Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance

Table 2 Content validity of patient-reported outcome measure ^~

Concept identified in literature review	SLE-specific HRQoL					Generic HRQoL		Fatigue			Pain		Depression		Work
	SLAQ	LupusQoL^$	LupusPRO^$	L-QoL	SLEQOL	SF-36v2	EQ-5D^#	FACIT-Fatigue	MFI	MAF	MPQ	BPI-SF	BDI	HADS	WPAI: Lupus
Disease-defining signs and symptoms
Marks on skin	✓
Weight gain/bloating	✓	✓
Hair loss	✓	✓	✓
Looking sick
Reduced cognitive function	✓	✓	✓		✓				✓
Fatigue	✓	✓	✓	✓	✓	✓		✓*	✓*	✓*			✓
Pain	✓		✓		✓	✓	✓				✓	✓
Fever	✓
Weakness						✓		✓*	✓*
Flu-like symptoms
Impacts
Physical functioning		✓	✓		✓	✓	✓		✓*	✓*		✓*
Daily activities		✓	✓	✓	✓	✓	✓	✓*	✓*	✓*		✓*			✓
Sleep problems		✓				✓		✓*	✓* (p)			✓*
Emotional/Psychological	✓	✓	✓	✓	✓	✓	✓	✓*		✓* (p)		✓*	✓	✓
Social functioning		✓		✓	✓	✓		✓*	✓* (p)	✓*
Leisure activities		✓			✓	✓			✓*	✓*
Relationships		✓		✓		✓				✓ (p)		✓*
Work & economic impacts
Work disability			✓		✓	✓				✓*		✓*			✓
Economic impact			✓		✓	✓
Total	8/27	11/27	9/27	5/27	10/27	12/27	4/27	6/27	8/27	8/27	1/27	7/27	2/27	1/27	2/27

SLAQ – Systemic Lupus Activity Questionnaire, SF-36v2 – Short Form [36] Health Survey, EQ-5D – EuroQol 5-Dimensions, FACIT-Fatigue - Functional Assessment of Chronic Illness Therapy, MFI – Multidimensional Fatigue Inventory, MAF – Multidimensional Assessment of Fatigue, MGQ – McGill Pain Scale, BPI – Brief Pain Inventory, BDI – Beck Depression Inventory, HADS – Hospital Anxiety and Depression Scale, WPAI:Lupus – Work Productivity and Activity Impairment Questionnaire: Lupus.
^~ The following symptoms were identified as important in the literature review, but are not measured by current PROs: flu-like symptoms, dry mouth, skin rash, speech problems, vision sensitivity to bright lights, sensitivity to hot/cold temperatures, reduced hand grip, haematological abnormalities, sleep related respiratory and movement problems ^$PRO measure has documented evidence of qualitative research with patients with SLE during item generation ^#Result valid for both the EQ-5D-3L and EQ-5D-5L *Concept assessed only as a fatigue related impact (p) Concept partially covered by one or more items.

ISSN: 1477-7525