bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP165 Changing Decision Criteria: An Analysis Of Health Technology Assessment Reports To The Brazilian Unified Health System
Authors: Borges Stefani , Rodrigues Fernanda , Pires Wolney , da Costa Nathalia , Louly Priscila , Prado Clementina , Santos Vania 
Published: December 2023

IntroductionIn Brazil, the National Committee for Health Technology Incorporation of the Brazilian Public Health System (Conitec) defines the criteria for incorporating technologies into the public health system. However, all recommendations are submitted to public consultations to ensure transparency and public participation.Contributions from the public consultation are analyzed and entered into Conitec’s final report and sometimes change the preliminary recommendation.MethodsThis descriptive, retrospective exploratory study aimed to gather qualitative and quantitative data on criteria considered by healthcare decision makers from Conitec and to identify which criteria most changed after reports were submitted to public consultation. Data from 2012 to November 2022 were collected from the Conitec website, entered into a specific extraction form, and analyzed using descriptive statistics.ResultsMedicines (77%) were the most frequently evaluated type of technology, followed by procedures (15%), and products (8%). A total of 763 recommendations were analyzed. Of these, 70 percent did not change the decision criteria from the preliminary to the final published report, 9 percent did change, and 20 percent were simplified analyses of technologies of relevant public interest that were of low cost and low budget impact (these were not submitted to public consultation or public hearing). As pharmaceutical companies usually propose cost reductions or discounts during the Conitec public consultations, most of the recommendations (45%) were modified in the final report, with incremental budgetary reduction being the main criterion. This study identified that most of the changes occurred in neurology and were related to the high incremental budgetary impact of technologies for the care of rare diseases like spinal muscular atrophy.ConclusionsAlthough different criteria are considered for Conitec recommendations, some of these are regarded as crucial for decision-making. Unfortunately, as there is no definition for the weight of each of these criteria, it is difficult to understand their influence on the recommendations made. Therefore, it is crucial to establish standardized criteria for proper decision-making.
OP171 Canadian Disease Registry Inventory: Environmental Scan Of The Literature
Authors: Hodgson Amanda , Loshak Hannah , Lachaud James , Bernard Amélie , Slade Teri , Mák Geneviève , Fowler Heather Smith 
Published: December 2023

IntroductionIn consideration of the lessons learned from other jurisdictions and other ongoing work in the disease registry data space, an opportunity existed to investigate the current Canadian landscape and identify opportunities for a Canadian registry list. Previously, no national-level inventory of registries existed in Canada that could provide the necessary information to support awareness and use of available data for decision-making.MethodsA literature search was conducted on key resources, including MEDLINE and a focused internet scan. No methodological filters were applied to limit retrieval by publication type. The search was limited to documents published in English or French.ResultsCore characteristics of the identified registries were extracted and contextual information on the current landscape of disease registries in Canada was explored. A literature review and draft inventory list has been produced.ConclusionsA CADTH environmental scan was undertaken to collect and report on existing Canadian disease registries and to identify key features, characteristics, and intersections. This information and analysis increase the potential of Canadian registries to inform decision-making and identifies opportunities for the optimal use of registry data in Canada more broadly.
PP11 Patient Involvement In Drug Evaluations To Inform Funding Decisions: A Singapore Case Study
Authors: Tan Ping-Tee , Pearce Fiona , Quek Shawn , Teo Sok Huang 
Published: December 2023

IntroductionPatient involvement has become increasingly integral to health technology assessment (HTA) processes globally due to greater recognition of the important contribution patients make to address uncertainties in the scientific evidence base and interpret results for real-world implementation. To align with best practices and encourage meaningful patient input in HTAs in Singapore, patient involvement processes were established by the Agency for Care Effectiveness (ACE) in 2021. This presentation discusses how patient groups were identified in Singapore and describes the new patient involvement processes.MethodsIn the absence of a centralized database, a stakeholder mapping exercise was undertaken in 2021 to identify all relevant patient and volunteer groups in Singapore. A comprehensive search of the Singapore Charity Portal, hospital websites, standard search engines and social media platforms was conducted.Identified groups were screened in line with specific inclusion criteria and contacted via email and cold calling to find out more about their remits. Plain English resources, targeted training materials and a process guide to encourage patient involvement in ACE’s work were co-developed with local patient organizations by drawing upon best practices from overseas HTA agencies contextualized to local patients’ needs. Supporting resources and processes were revised in 2022 based on ACE’s experience receiving inputs from patients and caregivers to inform drug HTAs.ResultsOne hundred and six patient groups covering 20 conditions were identified including registered organizations and informal support groups. In the first half of 2022, ACE received responses from 82 patients from ten patient organizations to inform seven drug HTAs for cancer, diabetes, HIV, and other conditions in line with the new patient involvement processes. Patient organizations viewed the opportunity to submit testimonials of their lived experience with different conditions as a meaningful and important activity for their members.ConclusionsPatient involvement processes have improved the legitimacy and acceptance of ACE’s work and will be continuously revised to ensure that they remain relevant and meet patients’ expectations and needs.
PP14 The Role Of Health Technology Assessment In The Public Hospitals Of The National Health Service Of Catalonia
Authors: Mestre-Lleixà Berta , Llinàs-Mallol Laura , Gallastegui-Calvache Edurne , Ramos-Masdeu Laia , Ruiz-Baena Jessica , Vivanco-Hidalgo Rosa Maria 
Published: December 2023

IntroductionHospitals play an essential role to facilitate the appropriate introduction of health technologies into the National Health System. We aimed to analyze if the decision-making at the hospital level is based on health technology assessment (HTA).MethodsWe developed a seventeen-question survey to assess the decision-making mechanisms for the introduction of health innovation into the public hospitals of the National Health Service (NHS) of Catalonia. All questions were related to the field of HTA and health innovation. We asked about the process of new health technology acquisition, the existence of HTA units, and the impact those units might have within the center. We invited the three main public healthcare providers (n= 68 centers). We performed a quantitative analysis grouping the results by type of healthcare provider.ResultsThirty-five different health providers (51.5%) remitted forty-two responses. We identified two differential mechanisms for the introduction of health innovation in those centers: 51.4 percent used a directive committee for decision-making, whereas 37.1 percent employed a technical commission. Some centers (8.6%) used both options. Both the directive committees and technical commissions predominantly considered the professional experience or scientific evidence provided by the healthcare professionals of the center (80%) or external HTA reports or clinical practice guidelines (65.7%) to guide their decision-making. Using HTA products developed within the center was less frequent (34.3%). Only 57.1 percent of the healthcare providers had an HTA unit, but 75 percent of them declared that HTA products had a direct and quantifiable impact on their decision-making regarding the introduction of innovation. Healthcare providers without HTA units manifested their willingness to adopt HTA practices into their decision-making processes.ConclusionsHTA at the hospital level is not a common practice when deciding to introduce innovative health technologies in the NHS of Catalonia. However, the main healthcare providers agreed that the introduction of HTA is necessary for improving their decision-making and that the HTA agency, Agency for Health Quality and Assessment of Catalonia (AQuAS) will play a key role (training, promoting, and assessing).
PP38 Designing A Training And Capacity Building Pathway In Patient Involvement
Authors: Triñanes Yolanda , Faraldo-Vallés María J. , Gómez Patricia , Cantero-Muñoz Paula , Vicente-Edo María J. , Reviriego-Rodrigo Eva , Novella Blanca , Toledo-Chávarri Ana 
Published: December 2023

IntroductionThe Patient Involvement (PI) Interest Group of the Spanish Network of Health Technology Assessment Agencies (RedETS) was set up in 2017 by a group of health technology assessment (HTA) researchers interested in PI. Since its inception, training and capacity-building to support PI and patient-based evidence in HTA processes has been one of its main aims. The objective of this work was to identify the needs and priorities related to training and capacity building activities to be developed within the framework of the PI Interest Group.MethodsThe PI Interest Group met on November 14, 2022, for its Annual Meeting. The group discussed the needs, priorities and possibilities on training, and carried out a prioritization exercise. For this purpose, a self-reported and anonymous questionnaire was used, which included 16 training activities. Every item was scored with a Likert-type scale ranging from 0 to 10.ResultsThe questionnaire was answered by twenty participants. The most highly rated training activities (mean less than or equal to 8) were: qualitative evidence synthesis (8.75); PI case studies (basic (8.65) and advanced (8.56) level); quality assessment tools for qualitative evidence (8.37); and qualitative research (8.11). Other proposals scoring above 7 points were: ethical aspects related to PI, evaluation of patient participation and impact, identification and recruitment procedures, and discrete choice experiments. The group agreed to organize bi-monthly webinars and three structured training activities for the whole RedETS network on: Qualitative Evidence Synthesis, Qualitative Research and PI Case Studies.ConclusionsThe prioritization of training activities according to PI Interest Group members allowed planning a tailored capacity-building program adapted to the needs of RedETS.
PP41 Using Medicare Claims Data To Support Reimbursement Of A Novel Leadless Pacing System For The Management Of Bradycardia
Authors: Makino Koji , Mudge Mia , Zaunmayr Chelsea , Tilden Dom 
Published: December 2023

IntroductionThe Micra Transcatheter Pacing System (Micra TPS) is a single-chamber transcatheter leadless pacemaker (LPM). LPMs do not require leads or a subcutaneous pocket, which represent the primary sources of device-related complications with conventional transvenous pacemakers (TVPMs). Complications such as infections and lead dislodgements cause significant patient burden, which have significant economic consequences. Running a randomized controlled trial (RCT) to estimate risk differences of infrequent events requires large sample sizes and long follow-up periods. Real-world observational data, while informative, requires an appropriate study design and statistical adjustments to control for potential biases.MethodsThe Micra Coverage with Evidence Development (CED) study was a cohort study of LPM versus TVPM based on US Medicare claims data of 16,431 patients with 2-year follow up (LPM: n=6,219; TVPM: n=10,212). Propensity score matching (PSM) was applied to account for differences in baseline characteristics. As no RCT was identified in the literature, this study was presented to the Australian payer as the primary source of clinical evidence, upon which a cost-utility analysis was conducted.ResultsAfter PSM, the CED study demonstrated significantly more complications with TVPM versus LPM with adjusted rates of 6.5 percent and 4.6 percent (p<0.001). Significant differences favoring LPM (p<0.01) were observed in device breakdown (1.4% vs 2.0%), dislodgment (0.4% vs 1.2%) and infection (<0.1% vs 0.6%). Based on these findings, a claim of superior safety was accepted by Medical Services Advisory Committee (MSAC) to support reimbursement. In making this decision, MSAC considered that the large sample size and propensity weighting overcame some of the potential biases and the magnitude of the benefit supported cost-effectiveness relative to TVPM.ConclusionsThe lack of a sufficiently powered RCT with an extended follow-up period can mean the impact and benefits of new technologies that reduce clinically important adverse events of relative infrequency are not formally incorporated into payer decision making, particularly where RCTs are a requirement. A well-designed observational study can provide valuable, real-world evidence to support a HTA for reimbursement decisions.
PP50 Early Diagnosis Effect Of Newborns With Critical Congenital Heart Disease Using National Health Insurance Data In South Korea
Authors: Choi Miyoung , Kim Jimin , Park Chanmi , Choi Byung Min , Ha Gisu , Shin Hong Joo , Kim Sujin , Shin Jeonghee , Choi Eui Kyung 
Published: December 2023

IntroductionCritical congenital heart disease (CCHD) refers to a group of heart defects that cause serious, life-threatening symptoms in the neonatal period and requires timely surgical or catheter interventions. We tried to explore current status of CCHD burden and the effect of early diagnosis of CCHD to mortality using the Korean national health insurance (NHI) data.MethodsWe analyzed the national health insurance (NHI) data from 2014 to 2018. We identified CCHD patients using the diagnosis codes and intervention codes from the claim data and the prevalence, mortality and medical expenditure of CCHD were analyzed. We linked neonatal data with their mother’s medical claim data and developed retrospective cohort data set for analyzing the effect of early diagnosis to mortality and related outcomes of CCHD treatment.ResultsThe annual prevalence of neonatal CCHD in Korea was 0.144% percent. A total of 2,241 CCHD neonates, 1,546 (69.0%) underwent cardiac ultrasound within three days after birth, and mothers of 419 neonates had a record of prenatal fetal ultrasound (18.7%). In our comparison of neonates diagnosed with CCHD within three days of birth with those diagnosed with CCHD on or after day 4 of birth, the probability of early diagnosis increased for preterm infants and infants with low birth rate. Regarding mortality rate, most types of CCHD showed a significantly higher mortality rate in the early diagnosis group.ConclusionsThe reason for the high mortality rate despite a high early diagnosis rate pertains to the high percentage of patients with severe conditions that induce a serious heart rate within three days of birth. More than half of the neonates with CCHD were found to have not undergone a prenatal fetal ultrasound, rendering this an important policy target.
PP52 Will Joint European Health Technology Assessment Provide Additional Benefits Over Individual Country-wise Assessments?
Authors: Arora Rhythm , Gonzalez Ignacio Garcia , Delaitre-Bonnin Caroline 
Published: December 2023

IntroductionIn December 2021 the European Union (EU) Health Technology Assessment (HTA) Regulation, a key pillar of the EU Pharmaceutical Strategy, was adopted by the Council and the European Parliament. The focus areas of Joint HTA Cooperation include Joint Clinical Assessments (JCA), Joint Scientific Consultations (JSC), and joint early-stage horizon scanning. The European HTA regulation will be adopted in a stepwise approach and from 2030 onwards, all products (drugs, high-risk medical devices, and in vitro diagnostics) approved in all indications will be subjected to JCA in EU.MethodsA targeted literature research was performed for policies and the European Network for HTA (EUnetHTA) methodological guidelines describing the HTA methods including scoping process, comparators, endpoints, the applicability of evidence, and validity of clinical studies. Additionally, the anticipated opportunities and challenges were also summarized with respect to these methods.ResultsEUnetHTA put forward a timeline for different activities over the next three years as part of the new EU HTA Regulation, including key deadlines for ongoing EUnetHTA consultations on the processes and methods. EUnetHTA will set up a new ecosystem across the EU as it aims to reduce duplication and time to access by supplementing multiple national clinical assessments with a joint central assessment. In any case, assessment of added value and pricing and reimbursement decisions will still occur at the national level.Additionally, EU HTA may promote harmonization of processes, standards, and evidence requirements, which will increase predictability and simplify evidence requirements. However, differences in clinical practice, standard of care, and national priorities may lead to assessments that are not generalizable to all Member States.ConclusionsThe joint EU HTA cooperation will benefit countries which have less developed or do not have established HTA expertise or infrastructure. However, the JCA process could result in increased requirements for clinical evidence generation as relative effectiveness and relevance of outcomes to patients gain further importance for products to successfully gain access across countries.
PP55 Citizens’ General Needs Assessment In SOTERIA Project: ‘User-friendly Digital Secured Personal Data And Privacy Platform’
Authors: Arana-arri Eunate , Imaz-Ayo Natale , del Burgo Ainara Velez , Idoyaga Eneko , Barasoain Maitane , Orcajo Janire , Lazar Iuliana , Van Thuy Luyen , Keba Varvara , Galariotis Emilios , Oliveira Tiago 
Published: December 2023

IntroductionDuring the COVID-19 pandemic, the use of e-services increased, bringing a better choice of technologies and services. Nevertheless, these services require the use of sensitive personal data, which increased the level of risk because of potential privacy and security breaches. As a result, citizens are more concerned about their privacy, security, and personal data protection. The SOTERIA project aims to provide a secure and user-driven solution. This study aims to identify barriers and key points related to citizens when using digital systems for data interoperability.MethodsBoth qualitative and quantitative approaches were applied in order to identify and measure citizens’ general needs regarding the tool to be developed within the context of SOTERIA. The questionnaire was distributed throughout the three European countries under study: Austria, Romania, and Spain, with 400 responses collected in each country. The distribution of sex, age, occupation and educational level was representative in the entire sample.ResultsThis study corroborates the critical role of perceived security in the intention to adopt new technologies. In addition, to trust and being consistent with the extant literature on technology adoption/acceptance, perceived benefits and usefulness also play a crucial role in driving attitudes and behavioral intention to adopt digital data wallet (DDW). Our findings show that perceived ease of use, the user’s belief of having no difficulty using the technology (i.e., DDW), is a significant predictor of consumers’ intentions to use DDW. Our qualitative data from both the in-depth interviews and focus groups also revealed convenience, being comfortable, and/or less time and energy needed to use DDW in comparison to one’s current situation, to be a determinant of perceived benefits. Transparency, which provides consumers with knowledge of how firms manage their personal information, was also viewed as important among our participants in both in-depth interviews and focus groups. Our findings corroborate previous studies that report the control of privacy concerns, or the extent to which consumers believe they can manage the flow of information, feel comfortable and enhance their perceived view of privacy or lower privacy concerns.ConclusionsOur qualitative studies confirmed that trust, or consumers’ expectation of how data will be handled in the future plays an important role in influencing the intention of DDW adoption.
PP71 Hospitalization Costs Associated With Advanced Non-Small Cell Lung Cancer In China: Real World Evidence From Jiangsu
Authors: Xia Yu , Yang Yi , Chen Yingyao 
Published: December 2023

IntroductionNon-small cell lung cancer (NSCLC) constitutes 85 percent of lung cancer diagnoses and poses an economic threat to the sustainability of healthcare services. This study was conducted to estimate hospitalization costs associated with advanced NSCLC without sensitizing EGFR (epidermal growth factor receptor) and ALK (anaplastic lymphoma kinase) alterations in China and explore the potential predictors.MethodsData linked with patients with advanced NSCLC (stage IIIB–IV) without sensitizing EGFR and ALK alterations were obtained from the electronic medical record system of one general hospital and one cancer hospital in Jiangsu province, China, ranging from January 2017 to December 2020. We excluded patients with lung metastases from tumors elsewhere in the body. The socio-demographic characteristics, disease-related characteristics, and hospitalization cost of eligible patients were extracted. We used the generalized linear model (GLM) to assess the potential influencing factors of hospitalization cost.ResultsPatients with advanced NSCLC (n=7,260) were included in this study. The median hospitalization cost of advanced NSCLC was USD11,540.47. The median hospitalization examination and test costs were USD1,539.46, and the median hospitalization drug cost was USD6,351.47. GLM results showed that patients aged 60 or older (95% Confidence Interval [CI]: -1019.1,128.6), who had no gene driver (95%CI: -1,681.6,-233.6) were more likely to have relatively lower hospitalization costs for advanced NSCLC. Patients treated in cancer hospital (95%CI: 1,329.1,2,620.0) and with non-squamous carcinoma (95%CI: 171.3, 1,235.4) may have higher hospitalization costs. Compared with Urban Employee Basic Medical Insurance, patients with free medical services (95%CI: 1,248.4,6,298.7) were associated with higher hospitalization costs. Patients with higher hospitalization frequency and longer length of hospital stay (p < 0.05) were linked to higher hospitalization costs.ConclusionsThe hospitalization costs linked to advanced NSCLC is considerable for patients, with drug costs accounting for the largest. More efforts still need to be made to alleviate the direct medical burden.