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Table 2 Schedule of assessments

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

  Enrolment 1 montha 3 monthsa 6 monthsa 12 monthsa 18 monthsa 24 monthsa
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 adherenceb   X X X X X X
GETEc   X   X    
CLDQb 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
  1. 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
  2. aTarget dates only; flexible depending on patient response
  3. 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
  4. cTo be collected at the clinic visit closest to the indicated study date; no additional clinic visits to be scheduled for study participation
  5. 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
  6. eAustralia, UK, Ireland, France and Germany, where the proxy response has been validated