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

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.

尽管专家建议每年进行肛门直肠指检（DARE）以检测肛门癌， 男男性行为者（MSM）中的肿瘤，临床医生严重未充分利用该程序， 不知道如何提高利用率。这是有问题的背景下，一个非常高的发病率肛门 MSM中的癌症，肛门癌前病变没有经过证实的治疗方法，缺乏筛查基础设施 用于检测癌前病变，即使是在高资源国家。这项研究的长期目标是 通过增加肛管肿瘤的检测，降低肛门癌的发病率和死亡率， 肛管的伴侣触诊。我们的初步数据表明，这些检查是可行的， 在MSM中可以接受。在200名男男性接触者的多样化样本中，93%的男性正确地将他们的自我肛门检查分类为 (SAE)或伴侣肛门检查（PAE）正常或异常，94%的人认为检查是可以接受的。 鉴于这些发现，我们的总体目标是通过评估检查来确定SAE和PAE的可行性。 两个临床试验机构结果的准确性和一致性。准确度将被定义为 中心假设是，第1次访视时的SAE和PAE均 在两次访视中的每次访视时，使用临床医生DARE作为金标准，灵敏度≥70%，特异性≥90%。我们 将通过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;以及3）确定以下因素的影响 SAE、PAE和DARE对生存率和生活质量的影响，并评价这些策略的成本-效果 艾滋病毒阳性和艾滋病毒阴性的男男性行为者中。这些目标将通过在休斯顿和芝加哥进行的一项研究来实现， 100对MSM夫妇的样本（即，200名伴侣）和600名单身男男性行为者（三分之二艾滋病毒呈阳性），年龄在25-80岁之间 年，将进行临床医生指导的SAE或PAE。然后，个人SAE和伴侣PAE将 与临床医生的DARE相比。将在两次访视（间隔12个月）中的每次访视时进行评估 此外，还要评估考试准确性的保持情况。目标1和2的预期成果是敏感性， 特异性和识别与准确性相关的临床和行为因素。目标3的结果将是 计算增量成本效益比率和净货币效益，以评估经济效益， SAE、PAE和DARE的可行性。这项研究意义重大，因为它将证明， 肛门疾病的高发病率可以识别疾病的存在。当前应用程序将提供 关键数据可能会挑战现状假设，即肛门触诊必须由 临床医生拟议的研究还增加了正在进行的研究，重点是检测肛门癌前病变， 缺乏经证实的治疗癌前病变的有效性，缺乏筛查基础设施， 检测癌前病变、在资源匮乏的环境中进行自我检查的可能性以及解决问题的必要性 与耻辱有关的障碍，这些障碍将推迟男子到诊所进行肛门生殖器检查。