bluuebunny/crossref_metadata_2025_split huggingface dataset:
Morphological traits and spatial distribution of azooxanthellate corals of Rhizangiidae in the Laccadive Sea
Authors: Viswambharan Divya , K. R. Sreenath 
Published: January 2025

Abstract
Azooxanthellate corals of Rhizangiidae, with their distinctive morphological and ecological features, are widely distributed across global oceans but remain under-studied due to identification challenges. Comprehensive underwater surveys across diverse marine habitats such as rocky reefs and submerged shipwrecks were undertaken, and findings highlighted the exclusive presence of Culicia stellata in natural rocks, off the coast of Kaup for the first time in Indian EEZ. The study also records the presence of Cladangia exusta, nearly six decades after the first record from off Cochin, Laccadive Sea. This research presents a detailed study of the taxonomic description, distribution, and ecological preferences of Cladangia exusta and Culicia stellata in the Laccadive Sea. This study underscores the importance of accurate species identification for effective conservation strategies and enriching biodiversity records.
Rethinking rebel victory in civil war
Authors: Wedgwood Young Enrique , Florea Adrian 
Published: January 2025

Abstract
Research on civil war termination typically classifies conflict outcomes into homogeneous categories. Civil wars are conventionally described as ending in ‘victory’ for one side, ‘negotiated settlement’, or ‘stalemate’. However, each of these common categories conceals a significant degree of unexplored variation. Not all peace processes are the same, nor should we assume equivalence between all ‘victory’ outcomes. Ignoring the variability in outcomes obscures our understanding of how civil wars actually end and can undermine efforts to examine how this may influence the sustainability of the ensuing peace. This article focuses on the concept of rebel victory and argues that it has been used to describe a wide range of civil war outcomes that share some features but that also differ along three dimensions: (i) the residual threat posed by the defeated regime; (ii) the role of external actors in enabling victory; and (iii) rebel fragmentation. The article describes these dimensions and the influence that they can exert on the likelihood of continued political instability in the aftermath of rebel victories. The examples of rebel victories in the Central African Republic (2003 and 2012) are used to demonstrate the analytical utility of this novel conceptualisation of rebel victory.
OP10 Affordability Decision Rules: Systematic Review And Categorization Of Budget Impact Thresholds For 174 Countries Based On International Practices
Authors: Pichon-Riviere Andres , Cairoli Federico , Marti Sebastian Garcia , Augustovski Federico 
Published: January 2025

IntroductionEffective health intervention coverage decision-making hinges on understanding budget impact (BI). Despite progress in estimating cost-effectiveness thresholds, a standardized approach for defining BI, particularly high BI, remains elusive. Addressing this gap, our systematic review aims to identify existing BI thresholds and establish universally applicable BI categories, providing a much-needed framework for global health policy.MethodsIn our systematic review, we adhered to Cochrane methods and PRISMA reporting guidelines (PROSPERO protocol CRD42020221652). We included articles that detailed current BI or affordability thresholds used by national or regional healthcare systems, sourcing from PubMed, Embase, and International Network of Agencies for Health Technology Assessment (INAHTA) communications. To address variability across jurisdictions, we normalized BI/affordability thresholds to a fraction of each country’s total healthcare expenditure. This approach enabled us to categorize BI thresholds into four distinct levels (low, moderate, high, and very high) and apply these categories universally across countries.ResultsWe retrieved 1,592 records, identifying affordability thresholds and their underlying rationales in 12 countries: Argentina, Australia, England, Canada, Germany, France, Netherlands, USA, Taiwan, Ukraine, Scotland, and Singapore. Utilizing this data, we established four BI threshold levels relative to the total health budget: low (below 0.00005), moderate (0.00005 to <0.0001), high (0.0001 to <0.0002), and very high (>=0.0002). We then extrapolated these thresholds, along with their uncertainty ranges, to 174 countries, using 2022 World Bank data.ConclusionsOur study provides a comprehensive overview of current global affordability thresholds and their implications for healthcare coverage and reimbursement. We found that explicit BI thresholds are predominantly established in high-income countries. Our findings offer critical, evidence-based guidance on affordability decision rules, applicable to health systems in 174 countries, thereby contributing significantly to the standardization and informed policymaking in global healthcare.
OP11 Assessing Patient And Societal Unmet Needs: The Needs Examination, Evaluation And Dissemination (NEED) Assessment Framework
Authors: de Noordhout Charline Maertens , Levy Muriel , Schönborn Claudia , De Jaeger Mats , Kohn Laurence , Claerman Rani , De Pauw Robby , Cleemput Irina 
Published: January 2025

IntroductionThe healthcare ecosystem is predominantly supply-driven, leading to a lack of innovation in financially less-attractive health areas, inefficient use of public resources for healthcare, and unmet patient and societal needs. This study proposes a framework to identify unmet health-related patient and societal needs for different health conditions, to inform and support the development of needs-driven healthcare policy and innovations.MethodsTwo systematic literature reviews were conducted: one to update an already published literature review that identified tools for measuring patient needs; another to identify criteria for measuring health-related societal needs. Ovid MEDLINE and Embase were searched for English, French, and Dutch publications. In April 2023, 22 Belgian stakeholders and experts reviewed selected societal needs criteria. The NEED (Needs Examination, Evaluation and Dissemination) assessment framework, incorporating literature-derived patient and societal needs criteria, underwent discussions with the Health Minister’s Cabinet and federal health agencies from May to July 2023. The framework was challenged in November 2023 during international and national advisory committee meetings.ResultsThe literature reviews covered 52 studies. The NEED framework addresses patient, societal, and future needs across health, healthcare, and social domains. Patient-level criteria (13) include health (e.g., impact on quality of life), healthcare (e.g., burden of treatment), and social (e.g., social support). Societal needs criteria (6) encompass health (e.g., transmissibility), healthcare (e.g., value for money), and social (e.g., productivity losses). Future needs criteria (2) consider future burden of disease and economic burden. Each criterion (total: 40) has measurable indicators with calculation methods and data sources. Equity is recognized as a transversal dimension, requiring unmet needs data disaggregated by population group.ConclusionsFor the first time, a transparent scientific framework containing criteria and indicators for assessing the unmet needs of patients and society has been developed. This lays the foundations for a major shift towards a more needs-driven healthcare policy and innovation.
OP12 Identification Of Patient And Societal Needs In Melanoma: Application Of The Needs Examination, Evaluation And Dissemination (NEED) Assessment Framework
Authors: Schönborn Claudia , De Jaeger Mats , Levy Muriel , Kohn Laurence , Claerman Rani , De Pauw Robby , Cleemput Irina , de Noordhout Charline Maertens 
Published: January 2025

IntroductionThe NEED (Needs Examination, Evaluation and Dissemination) assessment framework aims to identify patient and societal unmet needs in various diseases, highlighting gaps for intervention. This approach is exemplified through a malignant melanoma case study, ranking sixth in European cancers. Therapeutic progress has been made over the last decade, prompting an assessment of remaining unmet needs.MethodsThe applicability of the NEED framework has been evaluated through a case study of melanoma in Belgium. The methodology had four components: (i) an overall description of the disease based on the scientific (published and grey) literature and clinical expert input; (ii) an online survey on the unmet needs of patients (n=37); (iii) semistructured interviews with individuals affected by melanoma (n=9); and (iv) secondary data collection for each NEED framework criterion, including scientific literature and public databases. The survey results were analyzed with descriptive statistics, and the interview transcripts were analyzed using a thematic analysis.ResultsUnmet needs in melanoma were categorized as patient-level health, healthcare, and social needs, alongside wider societal needs. Patients experienced a substantial burden from mortality in advanced stages, burdensome symptoms such as fatigue, and notable side effects of systemic treatment. Inadequate psychological support contributed to high levels of fear and anxiety. A scarcity of dermatologists posed a barrier to timely care access, and low awareness of melanoma risk led many patients to delay seeking medical attention, with significant societal implications for melanoma prevention efforts. The case study also identified research gaps concerning social and ethnic inequalities in melanoma care in Europe.ConclusionsUsing the NEED framework highlighted melanoma patients’ most crucial unmet needs. This evidence can be used to assess whether new interventions address the highest unmet patient or societal needs. Challenges in ensuring adequate sample size limit the generalizability of results. Capturing melanoma’s complexity in a snapshot masks some needs heterogeneity.
OP32 Identification Of Factors Alongside Costs And Effectiveness For The Technology Assessment Of Comprehensive Genomic Profiling: A Systematic Review
Authors: Schaik Lucas van , Engelhardt Ellen , Wilthagen Erica , Steeghs Neeltje , Coves Andrea Fernandez , Joore Manuela , Harten Wim van , Retèl Valesca 
Published: January 2025

IntroductionComprehensive genomic profiling (CGP) identifies many targets at once. However, it is challenging for reimbursement decision-makers to incorporate all potential effects in their assessment. The aim of this study is twofold: first, to identify which factors, besides effectiveness and costs, might influence the choice for CGP in advanced cancer patients, and second, to identify the available evidence for these factors.MethodsWe performed a systematic literature review in MEDLINE, Embase, and Scopus with a two-step design. First, a scoping search was performed to identify relevant factors. Extracted factors were grouped with domains of the EUnetHTA core model and ISPOR (Professional Society for Health Economics and Outcomes Research) “value flower.” Two expert sessions were held to validate factors and construct definitions. Second, a systematic search was conducted to identify the available empirical evidence for these factors. Eligibility criteria for the systematic search were the use of CGP (≥200 genes), advanced cancer patients, and the presentation of empirical evidence on one of the factors.ResultsFive factors were identified in the scoping search: “feasibility” (adopting tests in the health care system), “test journey” (pathway from requesting tests until reporting of results), “wider implications of diagnostic results” (impact of test beyond identifying on-label treatments), “organization of laboratories” (organization of tests and access to tests), and “scientific spillover” (learnings of testing). Eighty-three articles were included following the systematic search, and empirical evidence was identified for the factors “test journey” and “wider implications of diagnostic results”. Few studies had adequate comparative study designs. Heterogeneity was observed among studies in the definitions of outcomes and the reported evidence.ConclusionsComprehensive reimbursement decision-making for CGP can be supported by including the five identified factors. However, quantifiable evidence was only identified for the “patient test journey” and “wider implications of diagnostic results”. Current literature provides limited high-quality evidence to establish the added benefit of CGP, as adequately designed comparisons are lacking. For evidence-based decision-making, uniform outcome measurements are recommended.
OP35 Early Access To Medicinal Products In France: A Positive Evaluation Two Years Into The New Framework
Authors: Crespel Virginie , Roux Guillaume , Desbiolles Alice , Beaufils Alexandre , Diatta Thierno , Pelon Floriane , Thomassin Camille 
Published: January 2025

IntroductionIntroduced in July 2021, early access to pharmaceuticals allows French patients to have rapid and reimbursed access to presumed innovative medicines prior to marketing authorization or regular reimbursement registration. The French National Authority for Health (Haute Autorité de Santé [HAS]) is responsible for granting early access authorizations and for health technology assessment upstream of regular reimbursement. This analysis evaluates the outcomes of the 2021 reform.MethodsIn collaboration with the national regulatory body (ANSM) and the Ministry of Health, a descriptive and retrospective analysis has been conducted to assess the impact of this reform. The data were extracted from published HAS decisions and from the HAS internal information system (EVAMED). The period considered is the first two years of the reform, from 1 July 2021 to 30 June 2023. Different information has been analyzed, such as conclusions of decisions returned, therapeutic areas concerned, and decision processing time. An additional analysis focused on HAS opinions on regular reimbursement for the medicines for which early access was granted.ResultsIn two years, over 250 applications (including first applications, modifications, and renewals) have been submitted, increasing over time, and 180 decisions were issued by HAS within this period. Eighty percent of HAS decisions were positive for early access. Among the medicines for which early access was granted, 86 were also assessed for regular reimbursement, of which 78 percent obtained a positive clinical added value score (at least ASMR IV). Overall, the early access program is estimated to have facilitated coverage approximately nine months before regular reimbursement and benefited over 100,000 patients.Conclusions
Manufacturers make extensive use of early access applications. A positive assessment of the reform outcomes emerges from this analysis, emphasizing the role of HAS in accelerating patient access to presumed innovative treatments. In light of US experience and of the uncertainties surrounding fast-track authorization procedures, monitoring of the French early access system will continue.
OP38 Perinatal And Infant Mental Health Care: International Guideline Recommendations And Situation In Austria
Authors: Zechmeister-koss Ingrid , Reinsperger Inanna , Kern Julia , Edlinger Michael , Paul Jean 
Published: January 2025

IntroductionMental illnesses during pregnancy and after birth (perinatal period) affect one in five mothers and one in ten fathers. They can have adverse implications for child health and development and come with substantial economic costs. Many countries have developed integrated care models. We aim to summarize the international care model recommendations and contrast them with the current situation in Austria.MethodsWe conducted a scoping review of guidelines and recommendations for perinatal and infant mental health care (PIMHC) models and synthesized them into a best-practice model. The model overview targets prevention, early identification, and care of perinatal mental illness (PMI), as well as professional groups involved. We identified available Austrian PIMHC services via online search and expert consultation, clustered them according to our international model structure, and visualized availability on a geographical map. Additionally, we analyzed the use of five core mental health benefits from health insurance data. We narratively contrasted international recommendations with the Austrian availability and use of services.ResultsInternational recommendations suggest integrating primary prevention, systematic screening, and stepped care. After identifying a PMI, a care pathway needs to be defined, including diagnostic and coordinated needs-based care. For severe PMI, specialized services should be available and provided by trained psychiatrists and specialists, such as perinatal mental health midwives. In Austria, various services for different severity levels of PMI are available. However, large geographical variations and gaps exist regarding specialist services, such as mother–baby units. Specially trained health professionals are lacking. Still, almost one in five mothers claimed one of the defined mental health benefits during the perinatal period.ConclusionsPIMHC in Austria currently does not follow best-practice recommendations. The main gaps are in providing guideline-based specialized care by trained professionals. Insurance-funded mental health service use during the perinatal period corresponds with international prevalence figures, although only a part of available services is included in the analysis. To ensure women receive high-quality care, PIMHC needs to be more prioritized.
OP40 Circumstances That Unlock Payer Acceptability Of Innovative Trial Designs: A Case Study And Primary Research-Based Global Analysis
Authors: Sundaram Sudha , Sutharsan Vesshnu , Kielar Catherine , Nørtoft Emil 
Published: January 2025

IntroductionInnovative designs have been used to enhance trial efficiency and enable access to novel treatments when traditional randomized controlled trials (RCTs) were considered operationally challenging to implement. Besides demonstrating scientific and regulatory rigor, innovative approaches also need to be perceived favorably by payers. This work delves into payer perspectives on innovative designs, identifying circumstances that contribute to higher payer acceptability.MethodsUsing targeted searches, we mapped clinical trials since 2010 with novel design elements, including adaptive, master protocol, hybrid, enrichment, and innovative endpoints. Sixty-two asset-indication examples using these designs were identified across different therapeutic areas. Based on the availability of health technology assessment (HTA) reports and the innovative element’s impact on final HTA outcome, 17 of these identified examples were developed as case studies to highlight the designs’ implications for access. Interviews with eight payer-experts across US, France, Germany, and Japan were conducted to further validate the research, explore scenario analyses, and clarify how circumstances impacted payer acceptability of the studied innovative trial designs.ResultsWhile oncology has historically spearheaded innovative trial designs, other therapeutic areas are now incorporating innovative elements. Nonetheless, published payer guidance on innovative designs remains limited. We identified seven circumstances impacting payer acceptance of innovative designs: disease prognosis, eligible patient population size, type of treatment, mode of action, availability of treatment alternatives, comparative benefit versus standard of care, and launch sequence. Patient population size had the greatest impact on payer decisions, followed by comparative benefit and type of treatment; this suggests that payers may be inclined to accept innovative trial designs for small populations with high unmet need or therapies with transformative clinical benefits.ConclusionsInnovative trials trade some scientific validity for increased practicality compared to traditional RCTs. Stakeholders need to align on appropriateness and scientific validity of innovative designs for access decisions, while implementing measures to minimize uncertainties. Collaboration across stakeholders including regulators, payers, and manufacturers is needed to refine innovative methodologies and guide policies to improve the relevance of innovative trials for decision-making.
OP43 Incorporating Mathematical Modeling To Improve Accuracy Of Budget Impact Analysis: Using Screening For Hepatitis C As An Example
Authors: Wong William 
Published: January 2025

IntroductionThe majority of those infected with chronic hepatitis C (CHC) are asymptomatic. Population screening has proven to be both effective and cost effective. When considering whether to implement screening or not, the uncertainty of the budget impact plays an important role. This study aims to develop methods that improve the accuracy of budget impact analysis for a one-time CHC screening program.MethodsWe developed a back-calculation mathematical model that employs a Markov chain Monte Carlo algorithm to estimate the prevalence and proportion of undiagnosed CHC. Subsequently, we utilized a state-transition model to assess the budget impact of two strategies: (i) no screening; and (ii) screen-and-treat with direct-acting antiviral (DAA) for individuals born between 1945 and 1965 (“baby-boomer” birth cohort). Model data were gathered from published literature. Our analysis adopted a Canadian provincial payer perspective, employed a 10-year time horizon, and followed best-practice recommendations by not applying discounting.ResultsFor individuals born between 1945 and 1965, the estimated prevalence of CHC was 1.74 percent (95% confidence interval [CI]: 1.52, 2.30) with an undiagnosed proportion of 15.72 percent (95% CI: 11.27, 18.54). The initial budget impact analysis indicated an additional cost of CAD61.5 million (USD45.0 million) over 10 years for screening related individuals for CHC in Ontario. With these updated prevalence and undiagnosed proportion estimates, our projection suggests a 29.6 percent reduction in the budget impact, now estimated at CAD43.3 million (USD31.7 million).ConclusionsBy comparing the budget impact of the CHC screening strategy with other recommended health services and technologies in Ontario, we have concluded that CHC screening may be considered affordable. To enhance the accuracy of budget impact analysis for population-level screening decision-making, it is crucial to develop precise methodologies for estimating the underlying prevalence and undiagnosed proportions.