PURPOSE: The RGHQoL questionnaire has been employed in the assessment of quality of life (QoL) in patients with recurrent genital herpes (RGH); it is concerned with the impact of the virus on the everyday life of patients. No measure has been available for assessing impact of a herpes outbreak on patients with the condition. Some interventions for the condition attempt to abort an outbreak or to reduce its length and/or severity. An instrument was required to determine the benefit of such interventions from the patients’ perspective, in the context of a clinical trial.
METHODS: Content of the HOIQ was derived from 40 qualitative interviews with RGH patients who were asked to describe symptoms and functional limitations imposed by a herpes outbreak. Nineteen cognitive debriefing interviews were conducted with RGH patients, employing the draft HOIQ. Finally, the measure was employed in a web-based survey involving 158 patients in order to identify the final set of items and to establish unidimensionality, reproducibility, internal consistency and construct validity.
RESULTS: Interviews identified a number of areas of functioning that were affected during an outbreak; social, work and other activities, relationships, personal hygiene, choice of clothing, need to avoid becoming tired, worry and anxiety and fear of discovery. De-briefing interviews indicated that the content was appropriate for this patient group and that the measure was easy to understand and complete. Following Rasch analysis of the survey data a 12-item unidimensional measure was identified with good reproducibility, internal consistency and construct validity.
CONCLUSIONS: The HOIQ represents an effective method for determining the impact of a herpes outbreak. The measure is scheduled to be used on a daily basis during such outbreaks in a trial designed to determine the effectiveness of a new treatment for RGH.
