Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study

Table 1 Source and timing of measures

Measure	Source	Randomisation
Measure	Source	Pre^a	Post
Catheter blockage requiring intervention	D & CRF		Monthly completion for 24 months
S-CAUTI requiring antibiotics
Prophylactic antibiotic use
Catheter change
Adverse events
NHS/healthcare use
			Months
			6	12	18	24
EQ-5D-5L	PQ	✓	✓	✓	✓	✓
ICIQ-LTCqol	PQ	✓	✓	✓	✓	✓
GSE Scale	PQ	✓	✓	✓	✓	✓
ICECAP-A or O	PQ	✓	✓	✓	✓	✓
Satisfaction with treatment	PQ	✓	✓	✓	✓	✓
Participant/relative, friend or informal carer’s time and travel	PQ				✓

CRF case report form, D LTC diary/calendar, PQ participant/relative, friend or informal carer-completed questionnaire, S-CAUTI symptomatic catheter-associated urinary tract infection, EQ-5D-5L EuroQol questionnaire – 5 dimensions – 5 levels, ICIQ-LTCqol International Consultation on Incontinence Modular Questionnaire – Long Term Catheter quality of life, GSE General Self-Efficacy Scale, ICECAP-A ICEpop CAPability measure for Adults, ICECAP-O ICEpop CAPability measure for Older people
^aPre-randomisation is after informed consent has been given but prior to randomisation

ISSN: 1745-6215