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

即使专家建议每年进行肛门直肠指诊(DARE)来检测肛门癌 在男男性行为者(MSM)中，这一程序被临床医生严重利用不足，它是 不知道如何提高利用率。这在肛门发病率极高的情况下是有问题的 男男性接触者中的癌症，没有被证实的治疗肛门癌前病变的方法，以及缺乏筛查基础设施 用于检测癌前病变，即使在资源丰富的国家也是如此。这项研究的长期目标是 通过自身或通过增加肛管肿瘤的发现来降低肛门癌的发病率和死亡率 伴侣--肛管触诊。我们的初步数据表明，这些考试是可行的，而且 在男男性接触者中可以接受。在200名男男性接触者的不同样本中，93%的男性正确地将自己的肛门检查归类 (SAE)或伴侣肛门检查(PAE)正常或异常，94%的人表示这些检查是可以接受的。 鉴于这些发现，我们的总体目标是通过评估考试来确定SAE和PAE的可行性 两个临床站点结果的准确性和一致性。准确度将被定义为以下各项之间的一致性 临床医生敢于和参与者考试。中心假设是访问1的SAE和PAE都将具有 在两次就诊中，以临床医生DARE为金标准，≥70%的敏感性和≥90%的特异性。我们 我将用三个具体的目标来检验这一假设：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 SAE、PAE和DARE对生存和生活质量的影响，并评估这些策略的成本效益 在HIV+和HIV-MSM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 抽样调查对象为年龄在25-80岁之间的100对男男性接触者夫妇(即200人)和600名单身男男性接触者(三分之二为HIV阳性) 几年后，谁将进行临床医生指导的SAE或PAE。然后，个人的SAE和合作伙伴的PAE 与临床医生的胆量相比。评估将在每两次访问中进行，间隔12个月 另外，评估考试准确性的保留情况。目标1和目标2的预期结果是敏感的， 与准确性相关的临床和行为因素的特异性和识别。目标3的结果将是 计算增量成本-效果比和净货币收益以评估经济 SAE、PAE和DARE的生存能力。这项研究意义重大，因为它将证明一个拥有 相当高的肛门病患病率可以识别疾病的存在。当前应用程序将提供 可能会挑战肛门触诊必须由 临床医生。这项拟议的研究也是正在进行的专注于检测肛门癌前病变的研究的补充 缺乏已证实的治疗癌前病变的疗效，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可能性，以及解决以下问题的需求 与耻辱相关的障碍，将延误男性无生殖检查的诊所就诊。

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.