Abstract

BACKGROUND: Single use health technologies are known to be approximately 50% more environmentally harmful than their reusable equivalent [1-3]. This novel pilot study was undertaken for the Scottish Health Technologies Group (SHTG) and is the first UK published parallel assessment alongside a cost effectiveness evaluation [4]. The aim of this research was to use hybrid and innovative methodological approach to evaluate environmental impact, utilising established multidisciplinary methods, in conjunction with HTA principles.

METHODS: Through the application of environmental management principles and reporting, the Greenhouse Gas (GHG) Protocols [5], ISO14040 [6] and Publicly Available Specification (PAS) 2050 [7] were applied in combination with overarching HTA principles. An environmental life cycle assessment (LCA) of single use rhinolaryngoscopes was compared with a reusable equivalent. A hybrid approach was used to collect data to quantify carbon intensity including, process activity data, real world data and secondary data. Data were extrapolated to estimate national GHG emissions and waste volumes to support NHS sustainability targets. The carbon output per functional unit were categorised using thresholds based on PAS recommendations to strengthen support for the HTA decision making process. Sensitivity analyses were performed to overcome data issues. Further recommendations were made support NHS net zero targets, promoting the use of more sustainable health technologies along the healthcare pathway.

RESULTS: The carbon emissions of a single use flexible rhinolaryngoscope compared to its reusable equivalent was 6.03kgCO2e and 3.26kgCO2e respectively. The findings of the report are in line with research reporting similar carbon emissions and provide important methods for HTA. Data extrapolation (2264 procedures per annum) reveals the annual environmental impact of this technology, throughout NHS Scotland, to be 13,652kgCO2e and 7,381kgCO2e, for the single use and reusable devices, respectively. Raw material acquisition, the use of personal protective equipment and transportation were highlighted as carbon hotspots along the healthcare pathway. The estimated waste volumes are 12.58 tonnes and negligible volumes of clinical waste per annum for the single use versus reusable equivalent, respectively.

LIMITATIONS: A comparable LCA relies on a solid foundation of data. However, a high-level life cycle inventory based on good quality data was not possible for this parallel assessment, mainly attributed to the lack of access to primary data sources; influenced by a lack of regulation. Consequently, there was heavy reliance on secondary data and therefore the findings of this study may lack robustness and should be considered with caution.

IMPLICATIONS: The findings of this study support health technology environmental sustainability policy and framework development. This study recommends a hybrid methodological approach to evaluate environmental impact of health technologies. This approach supports product LCA [8] and carbon hotspot evaluation. This research also supports valuable data generation in a field nascent of research to support methodological development [9-11]. According to literature, this is the first parallel assessment as part of a HTA to be published [10]. Environmental outcomes used in the pilot study, align with government and NHS England net zero and waste reduction objectives [12]. This pilot study focuses on reporting GHG emissions. This is reasonable given that climate change and planetary health is determined largely by anthropogenic GHG emissions; fundamental for the stability of other environmental systems [13], and that national targets are focused on GHG emissions [12]. However, measuring GHG emissions and waste volumes only, can be considered a disadvantage, in that other important environmental impacts across other areas may be overlooked [1, 2, 14]. Therefore, future research should undertake a broader environmental assessment.

Abstract

This systematic review and meta-analysis was conducted to assess the randomized controlled trial (RCT) evidence available for renal denervation (RDN) in uncontrolled arterial hypertension. Twenty-five RCTs met the eligibility criteria for the systematic review, and 16 RCTs were included in the meta-analysis. The results of the random effects meta-analysis estimated a mean difference of -8.5 mmHg [95% confidence interval (CI) -13.5 to -3.6] for office SBP, -3.6 mmHg (95% CI -5.2 to -2.0) for 24 h SBP and -3.9 mmHg (95% CI -5.6 to -2.2) for ambulatory daytime SBP in favour of RDN compared with control (medication and/or sham-only) at primary follow-up. Similarly favourable results were observed across a range of prespecified subgroup analyses, including treatment-resistant hypertension. This meta-analysis suggests that the use of RDN in uncontrolled hypertension leads to consistent reductions in blood pressure. Reductions appear to be statistically consistent in the presence or absence of medications and in populations resistant to the use of three medications.

Abstract

BACKGROUND: NHS services are under considerable strain, leading to delays in treatment that can cause increased harm to patients. Urgent and emergency care (UEC) centres are at the forefront of the NHS and as such are susceptible to these system pressures. Virtual wards (VWs) have been identified as a potential tool to help ease system pressures. A VW enables patients who would otherwise be in hospital to receive acute care and treatment in their usual place of residence or other community settings. VWs can facilitate an early discharge from a hospital setting (step-down care) or provide an alternative to hospital admission (step-up care). There is some evidence supporting the safety of VWs, but further evaluation is needed in the consideration of clinical efficacy and cost-effectiveness. This research evaluates why evidence generation in the field of VWs is challenging and discusses important factors for future evaluation, with a focus on the key pathways outlined by the NHS.

METHODS: A pragmatic literature review of multiple areas of VWs was undertaken to understand the fast-moving evidence within VWs. The pragmatic literature review was focused on safety, clinical effectiveness ,and cost-effectiveness outcomes. Gap analysis was then undertaken based on the evidence identified, to understand where future evidence generation should be prioritised. This included identifying the issues with generating evidence for VWs. The authors had previously led an early value assessment (EVA) for NICE as part of their role as an external assessment group, which involved patient and clinical engagement. The specific EVA was focussed on VW for acute respiratory infection. The authors used this experience to help inform the pragmatic searches and key areas for gap analysis.

RESULTS: The evidence base for VWs suggests that they are potentially safe and effective, although, the evidence is limited. The evidence supporting the clinical effectiveness of VWs varies between the patient cohort analysed and whether the ward provides step-up, step-down or mixed model care. Most evidence identified was non-comparative, or underpowered to capture some of the relevant outcomes. Case studies were reported for VWs implementation in the NHS in England. However, these studies lacked peer review, involved small sample sizes and lacked transparency surrounding the costing of VWs. Key issues were identified with the evaluation of VW, including the consideration of varying components which make up a tech-enabled VW, a lack of comparison to manual forms of a VW, accounting for different populations and subgroups associated with the use of VWs, and how a VW may distort the population when compared with standard care. Key areas for future evidence generation included prospective cohort studies to better understand clinical and resource use outcomes, identifying the impact of differences in VW features, as well as studies which can identify the true resource use associated with implementing and running a VW.

IMPLICATIONS & LIMITATIONS: Technology-enabled VWs are complex care systems. There is some evidence that they may provide resource benefits to the NHS. However, unless they are appropriately evaluated, we may not understand the true clinical efficacy, safety risks and costs associated with VW implementation. This is especially pertinent given the rapid expansion of VW facilities across the NHS. Future evaluation will be key to determine whether VWs are an effective alternative to hospital care, the features that may drive this effectiveness, and how these features could be harnessed to optimise effectiveness. Limitations of this research include the pragmatic nature of the review, as well as the generalisability of some of the identified evidence for VWs.

Abstract

INTRODUCTION: Health inequalities can be described as avoidable, systematic and unjust differences in health between different groups within society. This research described and evaluated potential methods to measure impacts of health inequalities that could be used in health technology assessment (HTA) in the UK. The research included recommendations for current and future policy objectives relating to incorporating health inequalities.

METHODS: A targeted literature review was conducted to identify methodological approaches used to incorporate health inequalities in HTA. Stakeholder interviews and a workshop were conducted with a range of UK stakeholders. This engagement aimed to discuss any gaps in the literature, and consider if attitudes, methods and policies were evolving at the same rate as the literature. Other aims of the engagement included the reflection of stakeholder views on health inequalities and better understanding the perspectives of decision makers.

RESULTS: Five potential methods were identified to account for health inequalities, with equity-based weighting and distributional cost-effectiveness analysis considered the most feasible of the methods for quantification. Stakeholders reiterated that a deliberative process should remain the centre of HTA. Stakeholders also raised issues such as the burden on committees, trade-offs between complexity and accessibility, and the importance of measuring the size and direction of inequality impacts. Recommendations were then produced based on these findings to better account for inequalities in HTA, highlighting the importance of combining a range of approaches.

CONCLUSIONS: Both companies and HTA agencies should be more proactive in accounting for health inequalities. Companies should be encouraged to provide quantitative analysis on health inequalities, while decision makers should be trained on new methods. Despite the recent rise in quantitative methods, qualitative methods remain extremely important for a 'layered' approach to considering health inequalities.

Abstract

INTRODUCTION: Environmental sustainability and its incorporation in health technology assessment (HTA) is becoming increasingly researched globally. However, this has yet to lead to a significant impact on HTA processes. This research presents a novel case study, demonstrating how available methods can deepen the understanding of evidence-based approaches to healthcare decision making and support HTA sustainability policy development.

METHODS: A decision analytic model was developed for a digital health technology used to support primary care in the diagnosis and triage of musculoskeletal conditions. The model mapped the potential impact on the care pathway, capturing differences in resource use, including appointments, medications, diagnostic tests, surgical procedures and other non-pharmacological treatments. The model was populated from a UK perspective and captured both health-economic impact and carbon dioxide equivalents CO2e impact. Additional potential environmental impacts were then considered qualitatively as part of the evaluation.

RESULTS: The health economic modelling approach captures all stages of the patient care pathway and resource use demonstrating its practicality for simultaneously mapping out the carbon impacts. This methodological approach is reproducible, transparent and provides a standardised tool for use in future carbon, cost-comparison modelling. This would present decision makers with more complete information. There are some limitations to this approach, such as ambiguity regarding some carbon data estimates used, but still provides a more useful summary than no estimated quantification.

CONCLUSIONS: Adapting HTA will support wider efforts in health systems to reduce environmental impacts. This model can be practically applied to account for both cost and carbon data, facilitating a holistic and environmentally sustainable approach to decision making. As part of encouraging additional research into the environment, HTA agencies will need to provide 'incentives' for companies to undertake this additional research.

Abstract

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.