Statistical Methods of Cardiotoxicity Studies in Aids

艾滋病心脏毒性研究的统计方法

• 批准号: 6986243
• 负责人: Stuart R. Lipsitz
• 金额: $ 12万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6986243
• 关键词: AIDS; AIDS /HIV diagnosis; AIDS therapy; antiAIDS agent; blood pressure; cardiovascular disorder epidemiology; children; cytotoxicity; disease /disorder onset; disease /disorder proneness /risk; heart dimension /size; heart disorder; heart disorder diagnosis; heart function; human data; longitudinal human study; mathematical model; medical complication; method development; model design /development; pediatric AIDS; statistics /biometry; therapy adverse effect; vertical transmission

DESCRIPTION (provided by applicant): Data from longitudinal studies have suggested that patients infected with HIV-1 might have cardiovascular abnormalities. These abnormalities may be the result of the treatments (AZT, etc.) or the HIV-1 virus itself. In this grant, we will develop methods to analyze longitudinal and survival studies of heart function in AIDS patients. Cardiotoxicity in AIDS patients could be a leading cause of morbidity and mortality. Development of methods leading to increased understanding of the cardiotoxicity could prove invaluable in determining the appropriate time to give cardioprotective therapies. The developed methods will be applied to the Pediatric Pulmonary and Cardiac Complications (P2C2) of Vertically Transmitted HIV Infection Study, which was a large, prospective longitudinal study designed to monitor heart disease and the progression of cardiac abnormalities in children born to HIV-infected women. To truly understand the change in heart function over time, new models and methods need to be developed that take into account multiple measures of heart function (LV mass, end-diastolic dimension, end-systolic dimension, fractional shortening, etc.). The models and associated statistical methods should be such that biases do not result because of higher rates of clinic visits by sicker patients, higher chance of dropout for sicker patients, missed clinic visits due to patients' health conditions, etc. In this grant, we develop appropriate models and methods to deal with these situations. We will examine the following six Specific Aims. Regression models for Longitudinal Discrete and Continuous Outcomes; A likelihood method for Longitudinal Studies with Informative Dropout; A Protective Estimator for Mixed Discrete and Continuous Outcomes Subject to Nonignorable Non-monotone Missingness; Methods for Estimation in Longitudinal Studies with Outcome-Dependent Follow-Up; and Prediction in Multivariate Survival Models; Sensitivity Analysis for the previous six aims.

描述（由申请人提供）：纵向研究的数据表明，感染HIV-1的患者可能患有心血管异常。这些异常可能是治疗（AZT等）或HIV-1病毒本身的结果。 在这笔赠款中，我们将开发分析艾滋病患者心脏功能的纵向和生存研究的方法。艾滋病患者的心脏毒性可能是发病率和死亡率的主要原因。发展导致对心脏毒性的理解的方法的发展对于确定提供心脏保护疗法的适当时间而言是无价的。开发的方法将应用于垂直传播的HIV感染研究的小儿肺和心脏并发症（P2C2），该研究是一项大型的，前瞻性的纵向研究，旨在监测心脏病和受HIV感染的妇女出生的儿童的心脏异常进展。为了真正了解随着时间的推移心脏功能的变化，需要开发新的模型和方法，以考虑多种心脏功能度量（LV质量，末期舒适维度，终端局势降低维度，分数缩短等）。模型和相关的统计方法应该是，由于病人的诊所就诊率更高，病人辍学的机会更高，由于患者的健康状况而错过的诊所就诊，因此我们开发了适当的模型和方法来处理这些情况。我们将研究以下六个具体目标。纵向离散和连续结果的回归模型；纵向研究的可能性方法，内容丰富；混合离散和连续结果的保护性估计量受到不可贬低的非符号失调的影响；在纵向研究中进行估计的方法，并依赖结果依赖性随访；和多元生存模型的预测；对前六个目标的灵敏度分析。