دورية أكاديمية
Applying the intention-to-treat principle in practice: Guidance on handling randomisation errors
| العنوان: | Applying the intention-to-treat principle in practice: Guidance on handling randomisation errors |
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| المؤلفون: | Yelland, LN, Sullivan, TR, Voysey, M, Lee, KJ, Cook, JA, Forbes, AB |
| بيانات النشر: | SAGE PUBLICATIONS LTD |
| سنة النشر: | 2015 |
| المجموعة: | The University of Melbourne: Digital Repository |
| الوصف: | BACKGROUND: 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| ردمك: | 978-1-74077-451-2 1-74077-451-5 |
| تدمد: | 1740-7745 1740-7753 |
| العلاقة: | pii: 1740774515588097; Yelland, L. N., Sullivan, T. R., Voysey, M., Lee, K. J., Cook, J. A. & Forbes, A. B. (2015). Applying the intention-to-treat principle in practice: Guidance on handling randomisation errors. CLINICAL TRIALS, 12 (4), pp.418-423. https://doi.org/10.1177/1740774515588097Test.; http://hdl.handle.net/11343/261374Test |
| الإتاحة: | https://doi.org/10.1177/1740774515588097Test http://hdl.handle.net/11343/261374Test |
| حقوق: | CC BY ; https://creativecommons.org/licenses/by/4.0Test |
| رقم الانضمام: | edsbas.13F6790B |
| قاعدة البيانات: | BASE |
| ردمك: | 9781740774512 1740774515 |
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| تدمد: | 17407745 17407753 |