bluuebunny/crossref_metadata_2025 huggingface dataset:
Global Synthesis of Quantification of Fire Behaviour Characteristics in Forests and Shrublands: Recent Progress
Authors: Cruz Miguel G. , Hoffman Chad M. , Fernandes Paulo M.
Published: January 2025

Purpose of Review

The behaviour of wildland fires, namely their free spreading nature, destructive energy fluxes and hazardous environment, make it a phenomenon difficult to study. Field experimental studies and occasional wildfire observations underpin our understanding of fire behaviour. We aim to present a global synthesis of field-based studies in forest and shrublands fuel types published since 2003 with a focus on the most commonly measured fire behaviour attributes, namely rate of fire spread, ignition and spread sustainability, flame characteristics, fuel consumption and spotting behaviour.

Recent Findings

We present a synthesis of measured fire behaviour data collected in field experiments and wildfire environments encompassing the last two decades. We discuss the effect of a lack of standardised experimental methodologies in field studies, which has inhibited our quantitative understanding of the physical drivers of fire behaviour. The application of new fire environment and behaviour measuring sensors and methods offer opportunities for more comprehensive descriptions of fire spread characteristics, particularly when applied to wildfire events, to better capture scale dependent phenomena that do not occur at smaller experimental scales.

Fire behaviour data collected in field experiments and wildfires form the foundation of our quantitative understanding of fire dynamics. These data are used in the development and evaluation of predictive models with operational and scientific applications. We provide a broad synthesis of existing field-based studies in forest and shrubland ecosystems and discuss their limitations and needs for future research.
Look into the LITE in deep learning for time series classification
Authors: Ismail-Fawaz Ali , Devanne Maxime , Berretti Stefano , Weber Jonathan , Forestier Germain
Published: January 2025

Deep learning models have been shown to be a powerful solution for Time Series Classification (TSC). State-of-the-art architectures, while producing promising results on the UCR and the UEA archives, present a high number of trainable parameters. This can lead to long training with high CO2 emission, power consumption and possible increase in the number of FLoating-point Operation Per Second (FLOPS). In this paper, we present a new architecture for TSC, the Light Inception with boosTing tEchnique (LITE) with only $$2.34\%$$

2.34
%

of the number of parameters of the state-of-the-art InceptionTime model, while preserving performance. This architecture, with only 9, 814 trainable parameters due to the usage of DepthWise Separable Convolutions (DWSC), is boosted by three techniques: multiplexing, custom filters, and dilated convolution. The LITE architecture, trained on the UCR, is 2.78 times faster than InceptionTime and consumes 2.79 times less CO2 and power, while achieving an average accuracy of $$84.62\%$$

84.62
%

compared to $$84.91\%$$

84.91
%

with InceptionTime. To evaluate the performance of the proposed architecture on multivariate time series data, we adapt LITE to handle multivariate time series, we call this version LITEMV. To bring theory into application, we also conducted experiments using LITEMV on multivariate time series representing human rehabilitation movements, showing that LITEMV not only is the most efficient model but also the best performing for this application on the Kimore dataset, a skeleton-based human rehabilitation exercises dataset. Moreover, to address the interpretability of LITEMV, we present a study using Class Activation Maps to understand the classification decision taken by the model during evaluation.
Assessing the interaction of oceanic and riverine processes on coastal phytoplankton dynamics in the East China Sea
Authors: Gao Jiawei , Bi Rong , Sachs Julian P. , Wang Yaoyao , Ding Yang , Che Hong , Zhang Jing , Yao Peng , Shi Jie , Zhao Meixun
Published: January 2025

The interaction of riverine inputs and ocean current systems causes complex spatiotemporal variations in phytoplankton dynamics in marginal seas of the northwest Pacific Ocean, yet quantitative assessments of these variations and their causes remain limited. Here we evaluate phytoplankton biomass and community structure changes using lipid biomarkers, accompanying ocean circulation and nutrient variations in surface waters collected in spring and summer of 2017–2018 at 118 sites in the East China Sea off the Zhejiang coast. High biomass of diatoms, inferred from brassicasterol concentrations, shifted from the south in spring to the north in summer, while high dinoflagellate biomass, inferred from dinosterol concentrations, occurred mainly in the Changjiang (Yangtze) River plume and adjacent areas in both seasons. Seasonal variation in phytoplankton distribution was linked to the spatial extents of water masses such as the Changjiang Diluted Water (CDW) and the intrusion of the Kuroshio Subsurface Water (KSSW). A three end-member mixing model was applied to quantify water mass contributions. The results showed that an increase in the KSSW (from 0 to 40%) and a decrease in the CDW (from 100 to 20%) resulted in a significant (20%) increase in diatom proportions and a significant (20%) decrease in dinoflagellate proportions. Dinoflagellate proportions were highest in the CDW-dominated region, while diatoms and total phytoplankton biomass were higher in the CDW–KSSW mixing region and the KSSW-dominated region. This study highlights the dynamic response of the phytoplankton community to water mass changes in marginal seas that can aid coastal ecosystem management.
A Sponsor’s Best Practice and Operating Principles to Manage Data Monitoring Committees
Authors: Birck Malene Muusfeldt , Rasmussen Josephine Skovgaard , Helmark Ida Carøe , Lollike Karsten
Published: January 2025

The use of data monitoring committees (DMC) to safeguard patients’ safety in clinical trials has evolved over the last decades and has become increasingly common. To ensure well-operating and high-performing DMCs, pharmaceutical companies need to establish clearly defined operational processes while continuously seeking to optimize these and adapt to the needs of drug development. Although there are health authority guidelines on establishing and managing a DMC, the perspectives and experiences of sponsors are often underrepresented. This publication shares insights on a sponsor, Novo Nordisk (NN), regarding principles and practices for DMC establishment and management across varying trial types and therapeutic areas, including challenges and solutions. Highlighting NN’s structured and successful approach to DMCs, it details clearly defined roles and responsibilities that ensure productive DMC meetings and high-quality data for the DMC. Additionally, NN’s practices for clear, transparent, and trustful communication between the sponsor, the DMC, and the independent external statistical vendor are described. Processes for quality control, internal audits, and learnings from inspections and how these are incorporated for continuous improvement of the DMC process are discussed. While the processes and practices described are primarily designed for medium and large pharmaceutical companies, certain aspects may also be relevant and beneficial for smaller companies.
Exploring Demographic Factors Influencing Indian Nursing Students’ Willingness to Volunteer
Authors: Prashar Pradeepti , Sharma Dinesh Kumar
Published: January 2025

Objective

To investigate the demographic determinants influencing nursing students’ intentions to volunteer during health emergencies in India, providing insights that can inform policy and educational interventions to enhance their engagement and effectiveness in crisis situations.

Methods

A comprehensive cross-sectional survey was conducted among final-year nursing students, utilizing an online self-administered questionnaire developed through an extensive review of existing literature. The collected data were analyzed using the SPSS software tool.

Results

Four hundred nursing students participated in the study. The analysis showed that age, marital status, location, family income, educational program, and district strongly influence volunteer inclinations. Although they face challenges, nursing students’ desire to help during emergencies shows their dedication and importance within health care. Strategic assistance, flexible training, and recognition can increase volunteerism. Giving nursing students resources and support makes them confident, equipped, and motivated to respond to emergencies, improving community resilience and emergency health care.

Conclusions

This study enhances our understanding of demographic influences on volunteerism and informs strategies to foster a more robust and willing nursing workforce in India for future health emergencies. Future research should focus on understanding psychological factors in other states of India.
Social Media Memes and Early Public Opinion Formation Regarding Highly Pathogenic Avian Influenza (HPAI) as a Public Health Threat in the United States
Authors: Pascual-Ferrá Paola , Alperstein Neil , Barnett Daniel J. , Rimal Rajiv N.
Published: January 2025

Per Research Letter article type, we are not including an abstract.
A review of the effectiveness of short-time work programmes: The Spanish case from a comparative perspective
Authors: Vaquero García Alberto
Published: January 2025

This article evaluates short-time work (STW) schemes, known as temporary labour adjustment plans in Spain, from a comparative perspective. The use of STW schemes in the European Union during the COVID pandemic contained the redundancy processes that traditionally occur during adjustments to economic crises. These programmes not only made it possible to maintain employment but also allowed for a much faster economic recovery. The main contribution of this article is that it studies the functioning and results of this type of action in Spain and also considers the effects in other countries. This policy watch exercise also points to some recommendations for improving the functioning of STW schemes.
From blitzkrieg to blitzscaling: Assessing the impact of venture capital dynamics on military norms
Authors: Schwarz Elke
Published: January 2025

Venture capital (VC) has recently emerged as a powerful new actor in the military domain. In the USA, VC investment in defence startups doubled between 2019 and 2022. A similar trend is noticeable in Europe, where billions are funnelled into AI-drone startup companies, spurred by escalating conflicts around the globe. VC investment is a ‘high-risk-high-reward’ way of financing military technologies, which requires fast-paced exponential growth at scale (‘blitzscaling’) and the disruption of existing markets. But with disruption comes debris. What happens when military organisations, which must navigate ethical questions pertaining to life and death, become shaped in the image of Silicon Valley and VC funding? This paper argues that the VC sector exerts a significant influence not only on military procurement processes but also on the direction of military operations and practices. This, in turn, has potentially significant effects on the communities and stakeholders affected by military operations, including those caught in the crosshairs of VC-backed AI technologies.
Kurdish Bildungsroman and Its Historical and Social Concerns: The Case of Sayyed Qadir Hedayati
Authors: Bezdoode Zakarya
Published: January 2025

This research delves into the works of contemporary Kurdish novelist Sayyed Qadir Hedayati, specifically focusing on two of his novels: Bull Roar and Bardinah. These selected novels fall within the Bildungsroman genre, a category not commonly explored in Kurdish literature. The scarcity of such novels in the language prompted the investigation into the underlying reasons for their emergence in Hedayati's works. While Bildungsroman focuses on the formation of the individual, Hedayati's novels, very much like the early German cases of the genre, delineate the social and cultural concerns of a community. Through analysis, it is revealed that Kurdish Bildungsroman can flourish within specific historical and political contexts. The driving force behind the plot of these novels lies in the quest for identity in a controversial historical and political context. Hedayati utilizes the Bildungsroman genre to amplify the voices of a community that has grappled with marginalization. By doing so, he invites readers to immerse themselves in the intricate fabric of Kurdish life and development.
‘Digital Divide’: How Do Central and Local SOEs Respond Differently to Digitalization in China
Authors: Luo Xiaowei Rose , Wang Jun , Chen Shuangying , Chen Boyi
Published: January 2025

Despite the important role of state-owned enterprises (SOEs) in government policy implementation, there is a lack of research on how SOEs owned by different government entities differ. We draw on an attention-based view (ABV) to understand how central government-owned (called central SOEs) and local government-owned enterprises (called local SOEs) differ in their response to digitalization, a major state objective in China in recent years. The two types of SOEs differ in the foundational feature of attention structure – the rules of the game (as embodied in their different goals, identities, and evaluation of top executives) – as well as important features such as governance structures and resources. These features can trigger more attention in central SOEs to digitalization. Given the interdependence of these features in shaping the structural distribution of attention, we further propose how governance structures and resources can influence strategic attention differently in SOEs with different rules of the game. The arguments are tested using data from all Chinese-listed manufacturing SOEs between 2009 and 2020. The study reveals different responses to national strategy between central and local SOEs due to their distinct attention structures designed by the state. It also extends the ABV and research on corporate digital transformation.
OP09 Investigating The Nature And Scope Of Innovative Payment And Pricing Schemes For Health Technologies
Authors: Ardito Vittoria , Cavallaro Ludovico , Drummond Michael , Ciani Oriana
Published: January 2025

Introduction

Innovative pricing and payment schemes have been proposed to address the affordability issues raised by new health technologies or the uncertainty about their long-term safety and effectiveness. As part of the Horizon Europe project HI-PRIX, we investigated the nature, scope, and impact of these arrangements.

Methods

We undertook a PRISMA-ScR-compliant review in PubMed, Web of Science, and Scopus, from 2010 to 2023. We also searched health technology assessment (HTA) agency websites. The search strategy was structured around two blocks: “pricing/payment schemes,” and “innovativeness.” Studies illustrating pricing/payment schemes with sufficient level of details to explain their functioning were selected, also through a nested evaluation of an artificial-intelligence-powered tool for systematic reviews. These schemes were classified according to several criteria, such as their purpose, nature, governance, product category, data collection needs, foreseen distribution of risk, and implementation challenges. The study protocol was published in PROSPERO (CRD42023444824).

Results

“Innovative payment and pricing schemes” were defined as arrangements that go beyond price per unit of the technology, simple price/volume agreements, or expenditure caps. Seventy innovative schemes were identified, of which 25 were only illustrated theoretically, while 45 have been implemented in practice. So far, 170 real cases of implementation have been identified. The schemes target pharmaceuticals, vaccines, and/or medical devices. Whether designed to incorporate unique features of a given technology, or to address specific challenges, the schemes can be classified by different value drivers, including type of technology, therapeutic indication, or timeline of the agreement.

Conclusions

Available pricing and payment schemes have the potential to offer a comprehensive toolkit to policymakers facing reimbursement and access decisions, highlighting that it is not the scheme per se that is innovative, rather its application/use in a given context or for a given challenge. The catalog populates the Pay for Innovation Observatory, a publicly available repository.
OP15 Cost-Effectiveness Of Quantitative Fecal Immunochemical Tests For Detecting Suspected Colorectal Cancer In The Context Of Colonoscopy Capacity Constraints
Authors: Biz Aline Navega , Stevenson Matt , Whyte Sophie , Hamilton Jean , Ren Shijie , Heathcote Laura , Simpson Emma , Cooper Katy , Clowes Mark , Ball Alex , Benton Sally , Carten Rachel , Kurien Matt , Monahan Kevin , Harnan Sue
Published: January 2025

Introduction

Approximately 42,000 new cases of colorectal cancer (CRC) are diagnosed annually in the United Kingdom with 16,800 deaths. Evidence suggests that quantitative fecal immunochemical tests (FIT) are a good predictor of CRC risk in symptomatic patients presenting to primary care. We aimed to assess the cost-effectiveness of FIT in this setting, considering capacity constraints and waiting times for subsequent colonoscopy.

Methods

We compared two diagnostic FIT strategies, at various thresholds, in the model: (i) FIT for all patients and (ii) current practice where only low-risk patients received FIT. Patients with positive FIT scores and high-risk patients in current practice received colonoscopy. Diagnostic accuracy evidence from published literature, standard UK cost sources, and other sources were used to estimate health outcomes and costs. Waiting times before colonoscopy were assumed proportional to the numbers referred, with the impact of delayed colonoscopy taken from published models. Savings per quality-adjusted life years (QALYs) lost and incremental net monetary benefit (INMB) were used. Uncertainty was evaluated.

Results

Model results suggested that, compared to current practice, FIT generated a positive INMB for the majority of thresholds assessed (GBP200 [USD254] to GBP350 [USD445] per patient at a willingness to pay of GBP20,000 [USD25,474] per QALY gained). A reduction in the number of patients sent to colonoscopy led to cost savings. However, these thresholds were associated with slight QALY losses due to a small proportion of false negative results associated with significantly delayed diagnosis, which outweighed the benefits associated with quicker times to colonoscopy for those with positive FIT results. Savings of over GBP100,000 (USD127,374) per QALY lost were generated. Conclusions were robust to the sensitivity analyses undertaken.

Conclusions

With capacity constraints explicitly represented in the economic modeling, offering FIT to all patients presenting to primary care with symptoms suggestive of CRC was cost effective when compared to current practice. However, the optimal threshold could not be robustly determined due to limited diagnostic accuracy data, parameter uncertainty, and limitations in the model structure; additional primary research could reduce uncertainty.
OP16 “Progress Is Impossible Without Change”: A Case Study To Feasibly Incorporate Environmental Sustainability In Health Technology Assessment
Authors: Malcolm Robert , Naylor Rebecca , Pegg Melissa
Published: January 2025

Introduction

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

Methods

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

Results

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

Conclusions

Adapting HTA will support wider efforts in health systems to reduce environmental impacts. This model can be practically applied to account for both cost and carbon data, facilitating a holistic and environmentally sustainable approach to decision-making. As part of encouraging additional research into the environment, HTA agencies will need to provide “incentives” for companies to undertake this additional research.
OP19 Multiple-Criteria Decision Analysis: Techniques To Support Environmental Sustainability Framework Development In Health Technology Assessment
Authors: Pegg Melissa , Boutell Janet , Taylor Matthew
Published: January 2025

Introduction

Technical and trade-off issues to incorporating environmental data in health technology assessment (HTA) decision processes are known. Multiple-criteria decision analysis (MCDA) has been successfully used across disciplines, supporting multifaceted technology decision-making. Challenges in prioritizing environmental criteria, resource constraints, and other criteria to assess technologies can be overcome through the application of MCDA, also used in conjunction with other techniques in HTA.

Methods

A systematic review of methods to evaluate environmental sustainability in HTA was conducted following the PRISMA guidelines. Using a comprehensive search strategy, Ovid Embase, Web of Science (all databases), PubMed, EBSCOhost GreenFILE, IEEE Xplore, international HTA database, Cochrane Library, and grey literature were searched. The review analyzed the following broad themes: methods to overcome barriers, including how methods can handle “trade-off” issues between financial and environmental considerations; resource and expertise constraints; and data quality issues. This review determined how comprehensive the methods are for assessing sustainability in HTA. Frameworks were also ranked based on their overall transparency and feasibility.

Results

This review (SR) identified 10 key studies. Half of these studies outline MCDA models within the frameworks. All MCDA studies have been combined with other techniques to support sustainable technology decision-making HTA. Analytical MCDA models with roots in mathematics are highlighted as reproducible techniques to support multifaceted decision-making, particularly where there are conflicting criteria. Analytical hierarchy process (AHP) used in conjunction with a circular economy framework for health technology supports global health system net zero and wider sustainability goals. A performance matrix model elicits outcome trade-off by assigning weights to costs, technical performance, and environmental outcomes.

Conclusions

The multidisciplinary findings of this research provide valuable insight in an area where there is currently limited research, confirming and expanding on previous scoping reviews. The results highlight several comprehensive MCDA models supporting HTA sustainability framework development. Further research is warranted into the feasibility of the frameworks. Study selection and data extraction were undertaken independently due to project time constraints.
OP26 Artificial Intelligence For Literature Screening And Selection: Does The Evidence Support Its Use In Systematic Literature Reviews?
Authors: Rekowska Dominika , Gulser Sera Sahbaz , Santpurkar Nita , Fox Grace E. , Ali Shayan , Halfpenny Nick , Nass Petra
Published: January 2025

Introduction

The past decade has seen an exponential increase in peer-reviewed clinical research literature. Consequently, preparing and updating systematic literature reviews (SLRs) is more resource intensive and costly. Artificial intelligence (AI) could potentially accelerate SLR preparation. This study presents a review of evidence evaluating the accuracy of AI methods in SLR preparation and results of a case study using DistillerSR’s AI functionality.

Methods

The review was based on a search of MEDLINE, Embase, and Embase Preprints databases using title/abstract keywords and subject heading synonyms for AI, machine learning, natural language processing (NLP), and publication screening and selection. The protocol is published on PROSPERO (CRD42023452391). To supplement this review, we conducted a case study with DistillerSR’s AI tools. We applied the AI classifiers, which use NLP to learn patterns from multiple SLRs across several indications, which encompassed over 15,000 references’ titles and abstracts. We then compared those patterns with the human responses to build an AI model that can be applied to other references.

Results

The search identified 2,209 records. After deduplication, the titles/abstracts of 2,200 records were screened; of these, 79 full-text records were assessed. A total of 42 records met the eligibility criteria for inclusion. The majority were case studies. The most frequently reported tools were DistillerSR AI (n=9), Abstrackr (n=6), ASReview (n=2), and LiveSTART (n=2). The evidence showed efficiency gains, but accuracy varied across studies and AI tools. Results of the case study using DistillerSR’s AI tools indicated efficiency gains with adequate accuracy but with variability across different SLRs. Inclusion and exclusion of articles were consistent with the human decisions.

Conclusions

The findings of our review and case study indicated that AI can be used reliably in the screening of articles for SLRs and could improve efficiency. However, the evidence is still evolving, and additional studies are needed. There is a need for clear guidelines on the role of AI in study screening and selection for health technology assessments SLRs and submissions.
OP27 Artificial Intelligence Use In Health Technology Assessment In Low- And Middle-Income Countries
Authors: Ramos Maíra Catharina , Shimizu Helena Eri , Zimmermann Ivan Ricardo
Published: January 2025

Introduction

Health technology assessment (HTA), by investigating clinical, economic, and social consequences of technologies in a country, enhances health system equity and sustainability. In low- and middle-income countries (LMICs), economic constraints and inadequate access to specialized human resources present challenges. Therefore, strategies to optimize resource allocation in the health sector are necessary.

Methods

A literature review was carried out, with studies that directly identified barriers or facilitators for the use of artificial intelligence (AI) in HTA being considered eligible. The texts were analyzed from the perspective of LMIC. The searches were carried out on 8 August 2023 using the following databases: MEDLINE via PubMed, Web of Science, and Google Scholar. The selection was performed in two stages: (i) screening by title and abstract and (ii) evaluation of the eligibility criteria in full text.

Results

After conducting the search, five studies were selected for narrative synthesis. Evidence of the potential benefits of using AI in HTA in low- and middle-income countries includes rationalization of resources; reduction of the burden on health systems and minimization of human workload; efficiency in data analysis, including clinical data; prediction of economic impact; and support for managerial decision-making. However, important challenges were also raised, such as the deficiency of local infrastructure; the training and education of professionals; the lack of ethical regulation; and the organizational and political considerations of these countries.

Conclusions

There are few studies in the literature that provide scientific support on the use of AI in HTA decision-making in LMIC. The evidence points to increasing the efficiency and rationality of resources, enhancing the results arising from HTA. With this, it is expected to expand access to health technologies and enable more sustainable health systems.
OP28 Digi-HTA: The Assessment Method For Digital Health Technologies In Finland
Authors: Haverinen Jari , Falkenbach Petra , Turpeinen Miia , Röning Juha , Reponen Jarmo
Published: January 2025

Introduction

The ever-increasing number of new and innovative digital health technologies (DHTs) also sets new demands on health technology assessment (HTA) methods in addition to traditional HTA domains. In 2018, the Finnish Ministry of Social Affairs and Health recognized the need for new HTA methods for DHTs in Finland and commissioned method development.

Methods

The development work of the new HTA method for DHTs and the findings related to it were based on three substudies:

(i) The new HTA method was developed through a literature review, expert interviews, and four multiprofessional workshops.

(ii) Feedback about new HTA recommendations was collected from healthcare decision-makers through a web-based survey (n=24). Feedback on the developed HTA framework was collected through a web-based survey for companies offering DHT products (n=8).

(iii) Initial experiences about the state of data security and protection of assessed products were gathered through the assessment process.

Results

A new Digi-HTA method that supports a wide range of DHTs, such as health apps, AgeTech, artificial intelligence, and robotic solutions, was published in 2019. According to the healthcare decision-makers participating in the study, although the Digi-HTA recommendations included clear and beneficial information, their integration into healthcare decision-making processes should be improved. Responses from companies offering different DHTs indicated that the Digi-HTA framework would be an appropriate tool for performing assessments for their products. During the assessments, deficiencies in compliance with the best practices of data security and protection as well as data security problems were found.

Conclusions

The rapid development of DHTs requires that the HTA methods also adapt to the development so that no new and innovative products are excluded from the assessments. In addition to the value of DHTs, their quality, such as data security and protection, should be assessed so that decision-makers can be supported in the best possible ways.
OP36 Real-World Data From Early Access Programs In France: A Two-Year Review
Authors: Thomassin Camille , Fernandez Judith , Galbraith Margaret , Babin Céleste , Bardin Marion , Diatta Thierno , Desbiolles Alice , Beaufils Alexandre , Pelon Floriane , Cochat Pierre
Published: January 2025

Introduction

The 2021 reform of early access (EA) for medicinal products in France includes a mandatory data collection for each patient. The objective of this work was to perform a two-year review of the protocols for therapeutic use and data collection (PUT-RD) validated by the health technology assessment body (Haute Autorité de Santé [HAS]) in collaboration with the national regulatory body where applicable.

Methods

The minimum dataset defined in the PUT-RD varies depending on the regulatory status of the product and may include patients’ characteristics, conditions of use, efficacy, and safety data. A descriptive review of the PUT-RDs approved between 1 July 2021 and 30 June 2023 was carried out by HAS. The following information was retrieved in each published PUT-RD: type of EA (pre- or post-marketing authorization); collection of efficacy data (yes or no) (if yes, inclusion of a patient-reported outcome measure [PROM] or no); type of data source (registry or electronic platform provided by a contract research organization [CRO]).

Results

During the review period, a total of 98 PUT-RDs were validated, corresponding to 98 EA favorable decisions. EAs were authorized prior to marketing authorization in 40 percent of the cases. A collection of follow-up efficacy data was planned in 52 PUT-RDs, including integration of patients’ perspectives through a PROM in 32 PUT-RDs. Data collection through a registry was planned in six PUT-RDs (using the DESCAR-T registry), otherwise data collection was mainly planned through private electronic platforms operated by CROs (80% of the PUT-RDs).

Conclusions

To optimize the generation of relevant clinical data to be used in the regular HTA process, EAs should be requested early, prior to marketing authorization. Additionally, the use of existing data sources, in particular disease registries, is to be developed to avoid duplicate data collection and alleviate the burden for healthcare professionals.
OP37 The Spanish Health Technology Assessment Network Methodological Approach For The Utilization Of Real-World Data In The Preadoption Phase
Authors: García Guillermo Pérez , Fernandez Celia Muñoz , Remón Lucía Prieto , Orriols Carlos Tellería , Alemán Hugo Hernández , De Val Soledad Isern , Armesto Sandra García
Published: January 2025

Introduction

Preadoption assessments are the most frequent type of evaluation conducted by the Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS). RedETS aimed to develop a framework to utilize real-world data (RWD) to better adjust its assessments to the Spanish population’s context and provide live assessments throughout the lifecycle of health technologies.

Methods

A working group within RedETS was set up, which held several meetings to define the primary uses of RWD in the short term. Next, a manual review was conducted on national and international initiatives that provided guidance on the use of RWD in HTA. Common pathways for utilizing RWD in HTA were identified. The working group agreed to outline and explain the key overarching steps and provide general guidelines for working with RWD, developing as illustration a use case for an interventional technology. The Big Data project of Aragon (BIGAN) was chosen as the data source for the use case.

Results

We formulated a case for leveraging RWD in the assessment of implantable cardiac defibrillators (ICDs) for the prevention of sudden cardiac death (SCD). Based on this scenario, we developed a methodological framework outlining a workflow consistent with RedETS practices. RWD complemented the usual process of systematic review of a technology. Crucial steps comprised the definition of data requirements through a data model specification, an exploratory data analysis, and the construction of a decision model. We presented solutions for dealing with unavailable data on essential variables and unstructured records. We discussed the main limitations to account for when working with RWD.

Conclusions

The task ahead holds great hope but requires overcoming some challenges to fully deploy RWD-driven methods. This entails fostering collaboration with health authorities and designated data holders to address data access challenges. In the short term, it is essential to include data scientists in assessment teams and provide appropriate capacity-building to encompass RWD tools and modeling techniques.
OP47 New Health Technology Assessment Framework For Digital Health Technologies
Authors: Segur-Ferrer Joan , Moltó-Puigmartí Carolina , Peiró Roland Pastells , Vivanco-Hidalgo Rosa Maria
Published: January 2025

Introduction

Experts emphasize the necessity of reconsidering the approaches used in the health technology assessment (HTA) of digital health technologies (DHTs) to adequately address their particular characteristics. In this context, the Agency for Health Quality and Assessment of Catalonia was commissioned to develop a specific framework for the assessment of DHTs in collaboration with the agencies that constitute the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS).

Methods

To accomplish the assignment, a combination of methodologies was used. To establish the domains and dimensions, an international survey, a scoping review of the literature, and a thematic analysis were executed. To determine the evidence standards that DHTs must achieve according to the risk classification derived from their use, the updated version of the evidence standards framework (ESF) from the National Institute for Health and Care Excellence (NICE) was adapted to the Spanish context. National experts in the fields of HTA and DHTs collaborated on different tasks to develop the framework.

Results

The framework encompasses three distinct sections. The first section provides an introduction, detailing a DHT classification system that is based on the system proposed by NICE in their ESF. Following this, Section A elaborates on a comprehensive set of 13 domains, 41 dimensions, and nine sub-dimensions, offering a detailed description of each. Section B consists of the adaptation of the 21 evidence standards from the NICE ESF to the Spanish context. Of note, a clear link was established between the classification system, the domains, dimensions, sub-dimensions, and the evidence standards.

Conclusions

The resulting framework was published in November 2023. Since its publication, it has become the reference framework for the HTA of DHTs within the Spanish National Health System, primarily by the HTA agencies that constitute RedETS. The document will be periodically reviewed and, if necessary, adapted to align with emerging technologies and changes in legislation.
OP48 Establishing The Implant Subsidy List In Singapore: A Collaborative Approach Between Health Technology Assessment And National Procurement Agencies
Authors: Ee Wong Yen , Ding Wayne , Ho Yan Teck , Soon Swee Sung , Ng Kwong
Published: January 2025

Introduction

Public healthcare institutions (PHIs) experience rising and discordant implant costs. Implementing subsidies for implants without concurrent price harmonization through national procurement contracts impedes equitable patient access. This abstract describes the collaboration between the Agency for Care Effectiveness (ACE), Singapore’s national health technology assessment (HTA) agency, and the public healthcare supply chain agency (ALPS) to establish the Implant Subsidy List (ISL).

Methods

The alignment between ISL and concurrent national procurement contracts for implants required close coordination and co-development of streamlined and scalable processes. To achieve this, ACE and ALPS collaborated to understand the complex implant landscape by leveraging on known vendors and products and pre-empting upcoming ones, identifying key opinion leaders, and sharing technical expertise. Both agencies also developed common-use templates and streamlined vendor submission processes. Of note, joint request-for-proposal (RFP) exercises for national subsidy and procurement listings combined negotiation efforts to achieve lower implant prices. Regular cross-agency discussions enabled continuous knowledge sharing and process refinement in an evolving implants landscape.

Results

For phase one rollout of ISL, 15 implant topics across eight clinical functions were evaluated, supported by concurrent establishment of 15 national procurement contracts. As of December 2023, ACE listed 22,689 ISL implants for implementation, with more topics onboarded on a rolling basis. ACE and ALPS streamlined process flows, standardized communications channels and information, and utilized contractual tools. Vendors could submit for both subsidy and procurement through the secure ALPS portal, reducing duplication of work and errors while allowing procurement and subsidy consideration processes to proceed concurrently. Combined negotiation efforts have resulted in an average price reduction of 19 percent.

Conclusions

The alignment between national HTA and procurement agencies is important for successful scaling. The ACE–ALPS collaboration has synergized both agencies’ understanding of the complex implant landscape and established streamlined workplans and processes to support initial establishment of ISL and its maintenance. Challenges include navigating strict procurement rules and continuous cross-agency improvement efforts to ensure applicability in an evolving landscape.
OP51 Strategies For Training Laypeople To Participate In Health Technology Assessment: A Scoping Review
Authors: Dias Morais Quenia Cristina , Itaborahy Alex , Frossard Leny , Mateus Iandy , Leite Bianca , Santos Marisa
Published: January 2025

Introduction

This study aimed to map strategies for educating laypeople about health technology assessment (HTA). Although integrating community is challenging, the engagement of patients/public in the processes of HTA has garnered support and endorsement from international network agencies. Dissemination of information, educational empowerment, and training are vital to give individuals capacity to partake in the intricate web of processes actively.

Methods

This review considered studies addressing educative strategies to train laypeople on HTA, additionally mapping and summarizing relevant methodological papers from any international HTA agency. Four databases were searched for qualitative, quantitative, and mixed methods study designs. The grey literature search included policy and practice documents from HTA and health organization websites. Two reviewers independently completed title and abstract screening before the full-text review and data extraction.

Results

The main contributors to the production of knowledge about educating laypeople in HTA were the United Kingdom (40%), Spain (20%), and Canada (13%). Most studies included were conducted in the context of the United Kingdom (27%), followed by Spain (20%), and international networks context (20%). The main strategies included conference-like events (21%), the production of educational materials (18%), training (11%), and the use of plain language (8%). Furthermore, international HTA and health agencies have offered courses, and online training produced and made available online guidance materials for increasing laypeople’s participation in the HTA process.

Conclusions

Despite the global efforts to educate laypeople on HTA, jurisdictional variations underscore the need for a more inclusive approach. Strategies like events, educational material production, training, and clear-language use offer diverse avenues for public engagement. International agencies’ commitment to courses, online training, and guidance reflects a collective effort to enhance public involvement.
OP53 An Actionable And Legible Toolbox For The Appraisal Of Healthcare Innovations Developed Through Nationwide Stakeholder Collaboration
Authors: Plamondon Geneviève , Ganache Isabelle , Martin Mélanie , Lehoux Pascale
Published: January 2025

Introduction

In Québec, Canada, decisions about implementing innovations are taken both centrally for province-wide access and locally by healthcare institutions. There is no systematic evaluation process and various stakeholders are involved, notably within a new nationwide governance structure. There was a wish to increase consistency and clarity with the principles and methods used by various bodies across the innovation lifecycle.

Methods

The starting point was the Institut national d’excellence en santé et services sociaux (INESSS) multidimensional framework, which focuses on the population-level, clinical, economic, organizational, and sociocultural value of drugs, technologies, and interventions. The framework, already under evolution drawing on Responsible Innovation in Health (RIH), evolved through collaborative work between INESSS’ methodological and scientific teams, but also and foremost with diverse groups and institutions within the provincial innovation ecosystem (e.g., university-based incubators, regional hospitals). The first steps were to capture current concepts and practices from different stakeholders, as well as their operational needs in terms of assessment tools.

Results

This multistakeholder taskforce resulted in the development of an operational toolbox meant to guide the value appraisal of innovations through a lifecycle approach. First aimed at stakeholders involved locally in healthcare institutions, the work conducted was equally beneficial to INESSS by enabling its evaluation teams to contribute to the operational tools needed to enhance clarity and legibility of the agency’s processes and methods. The level of collaboration with stakeholders across the province was also unique and has strengthened the understandability and actionability of the toolbox developed. Some challenges were faced, and related actions will be discussed.

Conclusions

Both the taskforce process and its output contributed to improving consistency in the assessment of innovations across the province. They made more explicit what may sometimes be perceived as the HTA “black box.” The INESSS value appraisal framework also evolved considering key elements of responsibility from RIH and through this collaboration with stakeholders, and its applicability in different contexts was reinforced.
OP55 Transferability Of Economic Models Within Health Technology Assessment In Central And Eastern Europe: Bridging The Gap
Authors: Hołownia-Voloskova Malwina , Obrzut Grzegorz , Walczak Jacek
Published: January 2025

Introduction

Health technology assessment (HTA) plays a pivotal role in healthcare decision-making, evaluating the cost-effectiveness of emerging technologies. Central and Eastern Europe (CEE) presents a unique context for HTA, marked by diverse healthcare systems, economic variations, and regulatory frameworks. This study addresses the critical issue of transferability of economic models within HTA in CEE, aiming to bridge existing gaps and enhance the region’s capacity for informed decision-making.

Methods

A comprehensive and systematic approach was employed to assess the transferability of economic models in the context of HTA across CEE. We conducted an extensive literature review, analyzed HTA reports, and engaged in expert consultations to understand the nuances of the healthcare systems in the region. Key factors influencing the transferability of economic models, such as healthcare infrastructure, economic disparities, and regulatory landscapes, were systematically evaluated. The study focused on a range of economic models commonly used in HTA, including cost-effectiveness analysis, budget impact analysis, and multiple-criteria decision analysis.

Results

Our findings highlight the intricate dynamics influencing the transferability of economic models within HTA in CEE. While certain economic models exhibit a degree of generalizability across the region, there are notable variations based on specific contextual factors. Economic models designed for Western healthcare systems may not seamlessly translate to the CEE context due to differences in healthcare delivery, patient populations, and policy frameworks. The study identifies critical determinants of transferability, including the level of healthcare infrastructure development, economic disparities among CEE countries, and the diversity in regulatory approaches.

Conclusions

In conclusion, this study emphasizes the need for a nuanced and context-specific approach to the transferability of economic models within HTA in CEE. Bridging the gap in transferability enhances the region’s capacity for evidence-based healthcare resource allocation and contributes to the overall efficiency and sustainability of healthcare systems in CEE.