Using a balancing procedure in multi-centre clinical trials: simulation of patient allocation based on a trial of ventilation tubes for otitis media with effusion in infants
| Autor: | Gert Jan van der Wilt, Huub Straatman, Gerhard A. Zielhuis, Koen J. A. O. Ingels, Maroeska M. Rovers |
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| Rok vydání: | 2000 |
| Předmět: |
Research design
Male medicine.medical_specialty Randomization MEDLINE Subgroup analysis Dit projectnummer is bedoeld om de MTA projecten tijdelijk samen te brengen voordat ze in de officiele onderzoekslijn worden ondergebracht law.invention Randomized controlled trial law medicine Humans Multicenter Studies as Topic Randomized Controlled Trials as Topic business.industry Otitis Media with Effusion Health Policy Patient Selection Comparability Infant The effect of treatment of Otitis Media with effusion in infants Middle Ear Ventilation Confidence interval Onderzoek naar het effect van behandeling van Otitis Media met Effusie bij jonge kinderen [KNOOP-3] Clinical trial Research Design Physical therapy Female business |
| Zdroj: | International Journal of Technology Assessment in Health Care, 16, 276-281 International Journal of Technology Assessment in Health Care, 16, pp. 276-281 |
| ISSN: | 0266-4623 |
| Popis: | Objective: A basic issue in randomized controlled trials (RCTs) is whether we can safely assume comparability between groups at baseline with respect to all potentially important prognostic factors. In other words, did randomization work sufficiently well? In small trials balanced allocation procedures are employed, whereas in large-scale trials simple randomization will do. The question is: When should balancing be considered?Methods: We performed a simulation study in which we varied the number of categories in the prognostic factors and the number of patients.Results: Simulation showed that, in all instances, a balancing procedure almost always led to perfect or almost perfect balance, while the imbalance with simple randomization was larger. To study the effect of balanced and random allocation on subgroup analyses in our OME trial, we compared the quotient of the width of the confidence intervals (CI). The widest CI in random allocation over the 13 hospitals was on average 13% wider than in balanced allocation.Conclusion: Investigators should always consider balanced allocation, especially in categories with a low number of patients and when subgroup analysis over many categories is requested. |
| Databáze: | OpenAIRE |
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