Table 1 PROMs used in the PROmics^R study

GENERIC/ HEALTH ECONOMIC

EuroQol 5D-5L

8 timepoints

9 timepoints

Local health reimbursement requirement [58]

The EQ-5D-5L has been widely validated and its use in resource assessments is specified by the National Institute for Health and Care Excellence (NICE) [59]

It consists of five items and a visual analogue scale, it takes eight minutes to complete and has a same day recall period

SYMPTOM SPECIFIC

Fatigue Severity Scale

8 timepoints

9 timepoints

Preferred by PSC patients, use in prior trials, methodological consistency and maximised comparability between arms [60]

The FSS consists of nine items and requires less than five minutes to complete. It uses a two-week recall, and a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree)

A higher score indicates higher fatigue. It will be used in accordance with a user manual and is frequently used in a PSC population [61]

FACIT-Fatigue

8 timepoints

9 timepoints

Referenced by EMA and ICHOM for use in RA patients, and Methodological consistency and maximised comparability between arms [62]

The FACIT-Fatigue is a validated measure [63] and consists of 13 items and takes five minutes to complete

It uses a seven-day recall period and a 5-point Likert scale from 0 (not at all) to 4 (very much). Higher scores indicate less fatigue and better QoL

DISEASE SPECIFIC

PSC-PRO

8 timepoints

–

–

–

Only PSC-specific PRO available and developed with extensive patient input [61]

The PSC-PRO consists of 42 items and takes seven to fifteen minutes to complete

It uses a 24-h recall period for the symptom module and a seven-day recall period for the impact module. A dichotomous/5-point Likert (1 Never—5 Always)/0–10 rating scale is used throughout. A high score indicates worse health status. It will be used in accordance with a user manual and has been developed and validated in a PSC population [64]