| BackgroundThe characteristics of traditional Chinese medicine(TCM)are syndrome differentiation and treatment and holistic view.The diagnosis and treatment consider human social and natural attributes.At present,there is a lack of internationally recognized efficacy measurement and evaluation system based on evidence-based medicine which has strong applicability and does not deviate from the strict design principles that could reflect the characteristics of diagnosis and treatment of TCM.TCM is a kind of complex intervention,whose clinical effect is formed by the interaction of many effective ingredients.The evaluation of the curative effect of complex intervention of TCM requires new ideas and means in methodology to reflect the overall,dynamic and individual differences of TCM.How to define the elements of complex intervention is the key point of clinical efficacy evaluation.PurposesThe purpose of this study is to explore the complex intervention elements related to the efficacy of traditional Chinese medicine,in order to provide reference or basis for future clinical trials of traditional Chinese medicine.MethodsQualitative research method including qualitative literature research methods and qualitative field research methods were used in this study.Using semi-structured interviews,participant observation,and literature retrieval methods to collect data,using meta ethnography and theme analysis methods to carry out qualitative synthesis,and using the three-level coding procedure of grounded theory to analyze data,then we built a theoretical model of complex intervention of TCM.Finally,the validity of the research was verified by the method of triangulation.Qualitative literature was mainly qualitative synthesis.The method of systematic search was used to collect literatures.We searched the following databases up to July 2019:PubMed,EMBASE,Cochrane Library,CNKI,Wanfang Data,VIP database and Sinomed database.A combination of MeSH terms,emtree terms and keywords was used,including "empirical research","qualitative research","grounded theory","complex intervention","complex intervention","holistic system","complex system","integrated medicine","integrated support" and "integrated care".The included studies were selected independently according to the pre-designed eligibility criteria by two researchers.The quality of the included study was assessed by using the quality assessment tool:critical appraisal skills programme(CASP).The third-order structure of meta ethnography was used to analyze the data.First of all,the initial views,quotations,statements and explanations of the researchers were considered as the first-order structure.Secondly,the components of complex intervention and the original author’s own discourse(or wording)were listed as the second-order structure.Then by comparing the second-order structure,the results were translated into each other.Finally,theme analysis was used to summarize qualitative data and form a conceptual framework.In the field study,participants’ observation and interviews with TCM doctors and patients were used to collect first-hand data.The process of clinical diagnosis and treatment for TCM doctors who meet the inclusion criteria was observed.Objective sampling was used to select samples.Before the implementation of the observation,the informed consent of the observing was obtained.The researcher was used as the tool to collect data,and the implementable instrument(recorder)was used to observe the process of TCM diagnosis and treatment.The observer mainly collected data by writing field notes.Semi-structured interviews were conducted with TCM practitioners who met the inclusion criteria.Before the interview,the interviewers need to be trained and the interview outline should be made.Pre-interview should be conducted before formal interview.Informed consent was required for both interviews and recordings.Based on the collected observation and interview data,this paper analyzed the three-level coding of grounded theory,and finally constructed the theoretical model of complex intervention of TCM syndrome differentiation and treatment.ResultsThe results of meta-ethnography showed that there were three genera,that was,what should medical staff do?What qualifications should they have?What should patients do?Five themes were obtained from the factor synthesis:psychological support,physiological support,cognitive and behavioral support,environmental support and social support.In addition,16 subcategories were obtained from the coding.The core code of the five themes was humanistic care.Among the 25 patients interviewed,4 were from the digestive department of Dongzhimen Hospital,3 from the lung department of the China-Japan Friendship Hospital,2 from the comprehensive outpatient department of the Beijing University of Chinese Medicine Third Affiliated Hospital,2 from the comprehensive outpatient department of the Hongyitang TCM Clinic,2 from the comprehensive outpatient department of the Xiyuan Hospital of the Chinese Academy of Chinese Medical Sciences,and 12 from the comprehensive outpatient department of the Guoyitang Clinic of Beijing University of Chinese Medicine.Among the patients interviewed,one received acupuncture and moxibustion therapy,one received acupuncture and cupping therapy,and the other 23 received decoction therapy.There were 2 primary patients and 23 secondary patients.25 texts were transcribed and proofread and 184183 Chinese characters were obtained.By analyzing the interview texts of patients,491 open codes were obtained,and 4 main generic codes related to patients’ experience of TCM were obtained:relief of symptoms,psychological comfort,recovery of social functions,patients’ self-care behaviors;4 generic codes related to the characteristics of complex intervention in TCM were obtained:diversification and comprehensiveness of TCM intervention,individual treatment,communication between doctors and patients,and the idea of treating the root cause.Based on the relationship between genera and sub-genera,a theoretical model of complex intervention of TCM based on patient experience was constructed.21 TCM doctors with deputy senior professional titles or above were interviewed,including 18 general practitioners and 3 specialists.There were 23 interviews,with 6-55 years of occupation,38-80 years of age,and 20-90 minutes of per interview.223448 Chinese characters were obtained.According to the results of interview with TCM doctors,228 open codes were obtained.At the same time,by continuous comparison,three generic codes were obtained:the components of TCM complex intervention;the influencing factors for TCM complex intervention;the characteristics and efficacy of TCM complex intervention.There were 12 sub-categories:medical intervention,psychological intervention,social intervention,environmental intervention,stages of diagnosis and treatment process;doctors,patients,diseases,doctor-patient communication,environment;clinical diagnosis and treatment thinking of TCM complex intervention,complex intervention elements and curative effect.Based on the relationship between genera and para-genera,a theoretical model of complex intervention of TCM based on doctor’s point of view was constructed.32 observations were completed,involving 20 TCM doctors.The observation sites included Guoyitang Clinic of Beijing University of Chinese Medicine,Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing University of Chinese Medicine Third Affiliated Hospital,Xiyuan Hospital of the Chinese Academy of Chinese Medical Sciences,Beijing Hongyitang TCM Clinic and community health centers.The results of triangulation showed that the complex intervention factors of TCM were not only biological intervention,but also psychological,social,environmental,cognitive and behavioral.Complex intervention of TCM was a multi-dimensional and multi-methods dynamic circular interactive implementation process.ConclusionsThe obj ect of syndrome differentiation and treatment focused on patients,that was to say,biological,psychological,social,environmental,behavioral inducements or etiology acting on patients,and physiological and pathological changes occurring in patients,then doctor-patient relationship was triggered.Doctors were the implementers of syndrome differentiation and treatment.When facing the patient,the doctors analyzed the etiology,pathogenesis of the diseases based on his own professional knowledge.The process was related with the doctor’s moral level,doctor’s experience,TCM academic schools and other individual cognitive factors.Finally,complex interventions were provided,including medical intervention,psychological intervention,environmental intervention,social intervention and cognitive and behavioral intervention.The whole process of syndrome differentiation and treatment was a process of constant communication and feedback between doctors and patients. |
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