Table 1.
Timing | |||||||
---|---|---|---|---|---|---|---|
Intervention (PCNL or first session ESWL/FURS) | |||||||
Weeks post intervention | Additional intervention (pre and post if >12 weeks) or treatment-related hospitalisation | Post- randomisation 12 months |
|||||
Outcome measure | Source | Baselinea | Pre | 1 to 11 | 12 | ||
Health status EQ-5D-5L | PQ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Pain | PQ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Health profile SF12 | PQ | ✓ | ✓ | ✓ | ✓ | ||
Use of analgesics | PQ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Stone clearance (imaging) | CRF | ✓b | ✓ | ||||
Additional interventions received | CRF&PQ | ✓ | ✓ | ✓ | |||
Complications | CRF&PQ | ✓ | ✓ | ✓ | |||
NHS primary and secondary healthcare use | CRF, PQ | ✓ | ✓ | ✓ | ✓ | ||
Participant costs | PQ | ✓ | ✓ | ✓ |
CRF case report form, PQ participant completed questionnaire
aBaseline is after informed consent has been given but prior to randomisation
bstone imaging performed at 8-12 weeks post treatment