bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP97 Conduction System Pacing Implantation Through Electroanatomic Mapping-Guided Versus Fluoroscopy In Patients With Severe Bradyarrhythmias
Authors: Infante-Ventura Diego , León-salas Beatriz , Hernández-Yumar Aránzazu , Linertová Renata , García Javier García , López Raúl Quirós , Ramos Estefania Herrera , Trujillo-Martín Mar 
Published: January 2025

IntroductionElectroanatomic mapping (EAM) has been shown to be an alternative procedure to fluoroscopy for the implantation of conduction system pacing (His-bundle pacing [HBP] and left bundle branch pacing [LBBP]) in patients with severe bradyarrhythmias, mainly those vulnerable to ionizing radiation. However, the evidence of its beneficial and harmful effects has not been assessed in a systematic review (SR).MethodsAn SR of the available scientific literature was conducted on the safety, effectiveness, and cost-effectiveness of implantation of the HBP and LBBP using EAM system versus fluoroscopy in patients with bradycardia with an indication for pacing therapy. Cochrane methodology and PRISMA statement for reporting were followed. A partial economic evaluation was carried out to compare the costs of both pacemaker implantation strategies from the perspective of the Spanish National Health System. A budget impact analysis was also conducted with a five-year horizon.ResultsSeven comparative observational studies (N=259) analyzing the use of EAM versus fluoroscopy were selected. Statistically significant differences were observed in total fluoroscopy time: −9.87 minutes (95% confidence interval [CI]: −14.20, −5.53; p<0.01; I2=95%; k=7; n=231); His-lead fluoroscopic time: −8.08 minutes (95% CI: −10.36, −5.81; p<0.01; I2=0%; k=2; n=50); and His-lead radiation dose: −17.21 mGy (95% CI: −24.08, −10.34; p<0.01; k=1; n=20). No differences in total radiation dose, procedural success, immediate procedure-related complications, electrode revision, or device infection were found. The use of EAM represents an increase of EUR1,397.81 (USD1,513.88) per patient and a net budget impact of EUR1.63 million (USD1.77 million).ConclusionsNo differences between EAM and fluoroscopy in terms of procedure success and safety were found. Therefore, EAM is a valuable alternative for patients who should not be exposed to ionizing radiation. The inclusion of EAM systems, for the indication under study, in routine clinical practice would mean an increase in costs for the Spanish National Health System.
PP104 Utility Of Chemiluminescence Detection Of Anti-Domain
1 β2 Glycoprotein I Antibodies In Antiphospholipid Syndrome
Authors: Pino-Sedeño Tasmania del , Hernández-Yumar Aránzazu , Valcárcel-Nazco Cristina , De Armas-Castellano Aythami , González-Hernández Yadira , Infante-Ventura Diego , Martín Sánchez Juan Ignacio , Trujillo-Martín Mar 
Published: January 2025

IntroductionPatients with antiphospholipid syndrome (APS) present a significant risk of thrombotic events or morbidity during pregnancy, associated with the presence of persistently positive antiphospholipid antibodies (aPL). The risk stratification is crucial to adopt primary prophylaxis measures. With this objective, assays for the in vitro detection of anti-domain
1 β2 glycoprotein I (aD1 IgG) antibodies by chemiluminescence immunoassay (CLIA) have been developed.MethodsWe conducted a systematic review with meta-analyses on the effectiveness of incorporating aD1 IgG detection by CLIA for the identification of patients with APS at high risk of thrombosis or morbidity during pregnancy. A cost analysis was also conducted using a decision tree model from the perspective of the Spanish National Health System and a time horizon of three months. We ran extensive sensitivity analyses. Twelve diagnostic performance studies with a total of 3,570 patients were selected.ResultsThe sensitivity and specificity of aD1 IgG added to the conventional aPL criteria for obstetric and thrombotic manifestations ranged from 15 to 16 percent, and from 94 to 97 percent, respectively. The sensitivity of the detection of aD1 IgG in isolation for thrombotic and obstetric manifestations was 29 and 48 percent, and specificity was 60 percent, respectively. The GRADE quality of evidence was very low due to the risk of bias and indirectness issues. The incorporation of the aD1 IgG detection involves a higher cost per patient than the usual clinical practice, with an incremental difference of EUR24.04 (USD26.01).ConclusionsDespite its potential, the incorporation of the aD1 IgG detection by CLIA as an additional test to the determination of classical aPL for the identification of patients with APS at high thrombotic or obstetric risk may not be feasible due to the very low available evidence on diagnostic performance and increased costs.
PP105 Assessment Of Blood Biomarkers For The Diagnosis Of Alzheimer’s Disease: From Promise To Reality
Authors: Sanchez-Piedra Carlos , Cardaba-Arranz Mario , García-Carpintero Esther Elena , Imaz-Iglesia Inaki 
Published: January 2025

IntroductionThe objective of this assessment was to assess diagnostic effectiveness of phosphorylated isoforms of the tau protein (p-tau) in blood samples (plasma and/or serum) in Alzheimer’s disease diagnosis compared to clinical criteria, cerebrospinal fluid (CSF) biomarkers, positron emission tomography (PET), or post-mortem pathology imaging.MethodsA systematic review of MEDLINE, Cochrane, and Embase was undertaken from 1 January 2000 to 1 September 2022. QUADAS-2 was used to assess the quality of the studies. The selection and quality assessment was carried out independently by two reviewers.ResultsA total of 1,811 references were identified after eliminating duplicates, selecting five: two studies evaluated p-tau181, two others evaluated p-tau217, and one evaluated both isoforms. The studies provided information on diagnostic accuracy using ROC curves. However, none of the studies provided information on sensitivity and/or specificity. The ROC curve values ranged from 83.3 percent to 99.4 percent for p-tau181 and 84 percent to 94 percent for p-tau217. Information was presented in an unclear and heterogeneous way, so our PICO (population, intervention, comparator, outcome) questions were left unanswered. The heterogeneity was due to factors such as the type of isoform, the laboratory platform, and the classification criteria considered.ConclusionsDespite technology presenting as promising in several studies, the available evidence did not provide high-quality information about its diagnostic accuracy. Diagnostic technologies are often launched and marketed without enough high-quality evidence. The generation of evidence in diagnostic studies is often based on designs that do not provide adequate health technology assessment information.
PP107 Effectiveness And Safety Of Cytoreductive Surgery And Heated Intraperitoneal Chemotherapy For Pediatric Peritoneal Carcinomatosis: A Living Evidence Synthesis
Authors: Roteta Nora Ibargoyen , García Josune Domínguez , Jausoro-Zubiaga Ainhoa , Galnares-Cordero Lorea , Gutierrez-Ibarluzea Iñaki , Rojas Maria X. , Auladell-Rispau Ariadna , Verdugo-Paiva Francisca 
Published: January 2025

IntroductionThe evidence synthesis developed to inform decision-making on the use of cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC) for pediatric peritoneal carcinomatosis showed that currently available evidence is of very low quality. As new evidence could arise within the following months, we adopted a rigorous living evidence synthesis (LES) approach to provide a timely update and favor decision-making based on actual evidence.MethodsThis LES started with a baseline synthesis about the effects of CRS and HIPEC on pediatric peritoneal carcinomatosis. On 31 August 2023, we set up the evidence monitoring for up to 12 months. Following the Living Evidence to Inform Health Decisions (LE-IHD) framework, we planned and developed the evidence monitoring, supported by technological enablers. We searched for ongoing studies in trial registries every three months. New eligible studies were assessed following a systematic and reproducible process to decide on their incorporation in the evidence summary. This process was periodically reviewed to determine the continuation/withdrawal of the living mode.ResultsThe baseline synthesis identified one systematic review suggesting that CRS and HIPEC could increase overall survival in pediatric peritoneal carcinomatosis (very low-quality evidence), but no comparative data could be obtained against usual care. To date, the evidence monitoring has not identified new relevant studies on the impact of CRS and HIPEC in overall and disease-free survival, morbidity, or quality of life in pediatric peritoneal carcinomatosis. At the time of the conference, we will report on nine months of monitoring and regular updates including key messages on any changes in the evidence synthesis conclusions.ConclusionsFor HTA reports based on very low-quality evidence (uncertain results), the LE approach allows for timely updating of conclusions, adding value in decision-making. The LE-IHD framework facilitates HTA developers’ tasks for planning and conducting LE synthesis to inform health decisions.
PP108 A Systematic Review Of Reactogenicity And Safety Of Recombinant Zoster Vaccine For Prevention Of Herpes Zoster In Adults
Authors: Reece Emma , Jenkins Orla , Bergin Aoife , Reidy Ellen , Byrne David , Mc Loughlin Carol , Quigley Joan , Teljeur Conor , Harrington Patricia , Ryan Máirín 
Published: January 2025

IntroductionHerpes zoster (HZ), also known as shingles, is characterized by a vesicular skin rash, often associated with acute pain and itching. The safety profile of the recombinant zoster vaccine (RZV) in adults aged 50 years and older and in adults aged 18 and older who are at increased risk of HZ was assessed in this systematic review.Methods
A comprehensive electronic search was performed in Embase, MEDLINE, the Cochrane Library, and clinical trials registries. Searches were limited to the period from 2008 to July 2023. Article screening and data extraction were carried out by two independent reviewers. Risk of bias was assessed using the Cochrane revised Risk of Bias 2 (RoB2) tool for randomized controlled trials (RCTs). The Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool was used to assess the quality of non-randomized studies. An adapted version of the Newcastle–Ottawa Scale was used for the appraisal of quality of non-comparative studies.ResultsEighteen RCTs, four observational cohort studies, seven single-arm trials, and 11 single-arm observational studies were identified. Compared with placebo, solicited local (RZV: 74.1 to 84.0%; placebo: 7.9 to 11.9%) and systemic reactions (RZV: 53.0 to 66.1%; placebo: 6 to 11.4%) were more common in the vaccinated cohorts. Reactions were generally transient and mild to moderate in intensity. The most frequent reactions reported were pain at the reaction site, fatigue, and myalgia. The incidence of potential immune-mediated diseases (pIMDS), serious adverse events (SAEs), and fatalities was similar in vaccine and placebo groups. No SAEs, pIMDs, or deaths were reported as vaccine related.ConclusionsThe available data on RZV shows that while local and systemic adverse events are common with RZV, these are typically transient, and SAEs are uncommon in both the general population and those at increased risk of HZ.
PD01 Budget Impact Analysis Of Expanding Newborn Inherited Metabolic Diseases Screening In Shanghai, China
Authors: Xiao Dunming , Zhou Shanyan , Chen Yingyao 
Published: January 2025

IntroductionChina has a high incidence of birth defects. Tandem mass spectrometry (MS/MS) screening enables rapid detection of multiple inherited metabolic disorders and has been widely promoted globally. This study aimed to conduct a budget impact analysis of replacing phenylketonuria screening with MS/MS by calculating the financial impact of reimbursing the costs of MS/MS screening.MethodsAn Excel-based budget impact analysis model for MS/MS screening was developed. The number of newborns in Shanghai from 2024 to 2026 was estimated using the birth rate trend among the permanent population of Shanghai over the past decade. By integrating clinical screening data, along with the corresponding screening costs and diagnostic fees for the gold standard test, the financial impact of replacing phenylketonuria screening with MS/MS screening was calculated. The screening data for this study was extracted from a tertiary hospital in Shanghai. Demographic data were obtained from statistical websites, while cost data were derived from literature and a tertiary hospital in Shanghai.Results
The fiscal expenditures for phenylketonuria screening were CNY1.75 million (USD0.25 million), CNY1.65 million (USD0.23 million), and CNY1.56 million (USD0.22 million) for 2024, 2025, and 2026, respectively. In contrast, the corresponding fiscal expenditures for MS/MS were CNY25.23 million (USD3.54 million), CNY23.78 million (USD3.33 million), and CNY22.41 million (USD3.14 million). The additional fiscal expenditure for MS/MS, compared with phenylketonuria screening, was CNY23.48 million (USD3.29 million), CNY22.13 million (USD3.10 million), and CNY20.85 million (USD2.92 million), showing a yearly decreasing trend.ConclusionsThe financial impact of MS/MS screening was controllable. It was recommended that the cost of MS/MS screening in Shanghai be covered by government funding. The promotion of newborn screening using MS/MS deserves priority consideration and publicity in Shanghai, China.
PD08 Clinical And Cost Effectiveness Of Selected Diabetes Medicines In Ghana - An Adaptive Health Technology Assessment
Authors: Asante Hannah , Owusu Richmond , Asare Brian , Amankwah Ivy , Reuda Sergio Torres , Kazibwe Joseph , Ruiz Francis 
Published: January 2025

IntroductionThere is a need to consider whether treatments included in essential medicine lists, standard treatment guidelines, and health benefits packages are cost effective, improve financial sustainability, and increase equitable access to health care. This assessment evaluated the cost effectiveness of selected antidiabetic medicines for inclusion on Ghana’s Essential Medicines List and updated standard treatment guidelines, and reimbursement by the National Health Insurance Authority.MethodsThis study was produced in line with the broad steps of the Ghana health technology assessment (HTA) process guideline using an adaptive HTA (aHTA) approach and following the process used by the National Cancer Grid of India. High quality HTA evidence was sourced from four HTA agencies based on the population (children aged two years or older and adults older than 18 years using antidiabetics), intervention, comparator, and outcomes framework using an adaptability checklist developed by the researchers. A price benchmarking analysis was conducted to generate context relevant evidence on medicine prices in terms of local value for money.ResultsThe study found that all medicines evaluated (sitagliptin, vildagliptin, saxagliptin, insulin detemir, insulin degludec, insulin glargine, insulin glusiline, insulin aspart, and insulin lispro) were efficacious. The price benchmark analysis showed that insulin detemir, glargine, and degludec had higher price ratios than their comparators, and an annual drug cost per patient that was approximately two to four times higher. Insulin lispro, aspart, and glulisine had price ratios of 0.22 to 0.44 and an estimated annual cost of GHS1,894 to GHS3,552 (USD163.3 to USD306.2), which was two to five times higher per patient than the comparators. The cost of saxagliptin and vildagliptin were four and three times lower than those in the benchmark country (the UK).ConclusionsThe study revealed that all medicines included are efficacious and potentially cost effective. The price benchmark analysis showed that, except for gliclazide 80 mg, Ghana is paying less for antidiabetic medications than the UK. Cost effectiveness may not be a sufficient basis to include or exclude medicines for reimbursement because they have a potentially significant budget impact for the payer.
PD37 Development Of A Tool For Quality Assessment Of Health Economic Evaluations
Authors: Schneider Nayê Balzan , Migliavaca Celina Borges , Stein Cinara , Gräf Débora Dalmas , Escher Gabrielle Nunes , Decker Sérgio , Falavigna Maicon , Polanczyk Carisi 
Published: January 2025

IntroductionHealth economic analyses compare the necessary investments and health outcomes for two or more technologies, assisting in resource allocation. How these analyses are conducted directly affects the results obtained. Therefore, it is essential to consider their quality during decision-making. The aim of this study was to develop a domain-based tool for the critical assessment of cost-effectiveness and cost-utility studies.MethodsWe conducted a scoping review to identify tools available for the critical assessment of health economic analyses and extracted their recommendations. Based on the tools’ items and the discussions of a working group, we identified domains related to the methodological quality of health economic analyses for inclusion in the new tool. The items extracted during the scoping review were classified according to the previously defined domains and were used to identify complementary aspects that should be included in the new tool.Results
We identified 21 tools, all of which were checklists containing seven to 80 items. The following four quality domains were established for the new tool: (i) applicability of the research question; (ii) model structure; (iii) model parameters; and (iv) precision of the results. Assessment of each domain was guided by signaling questions. The first domain assessed the applicability of the research question to the desired setting; the second evaluated whether the model adequately represents the complexity of the clinical condition; the third assessed the quality (certainty) of the key parameters used in the model; and the fourth evaluated the certainty of the incremental cost-effectiveness or cost-utility ratio.ConclusionsThe tool was developed to integrate critical aspects that affect the methodological quality of health economic analyses, which are often missing in other tools. The quality of reporting was not included as a domain because it is already covered by existing tools. A multidisciplinary panel with different key stakeholders is being organized to review and refine the first version of the tool.
PD38 Ensuring Study Validity To Inform Health Technology Assessments Globally
Authors: Devine (Emily) Beth , Whiting Penny , Mallett Sue , Wolff Robert , Savovic Jelena 
Published: January 2025

IntroductionAssurance that supporting evidence is based on valid and unbiased assessments, evaluated using rigorously developed risk of bias (validity assessment) tools, is fundamental to good decision-making. Among those available, selecting and correctly using the best tool that is fit-for-purpose is challenging. Collaboration across the global evidence synthesis and health technology assessment (HTA) communities promotes best practices and harmonizes tool use across jurisdictions.MethodsWe have established the LATITUDES Network (https://www.latitudes-network.org/), a publicly available website library of validity assessment tools and resources to guide decision-makers in selecting and applying tools appropriate for particular contexts, including informing HTA reimbursement decisions, clinical guideline development, and stand-alone evidence synthesis projects. The internationally representative leadership team comprises five evidence synthesis experts who have been supported by a competitively awarded academic innovations grant. The 23-member advisory panel representing five continents provided expertise to finalizing criteria for tool inclusion, identifying key tools, and suggesting inclusion of additional tools. Formal launch took place at the 2023 Cochrane Colloquium.ResultsOfficially launched in September 2023, the LATITUDES Network indexes validity assessment tools developed for healthcare studies in an online library. To date, 10 key tools are featured to help reviewers identify the optimal tool for their use. Nineteen additional tools have met all screening criteria and are also recommended. Information characterizing each tool (e.g., citation and training materials) is provided. Seven tools are currently under development. A mechanism for users to suggest new tools is provided. Additional tools and information on toolkits and online training materials, as well as links to courses and events, will be added over time.ConclusionsLATITUDES aims to be the primary resource that provides key information to reviewers conducting validity assessments for evidence synthesis, clinical guideline development, and HTA decision-making. It is intended to increase the robustness of evidence synthesis by improving the process of validity assessment, helping scientists use tools more effectively and efficiently, promoting best practices, and harmonizing validity assessment across the globe.
PD40 Pilot Healthcare Programs - Bridging The Evidence Gap For Innovative Technologies
Authors: Gruszka Jarosław , Sejbuk-Rozbicka Katarzyna , Koperny Magdalena , Dzik Maciej , Pelczarska Aleksandra , Syta Joanna , Malinowska Kamila 
Published: January 2025

IntroductionThe scarcity of high quality evidence is a common constraint on the willingness to publicly fund innovative technologies. Our aim was to prepare a Methods and Process Guide to support the development of pilot healthcare programs in Poland. Such guides play a pivotal role in enhancing the quality of pilot programs and confidence in public funding decisions in health care.MethodsWe reviewed guidelines for pilot healthcare programs published by the World Health Organization (WHO) and other healthcare organizations and analyzed the pilot healthcare programs in Poland. The Ministry of Health in Poland and the general public will be invited to provide feedback on the Guide.ResultsPilot programs serve as valuable testing grounds for healthcare solutions in low risk, small-scale clinical practice settings. A pilot program may be considered for interventions with proven safety and effectiveness, and when the intervention is complex, its implementation requires testing, or the intervention is considered high cost. Our Methods and Process Guide defines key elements of pilot healthcare programs, including objectives, starting criteria, conducting conditions, and monitoring rules. Public consultation on the Guide is underway.ConclusionsThe publicly available Methods and Process Guide should enhance the methodological rigor of pilot healthcare programs in Poland. Well-designed pilot programs are expected to provide high quality real-world data that will facilitate public funding decisions for innovative technologies.