RT Book, Section
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.
SR Print(0)
ID 1183875987
T1 Randomized Trials Stopped Early for Benefit
T2 Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice, 3rd ed
YR 2015
FD 2015
PB McGraw-Hill Education
PP New York, NY
SN 978-0-07-179071-0
LK jamaevidence.mhmedical.com/content.aspx?aid=1183875987
RD 2024/10/09
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