This study combines quantitative and qualitative research of Chinese and Western medicine methodology in the treatment of diabetes,aiming at the current certain limitations in Chinese medicine clinical research method field,to explore more useful and enhancing patient compliance method in clinical research,to provide more advanced evidence,in order to facilitate the Chinese medicine clinical research results with international practice,raise evidence-based medicine in the promotion and application and the level of clinical research studies. This study is composed of three parts,including two literatuer summaries,two researches.The summary parts describe the advancements of patients research outcome(PRO),and the qualitative research approach in foreign patients about education,awareness and attitude of scientific research1 A multi-center,randomized control trials about diabetes patients clinical research education with a combination of qualitative research method PurposeTo explore the effectiveness and necessity of clinical science research education in the diabetes patients,to learn about the patients clinical research knowledge before and after the education,as well as the needs,attitudes,beliefs, expectations,willingness change about research knowledge.Through randomized controlled trials with combination of qualitative research methods to explore the importance of the scientific education mode in improving the evidence effectiveness of interventions,in order to enhance patient awareness of clinical research participation,motivation and compliance.MethodsTake advantage of the scientific research methods based on the combination of The semi-structured qualitative interviews and quantitative of randomized controlled trials.DesignThe diabetic patients carrying out education research are in the intervention group,those without education are in the control group,preliminarily evaluate the patient effectiveness and attitude of clinical research field,through the 6-center, randomized,controlled,combining qualitative research interviews with the semi-structured questionnaire methodology of exploratory clinical trials.①Objects selection:43 patients of type 2 diabetes in hospital patients of each center,6 centers with a total of 258 cases.②Intervention and control programs:The diabetic patients carrying out education research are in the intervention group,those without education are in the control group.③Index and methods of measurement:the entries in each issue are measure index,by semi-structured qualitative interviews.④Measurementsites and time:in hospital patients,carry out questionnaire measuring after oral informed consent.ResultsAfter three months of investigation and education,the six centers,there is no cases from the defaulters in our 258 patients.Education survey showed that patients with pre-clinical research and the apparent lack of knowledge,especially for clinical research nature,informed consent,placebo,follow-up,randomly assigned,as well as the understanding of ethics and so on.Education in this area can improve the patient's compliance,but also the needs of patients.The answer for each topic of the pilot group and the control group as an indicator to compare the value obtained statistically significant difference in the measurement of indicators.19 topics on the inter-group comparison,we can see the pilot group and the control group the answers p<0.05,19 pilot subject group comparison group is also the answer to p<0.05,there is significant statistical significance,that education are effective,it is clear that it can change the perception and attitude about clinical research,and the method is easy to use.Multiple linear regression analysis results:there are five topics showing that effect education has association with the degree of patients' education.Education with most patients with gender, age,duration,etc.has no association.At the same time,we use qualitative content analysis to explore the existence of the status of awareness and attitude of the main reasons for clinical research.Lack of trust and a sense of security-related,in addition to patient education,disease status,economic issues,family circumstances have acted on the patient's attitude,have a certain influence of cognitive,clinical research education is a general need for patients.Qualitative research can complement and further improve the quantitative results.Conclusion①qualitative and combination of qualitative and quantitative research methods are very practical and easily applied in clinical studies, particularly in the problems that patients do not want to tell a lot,in order to make timely adjustment in order to achieve scientific research or treatment purposes.A combination of both can provide a higher level of clinical evidence,which can become more fully and more extensive.②it is very necessary and practicable to practice scientific research education in clinical patients,and is good for patients recruitment,patient awareness,participation,and compliance improving,will help to obtain better research outcome.2 The outcome study based on patients reported about the MYMOP(measure yourself medical outcome profile)PurposeTo explore treatment effect index from the perspective of patients,to judge role of Chinese and Western medicine on the treatment of diabets changing prognosis as a represent of chronic diseases,provide a new and more practical tools.MethodsDesign:To evaluate the diabetes patients outcome based on the patients' self-report scale of symptoms.Methods:The investigators carry out 2 times of survey interview with the type 2 diabetes patients in Chinese medicine hospital.Follow-up sheets complete in 1-2 months after in the way of phone-call.Location:Four three-level hospitals of Chinese medicine in Beijing.Mainly in the wards.Objects:diabetes patients.Questionnaire:about the baseline information,symptoms,health status,activity, medication and so on.Investigation time:2008.5-2009.1Investigator training:Before the start of the clinical interview,researchers carry out the training program,in order to let all the contents of the questionnaire to be known by the participate in the study.Data acquisition:Carry out a survey questionnaire by the investigators immediately after the oral consent of the patients,and appropriate explanation.Analysis Method:Symptoms of 1 and health status is must to be filled,MYMOP table does not fill the two will be null and void.Each item on the table of the score is to ask the patients to their own past in the case of 1 week scoring from 0-6 points,0 represents "best-case scenario",6 on behalf of the "worst case scenario."ResultsSurvey of 322 diabetic patients from the four centers involved in the questionnaire in patients with symptoms,health status,.statistical analysis showed that at 2 months in all patients the total score of p<0.05,with statistical significance.Chinese medicine hospital treatment to the patients to improve health conditions and symptoms are satisfied with the situation.Patients with the most interference from the main causes of treatment for blood glucose instability, poor vision,heart discomfort,head discomfort,and so on.ConclusionMYMOP is particularly suitable for analysis of the efficacy of Chinese medicine in particular.Their questionnaires and charts can be used in case study, but further tests still need to be used to analyze if the tool in routine clinical practice can be applied. |