Skip to main content

Table 2 Description of the sensitivity analyses that will be made for the primary outcome

From: Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT)

  Imputations Adjusted Area under the curve (AUC) Intention-to-treat (ITT) principle
Fully adjusted analysis Yes, as in the primary analysis Adjusted for covariates (center, WHO performance status, time since the patient was diagnosed with metastases, treatment status, sex, age, diagnosis and education) that are associated with the primary outcome (P <0.10 in a univariate test) and where missing <5% Yes, as in the primary analysis Modified ITT analysis as in the primary analysis.
Complete case analysis No Yes, as in the primary analysis Yes, as in the primary analysis Violated, no imputations for patients who did not respond to the questionnaire. Analysis may be biased
Model for repeated measurement analysis Yes, as in the primary analysis Yes, as in the primary analysis No. The three- and eight-week follow-ups are assessed individually Modified ITT analysis as in the primary analysis
Per protocol analysis Yes, as in the primary analysis Yes, as in the primary analysis Yes, as in the primary analysis Violated, excluding patients who did not receive the experimental intervention (defined as at least one contact to the SPC team). The analysis thus only describes the effect of the intervention on those complying with the intervention, which is a subgroup of patients
Including patients who died Yes, as in the primary analysis Yes, as in the primary analysis Yes, as in the primary analysis ITT analysis. Multiple imputations for patients who do not respond or die