PSYCHOMETRIC VALIDATION OF PATIENT-REPORTED OUTCOME MEASURES OF PAIN IN U.S. PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
Author(s)
Naegeli AN1, Al Sawah S1, Tomaszewski EL2, Gemmen E3
1Eli Lilly and Company, Indianapolis, IN, USA, 2Quintiles, Pittsburgh, PA, USA, 3Quintiles, Rockville, MD, USA
OBJECTIVES: This study evaluated the psychometric properties of the Brief Pain Inventory-Short Form (BPI-SF) in patients with moderate-to-severe systemic lupus erythematosus (SLE). METHODS: Participants were recruited using a free electronic medication-monitoring service. Patients ≥18 years who self-reported a physician diagnosis of SLE (confirmed by medical record review) and active SLE demonstrated by a Systemic Lupus Activity Questionnaire (SLAQ) score of ≥11 (0-44 scale) were included. BPI-SF and SF-36 were administered in electronic format at baseline, week 2, and week 12. Psychometric properties of the BPI-SF and items and domains were evaluated by standard statistical techniques. RESULTS: A total of 122 patients were included. Cronbach’s alpha were >0.9 for all BPI-SF items. Test-retest reliability of the BPI-SF showed a stable correlation for item #7 (Intraclass Correlation Coefficient 0.79); all other items and domain correlations were >0.5. The BPI-SF domain and global scores were moderately positively correlated to the SLAQ score (all correlations r>0.4), but negatively correlated to the SF-36 Bodily Pain domain (r<-0.6). The BPI-SF domain and global scores were moderately negatively correlated to the SF-36 Physical Function domain and Physical Component scores, with low correlations between the pain severity domain and SF-36 Mental Component scores (r=-0.16). The BPI-SF item #3 (worst pain) was moderately positively correlated to the SLAQ score (r=0.49). Patients who self-reported inactive or less active disease activity (SLAQ <29) scored lower on domain and global scores (p<0.05) and item #3 (p<0.0001), compared to patients who self-reported active disease activity (SLAQ ≥29). The findings suggested all BPI-SF domain scores and item #3 were able to differentiate between patients with less severe or more severe pain. CONCLUSIONS: Assessment of pain intensity, as measured by the BPI-SF, demonstrated validity and reliability in a sample of patients with SLE and may be used as a patient-reported outcome tool in clinical trials.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PRM75
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Systemic Disorders/Conditions