Developing a national strategy of consumer and community involvement (CCI) for women's health research.

OBJECTIVE: To develop a consumer and community involvement (CCI) strategy for the Women's Health Research, Translation and Impact Network (WHRTN), an initiative of the Australian Health Research Alliance (AHRA). TYPE OF PROGRAM: A national network, comprising representatives from 14 nationally-accredited research translation centres that aims to embed CCI at a systems level, to improve equity and health outcomes across women's health. METHODS: A CCI Sub-Committee of WHRTN was established, chaired by a Consumer Advisor/Advocate. This committee invited both internal and external Consumer Advisor/Advocates to participate in a workshop, to guide the development of WHRTN's CCI Strategy in women's health research. RESULTS: A CCI Strategy document was written with input from workshop attendees and leading academics in women's health and has now been implemented into WHRTN, informing all aspect of the Network's programs and activities. DISCUSSION: Broad and early consumer involvement can facilitate meaningful partnerships between researchers and community, and enable genuine consumer contributions to research across strategy development, priority setting and undertaking research. Appropriate finances and time need to be allocated for CCI, with training in CCI a key enabler for its effective implementation.

Consumer and community involvement in research is increasingly recognised as an important component of high-quality research. It is now required by many research funders and organisations. However, researchers and organisations often struggle with how to initiate and implement consumer and community involvement at a systems level. In this paper, we outline the processes used to develop a national consumer and community involvement strategy for the Australian Health Research Alliance, Women's Health Research Translation and Impact Network. This provides a roadmap of how organisations can achieve a framework that supports consumer and community involvement across the research pathway. The strategy highlights the need for broad and early inclusion of consumers in decision making, financing consumer involvement, allowing time to build partnerships, and inclusion of training for researchers and consumers.

Global landscape analysis of no-fault compensation programmes for vaccine injuries: A review and survey of implementing countries.

To update the landscape analysis of vaccine injuries no-fault compensation programmes, we conducted a scoping review and a survey of World Health Organization Member States. We describe the characteristics of existing no-fault compensation systems during 2018 based on six common programme elements. No-fault compensation systems for vaccine injuries have been developed in a few high-income countries for more than 50 years. Twenty-five jurisdictions were identified with no-fault compensation programmes, of which two were recently implemented in a low- and a lower-middle-income country. The no-fault compensation programmes in most jurisdictions are implemented at the central or federal government level and are government funded. Eligibility criteria for vaccine injury compensation vary considerably across the evaluated programmes. Notably, most programmes cover injuries arising from vaccines that are registered in the country and are recommended by authorities for routine use in children, pregnant women, adults (e.g. influenza vaccines) and for special indications. A claim process is initiated once the injured party or their legal representative files for compensation with a special administrative body in most programmes. All no-fault compensation programmes reviewed require standard of proof showing a causal association between vaccination and injury. Once a final decision has been reached, claimants are compensated with either: lump-sums; amounts calculated based on medical care costs and expenses, loss of earnings or earning capacity; or monetary compensation calculated based on pain and suffering, emotional distress, permanent impairment or loss of function; or combination of those. In most jurisdictions, vaccine injury claimants have the right to seek damages either through civil litigation or from a compensation scheme but not both simultaneously. Data from this report provide an empirical basis on which global guidance for implementing such schemes could be developed.

Gonococcal vaccines: Public health value and preferred product characteristics; report of a WHO global stakeholder consultation, January 2019.

Renewed interest in developing vaccines against Neisseria gonorrhoeae has been sparked by the increasing threat of gonococcal antimicrobial resistance (AMR) and growing optimism that gonococcal vaccines are biologically feasible. Evidence suggests serogroup B Neisseria meningitidis vaccines might provide some cross-protection against N. gonorrhoeae, and new gonococcal vaccine candidates based on several approaches are currently in preclinical development. To further stimulate investment and accelerate development of gonococcal vaccines, greater understanding is needed regarding the overall value that gonococcal vaccines might have in addressing public health and societal goals in low-, middle-, and high-income country contexts and how future gonococcal vaccines might be accepted and used, if available. In January 2019, the World Health Organization (WHO) convened a multidisciplinary international group of experts to lay the groundwork for understanding the potential health, economic, and societal value of gonococcal vaccines and their likely acceptance and use, and for developing gonococcal vaccine preferred product characteristics (PPCs). WHO PPCs describe preferences for vaccine attributes that would help optimize vaccine value and use in meeting the global public health need. This paper describes the main discussion points and conclusions from the January 2019 meeting of experts. Participants emphasized the need for vaccines to control N. gonorrhoeae infections with the ultimate goals of preventing adverse sexual and reproductive health outcomes (e.g., infertility) and reducing the impact of gonococcal AMR. Meeting participants also discussed important PPC considerations (e.g., vaccine indications, target populations, and potential immunization strategies) and highlighted crucial research and data needs for guiding the value assessment and PPCs for gonococcal vaccines and advancing gonococcal vaccine development.

Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) - a natural experiment (protocol).

INTRODUCTION: Hepatitis C virus (HCV) is the second largest contributor to liver disease in the UK, with injecting drug use as the main risk factor among the estimated 200 000 people currently infected. Despite effective prevention interventions, chronic HCV prevalence remains around 40% among people who inject drugs (PWID). New direct-acting antiviral (DAA) HCV therapies combine high cure rates (>90%) and short treatment duration (8 to 12 weeks). Theoretical mathematical modelling evidence suggests HCV treatment scale-up can prevent transmission and substantially reduce HCV prevalence/incidence among PWID. Our primary aim is to generate empirical evidence on the effectiveness of HCV 'Treatment as Prevention' (TasP) in PWID. METHODS AND ANALYSIS: We plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle and syringe programmes (NSPs), pharmacies and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over 2 years from 2017/2018, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62% (from 26% to 10%) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome - chronic HCV prevalence in PWID - is measured using information from the Needle Exchange Surveillance Initiative survey in Scotland and the Unlinked Anonymous Monitoring Programme in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (specifically the Causal Impact Method) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale-up in HCV treatment to observe changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a 'virtual cohort' of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes. ETHICS AND DISSEMINATION: Extending HCV community care pathways is covered by ethics (ERADICATE C, ISRCTN27564683, Super DOT C Trial clinicaltrials.gov: NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (REC ref: 18/ES/0128) and ISCRCTN registration has been completed (ISRCTN72038467). Our findings will have direct National Health Service and patient relevance; informing prioritisation given to early HCV treatment for PWID. We will present findings to practitioners and policymakers, and support design of an evaluation of HCV TasP in England.

Increased uptake and new therapies are needed to avert rising hepatitis C-related end stage liver disease in England: modelling the predicted impact of treatment under different scenarios.

BACKGROUND & AIMS: Hepatitis C (HCV) related disease in England is predicted to rise, and it is unclear whether treatment at current levels will be able to avert this. The aim of this study was to estimate the number of people with chronic HCV infection in England that are treated and assess the impact and costs of increasing treatment uptake. METHODS: Numbers treated were estimated using national data sources for pegylated interferon supplied, dispensed, or purchased from 2006 to 2011. A back-calculation approach was used to project disease burden over the next 30 years and determine outcomes under various scenarios of treatment uptake. RESULTS: 5000 patients were estimated to have been treated in 2011 and 28,000 in total from 2006 to 2011; approximately 3.1% and 17% respectively of estimated chronic infections. Without treatment, incident cases of decompensated cirrhosis and hepatocellular carcinoma were predicted to increase until 2035 and reach 2290 cases per year. Treatment at current levels should reduce incidence by 600 cases per year, with a peak around 2030. Large increases in treatment are needed to halt the rise; and with more effective treatment the best case scenario predicts incidence of around 500 cases in 2030, although treatment uptake must still be increased considerably to achieve this. CONCLUSIONS: If the infected population is left untreated, the number of patients with severe HCV-related disease will continue to increase and represent a substantial future burden on healthcare resources. This can be mitigated by increasing treatment uptake, which will have the greatest impact if implemented quickly.

Human papillomavirus vaccination in Auckland: reducing ethnic and socioeconomic inequities.

BACKGROUND: The New Zealand HPV publicly funded immunisation programme commenced in September 2008. Delivery through a school based programme was anticipated to result in higher coverage rates and reduced inequalities compared to vaccination delivered through other settings. The programme provided for on-going vaccination of girls in year 8 with an initial catch-up programme through general practices for young women born after 1 January 1990 until the end of 2010. OBJECTIVE: To assess the uptake of the funded HPV vaccine through school based vaccination programmes in secondary schools and general practices in 2009, and the factors associated with coverage by database matching. METHODS: Retrospective quantitative analysis of secondary anonymised data School-Based Vaccination Service and National Immunisation Register databases of female students from secondary schools in Auckland District Health Board catchment area. Data included student and school demographic and other variables. Binary logistic regression was used to estimate odds ratios and significance for univariables. Multivariable logistic regression estimated strength of association between individual factors and initiation and completion, adjusted for all other factors. RESULTS: The programme achieved overall coverage of 71.5%, with Pacific girls highest at 88% and Maori at 78%. Girls higher socioeconomic status were more likely be vaccinated in general practice. CONCLUSION: School-based vaccination service targeted at ethic sub-populations provided equity for the Maori and Pacific student who achieved high levels of vaccination.

Measuring disparities in immunisation coverage among children in New Zealand.

For the past 20 years, New Zealand has experienced low immunisation coverage levels. Following the introduction of the National Immunisation Register (NIR) in 2005 many practitioners envisaged improved overall immunisation uptake through enhanced surveillance and monitoring capacities. This study aimed to investigate the geographical distribution and variables associated with disparities in immunisation uptake in New Zealand using a large NIR data set of children aged 12 months old in 2007-2009. DHB immunisation uptake was adjusted for individual ethnicity and deprivation status, year of birth and geographic location. Substantial variations in uptake by ethnicity and District Health Board (DHB) level were evident. Maori (NZ indigenous) and 'Other' ethnicity remain a substantial risk factor for low immunisation uptake after controlling for socio-economic deprivation. In addition, a general north-south gradient was confirmed across New Zealand. Current immunisation programme strategies for planners and providers in New Zealand need to recognise varying DHB compositions in order to provide efficient service provision and to focus on those groups at higher risk of not being immunised.

The cost of immunising at the general practice level.

INTRODUCTION: Childhood immunisation is one of the most cost-effective activities in health care. However, New Zealand (NZ) has failed to achieve national coverage targets. NZ general practice is the primary site of service delivery and is funded on a fee-for-service basis for delivery of immunisation events. AIM: To determine the average cost to a general practice of delivering childhood immunisation events and to develop a cost model for the typical practice. METHODS: A purposeful selection of 24 diverse practices provided data via questionnaires and a daily log over a week. Costs were modelled using activity-based costing. RESULTS: The mean time spent on an immunisation activity was 23.8 minutes, with 90.7% of all staff time provided by practice nurses. Only 2% of the total time recorded was spent on childhood immunisation opportunistic activities. Practice nurses spent 15% of their total work time on immunisation activity. The mean estimated cost per vaccination event was $25.90; however, there was considerable variability across practices. A 'typical practice' model was developed to better understand costs at different levels of activity. CONCLUSIONS: The current level of immunisation benefit subsidy is considerably lower than the cost of a standard vaccination event, although there is wide variability across practices. The costs of delivery exceeding the subsidy may be one reason why there is an apparently small amount of time spent on extra opportunistic activities and a barrier to increasing efforts to raise immunisation rates.

Estimated progression rates in three United Kingdom hepatitis C cohorts differed according to method of recruitment.

OBJECTIVES: To estimate hepatitis C virus (HCV) progression rates between disease stages prior to cirrhosis, using data from liver biopsies in three observational cohorts. To demonstrate how the method of cohort recruitment can influence the estimation of HCV-progression rates. STUDY DESIGN AND SETTING: Data came from three United Kingdom observational cohorts, assembled from different referral sources. In total, 987 HCV-infected patients with an estimated (or known) date of infection and at least one histologically scored liver biopsy were eligible for inclusion in the analysis. Liver biopsy scores were used to determine the stage of HCV-related liver disease. A three-state continuous time Markov model was used to estimate covariate-specific average probabilities of progression of disease. RESULTS: After adjusting for confounders, considerably different rates of disease progression were estimated in the three cohorts. For a group of patients with the same demographics, the estimated 20-year probability of progression to cirrhosis was 12% (95% confidence interval CI = 6-22) in a hospital-based cohort, 6% (95% CI = 3-13) in a posttransfusion cohort, and 23% (95% CI = 14-37) in a cohort recruited from a tertiary referral center. CONCLUSION: Researchers using estimates of disease progression should be aware that the method of cohort recruitment has considerable influence on the progression rates that are derived.

Family physician perspectives on barriers to childhood immunisation.

New Zealand (NZ) has inadequate vaccine coverage and associated disease outbreaks. International research illustrates the importance of provider behaviour in improving vaccine uptake. To understand the immunisation knowledge, views, concerns and educational needs of NZ family physicians, qualitative and quantitative national data was gathered from randomised telephone surveys. Response rate was 60% with respondents' characteristics closely matched to key demographics of NZ family physicians. The most significant barrier to improving immunisation rates identified was parental concern over vaccine safety and associated misconceptions. The second major barrier identified was lack of funding to health providers. A clear need for improvement in family physician knowledge of contraindications to vaccines was highlighted. Family physicians expressed a need for better resources to more effectively address parental fears and misconceptions. Strategies to address these issues include an increased focus on family physician educational needs, extra resources to assist with more effective communication to parents and a review of the present funding of providers for immunisation services.