| ObjectiveAiming at the problems of low data management level and low utilization rate of clinical research data management software in clinical research of traditional Chinese medicine,the selection methods of clinical research data management software are summarized.Established a database of chronic heart failure cohort studies in seven Chinese medicine hospitals,and used the database to establish a cohort of patients with chronic heart failure and atrial fibrillation in a Chinese medicine hospital to explore the effect of traditional Chinese medicine treatment on the occurrence of end events in patients with chronic heart failure and atrial fibrillation.MethodThrough literature survey,consult clinical research and data management related literature,analyze the problems of domestic clinical research application data management software and the progress made by clinical research data management software in Chinese medicine clinical research,and summarize the clinical research data management software selection method.The software selection method was applied to the data management work of the National Natural Science Foundation-funded project "Selection of Alternative Indexes and Research on Alternative Mechanisms of Clinical Efficacy Evaluation of Traditional Chinese Medicine(No.81774047)"(hereinafter referred to as the project).Epidata was used to collect research data of patients with chronic heart failure in seven Chinese medicine hospitals,and the research data was transferred to a network database constructed by Python+Django+My SQL to establish a database of chronic heart failure cohort research in seven Chinese medicine hospitals.Use the database to establish a cohort of patients with chronic heart failure and atrial fibrillation that meet the required sample size and loss of follow-up rate,and use logistic regression and Cox regression statistical methods to explore the relevant factors that affect the occurrence of end events during hospitalization and follow-up of patients with chronic heart failure and atrial fibrillation.Result1.Summarize the selection method of clinical research data management software and apply it to the research data management of the subject project queue.A network-based clinical database of chronic heart failure patients in Chinese medicine hospitals was constructed.Based on the database of chronic heart failure patients in Chinese medicine hospitals,a rapid establishment of chronic heart failure patients with atrial fibrillation was established.2.A total of 632 patients were included in the cohort of patients with chronic heart failure and atrial fibrillation,and 70 patients were lost to follow-up.The rate of lost follow-up was 11.08%.NYHA classification(OR=1.161,95%CI=1.035-1.834)during hospitalization was a factor related to death in patients with chronic heart failure and atrial fibrillation.During follow-up,age(OR=1.052,95%CI=1.025-1.079),NYHA classification(OR=1.681,95%CI=1.092-4.749)and diabetes(OR=1.790,95%CI=0,323-1.932)are chronic Related factors of cardiac death in patients with failure and atrial fibrillation.Chinese medicine treatment(OR=0.456,95%CI=0.214-0.971),age(OR=1.027,95%CI=1.009-1.117),NYHA classification(OR=1.525,95%CI=1.831-2.801)are chronic Related factors of heart failure rehospitalization in patients with failure and atrial fibrillation.Conclusion1.The selection method of TCM clinical research data management software was summarized,and the cohort study database of patients with chronic heart failure in 7 traditional Chinese medicine hospitals was established.2.Chinese medicine treatment can reduce the incidence of heart failure rehospitalization in patients with chronic heart failure and atrial fibrillation. |
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