Outcome measures | Source | Timing | ||
---|---|---|---|---|
Recruitment | Post randomization | |||
4 weeks | 12 weeks | |||
Need for additional intervention | Case report form | × | × | |
Additional interventions received | Participant questionnaire and case report form | × | × | |
Pain (numeric rating scale) | Participant questionnaire | × | × | |
Health profile and status (SF36, EQ5D) | Participant questionnaire | × | × | × |
Use of analgesics | Participant questionnaire | × | ||
Adverse events | Participant questionnaire | × | × | |
Time to passage of stone | Participant questionnaire and case report form | × | × | |
NHS primary and secondary healthcare use | Participant questionnaire and case report form | × | ||
Participant out of pocket costs | Participant questionnaire | × |