Delirium is an acute, transient, usually reversible, fluctuating disturbance in consciousness, attention, cognition, and perception. Delirium after cardiac operations is associated with increased morbidity, reduced cognitive functioning, increased short-term and long-term mortality, longer hospitalization and higher hospitalization cost. The diagnosis, prevention and treatment of delirium are of great importance for perioperative care of patients undergoing cardiac surgery. Effective delirium screening tools are very helpful for the recognition and monitoring of delirium after cardiac surgery. In recent years, there has been many new strategies for the treatment, nursing care and prevention of delirium after cardiac surgery. This review focuses on the incidence, risk factors, diagnostic methods, treatment and preventive strategies of delirium after cardiac surgery.
Pragmatic randomized controlled trials can provide high-quality evidence. However, pragmatic trials need to frequently encounter the missing outcome data due to the challenges of quality assurance and control. The missing outcome could lead to bias which may misguide the conclusions. Thus, it is crucial to handle the missing outcome data appropriately. Our study initially summarized the bias structures and missingness mechanisms, and then reviewed important methods based on the assumption of missing at random. We referred to the multiple imputations and inverse probability of censoring weighting for dealing with missing outcomes. This paper aimed to provide insights on how to choose the statistical methods on missing outcome data.
ObjectiveTo examine statistical performance of different rare-event meta-analyses methods.MethodsUsing Monte-Carlo simulation, we set a variety of scenarios to evaluate the performance of various rare-event meta-analysis methods. The performance measures included absolute percentage error, root mean square error and interval coverage.ResultsAcross different scenarios, the absolute percentage error and root mean square error were similar for Bayesian logistic regression model, generalized mixed linear effects model and continuity correction, but the interval coverage was higher with Bayesian logistic regression model. The statistical performances with Mantel-Haenszel method and Peto method were consistently suboptimal across different scenarios.ConclusionsBayesian logistic regression model may be recommended as a preferred approach for rare-event meta-analysis.
With the establishment and development of regional healthcare big data platforms, regional healthcare big data is playing an increasingly important role in health policy program evaluations. Regional healthcare big data is usually structured hierarchically. Traditional statistical models have limitations in analyzing hierarchical data, and multilevel models are powerful statistical analysis tools for processing hierarchical data. This method has frequently been used by healthcare researchers overseas, however, it lacks application in China. This paper aimed to introduce the multilevel model and several common application scenarios in medicine policy evaluations. We expected to provide a methodological framework for medicine policy evaluation using regional healthcare big data or hierarchical data.
With the increasing improvement of real-world evidence as a research system and guideline specification for pre-market registration and post-market regulatory decision support of clinically urgent drug and mechanical products, identifying an approach to ensure the high quality and standards of real-world data and establishing a basis for the generation of real-world evidence is receiving increasing attention and concern from regulatory authorities. Based on the experience of Boao hope city real-world data research pattern and ophthalmic data platform construction, this paper discussed the "source data-database-evidence chain" generation process, data management, and data governance in real-world study from the special features and necessity of multiple sources and heterogeneity of data, multiple research designs, and standardized regulatory requirements, and provided references for further construction of comprehensive research data platforms in the future.
Research of generating real-world evidence using real world data has attracted considerable attention globally. Outcome research of treatment based on existing health and medical data or registries has become one of the most important topics. However, there exists certain confusions in this line of research on how to design and implement appropriate statistical analysis. Therefore, in the fourth chapter of the series technical guidance to develop real world evidence by China REal world data and studies Alliance (ChinaREAL), we aim to provide an guidance on statistical analysis in the study to assess therapeutic outcomes based on existing health and medical data or registries.In this chapter, we first emphasize the significance of pre-specified statistical analysis plan, recommending key components of the statistical analysis plan. We then summarize the issue of sample size calculation in this content and clarify the interpretation of statistical p-value. Secondly, we recommend procedures to be considered to tackle the issue related to the selection bias, information bias and most importantly, confounding bias. We discuss the multivariable regression analysis as well as the popular causal inference models. We also suggest that careful consideration should be made to deal with missing data in real-world databases. Finally, we list core content of the statistical report.