Protocol for an economic evaluation alongside the Re-Evaluating the Inhibition of Stress Erosions (E-REVISE) trial

INTRODUCTION: Economic evaluations in healthcare can guide practice and inform policy. The objective of this paper is to present the protocol for a health economic evaluation comparing the cost-effectiveness of prophylactic treatment using pantoprazole 40 mg daily compared with no pantoprazole to prevent upper gastrointestinal (GI) bleed among invasively ventilated patients. METHODS AND ANALYSIS: This is an economic evaluation conducted alongside the R e-Evaluating the Inhibition of Stress Erosions (REVISE) trial (ClinicalTrials.gov NCT03374800). The primary outcome is the incremental cost per clinically important upper GI bleed prevented. The base-case analysis will focus on the entire international cohort of 4821 REVISE patients. The analysis will be conducted from a healthcare payer perspective over a time horizon of ICU admission to hospital discharge or death. To facilitate comparisons across countries given the international scope of the REVISE trial, costs will be presented in United States dollars. The study protocol was developed following the Professional Society for Health Economics and Outcomes Research guidelines. ETHICS AND DISSEMINATION: The trial was approved by each participating institution; this economic evaluation was approved by the Hamilton Integrated Research Ethics Board. Given widespread daily use of proton pump inhibitors for critically ill patients, the results of this economic evaluation will be of high relevance to patients, family members, physicians, pharmacists, policymakers and guideline developers. Integrated knowledge translation will involve periodic progress reports to collaborators. End-of-study knowledge translation will include rounds, videoconferences, abstracts and slide-decks for intensive care unit quality councils and healthcare organisations, and open-access publications. Patient and family partners will co-create lay language summaries for traditional and social media to help inform all interest groups.