| ObjectiveStudies have shown that patients have positive attitude towards participating in medical decision-making but to a low degree.In the field of Chinese medicine(CM),its theory is usually combined with traditional culture,philosophy and other concepts,causing obstacles to public understanding.And the information asymmetry between physicians and patients makes it even more difficult to involved patients in their medical decision-making process.Shared decision making(SDM),as a healthcare service model,requires clinical practice to follow the "patient-centred" medical principle and emphasizes patient participation in the medical decision-making process,which promotes medical equality and improves the quality and effectiveness of healthcare services.However,its methodology has not yet been introduced into the field of CM,and there is still a lack of clear guidance on how to implement SDM in clinical practice.Our aim here is to(1)give insight in the prominence of components present in SDM models in CM,(2)describe the responsibilities that healthcare professionals and patients should take,(3)develop a conceptual framework of the SDM model that meets the characteristics of CM and(4)explore the feasibility and benefit of the application of this SDM model in CM,with the aim of providing references for the application of the SDM in the clinical practice of CM in the future.MethodsMixed method research designs combining qualitative with quantitative research were used in this study.Firstly,the conceptual framework of SDM in CM model was established through qualitative research methods,including the literature research method,qualitative interview research method,triangulation method,and questionnaire survey method.Secondly,the applicability of the SDM model in CM was evaluated by the mixed quantitative and qualitative methods.1.Developing a conceptual framework for the SDM model in CM.(1)The method of the systematic review was first used to conduct a comprehensive search of literature related to the "SDM model".We searched the following databases up to December 31st,2022:CNKI,WANFANG DATA,SinoMed database,VIP database,PubMed,Embase,Cochrane library,PsycINFO and Web of Science.A combination of subject headings and text words was used,including "shared decision" "shared medical decision""shared treatment decision""shared clinical decision",and eligible studies were included according to the pre-designed screening criteria.Secondly,the thematic synthesis method was adapted to describe the published conceptual model.Through the coding of text line-byline,the development of descriptive themes and the generation of analytical themes,the core components of the SDM model were identified and summarized,and the conceptual framework of SDM was generated afterwards.(2)Grounded theory(GT)was used to underpin the qualitative interview study.Semistructured interviews were conducted among CM physicians,nurses and patients through oneon-one in-depth interviews from December 2022 to June 2023,in order to explore their experiences and perspectives towards SDM.Purposive sampling was used which involved selecting participants.And a sample size of ten to fifteen of CM physicians and nurses as well as ten of patients was tentatively established to achieve information saturation.The interview outlines were developed according to the SDM conceptual framework established by the literature research and before the formal interviews,pre-interviews were conducted.The interviews were recorded,and the data were transcribed,read and analyzed afterwords.Next,the data was analyzed with the three-level coding of GT.and the core components of the SDM model involved in the process of CM diagnosis and treatment were deeply discussed.Then,the conceptual framework of SDM model in CM based on the experiences and perspectives of CM healthcare professionals and patients were developed respectively.(3)The content validity of the study was evaluated mainly from triangulation,including data triangulation and methodological triangulation.Through the verification of literature data and interview data from CM healthcare professionals and patients mutually,the similarities and differences of SDM model components in the results of three different sources of data were compared and analyzed,and the conceptual framework of SDM model in CM was generated.Through peer expert review,the external evaluation of the established conceptual framework of SDM model in CM was carried out.We sent out consultation questionnaires to experts in the fields of CM,integrated Chinese and Western medicine,as well as evidencebased medicine nationwide.Moreover,the main content of the questionnaire closely revolved around the conceptual framework established.Descriptive statistical methods were used to report on each item,and their opinions were used as references for the revision and establishment of the conceptual framework.Finally,the conceptual framework of SDM model in CM was established.2.Applicability assessment of the SDM model in CMA two-stage before-after study in the same patient design with mixed qualitative and quantitative methods was used to conduct an implementation study.Patients with chronic kidney disease(CKD)stages 1-5 who were not on dialysis and had functional constipation were recruited and enrolled from the chronic disease outpatient department in Guangdong Provincial Hospital of Chinese Medicine.Patients in the first stage received information and decisional support as usual(traditional decision-making model),and patients in the second stage received the SDM intervention,consisting of patient decision aid and patient education.And healthcare professionals received a training on SDM.And then,the information on time consuming and the utilization of the SDM model in each stage were collected by using the SDM implementation checklist.Meanwhile,9 item shared decision making questionnaire(SDM-Q-9),low literacy decisional conflict scale(DCS-LL)and patient’s satisfaction with participation in medical decision-making scale were used respectively to assess the degree of the patients’ participation in the medical decision-making,decision quality and satisfaction.Additionally,data on patients’ experience of participating in the SDM and the barriers and facilitators of the implementation of the SDM model identified by physicians,patients and observers were collected through the qualitative interview and the observation methods.Results1.Development of the conceptual framework for the SDM model in CM(1)According to the results of the literature review,a total of 50 SDM model studies were included in the systematic review,43 of which were from developed countries.Twelve models were generic,the others were specific to a healthcare setting,and 25 models were related to the treatment decisions.Of 25 studies reported on the roles of both patients and healthcare professionals.Through the thematic synthesis method,the components of SDM model were analyzed from three perspectives,including the responsibility and role of healthcare professionals,the responsibility and role of patients and the shared responsibility of both parties.After analyzing and summarizing the text coding,we summarized nine,three and three descriptive themes respectively.By summarizing the descriptive themes,three analytical themes were obtained:preparation,information exchange,and decision-making and execution.Ultimately,based on the relationship between analytical themes and descriptive themes,the conceptual framework of SDM model was developed based on the components summarized.(2)Of sixteen CM healthcare professionals were interviewed in this study,including nine physicians and seven nurses,with 10-22 years of professional experience,37-50 years of age,and 39-103 minutes per interview.Of 186 open codes were obtained from 193,975 Chinese characters within these sixteen transcriptions.Through analyzing the internal relationship of text,codes and categories,three themes were finally obtained:the components of SDM in CM,the factors influencing the implementation of SDM,and the characteristics of SDM in CM.The first theme included four categories:healthcare professionals’duties,healthcare professionals’qualifications,patients’responsibilities,and family members’roles.Meanwhile,the factors influencing the implementation of SDM included three categories:characteristics of individuals,the inner setting and the outer setting.Additionally,the third theme included four categories:holistic concept,people oriented,treatment according to syndrome differentiation,and qualitative and quantitative evidence synthesis.Finally,based on the relationship between themes and categories,a preliminary conceptual framework of SDM in CM according to the perspectives of healthcare professionals was developed.A total of eleven patients were interviewed,with 33-65 years of age,and 20-52 minutes per interview respectively.Of 88,597 Chinese characters and 68 open codes were obtained.Three themes were finally gained:the cognition of patients’ participation in SDM,the factors influencing patients,participation in SDM and the characteristics of CM intervention.The cognition of patients’ participation in SDM included two categories:physicians’ support and patients’ cooperation.The factors influencing patients’ participation in SDM included two categories:patients’ perception and trust in physicians.Likewise,the characteristics of CM intervention included two categories:the guiding ideology as well as the diversity and comprehensiveness of treatment methods in CM.Lastly,according to the relationship between themes and categories,a preliminary conceptual framework of SDM in CM based on the experience of patients was developed.(3)Through the triangulation of literature data,healthcare professionals’and patients’interviews,it indicated that there was great consistency among these data in the conceptual framework of SDM model in CM.It also showed that the SDM process mainly consisted of three stages and the participants mainly involved healthcare professionals,patients and their families.What’s more,the main content of the model covered the responsibilities of healthcare professionals and patients at different stages.Consequently,the conceptual framework of SDM model in CM was presented as a phased implementation process of physician-patient interaction based on syndrome differentiation,guided by the holistic concept and combined with qualitative and quantitative evidence.After then,a total of twenty experts,from CM,integrated Chinese and Western Medicine as well as evidence-based medicine,were invited to participate in the survey to evaluate the SDM model preliminarily established in the form of electronic questionnaires.Among these experts,most of them showed positive comments on the rationality of the overall structure and specific content of the model,and these consensus opinions also supported the rationality.With no doubt,the suggestions put forward by the experts for some items also provided a reference for further optimization.Finally,the conceptual framework of SDM in CM was established.2.Applicability assessment of the SDM model in CMA total of 38 CKD stages 1-5 non-dialysis patients with functional constipation were included under a two-stage control study between traditional decision making model and CM SDM model.An implementation design of CM SDM was constructed based on the conceptual framework established,and the applicability of the implementation scheme was evaluated in this study.The results showed that the SDM model was implemented with high fidelity,with 35.71%of the indicators implemented at 100%and 71.43%of the indicators implemented at more than 80%.while the implementation rate of the item of "the environment is quiet and closed" was less than 70%.In addition,patients’acceptance of the SDM model in CM was high,and the factors such as the physician-patient attitudes,patient characteristics,knowledge and skills,environment,resources,and system support were the key factors influencing the implementation of the SDM process in the hospital setting.In terms of patients’ participation in medical decision making,the mean of SDM-Q-9 score was 61.23 ± 8.34 before the intervention of traditional decision-making model and 65.56(55.56～66.67)after the intervention.The mean of the second stage was 61.29± 10.60 before the intervention of SDM model,and 82.22±8.83 after the intervention.The difference between the two stages was statistically significant(P<0.05),indicating that compared with the intervention of traditional decision-making model,patients who received the intervention of SDM model showed an increase in the degree of participation in medical decision making.In terms of the quality of patient participation in medical decision making,the mean of DCSLL total score before the intervention of traditional decision-making model was 45.53± 11.44,and after the intervention was 44.08±12.35.In the second stage of the intervention of SDM model,the mean of the total score was 45.00(40.00～50.00)before intervention and 17.50(7.50～25.00)after intervention.The difference between the scores of the two stages was statistically significant(P<0.05).Compared with the intervention of traditional decisionmaking model,the quality of participation in decision-making improved among the patients who received the intervention of SDM model.At the same time,the complex intervention of the SDM model also reduced the uncertainty of patients in the decision-making process,enhanced the information notification and external support in the decision-making process(P<0.05).In terms of the satisfaction of patient participation in medical decision making,the mean of patient’s satisfaction with participation in medical decision-making total score before the intervention of traditional decision-making model was 73.01±6.63,and after the intervention was 74.70± 5.65.In the second stage of the intervention of SDM model,the mean of the total score was 73.34± 5.35 before intervention and 91.64 ± 3.73 after intervention.The difference between the scores of the two stages was statistically significant(P<0.05).Compared with the intervention of traditional decision-making model,the patients who received the intervention of SDM model had improved the satisfaction of participation in decision-making.At the same time,the complex intervention of the SDM model also improved patient’ information satisfaction,communication and negotiation satisfaction,decision-making satisfaction,as well as the total satisfaction and confidence in the decisionmaking process(P<0.05).Besides,there were no serious adverse events during the trial.ConclusionThe SDM model established in this study,starting from the development of the conceptual framework,not only followed the basic design principles and methods of the conceptual framework of the modern medical practice but also reflects the special consideration of the complex intervention of CM.Moreover,the implementation study of applicability assessment under the routine care from the outpatient department in the hospital of CM showed that the SDM model in CM can improve the degree,quality and satisfaction of patient’s participation in medical decision-making.Therefore,this study is expected to provide a methodological reference for future research,and further promote the development and application of the SDM model. |
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