Radiographs & Event forms | Screening | Enrolment | 7 days (4–10 days) | 14 days (11–17 days) | 30 days (23–37 days) | 3 months (11–15 weeks) | 6 months (6–7 months) |
---|---|---|---|---|---|---|---|
X-ray or CT-scan | X | Â | Â | Â | Â | Â | Â |
Screening | X | Â | Â | Â | Â | Â | Â |
Informed Consent | Â | X | Â | Â | Â | Â | Â |
Shared Decision | Â | X | Â | Â | Â | Â | Â |
Baseline Data | Â | Â | X | Â | Â | Â | Â |
General Clinical FU | Â | Â | X | X | X | X | X |
QoL (EQ-5D and QUALIDEM) | Â | Â | Xa | X | X | X | X |
PACSLAC and Analgesic use | Â | Â | Xa | X | X | X | X |
Complications and mortality | Â | Â | X | X | X | X | X |
(Secondary) Interventions | Â | Â | X | X | X | X | X |
Satisfaction of patient (or proxy) | Â | Â | Xb | Xb | Xb | Xb | X |
QODD | Â | Â | Xb | Xb | Xb | Xb | Xb |
Satisfaction of caregiver | Â | Â | Xb | Xb | Xb | Xb | X |
Health Care Use | Â | Â | Xa | X | X | X | X |
Early Withdrawal | Â | Â | c | c | c | c | c |