Table 1

PRO instruments included in the PROmics system for the POLARISE trial

PRO instrument	Concept of interest	Disease cohort				Rationale for selection
PRO instrument	Concept of interest	PSC	RA	LN	CD	Rationale for selection
PRO-CTCAE	Burden (frequency, severity, interference) of symptomatic toxicities	X	X	X	X	Side effect and adverse event monitoring
FACT-G GP5	Global tolerability of treatment	X	X	X	X	Monitoring of treatment tolerability from the patient perspective
EuroQol 5 Dimensions-5 Level	Health status	X	X	X	X	Local health reimbursement requirement
Fatigue Severity Scale	Fatigue severity and impact on daily living	X	X	X	X	Preferred by PSC patients, use in previous trials, methodological consistency and to maximise comparability between trial arms
FACIT-Fatigue	Quality of life rating to fatigue	X	X	X	X	Recommended for use in RA patients by the European Medicines Association and the International Consortium for Health Outcomes Measurement, methodological consistency, maximise comparability between trial arms
PSC-PRO	PSC symptom severity and impact	X				PSC-specific PRO instrument, patient preference, instrument developed with extensive patient input

CD, Crohn’s disease; LN, lupus nephritis; PRO-CTCAE, patient-reported outcomes Version of the Common Terminology Criteria for Adverse Events; PSC, primary sclerosing cholangitis; RA, rheumatoid arthritis.