Poor allocation concealment methods are associated with heterogeneity in age and statistical significance of the primary outcome: Review of recent trials published in four general medical journals.
Randomized controlled trial
allocation concealment
bias
Journal
Journal of evaluation in clinical practice
ISSN: 1365-2753
Titre abrégé: J Eval Clin Pract
Pays: England
ID NLM: 9609066
Informations de publication
Date de publication:
Aug 2020
Aug 2020
Historique:
received:
17
09
2019
revised:
21
10
2019
accepted:
23
10
2019
pubmed:
13
12
2019
medline:
29
7
2021
entrez:
13
12
2019
Statut:
ppublish
Résumé
To assess the association of the quality of allocation concealment with heterogeneity in age, the P value of the primary outcome and statistical significance of the primary outcome. We extracted data from articles published in four major medical journals in 2017 and 2018 that reported the results of randomized controlled trials. The outcome measures were the quality of allocation concealment used in the trial, the P value of the primary outcome, whether the P value of the primary outcome was statistically significant and the level of heterogeneity in age between the treatment groups (measured using the I Trials that used inadequate concealment methods were more likely to report statistically significant findings than trials that used good or adequate methods (OR 1.90; 95% CI: 0.91 to 3.95; P = .09). The values of I There is evidence of an association between poor allocation concealment methods and statistical significance of the primary outcome. Trials that use inadequate allocation concealment methods are more likely to have statistically significant P values compared with trials using good or adequate allocation concealment methods.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1316-1319Informations de copyright
© 2019 John Wiley & Sons, Ltd.
Références
Altman DG, Bland JM. Treatment allocation in controlled trials: why randomise? BMJ. 1999;318(7192):1209.
Attia A. Bias in RCTs: confounders, selection bias and allocation concealment. Middle East Fertility Soc J. 2005;10(3):258.
Torgerson DJ, Roberts C. Randomisation methods: concealment. BMJ. 1999;319(7206):375-376.
Dettori J. The random allocation process: two things you need to know. Evid Based Spine-Care J. 2010;1(03):7-9.
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408-412.
Hansson L, Lindholm LH, Niskanen L, et al. Effect of angiotensin-converting-enzyme inhibition compared with conventional therapy on cardiovascular morbidity and mortality in hypertension: the Captopril Prevention Project (CAPPP) randomised trial. The Lancet. 1999;353(9153):611-616.
Peto R. Failure of randomisation by “sealed” envelope. The Lancet. 1999;354(9172):73.
Kennedy AD, Torgerson DJ, Campbell MK, Grant AM. Subversion of allocation concealment in a randomised controlled trial: a historical case study. Trials. 2017;18(1):204.
Hewitt C, Hahn S, Torgerson DJ, Watson J, Bland JM. Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. BMJ. 2005;330(7499):1057-1058.
Clark L, Fairhurst C, Torgerson DJ. Allocation concealment in randomised controlled trials: are we getting better? BMJ. 2016;355:i5663.
Pildal J, Hrobjartsson A, Jørgensen K, Hilden J, Altman D, Gøtzsche P. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol. 2007;36(4):847-857.
Hopewell S, Dutton S, Yu L-M, Chan A-W, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ. 2010;340:c723.
Higgins JP, Green S. Cochrane Handbook for Systematic Reviews of Interventions. 2008.
Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014;14(1):135.
Altman DG, Bland JM. How to obtain the P value from a confidence interval. BMJ. 2011;343:d2304.
R Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria; 2017.
Wickham H. ggplot2: Elegant Graphics for Data Analysis. New York: Springer-Verlag; 2016.
Clark L, Fairhurst C, Hewitt CE, et al. A methodological review of recent meta-analyses has found significant heterogeneity in age between randomized groups. J Clin Epidemiol. 2014;67(9):1016-1024.
Trowman R, Dumville JC, Torgerson DJ, Cranny G. The impact of trial baseline imbalances should be considered in systematic reviews: a methodological case study. J Clin Epidemiol. 2007;60(12):1229-1233.
Chan A-W, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. The Lancet. 2005;365(9465):1159-1162.