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The use of unequal randomisation in clinical trials - an update

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The use of unequal randomisation in clinical trials - an update. / Peckham, Emily; Brabyn, Sally; Cook, Liz et al.
In: Contemporary Clinical Trials, Vol. 45, No. A, 01.11.2015, p. 113-122.

Research output: Contribution to journal › Article › peer-review

HarvardHarvard

Peckham, E, Brabyn, S, Cook, L, Devlin, T, Dumville, J & Torgerson, DJ 2015, 'The use of unequal randomisation in clinical trials - an update', Contemporary Clinical Trials, vol. 45, no. A, pp. 113-122. https://doi.org/10.1016/j.cct.2015.05.017

APA

Peckham, E., Brabyn, S., Cook, L., Devlin, T., Dumville, J., & Torgerson, D. J. (2015). The use of unequal randomisation in clinical trials - an update. Contemporary Clinical Trials, 45(A), 113-122. https://doi.org/10.1016/j.cct.2015.05.017

CBE

Peckham E, Brabyn S, Cook L, Devlin T, Dumville J, Torgerson DJ. 2015. The use of unequal randomisation in clinical trials - an update. Contemporary Clinical Trials. 45(A):113-122. https://doi.org/10.1016/j.cct.2015.05.017

MLA

Peckham, Emily et al. "The use of unequal randomisation in clinical trials - an update". Contemporary Clinical Trials. 2015, 45(A). 113-122. https://doi.org/10.1016/j.cct.2015.05.017

VancouverVancouver

Peckham E, Brabyn S, Cook L, Devlin T, Dumville J, Torgerson DJ. The use of unequal randomisation in clinical trials - an update. Contemporary Clinical Trials. 2015 Nov 1;45(A):113-122. doi: 10.1016/j.cct.2015.05.017

Author

Peckham, Emily ; Brabyn, Sally ; Cook, Liz et al. / The use of unequal randomisation in clinical trials - an update. In: Contemporary Clinical Trials. 2015 ; Vol. 45, No. A. pp. 113-122.

RIS

TY - JOUR

T1 - The use of unequal randomisation in clinical trials - an update

AU - Peckham, Emily

AU - Brabyn, Sally

AU - Cook, Liz

AU - Devlin, Thomas

AU - Dumville, Jo

AU - Torgerson, David J

N1 - Copyright © 2015. Published by Elsevier Inc.

PY - 2015/11/1

Y1 - 2015/11/1

N2 - OBJECTIVE: To update a 2005 review of the reasons researchers have given for the use of unequal randomisation in randomised controlled trials (RCTs).MAIN MEASURES: Intervention being tested; type of study; number of participants; randomisation ratio; sample size calculation and reason given for using unequal randomisation.METHODS: Review of trials using unequal randomisation.DATABASES AND SOURCES: Cochrane library, Medline and CINAHL.RESULTS: A total of 86 trials were identified. Of these 82 trials (95%) recruited patients in favour of the experimental group. Various reasons for the use of unequal randomisation were given including: gaining treatment experience; identification of adverse events; ethical; logistic and enhancing recruitment. No trial reported explicitly used it for cost-effectiveness. Most of the papers (i.e. 47, 55%) did not state why they had used unequal randomisation and only 38 trials (44%) appeared to have taken the unequal randomisation into account in their sample size calculation.CONCLUSION: Most studies did not mention the rationale for unequal allocation, and a significant proportion did not appear to account for it in the sample size calculations. Unlike the previous review economic considerations were not stated as a rationale for its use. A number of trials used it to enhance recruitment, although this has not been tested.

AB - OBJECTIVE: To update a 2005 review of the reasons researchers have given for the use of unequal randomisation in randomised controlled trials (RCTs).MAIN MEASURES: Intervention being tested; type of study; number of participants; randomisation ratio; sample size calculation and reason given for using unequal randomisation.METHODS: Review of trials using unequal randomisation.DATABASES AND SOURCES: Cochrane library, Medline and CINAHL.RESULTS: A total of 86 trials were identified. Of these 82 trials (95%) recruited patients in favour of the experimental group. Various reasons for the use of unequal randomisation were given including: gaining treatment experience; identification of adverse events; ethical; logistic and enhancing recruitment. No trial reported explicitly used it for cost-effectiveness. Most of the papers (i.e. 47, 55%) did not state why they had used unequal randomisation and only 38 trials (44%) appeared to have taken the unequal randomisation into account in their sample size calculation.CONCLUSION: Most studies did not mention the rationale for unequal allocation, and a significant proportion did not appear to account for it in the sample size calculations. Unlike the previous review economic considerations were not stated as a rationale for its use. A number of trials used it to enhance recruitment, although this has not been tested.

U2 - 10.1016/j.cct.2015.05.017

DO - 10.1016/j.cct.2015.05.017

M3 - Article

VL - 45

SP - 113

EP - 122

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - A

ER -