bluuebunny/crossref_metadata_2025_split huggingface dataset:
PD20 Economic Assessment And Budget Impact Model Of Injectable Ganciclovir For Cytomegalovirus Infection In Immunosuppressed Patients In Brazil
Authors: Alvernaz dos Santos Bárbara Rodrigues , Martins Álex , Silva Mendes Ana Clara , Pereira Camila , Nassif Livia , Gargano Ludmila , Freitas Isabela , Muniz-Júnior Roberto , de Assis Acurcio Francisco , Alvares-Teodoro Juliana , Guerra-Junior Augusto 
Published: January 2025

IntroductionCytomegalovirus (CMV), a prevalent human herpes virus, has long periods of latency. It can reactivate following immunosuppression causing diverse clinical manifestations. In immunocompetent individuals, CMV infections are usually asymptomatic. However, in immunosuppressed individuals, such as patients with human immunodeficiency virus, CMV infections can cause serious complications. Antiviral treatment is crucial for minimizing health risks and preventing severe outcomes, such as retinitis and colitis, in this population.MethodsA cost-effectiveness analysis was conducted using a decision tree model to estimate the incremental cost-effectiveness ratio (ICER) of ganciclovir (1 mg/mL) for people with acquired immunodeficiency syndrome (AIDS) affected by CMV-related retinitis or colitis. The model compared ganciclovir therapy to no ganciclovir, with the outcome being progression of CMV disease. Budget impact was considered over a five-year time frame with 100 percent diffusion among patients with AIDS and CMV-related colitis.ResultsIn patients with AIDS and CMV-related retinitis, use of ganciclovir incurred an incremental cost of BRL29,378.95 (USD5,188.70) with an incremental effectiveness of 0.51 in the therapeutic response rate and an ICER of BRL57,605.79 (USD10,173.93). For those with AIDS and CMV-related colitis, ganciclovir incurred an incremental cost of BRL10,040.71 (USD1,773.32), with an incremental effectiveness of 0.26 and an ICER of BRL38,618.11 (USD6,820.45). The estimated cumulative budget impact, considering 100 percent ganciclovir diffusion over five years, was BRL1,124,800,751.17 (USD198,654,342.23) and BRL571,223,309.75 (USD100,885,415.26) for patients with AIDS CMV-related retinitis and colitis, respectively.ConclusionsThe application of economic evaluation and budget impact tools is crucial for maintaining health system sustainability. Introducing treatments with high ICERs and budget impact can jeopardize the health system and access to treatments. Upholding criteria, such as the willingness-to-pay threshold, is essential for ensuring the sustainability and continuity of health care.
PD24 Innovation In Chronic Obstructive Pulmonary Disease Care: Cost Effectiveness Of A New Self-Management Maintenance Program In The United Kingdom
Authors: Gumber Anil , Khan Amir J , Richardson Matthew , Hong Annabel , Nolan Claire , Alqahtani Khaled , Man William , Singh Sally , Smart Freda , Hedger Chris , Houchen-Woolloff Linzy , Szczepura Ala 
Published: January 2025

IntroductionInnovation is needed for the growing number of patients with chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) is effective in improving exercise tolerance and quality of life, but these benefits do not appear to be sustained. This highlights the need for cost effective methods to maintain benefits on completion of therapy. The findings of a large trial from the UK are reported.Methods
A two-center randomized controlled trial of patients discharged from PR compared the costs and benefits of PR maintenance with standard care. National Health Service (NHS) resource use, personal expenditure, and societal costs were recorded over one year, and bottom-up costing was undertaken for the PR maintenance program. Changes in health-related quality of life were recorded using the EQ-5D-5L, and differences were compared with the level identified as significant for COPD. A cost utility analysis was undertaken from an NHS perspective; uncertainties in cost and outcome data were incorporated into a sensitivity analysis. Cost-effectiveness ratios and cost-effectiveness acceptability curves (CEACs) were computed.ResultsThe study included 116 patients who had finished PR within the last four weeks. The economic analysis showed that mean healthcare costs per patient for PR maintenance were approximately GBP139.72 (EUR165.57) lower than for usual care. The observed 0.118 advantage in mean quality-adjusted life-years (QALYs) (p<0.05) was above the threshold (0.051) for COPD significance. CEACs indicated there was a 97 percent chance of achieving GBP20,000 (EUR23,699.80) per QALY (NICE acceptance level ≤GBP30,000 (EUR35,549.70). Patient and societal costs increased this percentage. It was estimated that if patients with COPD completed a maintenance program following PR, the NHS could save up to GBP28.6 million (EUR33.89 million).Conclusions
Our findings confirm that a structured PR maintenance program is highly cost effective in extending the benefits of short-term PR. The trial, undertaken during COVID, also signals the potential for emerging digital innovations to provide future transformative change in delivering self-management programs to sustain health and reduce NHS costs for people living with chronic conditions.
PD30 How Is Sustainability Incorporated Into Healthcare Systems? A Progress Report Card For The EU5
Authors: Marlow Laurie , Webb Sarah , Sulanowska Joanna 
Published: January 2025

IntroductionIn 2020, the World Health Organization (WHO) released guidance for climate-resistant and environmentally sustainable healthcare facilities. Implementation of sustainability into healthcare policy is at varying stages, and its impact on technology appraisal and procurement is expected to differ across countries. The objective of this research was to review healthcare sustainability policy and implementation progress across the EU5.MethodsHealthcare sustainability policies in the EU5 (France, Germany, Italy, Spain, and the UK) were reviewed. Policies were identified via government websites (e.g., the Ministere de la sante et de la prevention) and through review of climate and sustainability policy news on the WHO website. Common goals featured in the policies included carbon reduction plans, reduction of single use plastics, ethical and environmental considerations, and self-sustainability. These four goals were selected to form sustainability categories for comparisons across markets. The policies were reviewed for each of the categories with respect to level of inclusion, targets, and anticipated implementation dates.ResultsThe UK had clear policies focusing on carbon and emission reduction. Implementation of these policies began in April 2023 and will become a requirement for all new procurements from April 2024. France, Italy, and Spain mentioned carbon emission reduction and environmental impact in policies, but targets and guidelines have yet to be set. Italy and the UK had policies relating to reduction of single-use plastics, whereas the other markets did not. Germany had limited policies mandating changes geared toward increased environmental sustainability, focusing instead on self-sustainability and resilience in the market.ConclusionsAs expected, incorporation of sustainability plans into healthcare policy is variable. Within markets with established policies, such as the UK, there is progress toward mandating the inclusion of sustainability policy in procurement, the impact of which may be seen in early 2024. Although the progress of implementing sustainability in other markets is slower, countries are moving toward environmentally sustainable healthcare policies.
PD41 Quality Of Diagnostic Test Accuracy Systematic Reviews In Neglected Diseases Registered In PROSPERO: Meta-Epidemiological Review Of Methodological Compliance
Authors: Komoda Denis Satoshi , de Almeida Cardoso Marilia Mastrocolla , Fernandes Brígida Dias 
Published: January 2025

IntroductionDiagnostic test accuracy (DTA) systematic reviews (SR) provide acknowledged challenges for health technology assessment (HTA) due to insufficiency of trials and a paucity of methodological frameworks (compared with interventional SRs). Additionally, research in neglected tropical diseases (NTDs) is scarce. Assessing the methodological compliance of a SR protocol in this context is of utmost importance for developing robust HTA in NTD.MethodsA search strategy was conducted in PROSPERO in November 2023 to identify protocols of SRs on diagnostic test accuracy using the following terms: “diagnostic accuracy test”, “diagnostic test”, and “diagnostic accuracy”. Deduplication was performed using Excel’s “remove duplicates” functionality. Eligible studies were SRs with predicted meta-analyses on DTA in any NTD (as per the World Health Organization list). in vitro studies, those with non-human populations, and methodological studies were ineligible. The variables of interest included registry characteristics (author, year, country), protocol status, and methodological characteristics (pre-defined statistical analyses, sensitivity analyses, and heterogeneity analyses). The results were presented using descriptive statistics and narrative analysis of methodological issues.ResultsFrom 7,931 registries, 106 protocols were selected that anticipated conducting a meta-analysis of DTA in the context of NTDs. The number of registry entries has grown steadily from one protocol in 2012 to 17 in 2023. Twenty-three NTDs were identified, the three most common being dengue (n=23; 22%), leishmaniasis (n=18; 17%), and syphilis (n=12; 11%). Only 14 protocols were reported as published. Regarding quality of reporting and methods, half (n=54) of the reports explicitly stated a meta-analytical approach in their title. Only 16 mentioned a sensitivity analysis and 32 did not mention an analysis of heterogeneity.ConclusionsThe meager number of protocols reported as published could mean a lack of updates or publications, or both. The absence of essential methodological descriptions in protocol titles and body text is worrisome and may ultimately be reflected in the number of publications. Further analysis should assess the specifics of methodological quality based on well-established methodological frameworks for quality of reporting and methods.
PD60 The Importance Of Systematic Reviews Addressing Questions Of Prevalence In Health Technology Assessment
Authors: Migliavaca Celina Borges , Barker Timothy Hugh , Stein Cinara , Colpani Verônica , Munn Zachary , Falavigna Maicon 
Published: January 2025

IntroductionThe use of systematic reviews (SRs) of interventions is commonplace in health technology assessment (HTA). However, SRs synthesizing other data types, such as prevalence, are rarely used. These SRs may complement the HTA process by gathering complementary evidence essential for developing trustworthy recommendations. We aimed to discuss the importance and application of SRs of prevalence in the context of HTA.MethodsA methodological working group, the Prevalence Estimates Reviews – Systematic Review Methodology Group (PERSyst), was created to provide guidance on how to improve the development of SRs and meta-analyses of prevalence. As part of the group’s work, a guide for HTA developers regarding the value of SRs of prevalence was developed.ResultsThere are many benefits to including SRs of prevalence in the process of HTA. These include providing data for estimating burden of disease; helping to set priorities regarding technology assessment; informing the absolute impact on health outcomes from association measures (e.g., relative risk) reported in clinical studies; and providing data for estimating resource requirements for and feasibility of implementing health technologies under consideration. Within the GRADE framework, prevalence estimates are necessary to assess the quality of diagnostic test accuracy evidence and to support decision-making using the Evidence to Decision framework.ConclusionsAlthough not commonly used, SRs of prevalence are an important tool in the process of HTA. There is a need for standardization of methodologies and guidance on how to use these reviews in the HTA process.
PD61 Thromboprophylaxis After Major Orthopedic Surgeries: Health Technology Assessment To Promote Access To Oral Anticoagulants
Authors: Ribeiro Mayra Carvalho , Santos Fidelis Giovana Fernanda , Silveira Correa Carlos Roberto , de Oliveira Conterno Lucieni , de Oliveira Motta Maia Flávia 
Published: January 2025

Introduction
While implementing an evidence-based guideline for venous thromboembolism (VTE) prophylaxis in a Brazilian tertiary hospital, we identified an unmet need for patients undergoing major orthopedic surgery. The Brazilian Unified Health System (SUS) does not provide access to direct oral anticoagulants (DOACs) or enoxaparin. Therefore, an assessment of the efficacy, safety, and budgetary impact of these medications from a hospital perspective is warranted.MethodsOur Health Technology Assessment Center performed an overview of systematic reviews (SR) to compare the efficacy and safety of DOACs with enoxaparin. The Cochrane Library, Embase, and MEDLINE databases were searched in May 2023. The relative risks of symptomatic VTE, clinically relevant bleeding, and mortality were collected. The AMSTAR-2 tool was used to assess the methodological quality of included SRs. Treatment costs and estimates of the number of patients undergoing knee or hip arthroplasty were derived from historical institutional data.ResultsOf the 32 SRs included in the analysis, seven performed a network meta-analysis. All SRs had at least one flaw in a critical methodological domain, mainly in not providing the list of excluded studies. Regarding mortality rates, most SRs did not detect any differences between the treatments. The risk of experiencing VTE was lower with DOACs in eight SRs for hip arthroplasty and in five SRs for knee arthroplasty. The risk of major bleeding was similar between the treatments in all but two SRs. Substituting enoxaparin for DOACs led to a cost reduction of BRL490 (USD98) per patient, which could save BRL29,890 (USD6,038) per year.ConclusionsPatients undergoing hip and knee arthroplasties are at high risk for the occurrence of VTE. Our overview of SRs showed that the efficacy and safety of DOACs are well recognized. DOACs reduce the risk of VTE, but to date patients in Brazil do not have access to these medicines through the SUS. By providing DOACs, hospitals could ensure adequate prophylaxis without increasing costs.
PD65 How Methods Innovation In Health Technology Assessment Missed The Opportunity To Include Health Equity In The Value Puzzle
Authors: Sarri Grammati , Radhakrishnan Amruta , Muir Jeffrey , Stillman Ipek Ozer 
Published: January 2025

IntroductionReconstructing the value puzzle in health technology assessment (HTA) of new technologies is an ongoing discussion among different stakeholders. Little progress has been made toward consistently and transparently incorporating additional value elements, such as health equity, or moving the focus beyond the traditional value elements of clinical benefit and economic cost associated with the introduction of new technologies.MethodsThe objective was to conduct a series of pragmatic reviews of recent HTA guidance documents, international organizations, and previous systematic reviews to answer the following research questions.•Would increased familiarity with real-world evidence, advanced analytics, and expanded forms of economic modeling create the forum for HTA bodies to reconsider their processes and include health equity when assessing new products?•Which methods innovations would facilitate changes in HTA methods and processes to consistently and transparently assess health equity value elements?Results were documented and qualitatively synthesized by outlining missed opportunities and highlighting potential barriers to integrating equity-informed HTA processes.ResultsOur findings were grouped into three main parts: HTA guidance summaries, trends summarized by key organizations (HTAi, ISPOR, and others), and peer reviewed publications. HTA bodies have increasingly emphasized health equity concerns and the importance of standardizing methods to support health equity considerations but have not recommended explicit quantitative methods. Our database search found previous systematic literature reviews explicitly referring to methods of integrating real-world evidence into comparative effectiveness assessments, whereas modeling techniques such as distributional, augmented, or cost-effectiveness analyses, and multicriteria decision-making can integrate health equity effects for both patients and healthcare systems.ConclusionsOur research showcases the gap between recognizing health equity as a missing element in HTA and incorporating methods to implement such considerations into real-life decision-making. Greater familiarity with health equity methods may move the discussion from “whether” to “how” additional value elements such as health equity can inform decision-making.
PD76 Cost-Effectiveness Analysis Of An Influenza Vaccination Program In Algeria, Egypt, Saudi Arabia, Turkey, and the United Arab Emirates
Authors: Jones Arun , Mongan Suzanna , Saleh Ahmed Abdou , Rachida Khelafi , Idrees Majdy , Tag El Din Mohamed Awad , Ergönül Önder , Kim Kyoo , Aouida Nesrine , Kondratenko Alona , Kim Dr Hansoo 
Published: January 2025

IntroductionInfluenza causes seasonal epidemics and is a significant burden. Annual vaccination is an effective way to prevent influenza and its complications. However, vaccination coverage remains low in North Africa and the Middle East. Quadrivalent vaccines offer protection but require monetary investments. This study aimed to quantify the costs and benefits of subunit quadrivalent influenza vaccination among healthy adults in the selected countries.MethodsA decision tree was used to model the costs and outcomes of treatment with an inactivated subunit quadrivalent vaccine, compared with no vaccine, in healthy adults from the societal and payer perspectives. Outcomes measured include productive days gained through reduced absenteeism and the proportion of the population acquiring influenza. Each country’s expected health resource utilization costs for influenza were determined through literature searches and consultations with clinical experts. Deterministic and probabilistic sensitivity analyses were undertaken to characterize the effects of parameter uncertainty on our results.ResultsWe found that in every country the proportion of people who acquired influenza was 2.4 times lower in vaccinated individuals than in the unvaccinated. This resulted in between 0.9 and 1.5 more productive days worked for vaccinated individuals. The average cost savings from the societal perspective ranged from USD12.36 to USD276.85 per person. Deterministic sensitivity analysis indicated that influenza prevalence was the strongest driver of the model results. A probabilistic sensitivity analysis of over 1,000 simulations resulted in cost savings 54.4 to 99.3 percent of the time.ConclusionsVaccination with a subunit quadrivalent influenza vaccine results in cost savings when compared with no vaccination in every country studied. We therefore conclude that, in terms of cost effectiveness, vaccination with a subunit quadrivalent influenza vaccine is dominant over no vaccination in Algeria, Egypt, Saudi Arabia, Turkey, and the United Arab Emirates.
PD77 Review Of Multicriteria Decision Analysis-Like Processes For Prioritization Of Newborn Bloodspot Screening Conditions
Authors: Finnegan Eanan , Maher Arielle , Jordan Karen , O’Donnell Helen , Comber Laura , Spillane Susan , Harrington Patricia , Ryan Máirín 
Published: January 2025

IntroductionNewborn bloodspot screening (NBS) is used to identify rare, serious health conditions. The choice of conditions to screen for can be contentious, with no internationally agreed panel. Multicriteria decision analysis (MCDA), involving a priori identification and weighting of criteria, has been proposed as an approach to assess and rank conditions for inclusion in newborn screening panels or for further assessment.MethodsThe aim of this review was to summarize existing MCDA-like processes used internationally in the context of NBS conditions. Publications were identified using a scoping methodology including electronic database and gray literature searches. Information on the methodology used to derive criteria and weightings, the criteria used, the scoring systems, and the weightings were extracted. The results were synthesized narratively.ResultsFive publications reporting on the use of MCDA or MCDA-like processes in the context of NBS were identified. In three publications, the aim of the MCDA processes was to select conditions for inclusion in an NBS panel. Two referred to the potential use of MCDA to inform prioritization of candidate conditions for future evaluation. While the criteria used were broadly consistent across studies, assigned weightings varied. Key challenges noted in the studies in relation to applying MCDA included the subjectivity associated with the choice and weighting of criteria, the absence of data to inform criteria, and its low discriminatory power.ConclusionsChoosing criteria and weightings for MCDA processes regarding NBS can be a highly deliberative process that is intrinsically linked to the values and perspectives of those involved. Given the lack of international consensus on criteria and weightings, MCDA processes to aid decision-making would likely require a de novo tool or careful adaptation of an existing tool to reflect local contexts.
PD89 Guidance For Designing Pivotal Studies Of High-Risk Medical Devices By International Regulatory Authorities: A Systematic Review
Authors: Schnell-Inderst Petra , Rochau Ursula , Fraser Alan G. , Siebert Uwe 
Published: January 2025

IntroductionHealth technology assessment of medical devices often faces the challenge that approval studies have an insufficient study design. The European Medical Device Regulation (MDR), which has been in force since May 2021, places stricter requirements on clinical studies for high-risk medical devices. One important way of implementing the regulation is through guidance documents from the Medical Device Coordination Group (MDCG).Methods
Our objective was to systematically identify and analyze recommendations for the design of pivotal studies of high-risk therapeutic medical devices from the MDCG and other regulatory authorities of high-income countries. We systematically searched the websites of regulatory authorities and included both cross-device and device-specific recommendations on clinical trial design for cardiovascular, orthopedic, and diabetes related high-risk medical devices. We extracted and compared the recommendations according to the following seven topics: definitions of study types and level of evidence; need for clinical investigations; appropriate choice of study methodology; general aspects; statistical methods; consideration of context and learning curve; and reporting.ResultsWe included 30 documents from regulatory authorities. Eight documents from the European Union (EU) focused mainly on procedural issues and reporting. Guidance on appropriate levels of evidence and choice of study methodology for design and analysis of clinical investigations was missing. Eleven guidance documents were from the United States Food and Drug Administration, which provided detailed recommendations on almost all topics regarding study design as well as new methods. The remaining documents originated from four other countries and the International Medical Device Regulators Forum. A document from Australia included device-specific recommendations but hardly any general recommendations on clinical trials.ConclusionsThe recommendations published to date in the EU are insufficient to support stakeholders in choosing or assessing appropriate study designs to implement the evidence requirements of the European MDR. Detailed guidance from the MDCG is needed to create a common understanding between manufacturers, notified bodies, MDR expert panels, and competent authorities regarding what sufficiency of clinical data means.