Primary and secondary objectives for the OPTIMUM trial
| Objectives | Outcome measures | Time points of evaluation |
|---|---|---|
| Primary objective | ||
| To assess whether a minimally invasive evidence-based pathway for the outpatient management of malignant pleural effusion improves global health-related quality of life at 30 days | Self-reported health-related quality of life based on EORTC QLQ-C30 questionnaire | Day 30 |
| Secondary objectives | ||
| Improvement in global health-related quality of life at 60 and 90 days | Self-reported health-related quality of life based on EORTC QLQ-C30 questionnaire | Day 60, 90 |
| Pleurodesis failure rate | Subsequent pleural intervention required on the same side as pleurodesis Chest X-ray opacification greater than 25% on side of intervention judged by two independent clinicians | Day 30, 60, 90 |
| Improvement in symptoms of pain and breathlessness | Medical Research Council (MRC) Dyspnoea Scale 100 mm Visual Analogue Scale for pain and breathlessness | Day 30, 60 and 90 |
| Complication rate | Clinical review and adverse event documentation | Day 7, 14, 30, 60 and 90 |