OBJECTIVE: To develop measures of the day-to-day symptomatic and functional impact of recurrent genital herpes (RGH) outbreaks. The Herpes Outbreak Impact Questionnaire (HOIQ) and the Herpes Symptom Checklist (HSC) were designed to be acceptable to clinical professionals and to reflect patients' experience.
METHODS: Scale content was derived via literature review and interviews with RGH patients and physicians. Questionnaires were assessed for face/content validity in the UK and the language checked for acceptability in the United States. The US measures were assessed for face/content validity with patients. Scaling/psychometric properties were determined via web survey. Participants completed the questionnaires twice during an outbreak, with 24 to 72 hours between administrations.
RESULTS: Respondents found the questionnaires relevant and easy to understand and complete. Application of Rasch analysis resulted in the removal of two HOIQ items. Both scales were found to be unidimensional. Item stability testing for the HOIQ indicated that the measure is reproducible. Internal consistency was good (alpha: time 1 = 0.87, time 2 = 0.91). Discriminative validity was demonstrated by the measure's ability to distinguish between individuals who differed by self-reported severity of outbreak. The HOIQ and HSC were both responsive to change over time.
CONCLUSIONS: The HSC and the HOIQ can determine the impact of a herpes outbreak effectively. They are designed to be used daily during such outbreaks and to determine the effectiveness of RGH treatment.