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OBJECTIVE: A pressure ulcer (PU) develops initially at the cellular level, progressing through damage to subepidermal cells and surrounding tissues before it becomes visible on the surface of the skin. Changes in subepidermal moisture (SEM) are a biomarker for the early stages of PU development. The objective of this study was to evaluate the cost-effectiveness of adding measurement of SEM to current standard of care (SoC), with the aim of reducing the incidence of hospital-acquired pressure ulcers (HAPUs).
METHOD: A decision-tree model was developed. Outcomes were the incidence of HAPUs, quality-adjusted life-years (QALYs) and costs to the UK National Health Service (NHS) at 2022/23 prices. The effects of parameter uncertainty were tested in univariate and probabilistic sensitivity analysis.
RESULTS: In a typical NHS acute hospital with 480 beds, the addition of SEM assessment as an adjunct to SoC is expected to reduce the incidence of HAPUs by 32.9% and lead to a cost saving of £26.53 per admission. The probability that adjunctive SEM is cost-effective at a threshold of £30,000 per QALY is 69%.
CONCLUSION: SEM assessments make it possible to implement early and anatomy-specific interventions which can improve the effectiveness of PU prevention and reduce healthcare costs.
OBJECTIVES: The objective of this paper is to present the Environmental Sustainability in Health Technology Assessment (ESHTA) Working Group’s (WG’s) opinion on the definition and scope of early Health Technology Assessment (HTA) developed by a WG under HTA International. The aim is to provide suggestions on how early HTA can support the goals of enhancing environmental sustainability in healthcare.
METHODS: The HTAi ESHTA WG presents our opinion on the proposed definition and scope of early HTA. This includes a broad range of perspectives from stakeholder groups including patient experts, a policy maker, a statistician, HTA researchers and a healthcare professional, located across lower to higher resource settings and several jurisdictions. We suggest how early HTA can support the goals of enhancing environmental sustainability in healthcare.
RESULTS: HTA agencies play a crucial role in embedding sustainability into their evaluations and practices. Integrating environmental sustainability into HTA at three critical stages – product conceptualization, reimbursement decisions, and point of care – can optimize resource use and reduce environmental impacts. Developing sustainability metrics, defining environmental impact categories, and identifying suitable methods for assessing health technologies are essential steps. Early engagement is also vital for optimizing trade-offs and increasing acceptance by diverse stakeholders.
CONCLUSIONS: Incorporating environmental sustainability into early HTA can enhance the likelihood of regulatory approval and reimbursement, ultimately benefiting patients and healthcare systems. By integrating sustainability considerations at the design stage, the potential for environmental impact reduction is maximized. Future efforts should focus on developing comprehensive guidelines and methods, ensuring collaboration between early HTA and ESHTA WGs.
BACKGROUND: Non-inferiority and clinical equivalence clinical trials can be used to determine whether a health technology is no worse than an existing treatment. This study identified international guidance for conducting non-inferiority and clinical equivalence trials and investigated the current practices in conducting and reporting such trials, especially in the context of Health Technology Assessment (HTA).
METHODS: A pragmatic approach was used to identify international guidelines and published literature reporting approaches for the conduct and reporting of non-inferiority or clinical equivalence studies. Guidelines from both HTA and regulatory bodies were considered, and literature reviews from 2010 to 2023 were identified. The results of the reviews were supplemented by stakeholder interviews and synthesised to form a series of recommendations for the UK National Institute for Health and Care Excellence in the appraisal of non-inferiority and equivalence trials.
RESULTS AND CONCLUSION: The majority of guidelines (13/15) discussed methods to determine the non-inferiority margin and how the analysis should be conducted. Despite this, the quality of reporting in non-inferiority and clinical equivalence trials is consistently poor. Prior to presentation of trial evidence, HTA submissions that claim non-inferiority or equivalence should present the technical, biological and/or pharmacokinetic reasonings that support the claim.
The dynamic nature of infectious diseases introduces inherent challenges to the design of vaccine clinical trials, which consequently makes vaccine indirect treatment comparisons (ITCs) and meta-analyses (MAs) more challenging compared with regular pharmaceuticals. However, comparisons of efficacy and safety between vaccines are being frequently required in vaccine decision making due to a low number of head-to-head clinical trials in the vaccine landscape. The introduction of the European Union Health Technology Assessment (HTA) Regulation (EU HTAR) aims to harmonize HTA efforts across Europe. However, the EU HTAR could also escalate existing challenges for conducting vaccine MAs and ITCs. Such challenges include generating efficacy evidence in time for Joint Clinical Assessment (JCA), incorporating high levels of heterogeneity due to infectious disease-specific characteristics, and tackling a high number of PICOs per submission—likely driven by heterogeneity in the available data and differences in national vaccine calendars. Opportunities to tackle these challenges include introducing a stepwise approach to vaccine assessment in JCA, best-practice recommendations for conducting/interpreting vaccine MAs and ITCs, and condensing the number of PICOs to create larger ‘catch-all’ ITC networks. This perspective article explores these challenges and opportunities further.
No abstract available
BACKGROUND: People with stomas report a substantial negative impact of stomal effluent leaking outside the ostomy baseplate and subsequent complications in their professional and social lives, causing immense worry. However, many patients are not able to recognize leakages in a timely manner. We conducted a cost-effectiveness study to evaluate the impact of a digital leakage notification system (DLNS) to reduce leakages outside the baseplate (LOB) and worry about leakage for people with intestinal stomas from a UK National Health Service and Personal Social Services perspective.
METHODS: A Markov model for ostomy care was used to compare health-related quality of life and costs for adults with ileostomies or colostomies using UK standard of care ostomy products with the DLNS (intervention) or without the DLNS (comparator). The base case model used a 3-year time horizon with 1-week cycles and an annual 3.5% discounting of utilities and costs. Patients in all health states experience LOB events and/or worry about leakage as events associated with one-time utility decrements and costs of additional healthcare provider visits and ostomy product use. Probabilities of LOB (DLNS, 46.5%; comparator, 78.6%) and worry about leakage (DLNS, 39.1%; comparator, 78.6%) were based on clinical trial results. Peristomal skin complications were included in the model with the same probabilities of occurrence in the intervention and comparator arms. Sensitivity and scenario analyses were performed to test the robustness of the base case model assumptions.
RESULTS: In the base case analysis, the DLNS arm had 49.81 fewer LOB events per person than the comparator arm, resulting in 0.309 incremental quality-adjusted life-years (QALYs) and cost savings of British Pound Sterling (GBP) £1703 per person over 3 years (2023/2024 costing year). The DLNS arm had 56.98 fewer worry about leakage events per person, resulting in cost savings of £403 per person. Total costs and QALYs were £18,600 and 1.818 for the intervention arm, respectively, and £18,566 and 1.509 for the comparator arm. Overall, the DLNS provided 0.309 incremental QALYs at an incremental cost of £34 versus the comparator arm for an incremental cost-effectiveness ratio of £110/QALY gained, well below a willingness-to-pay threshold of £20,000/QALY. Sensitivity analyses showed the DLNS was cost-effective in 97.6% of simulations.
CONCLUSIONS: This analysis suggests that the DLNS added to standard of care ostomy products is a cost-effective intervention to help prevent LOB events and reduce worry about leakage for people with stomas in the UK. Results of the present study suggest that timely awareness of leakage has a positive impact on the health-related quality of life of people with stomas and on the direct costs of stoma management in the UK.
OBJECTIVES: Probabilistic sensitivity analysis (PSA) is a method to account for uncertainty in cost-effectiveness analysis. The degree of correlation between input parameters is not well reported and is often overlooked in PSA. This means PSA results could be mis-estimating uncertainty. This study aimed to develop a simple model to explore the impact of input correlation on the incremental cost-effectiveness ratio (ICER) and the reported likelihood of cost-effectiveness.
METHODS: A Markov model was developed with 3 different approaches to correlation: no correlation, partial correlation, and perfect correlation. A hypothetical case study was used to explore the impact of each correlation option on the intervention's likelihood of cost-effectiveness. Scenario analyses were also used to investigate whether the findings were consistent across different scenarios.
RESULTS: The ICER was comparable across the correlation options. In all scenarios, the no-correlation option had the most certain decision outcomes, and the perfect-correlation option had the least certain likelihood. The proximity of the ICER to the willingness-to-pay threshold influenced the impact of correlation on the PSA results.
CONCLUSION: This study suggests that the approach toward modeling parameter correlation in PSA has a substantial impact on the level of certainty in model outputs. By ignoring this, the level of certainty of cost-effectiveness could be over or underestimated. Therefore, researchers and decision makers should be careful to consider the potential impact of inter-parameter correlation.
