Optimizing Age-based Anal Cancer Screening Among People Living with HIV using Decision Analytic Modeling

使用决策分析模型优化艾滋病毒感染者中基于年龄的肛门癌筛查

• 批准号: 10350629
• 负责人: Ashish A. Deshmukh
• 金额: --
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-05 至 2022-08-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10350629
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adoption; Age; Aging; Algorithms; American; Anus; Area; Biological; CD4 Lymphocyte Count; Cancer Etiology; Cells; Cervical Cancer Screening; Clinical; Clinical Trials; Collaborations; Colorectal Cancer; Cytology; Data; Databases; Detection; Diagnosis; Disease; Epidemiology; Etiology; Frequencies; Future; Goals; Guidelines; HIV; HPV-High Risk; Human Papillomavirus; Human papilloma virus infection; Incidence; Individual; Life Expectancy; Literature; Malignant Neoplasms; Malignant Squamous Cell Neoplasm; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Malignant neoplasm of prostate; Mass Screening; Mathematics; Measures; Methods; Modeling; Morbidity - disease rate; Natural History; Outcomes Research; Patient-Focused Outcomes; Persons; Policies; Population; Prevention; Preventive healthcare; Quality of life; Randomized Clinical Trials; Recurrence; Regimen; Research; Research Design; Risk; Screening for cancer; Sex Behavior; Squamous intraepithelial lesion; Survival Rate; Treatment Effectiveness; Treatment Efficacy; Uncertainty; United States; United States Department of Veterans Affairs; Viral; Woman; Work; base; cancer prevention; clinical care; clinical decision-making; clinical practice; clinically significant; cohort; comparative effectiveness; cost; cost effective; cost effectiveness; data warehouse; efficacy evaluation; experience; high risk; improved; innovation; malignant breast neoplasm; mathematical model; men; men who have sex with men; models and simulation; mortality; multiple datasets; older men; prevent; public health priorities; screening; screening guidelines; screening policy; sex; virtual

PROJECT SUMMARY/ABSTRACT Anal cancer is the second most common non-AIDS defining cancer and a leading cause of morbidity among HIV-infected (HIV+) persons in the United States (US). The incidence of anal cancer increases with age. With nearly 50% HIV+ persons are now 50-years or older, preventative health care in the form of screening is a major public health priority to decrease their risk of developing anal cancer. Because anal cancer is biologically similar to cervical cancer, current guidelines (inferred from cervical cancer literature) recommend screening HIV+ men and women using anal cytology for detection of high-grade squamous intraepithelial lesions (the anal cancer precursor); however, optimal screening regimen (age to start and stop screening as well as optimal screening frequency) for the prevention of anal cancer still remains unknown. Due to the lack of clear understanding of harms versus benefits of screening, only 11% of HIV+ persons had an anal cytology in the preceding year, leading to 50% of diagnoses occurring at stage III or worse when the 5-year survival rate is less than 40%. The goal of the proposed research is to identify appropriate candidates for screening and determine age- specific screening algorithms to reduce anal cancer morbidity and mortality among HIV+ men and women. We will integrate evidence from two large clinical trials and several large databases into mathematical modeling, a complementary approach to randomized clinical trials. In Aim 1, we will measure the impact of age and HIV disease status (i.e., HIV viral suppression, CD4 count) on the incidence of anal HSIL, HSIL recurrence, and progression to anal cancer. In Aim 2, we will develop a clinically-valid mathematical model of anal cancer natural history in HIV+ men and women and use it to determine optimal age-specific anal cancer screening algorithm. Finally, in Aim 3, we propose to determine the minimum necessary efficacy (by age) of anal HSIL treatment for HIV+ men and women to provide clinically significant benefits for screening and finally determine areas of future research to improve the value of anal cancer screening. The proposed research is innovative because it applies advanced modeling approach with multiple datasets to address a problem that has not been solved by empirical methods. The research team is ideally suited, with an established track record in HIV and HPV epidemiology, cancer outcomes research, and clinical care, having substantial experience in developing mathematical models to inform clinical decision making. The end results of the proposed study will be age-specific anal cancer screening recommendations for HIV+ men and women that will inform anal cancer prevention policies and practice and ultimately reduce morbidity and mortality.

项目摘要/摘要 肛门癌是定义癌症的第二大最常见的非辅助药物，也是发病率的主要原因 美国（美国）的HIV感染者（HIV+）人。肛门癌的发生率随着年龄的增长而增加。和 现在，将近50％的艾滋病毒+患者已经50岁或以上，以筛查形式的预防性医疗保健为 主要的公共卫生优先事项可以降低患肛门癌的风险。因为肛门癌在生物学上是 与宫颈癌类似，当前的指南（根据宫颈癌文献推论）建议筛查 HIV+男性和女性使用肛门细胞学来检测高级鳞状上皮内病变（该病变 肛门癌前体）；但是，最佳筛选方案（开始和停止筛查的年龄以及 预防肛门癌的最佳筛查频率仍然未知。由于缺乏清晰 了解危害与筛查的益处，只有11％的艾滋病毒+患者在 前一年，导致5年生存率为第三阶段或更糟的诊断的50％ 小于40％。 拟议的研究的目的是确定适当的筛查候选者并确定年龄 - 特定的筛查算法可降低艾滋病毒+男性和女性的肛门癌发病率和死亡率。我们 将将来自两个大型临床试验和几个大数据库的证据整合到数学建模中， 一种随机临床试验的补充方法。在AIM 1中，我们将衡量年龄和艾滋病毒的影响 疾病状况（即HIV病毒抑制，CD4计数）关于肛门HSIL的发生率，HSIL复发和 进展为肛门癌。在AIM 2中，我们将开发肛门癌的临床播种数学模型 艾滋病毒+男性和女人的自然病史，并使用它来确定最佳年龄特异性肛门癌筛查 算法。最后，在AIM 3中，我们建议确定肛门HSIL的最低必要功效（按年龄） 艾滋病毒+男性和女性的治疗可为筛查提供临床上的显着好处，并最终确定 未来研究的领域，以提高肛门癌筛查的价值。 拟议的研究具有创新性，因为它使用多个数据集应用高级建模方法 解决了尚未通过经验方法解决的问题。研究小组非常适合 艾滋病毒和HPV流行病学，癌症结果研究和临床护理中的尚有往绩记录 在开发数学模型以为临床决策提供信息方面的丰富经验。最终结果 拟议的研究将是针对HIV+男性和女性的特定年龄肛门癌筛查建议 这将为肛门癌的预防政策和实践提供依据，并最终降低发病率和死亡率。