Table 4 Target population and intercurrent event handling by outcome variable groupings
Outcomes | Estimand attributes |
|---|---|
1–17: Infant cognitive development and anthropometrics at 24 months of age | Target population: Infants of mothers with adequate iodine intake from food early in pregnancy (> 165 µg/day) who survive to 24 months of age Intercurrent events: Non-compliance with the randomised supplement regime will be ignored under a treatment policy strategy. Miscarriages, terminations, stillbirths and infant deaths will be excluded from analysis according to the target population attribute |
18–24: Infant birth and birth hospitalisation characteristics | Target population: Infants of mothers with adequate iodine intake from food early in pregnancy (> 165 µg/day) who are live-born Intercurrent events: Non-compliance with the randomised supplement regime will be ignored under a treatment policy strategy. Miscarriages, terminations and stillbirths will be excluded from analysis according to the target population attribute |
25–28: Maternal complications during pregnancy, delivery type and postpartum haemorrhage | Target population: Mothers with adequate iodine intake from food early in pregnancy (> 165 µg/day) who deliver a live-born infant Intercurrent events: Non-compliance with the randomised supplement regime will be ignored under a treatment policy strategy. Miscarriages, terminations and stillbirths will be excluded from analysis according to the target population attribute |