Table 2 Outcome measures, their priorities, times of measurement, mathematical types and analytical categories (defining the statistical analysis to which they will be subjected)
Outcome | Times of measurements | Type of quantity | Regression analysis to be applied |
|---|---|---|---|
Primary outcome | |||
ATD treatment failure | End of trial | Binary | Logistic regression |
Secondary outcomes | |||
1. ATD treatment within last 12 months | End of trial | Binary | Logistic regression |
2. Thyroid hyperfunction after ATD treatment withdrawal | End of trial | Binary | Logistic regression |
3. Ablative therapy | End of trial | Binary | Logistic regression |
4. Global QoL ThyPRO score | a) Time sequence of five measurements† | Numerical | a) Mixed-model with repeated measures (MMRM) |
b)12 months following ATD treatment withdrawal‡ | b) General linear univariate model. As sensitivity analysis: Mann-Whitney test | ||
5. Level of TRAb | After 18 months and at the end of intervention period | Numerical | General linear univariate model. As sensitivity analysis: Mann-Whitney test |
6. ThyPRO - hyperthyroid symptoms | a) Time sequence of five measurements† | Numerical | a) Mixed-model with repeated measures (MMRM) |
b) 12 months following ATD treatment withdrawal‡ | b) General linear univariate model. As sensitivity analysis: Mann-Whitney test | ||
7. ThyPRO - eye symptoms | a) Time sequence of five measurements† | Numerical | a) Mixed-model with repeated measures (MMRM) |
b) 12 months following ATD treatment withdrawal‡ | b) General linear univariate model. As sensitivity analysis: Mann-Whitney test | ||
8. Adverse reactions | End of trial | Rate = count/period of intervention/day | Generalised linear model, Poisson distribution, link = log. As sensitivity analysis: Mann-Whitney test |
9. Serious adverse reactions | End of trial | Rate = count/period of intervention/day | Generalised linear model, Poisson distribution, link = log. As sensitivity analysis: Mann-Whitney test |
Exploratory outcomes | |||
1. Time to ATD withdrawal § | End of trial | Numerical (time until ATD withdrawal (or censoring)) | Cox proportional hazard rate model.As sensitivity analysis: Kaplan-Meier estimates of survival function |
2. Incidence of Graves’ orbitopathy - CAS score | End of trial | Binary (CAS >1) | Logistic regression |
3. ThyPRO - Hypothyroid symptoms | a) Time sequence of five measurements† | Numerical | a) Mixed-model with repeated measures (MMRM) |
b) 12 months following ATD treatment withdrawal‡ | b) General linear univariate model. As sensitivity analysis: MannWhitney test |