bluuebunny/crossref_metadata_2025_split huggingface dataset:
PD129 Extension Of An Influenza Vaccination Program To Include Those Aged 50 To 64 Years: A Rapid Health Technology Assessment Approach
Authors: Cardwell Karen , Mc Loughlin Carol , Swanton Dana , Harrington Patricia , Teljeur Conor , Ryan Máirín 
Published: January 2025

IntroductionInfluenza causes considerable morbidity and mortality. Vaccine effectiveness is variable due to the evolution of influenza viruses and antigenic mismatch. In Ireland, influenza vaccination is reimbursed for all individuals aged at least 65 years as well as those who are at increased risk of exposure or severe disease. However, it is unclear whether reimbursement should be extended from 2023 to 2024 to those aged 50 to 64 years in the general population.MethodsA rapid health technology assessment (HTA) format was chosen due to time constraints, as the findings were to inform a decision for the upcoming influenza season only and would not result in a permanent change to the vaccination program. National sentinel surveillance data (for seasons 2010-2011 to 2022-2023) and hospitalization data for the publicly funded healthcare system (for years 2010-2022) were used. Central Statistics Office data indicated that the projected population for 2023 of those aged 50 to 64 years was 914,379. Given the one-year timeframe, the economic evaluation was limited to a costing analysis to estimate the potential cost associated with expanding the program.ResultsSurveillance data showed year-on-year variability in influenza incidence. Excluding the years not considered representative due to the influence of COVID-19, on average 12.9 percent (range 9 to 17%) of notified cases, 11.8 percent (range 9 to 17%) of influenza-related hospital admissions, 23.2 percent (range 12 to 34%) of influenza-related intensive care admissions, and 9.6 percent (range 0 to 44%) of influenza-related deaths per year were in people aged 50 to 64 years. Data were not disaggregated according to vaccination or risk status. The estimated mean incremental cost of extending eligibility for the 2023 to 2024 season (based on a 35% uptake rate) was EUR2.27 million (range EUR1.9 million to EUR2.65 million, depending on vaccine costs).ConclusionsGiven the relatively modest number of influenza-related hospitalizations in the 50-
to 64-year age group, and the substantial year-on-year variability in vaccine effectiveness, the potential for a reduction in demand for hospital care is likely to be small. While a rapid HTA approach facilitates timely decision support, it creates challenges for exploring the more complex facets of an intervention.
PD133 Exploring Real-World Data Based Financing Models For Lung Cancer Immunotherapy In The Czech Republic
Authors: Bártová Adéla , Říhová Barbora 
Published: January 2025

IntroductionIn alignment with recommendations from the Czech Society for Oncology, immunotherapy is gaining prominence in managing metastatic lung cancer. Public health insurance in the Czech Republic covers immunotherapy for defined categories of these malignancies. Our study aimed to evaluate the impact of introducing performance-based risk-sharing agreements (PBRSA) on budgetary considerations for immunotherapy treatment.MethodsIn collaboration with the Masaryk Memorial Cancer Institute in Brno, we conducted a retrospective analysis of 127 patients with lung cancer who were treated with immunotherapy (42 received nivolumab) between 2018 and 2022. We explored the reimbursed indications for pembrolizumab, nivolumab, atezolizumab, and durvalumab. Real-world progression-free survival (PFS) data from the medical records were compared with PFS data from randomized controlled trials. Patients were classified as either successfully or unsuccessfully treated according to the PFS threshold established in the comparator arm of the respective trials. Additionally, we explored a hypothetical scenario involving the potential implementation of PBRSA depending on the level of outcome achieved.Results
In patients with advanced lung cancer who had received prior chemotherapy, nivolumab succeeded in 29 patients but failed to meet the defined success threshold in 13 patients. Unsuccessful cases incurred an average cost of EUR9,300 per patient over a median treatment period of 1.7 months. In contrast, the cost of successful treatment exceeded EUR29,700 per patient, which was sustained for a median treatment duration of 5.5 months. Manufacturers could cover up to 66 percent of the cost associated with unsuccessful treatment in the 13 patients, which would exceed EUR41,000. This approach might cover the expenses for one additional patient. The same calculation was performed for all other checkpoint inhibitors.ConclusionsThe analysis emphasizes the vital role of risk-sharing agreements in enhancing the affordability and sustainability of high-cost advanced therapies. Discrepancies between real-world clinical data and registration studies challenge full reimbursement sustainability. By redistributing financial responsibility, PBRSA alleviate costs for insurers and simplify market entry for manufacturers, contributing to a dynamic and inclusive healthcare landscape.
PD136 Re-evaluation Of Chest X-Ray Screening For Lung Cancer With Consideration Of Study Context
Authors: Hamashima Chisato , Terasawa Teruhiko , Kataoka Yuki , Anan Keisuke , Hosono Satoyo 
Published: January 2025

IntroductionLung cancer causes a heavy burden worldwide and an efficient screening program is needed. Although low dose computed tomography screening has become mainstream for lung cancer screening, chest X-ray (CXR) screening has continued in Japan. We re-evaluated the efficacy and effectiveness of CXR screening and reconsidered the context of the studies.MethodsWe performed a systematic review and meta-analysis of CXR screening for lung cancer. The study design included randomized controlled trials (RCTs), cohort studies, and case-control studies (CCSs) that evaluated the efficacy or effectiveness of CXR screening. Searches were conducted in the PubMed, Cochrane Library, Web of Science, and Ichushi-Web databases for literature published up to April 2022. We examined the settings of the selected studies.ResultsFrom about 4,000 candidate articles, six RCTs, one cohort study, and six CCSs were selected. Five RCTs were conducted in the 1960s and 1970s, except for the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial. Six CCSs conducted in Japan reported reductions in mortality from lung cancer. A meta-analysis of the six CCS showed a 47 percent reduction in mortality from lung cancer (adjusted odds ratio 0.53, 95% confidence interval: 0.50, 0.63). In the PLCO trial, mortality was reduced by nine percent at the six-year follow up, but this result was not statistically significant. The histological distribution of lung cancer was similar between the PLCO trial and the Japanese CCSs.ConclusionsThe dilution effect might affect the PLCO trial results because of extended follow up beyond the lead time of CXR screening. Although evidence on CXR screening for lung cancer is limited, CXR screening might be adopted in Japan considering the histological changes in lung cancer that have occurred due to the decline in smoking rate.
PD137 Reviewing The Health Technology Assessment And Regulatory Policy Landscape On Acceptability Standards For Real-World Evidence - Initial Findings
Authors: Cresswell Katharine , Claire Ravinder , Avsar Tuba Saygin , Hudson Thomas , Purcell Rose , Peeters Rita , Jensen Lotte Groth , Chen Yun , Mogensen Stine Hasling , Bisordi Fabio , Crane Gracy , Dawoud Dalia , Colvin Heather 
Published: January 2025

IntroductionThere is an increasing number of policy and guidance documents on the use and acceptability of real-world evidence (RWE) to support regulatory and health technology assessment (HTA) decision-making. The Innovative Health Initiative Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance (IDERHA) partnership is undertaking a global landscape review of these documents to understand where there is consensus and divergence, and where further policy development is needed.MethodsA literature search of the MEDLINE and Embase databases was performed, in addition to handsearching the websites of specific HTA and regulatory organizations. All policies, standards, frameworks, and guidance documents on requirements for acceptable RWE data use published from 2017 were included. Two reviewers independently extracted data using a standard data extraction form that was pilot tested before use. Any discrepancies between the reviewers were resolved by consensus. Extracted data are currently being analyzed by researchers with regulatory or HTA expertise. A workshop held in October 2023 sought input from experts on analysis plans.ResultsThe initial literature search yielded 3,184 results. After screening against the inclusion criteria, a total of 87 documents were selected for full-text review (21 HTA and 62 regulatory documents). Of these, 32 were identified as key documents and prioritized for initial review. Key themes in the documents, including transparency, data collection, study design, and data quality, were identified and validated in a workshop with five regulatory or HTA experts. Data extraction is ongoing for the remaining documents and any further themes identified will be added. Any gaps and areas of divergence will be identified, so they can be addressed by future IDERHA work.ConclusionsThis review assessed the increasingly complex global landscape of regulatory and HTA policies and guidance on the use of RWE. Through the exploration of similarities, differences, and gaps in these policies, this work will extend the current understanding of best practice and identify areas that need development of further guidance.
PD140 A Strengths, Weaknesses, Opportunities, And Threats Analysis Of Prehabilitation Before Elective Surgery For Frail Elderly Patients
Authors: Felgner Susanne , Fuchs Tamina , Pfab Carina , Sontag Anna Frederike , Eckhardt Helene , Quentin Wilm , Weber Zoe , Kiselev Jörn , Rombey Tanja 
Published: January 2025

IntroductionAs part of the prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) randomized controlled trial (NCT04418271), we are investigating the approach of multimodal prehabilitation (e.g., physiotherapy) combined with frailty screening and a shared decision-making conference for frail elderly patients prior to elective surgery. The aim of this analysis was to identify strengths, weaknesses, opportunities, and risks of the PRAEP-GO intervention to inform its implementation within the German healthcare system.MethodsThis strengths, weaknesses, opportunities, and threats (SWOT) analysis was based on two expert interview studies and a realist review aiming to identify factors that might facilitate or hinder the implementation of prehabilitation from the perspectives of health service providers and patients. As part of the SWOT analysis, one author categorized these factors into external and internal factors, assessed their importance (scale of one [no/barely] to five [very high] points) and visualized it using radar plots, and assigned them to the categories of strengths, weaknesses, opportunities, or threats. Strategies were then developed to address the following combinations of the categories: strengths/opportunities, strengths/threats, weaknesses/opportunities, and weaknesses/threats.ResultsIn the expert interviews and the realist review, 45 facilitating and 28 hindering factors focusing on health service provision, patients, and the implementation of prehabilitation for frail patients in general were identified. In the SWOT analysis these factors were assigned to 60 internal (resource analysis) and 13 external factors (environmental analysis), and were further sorted into eight and five categories, respectively; for example, “equipment” and “staff” (these two categories were assigned the highest importance [5 points]). Strategies for utilizing strengths and opportunities included, for example, promotion of interdisciplinary cooperation between service providers. The weaknesses and risks of PRAEP-GO might be mitigated, for example, by improving infrastructures.ConclusionsA variety of factors in different categories may facilitate or hinder the implementation of PRAEP-GO. Based on preliminary results from this analysis, the identified strengths of prehabilitation outweigh its weaknesses, but when analyzing the external factors, the identified risks outweigh the benefits. Thus, the implementation of prehabilitation should be prepared by optimizing framework conditions (e.g., transportation for patients and allocation of personnel).
PD141 Health Technology Assessment Methodology Approach For Precision Personalized Medicine: An Innovative Public Procurement Case Study
Authors: Dobrzynska Agnieszka , Garcia-Sanz Patricia Julia , Rosario Lozano María Piedad , Aguilera-Cobos Lorena , Blasco-Amaro Juan Antonio 
Published: January 2025

IntroductionInnovative public procurement (IPP) is a driver of innovation across sectors. IPP involves the strategic acquisition of cutting-edge technologies and solutions by public entities in collaboration with the private sector. This approach aims to leverage the potential of “omics” technologies, such as genomics and proteomics, within the public sector to advance healthcare solutions.MethodsThe IPP process comprises key phases such as needs identification, solicitation preparation, execution, evaluation and awarding, and impact and assessment. The methodology applied was based on the Rapid Assessment Tool for Omics Technologies developed by the Andalusian Agency for Health Technology Assessment, accompanied by clinical validity reports from the impact and evaluation phase of the Technical Office for IPP of Andalusia. The aim was to assess the clinical validation results of two omics technologies, that is, two diagnostic tests. A systematic review was performed to identify existing evidence. We also addressed the challenges associated with implementing the Rapid Assessment Tool in the IPP process.Results
Systematic reviews identifying evidence on the clinical validity and utility of omics technologies provided a foundation for the subsequent evaluation of two technologies in development, once the clinical trials had finished. An analysis of scientific evidence, together with the compilation of information provided by industry, was conducted through a questionnaire and clinical data derived from the company’s studies. The analysis of clinical and diagnostic validity was not conclusive. We delivered the final assessment report to support decision-making in the public health system of Andalusia.Conclusions
Both assessed technologies presented a high degree of innovation, but different challenges and issues were identified during the application of the Rapid Assessment Tool for Omics Technologies. Further improvement in IPP procedures for innovative technologies in Andalusia, including integration of our methodological approach at the start the IPP process, could facilitate the acquisition of cutting-edge technologies in collaboration with public entities.
PD149 Comparison Of The Draft European Union Health Technology Assessment Template With Germany’s AMNOG Template
Authors: Reuter Eva-Maria , Klein-Hessling Thomas , Rittmeyer Carolin , Schweitzer Maria Katharina , Werner Sebastian 
Published: January 2025

Introduction
European Union Health Technology Assessment (EU HTA) aims to use resources more efficiently, ensure high quality assessments, and promote the widespread availability of medicinal products. We compared the draft EU HTA template (EUnetHTA21 submission dossier template) with Germany’s Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) template to assess their conformity and to estimate whether the draft EU HTA template requires more or less effort than the AMNOG template.MethodsFour experts (two statisticians and two medical writers) independently compared 39 categories of both templates following the four-eyes principle. The categories were defined based on the formal and methodological requirements as well as on the specific instructions regarding content, data presentation, and documentation in both templates. We assessed each category for conformity between templates (low, medium, high) and determined the EUnetHTA21 template’s additional effort (much less, less, equivalent, more, much more) relative to the AMNOG template. The comparison was carried out under the assumption that only a single research question on a population, intervention, comparator, and outcome (PICO) would be addressed in both submission procedures.ResultsWe found that the draft EUnetHTA21 template and the AMNOG template had substantial conformity in most categories (21/39), indicating comparable or identical formal and methodological requirements. For 10 of the 39 categories the conformity between templates was rated as medium. Low conformity was found for eight of the 39 categories, including categories outside one template’s scope. For most categories (20/39) we expect an equivalent effort per PICO. More or much more effort is expected for 13 of the 39 categories. For only six of the 39 categories, less or much less effort is expected for the draft EUnetHTA21 template, compared with the AMNOG template.ConclusionsThe analysis highlights strong similarities between the templates but shows increased effort per PICO with the draft EUnetHTA21 template. This effort will be further increased with multiple PICO questions. This could challenge the feasibility of the EU HTA process, especially considering the short timeframe required. The template comparison will be updated once the final EU HTA template is available.
PD168 Developing And Implementing A Value Framework For Rapid Health Technology Assessments: Enhancing Evidence-Informed Coverage In Resource-Constrained Settings
Authors: Alcaraz Andrea , Argento Fernando , Alfie Verónica , Marti Sebastian Garcia , Bardach Ariel , Ciapponi Agustín , Augustovski Federico , Pichon-Riviere Andres 
Published: January 2025

IntroductionValue frameworks play a crucial role in bridging the gap between evidence and decision-making in health care, particularly in settings with limited budgets. In this study, we present the results of an implemented value framework (VF) to provide coverage recommendations in rapid health technology assessment (HTA) reports.MethodsA search was performed to identify existing HTA frameworks. Relevant criteria and methods of assessment were then selected. A color-coded system was applied to categorize each criterion. A Delphi panel was conducted to determine the overall recommendations and to weigh the criteria and correlate them with the recommendations. To assess the performance, we reviewed the results of rapid HTA reports from the last five years.ResultsThe value framework had three domains. We adapted widely used methodologies for the quality of evidence and net benefit domains. The economic impact domain was the most complex to assess, so a customized method was developed. Analysis of 265 HTAs revealed the distribution of recommendations across various criteria and technology types. Most recommendations were for drugs (40.5%) or for therapeutic procedures (36%). Among the final recommendations, 0.8 percent were favorable, 19.7 percent were uncertain, and 44 percent were unfavorable.ConclusionsThe VF demonstrated its versatility and practicality in meeting the needs of rapid HTA requesters and facilitating evidence-informed decision-making. The VF serves as a valuable tool for conducting adaptive rapid HTAs and supports decision-making processes in Argentina and similar contexts.
PD172 Off-Label Rituximab As A First-Line Immunosuppressant Treatment For Generalized Myasthenia Gravis In Wales
Authors: Elliott Clare , Woodland Gail , Haines David , Coulson James 
Published: January 2025

IntroductionGeneralized myasthenia gravis (gMG) is a chronic autoimmune disorder that leads to muscle weakness and fatigue. Initial treatment is with pyridostigmine and corticosteroids, but if these are ineffective off-label immunosuppressants are used. There is some published evidence that rituximab, an anti-CD20 monoclonal antibody, may be effective in the treatment of gMG, although it is unlicensed for this condition.MethodsEvidence for rituximab as a fourth-line or later immunosuppressant treatment for refractory gMG was assessed using the One Wales Medicines (OWM) process and made available in 2019. OWM provides an access route to medicines for specific patient cohorts where no licensed treatments are routinely available. A review in 2022 identified new evidence suggesting that lower dose rituximab could be an effective first-line immunosuppressant treatment for gMG. Clinicians confirmed an unmet need, so a reassessment by OWM was considered appropriate. Clinical and cost effectiveness were assessed through a literature search, budget impact analysis, and clinical expert opinion.ResultsThe OWM Advisory Group assessed the evidence outlined in an evidence summary report. Clinical experts also provided the clinical context and current treatment options for patients with gMG. Overall, it was found that rituximab as a first-line treatment provided a potential improvement in patient outcomes and value for money, compared with current therapy. It was, therefore, supported for routine use in April 2023. Starting and stopping criteria for rituximab were developed in collaboration with clinical experts. All patients in Wales who meet the agreed starting criteria will now be given the option of routine treatment with rituximab.ConclusionsThe OWM process allows routine access to rituximab as a first-line immunosuppressant treatment for gMG. The OWM team are collaborating with clinicians across Wales to instigate a new systematic method for collecting and analyzing patient outcomes. These real-world data will be used to assess benefit to ensure continued access to the best treatments for Welsh patients.
PD175 Using Machine Learning To Optimize Systematic Literature Reviews
Authors: Chacko Akshay 
Published: January 2025

IntroductionScreening and selecting publications are very time consuming when conducting systematic literature reviews. Currently, in the field of robotic-assisted surgery (RAS) there is an average of 12 to 15 studies published daily, making manual data management unsustainable. We aimed to investigate how machine learning (ML) can be used to optimize the manual processes of literature reviews.MethodsNew RAS publications in PubMed, Scopus, and Embase are routinely screened for relevancy and then tagged with metadata to aid future analysis. A curated library of approximately 40,000 tagged RAS publications served as our training dataset. To support manual screening and tagging efforts, multiple ML models were benchmarked, including logistic regression, decision trees, and gradient boosting. All model implementations came from the Python scikit-learn package. The evaluation metric for this study was the F1 score, and the fields of interest tagged were procedure type and surgical approach. Models were trained on publication abstracts and compared with a baseline keyword search to measure changes in performance.ResultsThe findings demonstrated that ML models can classify key metadata with high levels of accuracy. The decision tree model correctly labeled the five most common procedures in the dataset, with an average F1 score of approximately 0.90. This same model predicted surgical approach with an average F1 score of 0.84. It is important to note that different models performed best in different scenarios. To compensate for this variability, all models were fed into a stacking classifier—an ensemble model that takes the output of other models as input training data.ConclusionsIt is evident that ML models can reduce the cognitive burden of clinical librarians and shift their role from hand-screening papers to validating ML predictions. Future work may involve comparing the performance of traditional ML models with large language models (LLMs) to further improve F1 scores and reduce class imbalances.