in the aspects of implementation core elements,implementation context,facilitator and barriers,implementation effectiveness.These chapter included four studies.The second chapter was an evaluation of implementation core elements,comprising two sections.The first section was an overview of systematic review(Cochrane systematic review)to systematically sort,review and evaluate current smoking cessation interventions,identify the best intervention models in the field of smoking cessation currently,and construct core elements of implementation studies based on PICO;the second section was the umbrella review,an updated evaluation of the efficacy and safety of TCM smoking cessation by systematic reviews and randomized controlled trials,to identify the research trends and evidence gaps in TCM intervention modalities.The third chapter was an implementation context evaluation,based on a target implementation setting,a smoking cessation clinic in China,using a scoping review to systematically review and evaluate the current operational status of smoking cessation clinics,as well as the current status of clinical research conducted in smoking cessation clinics,and to qualitatively analyse the facilitators and barriers to affecting the the development of the implementation context,and determined the feasibility of integrating TCM interventions in the smoking cessation clinic.The forth chapter was an evaluation of implementation determinants,using one-to-one in-depth qualitative interviews with stakeholders in all aspects of smoking cessation clinic to develop an individualized interview protocol,which was connected with the facilitators and barriers which were identified in the 2nd Study,in order to form an ’evidence-practice’ bridge to qualitatively analyse the facilitators and barriers that influence the delivery of cessation clinic services in the current real-world clinical practice.In fifth chapter,a randomized controlled trial design with a mixed of quantitative and qualitative methods was used to conduct an hybrid effectiveness-implementation designs implementation study,to investigate the effectiveness of integrative TCM intervention in a smoking cessation clinic,to validate the methodological framework developed in the first chapter,and to verify the feasibility of the methodological framework developed in the previous chapter.Results The implementation science methodological study in the first chapter provides an introduction to the multidisciplinary theories and methodology of implementation science,and pointed out a methodological framework of TCM.The second to fifth chapter was the implementation research validation,based on the proposed methodological framework,yields the following results:The second chapter,in the first section,the overview of Cochrane reviews included 70 full-text Cochrane intervention reviews of smoking cessation,with AMSTRA-2 accessing quality,finally 51 rated as moderate quality,11 as high quality and 8 as low quality.In terms of study design,randomized controlled trials continued to be the most included and the best method of validating the effectiveness of interventions;in terms of study setting,outpatient clinics were the most frequently conducted studies due to their ability to provide smoking cessation interventions quickly and easily and their large coverage.In terms of participants type,most studies did not specifically screen the population and did not restrict pre-enrolment disease status,age,etc.In terms of outcome indicators,the smoking abstinence rate was still the core outcome indicator,but there was a lack of standardization of its calculation the measured time.In terms of interventions and effectiveness,there was still a lack of smoking cessation medication that has been proven to be exactly effective,safe and long-lasting.The results of the meta-analysis showed that the best effectiveness interventiona was Charybdotoxin,which has the same core component as Varenicline,as the currently recommended first-line drug in clinical guideline,while the effectiveness of different types of behavioral and psychological interventions was more uncertain,with inconsistent findings between studies.The second section of the umbrella reviews update included 14 randomized controlled trials(80 RCTs in total),11 systematic reviews and 8 clinical trial protocols,and the quality of the remaining 10 systematic reviews was low or very low,with the exception of one study published in Cochrane.After update,the overall quality of RCT remained low by Cochrane ROB tool,with a lack of adequate reporting in methodological parts.As for the systematic review level,there were problems of duplication of topic and wasted studies,all of which evaluated the efficacy and safety of acupuncture/acupoint stimulation for smoking cessation.As for the RCT level,the updated findings remained unchanged,with participants still predominantly healthy adults,interventions including oral herbal tonics and herbal tea bags,and various types of acupoint stimulation for external use.The control group was mostly as placebo and positive western medicine.The outcome indicators still failed to clearly differentiate and define the time point and calculation of smoking abstinence rate.The results of the updated meta-analysis showed no change in the overall findings,which still suggested a potential advantage in sustained abstinence rates when TCM was combined with western medicine compared to western medicine alone.The third chapter generalized evaluation included 19 studies on the topic of“smoking cessation clinic development" and 91 clinical studies conducted in the smoking cessation clinics.A pooled analysis of the cessation clinic development studies found that better reporting on the domain of institutional assessment than the other four domains(including environmental assessment,process assessment,outcome assessment and development assessment),and the overall quality was low based on the AHRQ assessment.A pooled analysis of clinical studies conducted in smoking cessation clinics found that the study population was predominantly adult,did not have underlying medical conditions,and the interventions followed our smoking cessation guidelines and were based on brief outpatient counselling interventions supplemented by non-nicotine medications(Bupropion hydrochloride extended release tablets and Varenicline),with a lack of TCM involvement in smoking cessation.A qualitative thematic-framework analysis of the factors affecting the development of smoking cessation clinics shown that,the facilitators and barriers to smoking cessation clinics including the aspects of varying degrees at the institutional level,physician level,leadership level,patient level,and general public level.The forth chapter summarized and analyzed seven experts in smoking cessation services by in-depth one-to-one interviews,combined with the thematic frameworks of the smoking cessation clinic evaluation framework and the Behaviour change wheel(policy loop),to develop two aspects of influencing factors:"cessation clinic as a organization" and "smoking cessation services as policy".Factors influencing institutional development included institutional setting,clinic implementation environment,clinic process,clinic outcomes,clinic development,individuals involved in the clinic,and historical development and geographic distribution of the clinic,while factors influencing service policy included communication/marketing,guidelines,finance,regulation/regulation,law,environmental/social planning,and service delivery.The fifth chapter enrolled 62 smoking adults,randomized 1:1 into a experimental group(TCM+Varenicline+standard smoking cessation interventions in clinic)and a control group(Varenicline+standard cessation interventions in clinic).After 4 weeks,the results of healthy outcomes under the intervention objectives in terms of abstinence rate,level of tobacco dependence(FTND),nicotine withdrawal symptoms(MNWS)and fire-related TCM symptoms shown no statistically significant differences between the two groups,but the experimental group showed a better trend of integrative TCM intervention than the control group in terms of FTND,MNWS and TCM symptoms.In terms of implementation outcomes under the implementation objectives,for the development of "smoking cessation behaviour",some patients in the experimental group promoted smoking cessation because they were more receptive to TCM tea bags and substituted their tea drinking habit for smoking behaviour,while patients in the control group had some expectation that drinking TCM tea would promote smoking cessation behaviour;for the development of "TCM tea drinking behaviour ",patients in the experimental group who had a previous tea drinking habit were more receptive to TCM tea bags and promoted smoking cessation behaviour,while patients in the control group wanted a variety of ways to treat smoking cessation,and both two groups were more receptive to the TCM tea bags due to its convenience and ease.Compared with the usual intervention in clinic,integrative TCM intervention can help increase the return visit rate.There were no serious adverse events during the trial.Conclusion Methodological research of implementation science on integrative TCM should be conducted with full reference to theories and methods from the relevant disciplines.The core elements on implementation science include an evidence-based PICO,evaluation of implementation context,evaluation of implementation determinants,and study design based on the research objectives.Implementation studies in smoking cessation clinic context have shown that integrative TCM interventions can improve the quality and effectiveness of smoking cessation services.