bluuebunny/crossref_metadata_2025_split huggingface dataset:
PD199 Global Collaboration Post-Brexit: Do Project Orbis And The Access Consortium Improve Access In The UK Compared With Europe?
Authors: Gassanova Aigun , Leong Katherine , Macaulay Richard 
Published: January 2025

IntroductionAs the newly independent regulator for medicines in the UK post-Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) has entered international regulatory collaborations, notably Project Orbis (PO) and the Access Consortium (AC), to help expedite marketing authorizations. This research compared regulatory and reimbursement outcomes for medicines approved in Great Britain through PO and the AC with corresponding outcomes from the EU4Health Programme.Methods
Products approved by the MHRA through PO and the AC were identified from the PO and New Active Substance Work Sharing Initiative websites, respectively. Marketing authorization dates and reimbursement outcomes were obtained from the respective regulatory and health technology assessment body websites on 20 November 2023.ResultsA total of 21 products have been authorized by the MHRA through either PO (17/21) or the AC (4/21); 17 of 21 have been authorized in Europe. Approval by the MHRA was 54 days earlier on average than for the European Medicines Agency. The results for various countries were as follows:•England: 14 of 21 (67%) products assessed (9/14 [64%] recommended);•Scotland: 14 of 21 (67%) products assessed (11/14 [79%] recommended);•France: 14 of 21 (67%) products assessed (2/14 [14%] received Amélioration du Service Médical Rendu level I to III);•Germany: 14 of 21 (67%) products assessed (5/14 [36%] achieved additional benefit);•Italy: 10 of 21 (48%) products assessed (9/10 [90%] reimbursed); and•Spain: 10 of 21 (48%) products assessed (7/10 [70%] reimbursed).Days from regulatory approval to HTA were 306 (Scotland), 308 (France), 310 (UK), 330 (Germany), 398 (Spain), and 404 (Italy).ConclusionsCompared with the EU4Health Programme, PO and the AC have enabled earlier marketing authorizations for medicines in the UK by an average of seven weeks. However, the proportion of therapies reimbursed and the delay from marketing authorization to reimbursement were comparable or more favorable for UK health technology assessment bodies. Thus, the UK may become a first-to-launch European market for certain therapies through PO and the AC.
PD203 Comparison Of Health Technology Assessment Methodologies Across Australia, Canada, New Zealand And The United Kingdom: Implications For Future Collaboration
Authors: Henderson Nadine , Theakston Claud , Brassel Simon , Garau Martina , Allen Rachel , Largeron Nathalie , Malottki Kinga , Patel Yuti , Garces Kirsten , Coombes Megan , Xavier Vanessa 
Published: January 2025

IntroductionIn 2022, a group of health technology assessment (HTA) bodies from Australia, Canada, and the UK announced a collaboration to identify solutions to common challenges. This collaboration was later expanded to include agencies from New Zealand and Quebec, Canada. Since one possible activity of the consortium is joint assessments, we compared the methodologies of the agencies on 11 topics to assess the feasibility of this.MethodsWe reviewed the methodological guidelines of the Canadian Agency for Drugs and Technologies in Health (CADTH), L’Institut national d’excellence en santé et services sociaux (INESSS), the National Institute for Health and Care Excellence (NICE), the Pharmaceutical Benefits Advisory Committee (PBAC), the Pharmaceutical Management Agency (Pharmac), and the Scottish Medicines Consortium (SMC). The topics considered were real-world evidence, consideration of health effects, economic reference case, survival analysis, surrogate endpoints, patient involvement, uncertainty, orphan pathways, clinical evidence requirements, carer perspective, and decision modifiers. We analyzed the level of alignment across the collaborating agencies using information from the guidelines, supplemented by published literature where necessary.ResultsThree topics exhibited high alignment: consideration of health effects, clinical evidence requirements and surrogate endpoints. The topics of orphan pathways and carer perspective had low alignment. The remaining topics had moderate alignment. Regarding orphan pathways, NICE and the SMC had separate processes for ultra-orphan drugs, CADTH and INESSS implicitly consider rarity, and PBAC and Pharmac do not appear to consider rarity. Since carer perspective is not commonly accepted in HTA, NICE was the only agency with relevant guidance on this topic. INESSS required the societal perspective as standard, while the PBAC and Pharmac explicitly excluded it. CADTH may consider carer perspective in some circumstances, whereas the SMC guidance was ambiguous.ConclusionsWhile there is good alignment on most topics, there are several areas where agencies would need to resolve divergences in preferred methodology if joint assessments are going to be carried out in the future. All relevant stakeholders should be part of this process, including patient groups and industry.
PD206 Health Technology Assessment And Decision-Making During The COVID-19 Pandemic: Analysis Of Processes And Results From 25 Health Ministries
Authors: Hasdeu Santiago , Alvarez Jorgelina , Beliera Anabel , Viamonte Julian Sanchez 
Published: January 2025

IntroductionThe decision-making process in public administration can be analyzed from different perspectives. Evidence-based policies are not the only support for public policy design. High variability was observed regarding the health technologies used during pandemics. The processes and results of decision-making on health technologies in 25 health ministries in Argentina during the COVID-19 pandemic were analyzed.MethodsThis retrospective study utilized triangulation of quantitative and qualitative methods. Information was retrieved for the years 2020 to 2021 through document review of official web pages, surveys, and interviews with decision-makers and advisors of the national ministry of health and 24 Argentinian provinces. Recommendations and reimbursement policies for seven health technologies were considered as tracers. Official health technology assessment (HTA) reports, laws, judicial rulings, journalistic news, and civil society actions on social networks and the internet regarding these technologies were analyzed. The ruling political party in each province was mapped, with the aim of exploring the political influences and intervening actors.ResultsContrary to World Health Organization (WHO) recommendations, ivermectin, inhaled ibuprofen, convalescent plasma, and equine serum were widely recommended and reimbursed outside a clinical trial context by most of the Argentinian ministries of health, leading to risks for patients and a huge opportunity cost. Health ministries with institutionalized HTA units had significantly higher adherence to WHO recommendations than other health ministries. Legislative and judicial powers influenced the use of health technologies through laws and judicial rulings. Researchers and civil society also influenced decision-makers. Partisan political issues did not fully explain the heterogeneity of the decisions made by the health ministries during the pandemic.ConclusionsThe impact of HTA organizations and their technical reports was limited. Health Ministries with institutionalized HTA units were more likely to adhere to WHO recommendations. The influence of different technical and political criteria, power relations within and outside the administrations, the pharmaceutical industry and academics, the media, social pressure, judicial and legislative powers, and the political context strongly influenced decision-making.
PD210 Sustainable Innovation In UK Care Homes: Acoustic Monitoring Systems In A “Living Lab” Setting - Technology Assessment Example
Authors: Nguyen Quang A , Wark Petra A , McCabe Louise , Zheng Dingchang , Jing Yanguo , Collinson Mark , Nomura Toshio , Rayner Vic , Russell Ed , Szczepura Ala 
Published: January 2025

IntroductionSuccessful development of technologies to support older people in care homes remains challenging. The strategic establishment of a group of residential settings providing 24-7 living labs plus an innovation hub is described. Acoustic monitoring (AM) for continuous nighttime checking of residents was selected for assessment. A pilot study in 2016 identified potential cost savings, reduced nighttime falls, and improved daytime well-being.MethodsThe AM system was systematically assessed in four WCS Care Group Ltd care homes following demonstration and testing in an innovation hub. The first author undertook a mixed-methods study (2019 to 2023) to assess the technology in terms of falls prevention, practical implementation, and future benefits of enhanced sound classification using artificial intelligence (AI). In 2020, a network of care providers, the National Care Forum (NCF), was funded by National Health Service Digital to develop three similar innovation hubs across England. The NCF undertook a national survey to identify priorities in terms of implementing new technologies in care homes.ResultsStructured interviews with care workers and observational assessment in four care homes confirmed that the AM system has the potential to identify active residents and reduce the risk of falls, although it cannot offer fall prediction or prevention functionality. Two new functions were proposed. Eight machine learning models for sound classification and demonstration tests in three simulated settings supported feasibility and adoption. A post-demonstration survey (n=39) identified a high probability of adoption for these additional functions. The NCF survey found that the top four new technologies of interest to care homes were medication management systems, electronic care planning, wearable GPS trackers, and AM systems.ConclusionsCare homes report interest in procuring AM systems, which could reduce the risk of falls. In addition, new AI-supported functions are acceptable to care providers. The UK government has proposed that 20 percent of care homes introduce AM by March 2024. Guidelines for future assessment of sustainable care technologies in living lab settings now need to be developed.
PD223 Early Dialogue With Researchers: The Case Of The OPTIBIO Study, Innovating From The Investigation Stages
Authors: Paz-Valiñas Lucinda , Rotea-Salvo Sandra , Carmen Maceira-Rozas Maria del , Casal-Acción Beatriz , Vallés María-José Faraldo 
Published: January 2025

IntroductionAn early dialogue (ED) is non-binding scientific advice given to industry in the initial stages of technology development to help create evidence that the health technology assessment (HTA) agency will request. ED could also be used in the academic ecosystem. We report our experience with the clinical validation of an algorithm to predict persistent remission in patients with rheumatoid arthritis treated with biological therapy.MethodsA systematic review (SR) was undertaken to compare optimization algorithms with current clinical management. The review focused on the effectiveness and safety of these tools and included clinical practice guidelines, SRs, and primary studies. Several meetings took place between the research team and HTA researchers to integrate HTA requirements (e.g., choice of comparators, relevant outcomes, quality of life, and patient groups) into the study design to ensure the quality and accuracy assurance of data collected as well as the proper monitoring of good clinical practice.ResultsLocal clinical practice guidelines pointed to the importance of optimization strategies to select the most suitable patients in remission. However, there is currently no validated algorithm to select these patients. The literature search retrieved 1,809 references. There were no primary studies identified and only two ongoing randomized controlled trials met the inclusion criteria: REMRABIT-Plus (OPTIBIO) and PATIO. There were some important differences between the studies with respect to the patient populations and stages of the disease. Based on these results, the review will continue in “living evidence” mode, with the aim of collecting new evidence as it becomes available.ConclusionsThere is currently an unfulfilled need between research projects in the academic context and HTA that can be resolved with ED. Collaboration in the early stages of technology development is fundamental to improving the appropriateness of data produced for future HTAs. This will facilitate quality decision-making on the incorporation of procedures into the National Health Service.
PD231 A New Way Of Identifying And Selecting Health Technology Assessment Topics: Using Social Media And Citizen Involvement
Authors: Jung Yeryeon , Lee Sou Hyun , Choi Hayoung 
Published: January 2025

IntroductionAs unfiltered health information overflows through social networking services, people’s health rights are being violated and unnecessary medical expenses are increasing. Citizens and patients participating in the group initiative Public Involvement in the National Evidence-based Healthcare Collaborating Agency (NECA), the sole health technology assessment (HTA) agency in South Korea, began monitoring information on health technology in social media from 2021 as a new way to identify HTA topics.MethodsCitizens and patients in Public Involvement in NECA were provided with search keywords related to “common diseases on general public” and “diseases with high public interest”. They monitored social media platforms for one month and collected information about health technologies, such as medicines and treatments without scientific evidence on their safety and effectiveness. The target information included subjective information on health technologies based on personal experience; information with unclear sources; information that might cause excessive anxiety and fear; and information with a high risk of side effects. Information was collected from the internet and a checklist was given to the participants to evaluate the suitability of the information.ResultsIn the topic selection process, NECA, and the Korean Society of Science Journalists (KSIA) evaluated the priority of HTA topics developed from the collected information. HTA topics were evaluated using five criteria, including the possible harm the information might cause throughout society. As a result, the safety and effectiveness of saw palmetto in patients with prostatic hyperplasia and high-dose intravenous vitamin C in patients with cancer were selected. NECA conducted health technology reassessments on these topics and was able to successfully disseminate the reassessment results in collaboration with the KSIA.ConclusionsParticipation in the HTA process using social media lowered the barriers that laypersons experience with HTA and increased the possibility of bringing HTA topics closer to citizens’ lives. However, as there were difficulties in collecting meaningful information for developing a HTA topic, providing systematic training on health information monitoring remains a challenge.
PD241 Supporting Patient Groups To Enhance Their Input To Health Technology Assessment
Authors: Cairns Daniel , Russell Kate , McCormack Jackie , Dickson Jennifer 
Published: January 2025

IntroductionThe Scottish Medicines Consortium (SMC) patient group submission process includes a written submission of patient experience evidence from Patient Group Partners (PGPs). To maximize the relevance and quality of information included in submissions, the first draft is reviewed by the Public Involvement Team and feedback is provided. The submission is then amended by the submitting PGP before final submission.MethodsUpon receiving a new written patient group submission, the Public Involvement Team reviews it and provides feedback highlighting any evidence gaps and areas where wording could be amended to strengthen the patient voice. The draft submission is then amended by the submitting PGP, with support from the SMC reviewer. Once finalized, the submission is collated into the body of evidence used by the SMC Committee members to assess a new medicine. The satisfaction of participating PGPs is continually assessed by an online survey. During the 2021 to 2023 period, the SMC received 232 patient group submissions, with 77 percent being amended and strengthened after receiving feedback.ResultsThe feedback and collaboration on amendments to draft submissions has improved the quality of patient experience evidence submitted to the SMC by PGPs. PGPs value their draft evidence being reviewed by the SMC Public Involvement Team prior to final submission. This approach resulted in high levels of trust in and satisfaction with how the SMC involves patient representatives in medicine assessments. In 2022, 89 percent of the 28 PGPs surveyed were very satisfied and 11 percent were satisfied with the support provided during the submission process.ConclusionsEvaluation of the SMC’s formal process to provide input and feedback on draft written patient group submissions demonstrates high levels of satisfaction with how the SMC works in partnership with PGPs. This approach has strengthened written evidence of patient experiences for SMC assessments. Furthermore, it helps to build and maintain a partnership approach in how the SMC works with PGPs.
“A little world within itself”: The South Carolina Penitentiary and the Roots of the Carceral State
Authors: Butorac Sean Kim 
Published: January 2025

AbstractThis article tracks the buildup of the South Carolina criminal legal system between 1867 and 1899 through three eras of its state penitentiary: from the politics of reform to convict leasing to the prison plantation. To track the delayed emergence and unusual trajectory of South Carolina’s criminal legal system, I argue that two approaches became entangled after the Civil War: On the one hand, a modern, nationalized politics of reform, and on the other, a decidedly Southern vision of crime and punishment haunted by the afterlife of slavery. It was the tension between—and variegated blending of—these two approaches that yielded a hybrid carceral project and set the trajectory for the state’s criminal legal system as it entered the twentieth century.
Isolated pulmonary valve endocarditis leading to right ventricular outflow obstruction
Authors: Kulkarni Ankita , Sabnis Girish , Rathod Keyur Rajendra 
Published: January 2025

AbstractIsolated native pulmonary valve endocarditis is rare. We present a rare case of isolated native pulmonary valve endocarditis resulting in severe right ventricular outflow tract obstruction in an immunocompetent patient with surgically repaired ventricular septal defect caused by Burkholderia cepacia.
Changes in grocery shopping behaviour among low-income households during the COVID-19 pandemic
Authors: Trude Angela CB , Lowery Caitlin M , Vedovato Gabriela M , Ali Shahmir H , Dudzik Josephine M 
Published: January 2025

Abstract

Objective:
The Supplemental Nutrition Assistance Program (SNAP) Online Purchasing Pilot (OPP) authorised the use of SNAP benefits online in Maryland in May 2020. We assessed shopping behaviour and intentions associated with uptake and intended future use of online grocery shopping during and after COVID-19 among SNAP-eligible households.

Design:
In this mixed-methods study, participants completed a survey on online grocery shopping, and a purposefully sampled subset participated in focus groups or in-depth interviews between November 2020 and March 2021.

Setting:
Predominantly urban households in Maryland

Participants:
Primary shoppers of SNAP-eligible households with young children (n 310)

Results:
Most participants reported first shopping for groceries online after the OPP was implemented (57 %). Families who purchased groceries in-store less frequently were less likely to report ever buying groceries online (rate ratio (RR): 0·66, 95 % CI 0·46, 0·93) compared with weekly grocery shoppers. Shoppers who intended to purchase more groceries online in the next 6 months were more likely to have online shopping experience, although this differed by timing of online grocery service adoption. Participants reported more negative attitudes towards in-store grocery shopping during the pandemic than prior to its onset and cited COVID-19 as a motivator for ordering groceries online in focus groups. Most participants who had shopped online planned to continue after the pandemic (79 %).

Conclusions:
Most participants who shopped online started during the COVID-19 pandemic and considered the pandemic a key motivator. Findings suggest that low-income households will continue to shop online, affirming the need for policies that promote equitable access to healthy food online.
Ignan Earths: Habitability of Terrestrial Planets With Extreme Internal Heating
Authors: Reinhold Matthew , Schaefer Laura 
Published: January 2025

AbstractIs it possible for a rocky planet to have too much internal heating to maintain a habitable surface environment? In the Solar System, the best example of a world with high internal heating is Jupiter's moon Io, which has a heat flux of approximately 2 W compared to the Earth's 90 mW . The ultimate upper limit to internal heating rates is the Tidal Venus Limit, where the geothermal heat flux exceeds the Runaway Greenhouse Limit of 300 W for an Earth‐mass planet. Between Io and a Tidal Venus there is a wide range of internal heating rates whose effects on planetary habitability remain unexplored. We investigate the habitability of these worlds, referred to as Ignan Earth's. We demonstrate how the mantle will remain largely solid despite high internal heating, allowing for the formation of a convectively buoyant and stable crust. In addition, we model the long‐term climate of Ignan Earth's by simulating the carbonate‐silicate cycle in a vertical tectonic regime (known as heat‐pipe tectonics, expected to dominate on such worlds) at varying amounts of internal heating. We find that Earth‐mass planets with internal heating fluxes below 15 W produce average surface temperatures that Earth has experienced in its past (below 30C), and worlds with significantly higher heat fluxes still result in surface temperatures far below that of 100C, indicating a wide range of internal heating rates may be conducive with habitability.
Impact of Dust and Temperature on Primary Productivity in Late Miocene Oceans
Authors: Pillot Q. , Sarr A.‐C. , Donnadieu Y. , Gramoullé A. , Suchéras‐Marx B. 
Published: January 2025

AbstractMost of the primary productivity in the ocean comes from phytoplankton, and is impacted, among other things, by the amount of nutrients available, as well as by temperature. The Late Miocene and Pliocene were marked by global aridification, linked to the emergence of the large deserts, likely increasing the input of dust and thus nutrients into the ocean. There was also a global decrease in temperature during this period, linked to a decline in atmospheric CO2 concentration. The objective of this study is to explore the sensitivity to dust and CO2 levels on primary productivity in the oceans under Late Miocene boundary conditions. Here we used simulations performed with the coupled ocean‐atmosphere model IPSL‐CM5A2 and its marine biogeochemistry component PISCES and a Late Miocene paleogeography. Our results show that an increase in dust input produces a quasi‐generalized increase in primary productivity, associated with a decrease in nutrient limitation. This increase in productivity also leads to nutrient deficits in some areas, such as coastlines and the Eastern Equatorial Pacific. The decrease in CO2 levels and the associated lower water temperatures lead to a reduction in primary productivity. This decrease is mainly due to a reduction in the supply of nutrients resulting from less intense remineralization. In addition, our results show that change in carbon export resulting from change in dust input and temperature are highly heterogeneous spatially. Simulations combined with sedimentary data suggesting a link between aridification, cooling and the Biogenic Bloom of the Late Miocene and Pliocene.