Randomization is not the (only) answer: A plea for structured objective evaluation of endoscopic therapy

Endoscopic therapy clearly has a primary role in many clinical conditions ( such as dysphagia, obstructive jaundice, bleeding, and colonic polyps). The re is much less certainty about the role of endoscopy in many other clinica l contexts (e.g. management of chronic pancreatitis). Randomization is the gold standard for evaluation of competing therapies. Unfortunately, there a re many difficulties in mounting meaningful randomized controlled trials of endoscopic methods. Many have been done, but few have provided us with rea l practical answers. This article argues that the evidence we need to advis e patients is often better obtained through very stringent observational st udies, provided that all necessary data elements are defined and documented and independent objective arbiters (referees) are fully involved in the pr ocess.