Determining the accuracy of self- and partner anal exams for detecting anal abnormalities.

确定自我和伴侣肛门检查检测肛门异常的准确性。

• 批准号: 10468124
• 负责人: ALAN GASPAR NYITRAY
• 金额: $ 63.25万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-17 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10468124
• 关键词: Address; Age; Agreement; Anal canal; Anus; Behavioral; Bisexual; Cervical; Chicago; Clinic; Clinical; Cost Analysis; Country; Couples; Cytology; Data; Detection; Development; Disease; Early Diagnosis; Economics; Eligibility Determination; Enrollment; Expert Opinion; Funding; Gays; General Population; Goals; Gold; HIV; HIV Seronegativity; HIV Seropositivity; Health Benefit; Healthcare; Human Papillomavirus; Incidence; Individual; Infrastructure; Intervention; Interview; Lesion; Malignant Neoplasms; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Methods; Morbidity - disease rate; Outcome; Palpation; Participant; Performance; Persons; Phase; Physicians; Pilot Projects; Population; Predictive Value; Procedures; Professional Organizations; Public Health; Quality of life; Randomized Clinical Trials; Rapid screening; Research; Resource-limited setting; Resources; Rest; Sampling; Screening for cancer; Sensitivity and Specificity; Site; Specificity; Testing; Training; Treatment Efficacy; Visit; aged; base; cost effective; cost effectiveness; cost-effectiveness evaluation; cost-effectiveness ratio; digital; efficacious treatment; incremental cost-effectiveness; insight; men; mortality; patient oriented; premalignant; screening; sex; social stigma; tumor; Address; Age; Agreement; Anal canal; Anus; Behavioral; Bisexual; Cervical; Chicago; Clinic; Clinical; Cost Analysis; Country; Couples; Cytology; Data; Detection; Development; Disease; Early Diagnosis; Economics; Eligibility Determination; Enrollment; Expert Opinion; Funding; Gays; General Population; Goals; Gold; HIV; HIV Seronegativity; HIV Seropositivity; Health Benefit; Healthcare; Human Papillomavirus; Incidence; Individual; Infrastructure; Intervention; Interview; Lesion; Malignant Neoplasms; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Methods; Morbidity - disease rate; Outcome; Palpation; Participant; Performance; Persons; Phase; Physicians; Pilot Projects; Population; Predictive Value; Procedures; Professional Organizations; Public Health; Quality of life; Randomized Clinical Trials; Rapid screening; Research; Resource-limited setting; Resources; Rest; Sampling; Screening for cancer; Sensitivity and Specificity; Site; Specificity; Testing; Training; Treatment Efficacy; Visit; aged; base; cost effective; cost effectiveness; cost-effectiveness evaluation; cost-effectiveness ratio; digital; efficacious treatment; incremental cost-effectiveness; insight; men; mortality; patient oriented; premalignant; screening; sex; social stigma; tumor

Even though expert opinion recommends annual digital ano-rectal exams (DARE) for detection of anal cancer tumors among men having sex with men (MSM), the procedure is severely underutilized by clinicians and it is not known how to increase utilization. This is problematic in the context of an extremely high incidence of anal cancer among MSM, no proven treatment for anal precancerous lesions, and lack of screening infrastructure for detecting precancerous lesions, even in high-resource countries. The long-term goal of this study is to decrease morbidity and mortality from anal cancer by increasing detection of anal canal tumors through self- or partner-palpation of the anal canal. Our preliminary data indicate these exams are feasible and highly acceptable among MSM. In a diverse sample of 200 MSM, 93% of men correctly classified their self-anal exam (SAE) or partner anal exam (PAE) as either normal or abnormal, and 94% said the exams were acceptable. Given these findings, our overall objective is to determine the viability of the SAE and PAE by assessing exam accuracy and consistency of results in two clinic sites. Accuracy will be defined as concordance between clinician DARE and participant exam. The central hypothesis is that both SAE and PAE at visit 1 will have ≥70% sensitivity and ≥90% specificity using the clinician DARE as the gold standard at each of two visits. We will test the hypothesis with three specific aims: 1) Estimate SAE and PAE sensitivity and specificity; 2) Determine independent factors associated with SAE and PAE concordance; and 3) Determine the impact of SAE, PAE, and DARE on survival and quality of life, and evaluate the cost-effectiveness of these strategies among HIV+ and HIV- MSM. The aims will be accomplished with a study in Houston and Chicago with a sample of 100 MSM couples (i.e., 200 partners) and 600 single MSM (two-thirds HIV-positive), aged 25-80 years, who will perform a clinician-taught SAE or PAE. The individual's SAE and partner's PAE will then be compared with the clinician's DARE. The assessment will be done at each of two visits, spaced 12-months apart, to assess retention of exam accuracy. The expected outcomes for aims 1 and 2 are sensitivity, specificity and identification of clinical and behavioral factors associated with accuracy. Aim 3 outcomes will be the computation of incremental cost-effectiveness ratios and net monetary benefits to assess the economic viability of SAE, PAE, and DARE. This study is significant because it will demonstrate that a population with substantial rates of anal disease can recognize when disease is present. The current application will provide pivotal data that may challenge the status quo assumption that anal palpation must be performed by a clinician. The proposed research also adds to ongoing research focused on detection of anal precancers given the lack of proven efficacy for treatment of precancerous lesions, the lack of screening infrastructure for detecting precancerous lesions, the potential for self-exams in low-resource settings, and the need to address stigma-related barriers that will delay clinic attendance for ano-genital examinations among men.

即使专家意见建议每年的数字ANO直肠考试（DARE）来检测肛门癌 与男性发生性关系（MSM）的男性中的肿瘤，该过程严重不足，临床医生不足，这是 不知道如何增加利用率。在极高的肛门事件中，这是有问题的 MSM中的癌症，没有可靠的肛门预科疗法治疗，缺乏筛查基础设施 用于检测癌前病变，即使在高资源国家也是如此。这项研究的长期目标是 通过自我或通过自我的检测来降低肛门癌的发病率和死亡率 肛门管的伴侣镇定。我们的初步数据表明这些考试是可行的，而且很高 可以在MSM中接受。在200 MSM的潜水员样本中，有93％的男性正确分类了他们的自我检查 （SAE）或伴侣肛门考试（PAE）是正常或异常，而94％的人表示考试是可以接受的。 鉴于这些发现，我们的总体目标是通过评估考试来确定SAE和PAE的生存能力 两个临床部位的结果的准确性和一致性。精度将定义为一致性 临床敢于参加考试。中心假设是SAE和PAE在访问1时都会有 ≥70％的灵敏度和≥90％的特异性，使用临床敢于在两次访问中的每一个中作为黄金标准。我们 将以三个特定目的检验假设：1）估计SAE和PAE的敏感性和特异性； 2） 确定与SAE和PAE一致性相关的独立因素； 3）确定 SAE，PAE和敢于生存和生活质量，并评估这些策略的成本效益 在HIV+和HIV- MSM中。目的将通过在休斯敦和芝加哥进行的研究来实现 100个MSM夫妇的样本（即200个合作伙伴）和600个单个MSM（三分之二的HIV阳性），年龄25-80 多年，他将进行临床教学的SAE或PAE。然后，个人的SAE和伴侣的PAE将是 与临床上的敢于相比。评估将在两次访问中的每一个，间隔12个月进行 除了评估考试准确性的保留。目标1和2的预期结果是灵敏度， 与准确性相关的临床和行为因素的特异性和鉴定。目标3的结果将是 评估经济的增量成本效益比和净货币收益的计算 SAE，PAE和DARE的生存能力。这项研究很重要，因为它将证明 肛门疾病的大量率可以识别出何时存在疾病。当前申请将提供 可能会挑战现状假设的关键数据，即必须由A进行肛门触诊 临床。拟议的研究还增加了正在进行的研究，重点是检测到肛门的预科生 缺乏治疗癌性病变的有效性，缺乏筛查基础设施 检测癌前病变，在低资源环境中进行自我检查的潜力以及需要解决的需求 与污名相关的障碍，将推迟男性肛门生成检查的诊所出勤。