Table 2

Summary of characteristics of instruments used to measure patient-reported outcomes in SLE

Measure	Instrument type	Items	Domains	Response format	Range of scores	Score interpretation	Mode of administration	Recall period	Normative data
SF36	Generic	36	Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health and health change. The domains can be further summarised into two component scores: the physical component summary and the mental component summary.	Likert scales (range: 3–6) and yes/no answers.	0–100	Higher scores indicate better health.	Paper and electronic.	Standard form: 4 weeks; acute form: 1 week.	Available for both summary scores in several populations.
EQ5D	Generic	6	Health profile: mobility, self-care, usual activities, pain/discomfort, anxiety/depression; health-state rating scale: current health.	Health profile items: 3-point Likert scale; health-state rating scale: 20 cm VAS.	Health profile items are aggregated to give a score that ranges from –0.11 to 1; VAS ranges from 0 to 100.	Health profile items: 1 is perfect health, 0 implies death and negative values mean health states worse than death; VAS: higher scores denote better health.	Paper.	Same day (current state).	Available in several populations including the US general population.
FACIT-Fatigue	Generic	13	Fatigue.	5-point Likert scale.	0–52	Higher scores indicate less fatigue.	Paper.	1 week; a 4-week recall period has shown to be comparable from a measurement perspective.	Available through a link between FACIT-Fatigue and PROMIS fatigue item-bank.
PROMIS Short Forms	Generic	4–10 items per domain	Cover one domain (various available spanning global, physical, social and mental health).	All items except pain intensity: 5-point Likert scale; pain intensity: 11-point rating from 0 to 10.	1–100	The higher the score, the more of that domain the patient experiences.	Paper and electronic.	All domains except physical function and social health: 7 days; physical function and social health: no time-frame.	Available for the US general population using a T-score metric.
PROMIS Profiles		4, 6 or 8 items per domain except pain intensity which is a single item	Physical function, pain interference, fatigue, sleep disturbance, satisfaction with participation in social roles, depression and anxiety, plus a single pain intensity item.
PROMIS CATs		4–12 items per CAT	Cover one domain (various available spanning global, physical, social and mental health).
LupusQoL	Disease-specific	34	Physical health, emotional health, body image, pain, planning, fatigue, intimate relationships and burden to others.	5-point Likert scale.	0–100	Higher scores indicate better health.	Paper and electronic.	4 weeks.	Not available.
LupusPRO	Disease-specific	43	HRQoL: SLE symptoms, cognition, SLE medications, physical health, pain vitality, body image, emotional health and procreation; non-HRQoL: desires/goals, relationship/social support, coping and satisfaction with medical care.	5-point Likert scale.	1– 100	Higher scores indicate better health.	Paper.	4 weeks.	Not available.
LIT	Disease-specific	10	Concentration, medication side effects, fulfilling family responsibilities, feelings of being worn out on waking, bodily pain and aching, limitation of activities due to pain/fatigue, anxiety, depression, self-consciousness related to physical appearance, and ability to plan activities.	5-point Likert scale.	0–100	Higher scores indicate greater negative impact of SLE.	Paper.	4 weeks.	Not available.

CAT, Computer Adaptive Tests; EQ5D, EuroQol-5D; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; HRQoL, health-related quality of life; LIT, Lupus Impact Tracker; LupusPRO, Lupus Patient Reported Outcomes; LupusQoL, Lupus Quality of Life questionnaire; PROMIS, Patient Reported Outcomes Measurement Information System item-bank; SF36, Medical Outcomes Study Short-Form 36; VAS, Visual Analogue Scale.