Comparison of Ventilator-free Days at 14 and 28 days as a Clinical Trial Outcome in Low- and Middle-income Countries.
Children
Clinical trials
Composite outcome measures
Intensive care
Low- and middle-income countries
Ventilator-free days
Journal
Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine
ISSN: 0972-5229
Titre abrégé: Indian J Crit Care Med
Pays: India
ID NLM: 101208863
Informations de publication
Date de publication:
Oct 2020
Oct 2020
Historique:
entrez:
7
12
2020
pubmed:
8
12
2020
medline:
8
12
2020
Statut:
ppublish
Résumé
Reporting ventilator-free days (VFDs) with time frame of 28 days is a popular composite outcome measure (COM) in trials. However, early deaths and shorter pediatric intensive care unit (PICU) stay predominate in low- and middle-income countries (LMICs). A shorter time frame may reduce sample size required. We planned to compute sample size requirements for different effect sizes from datasets of previously conducted prospective studies for 28-day and 14-day time frames (VFD The VFD Time-to-event occurred within 14 days in majority of patients. Sample size required for VFD Choice of time frame for assessing VFDs and other COMs in clinical trials should be guided by the clinical context. A shorter time frame may be rewarding in terms of smaller sample size in the prevalent clinical setting of LMICs. Further confirmation with more datasets and prospective studies is desirable. Baranwal AK, Kumar MP, Gupta PK. Comparison of Ventilator-free Days at 14 and 28 days as a Clinical Trial Outcome in Low- and Middle-income Countries. Indian J Crit Care Med 2020;24(10):960-966.
Identifiants
pubmed: 33281322
doi: 10.5005/jp-journals-10071-23568
pmc: PMC7689112
doi:
Types de publication
Journal Article
Langues
eng
Pagination
960-966Informations de copyright
Copyright © 2020; Jaypee Brothers Medical Publishers (P) Ltd.
Déclaration de conflit d'intérêts
Source of support: Nil Conflict of interest: None
Références
J Trop Pediatr. 2015 Oct;61(5):339-50
pubmed: 26130623
Crit Care Med. 2014 Nov;42(11):2409-17
pubmed: 25148597
Pediatr Crit Care Med. 2005 May;6(3 Suppl):S3-5
pubmed: 15857554
Crit Care Med. 2020 Feb;48(2):158-166
pubmed: 31939783
Crit Care Med. 2015 May;43(5):947-53
pubmed: 25654173
BMC Bioinformatics. 2011 Mar 17;12:77
pubmed: 21414208
Indian J Crit Care Med. 2014 Jul;18(7):437-41
pubmed: 25097356
Crit Care. 2013 Sep 19;17(5):R206
pubmed: 24050662
Brain Inj. 2017;31(3):396-400
pubmed: 28296528
Pediatr Crit Care Med. 2015 Sep;16(7):e194-200
pubmed: 26181296
BMJ. 2005 Mar 12;330(7491):594-6
pubmed: 15761002
Crit Care Med. 2017 Dec;45(12):2055-2060
pubmed: 29019851
Crit Care. 2018 Sep 23;22(1):232
pubmed: 30243300
Front Pediatr. 2014 Jul 25;2:78
pubmed: 25121078
Am J Respir Crit Care Med. 2015 May 15;191(10):1147-57
pubmed: 25734408
Crit Care Med. 2018 Dec;46(12):1943-1952
pubmed: 30277890
N Engl J Med. 2019 May 23;380(21):1997-2008
pubmed: 31112383
Crit Care Med. 2002 Aug;30(8):1772-7
pubmed: 12163791
Pediatr Crit Care Med. 2017 Feb;18(2):143-150
pubmed: 27941423
Pediatr Crit Care Med. 2016 Oct;17(10):907-916
pubmed: 27487912
Pediatr Crit Care Med. 2017 Jun;18(6):513-523
pubmed: 28410274
Indian J Pediatr. 2012 Nov;79(11):1454-8
pubmed: 22392263
N Engl J Med. 2017 Feb 23;376(8):729-741
pubmed: 28118549
J Clin Invest. 2016 Jan;126(1):23-31
pubmed: 26727230
Front Pediatr. 2018 Apr 09;6:93
pubmed: 29686979
Am J Respir Crit Care Med. 2014 Apr 15;189(8):998-1002
pubmed: 24735035
Pediatr Int. 2016 May;58(5):425-8
pubmed: 27173421
JAMA. 2019 Feb 19;321(7):654-664
pubmed: 30772908
Pediatr Crit Care Med. 2019 Jun;20(6):e263-e273
pubmed: 31166289
Pediatr Crit Care Med. 2018 Jul;19(7):e367-e373
pubmed: 29782390
Lancet Respir Med. 2020 Mar;8(3):267-276
pubmed: 32043986
Crit Care Med. 2018 Mar;46(3):425-429
pubmed: 29227369
N Engl J Med. 2010 Sep 16;363(12):1107-16
pubmed: 20843245
Indian Pediatr. 2015 Apr;52(4):311-3
pubmed: 25929629
Am J Respir Crit Care Med. 2018 Nov 1;198(9):1199-1207
pubmed: 29641221
Am J Respir Crit Care Med. 2019 Oct 1;200(7):828-836
pubmed: 31034248
JAMA Pediatr. 2019 Apr 1;173(4):352-362
pubmed: 30742207
Crit Care Med. 2014 Aug;42(8):1775-87
pubmed: 24690571