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dc.contributor.authorYelland, L.-
dc.contributor.authorSullivan, T.-
dc.contributor.authorVoysey, M.-
dc.contributor.authorLee, K.-
dc.contributor.authorCook, J.-
dc.contributor.authorForbes, A.-
dc.identifier.citationClinical Trials, 2015; 12(4):418-423-
dc.description.abstractBackground: The intention-to-treat principle states that all randomised participants should be analysed in their randomised group. The implications of this principle are widely discussed in relation to the analysis, but have received limited attention in the context of handling errors that occur during the randomisation process. The aims of this article are to (1) demonstrate the potential pitfalls of attempting to correct randomisation errors and (2) provide guidance on handling common randomisation errors when they are discovered that maintains the goals of the intention-to-treat principle. Methods: The potential pitfalls of attempting to correct randomisation errors are demonstrated and guidance on handling common errors is provided, using examples from our own experiences. Results: We illustrate the problems that can occur when attempts are made to correct randomisation errors and argue that documenting, rather than correcting these errors, is most consistent with the intention-to-treat principle. When a participant is randomised using incorrect baseline information, we recommend accepting the randomisation but recording the correct baseline data. If ineligible participants are inadvertently randomised, we advocate keeping them in the trial and collecting all relevant data but seeking clinical input to determine their appropriate course of management, unless they can be excluded in an objective and unbiased manner. When multiple randomisations are performed in error for the same participant, we suggest retaining the initial randomisation and either disregarding the second randomisation if only one set of data will be obtained for the participant, or retaining the second randomisation otherwise. When participants are issued the incorrect treatment at the time of randomisation, we propose documenting the treatment received and seeking clinical input regarding the ongoing treatment of the participant. Conclusion: Randomisation errors are almost inevitable and should be reported in trial publications. The intention-to-treat principle is useful for guiding responses to randomisation errors when they are discovered.-
dc.description.statementofresponsibilityLisa N Yelland, Thomas R Sullivan, Merryn Voysey, Katherine J Lee, Jonathan A Cook, Andrew B Forbes-
dc.rights© The Author(s) 2015. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License ( which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (
dc.subjectRandomisation error; intention to treat; guidelines; randomised controlled trial; ineligible participant-
dc.titleApplying the intention-to-treat principle in practice: guidance on handling randomisation errors-
dc.typeJournal article-
dc.identifier.orcidYelland, L. [0000-0003-3803-8728]-
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