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Table 4 Reasons why attributes of estimands were inferable or non-inferable

From: Estimands in published protocols of randomised trials: urgent improvement needed

Question

Trials—n/N (%)

Population

 Inferable (N = 32)

  Inferred as all eligible participants based on ITT description

32/32 (100%)

 Not inferable (N = 18)

  Analysis population not clearly described

11/18 (61%)

  Participants with treatment deviations excluded from analysis, but unclear whether target population was all patients (under hypothetical compliance) or subset of compliers

7/18 (39%)

Treatment condition(s)

 Inferable (N = 40)

  Inferred treatment policy based on ITT description

33/40 (83%)

  Inferred intended treatment based on the exclusion of certain deviations

7/40 (18%)

 Not inferable (N = 10)

  Unclear how treatment deviations will be handled in analysis

9/10 (90%)

  Unclear which treatment strategy planned analysis corresponds toa

1/10 (10%)

Population-level summary measure

 Inferable (N = 33)

  Inferred from the type of regression model

17 (52%)

  Stated type of summary measure they would estimate

16 (48%)

 Not inferable (N = 17)

  Analysis strategy not clearly described

8 (47%)

  Statistical test only

9 (53%)

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