Gerd Rippin, Shahrzad Salmasi, Héctor Sanz, Joan Largent
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Core Concepts in Pharmacoepidemiology: Time-To-Event Analysis Approaches in Pharmacoepidemiology.
Aim: This article provides an overview of time-to-event (TTE) analysis in pharmacoepidemiology.
Materials & methods: The key concept of censoring is reviewed, including right-, left-, interval- and informative censoring. Simple descriptive statistics are explained, including the nonparametric estimation of the TTE distribution as per Kaplan-Meier method, as well as more complex TTE regression approaches, including the parametric Accelerated Failure Time (AFT) model and the semi-parametric Cox Proportional Hazards and Restricted Mean Survival Time (RMST) models. Additional approaches and various TTE model extensions are presented as well. Finally, causal inference for TTE outcomes is addressed.
Results: A thorough review of the available concepts and methods outlines the immense variety of available and useful TTE models.
Discussion: There may be underused TTE concepts and methods, which are highlighted to raise awareness for researchers who aim to apply the most appropriate TTE approach for their study.
Conclusion: This paper constitutes a modern summary of TTE analysis concepts and methods. A curated list of references is provided.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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