This paper provides guidance for researchers with some mathematical background on the conduct of time‐to‐event analysis in observational studies based on intensity (hazard) models. Discussions of basic concepts like time axis, event definition and censoring are given. Hazard models are introduced, with special emphasis on the Cox proportional hazards regression model. We provide check lists that may be useful both when fitting the model and assessing its goodness of fit and when interpreting the results. Special attention is paid to how to avoid problems with immortal time bias by introducing time‐dependent covariates. We discuss prediction based on hazard models and difficulties when attempting to draw proper causal conclusions from such models. Finally, we present a series of examples where the methods and check lists are exemplified. Computational details and implementation using the freely available R software are documented in Supplementary Material. The paper was prepared as part of the STRATOS initiative.

中文翻译：

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观察性研究的事件发生时间分析：强度模型使用指南

本文为具有一定数学背景的研究人员提供了在基于强度（危险）模型的观察研究中进行事件时间分析的指导。讨论了时间轴、事件定义和审查等基本概念。介绍了风险模型，特别强调 Cox 比例风险回归模型。我们提供的检查列表在拟合模型和评估其拟合优度以及解释结果时可能很有用。特别关注如何通过引入时间相关的协变量来避免不朽时间偏差的问题。我们讨论基于危险模型的预测以及试图从此类模型得出正确因果结论时的困难。最后，我们提供了一系列示例，其中举例说明了方法和检查列表。补充材料中记录了使用免费R软件的计算细节和实现。该论文是作为 STRATOS 计划的一部分而编写的。