标题： 联合单侧和双侧数据的两个比例的风险差异检验 显示英文标题

标题： Testing Risk Difference of Two Proportions for Combined Unilateral and Bilateral Data

摘要： 在具有配对器官的临床研究中，二元结果通常表现出受试者内相关性，并可能包含单侧和双侧观察的混合数据。 在Donner的恒定相关性模型下，我们开发了三种基于似然的检验统计量（似然比检验、Wald型检验和得分检验），用于评估两个比例之间的风险差异。 模拟研究显示，三种检验在I型错误控制和功效方面表现良好，得分检验显示出稍好的稳定性。 对耳鼻喉科和眼科数据的应用说明了这些方法。 还提供了一个在线计算器用于功效分析和风险差异检验。 得分检验推荐用于实际应用以及结合单侧和双侧二元数据的未来研究。 显示英文摘要

摘要： In clinical studies with paired organs, binary outcomes often exhibit intra-subject correlation and may include a mixture of unilateral and bilateral observations. Under Donner's constant correlation model, we develop three likelihood-based test statistics (the likelihood ratio, Wald-type, and score tests) for assessing the risk difference between two proportions. Simulation studies demonstrate good control of type I error and comparable power among the three tests, with the score test showing slightly better stability. Applications to otolaryngologic and ophthalmologic data illustrate the methods. An online calculator is also provided for power analysis and risk difference testing. The score test is recommended for practical use and future studies with combined unilateral and bilateral binary data.