Study measures
NASH, sleep disturbance, itch, sleep loss
CHRONIC LIVER DISEASE
The 31-item version of NASH-CHECK implemented in the FLIGHT-FXR study comprised 10 items assessing symptoms and 21 items assessing HRQOL. The measure has a recall period of 7 days. The symptoms items use 11-point numerical rating scales (NRSs) ranging from 0 (indicating no symptoms) to 10 (indicating worst possible or extreme symptoms). HRQOL items are grouped into activity limitations (8 items) and emotions and lifestyle (13 items), representing the preliminary conceptual groupings reflected in the conceptual model derived during the qualitative development process for NASH-CHECK [Additional trial measures used as supporting measures in the psychometric evaluation included a visual analog scale (VAS) for itch severity (24-h recall period; responses ranging from 0 = “no itch at all” to 10 = “the worst imaginable itch”), a VAS for sleep disturbance due to itch (24-h recall period; responses ranging from 0 = “no sleep loss” to 10 = “cannot sleep at all”), and a 6-point Patient Global Impression of Severity of NASH symptoms (PGIS; 7-day recall period; responses ranging from “no symptoms” to “very severe”). The Chronic Liver Disease Questionnaire (CLDQ) [