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BackgroundProject Orbis is a global initiative that aims to streamline regulatory review processes across international regulators in the USA, Canada, Australia, UK, Israel, Brazil, Singapore, and Switzerland to bring promising cancer drugs to patients earlier. We explored the clinical benefit, time to regulatory approval and health technology assessment recommendations, reimbursement outcomes, and monthly treatment prices of cancer drugs reviewed through this initiative.MethodsFor this retrospective, comparative analysis, we identified cancer drug approvals reviewed through Project Orbis in the USA, Canada, and the UK between May 1, 2019, and Nov 1, 2023. Approvals of cancer drugs reviewed Project Orbis were extracted from the Food and Drug Administration (FDA) Oncology Centre of Excellence and all other FDA approvals from the Drugs@FDA database. The co-primary outcomes were time of regulatory review, time from regulatory approval to health technology assessment recommendation (England, Scotland, and Canada), reimbursement outcomes, clinical benefit (defined as median gains in progression-free survival and overall survival) between cancer drug approvals reviewed by Project Orbis and other FDA approval processes, and monthly treatment prices. The Wilcoxon rank-sum and Fisher's Exact tests were used to examine statistical significance between approvals reviewed through Project Orbis and other FDA approvals during the same period.FindingsBetween May 1, 2019 and Nov 1, 2023, 81 (33%) of 244 cancer drugs approved by the FDA were reviewed through Project Orbis. The median overall survival gains were 4·1 months (IQR 3·3-5·1) compared with 2·7 months (2·1-3·9) for other FDA approvals. Similarly, progression-free survival gains were 2·6 months (IQR 1·7-4·9) for Project Orbis compared with 2·6 months (0·6-5·1) for other FDA approvals. Neither overall survival (p=0·11) nor progression-free survival (p=0·44) gains were significantly different between the two cohorts of approvals. Of the 14 UK Medicines and Healthcare products Regulatory Agency (MHRA) approvals reviewed by the Scottish Medicines Consortium (SMC), the agency gave positive recommendations for all 14 (100%). Of the 15 MHRA approvals reviewed by the National Institute for Health and Care Excellence (NICE), the agency gave positive recommendations for six (40%). Of the 49 approvals reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH), the agency conditionally recommended 44 (90%). The time between regulatory approval to NICE recommendation increased from a median of 137 days (IQR 102-172) in 2021 to 302 days (184-483) in 2023, SMC recommendation increased from 185 days (in 2021 for one drug only) to 368 days (IQR 313-476) in 2023, and CADTH decision increased from 97 days (in 2020 for one drug only) to 202 days (IQR 153-304) in 2023. The median monthly price of approvals reviewed through Project Orbis was US$20 000 per month (IQR 13 000-37 000).InterpretationClinical outcomes of Project Orbis were no different than other FDA approvals during the same time, and access, after a successful health technology assessment, was considerably delayed or absent, raising questions about whether Project Orbis participation translates into faster patient access to medicines with high clinical benefit and sustainable costs. Although future challenges might benefit from regulatory harmonisation, the advantages are currently unclear.FundingNone.

The transition from traditional aviation fuels to low-emission alternatives such as hydrogen is a crucial step towards a sustainable future for aviation. Conventional jet fuels substantially contribute to greenhouse gas emissions and climate change. Hydrogen fuel, especially "green" hydrogen, offers great potential for achieving full sustainability in aviation. Hybrid/electric/fuel cell technologies may be used for shorter flights, while long-range aircraft are more likely to combust hydrogen in gas turbines. Liquid hydrogen is necessary to minimize storage tank weight, but the required fuel systems are at a low technology readiness level and differ significantly from Jet A-1 systems in architecture, operation, and performance. This paper provides an in-depth review covering the development of liquid hydrogen fuel system design concepts for gas turbines since the 1950s, compares insights from key projects such as NASA studies and ENABLEH2, alongside an analysis of recent publications and patent applications, and identifies the technological advancements required for achieving zero-emission targets through hydrogen-fuelled propulsion. [Display omitted] • Review the evolution and advancements in liquid hydrogen gas turbine fuel systems. • Compare different liquid hydrogen fuel systems for aviation and aerospace applications. • Analyze 11 relevant reports/projects and 15 patents on liquid hydrogen fuel systems. • Identification of the key technical challenges to adopting liquid hydrogen as a fuel. • Potential solutions to address the challenges for next-generation aero engines. [ABSTRACT FROM AUTHOR]

Implications of industry 4.0 (I4.0) for sustainable development have gained widespread attention from the perspectives of the circular economy, triple bottom line and sustainable supply chain. Evaluation of I4.0 enabling technologies to achieve digital transformation in the photovoltaic supply chain (PVSC) considers several aspects of sustainability and uncertain information. Therefore, the present work aims to develop a new decision-making framework for identifying I4.0 enablers as the ways to achieve digital transformation in the PVSC. The present framework is developed based on the combination of generalized Dombi operators, integrated objective-subjective weighting model and the weighted sum product method under interval-valued Pythagorean fuzzy (IVPF) environment. For this purpose, firstly some generalized weighted Dombi operators and their properties are introduced to aggregate the IVPF information. Second, an integrated weighting procedure is developed by combining the objective weights through proposed interval-valued Pythagorean fuzzy entropy-based formula and subjective weights through IVPF-Pivot Pairwise relative Criteria Importance Assessment model. Further, the practicability and effectiveness of the proposed model is tested on a case study of I4.0 enablers to achieve digital transformation in the PVSC from sustainability perspective. The result shows the significance degrees of social, environmental and economic dimensions are 0.2258, 0.4947 and 0.2795, respectively and the big data and data analytics should be chosen as the most suitable choice among others for given data. At last, sensitivity and comparative analyses are discussed to illustrate the reliability and robustness of the obtained result. The study emphasizes the practical consequences of the role and use of the triple bottom line in I4.0 implementation in PVSC sectors. The findings of this study help the policymakers and managers to achieve digital transformation in the photovoltaic sustainable supply chain through I4.0 technologies. [ABSTRACT FROM AUTHOR]

The goal in personalized assessment is to best fit the needs of each individual test taker, given the assessment purposes. Design‐In‐Real‐Time (DIRTy) assessment reflects the progressive evolution in testing from a single test, to an adaptive test, to an adaptive assessment system. In this article, we lay the foundation for DIRTy assessment and illustrate how it meets the complex needs of each individual learner. The assessment framework incorporates culturally responsive assessment principles, thus making it innovative with respect to both technology and equity. Key aspects are (a) assessment building blocks called “assessment task modules” (ATMs) linked to multiple content standards and skill domains, (b) gathering information on test takers’ characteristics and preferences and using this information to improve their testing experience, and (c) selecting, modifying, and compiling ATMs to create a personalized test that best meets the needs of the testing purpose and individual test taker. [ABSTRACT FROM AUTHOR]

Background: In the general population the prevalence of adolescent idiopathic scoliosis (AIS) is 2–3%. There is growing awareness of how AIS affects the quality of life of patients. However, the extent of the societal burden AIS poses remains poorly understood. Therefore, this study aimed to determine the societal burden of AIS. Methods: A cross-sectional burden of disease study was conducted using a bottom-up, prevalence-based approach. Patients with AIS or guardians of a child diagnosed with AIS residing in the Netherlands were eligible for inclusion. The survey was distributed between June - December 2022 and was completed once by each participant. Costs were assessed using the institute for Medical Technology Assessment - Medical Consumption and Productivity Cost Questionnaires. The health-related quality of life (HRQoL) was assessed using the EuroQol 5D-5L/EuroQol 5D Youth and the Scoliosis Research Society-22 revised questionnaires. Costs and HRQoL were identified, measured, and valued. Results: Participants (n = 229) were predominantly female (92%), on average 35 years old, and were employed (65%). The societal cost for a patient with AIS in the Netherlands was €12,275 per year. The largest costs were estimated for the healthcare and productivity losses. The mean utility score for adults was 0.7 (SD 0.20). Severe pain was experienced by 10% of the adult participants and 44% reported to experience moderate pain/discomfort. Statistically significant differences between different age groups were present for the sector costs and HRQoL. Conclusions: AIS negatively impacts societal costs and the HRQoL. Reducing the burden that is posed on the productivity sector by AIS and further improving the HRQoL for AIS patients is needed. [ABSTRACT FROM AUTHOR]

Abstract\nIMPLICATIONS FOR REHABILITATIONPurpose: Occupational therapists in the Veterans Health Administration have transitioned from in-person to videoconferencing for home assessments, benefiting Veterans living in remote and rural areas. However, videoconferencing has limitations, including restricted field of view and poor video quality, affecting hazard identification accuracy. This study aims to introduce and evaluate a three-dimensional (3D) model as an alternative technology for remote home assessments.Materials and methods: We created 3D models using a 360-degree camera and mobile app. Five occupational therapists individually completed virtual training and practice sessions to familiarize themselves with using the 3D model. Each participant then conducted a remote home assessment using the 3D model and completed questionnaires, System Usability Scale (SUS), and semi-structured interviews.Results: Participants spent an average of 10 min training and practicing with the 3D model, and most reported either maintaining or gaining confidence in using it compared to before. All participants successfully completed the assessments, which took an average of 17 min. They rated the 3D model as easy to use, with an average SUS score of 78.5. Participants preferred the 3D model over videoconferencing, noting that it effectively addressed current challenges, and expressed their willingness to integrate it into clinical practice.Conclusion: This study demonstrates that 3D models offer a promising option for remote home assessments. With minimal training, occupational therapists could conduct more effective assessments. It is recommended to use 3D models for an initial understanding of the home environment before videoconferencing-based assessments to enhance the remote assessment experience for occupational therapists and clients.Integrating 3D models into remote home assessments has the potential to improve access to rehabilitation services for individuals living in remote or rural areas, ensuring they can receive timely care despite geographic barriers.The use of 3D models would enable rehabilitation professionals, such as occupational therapists, to conduct more accurate home assessments, enhancing their ability to identify environmental barriers and overcome current technical limitations with videoconferencing.With minimal training requirements, rehabilitation professionals could easily adopt 3D models into remote home assessments in clinical practices.Integrating 3D models into remote home assessments has the potential to improve access to rehabilitation services for individuals living in remote or rural areas, ensuring they can receive timely care despite geographic barriers.The use of 3D models would enable rehabilitation professionals, such as occupational therapists, to conduct more accurate home assessments, enhancing their ability to identify environmental barriers and overcome current technical limitations with videoconferencing.With minimal training requirements, rehabilitation professionals could easily adopt 3D models into remote home assessments in clinical practices. [ABSTRACT FROM AUTHOR]

Slow progress towards implementation of conventional clinical bacteriology in low resource settings and strong interest in greater speed for antimicrobial susceptibility testing (AST) more generally has focused attention on next-generation rapid AST technologies. In this Review, we systematically synthesize publications and submissions to regulatory agencies describing technologies that provide phenotypic AST faster than conventional methods. We characterize over ninety technologies in terms of underlying technical innovations, technology readiness level, extent of clinical validation, and time-to-results. This work provides a guide for technology developers and clinical microbiologists to understand the rapid phenotypic AST technology landscape, current development pipeline, and AST-specific validation milestones. Authors present a scoping review synthesizing new and upcoming technologies providing rapid phenotypic antimicrobial susceptibility testing (AST). [ABSTRACT FROM AUTHOR]

Background: Pancreatic cancer (PC) is one of the most aggressive types of cancer. Despite advances in molecular diagnostics, PC diagnosis relies on imaging technologies and morphological assessment of fine needle aspirates (FNAs). MicroRNA (miRNA) involvement in PC pathogenesis and potential diagnostics application have been suggested, albeit current supporting evidence is lacking. Here, we investigated the association of selected miRNAs with PC incidence and clinical characteristics. Methods: Fold expression of miR‐216a‐3p, ‐217‐5p, ‐221‐3p, ‐222‐3p, and miR‐196a‐5p was assessed in 73 PC FNA cell‐block sections and 6 healthy pancreas tissues using Taqman advanced miRNA assays. Potential miRNA targets were ascertained using immunocytochemistry. Results: miR‐196a‐5p was upregulated in PC compared to healthy pancreatic tissue (β = −0.05, 95% CI: −0.065 – (−0.035); p < 0.001). miR‐221‐3p and miR‐222‐3p fold expression were strongly correlated (r = 0.897, p < 0.001), whereas miR‐196a‐5p fold expression correlated with that of miR‐221‐3p (r = 0.688, p < 0.001) and miR‐222‐3p (r = 0.489, p < 0.001). Moreover, miR‐196a‐5p fold expression positively correlated with tumor stage (r = 0.32, p = 0.034). miR‐217‐5p fold expression inversely correlated with KRAS expression (r = ‐0.69, p = 0.0027). Conclusion: Our study shows miR‐196a‐5p has reasonable specificity to PC and thus may have diagnostic and prognostic potential in PC as proposed in the literature. Moreover, KRAS and NFKBIA may be potential targets for miR‐217‐5p and miR‐196a‐5p, respectively. Thus, these miRNAs may be involved in tumor progression and may have valuable applications in novel therapeutics or treatment monitoring. [ABSTRACT FROM AUTHOR]

In health technology assessment, matching‐adjusted indirect comparison (MAIC) is the most common method for pairwise comparisons that control for imbalances in baseline characteristics across trials. One of the primary challenges in MAIC is the need to properly account for the additional uncertainty introduced by the matching process. Limited evidence and guidance are available on variance estimation in MAICs. Therefore, we conducted a comprehensive Monte Carlo simulation study to evaluate the performance of different statistical methods across 108 scenarios. Four general approaches for variance estimation were compared in both anchored and unanchored MAICs of binary and time‐to‐event outcomes: (1) conventional estimators (CE) using raw weights; (2) CE using weights rescaled to the effective sample size (ESS); (3) robust sandwich estimators; and (4) bootstrapping. Several variants of sandwich estimators and bootstrap methods were tested. Performance was quantified on the basis of empirical coverage probabilities for 95% confidence intervals and variability ratios. Variability was underestimated by CE + raw weights when population overlap was poor or moderate. Despite several theoretical limitations, CE + ESS weights accurately estimated uncertainty across most scenarios. Original implementations of sandwich estimators had a downward bias in MAICs with a small ESS, and finite sample adjustments led to marked improvements. Bootstrapping was unstable if population overlap was poor and the sample size was limited. All methods produced valid coverage probabilities and standard errors in cases of strong population overlap. Our findings indicate that the sample size, population overlap, and outcome type are important considerations for variance estimation in MAICs. [ABSTRACT FROM AUTHOR]

Purpose: Despite its promise to enhance patient outcomes and support clinical decision making, clinical use of artificial intelligence (AI) models at the bedside remains limited. Translation of advancements in AI research into tangible clinical benefits is necessary to improve neonatal and pediatric care for critically ill patients. This systematic review seeks to assess the maturity of AI models in neonatal and pediatric intensive care unit (NICU and PICU) treatment, and their risk of bias and objectives. Methods: We conducted a systematic search in Medline ALL, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, and Google Scholar. Studies using AI models during NICU or PICU stay were eligible for inclusion. Study design, objective, dataset size, level of validation, risk of bias, and technological readiness of the models were extracted. Results: Out of the 1257 identified studies 262 were included. The majority of studies was conducted in the NICU (66%) and most had a high risk of bias (77%). An insufficient sample size was the main cause for this high risk of bias. No studies were identified that integrated an AI model in routine clinical practice and the majority of the studies remained in the prototyping and model development phase. Conclusion: The majority of AI models remain within the testing and prototyping phase and have a high risk of bias. Bridging the gap between designing and clinical implementation of AI models is needed to warrant safe and trustworthy AI models. Specific guidelines and approaches can help improve clinical outcome with usage of AI. [ABSTRACT FROM AUTHOR]

Health technology assessment bodies advocate capturing the value of interventions in terms of their benefits to health and broader welfare. The wider societal impacts (WSI) framework considers how changes in health alter a person's net contribution to society—that is, what they produce minus what they consume. In this research, we review this framework and explore the scope to differentiate WSI by equity-relevant sociodemographic characteristics. This research updates previous calculations using publicly available data from population-based surveys in the United Kingdom. We then estimate for 199 chronic conditions: (1) WSI for the average person with the condition and (2) gain in WSI for an improvement of 0.1 in health-related quality of life score. The nature and availability of information varied across population-based surveys and precluded analyses to examine WSI by population subgroup. Our updated estimates mirrored earlier findings that consideration of the broader societal impacts of health would reprioritize interventions compared with assessment on health alone. For example, for the same improvement in health, a woman experiencing diseases of the circulatory system has the highest potential gain in WSI (£354/month) whereas a man experiencing HIV has the lowest potential gain (£233/month). The WSI framework provides a simple, indirect method to inform resource allocation decisions. Understanding the equity implications of this approach was hindered by differences in the information collected across population-based surveys. Findings demonstrate the potential reprioritization that may occur if the broader welfare benefits of health interventions were used to inform coverage decisions. • Health technology assessment agencies continue to indicate interest in capturing the value of health interventions in terms of both their benefits to health and societal welfare, but practical, reliable, and routine sources of this information are lacking. • Routine UK data sources inform the wider societal impacts framework, which provides a structured, indirect method to estimate the additional value beyond health in economic evaluation, but the equity implications beyond groups defined by age and sex remain unclear. • This article applies an updated wider societal impacts framework to 199 health conditions to indicate the reprioritization that might occur using a broader perspective for decision making. [ABSTRACT FROM AUTHOR]

To demonstrate how health technology assessment methods can be used to support Medicare's price negotiations for apixaban and rivaroxaban. Following the statutory outline of evidence that will be considered by Medicare, we conducted a systematic literature review, network meta-analyses, and decision analyses to evaluate the health outcomes and costs associated with apixaban and rivaroxaban compared with warfarin and dabigatran for patients with nonvalvular atrial fibrillation. Our methods inform discussions about the therapeutic impact of apixaban and rivaroxaban and suggest price premiums above their therapeutic alternatives over a range of cost-effectiveness thresholds. Network meta-analyses found apixaban resulted in a lower risk of major bleeding compared with warfarin and dabigatran and a lower risk of stroke/systemic embolism compared with warfarin but not compared with dabigatran. Rivaroxaban resulted in a lower risk of stroke/systemic embolism versus warfarin but not dabigatran, and there was no difference in major bleeding. Decision-analytic modeling of apixaban suggested annual price premiums up to $4350 above the price of warfarin and up to $530 above the price for dabigatran at cost-effectiveness thresholds up to $200 000 per equal value of life-years gained. Analyses of rivaroxaban showed an annual price premium of up to $3920 above warfarin and no premium above that paid for dabigatran. Although health technology assessment is typically performed near the time of regulatory approval, with modifications, we produced comparative clinical and relative cost-effectiveness findings to help guide negotiations on a "fair" price for drugs on the market for over a decade. • With modifications, health technology assessment can be used to assess drugs deep into their brand lifecycle. • Observational data can play a valuable role in postlaunch health technology assessments. • In jurisdictions in which the quality-adjusted life year is prohibited, the equal-value life year can provide a feasible alternative measure of health gain because it ensures that extended life is assigned an equal value for everyone regardless of baseline quality of life. [ABSTRACT FROM AUTHOR]

This study develops a prioritization framework to aid healthcare funding decision making in health technology assessment (HTA) in Australia using a multiple criteria decision analysis (MCDA) approach. MCDA frameworks for HTAs were reviewed through literature survey to identify the initial criteria and levels within each criterion. Key stakeholders and experts were consulted to confirm these criteria and levels. A conjoint analysis using 1000Minds was undertaken with policy makers from the Department of Health to establish ranking criteria and weighting scores. Monte Carlo simulations were used to examine the sensitivity of findings to factors affecting the ranking and weighting scores. The MCDA was then applied to 6 examples of chronic care models or technologies projects to demonstrate the performance of this approach. Five criteria (clinical efficacy/effectiveness, safety and tolerability, severity of the condition, quality/uncertainty, and direct impact on healthcare costs) were consistently ranked highest by healthcare decision makers. Among the criteria, patient-level health outcomes were considered the most important, followed by social and ethical values. The analyses were robust to inform the uncertainty in the parameter. This study has developed an MCDA tool that effectively integrates key priorities for HTA reviews, reflecting the values and preferences of healthcare stakeholders in Australia. Although this tool aims to align the assessment process more closely with health benefits, it also highlights the importance of considering other criteria. • Established knowledge includes prior studies on healthcare funding decision making and some regional pilot studies in Australia, notably in Queensland Health. The existing literature may touch upon multicriteria decision analysis frameworks but may lack a comprehensive examination of Australian policymakers' criteria preferences. • This study unveils the preferences of Australian policymakers, emphasizing "patient-level health outcomes" and "social and ethical values" over cost considerations, providing unique insights into decision-making criteria. • This study also demonstrates the multiple criteria decision analysis framework's practical utility as a transparent and cost-effective decision-aid tool, offering valuable implications for informed healthcare funding decisions and resource allocation. [ABSTRACT FROM AUTHOR]

Health technology assessment (HTA) of advanced therapy medicinal products (ATMPs), such as high-cost and one-time cell and gene therapies, is particularly challenging. Outcomes-based agreements (OBAs) are a potential solution to mitigate the risks while providing access to patients but are not widely used across Europe. This study aimed to develop policy recommendations to support the acceptability and implementation of OBAs in Europe. A policy sandbox approach was used to engage with stakeholders and explore how HTA organizations can support reimbursement decisions regarding OBAs for ATMPs. A panel of 38 experts from across the European region was convened in 2 workshops, representing payers, HTA organizations, patients, registries, and an industry trade body. Policy recommendations were developed to support the appropriate consideration of OBAs for reimbursing highly uncertain technologies, such as ATMPs. If a positive HTA recommendation cannot be made at the proposed price, then a simple price discount reflecting the uncertainty is preferred over complex solutions such as OBAs. If an OBA is pursued, it should be designed collaboratively with all stakeholders to understand data collection feasibility and minimize burden to patients and providers. Payers are encouraged to approach OBAs as a tool for informed decision making, including a readiness to make negative reimbursement decisions based on unfavorable evidence. The study presents a policy framework for using OBAs in reimbursement decisions. OBAs must be carefully designed, focusing on appropriateness and the burden of implementation. The relevant authorities should be committed to making decisions in light of the resulting evidence. • Outcomes-based agreements (OBAs) with further data collection offer a reimbursement solution for highly uncertain and innovative health technologies, generating evidence and supporting patient access. • However, OBAs are a complex solution that should be considered only if a simpler solution cannot be reached through standard health technology assessment processes and pricing solutions. • Burdens associated with implementing OBAs and data collection should be minimized by designing agreements in collaboration with all the stakeholders involved. [ABSTRACT FROM AUTHOR]

Health technology assessment (HTA) is increasingly crucial in medicine price negotiations in China, yet previous appraisals revealed national discrepancies on key economic evaluation issues: willingness-to-pay threshold, pricing models for multi-indication medicines, and comparator selection principles. This study aimed to collect expert opinions on these issues for future HTA evaluations. A nationwide anonymous web-based survey encompassing experts across academia, HTA, consultancy/contract research organization/industry, service provider, and payer. In 2023, a generic invitation containing a web link to the questionnaire was disseminated via WeChat using convenience and snowball sampling. Agreement rates for questionnaire views were analyzed using descriptive statistics. The relationship between participants' responses and demographics was examined using appropriate logistic models. A total of 303 responses were received from experts in 34 cities. Key expert views include a suggested base willingness-to-pay threshold ranging from 0.5 to 1.5 times gross domestic product (52.1% agreement); elevated thresholds for childhood diseases, rare diseases, end-of-life diseases, and first-in-class medicines (>78.0% agreement); a single pricing model for multi-indication medicines (60.4% agreement); consideration of multiple medicines as comparators (79.9% agreement); and avoiding the use of centrally procured medicines as comparators for medicines with a time to market of less than 3 years (71.0% agreement). Participants who are service provider had lower odds of selecting higher thresholds (odds ratio 0.26; P <.01) than responders from consultancy/contract research organization/industry. Expert views indicate the need for substantial changes in China's current HTA methods, highlighting the need for increased investment in HTA processes and expertise cultivation. • Since 2017, health technology assessment (HTA) has played a key role in price negotiations for medicines seeking coverage under China's national Social Health Insurance program. However, past HTA appraisals have revealed a lack of national consensus on various issues relating to economic evaluation, with particular focus on 3 key areas: willingness-to-pay thresholds, pricing models for multi-indication medicines, and comparator selection principles. • To address these gaps, we conducted a pioneering nationwide survey to gather perspectives from diverse stakeholders on the 3 key issues. Our study, one of the earliest global initiatives to systematically collect views on economic evaluations for HTA, received 303 responses from experts across 34 cities. This diverse sample, including participants from academia, HTA, consultancy, industry, service providers, and payers, ensures comprehensive insights. • Key expert views derived from this survey included a suggested base willingness-to-pay threshold ranging from 0.5 to 1.5 times gross domestic product; elevated thresholds for childhood diseases, rare diseases, end-of-life diseases, and first-in-class medicines; a single pricing model for multi-indication medicines; and consideration of multiple medicines as comparators. Implementing these recommendations would require substantial changes to China's HTA methods, highlighting the need for increased investment in HTA processes and expertise cultivation. [ABSTRACT FROM AUTHOR]

Treatment effect waning (TEW) refers to the attenuation of treatment effects over time. Assumptions of a sustained immuno-oncologic treatment effect have been a source of contention in health technology assessment (HTA). We review how TEW has been addressed in HTA and in the wider scientific literature. We analysed company submissions to English language HTA agencies and summarised methods and assumptions used. We subsequently reviewed TEW-related work in the ISPOR Scientific Presentations Database and conducted a targeted literature review (TLR) for evidence of the maintenance of immuno-oncology (IO) treatment effects post-treatment discontinuation. We found no standardised approach adopted by companies in submissions to HTA agencies, with immediate TEW most used in scenario analyses. Independently fitted survival models do however suggest TEW may often be implicitly modelled. Materials in the ISPOR scientific database suggest gradual TEW is more plausible than immediate TEW. The TLR uncovered evidence of durable survival in patients treated with IOs but no evidence that directly addresses the presence or absence of TEW. Our HTA review shows the need for a consistent and appropriate implementation of TEW in oncology appraisals. However, the TLR highlights the absence of direct evidence on TEW in literature, as TEW is defined in terms of relative treatment effects—not absolute survival. We propose a sequence of steps for analysts to use when assessing whether a TEW scenario is necessary and appropriate to present in appraisals of IOs. [ABSTRACT FROM AUTHOR]

Objectives: Published literature has levied criticism against the cost-minimisation analysis (CMA) approach to economic evaluation over the past two decades, with multiple papers declaring its 'death'. However, since introducing the requirements for economic evaluations as part of health technology (HTA) decision-making in 1992, the cost-minimisation analysis (CMA) approach has been widely used to inform recommendations about the public subsidy of medicines in Australia. This research aimed to highlight the breadth of use of CMA in Australia and assess the influence of preconditions for the approach on subsidy recommendations Methods: Relevant information was extracted from Public Summary Documents of Pharmaceutical Benefits Advisory Committee (PBAC) meetings in Australia considering submissions for the subsidy of medicines that included a CMA and were assessed between July 2005 and December 2022. A generalised linear model was used to explore the relationship between whether medicines were recommended and variables that reflected the primary preconditions for using CMA set out in the published PBAC Methodology Guidelines. Other control variables were selected through the Bolasso Method. Subgroup analysis was undertaken which replicated this modelling process. Results: While the potential for inferior safety or efficacy reduced the likelihood of recommendation (p < 0.01), the effect sizes suggest that the requirements for CMA were not requisite for recommendation. Conclusion: The Australian practice of CMA does not strictly align with the PBAC Methodology Guidelines and the theoretically appropriate application of CMA. However, within the confines of a deliberative HTA decision-making process that balances values and judgement with available evidence, this may be considered acceptable, particularly if stakeholders consider the current approach delivers sufficient clarity of process and enables patients to access medicines at an affordable cost. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study is to compare different information retrieval methods that can be used to identify utility inputs for health economic models. Methods: The usual practice of using systematic review methods was compared with two alternatives (iterative searching and rapid review), using a health technology assessment (HTA) case study in ulcerative colitis (UC). We analysed whether there were differences in the utility values identified when using the alternative search methods. Success was evaluated in terms of time, burden and relevance of identified information. The identified utility values were tested in an executable health economic model developed for UC, and the model results were compared. Results: The usual practice of using systematic review search approaches identified the most publications but was also the least precise method and took longest to complete. The inclusion of data from the different search methods in the model did not lead to different conclusions across search methods. Conclusions: In this case study, usual practice was less efficient and resulted in the same health economic model conclusions as the alternative search methods. Further case studies are required to examine whether this conclusion might be generalisable. [ABSTRACT FROM AUTHOR]

Previous research has shown that gendered societal expectations are adopted by students as seemingly personal and individualistic self‐assessments and preferences, which then lead to gender‐normative choices about college majors and careers. This study examines one seemingly objective mechanism, which millions use each year for guidance on college majors and careers. We examine two Career Assessment Tools (CATs) with deep institutional presence: O*NET and Traitify. Analyzing an exemplar case of engineering majors, we find that CATs are less likely to recommend engineering occupations to women, even after controlling for GPA, satisfaction with the major, and planned persistence. Even in our sample of engineering majors, CATs apparently use small differences in students' gender‐normative self‐expressive preferences to drive sharply different occupational recommendations, thereby solidifying pathways toward gender‐segregated occupations and reinforcing men's dominance of engineering. If women similar to our study participants take CATs, they are likely to be steered away from engineering occupations or majors. More broadly, CATs illustrate how taken‐for‐granted, seemingly neutral technologies can reinforce gender segregation. [ABSTRACT FROM AUTHOR]

Background: Alzheimer's disease (AD) is the most common neurodegenerative disorder which primarily involves memory and cognitive functions. It is increasingly recognized that motor involvement is also a common and significant aspect of AD, contributing to functional decline and profoundly impacting quality of life. Motor impairment, either at early or later stages of cognitive disorders, can be considered as a proxy measure of cognitive impairment, and technological devices can provide objective measures for both diagnosis and prognosis purposes. However, compared to other neurodegenerative disorders, the use of technological tools in neurocognitive disorders, including AD, is still in its infancy. Objective: This report aims to evaluate the role of technological devices in assessing motor involvement across the AD spectrum and in other dementing conditions, providing an overview of the existing devices that show promise in this area and exploring their clinical applications. Methods: The evaluation involves a review of the existing literature in the PubMed, Web of Science, Scopus, and Cochrane databases on the effectiveness of these technologies. 21 studies were identified and categorized as: wearable inertial sensors/IMU, console/kinect, gait analysis, tapping device, tablet/mobile, and computer. Results: We found several parameters, such as speed and stride length, that appear promising for detecting abnormal motor function in MCI or dementia. In addition, some studies have found correlations between these motor aspects and cognitive state. Conclusions: Clinical application of technological tools to assess motor function in people with cognitive impairments of a neurodegenerative nature, such as AD, may improve early detection and stratification of patients. [ABSTRACT FROM AUTHOR]

With the rapid development of mobile technology, its application in the educational sector, particularly in learning analytics, has garnered increasing attention. The widespread adoption of modern mobile devices has introduced new opportunities for educational assessment. However, challenges remain in effectively utilizing these technologies for educational assessment. Current research predominantly focuses on data collection and analysis, yet the methods employed are limited in scope and application. This study aims to address these gaps by exploring data collection methods and teaching assessment approaches based on mobile technology. The objective is to contribute new perspectives and methodologies that modernize educational assessment. Through an in-depth analysis of the application of mobile technology in educational assessment, this study seeks to provide educators with scientifically grounded assessment tools and strategies, enabling more precise teaching management and personalized education. [ABSTRACT FROM AUTHOR]

To meet the increasing demand for rapid and efficient evaluation of tunnel blasting quality, this study presents a comprehensive review of the current state of the art in tunnel blasting evaluation, organized into five key areas: Blasting Techniques and Optimization, 3D Reconstruction and Visualization, Monitoring and Assessment Technologies, Automation and Advanced Techniques, and Half Porosity in Tunnel Blasting. Each section provides an indepth analysis of the latest research and developments, offering insights into enhancing blasting efficiency, improving safety, and optimizing tunnel design. Building on this foundation, we introduce a digital identification method for assessing half porosity through 3D image reconstruction. Utilizing the Structure from Motion (SFM) technique, we re-construct the 3D contours of tunnel surfaces and bench faces after blasting. Curvature values are employed as key indicators for extracting 3D point cloud data from boreholes. The acquired postblasting point cloud data is processed using advanced software that incorporates the RANSAC algorithm to accurately project and fit the borehole data, leading to the determination of the target circle and borehole axis. The characteristics of the boreholes are analyzed based on the fitting results, culminating in the calculation of half porosity. Field experiments conducted on the Huangtai Tunnel (AK20 + 970.5 to AK25 + 434), part of the new National Highway 109 project, provided data from shell holes generated during blasting. These data were analyzed and compared with traditional onsite measurements to validate the proposed method's effectiveness. The computed half porosity value using this technique was 58.7%, showing minimal deviation from the traditional measurement of 60%. This methodology offers significant advantages over conventional measurement techniques, including easier equipment acquisition, non-interference with construction activities, a comprehensive detection range, rapid processing speed, reduced costs, and improved accuracy. The findings demonstrate the method's potential for broader application in tunnel blasting assessments. [ABSTRACT FROM AUTHOR]

The main objective of this experiment was to investigate the technological potential of upcycling unsparged non-conventional brewers' spent grains (BSGs) in bread-making and assess the comparative quality of bread enriched with non-fermented and lactic acid-fermented BSGs obtained from mashes brewed with starch adjuncts of buckwheat and oats. After the runoff of the first wort, unsparged non-conventional BSGs with approximately 75% moisture, acidic pH, and yield in the soluble extract above 56.6% (w/w d.m.) were used in substituting wheat flour with 5 and 15% (w/w d.m.) in bread-making recipes. The highest loaf volume value (318.68 cm3/100 g) was observed for 5% fermented buckwheat-BSG addition. Except for the samples with 5% fermented BSGs, specific volumes decreased. Crumb moisture was reduced by up to 22% for all samples, with this parameter related to bread weight. Bread porosity, elasticity, acidity, and overall sensory acceptability were better for fermented than non-fermented BSGs. The results proved that non-conventional BSGs with buckwheat and oats addition have the potential to be valorized in new bread assortments, and lactic acid fermentation applied to the BSGs is beneficial, even for overall sensory acceptability and quality of baked end-products. Technological, buckwheat-BSG was more convenient than oats-BSG. Further research continues to optimize and upscale Technology Readiness Levels. [ABSTRACT FROM AUTHOR]

This study aims to examine the critical role of the third-party partnership and extend the Extended Unified Theory of Acceptance and Use of Technology (UTAUT2) framework for restaurant customers' adoption of self-service technologies (SSTs). The study employs a systematic process and develops a full set of scales for constructing the third-party partnership. In addition, this study collects two sets of data for analysis purposes, with one from during the COVID-19 lockdown period and the other from the post-COVID-19 lockdown period. It uses comparison analysis in addition to PLS-SEM for model testing. Findings revealed that the third-party partnership significantly impacts perceived brand image both during and post-COVID-19 lockdown periods. In contrast, UTAUT2 factors (i.e., performance expectancy, effort expectancy, social influence, facilitating conditions, hedonic motivation, and habit) have positive effects only on the perceived brand image during the post-COVID 19 lockdown period. The perceived brand image mediates between the third-party partnership and word-of-mouth (WOM) behaviors during and post-COVID-19 lockdown periods; in contrast, in the post-COVID-19 lockdown period, perceived brand image mediated the effects of UTAUT 2 factors on WOM behaviors and intentions to pay a premium price. This study contributes to the knowledge on restaurant brand image through the study of brand image from the perspective of technology applications, that is, by conducting an assessment of technology applications that combined UTAUT2 with third-party partnership SSTs regarding customers' brand image identification in the restaurant industry. [ABSTRACT FROM AUTHOR]

The present study aimed to merge expertise from evidence-based practice and user-centered design to develop a rating scale for considering user input and other sources of information about end-users in studies reporting on the design of technology-based support for autism. We conducted a systematic review of the relevant literature to test the reliability and validity of the scale. The scale demonstrated acceptable reliability and validity based on a randomized sample of 211 studies extracted from the output of the systematic review. The scale can help provide a more complete assessment of the quality of the design process of technology-based supports for autism and be beneficial to autistic people, their families, and related professionals in making informed decisions regarding such supports. [ABSTRACT FROM AUTHOR]

The exhaled breath represents an ideal matrix for noninvasive biomarker discovery, and exhaled metabolomics have the potential to be clinically useful in the era of precision medicine. In this concise translational review, we specifically address volatile organic compounds in the breath, with a view toward fulfilling the promise of these as actionable biomarkers, in particular, for lung diseases. We review the literature paying attention to seminal work linked to key milestones in breath research; discuss potential applications for breath biomarkers across disease areas and healthcare systems, including the perspectives of industry; and outline critical aspects of study design that will need to be considered for any pivotal research going forward if breath analysis is to provide robust validated biomarkers that meet the requirements for future clinical implementation. [ABSTRACT FROM AUTHOR]

Our objective was to compare AOTMiT (Polish: Agencja Oceny Technologii Medycznych i Taryfikacji) recommendations to other HTA (Health Technology Assessment) agencies for newly registered drugs and new registration indications issued by the European Medicines Agency between 2014 and 2019. The study aims to assess the consistency and justifications of AOTMiT recommendations compared to that of other HTA agencies in 11 countries. A total of 2496 reimbursement recommendations published by 12 HTA agencies for 464 medicinal products and 525 indications were analyzed. Our analysis confirmed that the Polish AOTMiT agency seems to bear the closest resemblance to the corresponding HTA agencies from Canada (CADTH) and New Zealand (PHARMAC), when it comes to the outcome of HTA recommendations (positive or negative). Poland had a general scheme for justifying recommendations, similar to that of Ireland—four aspects (i.e., clinical efficacy, safety profile, cost-effectiveness, and impact on the payer's budget) are important for Poland when formulating the final decision. Compared to other countries, Poland shows a noticeably different pattern of justifying reimbursement recommendations, as revealed primarily in terms of budget impact and somewhat less so for cost-effectiveness rationales. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions The purpose of this study was to reveal inter‐ and intra‐rater reliability of the detailed evaluation of cognitive function by assistive robot for older adults.We investigated the inter‐rater and test–retest reliability. Neurobehavioral Cognitive Status Examination was conducted twice for each participant using an assistive robot and the examiner respectively (Experiment 1). The order of these two tests was randomly selected and the interval between them was 1 week. In Experiment 2, we investigated the test–retest reliability of the first robot test and this additional robot test was conducted approximately 6 weeks after Experiment 1.Fifty‐one (13 men and 38 women, mean age: 80.5 ± 5.6 years) participants went through Experiment 1 and 29 of those (eight men and 21 women, mean age: 80.4 ± 4.8 years) completed Experiment 2. In Experiment 1, the interclass coefficient (ICC) in orientation was in the high range and its Cronbach's α was 0.919, rated as excellent internal consistency. On the other hand, other items did not show positive results. In Experiment 2, the ICCs in orientation, attention, and repetition were in the adequate range, while other items showed marginal or low range.Orientation was supposed to be utilised for figuring out initial symptoms of dementia. In the future, as robot functions become more high‐tech, a partner robot might be able to measure the symptoms and severity of dementia. [ABSTRACT FROM AUTHOR]

Metal–organic frameworks (MOFs) are superior sorbents for water adsorption‐based applications. The unique step‐like water isotherm at a MOF‐specific relative pressure allows easy loading and regeneration over a small range of temperature and pressure conditions. With good hydrothermal stability and cyclic durability, it stands out over classical sorbents used in applications for humidity control, water harvesting, and adsorption‐based heating and cooling. These are easily regenerated at moderate temperatures using "waste" heat or solar heating. The isotherm thermodynamics and adsorption mechanisms are described, and the presence of MOFs in the water–air system is explained. Based on six selection criteria ≈40 reported MOFs and one COF are identified for potential application. Trends and approaches in further synthesis optimization and production scale‐up are highlighted. No‐MOF‐fits‐all, each MOF has its own specific step location matching only with a certain application type. Most applications are technically feasible and demonstrated on the bench‐scale or small pilot. Their maturity is benchmarked by their technology readiness level. Retrofitting existing applications with MOFs replacing classical desiccants may lead to rapid demonstration. Studies on techno‐economic analysis and life cycle analysis are required for a rational evaluation of the feasibility of promising applications. [ABSTRACT FROM AUTHOR]

BackgroundMethodsResultsDiscussionCognitive fatigue is a complex psychobiological state whereby task performance cannot be maintained. Return-to-work protocols typically rely on self-report measures, therefore the current systematic review aimed to identify “real-time” measures of objective cognitive fatigue to inform return-to-work protocols.Studies were included if participants were at least 18 years old, assessed “real-time” objective cognitive fatigue that could be used outside of the lab (neuroimaging measures were, therefore, excluded), used an induction task that was separate to the measurement, were adequately powered, compared objective cognitive fatigue at baseline and post-induction, and included a cognitive fatigue induction task that was at least 30 minutes long.Nine electronic databases were searched until 31 December 2022 (MEDLINE; PsychArticle; PubMED, ProQuest; ProQuest for gray literature; Google Scholar; The Cochrane Library; The Health Technology Assessment Database; and Web of Science), with alerts set up on Google Scholar to notify of new relevant research since this date (reviewed until December 2023). The checklist for quasi-experimental studies (Joanna Briggs Institute, 2014) was used to assess the risk of bias. Whilst a meta-analysis was planned, the data were unsuitable so only a narrative synthesis was conducted.Fifty-seven studies were included, which were conducted within a variety of settings including naturalistic work scenarios, driving, aviation, and artificial computer-based tasks.Whilst the review found a range of potential measurements, there were inconsistencies in findings across studies highlighting the need for more research into the reliable measurement of objective cognitive fatigue in natural settings.The findings suggest that eye- and body-related measures may be sensitive measures of objective cognitive fatigue. However, comparisons across measurement types should be cautiously interpreted because eye-related and cognitive measures were far more common. The review highlighted the need for more consistent and transparent reporting across the field to advance our understanding of cognitive fatigue. [ABSTRACT FROM AUTHOR]

The zeolite‐catalyzed methanol‐to‐aromatics (MTA) process is a promising avenue for industrial decarbonization. This process predominantly utilizes 3‐dimensional 10‐member ring (10‐MR) zeolites like ZSM‐5 and ZSM‐11, chosen for their confinement effect essential for aromatization. Current research mainly focuses on enhancing selectivity and mitigating catalyst deactivation by modulating zeolites′ physicochemical properties. Despite the potential, the MTA technology is at a low Technology Readiness Level, hindered by mechanistic complexities in achieving the desired selectivity towards liquid aromatics. To bridge this knowledge gap, this study proposes a roadmap for MTA catalysis by strategically combining controlled catalytic experiments with advanced characterization methods (including operando conditions and "mobility‐dependent" solid‐state NMR spectroscopy). It identifies the descriptor‐role of Koch‐carbonylated intermediates, longer‐chain hydrocarbons, and the zeolites′ intersectional cavities in yielding preferential liquid aromatics selectivity. Understanding these selectivity descriptors and architectural impacts is vital, potentially advancing other zeolite‐catalyzed emerging technologies. [ABSTRACT FROM AUTHOR]

Hydrogen could be a key driving force for decarbonizing various sectors. This analysis, based on the Slovak National Hydrogen Strategy, evaluates 6 low-emission hydrogen production methods, varying in raw material, technology, and operational conditions. Technologies are assessed using three criteria: levelized cost of energy, carbon footprint, and technology readiness level. Three alternative fuels are analysed: methanol, methane, and sustainable aviation fuel (SAF). Multi-criteria decision analysis evaluates 139 combinations of criteria importance. Proton exchange membrane electrolysis and steam biogas reforming (SBR) emerge as the most advantageous technologies, ranking first in 45 and 32 cases, respectively. Economically, high-temperature electrolysis and SBR are preferred, with a levelized cost (LCOH) of 11.7 €/kg H 2 under current conditions. SAF stands out as the best alternative fuel, with the lowest levelized cost of 3.3 €/kg. Reducing Slovakia's electricity price by 80% would make domestic hydrogen production increasingly competitive in Europe by 3.7 times reduction of LCOH. [Display omitted] • 3 alternative fuel pathways based on 6 hydrogen production technologies. • MCDA considers economic and environmental aspect and technology readiness. • Electrolysis evaluated as the most feasible solution for the national strategy. • SAF production is the most profitable pathway. [ABSTRACT FROM AUTHOR]

Background: Africa, specifically the Sub-Saharan region, has had numerous medical technology clinical trials to address the various healthcare challenges around infectious diseases, non-communicable diseases, and nutritional disorders it is facing. Medical device clinical trials provide performance data in terms of safety, efficacy, and efficiency, which is a requirement before commercialization. Key players such as academicians, governments, international organizations, and funders collaborate to drive these trials, but their growth in Africa remains slower compared to other parts of the globe. This paper aims to evaluate the number of medical device clinical trials conducted in different African countries that are registered on the clinicaltrials.gov website. Methods: Data on medical device clinical trials was mined from clinicaltrials.gov website accessed on 22nd September, 2022. The data extracted was analyzed and cleaned in Microsoft Excel and R. Countries were grouped into regions and descriptive statistical analyses for each region were done. Additionally, frequency distributions were also generated and no inferential statistical tests were performed, as the primary focus of this analysis was to describe the distribution of medical conditions across regions. Results: Thirty-one African countries had registered medical device clinical trials on the website with the majority taking place in Egypt and South Africa. Medical device trials for heart related issues took longer to complete compared to other conditions. Malaria, HIV, and male circumcision related device trials were mainly conducted in Eastern and Southern Africa while trials related to dental, fertility, and obesity were concentrated in Northern Africa. Female reproductive health issues were studied equally across all regions. Some African countries did not have any trials registered on clinicaltrials.gov website. Conclusion: Findings from this study clearly show the disparity in the number, status, and duration of medical device clinical trials across various African countries. [ABSTRACT FROM AUTHOR]

Health Technology Assessment (HTA) is essential for evidence-based healthcare decision-making, yet its integration into Iran's healthcare system faces political and logistical challenges. Despite HTA's potential to improve resource allocation, limited awareness, data gaps, and competing priorities hinder its implementation. This commentary emphasizes the need for political support, advocating capacity-building, collaboration, and alignment with long-term health policies. Leveraging international partnerships and monitoring outcomes can enhance HTA's role in improving healthcare in Iran and contributing to global health advancements. [ABSTRACT FROM AUTHOR]

Background: Research impact assessment is already being institutionalized in health research and innovation systems. In developing countries, there are many different research assessment models which have focused more on research output in academic levels and less on impact. Objective: The aim of this study is designing an Iranian impact-oriented model of research and technology evaluation. Method: This is a mixed study. In the quantitative part, by reviewing the literature, a list of research impact indicators that existed were gathered, reviewed, and scored by participants on importance, relevance, and measurability via a 5-point Likert scale. All indicators with a mean score equal to or greater than 3.5 entered the qualitative part, which were discussed in depth by engaging key stakeholders regarding their validity and feasibility through focus groups, interviews, and expert panels. Results: The Iranian research impact evaluation model was developed with four main pillars (including input and process, output, outcome, and impact), four areas (stewardship, advancing knowledge and translation, technology, and impact), and 30 indicators through key stakeholders participation in the Iranian health research system. Conclusions: This model has been introduced as the first model designed to evaluate the impact of health research and can be one of the most important tools for allocating limited funding resources while maximizing the desired impact of research in the community. [ABSTRACT FROM AUTHOR]

Background: According to scientific literature, some 99% of patients affected by Alzheimer's disease (AD) suffer from behavioral and psychological symptoms of dementia (BPSD), also known as neuropsychiatric symptoms (NPSs). In particular, agitation is one of the most difficult disorders to treat. States of agitation represent a very serious problem as they make these subjects dangerous for themselves and others and worsen as the disease advances. To date, there are no specific solutions for treating agitation. The only authorized drug is risperidone (as well as brexpiprazole, approved by the FDA on 11 May 2023), which can be used for no longer than 6–12 weeks because it increases the risk of death—owing to cardiocerebrovascular accidents—by 1.6–1.7 times. Methods: In order to address the latter noteworthy unmet medical need, NanoBEO was produced. The aim of the present work is to generate the health technology assessment (HTA) of this nanotechnological device. The latter consists of a controlled release system, based on solid lipid nanoparticles loaded with bergamot essential oil (BEO). Results: The results of the present research assessed the current evidence in the field of non-pharmacological treatments for this condition, including relevant primary preclinical and clinical data studies supporting the use of this device and the production of the operative plan for its launch on the market. The findings offer recommendations for decision-making on its implementation in dementia. Conclusions: NanoBEO represents a public-worth innovation in this neglected area, marking a significant advancement in the history of dementia, moving from academic research to product development. [ABSTRACT FROM AUTHOR]

At the 39th meeting of the International Society of Traumatic Stress Studies, three leading researchers and clinicians in technology‐enabled traumatic stress support were invited to reflect on their careers and contributions to the field. Dr. Brian P. Marx has led the development of large‐scale technologies to screen, assess, and treat traumatic stress pathology across diverse etiologies and needs. Dr. Barbara O. Rothbaum, a pioneer in the development of virtual reality for exposure therapy, has demonstrated the efficacy and scalability of digital treatment for traumatic stress. Retired Col. Dr. Eric Vermetten has worked extensively on the intersection of basic mechanisms, novel psychological and biological treatment, and technology for scalable assessment and treatment, primarily in military and mass casualty contexts. The panelists were asked to reflect on their initial ambitions, concerns, unexpected challenges, and the influence of their work on new research trajectories. Their insights provide valuable lessons about the process and content of their work, and their pioneering efforts have significantly advanced the field of technology‐enabled traumatic stress support. [ABSTRACT FROM AUTHOR]

The appraisal of vaccines in the European Union (EU) currently involves many different decision-making bodies and processes. The objective of this study was to help inform the development of standardized methodology and vaccine-specific processes for use in the EU Regulation on health technology assessment (HTA). Literature reviews and expert consultation were conducted to identify current practices and gaps related to vaccine appraisals and to develop guiding principles for the joint clinical assessment of vaccines. We found that significant variation exists across the EU member states in the decision-making processes when clinically evaluating vaccines. Three guiding principles consisting of 13 recommendations were developed to help inform the development of decision-making frameworks for the joint clinical assessment of vaccines in the EU: (1) support the creation of appropriate terminology and measurements for clinical appraisals of vaccines; (2) develop inclusive, timely, and transparent vaccine appraisal processes to support stronger evidence generation for vaccine decision making and appraisal; and (3) improve the collection and interoperability of real-world data, including robust surveillance, to foster evidence generation and support the standardization of vaccine clinical appraisals. Given the significance of vaccines for public health, there is an urgency to develop standardized and vaccine-specific methodologies and processes for use in the EU joint HTA framework. The proposed guiding principles could support the effective implementation of the EU Regulation on HTA for vaccines and have the potential to ensure consistent, transparent, and timely access to new vaccines in the EU. • Vaccine assessment is a key component of immunization systems across European Union (EU) member states, determining not only when and which vaccines are included in National Immunization Programmes but also whether they are funded by the government. • In the context of the EU Regulation on health technology assessment (HTA), which will enter into force in January 2025, this article discusses how the joint EU HTA framework can contribute to unlocking the full value of vaccination as the main tool for primary disease prevention and address the significant variations that currently exist in vaccine evaluations and decision-making processes. • Three guiding principles consisting of 13 recommendations were developed to assist decision makers in considering vaccine specificities in the implementation of the EU Regulation on HTA to standardize assessment processes and methodologies for vaccines and ultimately reduce inequalities in population access to vaccines. [ABSTRACT FROM AUTHOR]

Effective healthcare planning, resource allocation, and budgeting require accurate predictions of the number of patients needing treatment at specific cancer stages and treatment lines. The Predicting the Population Health Economic Impact of Current and New Cancer Treatments (PRIMCAT) for Colorectal Cancer (CRC) simulation model (PRIMCAT-CRC) was developed to meet this requirement for all CRC stages and relevant molecular profiles in Australia. Real-world data were used to estimate treatment utilization and time-to-event distributions. This populated a discrete-event simulation, projecting the number of patients receiving treatment across all disease stages and treatment lines for CRC and forecasting the number of patients likely to utilize future treatments. Illustrative analyses were undertaken, estimating treatments across disease stages and treatment lines over a 5-year period (2022-2026). We demonstrated the model's applicability through a case study introducing pembrolizumab as a first-line treatment for mismatch-repair-deficient stage IV. Clinical registry data from 7163 patients informed the model. The model forecasts 15 738 incident and 2821 prevalent cases requiring treatment in 2022, rising to 15 921 and 2871, respectively, by 2026. Projections show that over 2022 to 2026, there will be a total of 116 752 treatments initiated, with 43% intended for stage IV disease. The introduction of pembrolizumab is projected for 706 patients annually, totaling 3530 individuals starting treatment with pembrolizumab over the forecasted period, without significantly altering downstream utilization of subsequent treatments. PRIMCAT-CRC is a versatile tool that can be used to estimate the eligible patient populations for novel cancer therapies, thereby reducing uncertainty for policymakers in decisions to publicly reimburse new treatments. • Accurate forecasting of patient numbers at specific cancer stages and treatment lines is vital for efficient healthcare planning and resource distribution. However, current predictions are typically limited to overall and stage-specific incidence forecasting. To ensure effective healthcare planning, novel tools are needed for Australia's colorectal cancer (CRC) landscape. • The Predicting the Population Health Economic Impact of Current and New Cancer Treatments-CRC model, grounded in real-world Australian data, offers unparalleled granularity in predicting CRC patient counts segmented by disease stage, cancer type, and treatment utilization. The model's ability to simulate the introduction of new treatments, exemplified through the pembrolizumab case study, demonstrates its adaptability and relevance for both present and future healthcare scenarios. • The Predicting the Population Health Economic Impact of Current and New Cancer Treatments-CRC model sheds light on Australia's current CRC treatment trajectory. As a dynamic tool, it may assist policymakers in assessing the impact of introducing new cancer treatments by forecasting potential patient populations. Its adaptability ensures proactive healthcare planning, for various interventions throughout the patient pathway. [ABSTRACT FROM AUTHOR]

Uncertainty regarding the long-term relative effectiveness is an important factor in health technology assessment (HTA) of medicines. This study investigated how different HTA bodies address this uncertainty in their assessments. A total of 49 HTA reports from 6 national HTA bodies, assessing 9 medicines for spinal muscular atrophy, cystic fibrosis, and hypercholesterolemia, were included. In these reports, 81 relative effectiveness assessments and 45 cost-effectiveness assessments were performed on an indication level. We collected information on included trials, assessment outcomes, uncertainty regarding the long-term effectiveness, proposed managed entry agreements, and reassessments. Uncertainty regarding the long-term effectiveness was an important consideration in almost all cost-effectiveness assessments (91%) and three-quarters of relative effectiveness assessments (74%), despite differences in methodologies among HTA bodies. There were considerable differences in the amount and type of long-term effectiveness data included by HTA bodies due to timing and inclusion criteria. In total 23 managed entry agreements were proposed of which 14 were linked to uncertainty regarding the long-term effectiveness. In addition, 13 reassessments were performed of which 4 led to an increase in patient access because of more available long-term effectiveness data. Uncertainty regarding the long-term effectiveness is an important challenge for HTA bodies. There are large differences in the acceptance of evidence among HTA bodies, which leads to heterogeneity in the inclusion of available long-term effectiveness data for decision making. In cases with large uncertainty regarding the long-term effectiveness, outcome-based agreements and reassessments are used by HTA bodies, but differently between HTA bodies and indications. • To ensure patient access to effective medicines, health technology assessment (HTA) bodies are tasked with assessing the value of new therapies to make reimbursement recommendations. For medicines that seek reimbursement with limited long-term effectiveness data, this value assessment is challenging for HTA bodies. Given that these medicines can sometimes be very costly, the uncertainty regarding their long-term effectiveness introduces a financial risk to payers when reimbursing these medicines. • Differences in acceptance of evidence and timing of assessment led to differences in the amount and type of long-term effectiveness data used by HTA bodies. HTA bodies used outcome-based agreements and reassessments to address uncertainty regarding the long-term effectiveness to a limited extent and differences in implementation of these measures existed between HTA bodies and indications. • More alignment and transparency on the acceptance and inclusion of different types of evidence by HTA bodies might be needed to increase the quality of future studies, for instance through the EU joint clinical assessment and joint scientific consultations. Both outcome-based managed entry agreements and reassessments can be used to mitigate financial risk in cases with considerable uncertainty regarding the long-term effectiveness but more research is needed into their effective implementation. [ABSTRACT FROM AUTHOR]

Recent years have seen a surge of interest in the potential use of 3D bioprinting technologies for the development of tissues and organs with the aim of restoring, maintaining, or improving tissue function. Bioprinting studies frequently claim to be close to clinical translation, yet only report research at very early stages of the translational pipeline. Technology readiness levels (TRLs) are a systematic metric used to objectively assess the maturity of a technology, allowing researchers and stakeholders to understand how far a particular project has progressed from the conceptual stage towards clinical application. Bioprinting is an annex of additive manufacturing, as defined by the American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards, characterized by the automated deposition of living cells and biomaterials. The tissue engineering and regenerative medicine (TE&RM) community has eagerly adopted bioprinting, while review articles regularly herald its imminent translation to the clinic as functional tissues and organs. Here we argue that such proclamations are premature and counterproductive; they place emphasis on technological progress while typically ignoring the critical stage-gates that must be passed through to bring a technology to market. We suggest the technology readiness level (TRL) scale as a valuable metric for gauging the relative maturity of a bioprinting technology in relation to how it has passed a series of key milestones. We suggest guidelines for a bioprinting-oriented scale and use this to discuss the state-of-the-art of bioprinting in regenerative medicine (BRM) today. Finally, we make corresponding recommendations for improvements to BRM research that would support its progression to clinical translation. [ABSTRACT FROM AUTHOR]

New health technologies are constantly developing. However, their impacts on health and implications for health systems are not always clear. Faced with this situation, in the last 45 years, Health Technology Assessment (HTA) has taken an important role in the decision-making process related to the implementation of technologies in healthcare systems. According to the Core Model® EUnetHTA, a "full HTA" should cover nine domains: health problems and current use of technology, description and technical characteristics, safety, clinical effectiveness, costs and economic evaluation, ethical analysis, organizational aspects, patients and social aspects, legal aspects. In all domains of a HTA, the approach is evidence-based and uses epidemiological data, systematic reviews to gather the best level of proofs regarding clinical efficacy and safety of interventions and comparators and organizational and economic models. One exception is the ethical analysis, that uses value-based approach. Although in Neonatal Intensive Care Units (NICUs) there are highly advanced technological environments, HTA has not yet been widely used in this field for determining the "value" of the diagnostic and therapeutic procedures. An example of diagnostic tool used in NICUs is the near-infrared spectroscopy (NIRS), a noninvasive device that enables real-time monitoring of the condition of peripheral tissues in critically ill newborns. The availability of this diagnostic tool could improve the choice of the most appropriate treatment to the clinical situation of the newborn. The expected benefit of NIRS motivates the need of a full HTA. Conclusion: HTA is still little used in Neonatal Critical Care, but it may be the appropriate tool to determine the "value" of technologies used in this field. The implementation of clinical trials and HTA may help in an evidence-based evaluation of new technologies for the neonatal critical care. This could facilitate the rapid introduction of the best health technologies into clinical practice. What is Known: • Health Technology Assessment (HTA) has taken an important role in the decision-making process related to the implementation of technologies in healthcare systems • The centrality of ethics in HTA has been known. In fact, ethics is everywhere in HTA, and value judgments permeate all levels of HTA What is New: • HTA is still little used in Neonatal Critical Care, but it may be the appropriate tool to determine the "value" of technologies used in this field • The implementation of clinical trials and HTA may help in an evidence-based evaluation of new technologies for the neonatal critical care and in introduction of the best and ethically acceptable health technologies into clinical practice. [ABSTRACT FROM AUTHOR]

Background: Recent advances in the development of biomarker-directed therapy and immunotherapy, for advanced and metastatic gastric cancers, have the potential to improve survival and quality of life. Much attention has been directed towards second- and later-line treatments, and the landscape here is evolving rapidly. However, uncertainty in relative effectiveness, high costs and uncertainty in cost effectiveness represent challenges for decision makers. Objective: To identify economic evaluations for the second-line or later-line treatment of advanced and metastatic gastric cancer. Also, to assess key criteria (including model assumptions, inputs and outcomes), reporting completeness and methodological quality to inform future cost-effectiveness evaluations. Methods: A systematic literature search (from database inception to 5 March 2023) of EconLit via EBSCOhost, Cochrane Library (restricted to National Health Service [NHS] Economic Evaluation Database and Health Technology Assessment [HTA] Database), Embase, MEDLINE and of grey literature was conducted. This aimed to identify systemic treatments that align with National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) Clinical Practice Guidelines. Data were collected on key criteria and on reporting completeness and methodological quality. A narrative synthesis focussed on cost-effectiveness and cost-of-illness studies. Outcomes of interest included total and incremental costs and outcomes (life-years and quality-adjusted life-years), ratios of incremental costs per unit outcome and other summary cost and outcome measures. Also, for cost-effectiveness studies, reporting completeness and the methodological quality were assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and the Philips Checklist, respectively. Results: A total of 19 eligible economic evaluations were identified (cost-effectiveness studies [n = 15] and cost-of-illness studies [n = 4]). There was a general lack of consistency in the methodological approaches taken across studies. In the main, the cost-effectiveness studies indicated that the intervention under consideration was more effective and more costly than the comparator(s). However, most interventions were not cost effective. No studies were fully compliant with reporting-completeness and methodological-quality requirements. Given the lack of consistency in the approaches taken across cost-of-illness studies, outcomes could not be directly compared. Conclusions: To our knowledge, this is the first published systematic literature review that has qualitatively synthesised economic evaluations for advanced and metastatic gastric cancer. There were differences in the approaches taken across the cost-effectiveness studies and the cost-of-illness studies. The conclusions of most of the cost-effectiveness studies were consistent despite identified differences in approaches. In the main, the interventions under consideration were not cost effective, presenting challenges to sustainability and affordability. We highlight a requirement for cost-effectiveness evaluations and for second-line or later-line treatments of advanced and metastatic gastric cancer that consider all relevant comparators and that are compliant with reporting-completeness and methodological-quality requirements. By addressing the methodological gaps identified here, future healthcare decision-making, within the context of this rapidly changing treatment landscape, would be better informed. Prospero Registration Number: CRD42023405951. [ABSTRACT FROM AUTHOR]

There is increasing interest in the use of cure modelling to inform health technology assessment (HTA) due to the development of new treatments that appear to offer the potential for cure in some patients. However, cure models are often not included in evidence dossiers submitted to HTA agencies, and they are relatively rarely relied upon to inform decision-making. This is likely due to a lack of understanding of how cure models work, what they assume, and how reliable they are. In this tutorial we explain why and when cure models may be useful for HTA, describe the key characteristics of mixture and non-mixture cure models, and demonstrate their use in a range of scenarios, providing Stata code. We highlight key issues that must be taken into account by analysts when fitting these models and by reviewers and decision-makers when interpreting their predictions. In particular, we note that flexible parametric non-mixture cure models have not been used in HTA, but they offer advantages that make them well suited to an HTA context when a cure assumption is valid but follow-up is limited. [ABSTRACT FROM AUTHOR]

The COVID-19 crisis has necessitated the exploration of alternative learning methodologies to address the challenges of online education, especially in the context of teamwork. This case study examined the effectiveness of a small student team through a project focused on designing, fabricating, and testing a proof-of-concept prototype, specifically a Level 3 prototype according to the technology readiness level (TRL) scale. The project was predominantly carried out under the restrictions imposed by the pandemic. The student team consisted of two undergraduate engineering students with prior experience in project-based learning (PBL) courses. The effectiveness of this teamwork in the current project was found to be strongly influenced by attributes such as shared goals and values, commitment to team success, constructive feedback, and accountability. However, the students' previous experiences in larger teams indicated that characteristics such as ideal team composition, leadership, and open communication were more prominent in those contexts. While team size may explain these differences, further research is necessary to establish definitive conclusions. The contributions of each student to the teamwork were characterized by independence and self-pacing, which played a crucial role in achieving the desired project outcomes. In conclusion, this case study emphasizes the importance of adapting to remote teamwork scenarios and provides strategies for effective project management. The findings highlight the significance of shared goals, commitment, feedback, and accountability in fostering effective teamwork. Moreover, the contributions of independence and self-pacing were instrumental in navigating the challenges posed by limited face-to-face interactions. Future research should investigate the impact of team size on team dynamics, the development of self-regulation skills in similar contexts, and the dynamics of teamwork when students lack experience in a PBL course. These investigations will contribute to a comprehensive understanding of effective teamwork strategies in diverse educational settings. The insights gained from this study contribute to the ongoing discussion on effective teamwork strategies in remote learning environments. [ABSTRACT FROM AUTHOR]

Space solar power is an old idea. From its initial suggestion in the 1940s to the first practical concept by Dr. Peter Glaser in 1968, it has been analyzed, studied, and refined many times. Multiple government institutions, including NASA, JAXA, ESA, and CAST have invested significant funds into developing direct space solar power research. In parallel to these direct studies, considerable investment has also flowed into enabling technologies that serve as the cornerstone of current space solar power development concepts, including space solar panels, space hardware manufacturing, low-cost launch, wireless power transfer, robotic assembly, and swarm monitoring/control. In the last few years, space solar power concepts and studies have received increased funding, including non-governmental funding showing a strong positive growth trend. Multiple reports in 2021 and 2022, including from this author, have found that while space solar power has been technically feasible for decades, falling launch and hardware costs have only recently made it economically viable as well. Despite these findings, translation from economic feasibility to economic reality will require additional high-value investment. Sourcing these new funds requires investment context. This technical paper will present a state of the industry report on space solar power, including the total and source distribution of historical investments. It further contextualizes the investments in space solar power with the scale of investment in key technologies and their current technology readiness levels. The methodologies developed for this report and the data sourced are intended to serve as a catalyst, alongside industry feedback, to create a template for ongoing reporting of this growing market sub-sector and ultimately drive the full deployment of this technology. • NASA found in 1979 that Space Solar Power was technically and economically viable. • A half-century later solar power cost has fallen 99.8 %, launch has fallen 97.6 %. • A given solar panel will produce 6–20 times as much energy in space. • Direct investment into space solar power has reached $879 million. • Critical indirect investment, including into solar PV, is in hundreds of billions. [ABSTRACT FROM AUTHOR]

Space debris are a tangible risk for satellites in Earth orbits. Indeed, in the last decades fragmentation events have generated a large number of uncontrolled objects that have made the debris population grow. Modelling the space debris environment is becoming a fundamental task to evaluate the vulnerability of operational satellites, the probability of accidental collisions with uncontrolled objects, and the evolution of the debris population. With this aim, remote and in-situ measurements provide valuable data to tune the space debris population models and improve their reliability. While large satellites can be observed and tracked from ground, the sub-millimeter debris population requires in-situ measurements. In this context, in-orbit impact sensors are a key technology to obtain information about the sub-mm space debris environment. In this framework, a small-scale impact sensor sized to be integrated in a 2U CubeSat is being developed at the University of Padova. The sensor consists of a multitude of thin, conductive stripes arranged on a thin film of non-conductive material. When a debris hits the sensor, one or more stripes are severed, and the impact is detected. Moreover, the sensor design ensures low power consumption, making it feasible for CubeSat space missions. This work presents the latest outcomes obtained from the development of the sensor. Specifically, structural analyses are performed to assess that the sensor can withstand the launch loads, as well as thermal analyses to confirm its endurance capability with in-orbit temperatures. The number of expected impacts during the mission is predicted through orbital propagation, using state-of-the-art debris environment modelling tools. Finally, the paper presents a functional shooting test and vibration tests, executed onto a development model of the sensor, which verify its functionality and validate a Technology Readiness Level (TRL) of 4. • Space-borne sensor for in-situ monitoring of space debris. • Resistive impact sensor based on thin films and flexible PCB technology. • Thermal and structural analyses of CubeSat-sized impact sensor. • Vibrational test and functional test campaigns on a development model. [ABSTRACT FROM AUTHOR]

Assessment feedback is an essential way to promote student learning. Students and teachers may benefit from educational technologies during the feedback process. The purpose of this study was to identify the feedback dimensions that were fulfilled by iPad applications (apps) and to compare teacher practice to the affordances of apps. Typological data analysis was used to perform this qualitative case study. We analyzed seven apps (QR Code Reader, Schoology, Kahoot!, Nearpod,Socrative, ZipGrade, and The Physics Classroom) that a high school physics teacher used to provide feedback in a technology-enhanced classroom. Data sources included classroom video recordings and the websites of these apps. To facilitate the analysis of the data, we enhanced the feedback dimensions identified by Hatzipanagos and Warburton (2009). Our analysis highlighted the diverse capabilities of these apps with regard to supporting the following dimensions of effective feedback: dialogue, visibility, appropriateness, community, power, learning, timeliness, clearness, complexity, reflection, and action. We found that through additional discussion and interactions with students, the teacher could support dimensions that an app did not support. This study not only underscores the critical interplay between technological tools and teacher practices with regard to crafting effective feedback mechanisms but also offers practical recommendations for educators seeking to optimize technology-enhanced feedback in classroom settings. Future research is encouraged to explore the technology implementation experiences of less experienced teachers. Examining teachers working at various school levels and from various countries can offer valuable insights. [ABSTRACT FROM AUTHOR]

Informal e-learning systems often lack structured assessment mechanisms, making it difficult to assess the learning outcomes. This work aims to automate outcome-based assessment through the use of a large language AI model, in particular ChatGPT. Such automation can be of value to educators and developers of educational software, as it tackles the non-trivial task of evaluating educational trajectories from the outcome-based perspective. To achieve this aim, we proposed a system and validated it through a case study and two evaluation stages. In the first stage, we generated 40 assessment questions of various types, 12 of which were approved as high quality. In the second stage, we generated another 45 questions and conducted 5 individual peer evaluation sessions. The most significant automation aspects in guaranteeing the assessment quality were found to be the instructor involvement to monitor the process, the use of a high quality custom knowledge base, and formulation of the correct prompt instructions on the basis of the learning outcome statements. [ABSTRACT FROM AUTHOR]

Digitalization has been a widely discussed topic in recent years, and it has entered various areas, including education. The issue of identifying and applying pedagogical aspects in digitalization has not been sufficiently discussed in the literature. This deficiency is particularly obvious in terms of assessment, an integral part of the education. Assessment is one of the most important aspects in managing education environments. The research data were obtained by combining two methods: ten pedagogical practices were examined that utilized various technologies in assessment already in use before the pandemic; data from the previous focus group discussions were reviewed regarding to pedagogical principles. A concept map was used in formulating the principles. Finally, the Delphi method with five experts from four counties was applied to obtain an expert view. As a result, five pedagogical principles of digital assessment were developed: (1) the clear purpose of the assessment and explicit criteria; (2) choice of adequate technology; (3) sufficient digital competence and technological equipment; (4) use of technological opportunities; (5) consistent analysis and use of assessment data. This is especially important given the need to demonstrate the appropriate and full use of technology. Those pedagogical principles contribute to a shared understanding between stakeholders in education. [ABSTRACT FROM AUTHOR]