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.
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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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