Table 2 Sensitivity analyses for the primary outcome
Reason sensitivity analysis | How is the sensitivity analysis performed? |
|---|---|
Check the influence of inappropriate inclusion, potentially confounding co-morbid conditions and trial medication use | Participants will be excluded from the analysis if: • major inclusion or exclusion criteria are violated • incorrect trial medication is taken • major neurological or psychiatric disease was present at baseline |
Check the influence of classifying participants who did not understand the instructions at follow-up as having accelerated cognitive decline | The last observation carried forward method will be used for patients with missing MMSE and A&E RBI-scores at follow-up if the reason for missing is the inability of the patient to understand the instructions (instead of classifying them as having accelerated cognitive decline) |
Check for bias by differential lost to follow-up (worst case scenario) | All patients with missing MMSE and A&E RBI-scores at follow-up will be considered to have accelerated cognitive decline |
Investigate the impact of further baseline variables on the RBI score result, Check for confounding by depression symptoms | Age, gender, years of formal education, race, ethnicity and language and CES-D (score < 16, ≥16) are included as covariates in the logistic regression analysis |