MEASURING HEALTH-RELATED QUALITY-OF-LIFE IN PERSONS WITH GENITAL HERPES

A disease-specific measure was needed for use in an international clin ical trial to evaluate an investigational drug for genital herpes. A n ew measure was developed initially in the UK and translated and adapte d far use in France, Italy, Germany, Denmark, Spain and the USA. This paper describes the translation and adaptation of the USA measure. It also describes the assessment of internal consistency, reproducibility , content validity, and construct validity (convergent and discriminan t) of the measure. Two outcome measures of the final genital herpes-sp ecific measure were developed: (1) a 21-item symptoms subscale; and (2 ) a 20-item HRQOL subscale. Each measure was scored and analyzed separ ately; the psychometric testing discussed in this paper refers to the HRQOL subscale only. The internal consistency of the HRQOL subscale is high (r = 0.93), as is the reproducibility measured with a two week i nterval (r = 0.85). Convergent validity is moderate to high. (Fleming Self-Regard subscale, r = 0.48; SF-36 Social Functioning dimension r = 0.59; SF-36 Mental Health dimension r = 0.50). The number of herpes o utbreaks in the past year was a significant predictor of scores on the HRQOL subscale (0-1 outbreaks, mean = 82.1; 2+ outbreaks, mean = 72.1 P = 0.058) suggesting discriminant validity. The measure is currently in a phase III clinical trial including anti-viral therapy where the question of responsiveness can be addressed.