RESUMEN
Ménière's disease is a disabling condition causing vertigo and hearing loss yet remains incompletely understood. Registry studies have the potential to answer important questions about phenotypes and natural history of clinical conditions. The aim of this study was to explore the feasibility of a patient-centered national Ménière's disease registry. This was an observational study carried out at 4 state-funded hospitals and 4 independent clinics, within 3 distinct urban and rural regions within the UK. Adults with Ménière's disease were eligible to participate. A range of patient reported data, questionnaire data and clinical data (audiometric, radiological, and specialist balance testing data) was inputted into a bespoke database. The study recruited 411 participants. The majority of participants chose online recruitment (73%) and 27% chose via paper-based methods for participation. A small majority (57%) of participants were female. 96% of participants were of white ethnicity. Data completeness from online or postal data collection was similar. Around 20% of participants had audiological evidence of bilateral Ménière's disease. This feasibility study has successfully piloted methods for recruitment of hundreds of participants diagnosed with Ménière's disease. Participants actively contributed their data to a robust and extensive data collection platform. The positive outcomes from this initial feasibility study are anticipated to serve as a foundation for the future expansion of the registry. This expansion holds the potential to address a broad spectrum of request, encompassing all aspects of the nature of Ménière's disease.
Asunto(s)
Estudios de Factibilidad , Enfermedad de Meniere , Sistema de Registros , Humanos , Enfermedad de Meniere/epidemiología , Enfermedad de Meniere/diagnóstico , Masculino , Femenino , Persona de Mediana Edad , Adulto , Reino Unido/epidemiología , Anciano , Encuestas y CuestionariosRESUMEN
BACKGROUND: Influenza (flu) vaccination rates in UK care home staff are extremely low. Less than 40% of staff in care homes are vaccinated for influenza (flu), presenting risks to the health of frail residents and potential staff absence from cross-infection. Staff often do not perceive a need for vaccination and are unaware they are entitled to free flu vaccination. The FluCare study, a cluster randomised control trial (RCT), uses behavioural interventions to address barriers. Videos, posters, and leaflets are intended to raise awareness of flu vaccination benefits and debunk myths. On-site staff vaccination clinics increase accessibility. Financial incentives to care homes for improved vaccination rates and regular monitoring influence the environment. This paper outlines the planned process evaluation which will describe the intervention's mechanisms of action, explain any changes in outcomes, identify local adaptations, and inform design of the implementation phase. METHODS/DESIGN: A mixed method process evaluation to inform the interpretation of trial findings. OBJECTIVES: ⢠Describe the intervention as delivered in terms of dose and fidelity, including adaptations and variations across care homes. ⢠Explore the effects of individual intervention components on primary outcomes. ⢠Investigate the mechanisms of impact. ⢠Describe the perceived effectiveness of relevant intervention components (including videos, leaflets, posters, and flu clinics) from participant perspectives (care home manager, care home staff, flu clinic providers). ⢠Describe the characteristics of care homes and participants to assess reach. A purposive sample of twenty care homes (ten in the intervention arm, ten in the control arm) for inclusion in the process evaluation. Data will include (1) study records including care home site profiles, (2) responses to a mechanism of action questionnaire, and (3) semi-structured interviews with care home staff and clinic providers. Quantitative data will be descriptively reported. Interview data will be thematically analysed and then categories mapped to the Theoretical Domains Framework. DISCUSSION: Adopting this systematic and comprehensive process evaluation approach will help ensure data is captured on all aspects of the trial, enabling a full understanding of the intervention implementation and RCT findings. TRIAL REGISTRATION: ISRCTN ISRCTN22729870. Registered on 24 August 2022.
Asunto(s)
Gripe Humana , Humanos , Análisis Costo-Beneficio , Gripe Humana/prevención & control , Instituciones de Atención Ambulatoria , Terapia Conductista , Vacunación , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
The care home staff influenza vaccination rate in England is significantly lower than the 75% World Health Organisation recommendation. This represents a substantial potential for resident harm. Barriers to staff vaccination stem from individual and organisational levels. Existing interventions address some but not all barriers and are not underpinned by behavioural science theory. This study aims to estimate the effectiveness and cost-effectiveness of a theory-informed intervention to improve care home staff vaccination rates compared to routine practice.Set in care homes with both nursing and residential focus, and a range of ownership status, only homes providing long stay care to older people with a staff vaccination rate below 40% are eligible to participate. Participation expressions of interest will be sought using a variety of approaches prior to seeking consent.The primary outcome measure is the proportion of staff vaccinated at 6 months, with secondary outcome measures being proportion vaccinated at 3 months, numbers of staff sick days, general practitioner and nurse visits to care home, care home resident hospitalisations and mortality.Based on the assumptions that the mean cluster (care home) size is 54 staff, a coefficient of variation of 0.48, control vaccination rate is 55%, intervention 75%, intra-cluster correlation coefficient of 0.2 and with 90% power, and 20% attrition, we require 39 care homes per arm.Blocked randomisation will be at the level of care home, stratified by the proportion of non-white care home staff, and implemented by Norwich Clinical Trials Unit.The intervention comprises co-designed information videos and posters, provision of in-house staff vaccination clinics, and incentive scheme and monthly data collection on trial outcomes. Beyond usual practice, the control arm will additionally contribute monthly data.Data will be collected at the start, monthly and at 6 months, and analysis will be blind to allocation. Statistical analysis will use the intention-to-treat principle with the difference in vaccination rates between groups compared using a random effect logistic regression model at the staff-level.This will be the first study to use a theory-informed intervention designed to comprehensively address identified barriers to care home staff influenza vaccination.Trial registration: ISRCTN ISRCTN22729870 . Registered on 24 August 22. Secondary identifiers: R209939, IRAS 316820, CPMS 53812.