Statistical methods for primary and secondary outcomes {20a}
SECONDARY
Primary outcome:Treatment accuracy: a generalized estimating equation model with exchangeable correlation structure which adjusts for repeated measurements within individuals will be used to test the per fraction average chest wall displacements for all patients on each arm, testing for superiority (smaller chest wall displacement) of the Breathe Well arm compared to the RPM arm. No covariate adjustment, subgroup or sensitivity analysis is planned.Secondary outcomes:1. Setup time: Median and range of the appointment time will be reported for each arm. No statistical analysis is planned as clinically significant variation in the appointment time is highly dependent on hospital procedures and workflow.2. Patient comfort and user friendliness and 3. Technology assessment: The questionnaire tools used for secondary aims 2 and 3 are not validated tools so will only be used for qualitative analysis. The median and range response scores will be reported for each arm for each question.5. Estimated dose delivered: If the primary outcome shows superiority of the Breathe Well arm in treatment accuracy, the same model will be used to test for superiority (smaller dose differences) of the dose distributions between the Breathe Well arm and the RPM arm. If not, a qualitative analysis will be carried out identifying any patient anatomy- and treatment planning-related points of interest.