From: Estimands in published protocols of randomised trials: urgent improvement needed
Question | Â |
---|---|
Number of trials with ≥ 1 other intercurrent event | 10 |
Total number of other intercurrent events | 15 |
Type of other intercurrent events | |
 Change to assigned treatment | 4 |
 Use of non-trial treatment | 10 |
 No embryos to transfer in an IVF trial | 1 |
Planned strategy to handle other intercurrent events (n = 15) | |
 Stated | 0/15 (0%) |
 Inferable | 12/15 (80%) |
 Not inferable | 3/15 (20%) |
Reason inferable (n = 12) | |
 Analysis by ITT, inferred as treatment policy | 12/12 (100%) |
Reason not inferable (n = 3) | |
 Unclear how intercurrent events will be handled in the analysis | 1/3 (33%) |
 Participants with intercurrent events excluded, but unclear whether the intention is to target hypothetical or principal stratum strategy | 1/3 (33%) |
 Unclear which strategy intended analysis corresponds toa | 1/3 (33%) |