Table 1.

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