A Cross-Sectional Concept Elicitation Study to Understand the Impact of Herpes Zoster on Patients' Health-Related Quality of Life.

INTRODUCTION: After a chickenpox infection, the varicella zoster virus lies dormant in nerve cells and can be reactivated in later life to cause herpes zoster (HZ), also called shingles, a painful rash that may result in persistent postherpetic neuralgia (PHN). Treatment options are limited, and HZ/PHN may have substantial negative effects on health-related quality of life (HRQoL). This qualitative cross-sectional study explored the subjective patient experience and impact on HRQoL of HZ and PHN in adults aged ≥ 50 years in Canada. METHODS: Patients were eligible for the study if they were aged at least 50 years and had been diagnosed with HZ by a healthcare practitioner 7-60 days earlier for HZ patients and 90-365 days earlier for PHN patients. Eligible patients were invited to participate in concept elicitation interviews by telephone. Data from the interviews were transcribed and analyzed to identify key concepts related to symptoms and impacts on the patients' lives. RESULTS: A total of 32 patients participated, with a mean age of 61 years. Most (72%) were female. The most common symptoms reported were rash (n = 32), pain (n = 31), fatigue (n = 26), and itchiness (n = 20). The most commonly reported HRQoL domains affected were emotional functioning (n = 31), activities of daily living (n = 31), sleep (n = 29), physical functioning (n = 25) and hobbies (n = 21). A conceptual model was developed to summarize these symptoms and impacts. CONCLUSION: HZ negatively affected many dimensions of patients' HRQoL, particularly during the acute phase of illness. This qualitative study helps to broaden understanding of the subjective patient experience of HZ.

Improving knowledge and trust in vaccines: A survey-based assessment of the potential of the European Union Clinical Trial Regulation No 536/2014 plain language summary to increase health literacy.

The European Clinical Trial Regulation No 536/2014 is the first mandate for a non-technical, publicly disclosed, plain language summary (PLS) of clinical trial results. This easy-to-understand summary has the potential to inform the public about clinical trial results and thereby improve health literacy in vaccines. To investigate the utility of the PLS, we undertook 2 online surveys (July/October 2020) in the United Kingdom, the United States and India. Participants were selected by quota sampling to ensure representation of gender, age and parental status. Those lacking interest in vaccine clinical research were excluded. In survey 1, participants were questioned about their interest in and expectations of vaccine trial results. In survey 2, the perceptions of participants to a range of written communication styles used in publicly available PLSs were evaluated. A total of 66 (13%) and 122 (29%) individuals were excluded solely due to lack of interest in vaccine clinical research in surveys 1 and 2, respectively; 450 respondents (150/country) completed survey 1 and 300 (100/country) completed survey 2. In survey 1, there was a correlation (p < 0.01) between claimed knowledge of and trust in vaccines. Healthcare professionals were the most trusted source for vaccine information, while vaccine companies were ranked relatively low. In survey 2, infographic PLS formats were considered easiest to understand, most engaging and the strongest communicators. Emphasizing the main points of the infographics in the text did not improve comprehension or recall. Most respondents (86%) indicated that they would like to see this type of communication in the future. Overall, this research suggests that the PLS, by optimizing content and format, has a potential to increase health literacy, and thereby, as part of a wider integrated communication strategy, build vaccine knowledge and confidence.

Impact of respiratory syncytial virus disease on quality of life in adults aged ≥50 years: A qualitative patient experience cross-sectional study.

BACKGROUND: Information about the impact of respiratory syncytial virus (RSV) on quality of life in older adults is limited. This study characterized the patient experience of RSV illness in USA older adults and assessed the content validity of the InFLUenza Patient Reported Outcome (FLU-PRO) in this population. METHODS: This qualitative, non-interventional, cross-sectional study included hybrid concept elicitation and cognitive debriefing interviews with 30 individuals (age ≥50 years) with polymerase chain reaction-confirmed RSV diagnosed within 6 months of screening. Targeted literature review was first conducted to inform the development of interview materials. Webcam or telephone interviews were conducted by qualitative researchers using a semistructured interview guide. Interview transcripts were coded and analyzed using Excel and NVivo software. RESULTS: All participants reported impacts on daily activities, social activities, and relationships during RSV disease. Physical functioning was impaired in 25 (83%) participants, and 18 (60%) reported not engaging in leisure activities/hobbies. All nine participants who were working reported major impacts on work. Most (n = 28; 93%) described emotional impacts. A majority (n = 19; 63%) reported symptoms lasting beyond the acute disease stage from a week to >1 month. Symptom concepts reported generally matched FLU-PRO items and domains. Cognitive debriefing indicated that FLU-PRO was easy to understand and captured participants' experiences of RSV illness. CONCLUSIONS: This study indicates that RSV disease in adults aged ≥50 years in the USA has substantial impacts on daily life and that the concepts included in FLU-PRO are appropriate and fit for purpose as a measure of RSV symptoms in this population.

Outside in - inside out. Creating focus on the patient - a vaccine company perspective.

Involving patients in the development of medicines and vaccines should result in benefits to patients. The vaccine recipient is usually a healthy person. We describe the rationale and implementation of a vaccine company's initiative to encourage employees to identify with patients of the conditions prevented by the vaccines they help to produce. The Voice of the Patient ("VoP"), begun in 2014, is an educational programme directed at the 16,000 employees of a global vaccine company. It engages employees through an understanding that they are all "vaccine patients", and that they can make a difference by considering the impact of decisions made in their day to day work. The initiative includes presentations about vaccine-preventable diseases, global live webcasts with experts and patients, employee visits to healthcare facilities in developing countries, and the production of patient-focused sections in research publications. In a 2017 employee survey, 90% of respondents said they know how their daily work impacts patients and they demonstrate focus on patients. We believe this is preliminary evidence that, by supporting employee awareness of the impact of their individual roles, VoP could be a model for a type of initiative that will contribute to industry's continuing evolution towards more patient-centred healthcare.