Lessons from the ARDS network ventilator trial design controversy.
This article reviews the available published literature on the ARDSnet and summarizes the debate that occurred over the major ARDSnet trials. It discusses the challenges its organizers, supporters, and detractors faced. It reviews how uncertainty in research evolves and how it affects large trials of national or international scope. It also considers how the outcome of a scientific disagreement is shaped by the science and by how the debate is framed. The authors hope to illustrate some of the obstacles to performing outcome studies and clinical trials involving critically ill patients with complex syndromes that currently lack effective treatments.
Shanawani
Hasan
H
Duke University, Box 90141, Durham, NC 27705, USA. Hasan.shanawani@duke.edu
D000046:Academic Medical Centers; D026686:Beneficence; D002986:Clinical Trials as Topic / Q000941:ethics*; D028744:Ethics Committees, Research; D006801:Humans; D009316:National Institutes of Health (U.S.); D011175:Positive-Pressure Respiration / Q000009:adverse effects / Q000941:ethics*; D012128:Respiratory Distress Syndrome / Q000209:etiology / Q000401:mortality / Q000517:prevention & control / Q000628:therapy*; D036302:Therapeutic Human Experimentation / Q000941:ethics*; D013990:Tidal Volume / Q000502:physiology; D035501:Uncertainty; D014481:United States