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

Table 3 Content and face validity of each patient-reported outcome measure

PRO Instrument	Content and face validity evaluated with SLE patients using cognitive debriefing methodology	Item wording acceptable	Recall period acceptable for patient population	Response options acceptable
SLE-specific HRQoL
SLAQ	✗	✓	✗	✓
LupusQoL	✓	✓	✗	✓
LupusPRO	✓	✓	✗	✓
L-QoL	✓	✓	✓	✓
SLEQOL	✗	✗ ‘Fatigue’ not defined	✓	✗ Confusing
Generic HRQoL
SF-36v2	✗	✓	✗	✓
EQ-5D^#	✗	✓	✓	✓
Fatigue
FACIT-Fatigue	✗	✓	✓	✓
MFI	✗	✓	✗ ‘Lately’ too vague	✗ Confusing
MAF	✗	✗ ‘Fatigue’ not defined	✓	✗ Confusing
Pain
MPQ	✗	✗ Complex terms used	✓	✗ Complex terms used
BPI-SF	✗	✓	✗ Some items don’t specify recall	✓
Depression
BDI	✗	✗ No question wording	✗ None specified	✗ Lengthily
HADS	✗	✓	✓	✓
Work productivity
WPAI:Lupus	✗	✗ Some complex terms used	✓	✓

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. ^#Result valid for both the EQ-5D-3L and EQ-5D-5L.