Table 2 Suitability of re-randomization in the setting of (1) in vitro fertilization, (2) severe asthma exacerbations, and (3) acute sickle cell pain crises
Clinical area | Setting requirement | Justification |
|---|---|---|
In vitro fertilization | 1) Some patients may require treatment on multiple occasions | Some participants who do not become pregnant after their first IVF cycle may undergo further cycles |
2) The intervention(s) would be used for each new treatment episode | The interventions considered (minimal stimulation, sperm selection) are designed to be used for each new cycle | |
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 | The interventions considered (minimal stimulation, sperm selection) are short-term (during the IVF cycle) The follow-up period will vary between trials, but will often be complete once it is determined a cycle was unsuccessful | |
Severe asthma exacerbations | 1) Some patients may require treatment on multiple occasions | Some patients may experience more than one exacerbation during a given time period |
2) The intervention(s) would be used for each new treatment episode | The interventions considered (magnesium sulphate) are designed to be used for each new exacerbation | |
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 | The interventions considered (magnesium sulphate) is short-term, and given while a patient is experiencing an exacerbation. The follow-up period will vary between trials, but is often relatively short-term | |
Acute sickle cell pain crises | 1) Some patients may require treatment on multiple occasions | Some patients may experience more than one pain crisis during a given time period |
2) The intervention(s) would be used for each new treatment episode | The interventions considered (nitric oxide gas, ketoprofen) are designed to be used for each new pain crisis | |
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 | The interventions considered (nitric oxide gas, ketoprofen) is short-term, and given while a patient is experiencing a pain crisis. The follow-up period will vary between trials, but is often relatively short-term |