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: 10252791
• 负责人: ALAN GASPAR NYITRAY
• 金额: $ 62.71万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10252791
• 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; 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.

尽管专家意见建议每年进行肛门直肠数字检查 (DARE) 来检测肛门癌 男男性行为者 (MSM) 中的肿瘤，该手术严重未得到充分利用，并且 不知道如何提高利用率，这在肛门发生率极高的情况下是有问题的。 MSM 中的癌症、肛门癌前病变没有经过验证的治疗方法以及缺乏筛查基础设施 即使在资源丰富的国家也能检测癌前病变 这项研究的长期目标是 通过自身或其他方式增加肛管肿瘤的检出率，从而降低肛门癌的发病率和死亡率 我们的初步数据表明这些检查是可行且高度可行的。 在 200 名 MSM 的不同样本中，93% 的男性正确分类了他们的自我肛门检查。 (SAE) 或伴侣肛门检查 (PAE) 为正常或异常，94% 的人表示检查是可以接受的。 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 两个诊所结果的准确性和一致性 准确性将被定义为之间的一致性。 临床医生 DARE 和参与者检查的中心假设是，第 1 次就诊时 SAE 和 PAE 都会出现。 我们在每次就诊时使用临床医生 DARE 作为金标准，敏感性≥70%，特异性≥90%。 将通过三个具体目标来检验假设：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 对生存和生活质量的影响，并评估这些策略的成本效益 HIV+ 和 HIV-MSM 之间的研究将通过在休斯顿和芝加哥进行的一项研究来实现。 100 名 MSM 夫妇（即 200 名伴侣）和 600 名单身 MSM（三分之二 HIV 阳性）样本，年龄 25-80 岁 年，谁将执行临床医生教授的 SAE 或 PAE 然后将是个人的 SAE 和伴侣的 PAE。 与临床医生的 DARE 进行比较 评估将在两次就诊时进行，间隔 12 个月。 除此之外，为了评估考试准确性的保留，目标 1 和 2 的预期结果是敏感性， 与目标 3 结果相关的临床和行为因素的特异性和识别。 计算增量成本效益比和净货币效益以评估经济 SAE、PAE 和 DARE 的可行性 这项研究意义重大，因为它将证明患有 SAE、PAE 和 DARE 的人群。 当前的应用程序将提供大量的肛门疾病识别率。 关键数据可能会挑战肛门触诊必须由肛门触诊者进行的现状假设 拟议的研究还补充了正在进行的专注于检测肛门癌前病变的研究。 缺乏已证实的癌前病变治疗功效、缺乏癌症筛查基础设施 检测癌前病变、在资源匮乏环境中进行自我检查的潜力以及解决这些问题的必要性 与耻辱相关的障碍将延迟男性去诊所接受肛门生殖器检查。