Settings requirements for re-randomization trials |
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1)
Some patients may require treatment on multiple occasions
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2)
The intervention(s) would be used for each new treatment episode
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3)
The intervention duration and length of the follow-up period for each treatment episode are less than the overall length of the trial recruitment period
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Design requirements for re-randomization trials |
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Implementation of re-randomization trials |
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1)
Patients are enrolled as usual, randomized to a treatment group, and followed up until all outcomes have been collected
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2)
If patients experience new treatment episodes and require further treatment, they can be reenrolled and rerandomized, provided they have completed the follow-up period from their previous randomization
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3)
This process is repeated until the target sample size is met
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