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Table 1 Source and timing of measures

From: The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) protocol

 

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

 

✓

 

✓

 

✓

  1. CRF case report form, PQ participant completed questionnaire
  2. aBaseline is after informed consent has been given but prior to randomisation
  3. bstone imaging performed at 8-12 weeks post treatment