Patient-centered, comparative effectiveness of esophageal cancer screening: protocol for a comparative effectiveness research study to inform guidelines for evidence-based approach to screening and surveillance endoscopy

Abstract

BackgroundThe comparative effectiveness (CE) of endoscopic screening (versus no screening) for Barrett’s esophagus (BE) in patients with GERD symptoms, or among different endoscopic surveillance strategies in patients with BE, for the early detection of esophageal adenocarcinoma (EA) is unknown. Furthermore, it is unclear if patients or providers have or will adopt any of these strategies (screening only, screening and surveillance, vs. none), irrespective of their effectiveness. Endoscopic screening and surveillance is expensive and can be risky. Therefore, it is imperative to establish the CE and acceptability about the risks and outcomes related to these practices to better inform expert recommendations and provider-patient decisions.Methods/ResultsWe propose a mixed methods study which will involve: (1) an analysis of secondary databases (VA and VA-Medicare linked datasets for 2004–09) to examine CE of endoscopic screening and surveillance in an observational study cohort (an estimated 680,000 patients with GERD; 25,000–30,000 with BE; and 3,000 with EA); (2) a structured electronic medical record (EMR) review on a national sample of patients using VA EMRs to verify all EA cases, identify cancer stage, cancer-targeted therapy, and validate the screening and surveillance endoscopy; and (3) qualitative in depth interviews with patients and providers to elicit preferences, norms, and behaviors to explain clinical contexts of these findings and address gaps arising from the CE study.ConclusionThis study will compare clinical strategies for detecting and monitoring BE, a pre-cancerous lesion. Additionally, by eliciting acceptability of these strategies for patients and providers, we will be able to propose effective and feasible strategies that are likely to be implemented in routine use. Findings will inform recommendations for clinical practice guidelines. Our innovative approach is consistent with the methodological standards of patient-centered outcomes research, and our findings will offer a significant contribution to the literature on cancer surveillance.Trial RegistrationNot applicable

Use and Yield of Endoscopy in Patients With Uncomplicated Gastroesophageal Reflux Disorder

“…This was a retrospective cohort study using national administrative (Medical SAS Inpatient and Outpatient Data sets and Decision Support System Clinical Laboratory Results and Pharmacy National Data Extracts) and clinical data (Computerized Patient Record System) from the US Department of Veterans Affairs (VA). 3 Patients with a first International Classification of Diseases, Ninth Revision ( ICD-9 ) code in 2004 through 2009 for uncomplicated GERD (ie, without alarm symptoms or signs of anemia, decompensated liver disease, gastrointestinal tract [GI] bleeding, celiac disease, any metastatic cancer, or any chemotherapy) were included. Outcomes were receipt of screening EGD ( Current Procedural Terminology [ CPT ] codes) and yield for BE ( ICD-9 code of BE combined with EGD) and esophageal, gastric, or duodenal cancer (E/GC) (all validated by medical chart review).…”

Practical Guide to Understanding Comparative Effectiveness Research (CER)

“…Kramer et al 27 published a protocol for a large patient‐centered CER project to “inform guidelines for evidence‐based approach to screening and surveillance endoscopy” for esophageal carcinoma. Their proposal plans to use the extensive electronic medical record data in the Veterans Administration hospital systems for a cohort of 680,000 patients with GERD, 25,000 to 30,000 with Barrett's Esophagus, and 3000 patients with adenocarcinoma of the esophagus.…”

Choosing Wisely and the Perceived Drivers of Endoscopy Use

“…As part of a patient-centered, comparative effectiveness study of screening and surveillance esophagogastroduodenoscopy (EGD), we conducted qualitative interviews to explore patient and physician perceptions of one of the AGA Choosing Wisely items. 4 Analysis of these interviews identified factors perceived to influence under and over utilization of surveillance EGD for Barrett’s Esophagus in the context of AGA clinical practice guidelines.…”