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Re-randomization increased recruitment and provided similar treatment estimates as parallel designs in trials of febrile neutropenia

Kahan, BC; Morris, TP; Harris, E; Pearse, R; Hooper, R; Eldridge, S; (2018) Re-randomization increased recruitment and provided similar treatment estimates as parallel designs in trials of febrile neutropenia. Journal of Clinical Epidemiology , 97 pp. 14-19. 10.1016/j.jclinepi.2018.02.002. Green open access

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Abstract

BACKGROUND: Re-randomization trials allow patients to be re-enrolled for multiple treatment episodes. However, it remains uncertain to what extent re-randomization improves recruitment compared to parallel group designs, or whether treatment estimates might be affected. METHODS: We evaluated trials included in a recent Cochrane review of granulocyte colony-stimulating factors for patients with febrile neutropenia. We assessed the recruitment benefits of re-randomization trials; compared treatment effect estimates between re-randomization and parallel group designs; and assessed whether re-randomization led to higher rates of non-compliance and loss-to-follow-up in subsequent episodes. RESULTS: We included 14 trials (five re-randomization, nine parallel group). The re-randomization trials recruited a median of 25% (range 16- 66%) more episodes on average than they would have under a parallel-group design. Treatment effect estimates were similar between re-randomization and parallel group trials across all outcomes, though confidence intervals were wide. The re-randomization trials in this review reported no loss-to-follow-up and low rates of non-compliance (median 1.7%, range 0-8.9%). CONCLUSIONS: In the setting of febrile neutropenia, re-randomization increased recruitment whilst providing similar estimates of treatment effect to parallel group trials, with minimal loss-to-follow-up or non-compliance. It appears to be safe and efficient alternative to parallel group designs in this setting.

Type: Article
Title: Re-randomization increased recruitment and provided similar treatment estimates as parallel designs in trials of febrile neutropenia
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jclinepi.2018.02.002
Publisher version: https://doi.org/10.1016/j.jclinepi.2018.02.002
Language: English
Additional information: �Copyright © 2018 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/lice nses/by-nc-nd/4.0/).
Keywords: Re-randomization, Randomized controlled trials, Clinical trials, Febrile neutropenia, Re-enrolment, Poor recruitment
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10044555
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