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

Holloway, Laura; Humphrey, Louise; Heron, Louise; Pilling, Claire; Kitchen, Helen; Højbjerre, Lise; Strandberg-Larsen, Martin; Hansen, Brian Bekker

doi:10.1186/s12955-014-0116-1

Table 4 Psychometric properties of patient-reported outcome measures in patients with SLE

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

Instrument	Psychometrically validated in a SLE population	Reliability		Validity			Ability to detect change
Instrument	Psychometrically validated in a SLE population	Internal consistency (Cronbach’s α)	Test-retest (ICC)	Construct validity	Known groups validity	Concurrent validity	Ability to detect change
SLAQ	✓ [47],[78]	✓ (0.87) [47]	-	✓ [47],[50]	-	✓ [78]	✓ [47]
LupusQoL	✓ [50]	✓ (>0.70) [50]	✓ (0.72-0.93) [50]	✓ [50]	✓ [50]	✓ [50]	-
LupusPRO	✓ [52],[76]	✓ (0.72-0.94) [52]	✓ (>0.70, except for 3 domains) [52]	✗ (High floor effects) [52] -	✓ [52],[76]	✓ [52]	-
L-QoL	✓ [40]	✓ (0.92) [40]	✓ (0.92) [40]	-	✓ [40]	✓ [40]	-
SLEQOL	✓ [55]	✓ (0.95) [55]	✓ (0.83) [55]	✗ (High floor effects) [55]	-	Partial [55]	Partial [55]
SF-36v2	✗	Partial (>0.70) [80],[81]	Partial[80],[81]	Partial[80],[81]	Partial[80],[81]	Partial[80],[81].	✗ (for SLE) [55],[60]Partial[80]
EQ-5D	✓ [75]	-	EQ-5D Index: Partial (0.89) [75] EQ-5D VAS: Partial (0.77) [75]	✗ [82]	✓ [76]	✓ [76]	✓ [76]
FACIT-Fatigue	✓ [77]	✓ (>0.95) [77]	Partial (0.95) [83]	-	✓ [77]	✓ [77]	✓ [77]
MFI	✗	Partial (0-68-0.89) [84]	-	Partial[84],[85] I	Partial[84],[86]	Partial[84]	Partial[87]
MAF	✗	Partial (0.93) [68]	Partial (0.87) [88]	Partial[89]	Partial[90]	Partial[68]	Partial[91]
MPQ	✗	Partial (α not provided) [69]	Partial (r= > 0.70) [69],[92]	-	-	Partial[93]	Partial[94]
BPI-SF	✗	Partial (0.80-0.92) [95]	Partial (0.83-0.88) [96]	Partial[95],[97],[98]	Partial[95],[99]	Partial[99]	Partial[100],[101]
BDI	✗	Partial (0.81) [102]	Partial (0.93) [102]	Partial[102],[103]	Partial[102],[103]	Partial[102]	-
HADS	✗	Partial (0.83, Anxiety sub-scale; 0.82, Depression sub-scale) [104]	Partial (0.84-0.85 for both sub-scales) [105]	Partial[73],[104]	Partial[105]	Partial[104],[106]	Partial[105]
WPAI:Lupus	✗	-	Partial (Pearson’s: 0.71-0.75) [74]	-	Partial[107]	Partial[108]	Partial[107]

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.
✓, evidence of psychometric acceptability in SLE population; Partial, evidence of psychometric acceptability in non-SLE population; ✗, evidence does not meet psychometrical acceptability threshold; −, no evidence available.

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