Comparative Effectiveness of Screening and Surveillance Endoscopy

描述(由申请人提供)：由于缺乏对GERD或Barrett‘s食道(BE)人群EA风险的强有力的循证发现，在有GERD症状的患者(与没有筛查的患者)或不同监测策略(频率、强度)之间筛查内窥镜的比较有效性(CE)尚不清楚。此外，目前还不清楚患者或提供者是否会接受或接受这些策略中的任何一种，而不管它们的有效性如何。筛查和监测费用高昂，而且有风险。因此，当务之急是建立CE以及患者和提供者对这些做法的风险认知、结果预期和情感反应，以支持或驳斥专家建议(及其衍生的临床政策)的有效性。目前还没有针对高危人群的队列研究，涉及筛查或监视内窥镜检查的CE，也没有深入的研究来检查筛查或监视中决策的决定因素。我们建议的研究有以下目标。目的#1.比较接受不同强度筛查(与无筛查)和监测内窥镜检查(无、每两年一次、每三年一次)的患者之间EA的风险(发现率)和结果(阶段、治疗、生存)。我们将通过估计以下可能性来解释筛查和监测内窥镜对EA的影响：1)早期EA；2)EA的根治性治疗；3)死亡率。目的#2.确定电针治疗预期结果的预测因素(低发病率和低电针死亡率)。潜在的预测因素包括人口统计学特征(例如年龄)、GERD特征(例如持续时间)、干预措施(例如PPI、ASA/NSAID、胃底折叠术、消融术)以及其他BE危险因素(例如肥胖、吸烟)。目的#3：了解患者和医生对替代的内窥镜筛查和监测策略的风险认知、结果预期和情感反应。来自这些深入的定性访谈的数据将被用来指导潜在干预措施的设计，以加强这项CE研究的关键结果的传播和实施。我们提出了一项采用混合方法的研究方法，其中我们将(1)使用二级数据库(VA和VA-Medicare关联数据集2000-08)在观察性研究队列中检查筛查和监测的CE(估计有100,000名GERD患者，15,000-20,000名BE患者，2000-3000名EA患者)；(2)使用VA电子医疗记录对全国患者样本进行详细的结构化电子病历(EMR)审查，以验证所有EA病例，识别癌症分期，癌症靶向治疗，并验证筛查和监视内窥镜检查；以及(3)从关于患者和提供者偏好以及理性和行为效用的深入访谈中产生定性数据，以解释队列研究的一些发现，并为这项研究得出的建议提供信息。 公共卫生相关性：对胃食道反流或Barrett‘s食道的患者进行内窥镜检查的益处尚不清楚。这项研究建议比较不同的内窥镜检查方法(无、每年一次、每两年一次等)，并评估这些方法在食道癌的早期发现以及食道癌患者的治疗和生存方面的益处。

DESCRIPTION (provided by applicant): The comparative effectiveness (CE) of screening endoscopy in patients with GERD symptoms (vs. no screening) or among different surveillance strategies (frequency, intensity) is unclear due to lack of strong evidence-based findings for GERD or Barrett's esophagus (BE) population at risk of EA. Furthermore, it is unclear if patients or providers will accept or embrace any of these strategies irrespective of their effectiveness. Screening and surveillance is expensive and has risks. Therefore, it is imperative to establish the CE as well as patient- and provider- risk perceptions, outcome expectancies and affective responses of these practices to support or refute the validity of expert recommendations (and clinical policies that derive from them). There have been no cohort studies of at risk populations addressing the CE of screening or surveillance endoscopy, and there have been no in depth studies to examine determinants of decision making in screening or surveillance. Our proposed study has the following Aims. Aim #1. To compare the risk (detection rate) and outcomes (stage, treatment, survival) of EA among patients undergoing different intensity of screening (vs. none) and surveillance endoscopy (none, once every 2 yrs, once every 3 yrs). We will explain the effect of screening and surveillance endoscopy on EA by estimating likelihood of: 1) early stage EA; 2) curative treatments for EA; and 3) mortality. Aim #2. To identify predictors of desired outcomes of EA (low incidence and low EA mortality). Potential predictors include demographic features (e.g., age), GERD features (e.g., duration), interventions (e.g., PPI, ASA/NSAID; fundoplication; ablation), and other BE risk factors (e.g., obesity, smoking). Aim #3. To elicit patients' and physicians' risk perceptions, outcome expectancies and affective responses to alternative endoscopic screening and surveillance strategies. Data from these in-depth qualitative interviews will be used to inform the design of potential interventions to enhance the dissemination and implementation of the key findings from this CE research. We propose a study with a mixed methods approach where we will (1) use secondary databases (VA and VA- Medicare linked datasets for 2000-08) to examine CE of screening and surveillance in an observational study cohort (an estimated 100,000 patients with GERD, 15,000-20,000 with BE, and 2000-3000 with EA); (2) conduct a detailed structured electronic medical record (EMR) review on a national sample of patients using VA electronic medical records to verify all EA cases, identify cancer stage, cancer-targeted therapy, and validate the screening and surveillance endoscopy; and (3) generate qualitative data from in depth interviews on patient and provider preferences and rational and behavioral utilities to explain some of the cohort study findings and inform the recommendations resulting from this research. PUBLIC HEALTH RELEVANCE: The benefits of performing endoscopy in patients with gastroesophageal reflux is unclear or with Barrett's esophagus. This study proposed to compare different practices of performing endoscopy (none, once a year, once every two years, etc.), and evaluate the benefit of these practices on early detection of esophageal cancer, as well as treatment and survival of patients with esophageal cancer.