Comparative Effectiveness of endoscopic assessment of GER and BE

描述（由申请方提供）：Barrett食管（BE）是一种众所周知的格尔并发症，是已知的食管腺癌（EAC）最严重的前体。因此，非常需要鉴定用于早期检测BE的有效筛查方法。目前BE筛查的障碍包括1）无法在人群中有效利用镇静内镜（sEGD）和2）目前基于GER的BE检测范例。转诊中心的研究表明，非镇静经鼻内窥镜检查（uTNE）和sEGD之间的准确性相当。然而，在一般人群中，uTNE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对BE筛查的显著兴趣水平，并证明了在确定的人群中使用uTNE和sEGD的初步可行性。我们建议检验中心假设，即在BE人群筛查中，uTNE的相对有效性将大于sEGD，具体目标如下：具体目标1：评估在人群队列中使用uTNE和sEGD筛查BE的参与情况。Subaim 1a：比较使用uTNE和sEGD进行BE筛查的参与率。我们将从一个确定的人群队列中随机抽取三个年龄（> 50岁）、性别和反流症状分层的队列（每个队列150名受试者）。每例受试者将随机分配至sEGD（队列1）或医院内的uTNE（huTNE，队列2）或移动的医疗保健货车内的uTNE（muTNE，队列3）。Subaim 1b：评估参与BE人群筛查的预测因素。将收集并分析先验人口统计学和临床因素，以确定参与筛选的预测因素。具体目的2：前瞻性比较uTNE和sEGD在人群队列中的临床有效性。Subaim 2a：比较sEGD、huTNE和muTNE队列之间的食管评估质量。质量标准将包括1）成功的食管插管，2）完整的食管评价，3）成功的活检采集，4）使用经验证的评分进行视频评价的独立质量评分。Subaim 2b：使用经验证的症状问卷，比较按有/无格尔症状分层的队列之间食管损伤（食管炎、狭窄和BE）的检出率。具体目标3：在基于人群的队列中前瞻性比较使用sEGD、huTNE和muTNE进行筛查的短期资源利用和患者偏好。Subaim 3a：在三个测试策略队列中使用经验证的工具测量短期患者报告的无效性（与每种测试策略相关的患者偏好）。Subaim 3b：比较总短期成本（直接和间接）以及与每种测试策略相关的服务类型的成本分布。提出的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，这有可能改善EAC患者的结局。 公共卫生相关性：巴雷特食管是食管腺癌的前兆和强风险因素：在美国，这种癌症的发病率迅速上升。在本提案中，我们的目标是通过比较社区中常规内镜检查（使用镇静剂进行）与未使用镇静剂的经鼻内镜检查（使用通过鼻子插入的细内窥镜），确定社区中检测巴雷特食管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.