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）：即使疾病的发生率和死亡率增加，也没有针对肛门癌的标准筛查方案；但是，数字肛门直肠检查（也称为数字直肠检查）将在任何推荐的协议中发挥作用。批判性，更少尽管这是一个简单而快速的程序，但仍在医生进行数字厌食检查。如果与男性发生性关系（MSM）可以学会检查肛管，那么该人群中早期癌症的检测和治疗可能会增加。这项II期可行性研究将研究增加数字肛门检查（DAE），以增强27-80岁的MSM肛门癌的筛查。我们假设MSM的DAE发现将与护士从业人员DAE具有中等或实质性的一致性，以检测肛门异常（定义为孔雀瘤，痔疮，裂痕和恶性肿瘤）。作为次要假设，我们认为，夫妻内部进行的合作伙伴辅助DAE将与护士从业者DAE达成更好的同意，而不是一个人进行的自我。并不是建议外行人认识到特定的条件，而是任何异常都应该引发医生探访。具体目的是：1。估计200 MSM的数字肛门考试与经验丰富的护士从业者的黄金标准之间的一致性。这个目标将回答以下问题：在最佳情况下，MSM执行自己的DAE后是否会报告准确的发现？ 2。确定与MSM和护士从业者DAE的一致性独立相关的因素，包括年龄，夫妻中的单身男人与男人，种族，种族和腰围。此目标将提供有关MSM更有可能执行准确DAE的见解。 3.评估DAE的可接受性，自我效能感，安全性和随后的护理意图。这个目标将回答以下问题：表现出色的DAE是否具有足够的可接受性和安全性并触发适当的后续护理？目的是提高有关如何增加使用数字肛门检查以降低肛门癌发病率和死亡率的知识。该研究将澄清单人是否可以做一个自数肛门考试或考试需要伴侣，或者实际上是否需要检查临床医生出于安全，准确性或可接受性的原因。