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Table 2 Content validity of patient-reported outcome measure ~

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

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
  1. 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.
  2. ~ 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.