Design of the Prospective Real-world Outcomes Study of hepatic encephalopathy Patients’ Experience on Rifaximin-α (PROSPER): an observational study among 550 patients

Table 2 Schedule of assessments

	Enrolment	1 month^a	3 months^a	6 months^a	12 months^a	18 months^a	24 months^a
Informed consent provided by patient and caregiver (note that caregiver consent is optional for patient study inclusion)	X
Retrospective chart review (collection of demographic and medical history data)	X
Ongoing clinical data, including clinical outcomes, laboratory measures, medication dose/schedule, resource utilisation, medication adherence^b		X	X	X	X	X	X
GETE^c		X		X
CLDQ^b	X				X		X
EQ-5D-5L (patient)^d	X		X	X	X	X	X
EQ-5D-5L Proxy (caregiver)^d,e	X		X	X	X	X	X
WPAI (patient)^c	X		X	X	X	X	X
WPAI (caregiver)^c	X		X	X	X	X	X

CLDQ Chronic Liver Disease Questionnaire, EQ-5D-5 L Euroqol-5 Dimension-5 level measure, GETE Global Evaluation of Treatment Effectiveness questionnaire, WPAI Work Productivity and Activity Impairment questionnaire
^aTarget dates only; flexible depending on patient response
^bTo be collected at all clinic visits but not at fixed time intervals; clinic visits will be scheduled by investigator and patient according to normal management and not defined by study protocol
^cTo be collected at the clinic visit closest to the indicated study date; no additional clinic visits to be scheduled for study participation
^dTo be requested for patient completion via paper submission or online portal or at clinic visit closest to the indicated date; clinic visit may not be required
^eAustralia, UK, Ireland, France and Germany, where the proxy response has been validated