Comparative Effectiveness of endoscopic assessment of GER and BE

描述(申请人提供)：Barrett‘s食道(BE)是GER的一个众所周知的并发症，是已知的食管腺癌(EAC)最强烈的前驱症状。因此，寻找有效的筛查方法以早期发现BE是非常必要的。目前筛查的障碍包括1)无法在人群中有效地使用镇静内窥镜(SEGD)，以及2)目前基于GER的检测BE的范例。转诊中心研究表明，未用镇静剂的经鼻内窥镜检查(UTNE)和SEGD检查具有类似的准确性。然而，UTNE在普通人群中的患者可接受性和诊断率仍然未知。我们小组的初步研究已经确定了人们对BE筛查的显著兴趣，并证明了在特定人群中使用UTNE和SEGD的初步可行性。我们建议检验中央假设，即UTNE在BE人群筛查中的相对有效性将大于SEGD，具体目标如下：具体目标1：评估人群队列中UTNE和SEGD在BE筛查中的参与度。Subaim 1a：比较BE筛查与UTNE和SEGD的参与率。我们将从一个确定的人群队列中随机抽取三个年龄(&gt；50岁)、性别和反流症状分层队列(各150名受试者)。每个受试者将被随机分配到SEGD(队列1)，或在医院的UTNE(huTNE，队列2)，或在流动医疗车内的UTNE(MuTNE，队列3)。Subaim 1b：评估参与BE人群筛查的预测因素。将收集和分析先验的人口统计学和临床因素，以确定参与筛查的预测因素。具体目标2：前瞻性比较UTNE和SEGD在人群队列中的临床疗效。Subaim 2a：比较SEGD、huTNE和muTNE队列的食道评估质量。质量标准将包括1)成功的食道插管，2)完成的食道评估，3)成功的活检获取，4)通过视频评估的独立质量评分。Subaim 2b：使用有效的症状问卷，比较有无GER症状的队列之间的食道损伤(食管炎、狭窄和BE)的检出率。具体目标3：前瞻性比较基于人群的队列中使用SEGD、huTNE和muTNE进行筛查的短期资源利用和患者偏好。Subaim 3a：使用三个测试策略队列中经过验证的工具来测量患者报告的短期不良反应(与每个测试策略相关的患者偏好)。Subaim 3b：比较与每个测试策略相关的短期总成本(直接和间接)以及按服务类型分配的成本。这项拟议研究的意义是基于需要确定有效的基于社区的BE筛查策略，这可能会改善EAC患者的预后。 公共卫生相关性：Barrett‘s食道是食管腺癌的先兆和强烈的风险因素：食管腺癌是一种在美国发病率迅速上升的癌症。在这项建议中，我们的目标是通过比较社区中常规的内窥镜检查(在镇静下进行)和未使用镇静的经鼻内窥镜检查(使用通过鼻子插入的细小内窥镜)来确定在社区中检测Barrett‘s食道的最可接受和最准确的方法。

DESCRIPTION (provided by applicant): Barrett's esophagus (BE), a well-known complication of GER, is the strongest known precursor of esophageal adenocarcinoma (EAC). Thus, identifying effective screening approaches for the early detection of BE are highly desired. Current impediments to BE screening include 1) the inability to utilize sedated endoscopy (sEGD) effectively in populations and 2) current GER-based paradigms for detecting BE. Referral center studies demonstrate comparable accuracy between unsedated transnasal endoscopy (uTNE) and sEGD. However, patient acceptability and diagnostic yield with uTNE in general populations remain unknown. Preliminary Studies from our group have identified a significant level of interest for BE screening, and demonstrated initial feasibility of using uTNE and sEGD within a defined population. We propose to test the Central Hypothesis that the comparative effectiveness of uTNE will be greater than sEGD in population screening for BE with the following specific aims: Specific Aim 1: To assess participation in screening for BE with uTNE and sEGD in a population cohort. Subaim 1a: To compare participation rates for BE screening with uTNE and sEGD. We will randomly sample three age (> 50 years), gender and reflux symptom stratified cohorts (150 subjects each) from a defined population cohort. Each subject will be randomized to either sEGD (cohort 1), or uTNE in the hospital (huTNE, cohort 2), or uTNE within a mobile health care van (muTNE, cohort 3). Subaim 1b: To assess predictors of participation in population screening of BE. A priori demographic and clinical factors will be collected and analyzed to identify predictors of participation in screening. Specific Aim 2: To prospectively compare the clinical effectiveness of uTNE and sEGD in a population cohort. Subaim 2a: To compare the quality of esophageal assessment between sEGD, huTNE and muTNE cohorts. Quality criteria will include 1) successful esophageal intubation, 2) complete esophageal evaluation, 3) successful biopsy acquisition, 4) independent quality score by video evaluation using a validated scoring too. Subaim 2b: To compare the rates of detection of esophageal injury (esophagitis, strictures and BE) between cohorts stratified by presence/absence of GER symptoms using a validated symptom questionnaire. Specific Aim 3: To prospectively compare the short-term resource utilization and patient preferences for screening using sEGD, huTNE and muTNE in a population-based cohort. Subaim 3a: To measure the short term patient reported disutilities (patient preference associated with each test strategy) using a validated tool in the three test strategy cohorts. Subaim 3b: To compare the total short term costs (direct and indirect) and distribution of costs by type of service associated with each test strategy. The Significance that underlies the proposed research is based on the need to identify effective community- based screening strategies for BE which has the potential of improving outcomes of patients with EAC. PUBLIC HEALTH RELEVANCE: Barrett's esophagus is a precursor and strong risk factor for esophageal adenocarcinoma: a cancer with rapidly rising incidence in the United States. In this proposal we aim to identify the most acceptable and accurate way to detect Barrett's esophagus in the community by comparing regular endoscopy (performed with sedation) to unsedated transnasal endoscopy (using a thin endoscope inserted through the nose) in the community.