Thoughts and experiences in design and implementation of a trial of therapeutic endoscopy in upper gastrointestinal hemorrhage
This paper deals with some of the ideas, concerns, and experiences involved with the design and ultimate implementation of a therapeutic trial of endoscopy in upper gastrointestinal hemorrhage. The initial issue, prior to even considering the undertaking of a clinical study or trial, must address whether or not the question or questions being asked are important ones. Upper gastrointestinal hemorrhage, for the purpose of this discussion, can be defined as emesis of bright red blood, clots, or coffee-ground material or as the presence of grossly visible blood in the nasogastric aspirate which may be associated with melena or hematochezia. Upper gastrointestinal hemorrhage, as just defined, is an important medical problem, accounting for approximately 150,000-250,000 hospital admissions yearly in the United States (1). With the median duration of hospitalization for upper gastrointestinal hemorrhage being 7.5 days (2) and the average cost per day being approximately $300-$400 in many hospitals throughout the United States, conservative estimates of the cost for upper gastrointestinal hemorrhage range from $350 million to $750 million per year. So the economic impact of this problem is immense. Of greater concern is the fact that, despite improvement in the general care of the critically ill patients and despite improvements in the