Disseminated varicella zoster virus infection following live attenuated herpes zoster vaccine: descriptive analysis of reports to Australia's spontaneous vaccine pharmacovigilance system, 2016-2020.

OBJECTIVES: To examine the reported incidence and features of disseminated varicella zoster virus (VZV) infection following live attenuated herpes zoster vaccine live (ZVL: Zostavax, Merck) in immunocompromised people in Australia. DESIGN AND SETTING: ZVL was funded in 2016 in Australia for people aged 70 years, with a catch-up programme for those 71-79 years. From 2016 to 2020, three deaths due to disseminated vaccine-strain VZV infection occurred following inadvertent ZVL administration in individuals with varying levels of immunocompromise. This descriptive study examined 4 years of national surveillance data reported to the Therapeutic Goods Administration's Adverse Event Monitoring System (AEMS). Denominator data for rates were from doses recorded in the Australian Immunisation Register. PARTICIPANTS: Individuals vaccinated between 1 November 2016 and 31 December 2020 who experienced adverse event(s) following immunisation (AEFI) after ZVL recorded in the AEMS. PRIMARY AND SECONDARY OUTCOME MEASURES: Rates and outcomes of confirmed (Oka strain positive) or probable disseminated VZV infection, and inadvertent administration of ZVL in immunocompromised individuals. RESULTS: 854 AEFI were reported from 1 089 966 doses of ZVL administered (78.4 per 100 000 doses). Of those, 14 were classified as confirmed (n=6, 0.55 per 100 000) or probable (n=8) disseminated VZV infection. The confirmed cases were all hospitalised, and most (5/6) were immunocompromised; three cases died. Thirty-seven individuals were reported as vaccinated despite a contraindication due to immunocompromise (3.4 per 100 000), with 12/37 (32%) hospitalised. CONCLUSIONS: Disseminated VZV is potentially life-threatening and occurs mostly in those with severe immunocompromise. Inadvertent administration of ZVL to immunocompromised individuals has occurred despite initial provider guidance and education. Multiple additional strategies to assist providers to identify contraindications have been implemented to prevent adverse outcomes.

Experiences of Patient-Led Surveillance, Including Patient-Performed Teledermoscopy, in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study.

BACKGROUND: Current clinician-led melanoma surveillance models require frequent routinely scheduled clinic visits, with associated travel, cost, and time burden for patients. Patient-led surveillance is a new model of follow-up care that could reduce health care use such as clinic visits and medical procedures and their associated costs, increase access to care, and promote early diagnosis of a subsequent new melanoma after treatment of a primary melanoma. Understanding patient experiences may allow improvements in implementation. OBJECTIVE: This study aims to explore patients' experiences and perceptions of patient-led surveillance during the 6 months of participation in the MEL-SELF pilot randomized controlled trial. Patient-led surveillance comprised regular skin self-examination, use of a mobile dermatoscope to image lesions of concern, and a smartphone app to track and send images to a teledermatologist for review, in addition to usual care. METHODS: Semistructured interviews were conducted with patients previously treated for melanoma localized to the skin in New South Wales, Australia, who were randomized to the patient-led surveillance (intervention group) in the trial. Thematic analysis was used to analyze the data with reference to the technology acceptance model. RESULTS: We interviewed 20 patients (n=8, 40% women and n=12, 60% men; median age 62 years). Patients who were more adherent experienced benefits such as increased awareness of their skin and improved skin self-examination practice, early detection of melanomas, and opportunities to be proactive in managing their clinical follow-up. Most participants experienced difficulty in obtaining clear images and technical problems with the app. These barriers were overcome or persevered by participants with previous experience with digital technology and with effective help from a skin check partner (such as a spouse, sibling, or friend). Having too many or too few moles decreased perceived usefulness. CONCLUSIONS: Patients with melanoma are receptive to and experience benefits from patient-led surveillance using teledermoscopy. Increased provision of training and technical support to patients and their skin check partners may help to realize the full potential benefits of this new model of melanoma surveillance.