Objective To evaluate the therapeutic effectiveness and safety of ibutilide versus amiodarone in the treatment of atrial fibrillation and atrial flutter. Methods An electronic search in databases including PubMed, Embase, CNKI, WanFang Data, VIP Database, and The Cochrane Library (Issue 2, 2011), published from January 1994 to January 2011,was conducted to include both English and Chinese randomized controlled trials (RCTs) about ibutilide versus amiodarone in treating atrial fibrillation and atrial flutter. Two reviewers independently screened the studies according to the inclusive and exclusive criteria, extracted the data, assessed the methodological quality, and then performed Meta-analysis by using RevMan 5.0 software. Results Eight RCTs involving 506 patients were finally included. The results of Meta-analysis showed: a) The total effective rate of alleviating atrial fibrillation and atrial flutter in the ibutilide group was superior to that of the amiodarone group (OR=2.27, 95%CI 1.19 to 4.33, P=0.01); b) Four RCTs showed that ibutilide was similar to amiodarone for alleviating atrial fibrillation (OR=1.61, 95%CI 0.96 to 2.71, P=0.07), but the former was superior to the latter for alleviating atrial flutter (OR=8.97, 95%CI 4.51 to 17.84, Plt;0.000 01); c) Five RCTs showed that ibulitide took shorter time to alleviate atrial fibrillation and atrial flutter compared with amiodarone (WMD= –126.55 min, 95%CI –202.35 to –50.76, P=0.001); d) Four RCTs showed that the total adverse effect rates in the two groups had no significant difference (OR=1.13, 95%CI 0.37 to 3.43, P=0.83), but there were more cardiovascular side-effects in the ibutilide group (OR=2.36, 95%CI 1.40 to 4.01, P=0.001). Conclusion Compared with amiodarone, ibutilide has a higher total effective rate in cardioversion of atrial fibrillation and atrial flutter, and it obviously takes shorter time to alleviate atrial fibrillation and atrial flutter, but there is no significant difference in the cardioversion rate of atrial fibrillation between them. There is no significant difference in total side-effect rates between the two groups, but the cardiovascular adverse reaction in the ibutilide group is significantly higher than that of the amiodarone group. Because of the limited quantity and quality of the included studies, this conclusion has to be further proved by more high-quality RCTs.
Data integrity, accuracy, and traceability are key elements of high-quality clinical research, as well as weak links in the promotion of clinical research transparency. How to promote data quality has become a major concern to all clinical research stakeholders. In this article, we dissected and analyzed data generation and capturing process in clinical research, and identified a key aspect in improving data quality: to promote electronic source data, especially to break the barrier between electronic health records and clinical research systems. Additionally, we summarized the experiences regarding this issue in China and overseas to propose a solution suitable for China to improve data quality in clinical research: to strengthen clinical research source data management by building clinical research source data platform and adopt common source data management process in hospitals.
ObjectivesTo establish an appropriate data governance mode in according with the database status of clinical study.MethodsForty-six doctors of different seniority with clinical research experience from six hospitals in Beijing were selected by stratified purposeful sampling and semi-structured interview and were used to understand the status and shortcomings of data acquisition and storage in clinical research. The data resource of current clinical studies were summarized and the main target of data governance and the characteristics of clinical study data were explored to establish the domains of clinical study data governance to construct the framework of clinical research data governance.ResultsCurrently, the data sources of clinical studies were diverse, including real-world data from various medical and health records, data collected independently for clinical studies and numerous other sources. However, since collecting the data from electronic medical records was difficult for numerous reasons, a large number of researchers still collected research data by hand writing and stored it insecurely. In addition, the combination of electronic information from multiple sources was difficult. Building ALCOA+CCEA standard clinical research data management system based on clinical research data governance was urgent. Data governance includes data architecture, data model, data standards, data quality, master data, timeliness management, metadata and data security, while life cycle management and data insight were not essential parts.ConclusionsBased on the real-world data resources, domains of data governance in clinical study should include data architecture, data model, data standards, data quality, master data, timeliness management, metadata and data security.
ObjectiveTo construct a strategy for classification of clinical research data security for real-world research, based on the features of clinical research data.MethodsBased on the laws, regulations, and data security classification method in relevant fields, the clinical research data was classified into five security levels. Then, the method was gradually perfected through three times of revisions, which followed the advice from experts who were experienced in many relative areas, such as clinical medicine, clinical research methodology, clinical research management, ethics, genetics and public health data application and management.ResultsExperts’ opinions gradually converged through several times of consultation. The clinical research data was finally classified into five security levels with explicit definition and security policy for each security level. Thirty-three data categories, which covered demographic information, clinical examination, diagnosis, treatment information, genetic information, health economics information, medical data and information on research processes that have been published, were included in the five security levels.ConclusionsSince there is an increasing trend of data scale and the data security classification and management are necessary to ensure the data security and appropriately utilization of data. The method of clinical research data classification proposed in this paper can provide beneficial references for the further improvement of data security in the future.