| Purposes of Research:Combining and Integrating the qualitative research methods and quantitative research methods,to explore the theoretical phases of the traditional Chinese medicine(TCM)complex intervention in Rheumatoid arthritis(RA).uses the theory,methods and forms of quantitative research: grounded theory,content analysis,panel of experts interview(group interview), individual interview,to achieve initial results,and build experience on TCM Quantitative research.Research methods and content:This study is an exploratory research,using the investigative research combined and integrated of qualitative research methods and quantitative research methods.It including:(1)A preliminary study on TCM ancient literature relative to RA(TCM diagnosis is close to Bi or Lijie),using the content analysis based on the grounded theory.(2)A preliminary study using the content analysis on modern literature,which reported treating in RA with Traditional Chinese Medicine or Integrated Traditional and Western Medicine.On the basis of the literature,using the panel of experts interview to develop the Interview Outline,holding semi-structured interviews with individual RA outpatients.Main results:(1)Preliminary study on TCM ancient literature relative to RA,using the content analysis based on the grounded theory:Totally 230 pieces of TCM ancient literature relative to RA were evolved in the study.205 pieces(89.1%) described the etiology and pathogenesis,194 pieces(84.3%)described the exogenous pathogens,and 150 pieces(77.3%)described not less 3 kinds of exogenous pathogens.149 pieces(76.8%)described the wind,cold and dampness at the same time.The mainstream view of the ancient doctors seems that BI (RA)is caused by exogenous pathogens combining by wind-cold-dampness.114 pieces(49.6%)described insufficiency of qi,52 pieces(22.6%)described blood stasis,51 pieces(22.2%)described eating and drinking without temperance,40 pieces(17.4%)described internal retention of phlegm,and 16 pieces(7.0%)described emotional frustration.More of the ancient TCM doctors thought that RA(BI)is the result from many etiologies and pathogenesis working together.138 pieces described the therapeutic purposes.40 pieces(29%) described one therapeutic purpose,98 pieces(71%)described two or more therapeutic purposes.The ancient TCM doctors not only focus on the purpose of stopping the joint swelling and pain,but also making the movement fluent, and they paid more attention to regulation the function of the qi and blood,, regulation the function of zangfu-organs.147 pieces described the TCM principle of treatment.126 pieces(85.7%)described one principle,126 pieces (85.7%)described two or more.The principle be most described is eliminating the pathogens.The second is regulating the Yin-Yang and qi-blood.The third is eliminating the inner the pathogens.10 pieces(4.3%)described regulating mental activities as a principle of treatment.196 pieces described the TCM therapeusis.125 pieces(68.3%)described one,45 pieces(23.0%)described two, 22 pieces(11.2%)described three.4 pieces(2.0%)described four TCM therapeusis.Practice proved that study on TCM ancient literature relative to RA,using the content analysis is feasible.The ancient literature studyprovides the base data to next stage,and the information acquisition sheet becomes the main framework of the modern literature study.(2)Preliminary study using the content analysis on modern literature treating in RA with TCM or Integrated Traditional and Western Medicine.Totally 79 pieces of Traditional Chinese Medicine or Integrated Traditional and Western Medicine RCT literature,which JADAD score is no less than 2,were evolved in the study.50 pieces(63.3%)described the according principles of the TCM treatment programs.37 pieces(46.8%)described one principle.15 pieces (15.2%)described two.Only one piece described three principles.In this 50 pieces,49(98%)described their treatments programs according the TCM pathogenesis and syndrome differentiation,13 pieces(26%)according the RA active or remission,2 pieces(4%)according the RA early,mid and late stages. In all the 79 pieces,63 pieces(79.7%)described a kind of the TCM therapeusis, 16 pieces(20.3%)described two or more.There are a variety of the TCM therapeusis,including oral administration of TCM herbal decoction,oral administration of TCM patent,external administration of TCM herbal drugs, Acupuncture therapy,TCM injection therapy,TCM Diet,exercise rehabilitation, and so on.But only a small part researches had employed composite intervention.71 pieces(89.9%)focus on the purpose of stopping the joint swelling and pain,as well as making the movement fluent.11 pieces(13.9%) described that improve the quality of life is one of their therapeutic purpose. About 80%researches described three or more therapeutic purposes,that shown the multidimensional nature.65 pieces(82.3%)described the TCM principle of treatment.More than 50%of them described three or more.In all 79 pieces, 57 pieces(72.2%)described the principle of eliminating the pathogens,35 pieces(44.3%)described eliminating the inner the pathogens,62 pieces(78.5%) described dredging meridians,23 pieces(29.1%)described regulating the Yin-Yang and qi-blood,24 pieces(30.4%)described reinforcing liver benefiting kidney the liver and kidney and strengthen the bones and tendons. Only a piece(1.3%)described regulating mental activities as a principle of treatment.It shows that TCM researches on treating RA in a multidimensional perspective.More of them considered both prevention and treatment of disease, considered both treatmentbased on syndrome differentiation and treatment based on disease differentiation.These are the spontaneous reflection and application of the idea of complex intervention in clinical research.But the researchers paid more attention to endotherapy than external treatment.Practice proved that study on modern literature,which reported RCT research of treating in RA with Traditional Chinese Medicine or Integrated Traditional and Western Medicine,to establish the complex intervention theoretical basis,by using the content analysis,is feasible.The modern literature study provides the base for next stage work:individual interviews with RA patients. (3)Semi-structured interviews with individual RA outpatients:There were 25 respondents take part in the individual interviews with RA outpatients.The respondents' awareness of RA was low.All the respondents complained the joint problems,which including 2 to 6 kinds specific signs and symptoms.19 respondents(76%)suffered four or more joint problems.All the respondents complained the abilities decline problems.80 percent of them thought two and more of their abilities declined.24 respondents(98%)complained their activities of daily living declined.18 respondents(72%)complained their work abilities declined.12 respondents(48%)complained their social intercourse abilities declined.19 respondents(76%)talked about their adverse psychological problems and experience.A respondent experienced four kinds of adverse psychological problems or bad mood.14 respondents(56%) considered that the most serious annoyances are joint problems.For other 10 respondents(36%),the most serious annoyances are abilities decline problems. Only one respondent considered the most serious annoyances are adverse psychological problems and experience.14 respondents(56%)considered that the most serious annoyances are joint problems.10 respondents(36%) considered the most serious annoyances are abilities decline problems.Only one respondent considered the most serious annoyances are adverse psychological problems and experience.9 respondents(36%)considered that the secondary serious annoyances are joint problems.13 respondents(52%)the secondary serious annoyances are abilities decline problems.Only one respondent considered the secondary serious annoyances are adverse psychological problems and experience.Two respondents could not make clear which is the secondary serious annoyance.10 respondents(40%)considered the tertiary serious annoyances are adverse psychological problems and experience. 4 respondents(40%)considered the tertiary serious annoyances are declines of family and social support.One respondent considered the tertiary serious annoyances are joint problems.One respondent considered the tertiary serious annoyances are abilities decline problems.8 respondents(32%)could not make clear which is the tertiary serious annoyance.21 respondents(84%)had the low awareness of RA treatment.24 respondents expressed their expectation of therapeutic effect.7 respondents hoped their RA could be cured.Comprehensive analysis of the first three expectation of therapeutic effect,in descending order are stopping the joint swelling and pain,making the movement fluent, reducing or preventing RA activities and delaying the disease progression. According to the approved degree by 25 respondents experience,the TCM therapeusis,in descending order are oral administration of TCM herbal decoction,the use of TCM health education,external administration of TCM herbal drugs,TCM Diet,oral administration of TCM patent,TCM injection therapy,TCM massage,Acupuncture therapy and TCM exercise.At least,there were i0 kinds of the TCM therapeusis approved by the respondents.And 20 respondents(80%)approved three or more of these TCM therapeusis.16 respondents(64%)combination with two or more TCM therapeusis in treat RA. Less than a half of the respondents heard about the differentiation of symptoms and signs for classification of TCM syndromes,as well as the sense.15 respondents made sure that combined therapy and overall treatment is the important characteristic of TCM in treat RA.14 respondents considered that c regulation the function of the qi and blood,regulation the function of zangfu-organs is the characteristic of TCM when treating RA.9 respondents (36%)heard of regulating mental activities as a TCM characteristic.Practice proved that individual interviews could comprehend the true aspiration and viewpoint of the RA patients effectively,so that from the patient's perspective to establish the RA TCM complex intervention theoretical basis is feasible.Conclusion:It is very important to conduct theoretical preparations for the development of the TCM complex intervention.Mainly to qualitative research, this study reflected "Triangulation" and "Grounded theory".From the planning to practice,during the data collecting and analysis,this study had combined and integrated the qualitative and quantitative research.Based on the health outlook,prevention and cure theory of TCM,and the characteristic of RA,this study shaped a multidimensional,comprehensive hierarchical theory structure of the TCM complex intervention in RA,by combining literature research and interviews.Limited by conditions and experience,this study is just a preliminary approach.
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