Estimands in published protocols of randomised trials: urgent improvement needed

Table 7 Description of other intercurrent events

Question
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 to^a	1/3 (33%)

^aActual dose of concomitant treatment given in each arm to be included as a covariate in regression model; unclear what intended treatment strategy this approach corresponds to

ISSN: 1745-6215