Further validation and responsiveness assessment of the Herpes Outbreak Impact Questionnaire and Herpes Symptom Checklist.

OBJECTIVE: The Herpes Outbreak Impact Questionnaire (HOIQ) and Herpes Symptom Checklist (HSC) are patient-completed questionnaires for assessing genital herpes outbreaks. This report describes the validation of paper-and-pencil versions of the scales and responsiveness assessments in an Australian clinical trial. METHODS: Acceptability of the language of the original UK versions was tested with Australians. The HOIQ and HSC were then field-tested with patients. The new versions were validated using patients' daily responses to the questionnaires in a famciclovir study. RESULTS: The HOIQ and HSC were readily adapted into Australian English and were acceptable to patients. Psychometric sample: N = 151; 81 (54%) male; mean age 39.9 +/- 11.6 years; mean outbreaks 5.1 +/- 3.0 per year. Internal consistency was good (alphas at outbreak 1 ranged 0.84-0.90 HOIQ and 0.73-0.87 HSC). Rasch analysis showed item stability over time. Correlations between HOIQ and HSC ranged from 0.46 to 0.60. Both scales distinguished outbreak healing presence or absence at day 6 (P = 0.001), and the HOIQ scale distinguished between symptom severity groups (P < 0.001). Scale scores declined significantly over study duration, exhibiting large effect sizes. CONCLUSIONS: The paper-and-pencil HOIQ and HSC were reliable, valid, and responsive in a clinical trial setting. These instruments are recommended for use in clinical studies.

Factors affecting nebulised medicine adherence in adult patients with cystic fibrosis: a qualitative study.

BACKGROUND: Nebulised medicines contribute to the high treatment burden experienced by patients with cystic fibrosis (CF). OBJECTIVES: This study explored experiences of adult patients with CF when using nebulised medicines, factors impacting on their adherence to nebulised therapy and strategies they used to facilitate adherence. SETTING: Community setting, in Sydney, Australia. METHODS: Ten patients with CF were recruited through a CF patient organisation. Semi-structured face-to-face interviews were conducted, addressing the study objectives. Interviews were audio-recorded, transcribed verbatim and content analysed for anticipated and emergent themes. MAIN OUTCOME MEASURE: Experiences with using nebulised medicines; and barriers and facilitators of adherence to nebulised medicines. RESULTS: Participants' age ranged from 22 to 45 years, with half being male. Four broad themes (with more specific sub-themes) were identified from the interviews: experiences with using nebulised medicines (cleaning nebuliser, time taken to use nebuliser medicine, flexibility in use of nebuliser); feelings about using nebulised medicines (necessary/important, dislike, part of life); factors impacting non-adherence (time consuming therapy, side effects/effects of medicine, work/social demands, lack of perceived importance); factors and strategies facilitating adherence (perceived medicine importance, habit/routine, support, health benefits, technology/medicine dose form, timetabling). CONCLUSIONS: Nebulised therapy for cystic fibrosis patients takes a substantial amount of time, with patients trying to alter their routine to incorporate nebulising into their daily lives. However there are still many factors that lead to low adherence, including work/social demands and travelling. Patients balance the necessity for nebulised therapy against the barriers, and engage in intentional non-adherence at times. Future strategies and resources should target and address specific factors identified by patients with CF as being important and impacting their adherence to nebulised medicines.

2-day versus 5-day famciclovir as treatment of recurrences of genital herpes: results of the FaST study.

BACKGROUND: The brief period of viral replication in recurrent genital herpes lesions suggests shorter therapeutic regimens may be as effective as standard 5-day courses. OBJECTIVE: To demonstrate that a 2-day course of famciclovir 500 mg statim, then 250 mg twice daily was non-inferior to the standard 5-day course of 125 mg twice daily. METHODS: Patients were randomly assigned either the 2-day or 5-day famciclovir course and initiated therapy within 12 h of onset of prodromal symptoms. They were instructed to complete daily questionnaires on herpes-related symptoms and functioning and to attend the clinic for assessment of healing 5.5 days after initiating therapy. RESULTS: A total of 873 patients were randomised at least once and 1038 recurrences were treated. The proportion of evaluable recurrences with lesions present at 5.5 days was less in the 2-day arm (24%) than in the 5-day (28%) arm. The upper 97.5% confidence limit (CL) for this difference in favour of the 2-day arm was 2% in favour of the 5-day arm, well within the 10% predefined for non-inferiority. The upper 97.5% CL was similar in the intent-to-treat, evaluable and per-protocol recurrence populations and when adjusted for baseline differences (in gender, age, herpes history and HIV infection) or for clustering of recurrences within patients. Both treatments had similar side-effects; proportion of lesions aborted; time to next recurrence; patient-reported symptoms; and impact on daily functioning. CONCLUSIONS: The 2-day course was as safe and effective as the standard 5-day course and can only enhance patient convenience and compliance.