TY - CHAP M1 - Book, Section TI - Randomized Trials Stopped Early for Benefit A1 - Bassler, Dirk A1 - Montori, Victor M. A1 - Devereaux, PJ A1 - Schünemann, Holger J. A1 - Meade, Maureen O. A1 - Cook, Deborah J. A1 - Guyatt, Gordon A2 - Guyatt, Gordon A2 - Rennie, Drummond A2 - Meade, Maureen O. A2 - Cook, Deborah J. Y1 - 2015 N1 - T2 - Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice, 3rd ed AB - Investigators may stop randomized clinical trials (RCTs) earlier than planned because of perceived harm of the experimental intervention, because they lose hope in achieving a positive result, or because the sponsor wishes to save money.1 The reason for early stopping that may have the most effect on clinical practice, however, is that investigators note treatment effects that appear to be unlikely by chance—and that are usually large—that persuade them that the experimental intervention is beneficial. Trials stopped early for apparent benefit—which we will refer to as truncated RCTs (tRCTs)—often receive considerable attention. They appear in the most prominent journals and in the popular press2,3 markedly increasing the likelihood of widespread dissemination and subsequent citation. These trials may, with remarkable rapidity, form the basis of practice guidelines and criteria for quality of medical care—and such recommendations may persist after subsequent studies have debunked the results of the tRCTs. For example, such has been the fate of stopped-early RCTs documenting the effect of tight glucose control with insulin in patients in the intensive care unit, β-blockers in patients undergoing vascular surgery, and activated protein C in sepsis.4 SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/10/09 UR - jamaevidence.mhmedical.com/content.aspx?aid=1183875987 ER -