title: Clinical Research in Acute Fatal Illness: Lessons From Extracorporeal Membrane Oxygenation.
abstract: Clinical research to evaluate the effectiveness of life support systems in acute fatal illness has unique problems of logistics, ethics, and consent. There have been 10 prospective comparative trials of extracorporeal membrane oxygenation in acute fatal respiratory failure, utilizing different study designs. The trial designs were prospective controlled randomized, prospective adaptive randomized, sequential, and matched pairs. The trials were reviewed with regard to logistics, ethics, consent, statistical methods, economics, and impact. The matched pairs method is the best study design for evaluation of life support systems in acute fatal illness.
authors.affiliation: Department of Surgery, University of Michigan Medical School, Ann Arbor, MI, USA robbar@umich.edu.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Bartlett
mesh_terms: D035843:Biomedical Research; D002985:Clinical Protocols; D015199:Extracorporeal Membrane Oxygenation / Q000379:methods*; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D008020:Life Support Care / Q000941:ethics / Q000379:methods; D008021:Life Support Systems / Q000941:ethics; D016015:Logistic Models; D016555:Matched-Pair Analysis; D011446:Prospective Studies; D012131:Respiratory Insufficiency / Q000628:therapy*
keywords: ECMO; clinical research; randomized trials; respiratory failure; trial designs