| Timings | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Event | Pre-screening | Consent/baseline | IPC insertion | Pre-randomisation | Randomisation | Follow-ups (days post-randomisation) | On-going | ||||
14 | 28 | 42a | 56a | 70 | |||||||
Provide patient information sheet | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Sign consent | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Thoracic ultrasound | Â | X | Â | Â | X | X | X | X | X | X | Â |
Chest X-ray | Â | Â | X | Â | X | X | X | X | X | X | Â |
Standard blood tests | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Trial blood samples (Southmead and Oxford only) | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Trial pleural fluid samples (Southmead and Oxford only) | Â | Â | X | Â | X | X | X | X | X | X | Â |
Manometry | Â | Â | X | Â | Â | Â | Â | Â | Â | Â | Â |
Instillation of talc/placebo | Â | Â | Â | Â | X | Â | Â | Â | Â | Â | Â |
Community IPC drainages | Â | Â | Â | Xb | Â | Â | Â | Â | Â | Â | X |
Drainage booklet | Â | Â | X | Â | Â | Â | Â | Â | Â | Â | X |
Daily VAS scores | Â | Â | Â | X | X | Â | Â | Â | Â | Â | X |
Collection of VAS booklet | Â | Â | Â | Â | X | X | X | X | X | X | Â |
EQ-5D questionnaire | Â | X | Â | Â | X | X | X | X | X | X | Â |
QLQ-C30 questionnaire | Â | X | Â | Â | X | X | X | X | X | X | Â |
Patient diary | Â | Â | Â | X | Â | Â | Â | Â | Â | Â | X |