Abstract
Of major concern in N-of-1 trials, common to any epidemiological approach, is the introduction of bias and confounding. These factors may modify the size of the treatment estimate or shift the treatment estimate away from its true value. The methodological approaches of randomization, allocation concealment, and blinding are employed to prevent or minimize confounding and bias in trials. This chapter provides definitions and describes the various methods of randomization, allocation concealment, and blinding that can be adopted in N-of-1 trials. In addition, the chapter details the roles of specific research staff and the information required for the reporting of N-of-1 trial blinding methods in medical journals.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Clark L, Schmidt U, Tharmanathan P, Adamson J, Hewitt C, Torgerson D (2013) Allocation concealment: a methodological review. J Eval Clin Pract 19:708–712
Consort (2015) Consort glossary. Available: http://www.consort-statement.org/resources/glossary
Elkins M (2013) Concealed allocation in randomised trials. J Physiother 59:134–136
Forder PM, Gebski VJ, Keech AC (2005) Allocation concealment and blinding: when ignorance is bliss. Med J Aust 182:87–89
Friedman LM, Demets DL, Furberg C (1998) Fundamentals of clinical trials. Springer, New York
Gluud LL (2006) Bias in clinical intervention research. Am J Epidemiol 163:493–501
Herbison P, Hay-Smith J, Gillespie WJ (2011) Different methods of allocation to groups in randomized trials are associated with different levels of bias. A meta-epidemiological study. J Clin Epidemiol 64:1070–1075
Hewitt C, Hahn S, Torgerson DJ, Watson J, Bland JM (2005) Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. BMJ 330:1057–1058
Juni P, Altman DG, Egger M (2001) Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 323:42–46
Kjaergard LL, Villumsen J, Gluud C (2001) Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Ann Intern Med 135:982–989
Matthews J (2000) An introduction to randomized controlled clinical trials. Arnold, London
Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, Tugwell P, Klassen TP (1998) Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 352:609–613
Roberts C, Torgerson D (1998) Randomisation methods in controlled trials. BMJ 317:1301
Schulz KF, Grimes DA (2002a) Allocation concealment in randomised trials: defending against deciphering. Lancet 359:614–618
Schulz KF, Grimes DA (2002b) Blinding in randomised trials: hiding who got what. Lancet 359:696–700
Schulz KF, Chalmers I, Hayes RJ, Altman DG (1995) Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 273:408–412
Schulz KF, Chalmers I, Altman DG (2002) The landscape and lexicon of blinding in randomized trials. Ann Intern Med 136:254–259
Schulz KF, Altman DG, Moher D, Group C (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 340:c332
Viera AJ, Bangdiwala SI (2007) Eliminating bias in randomized controlled trials: importance of allocation concealment and masking. Fam Med 39:132–137
Yelland MJ, Nikles CJ, Mcnairn N, Del Mar CB, Schluter PJ, Brown RM (2007) Celecoxib compared with sustained-release paracetamol for osteoarthritis: a series of n-of-1 trials. Rheumatology (Oxford) 46:135–140
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer Science+Business Media Dordrecht
About this chapter
Cite this chapter
Senior, H. (2015). Randomization, Allocation Concealment, and Blinding. In: Nikles, J., Mitchell, G. (eds) The Essential Guide to N-of-1 Trials in Health. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-7200-6_7
Download citation
DOI: https://doi.org/10.1007/978-94-017-7200-6_7
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-017-7199-3
Online ISBN: 978-94-017-7200-6
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)