Common scale minimal sufficient balance: An improved method for covariate-adaptive randomization based on the Wilcoxon-Mann-Whitney odds ratio statistic.

Hannah Johns, Dominic Italiano, Bruce Campbell, Leonid Churilov
Author Information
  1. Hannah Johns: Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia. ORCID
  2. Dominic Italiano: Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.
  3. Bruce Campbell: Department of Medicine and Neurology, Melbourne Brain Centre and Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.
  4. Leonid Churilov: Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.

Abstract

Minimal sufficient balance (MSB) is a recently suggested method for adaptively controlling covariate imbalance in randomized controlled trials in a manner which reduces the impact on randomness of allocation over other approaches by only intervening when the imbalance is sufficiently significant. Despite its improvements, the approach is unable to consider the relative clinical importance or magnitude of imbalance in each covariate weight, and ignores any imbalance which is not statistically significant, even when these imbalances may collectively justify intervention. We propose the common scale MSB (CS-MSB) method which addresses these limitations, and present simulation studies comparing our proposed method to MSB. We demonstrate that CS-MSB requires less intervention than MSB to achieve the same level of covariate balance, and does not adversely impact either statistical power or Type-I error.

Keywords

References

  1. Stroke. 2007 Mar;38(3):1091-6 [PMID: 17272767]
  2. N Engl J Med. 2019 May 9;380(19):1795-1803 [PMID: 31067369]
  3. Int J Stroke. 2015 Aug;10(6):985-7 [PMID: 25854537]
  4. Biometrics. 2015 Mar;71(1):139-145 [PMID: 25156540]
  5. N Engl J Med. 2018 Apr 26;378(17):1573-1582 [PMID: 29694815]
  6. Eur Heart J. 2012 Jan;33(2):176-82 [PMID: 21900289]
  7. N Engl J Med. 2015 Mar 12;372(11):1009-18 [PMID: 25671797]
  8. Stat Med. 2022 May 10;41(10):1846-1861 [PMID: 35176811]
  9. Pharm Stat. 2016 Sep;15(5):430-7 [PMID: 27485522]
  10. Int J Stroke. 2014 Jan;9(1):126-32 [PMID: 24207098]
  11. Int J Stroke. 2019 Feb;14(2):207-214 [PMID: 30196789]
  12. Biostatistics. 2016 Jan;17(1):178-87 [PMID: 26353896]
  13. JAMA Neurol. 2018 Feb 1;75(2):219-226 [PMID: 29228079]
  14. BMJ. 1999 Jul 17;319(7203):185 [PMID: 10406763]
  15. Stat Med. 2020 Aug 30;39(19):2506-2517 [PMID: 32363614]
  16. Stat Med. 2021 Jun 30;40(14):3367-3384 [PMID: 33860957]
  17. N Engl J Med. 2015 Mar 12;372(11):1019-30 [PMID: 25671798]
  18. JAMA. 2020 Apr 7;323(13):1257-1265 [PMID: 32078683]
  19. Contemp Clin Trials. 2015 Nov;45(Pt A):21-5 [PMID: 26244705]
  20. Med J Aust. 2002 Nov 18;177(10):565-7 [PMID: 12429008]
  21. Int J Stroke. 2021 Jun;16(4):420-428 [PMID: 32854602]
  22. Stat Methods Med Res. 2015 Dec;24(6):989-1002 [PMID: 22287602]
  23. Lancet. 2015 Jul 4;386(9988):46-55 [PMID: 25892679]
  24. J Biopharm Stat. 2018;28(4):778-796 [PMID: 29172988]
  25. Stat Methods Med Res. 2021 Feb;30(2):580-611 [PMID: 32726191]
  26. JAMA Neurol. 2018 Dec 1;75(12):1470-1476 [PMID: 30128538]
  27. BMC Musculoskelet Disord. 2015 Oct 16;16:303 [PMID: 26474988]
  28. Int J Stroke. 2014 Dec;9(8):999-1005 [PMID: 25196780]

MeSH Term

Computer Simulation
Humans
Odds Ratio
Random Allocation
Research Design

Word Cloud

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