Alternative clinical trial designs.
Journal
Trauma surgery & acute care open
ISSN: 2397-5776
Titre abrégé: Trauma Surg Acute Care Open
Pays: England
ID NLM: 101698646
Informations de publication
Date de publication:
2020
2020
Historique:
received:
27
11
2019
accepted:
03
12
2019
entrez:
11
3
2020
pubmed:
11
3
2020
medline:
11
3
2020
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 32154379
doi: 10.1136/tsaco-2019-000420
pii: tsaco-2019-000420
pmc: PMC7046952
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
e000420Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
JAMA. 2015 Feb 3;313(5):471-82
pubmed: 25647203
J Trauma Acute Care Surg. 2017 Sep;83(3):464-468
pubmed: 28598906
Cancer Res. 1987 Nov 1;47(21):5782-7
pubmed: 2822233
J Trauma. 2009 Sep;67(3):565-72; discussion 571-2
pubmed: 19741401
JAMA. 2015 May 26;313(20):2068-9
pubmed: 26010636
Clin Trials. 2005;2(4):282-90; discussion 301-4, 364-78
pubmed: 16281426
Int J Stroke. 2019 Dec;14(9):977-982
pubmed: 31423922
J Trauma Acute Care Surg. 2015 Sep;79(3):335-42
pubmed: 26307863
BMJ. 2015 May 08;350:h2147
pubmed: 25956159
J Trauma. 2007 Feb;62(2):307-10
pubmed: 17297317
Injury. 2014 Sep;45(9):1287-95
pubmed: 24996573
J Trauma Acute Care Surg. 2013 Jan;74(1):105-11; discussion 111-2
pubmed: 23271084
BMC Musculoskelet Disord. 2010 May 06;11:85
pubmed: 20459600
JAMA Surg. 2017 Mar 1;152(3):221-222
pubmed: 28030708
N Engl J Med. 2018 Jul 26;379(4):315-326
pubmed: 30044935
JAMA. 2003 May 21;289(19):2545-53
pubmed: 12759326
Clin Epidemiol. 2018 Mar 23;10:343-351
pubmed: 29606891
Stroke. 2003 Nov;34(11):2543-8
pubmed: 14563972
JAMA. 2015 Apr 14;313(14):1463-4
pubmed: 25871672
Circ Cardiovasc Qual Outcomes. 2017 Aug;10(8):
pubmed: 28798016
Health Technol Assess. 2016 Nov;20(85):1-276
pubmed: 27897967
BMJ. 2015 Feb 06;350:h391
pubmed: 25662947
J Clin Epidemiol. 2020 Jan;117:52-59
pubmed: 31585174
N Engl J Med. 2015 Dec 31;373(27):2629-41
pubmed: 26448371
J Trauma Acute Care Surg. 2012 May;72(5):1127-34
pubmed: 22673236
Trials. 2009 Jun 03;10:37
pubmed: 19493350