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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.
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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.
INTRODUCTION: Carbapenemase-producing Enterobacterales (CPE) are bacteria that produce carbapenemases, enzymes that destroy carbapenem antibiotics and result in carbapenem resistance. Early identification of individuals who have been colonised or infected is important to correctly implement infection prevention and control procedures. Chromogenic media culture is traditionally the most common method of screening for high-risk patients. However, there is a long wait for results, which has substantial cost and operational implications. Xpert Carba-R is a rapid molecular test that provides CPE screening results in 50 min. This study aimed to assess the cost impact of high-risk CPE screening with Xpert Carba-R compared with media culture.
METHODS: An economic model was developed using a probabilistic cost-comparison approach to estimate the costs associated with Xpert Carba-R, from a National Health Service and personal social services perspective. The model cohort was individuals at high risk of CPE colonisation and used an 8.30-day mean time horizon for all patients to cover hospitalisation time, with an extra 5.80 days added for patients that were truly colonised to cover the time they would spend in isolation (14.10-day time horizon overall). Deterministic sensitivity analysis and scenario analysis were used to determine the robustness of the findings.
RESULTS: The model found that Xpert Carba-R is cost saving compared with media culture, with incremental cost savings of £818.28 per person. Despite greater technology costs, there are cost savings associated with preventing unnecessary isolation.
CONCLUSION: The analysis found Xpert Carba-R to be cost saving compared with media culture for CPE screening in high-risk patients. The model did not explore onwards transmission or the opportunity cost of releasing isolation spaces, so the cost savings are likely to be far greater than those demonstrated in this study.
BACKGROUND: Healthcare accounts for up to 5% of worldwide carbon emissions and costs global economies an estimated $9 trillion annually. Primary care accounts for up to one-fifth of all NHS carbon emissions, with musculoskeletal (MSK) pain accounting for 14%-30% of all primary care consultations.
METHODS: A cost-carbon calculator model was used to undertake a retrospective economic and environmental analysis of resource use for non-inflammatory MSK pain primary care consulters. Data used to populate the model was derived from Electronic Health Records and patient surveys collected during The Multi-level Integrated Data for Musculoskeletal Health Intelligence and ActionS GP Study. The model was utilised to estimate the mean (with 95%CI's) cost and carbon output per MSK consulter, while also examining variations at two levels: (a) the Primary Care Network (PCN), and (b) the consulter's index MSK pain site.
RESULTS: One thousand eight hundred seventy-five individuals from 30 NHS primary care practices across 13 PCNs were eligible for EHR and survey data analysis. The mean carbon and cost output per person (over 6 months) was 46.91 kg CO2e (95% CIs; 45.02, 48.81 kg CO2e) and £182.65 (95% CIs; £178.69, £190.62), respectively, with substantial variation observed across PCNs. The resource category with the highest carbon footprint was consistently pharmacological intervention across all PCNs. Individuals who consulted for multisite/widespread pain and back pain had the highest mean carbon and cost output respectively.
CONCLUSION: This is the first study, we are aware of, that presents data on both the environmental and economic impact of the primary care of non-inflammatory MSK pain. Future work should focus on benchmarking the cost and carbon output of MSK care pathways and standardising methods that are implemented to influence sustainable practice and policy development.
