The feasibility of self or partner-assisted digital anal exam screening

自我或伴侣协助数字肛门检查筛查的可行性

基本信息

批准号：
8757029
负责人：
ALAN GASPAR NYITRAY
金额：
$ 21.23万
依托单位：
UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-15 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8757029
关键词：
Age Agreement Anal canal Anatomy Anus Behavioral Caring Clinic Clinical Colposcopy Communities Couples Data Detection Diagnostic Disease Early Diagnosis Early treatment Educational process of instructing Effectiveness Eligibility Determination Ethnic Origin Feasibility Studies Goals Gold Health Hemorrhoids Human Papillomavirus Human papilloma virus infection Incidence Knowledge Learning Literature Malignant Neoplasms Malignant neoplasm of anus Malignant neoplasm of cervix uteri Methods Modality Modeling Molecular Morbidity - disease rate Nurse Practitioners Pap smear Participant Pelvis Persons Phase Phase III Clinical Trials Physicians Play Population Positioning Attribute Procedures Protocols documentation Race Recording of previous events Recruitment Activity Reporting Research Research Infrastructure Resolution Role Safety Self Efficacy Testing Training United States Unmarried person Visit aged analog condyloma design digital efficacy trial experience follow-up high risk innovation insight medical schools men men who have sex with men mortality online tutorial prevent public health relevance rectal screening skills tumor waist circumference

项目摘要

DESCRIPTION (provided by applicant): There is no standard screening protocol for anal cancer even as disease incidence and mortality increases; however, a digital anorectal exam (also called a digital rectal exam) will play a role in any recommended protocol. Critically, fewer digital anorectal exams are being performed by physicians even though it is a simple and quick procedure. If men who have sex with men (MSM) can learn to examine the anal canal, then detection and treatment of early cancers among this population may increase. This Phase II feasibility study will investigate increasing digital anal exam (DAE) use to enhance screening for anal cancer among MSM aged 27-80 years. We hypothesize that MSM's DAE findings will have moderate or substantial agreement with a nurse practitioner DAE for detecting an anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a secondary hypothesis we believe a partner-assisted DAE conducted within a couple will have better agreement with the nurse practitioner DAE than will a self-DAE conducted by a single person. It is not proposed that lay persons recognize specific conditions but, rather, that any abnormality should trigger a doctor visit. The specific aims are: 1. Estimate the agreement between the digital anal exams of 200 MSM and the gold standard of a highly experienced nurse practitioner. This aim will answer the question: under optimal circumstances, will MSM report accurate findings after performing their own DAE? 2. Determine factors independently associated with concordance of MSM and nurse practitioner DAEs including age, single men vs. men in couples, race, ethnicity and waist circumference. This aim will provide insight into which MSM are more likely to perform accurate DAEs. 3. Assess DAE acceptability, self-efficacy, safety, and intentions-to-seek subsequent care. This aim will answer the question: will lay-performed DAEs have sufficient acceptability and safety and trigger appropriate follow-up care? The goal is to advance knowledge of how to increase use of digital anal exams to reduce anal cancer morbidity and mortality. The study will clarify if single persons can do a self-digital anal exam, or perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for reasons of safety, accuracy, or acceptability.

描述（由申请人提供）：即使肛门癌的发病率和死亡率增加，但仍没有标准的筛查方案；然而，肛门直肠指检（也称为直肠指检）将在任何推荐方案中发挥作用。关键是，更少尽管数字肛门直肠检查是一个简单而快速的过程，但仍由医生进行。如果男男性行为者 (MSM) 能够学会检查肛管，那么该人群中早期癌症的检测和治疗可能会增加。这项 II 期可行性研究将调查增加数字肛门检查 (DAE) 的使用，以加强 27-80 岁 MSM 中肛门癌的筛查。我们假设 MSM 的 DAE 结果与执业护士 DAE 在检测肛门异常（定义为尖锐湿疣、痔疮、裂隙和恶性肿瘤）方面具有中等或实质性一致性。作为次要假设，我们认为，与由一个人进行的自我 DAE 相比，在夫妻中进行的由伴侣协助的 DAE 与执业护士 DAE 的一致性会更好。并不建议非专业人士识别特定情况，而是建议任何异常情况都应去看医生。具体目标是： 1. 评估 200 位 MSM 的数字肛门检查与经验丰富的执业护士的黄金标准之间的一致性。这一目标将回答以下问题：在最佳情况下，MSM 在执行自己的 DAE 后会报告准确的结果吗？ 2. 确定与 MSM 和执业护士 DAE 一致性独立相关的因素，包括年龄、单身男性与已婚男性、种族、民族和腰围。这一目标将深入了解哪些 MSM 更有可能执行准确的 DAE。 3. 评估 DAE 的可接受性、自我效能、安全性和寻求后续护理的意愿。这一目标将回答以下问题：非专业人士执行的 DAE 是否具有足够的可接受性和安全性并引发适当的后续护理？目标是增进对如何增加数字肛门检查的使用以降低肛门癌发病率和死亡率的了解。该研究将阐明单身人士是否可以进行自我数字化肛门检查，或者检查可能需要合作伙伴，或者事实上，出于安全性、准确性或可接受性的原因，检查需要临床医生。