RT Journal Article
SR Electronic
T1 Alternative clinical trial designs
JF Trauma Surgery & Acute Care Open
JO Trauma Surg Acute Care Open
FD BMJ Publishing Group Ltd
SP e000420
DO 10.1136/tsaco-2019-000420
VO 5
IS 1
A1 John A Harvin
A1 Ben L Zarzaur
A1 Raminder Nirula
A1 Benjamin T King
A1 Ajai K Malhotra
A1 ,
YR 2020
UL http://tsaco.bmj.com/content/5/1/e000420.abstract
AB High-quality clinical trials are needed to advance the care of injured patients. Traditional randomized clinical trials in trauma have challenges in generating new knowledge due to many issues, including logistical difficulties performing individual randomization, unclear pretrial estimates of treatment effect leading to often unpowered studies, and difficulty assessing the generalizability of an intervention given the heterogeneity of both patients and trauma centers. In this review, we discuss alternative clinical trial designs that can address some of these difficulties. These include pragmatic trials, cluster randomization, cluster randomized stepped wedge designs, factorial trials, and adaptive designs. Additionally, we discuss how Bayesian methods of inference may provide more knowledge to trauma and acute care surgeons compared with traditional, frequentist methods.