VALIDATION OF A NEW SELF-ASSESSMENT QUESTIONNAIRE AND THE SKINDEX-29 QUALITY OF LIFE (QOL) INSTRUMENT FOR CHRONIC HAND DERMATITIS (CHHD)- A PILOT STUDY
Author(s)
Fowler J1, Ghosh A2, Duh MS2, Raut M3, Reynolds J2, Thorn D3, Den E2, Chang J3, 1University of Louisville, Lousville, KY, USA; 2Analysis Group, Boston, MA, USA; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
OBJECTIVE: The lack of specific ICD-9 codes and under self-reporting and diagnosis of ChHD suggests a need for a self-assessment survey to identify ChHD. This pilot study was conducted to validate a newly designed self-assessment questionnaire and the Skindex-29 QoL instrument for use by ChHD patients. METHODS: A clinical questionnaire, consisting of 16 questions, was developed to identify patients with ChHD and to assess its severity, through patient self-administration. Sensitivity, specificity, and receiver operating characteristic (ROC) curve were used to evaluate how closely the ChHD diagnosis based on self-assessment concurred with physician's diagnoses. Also, Skindex-29, a QoL instrument with 29 questions not previously validated in a ChHD population, was evaluated for internal consistency and construct validity for ChHD patients in this study. Forty-patients (ChHD n = 20; other skin disorders n = 20), with a mean age of 46.6 ± 14.8 years and 30% males, were randomly selected from a dermatology clinic in Louisville, Kentucky for this pilot study. RESULTS: The performance of the clinical questionnaire matched the physicians' diagnosis in identifying ChHD with a sensitivity of 85%, a specificity of 95%, and an area under the ROC curve of 0.83. The internal consistency of the Skindex-29 was higher than that reported previously in a general dermatology population, with a Cronbach alpha of 0.77 to 0.94 for 3 different (symptoms, emotions and functioning) domains. The construct validity of Skindex-29 was evaluated by examining the correlation between the overall score and physician's assessment of ChHD severity. The Pearson rho was 0.55 (p = 0.07), slightly lower than that reported previously, but higher than that reported for other QoL instruments. CONCLUSIONS: This study indicates that the newly developed ChHD self-assessment instrument and the Skindex-29 questionnaire appear to have reasonable performance and validity for ChHD patients. Further validation studies with a larger sample size will be needed to confirm these findings.
Conference/Value in Health Info
2004-05, ISPOR 2004, Arlington, VA, USA
Value in Health, Vol. 7, No. 3 (May/June 2004)
Code
PES16
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Sensory System Disorders