The Economic Impact of Introducing RefluxStop for Refractory Gastroesophageal Reflux Disease on the Italian Healthcare System.

INTRODUCTION: Gastroesophageal reflux disease (GERD) is a common ailment associated with troublesome symptoms. The standard of care in Italy involves initial treatment with proton pump inhibitor (PPI)-based medical management or laparoscopic Nissen fundoplication (LNF) for patients unwilling to continue or intolerant of long-term PPI therapy. RefluxStop is a novel medical device, intended for laparoscopic implantation, that has recently proven to be an efficacious and cost-effective treatment option for patients with GERD. This analysis aims to describe the short-term budget impact of introducing RefluxStop as a GERD treatment option within the Italian National Health Service (SSN). METHODS: A model adherent to international best practice recommendations was developed to estimate the budget impact of introducing RefluxStop over a 5-year time horizon. Two scenarios were considered: one without RefluxStop (i.e., comprising PPI therapy, LNF, and magnetic sphincter augmentation using the LINX system); and one with RefluxStop (i.e., addition of RefluxStop to the three treatment options previously mentioned). Clinical benefits and costs associated with each intervention were included in the analysis. RESULTS: Over 5 years, the introduction of RefluxStop resulted in avoidance of 95 surgical failures, 11 reoperations, and 64 endoscopic esophageal dilations. Introduction of RefluxStop resulted in an almost neutral impact on the existing budget with a 0.316% increase in the annual Italian SSN spending on GERD treatment. CONCLUSION: Introduction of RefluxStop as a GERD treatment option in Italy is likely to be associated with substantial clinical benefits and a marginal budget impact.

Cost-effectiveness of the RefluxStop device for management of refractory gastroesophageal reflux disease in Switzerland.

BACKGROUND: One of the most prevalent conditions in Western societies is gastroesophageal reflux disease (GERD). In Switzerland, the standard treatment for GERD is proton pump inhibitor (PPI)-based medical management, but surgical options such as Nissen fundoplication and magnetic sphincter augmentation (MSA) are available. RefluxStop is a novel device that offers an alternative solution. The purpose of this report is to evaluate the cost-effectiveness of RefluxStop compared to PPIs and existing surgical treatments. METHODS: A model (Markov) was developed using the Swiss healthcare payer perspective with a lifetime horizon, 1-month cycle length, and a 3% annual discount rate for costs and benefits. Adverse events specific to treatment arms were incorporated, and benefits were measured in quality-adjusted life-years (QALYs). Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Deterministic and probabilistic sensitivity analyses were used to explore uncertainty. Since there are no head-to-head studies between RefluxStop and PPI therapy, Nissen fundoplication, or MSA, a limitation of this study is the use of naïve, indirect comparison of clinical effectiveness between the studied treatment options. RESULTS: Higher QALYs and lower costs were provided by RefluxStop compared to Nissen fundoplication and the MSA system. The incremental cost-effectiveness ratio (ICER) for RefluxStop was CHF 2,116 in comparison to PPI-based medical management. At a cost-effectiveness threshold of CHF 100,000 per QALY gained, the probability of RefluxStop being cost-effective was high, with probabilities of 100%, 97%, and 100% against PPI-based medical management, Nissen fundoplication, and MSA, respectively. The robustness of the analysis was provided by deterministic and probabilistic sensitivity analyses. CONCLUSION: This cost-effectiveness analysis demonstrates that there is a high likelihood of RefluxStop being a cost-effective treatment modality in adults with GERD when compared with other treatment options available in Switzerland.

Gastroesophageal reflux disease (GERD) is one of the most prevalent conditions in Western societies. Standard treatment in Switzerland entails proton pump inhibitor (PPI)-based medical management or surgical options (i.e., Nissen fundoplication and magnetic sphincter augmentation [MSA]) in selected cases. RefluxStop is a new technology indicated for the surgical treatment of GERD that restores the normal anatomy of the anti-reflux barrier. The clinical benefits and monetary costs of RefluxStop must be weighed against available treatment options to determine the role of this new technology in Switzerland. Cost-effectiveness analyses compare the relative costs and clinical outcomes of disease management when pursuing different paths in the patient journey landscape, as measured by quality-adjusted life-years (QALYs). In the present study, RefluxStop in comparison to Nissen fundoplication, and MSA, provided higher QALYs and lower costs. Against PPI therapy, the costs were slightly higher but the QALYs were also higher, generating a favourable Incremental cost-effectiveness ratio. Furthermore, at the cost-effectiveness threshold of CHF 100,000 per QALY gained, RefluxStop was highly likely to be cost-effective in comparison to PPI therapy, Nissen fundoplication, and MSA with probabilities of 100%, 97%, and 100%, respectively. Ultimately, this cost-effectiveness analysis showed that RefluxStop has a high likelihood of cost-effectiveness as a GERD treatment in Switzerland against other treatment options, with results being robust even with uncertainties considered in additional sensitivity analyses.

Implementation strategy in collaboration with people with lived experience of mental illness to reduce stigma among primary care providers in Nepal (RESHAPE): protocol for a type 3 hybrid implementation effectiveness cluster randomized controlled trial.

BACKGROUND: There are increasing efforts for the integration of mental health services into primary care settings in low- and middle-income countries. However, commonly used approaches to train primary care providers (PCPs) may not achieve the expected outcomes for improved service delivery, as evidenced by low detection rates of mental illnesses after training. One contributor to this shortcoming is the stigma among PCPs. Implementation strategies for training PCPs that reduce stigma have the potential to improve the quality of services. DESIGN: In Nepal, a type 3 hybrid implementation-effectiveness cluster randomized controlled trial will evaluate the implementation-as-usual training for PCPs compared to an alternative implementation strategy to train PCPs, entitled Reducing Stigma among Healthcare Providers (RESHAPE). In implementation-as-usual, PCPs are trained on the World Health Organization Mental Health Gap Action Program Intervention Guide (mhGAP-IG) with trainings conducted by mental health specialists. In RESHAPE, mhGAP-IG training includes the added component of facilitation by people with lived experience of mental illness (PWLE) and their caregivers using PhotoVoice, as well as aspirational figures. The duration of PCP training is the same in both arms. Co-primary outcomes of the study are stigma among PCPs, as measured with the Social Distance Scale at 6 months post-training, and reach, a domain from the RE-AIM implementation science framework. Reach is operationalized as the accuracy of detection of mental illness in primary care facilities and will be determined by psychiatrists at 3 months after PCPs diagnose the patients. Stigma will be evaluated as a mediator of reach. Cost-effectiveness and other RE-AIM outcomes will be assessed. Twenty-four municipalities, the unit of clustering, will be randomized to either mhGAP-IG implementation-as-usual or RESHAPE arms, with approximately 76 health facilities and 216 PCPs divided equally between arms. An estimated 1100 patients will be enrolled for the evaluation of accurate diagnosis of depression, generalized anxiety disorder, psychosis, or alcohol use disorder. Masking will include PCPs, patients, and psychiatrists. DISCUSSION: This study will advance the knowledge of stigma reduction for training PCPs in partnership with PWLE. This collaborative approach to training has the potential to improve diagnostic competencies. If successful, this implementation strategy could be scaled up throughout low-resource settings to reduce the global treatment gap for mental illness. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04282915 . Date of registration: February 25, 2020.

HeAlth System StrEngThening in four sub-Saharan African countries (ASSET) to achieve high-quality, evidence-informed surgical, maternal and newborn, and primary care: protocol for pre-implementation phase studies.

To achieve universal health coverage, health system strengthening (HSS) is required to support the of delivery of high-quality care. The aim of the National Institute for Health Research Global Research Unit on HeAlth System StrEngThening in Sub-Saharan Africa (ASSET) is to address this need in a four-year programme, with three healthcare platforms involving eight work-packages. Key to effective health system strengthening (HSS) is the pre-implementation phase of research where efforts focus on applying participatory methods to embed the research programme within the existing health system. To conceptualise the approach, we provide an overview of the key methods applied across work-package to address this important phase of research conducted between 2017 and 2021.Work-packages are being undertaken in publicly funded health systems in rural and urban areas in Ethiopia, Sierra Leone, South Africa, and Zimbabwe. Stakeholders including patients and their caregivers, community representatives, clinicians, managers, administrators, and policymakers are the main research participants.In each work-package, initial activities engage stakeholders and build relationships to ensure co-production and ownership of HSSIs. A mixed-methods approach is then applied to understand and address determinants of high-quality care delivery. Methods such as situation analysis, cross-sectional surveys, interviews and focus group discussions are adopted to each work-package aim and context. At the end of the pre-implementation phase, findings are disseminated using focus group discussions and participatory Theory of Change workshops where stakeholders from each work package use findings to select HSSIs and develop a programme theory.ASSET places a strong emphasis of the pre-implementation phase in order to provide an in-depth and systematic diagnosis of the existing heath system functioning, needs for strengthening and stakeholder engagement. This common approach will inform the design and evaluation of the HSSIs to increase effectiveness across work packages and contexts, to better understand what works, for whom, and how.

Implementation science protocol for a participatory, theory-informed implementation research programme in the context of health system strengthening in sub-Saharan Africa (ASSET-ImplementER).

OBJECTIVES: ASSET (Health System Strengthening in sub-Saharan Africa) is a health system strengthening (HSS) programme involving eight work-packages (ie, a research study that addresses a specific need for HSS) that aims to develop solutions that support high-quality care. Here we present the protocol for the implementation science (IS) theme within ASSET (ASSET-ImplmentER) that aims to understand what HSS interventions work, for whom and how, and how IS methodologies can be adapted to improve the HSS interventions within resource-poor contexts. SETTINGS: Publicly funded health facilities in rural and urban areas in in Ethiopia, South Africa, Sierra Leone, and Zimbabwe. PARTICIPANTS: Research staff including principal investigators, coinvestigators, field staff, PhD students, and research assistants. INTERVENTIONS: Work-packages use a mixed-methods effectiveness-effectiveness hybrid designs. At the end of the pre-implementation phase, a workshop is held whereby the IS theme, jointly with ASSET work-packages apply IS determinant frameworks to research findings to identify factors that influence the effectiveness of delivering evidence-informed care. Determinants are used to select a set of HSS interventions for further evaluation, where work-packages also theorise selective mechanisms.In the piloting and rolling implementation phase, work-packages pilot the HSS interventions. An iterative process then begins involving evaluation, reflection and adaptation. Throughout this phase, IS determinant frameworks are applied to monitor and identify barriers/enablers to implementation. Selective mechanisms of action are also investigated. Implementation outcomes are evaluated using qualitative and quantitative methods. The psychometric properties of outcome measures including acceptability, appropriateness and feasibility are also evaluated. In a final workshop, work-packages come together, to reflect and explore the utility of the selected IS methods and provide suggestions for future use.Structured templates are used to organise and analyse common and heterogeneous patterns across work-packages. Qualitative data are analysed using thematic analysis and quantitative data are analysed using means and proportions. CONCLUSIONS: We use a novel combination of IS methods at a programmatic level to facilitate comparisons of determinants and mechanisms that influence the effectiveness of HSS interventions in achieving implementation outcomes across different contexts. The study also contributes conceptual development and clarification at the underdeveloped interface of IS, HSS and global health.The ASSET-ImplementER theme is considered minimal risk as we only interview researchers involved in the different work-packages. To this effect we have received approval from King's College London Ethics Committee for research that is considered minimal risk (Reference number: MRA-20/21-21772).

Selective dorsal rhizotomy; evidence on cost-effectiveness from England.

OBJECTIVES: Selective dorsal rhizotomy (SDR) has gained interest as an intervention to reduce spasticity and pain, and improve quality of life and mobility in children with cerebral palsy mainly affecting the legs (diplegia). We evaluated the cost-effectiveness of SDR in England. METHODS: Cost-effectiveness was quantified with respect to Gross Motor Function Measure (GMFM-66) and the pain dimension of the Cerebral Palsy Quality of Life questionnaire for Children (CPQOL-Child). Data on outcomes following SDR over two years were drawn from a national evaluation in England which included 137 children, mean age 6.6 years at surgery. The incremental impact of SDR on GMFM-66 was determined through comparison with data from a historic Canadian cohort not undergoing SDR. Another single centre provided data on hospital care over ten years for 15 children undergoing SDR at a mean age of 7.0 years, and a comparable cohort managed without SDR. The incremental impact of SDR on pain was determined using a before and after comparison using data from the national evaluation. Missing data were imputed using multiple imputation. Incremental costs of SDR were determined as the difference in costs over 5 years for the patients undergoing SDR and those managed without SDR. Uncertainty was quantified using bootstrapping and reported as the cost-effectiveness acceptability curve. RESULTS: In the base case, the incremental cost-effectiveness ratios (ICERs) for SDR are £1,382 and £903 with respect to a unit improvement in GMFM-66 and the pain dimension of CPQOL-Child, respectively. Inclusion of data to 10 years indicates SDR is cheaper than management without SDR. Incremental costs and ICERs for SDR rose in sensitivity analysis applying an alternative regression model to cost data. CONCLUSIONS: Data on outcomes from a large observational study of SDR and long-term cost data on children who did and did not receive SDR indicates SDR is cost-effective.

Cost-effectiveness of staffing levels on conflict and containment on psychiatric wards in England.

WHAT IS KNOWN ON THE SUBJECT?: Literature on staffing levels and outcomes in psychiatric wards is limited and shows mixed associations Lack of economic evidence on conflicts and containment in psychiatric care Data from the City-128 study showed that regular qualified nurse staffing levels in the preceding shifts were associated with raised conflict and containment levels WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE?: This is the first economic analysis using the City-128 data, with costs and outcomes data have been combined. Cost-effectiveness of different staffing levels in relation to conflicts and containments in England, using data from the City-128 study Both day and night shifts appeared to show that the low staff scenario was cost-effective in terms of conflicts and containment averted, even after attempts were made to adjust for patient severity WHAT ARE THE IMPLICATIONS FOR PRACTICE?: This paper could be an indication towards further investigation into how mental health inpatient care, specially nursing is organized in England. Abstract Introduction Evidence from City-128 study shows a positive association between staffing levels and conflicts/containment. Economic evidence on this topic is scarce, with no economic analyses combining costs and outcomes. Aim/Question To assess the cost-effectiveness of different staffing levels in relation to conflicts and containments in England, using City-128 study data. Methods Shifts were grouped into three groups based on staff-to-bed ratio. Cost information was combined with total conflicts and containment measures to assess cost-effectiveness. Results The cost-effectiveness analysis of the three staffing scenarios for both day and night shifts appeared to show that the low staff scenario was cost-effective in terms of conflicts and containment averted, even adjusting for patient severity. A production function analysis also revealed that increased staff numbers were associated with higher numbers of events. Discussion Causation cannot be attributed and neither can recommendations be made on optimal staffing levels. The impact on other outcomes such as symptoms, functioning and length of stay, and other factors should be explored, and these may all benefit from increased staff numbers. Implications for practice These results indicate that increasing staff numbers may not necessarily improve conflict and containment outcomes. They may produce positive outcomes in other domains.

The Cost-Effectiveness of the Improving Access to Psychological Therapies (IAPT) Programme in Severe Mental Illness: A Decision Analytical Model Using Routine Data.

This is the first site level economic evaluation of the Improving Access to Psychological Therapies programme for severe mental illness (IAPT-SMI) that is funded by NHS England. It also aims to illustrate the challenges involved in evaluations based on routine data with low internal validity. Six IAPT-SMI pilot sites treated 1 of 2 clinical groups: (i) psychosis or bipolar disorder; (ii) personality disorder. A decision analytical model nested in a before-after framework- the same patients 12 months after treatment versus 12 months before treatment-was used to compare the cost-effectiveness of IAPT-SMI with treatment as usual (TAU). IAPT-SMI appears to be more costly overall but save non-psychological treatment costs. There is evidence it may improve function and lower incidence of harmful behaviour. However, there is a need for evaluations with a more conventional study design that measure a more comprehensive array of resource use and clinical outcomes.