Comparative Effectiveness of Screening and Surveillance Endoscopy

描述（由申请方提供）：由于缺乏GERD或Barrett食管（BE）EA风险人群的强有力循证结果，因此在有GERD症状的患者中（与无筛查相比）或在不同监测策略（频率、强度）中筛查内镜检查的比较有效性（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任何这些策略，无论其有效性如何。筛查和监测费用昂贵，而且有风险。因此，必须建立CE以及患者和提供者对这些实践的风险认知、结局预期和情感反应，以支持或反驳专家建议（以及由此产生的临床政策）的有效性。目前还没有针对高危人群的队列研究来讨论筛查或监测内镜检查的CE，也没有深入研究来检查筛查或监测决策的决定因素。我们提出的研究有以下目的。目标1。比较接受不同强度筛选（与无）和监测内镜检查（无、每2年1次、每3年1次）的患者中EA的风险（检出率）和结局（分期、治疗、生存期）。我们将通过估计以下可能性来解释筛选和监测内镜检查对EA的影响：1）早期EA; 2）EA的治愈性治疗; 3）死亡率。目标2。确定EA预期结局的预测因素（低发病率和低EA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（例如，PPI、阿萨/NSAID;胃底折叠术;消融术）和其他BE风险因素（例如，肥胖、吸烟）。目标3。了解患者和医生对替代内镜筛查和监测策略的风险认知、结局预期和情感反应。从这些深入的定性访谈中获得的数据将用于为潜在干预措施的设计提供信息，以加强本CE研究关键结果的传播和实施。我们提出了一个研究与混合方法的方法，我们将（1）使用二级数据库（VA和VA-2000-08年医疗保险相关数据集），以检查观察性研究队列中筛查和监测的CE（估计100，000例GERD患者，15，000 - 20，000例BE患者，2000-3000例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医疗记录（EMR）审查，以验证所有EA病例，确定癌症阶段，癌症靶向治疗，并验证筛查和监测内窥镜检查;（3）从患者和提供者偏好以及理性和行为效用的深入访谈中生成定性数据，以解释一些队列研究结果并告知本研究产生的建议。 公共卫生相关性：对胃食管反流或Barrett食管患者进行内镜检查的益处尚不清楚。本研究拟比较进行内镜检查的不同做法（无、每年一次、每两年一次等），并评估这些做法对食管癌的早期发现以及食管癌患者的治疗和生存的益处。

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.