An economic evaluation and incremental analysis of the cost effectiveness of three universal childhood varicella vaccination strategies for Ireland.

BACKGROUND: The cost effectiveness of childhood varicella vaccination is uncertain, as evidenced by variation in national health policies. Within the European Economic Area (EEA), only 10 of 30 countries offer universally funded childhood varicella vaccination. This study estimates the cost effectiveness of universal childhood varicella vaccination for one EEA country (Ireland), highlighting the difference in cost effectiveness between alternative vaccination strategies. METHODS: An age-structured dynamic transmission model, simulating varicella zoster virus transmission, was developed to analyse the impact of three vaccination strategies; one-dose at 12 months old, two-dose at 12 and 15 months old (short-interval), and two-dose at 12 months and five years old (long-interval). The analysis adopted an 80-year time horizon and considered payer and societal perspectives. Clinical effectiveness was based on cases of varicella and subsequently herpes zoster and post-herpetic neuralgia avoided, and outcomes were expressed in quality-adjusted life-years (QALYs). Costs were presented in 2022 Irish Euro and cost effectiveness was interpreted with reference to a willingness-to-pay threshold of €20,000 per QALY gained. RESULTS: From the payer perspective, the incremental cost-effectiveness ratio (ICER) for a one-dose strategy, compared with no vaccination, was estimated at €8,712 per QALY gained. The ICER for the next least expensive strategy, two-dose long-interval, compared with one-dose, was estimated at €45,090 per QALY gained. From a societal perspective, all three strategies were cost-saving compared with no vaccination; the two-dose short-interval strategy dominated, yielding the largest cost savings and health benefits. Results were stable across a range of sensitivity and scenario analyses. CONCLUSION: A one-dose strategy was highly cost effective from the payer perspective, driven by a reduction in hospitalisations. Two-dose strategies were cost saving from the societal perspective. These results should be considered alongside other factors such as acceptability of a new vaccine within the overall childhood immunisation schedule, programme objectives and budget impact.

The economic impact of the introduction of universal rotavirus vaccination on rotavirus gastroenteritis related hospitalisations in children in Ireland.

BACKGROUND: Rotavirus gastroenteritis (RVGE), a vaccine preventable disease, remains a common cause of severe gastroenteritis in children globally. Ireland introduced the universal rotavirus vaccination to the national immunisation programme in 2016. In this paper the economic impact on RVGE related hospitalisations amongst children under 5 years is examined. METHODS: Using national data from all Irish public hospitals, an Interrupted Times Series Analysis (ITSA) compares RVGE hospitalisations amongst children under 5 years, pre- and post-vaccine introduction. Costs are estimated and ITSA results are compared to the counterfactual to estimate the economic impact of the vaccine. A probit model examines patient characteristics pre- and post-vaccine introduction. RESULTS: Vaccine introduction coincided with lowered RVGE related hospitalisations. While this effect was delayed (1 year) there is evidence of a sustained impact. RVGE patients' post-vaccine introduction were likely to be over 2 years (p = 0.001) and length of stay was lower on average (p = 0.095). The counterfactual analysis revealed 492 RVGE hospitalisations were avoided on average annually since the introduction of the vaccine. This has an estimated economic value of €0.92 million per annum. CONCLUSIONS: Following the introduction of the rotavirus vaccine in Ireland, hospitalisations for RVGE decreased significantly and those hospitalised were older and with a reduced length of stay on average. This has the potential for significant cost savings for the Irish healthcare system.

The Women's Health Initiative cancer survivorship clinic incorporating electronic patient-reported outcomes: a study protocol for the Linking You to Support and Advice (LYSA) randomized controlled trial.

BACKGROUND: The improved survival rate for many cancers in high-income countries demands a coordinated multidisciplinary approach to survivorship care and service provision to ensure optimal patient outcomes and quality of life. This study assesses the feasibility of introducing a Women's Health Initiative cancer survivorship clinic in Ireland. METHODS: The trial https://spcare.bmj.com/content/9/2/209.short comprises an intervention and control arm. Two hundred participants will be recruited. Key eligibility (1) women with early-stage hormone receptor-positive breast or gynecologic cancer (cervix or endometrial), within 12 months of completion of primary curative therapy, and (2) access to the Internet. The complex intervention comprises a nurse-led clinic targeting symptom management through a trigger alert system, utilizing electronic patient-reported outcome (ePRO) assessments at baseline, and 2, 4, 6, 8, 10, and 12 months. It also includes input from a dietitian monitoring diet and nutritional status. The control group will receive their usual care pathway standard of care and attend the cancer survivorship clinic and complete ePRO assessments at the start and end of the study. The primary endpoint (feasibility) includes the proportion of enrolled participants who complete baseline and follow-up ePRO surveys and partake in health professional consultations after ePRO data triggers. Secondary endpoints include changes in cancer-related symptom scores assessed by ePROs, health-related Quality of Life Questionnaire (QLQ) scores, Appraisal Self-Care Agency-R scores, and adjuvant endocrine therapy medication adherence. A process evaluation will capture the experiences of participation in the study, and the healthcare costs will be examined as part of the economic analysis. Ethical approval was granted in December 2020, with accrual commencing in March 2021. DISCUSSION: This protocol describes the implementation of a parallel arm randomized controlled trial (RCT) which examines the feasibility of delivering a Cancer Survivorship Clinic. The ePRO is an innovative symptom monitoring system which detects the treatment-related effects and provides individualized support for cancer survivors. The findings will provide direction for the implementation of future survivorship care. TRIAL REGISTRATION: ClinicalTrials.gov , NCT05035173 . Retrospectively registered on September 5, 2021.

Counting the social, psychological, and economic costs of COVID-19 for cancer patients.

PURPOSE: Cancer patients were particularly vulnerable to the adverse impacts of the COVID-19 pandemic given their reliance on the healthcare system, and their weakened immune systems. This systematic review examines the social, psychological, and economic impacts of COVID-19 on cancer patients. METHODS: The systematic search, conducted in March 2021, captures the experience of COVID-19 Wave I, when the most severe restrictions were in place globally, from a patient perspective. RESULTS: The search yielded 56 studies reporting on the economic, social, and psychological impacts of COVID-19. The economic burden associated with cancer for patients during the pandemic included direct and indirect costs with both objective (i.e. financial burden) and subjective elements (financial distress). The pandemic exasperated existing psychological strain and associated adverse outcomes including worry and fear (of COVID-19 and cancer prognosis); distress, anxiety, and depression; social isolation and loneliness. National and institutional public health guidelines to reduce COVID-19 transmission resulted in suspended cancer screening programmes, delayed diagnoses, postponed or deferred treatments, and altered treatment. These altered patients' decision making and health-seeking behaviours. CONCLUSION: COVID-19 compounded the economic, social, and psychological impacts of cancer on patients owing to health system adjustments and reduction in economic activity. Identification of the impact of COVID-19 on cancer patients from a psychological, social, and economic perspective following the pandemic can inform the design of timely and appropriate interventions and supports, to deal with the backlog in cancer care and enhance recovery.

Would universal general practitioner care impact Irish adolescents' utilisation?

INTRODUCTION: Health systems' characteristics influence individuals' health care utilisation. Unlike their European neighbours the majority of Irish citizens pay for General Practitioner (GP) care. The current strategy for health care reform proposes universal GP care (i.e. the removal of GP care fees), to be introduced on a phased basis, prioritising under 18s. METHODS: Employing data from the Growing Up in Ireland survey, and controlling for health care need, and other predisposing and enabling factors, propensity score matching is used to estimate the effect of GP cover (free GP care at point of use) on GP utilisation over a 12-month period amongst 16/17 year olds (n= 4308). RESULTS: Results indicate having GP cover increases the average number of GP consultations by 38% per annum. When the sample is restricted to individuals without chronic conditions, a 42% increase in annual number of GP consultations is found. It is reasonable to expect that extending free GP care via a universal care model would be associated with a higher propensity to utilise GP services amongst 16/17 year olds. CONCLUSIONS: This has economic implications for health care budgets and workforce planning. While most adolescents are healthy, investment in their health provides current and future health benefits; however a universal system will require investment, necessitating displacement of resources elsewhere, to meet demand.

Atrial fibrillation (AF) pilot screening programme in primary care in Ireland: an implementation study protocol.

INTRODUCTION: Atrial fibrillation (AF) is a major risk factor for stroke. There is a fivefold increase in stroke risk in the presence of AF. The irregular beating of the heart enables blood stasis which allows clots to form. These can migrate to the brain causing a stroke. AF is common and its incidence increases with age. AF is often asymptomatic and early detection enables effective preventive treatment reducing stroke risk by up to two-thirds.Stroke contributes significantly to morbidity and mortality globally. In Ireland, it is the leading cause of acquired disability and second leading cause of death. The cost associated with stroke is significant. Stroke risk increases with age and is a public health priority.Internationally, there is consensus among experts that AF screening is valuable. In Ireland, the National Cardiovascular Policy recommended establishing a screening programme. However, there are many ways to screen for AF including pulse palpation, mobile ECG devices, 12-lead ECG and personal health monitoring devices.This study aims to investigate the acceptability, feasibility and impact of AF screening in primary care using a handheld mobile ECG device. METHODS AND ANALYSIS: General practitioners (GPs) and practice nurses in the South of Ireland will opportunistically screen patients aged ≥65 years for AF at routine consultation using a handheld one-lead ECG device, KardiaMobile. This study will screen up to 4000 patients. Blood pressure and smoking status will be checked concurrently. A mixed-method evaluation will be undertaken including a partial economic evaluation. Anonymised data will be collected from participating practices and qualitative interviews will be conducted with GP, nurse and patient participants. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Clinical Research Ethics Committee in University College Cork. Dissemination will involve publication in peer-reviewed journals and presentation at national and international conferences.

Economic evaluation of the Happy Talk pilot effectiveness trial: A targeted selective speech, language and communication intervention for children from areas of social disadvantage.

Purpose: This study presents a cost-effectiveness analysis of a targeted selective pre-school intervention programme, "Happy Talk", which focuses on language development, by simultaneously enhancing parental interaction and the pre-school environment.Method: Happy Talk (delivered to 77 children) is an add on intervention, and is compared to usual care, adopting a healthcare perspective. Cost-effectiveness analyses were carried out using the Pre-school Language Scale 5- Total (PLS-5) for baseline analysis and the Child Health Utility Instrument (CHU9D) in a secondary analysis.Result: Baseline cost-effectiveness analysis showed Happy Talk was more effective (6.3 point change in total PLS-5 standard score - effect size 0.463SD and more expensive (€82.06) than usual care (cost-effectiveness ratio is €13.02 per unit change). Employing a proxy to estimate monetary net benefit, the benefits outweigh the costs, showing that it is cost-effective. However, results do not persist when health-related quality of life outcome measures are considered.Conclusion: Findings suggest a targeted selective public health approach, could be considered value for money to reduce the societal burden of children with low levels of speech, language and communication. However, measurement of longer term outcomes and a larger trial are required, to definitively inform policy changes.

Assessing direct healthcare costs when restricted to self-reported data: a scoping review.

BACKGROUND: In the absence of electronic health records, analysis of direct healthcare costs often relies on resource utilisation data collected from patient-reported surveys. This scoping review explored the availability, use and methodological details of self-reported healthcare service utilisation and cost data to assess healthcare costs in Ireland. METHODS: Population health surveys were identified from Irish data repositories and details were collated in an inventory to inform the literature search. Irish cost studies published in peer-reviewed and grey sources from 2009 to 2019 were included if they used self-reported data on healthcare utilisation or cost. Two independent researchers extracted studies' details and the PRISMA-ScR guidelines were used for reporting. RESULTS: In total, 27 surveys were identified containing varying details of healthcare utilisation/cost, health status, demographic characteristics and health-related risk and behaviour. Of those surveys, 21 were general population surveys and six were study-specific ad-hoc surveys. Furthermore, 14 cost studies were identified which used retrospective self-reported data on healthcare utilisation or cost from ten of the identified surveys. Nine of these cost studies used ad-hoc surveys and five used data from pre-existing population surveys. Compared to population surveys, ad-hoc surveys contained more detailed information on resource use, albeit with smaller sample sizes. Recall periods ranged from 1 week for frequently used services to 1 year for rarer service use, or longer for once-off costs. A range of perspectives (societal, healthcare and public sector) and costing approaches (bottom-up costing and a mix of top-down and bottom-up) were used. The majority of studies (n = 11) determined unit prices using multiple sources, including national healthcare tariffs, literature and expert views. Moreover, most studies (n = 13) reported limitations concerning data availability, risk of bias and generalisability. Various sampling, data collection and analysis strategies were employed to minimise these. CONCLUSION: Population surveys can aid cost assessments in jurisdictions that lack electronic health records, unique patient identifiers and data interoperability. To increase utilisation, researchers wanting to conduct cost analyses need to be aware of and have access to existing data sources. Future population surveys should be designed to address reported limitations and capture comprehensive health-related, demographic and resource use data.

Estimating the economic cost of nurse sensitive adverse events amongst patients in medical and surgical settings.

AIMS: To identify the costs associated with nurse sensitive adverse events and the impact of these events on patients' length of stay. DESIGN: Retrospective cohort study using administrative hospital data. METHODS: Data were sourced from patient discharge information (N = 5544) from six acute wards within three hospitals (July 2016-October 2017). A retrospective patient record review was undertaken by extracting data from the hospitals' administrative systems on inpatient discharges, length of stay and diagnoses; eleven adverse events sensitive to nurse staffing were identified within the administrative system. A negative binomial regression is employed to assess the impact of nurse sensitive adverse events on length of stay. RESULTS: Sixteen per cent of the sample (n = 897) had at least one nurse sensitive adverse event during their episode of care. The model revealed when age, gender, admission type and complexity are controlled for, each additional nurse sensitive adverse event experienced by a patient was associated with an increase in the length of stay beyond the national average by 0.48 days (p = .001). Applying this to the daily average cost of inpatient stay per patient (€1456), we estimate the average cost associated with each nurse sensitive adverse event to be €694. Extrapolating this nationally, the economic cost of nurse sensitive adverse events to the health service in Ireland is estimated to be €91.3 million annually. CONCLUSION: These potentially avoidable events are associated with a significant economic burden to health systems. The estimates provided here can be used to inform and prepare the way for future economic evaluations of nurse staffing initiatives that aim to improve care and safety. IMPACT: As many of these nurse sensitive adverse events are avoidable, in addition to patient benefits, there is a potential substantial financial return on investment from strategies such as improved nurse staffing that can reduce their occurrence.

A micro costing analysis of the development of a primary care intervention to improve the uptake of diabetic retinopathy screening.

BACKGROUND: The application of economic analysis within implementation science is still developing and the cost of intervention development, which differs markedly from the costs of initial implementation and maintenance, is often overlooked. Our aim was to retrospectively cost the development of a multifaceted intervention in primary care to improve attendance at diabetic retinopathy screening. METHODS: A retrospective micro costing of developing the intervention from the research funder perspective was conducted. It was based on a systematic intervention development process involving analysis of existing audit data and interviews with patients and healthcare professionals (HCPs), conducting consensus meetings with patients and HCPs, and using these data together with a rapid review of the effectiveness of interventions, to inform the final intervention. Both direct (non-personnel, e.g. travel, stationary, room hire) and indirect (personnel) costs were included. Data sources included researcher time logs, payroll data, salary scales, an online financial management system, invoices and purchase orders. Personnel involved in the intervention development were consulted to determine the activities they conducted and the duration of their involvement. Sensitivity and scenario analyses were conducted to estimate uncertainty around parameters and scope. RESULTS: The total cost of intervention development (July 2014-January 2019) was €40,485 of which 78% were indirect (personnel) costs (€31,451). In total, personnel contributed 1368 h to intervention development. Highest cost activities were the patient interviews, and consensus process, contributing 23% and 34% of the total cost. Varying estimated time spent on intervention development activities by + 10% increased total intervention development cost by 6% to €42,982. CONCLUSIONS: Our results highlight that intervention development requires a significant amount of human capital input, combining research experience, patient and public experience, and expert knowledge in relevant fields. The time committed to intervention development is critical but has a significant opportunity cost. With limited resources for research on developing and implementing interventions, capturing intervention development costs and incorporating them as part of assessment of cost-effective interventions, could inform research priority and resource allocation decisions.

A cost analysis of a community-based support centre for cancer patients and their families in Ireland: the EVeCANs study.

Cancer patients and their families experience a range of physical, psychological and financial adverse effects. Community-based cancer centres offer a range of services and interventions, free of charge, to support those affected by cancer. While shown to be effective, there is a lack of information on the costs of these services. Our aim was to estimate the resource impact of a community-based cancer support centre. Over a 7-month period, there were 2032 contacts with 238 clients whose average age was 60 years. The most frequently used services were transport to treatment (20%), complementary therapies (48%), exercise classes (10%) and counselling (9%). This cost analysis estimated total annual cost to provide all services was €313,744. Average annual cost per person was €1138. Current uptake at the centre represents 8% of all cancer incidences in seven counties surrounding the centre. If uptake increases by 10%, scenario analyses predict an increase in total costs increase to €429,043 and a decrease in costs per patient to €915. As cancer incidences increase, the need for supportive care is growing. Community-based services have been established to meet these needs and fill this gap in national health services. Long-term sustainability of these centres is uncertain as they are entirely reliant on donations and volunteers. This analysis estimates the costs of one such community-based cancer support centre, for the first time in Ireland. Findings can be used to inform future planning of cancer supportive care services, including establishing links between tertiary and community-based centres, and cost effectiveness analyses, nationally and internationally.

A two-tiered public-private health system: Who stays in (private) hospitals in Ireland?

Despite efforts to create a universal, single-tiered Irish health system, an unequal "two-tiered" system persists. The future blueprint for Irish health care, Sláintecare, recommends a separation of public and private hospital treatment. This study examines patterns of overall and private hospital utilisation in Ireland that could help identify some of the impacts of the proposed separation of public and private hospital treatment. Using data from EU-SILC (2016) (n = 10,131) the factors associated with inpatient hospitalisation and private inpatient hospitalisation are estimated using probit models. Unsurprisingly, those who are economically inactive are more likely to have had an inpatient stay. Furthermore, those aged over 65, with a chronic illness, with a medical/ GP visit card and private health insurance and those with only private health insurance are also more likely to have had an inpatient stay. Those with only primary education are less likely to report an inpatient stay in private hospital. Those aged over 25 and less than 65, those with a medical/ GP visit card and private health insurance and those with only private health insurance are significantly more likely to opt for a private hospital. Understanding overall and private hospital utilisation patterns is imperative for implementing universal health care and associated resource planning and fulfilling policy recommendations.

Feasibility of an implementation intervention to increase attendance at diabetic retinopathy screening: protocol for a cluster randomised pilot trial.

BACKGROUND: Diabetic retinopathy screening (DRS) leads to the earlier detection of retinopathy and treatment that can prevent or delay the development of diabetes-related blindness. However, uptake continues to be sub-optimal in many countries, including Ireland. Routine management of type 2 diabetes largely takes place in primary care. As such, there may be an opportunity in primary care to introduce interventions to improve DRS uptake. However, few studies test the feasibility of interventions to enhance DRS uptake in this context. Our aim is to investigate the feasibility of an implementation intervention (IDEAs (Improving Diabetes Eye screening Attendance)) delivered in general practice to improve the uptake of the national DRS programme, RetinaScreen. METHODS: The IDEAs study is a cluster randomised pilot trial with an embedded process evaluation and economic evaluation. Following stratification by practice size, eight general practices (clusters) will be randomly allocated to intervention (n = 4) or wait-list control groups (n = 4). The intervention will be delivered for 6 months, after which, it will be administered to wait-list control practices. The intervention is multi-faceted and comprises provider-level components (training, audit and feedback, health care professional prompt, reimbursement) and patient-level components (GP-endorsed reminder with information leaflet delivered opportunistically face-to-face, and systematically by phone and letter). Patient inclusion criteria are type 1 or type 2 diabetes and DRS programme non-attendance. A multi-method approach will be used to determine screening uptake, evaluate the trial and study procedures and examine the acceptability and feasibility of the intervention from staff and patient perspectives. Quantitative and qualitative data will be collected on intervention uptake and delivery, research processes and outcomes. Data will be collected at the practice, health professional and patient level. A partial economic evaluation will be conducted to estimate the cost of delivering the implementation intervention in general practice. Formal continuation criteria will be used to determine whether IDEAs should progress to a definitive trial. DISCUSSION: Findings will determine whether IDEAsis feasible and acceptable and will be used to refine the intervention and study procedures. A definitive trial will determine whether IDEAs is a cost-effective intervention to improve DRS uptake and reduce diabetes-related blindness. TRIAL REGISTRATION: ClinicalTrials.gov NCT03901898. Registered 3rd April 2019.

Development of an intervention to facilitate implementation and uptake of diabetic retinopathy screening.

BACKGROUND: 'Implementation interventions' refer to methods used to enhance the adoption and implementation of clinical interventions such as diabetic retinopathy screening (DRS). DRS is effective, yet uptake is often suboptimal. Despite most routine management taking place in primary care and the central role of health care professionals (HCP) in referring to DRS, few interventions have been developed for primary care. We aimed to develop a multifaceted intervention targeting both professionals and patients to improve DRS uptake as an example of a systematic development process combining theory, stakeholder involvement, and evidence. METHODS: First, we identified target behaviours through an audit in primary care of screening attendance. Second, we interviewed patients (n = 47) and HCP (n = 30), to identify determinants of uptake using the Theoretical Domains Framework, mapping these to behaviour change techniques (BCTs) to develop intervention content. Thirdly, we conducted semi-structured consensus groups with stakeholders, specifically users of the intervention, i.e. patients (n = 15) and HCPs (n = 16), regarding the feasibility, acceptability, and local relevance of selected BCTs and potential delivery modes. We consulted representatives from the national DRS programme to check intervention 'fit' with existing processes. We applied the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects, and equity) to select the final intervention components, drawing on findings from the previous steps, and a rapid evidence review of operationalised BCT effectiveness. RESULTS: We identified potentially modifiable target behaviours at the patient (consent, attendance) and professional (registration) level. Patient barriers to consent/attendance included confusion between screening and routine eye checks, and fear of a negative result. Enablers included a recommendation from friends/family or professionals and recognising screening importance. Professional barriers to registration included the time to register patients and a lack of readily available information on uptake in their local area/practice. Most operationalised BCTs were acceptable to patients and HCPs while the response to feasibility varied. After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients. CONCLUSIONS: Using the example of an intervention to improve DRS uptake, this study illustrates an approach to integrate theory with user involvement. This process highlighted tensions between theory-informed and stakeholder suggestions, and the need to apply the Theoretical Domains Framework (TDF)/BCT structure flexibly. The final intervention draws on the trusted professional-patient relationship, leveraging existing services to enhance implementation of the DRS programme. Intervention feasibility in primary care will be evaluated in a randomised cluster pilot trial.

A cost-effectiveness analysis of dialectical behaviour therapy for treating individuals with borderline personality disorder in the community.

BACKGROUND/AIMS: This paper investigates the cost-effectiveness of dialectical behaviour therapy (DBT) for treating individuals with borderline personality disorder (BPD) in a community setting in Ireland, in the short term. METHODS: Resource utilisation and effectiveness data were collected as part of the National DBT Project, Ireland, and are incorporated into a cost-effectiveness analysis. The perspective taken was that of the service provider and payer. Direct health resources were included and effectiveness was measured using the EQ-5D-5L questionnaire. To examine cost-effectiveness, incremental costs are compared with incremental quality-adjusted life years, to estimate an incremental cost-effectiveness ratio. A probabilistic sensitivity analysis was employed to investigate parameter uncertainty. Scenario analyses are employed to investigate cost-effectiveness of DBT with varying assumptions around effectiveness and costs. RESULTS: The baseline analysis reveals that DBT is more expensive and more effective than routine clinical care (without DBT). The low incremental cost-effectiveness ratio suggests DBT can be considered cost effective in the short term. In each scenario analyses considered, the probability that DBT is cost effective is greater than 50%. CONCLUSIONS: Mental health care provision, including that of DBT, varies across jurisdictions, necessitating economic evaluations of current practice in community-based services, on a country-by-country basis, to inform resource allocation decisions. In line with previous research, the analysis here indicates DBT can be considered cost effective in the short term. Future data collection on alternative comparators and long-term outcomes associated with DBT is warranted to investigate the longer term cost-effectiveness of DBT.

To HTA or Not to HTA: Identifying the Factors Influencing the Rapid Review Outcome in Ireland.

OBJECTIVES: Reimbursement systems are evolving and endeavor to balance access and affordability. One such evolution in Ireland is the compulsory rapid review (RR) process, the outcome from which is a recommendation for a health technology assessment (HTA) or no HTA. For drugs that avoid an HTA, evaluation times are shorter, lengthy price negotiations are avoided, and access is faster. In the absence of formal decision-making criteria around the requirement of an HTA, this study examines the factors influencing the outcome of the RR process in Ireland. METHODS: A database was developed combining data from publicly available sources for drug evaluations conducted by the National Centre for PharmacoEconomics (NCPE) (January 2010-June 2017, n = 296). Because Irish cost data were not publicly available for all drugs, cost data from the Scottish Medicines Consortium were employed as a proxy. Employing logistic regressions, the factors influencing the RR outcome are revealed. RESULTS: After an RR, an HTA was recommended for 55% of drugs. The regression results revealed therapeutic area (endocrine, musculoskeletal, and neoplasm), first-in-class and orphan disease increased the probability of an HTA. Furthermore, when proxy costs were included, results revealed that every €1000 increase in annual drug costs per patient increased the probability of an HTA being required by 1% and that an HTA was more likely than no HTA when annual drug costs exceeded €15 000. CONCLUSION: Given the current focus on access and affordability, this study identifies the factors influencing the requirement of an HTA in Ireland.

PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol.

INTRODUCTION: Women presenting with suspected pre-eclampsia are currently triaged on the basis of hypertension and dipstick proteinuria. This may result in significant false positive and negative diagnoses resulting in increased morbidity or unnecessary intervention. Recent data suggest that placental growth factor testing may be a useful adjunct in the management of women presenting with preterm pre-eclampsia. The primary objective of this trial is to determine if the addition of placental growth factor testing to the current clinical assessment of women with suspected preterm pre-eclampsia, is beneficial for both mothers and babies. METHODS AND ANALYSIS: This is a multicentre, stepped wedge cluster, randomised trial aiming to recruit 4000 women presenting with symptoms suggestive of preterm pre-eclampsia between 20 and 36+6 weeks' gestation. The intervention of an unblinded point of care test, performed at enrolment, will quantify maternal levels of circulating plasma placental growth factor. The intervention will be rolled out sequentially, based on randomisation, in the seven largest maternity units on the island of Ireland. Primary outcome is a composite outcome of maternal morbidity (derived from the modified fullPIERS model). To ensure we are not reducing maternal morbidity at the expense of earlier delivery and worse neonatal outcomes, we have established a co-primary outcome which will examine the effect of the intervention on neonatal morbidity, assessed using a composite neonatal score. Secondary analyses will examine further clinical outcomes (such as mode of delivery, antenatal detection of growth restriction and use of antihypertensive agents) as well as a health economic analysis, of incorporation of placental growth factor testing into routine care. ETHICS AND DISSEMINATION: Ethical approval has been granted from each of the seven maternity hospitals involved in the trial. The results of the trial will be presented both nationally and internationally at conference and published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02881073.

Have bailouts shifted the burden of paying for healthcare from the state onto individuals?

BACKGROUND/AIMS: The financial crisis that enveloped Europe in 2009 created financial pressure for governments and required a number of countries to obtain a financial bailout from the IMF. The purpose of this paper is to examine the effect of the financial crisis on public health expenditure in bailout countries and if bailouts shift the burden of paying for healthcare from the state onto individuals. METHODS: Quantitative health expenditure data were collected from the WHO and OECD for the period 2004-2015 and evaluated using a comparison of means Welch's t test. RESULTS: The majority of bailout countries recorded a decrease in public health expenditure as a percentage of total government expenditure, with Ireland recording the largest decrease with government health expenditure as a percentage of total government expenditure, falling by 22% (P < .01). In addition, the results also suggest that the burden of paying for healthcare shifted from the state onto individuals in three countries, namely Hungary, Ireland and Portugal, where public health expenditure declined and private expenditure increased significantly. CONCLUSIONS: The ramifications of shifting the burden of paying for healthcare from the state onto individuals at this point remain unclear with further research required to identify the long-term consequences for healthcare.