bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP154 Horses For Courses: Developing A Proportionate Approach To Health Technology Assessment In England
Authors: Watson Ian , Dilkes Jenna , Ellison-Roberts Geoff , Prescott Jenniffer 
Published: December 2023

IntroductionThe number and range of technologies that the National Institute for Health and Care Excellence (NICE) evaluates has never been greater, and with that comes an increasing requirement for capacity. However, not all technologies need the full intensity of the current standard evaluation process. This presents an opportunity to differentiate evaluation processes, and in doing so release capacity for more evaluations. NICE has embarked on a project to develop proportionate appraisal processes, allowing promising medicines to move through refined processes that better match the specific needs of individual evaluations.MethodsThe proportionate approach to technology appraisals (PATT) project was initiated in June 2022. Multiple work strands were established to develop and test potential proportionate approaches, focusing mainly on streamlined approaches for appraisals in which a lighter-touch approach is sufficient. By creating an accountability framework which empowered staff across NICE, new processes were developed using test-and-learn principles: piloting key concepts using retrospective reviews and live appraisals and adjusting the approach based on their findings. The impacts of each approach on NICE, on stakeholders and on the individual appraisals were monitored and assessed.ResultsThe project has identified a range of procedural, methodological and operational improvements across the NICE technology appraisal process. Substantial efficiencies have been found, including consolidation of activities, reducing duplication of effort and minimizing disproportionate steps. The test-and-learn approach has proved successful, both in rapidly identifying unsuccessful ideas and in refining and adjusting processes in light of new information and challenges.ConclusionsThe proportionate approach to technology appraisals project represents an important part of improving and streamlining NICE’s approach to health technology assessment, reflecting the increasing demands on the program. Developing proportionate approaches allows efficient use of limited evaluation resources to continue supporting rapid, evidence-based access to innovative technologies. The project also provides a valuable demonstration of an agile, flexible approach to process improvement, paving the way to rapid, dynamic updates in the future.
OP168 Costs And Effectiveness Of Whole Exome Sequencing (WES) In Patients With Unsolved Rare Disease Through The Diagnostic Pathway
Authors: Marshall Deborah A , Degeling Koen , Tagimacruz Toni , Seeger Trevor A. , Boycott Kym M , Bernier Francois , Mendoza-Londona Roberto , MacDonald Karen V. , Hartley Taila , Hayeems Robin Z. 
Published: December 2023

IntroductionPatients suspected of having a rare genetic disease often experience lengthy and costly diagnostic odysseys. The timing of whole exome sequencing (WES) in the testing sequence, its diagnostic yield and test costs in the sequence all factor into estimates of cost-effectiveness analysis for health technology assessment.MethodsWe modeled the diagnostic pathway using a discrete event simulation model, starting with the first test result. We defined and populated the simulation based on data from the electronic medical records of n=307 from the Care-for-Rare SOLVE multi-center Canadian observational cohort. Five alternative diagnostic pathways were modeled based on the observed data: no WES, and WES as the first, second, third or fourth test in the sequence. WES as the second test in the sequence is considered standard of care in medical genetic centers in Canada. We assessed effectiveness of WES in terms of diagnostic yield, time to diagnosis, and costs as patient-level overall test costs (2020 CAD/USD) across the diagnostic pathway.ResultsCompared to molecular and specialized diagnostic tests only (i.e., no WES), WES increased diagnostic yield from 5 percent to 40 percent. The shortest time to diagnosis for those with a diagnosis was 1.82 years in the diagnostic pathway with WES as the second test. Test costs for each pathway were CAD2,800 (USD2,087, no WES), CAD2,700 (USD2,013, WES as first test), CAD3,500 (USD2,609, WES as second test), CAD4,500 (USD3,354, WES as third test), and CAD5,300 (USD3,951, WES as fourth test).ConclusionsPlacing WES earlier in the diagnostic pathway for patients suspected of having a rare disease is associated with an increased diagnostic yield, reduced time to diagnosis and lower overall test costs with the benefits being greater the earlier in the pathway that WES is implemented.
OP172 International Collaboration For Translating The Peer Review Of Electronic Search Strategies (PRESS) Checklist: A Harmonized Approach
Authors: Hodgson Amanda , Masterson Daniele , Ferreira T. P. , Laguardia Josué , da Silva Cicera Henrique , Martinez Silveira Martha Silvia , McGowan Jessie , Rabb Danielle 
Published: December 2023

IntroductionThe PRESS guideline and checklist provides a set of recommendations concerning the information that should be used by librarians and other information specialists when they are asked to evaluate electronic search strategies. CADTH and PRESS authors were approached for permission to translate this checklist into various languages.MethodsThe team from Fundação Oswaldo Cruz and the Universidade Federal do Rio de Janeiro asked CADTH for permission to translate the PRESS guideline and checklist for their research work. They translated PRESS following the steps advocated by the scientific literature on the translation of standardized questionnaires.ResultsCADTH is now sharing and actively disseminating the PRESS translations in French and Portuguese (and a forthcoming version in Spanish) via the Finding the Evidence website and through related presentation activities.ConclusionsThe coordinated translation of key health technology assessment (HTA) tools provides an avenue for international uptake and improvement of best practice in information retrieval, which is a foundational feature of HTA work. With the absence of formal translation guidelines on the translation of protocols such as PRESS, CADTH would benefit from developing guidance for HTA teams requesting to translate our tools. CADTH is currently conducting research on the uptake and use of PRESS, which will inform future knowledge mobilization strategies such as translation standards and communications.
PP01 Health Technology Assessment Of Cervical Artificial Disc Replacement: Highlighting The Need For A Consistent International Approach
Authors: Zhang Enti , Annoni Elena , Strachan Liesl 
Published: December 2023

IntroductionCervical artificial disc replacement (C-ADR) is not a new technology but one that has seen many technological advances in the past 10 years. Indeed, a recent review described total disc arthroplasty as the most innovative development in the history of spinal surgery. The primary goals of C-ADR are to reduce or eliminate pain, and restore normal segmental motion. The aim of this analysis was to identify, extract and examine key health outcomes and economic data from published health technology assessment (HTA) reports on C-ADR, with the aim of understanding how the evolution of this technology has influenced assessments internationally.MethodsA comprehensive search of over 90 HTA organization websites and the INAHTA HTA database using key terms for C-ADR surgical procedures was coupled with a literature search of recent systematic reviews. No language restrictions were applied.ResultsTwenty HTA reports of C-ADR surgery published from 2005 to 2022 were included for review. Several HTAs (4/20) were updates or reassessments by the same agency and one was an update across agencies (Italy update of Belgian HTA). While many of the HTAs concluded C-ADR is as effective as standard care and superior in certain outcomes, there was no pattern or consistency in the conclusions or recommendations from these assessments, even as the evidence base expanded over time. Our analysis found this was largely due to variations in HTA approaches among agencies including: differences in research questions asked, PICO (Population, Intervention, Comparator, Outcomes) criteria and methods performed, such as: rapid versus full systematic reviews; inclusion of economic evaluations and/or budget impact analyses.Indeed, one of the only predictive factors for a positive HTA was a favorable cost-effectiveness analysis.ConclusionsC-ADR is an established technology with extensive HTA investigation internationally. The lack of a consistent approach taken by HTA bodies made prediction of successful HTA outcomes difficult. Future alignment of key evaluation processes and methods may help address current international variations and support consistent decision making on patient access.
PP13 Results Of An International Survey About Barriers In Patient Involvement In Health Technology Assessment Of Digital Health Technologies
Authors: Gallastegui-Calvache Edurne , Moltó-Puigmartí Carolina , Segur-Ferrer Joan , Vivanco-Hidalgo Rosa Maria 
Published: December 2023

IntroductionIn recent years, several efforts have been initiated by health technology assessment (HTA) agencies to increasingly incorporate patient involvement (PI) into their assessment processes. The rationale behind PI in HTA is that patients can give their perspective and experiences about health, illness and the use of health technologies, complementing clinical and healthcare system standpoints.A recent systematic review summarized current evidence on the barriers and facilitators of PI in HTA. Barriers and facilitators were classified according to the context in which they appear, as organizational, decision-making, political and community-related.Digital health technologies offer a singular opportunity to address some challenges faced by healthcare systems. However, we hypothesized that their intrinsic characteristics may have some implications for PI in digital HTA. We conducted a survey to gain knowledge about barriers in PI in digital HTA.MethodsThe survey was elaborated using Microsoft Forms and consisted of 31 questions divided into four blocks (organizational, decision-making, political and community-related). It was sent to three Spanish, one Catalan and one International patient umbrella organizations. The results were analysed using Microsoft Excel.ResultsA total of four responses were received from three Spanish and one Catalan patient umbrella organizations. Results showed high, partial, and low concordance among organizations in 65 percent, 19 percent and 16 percent of the answers received, respectively. According to the results, most of the barriers for PI seem to be the same for HTA of digital health technologies as for other types of health technologies. However, two or three of the four umbrella organizations consider that HTA of digital health technologies might pose greater challenges in terms of achieving significant patient participation, sufficient patient training and knowledge of HTA processes, proper preparation and tools of the HTA experts and logistics during the HTA process.ConclusionsBarriers in PI are mostly the same for digital or other types of health technologies. Few differences are related to patient training, tools, and logistics during HTA process.
PP18 Unlocking The Potential Of Medical Device Reimbursement In India For Better Health Outcomes
Authors: Goel Ashwin , Sunderland Stephen , Srinivasan Shruti , Fahim Arif , Pusha Monika , Kataria Kirti 
Published: December 2023

IntroductionThe Indian healthcare landscape has witnessed several promising changes including the introduction of a comprehensive medical technology inclusion process, Diagnosis-related group (DRG)-pilot and value-based incentives for hospital services under the national public health insurance scheme. Realizing the need for a more patient-centric stance towards improving healthcare outcomes as the way forward, we propose incremental changes including greater participation of public and private care-providers in topic prioritization and the appraisal committee. We also propose a unique evidence-driven approach using reimbursement as a lever for rewarding quality and innovation in medical technologies.MethodsWe developed two discussion guides to capture the ideas around deeper involvement of care-providers and patient societies, and introduction of value-based reimbursement for incentivizing high-quality implantable medical devices in India. The guides were prepared using secondary research and key informant interviews. Over 25 key stakeholders representing payers, regulatory agencies, government authorities, clinical experts, and industry players selected through quota sampling participated in a roundtable meeting. Based on the meeting outcomes, key recommendations for leveraging medical device reimbursement for better health outcomes were developed.ResultsThis qualitative research was carried out with participation of key stakeholders across the medical device reimbursement process. The group proposed recommendations for bringing care-providers closer to the process through a structured and inclusive nomination approach involving therapy users and patient groups at various stages of evaluation. Complementing the existing value-based incentives framework for hospital services, we proposed a similar two-step pathway for incentivizing quality of implantable medical devices. The proposal includes the introduction of certification-based and outcome-based incentives built on a scientific and holistic evaluation criterion.ConclusionsThrough this process, we created a pragmatic and concrete call for a stronger voice from care-providers and patient groups in the evaluation process. Consecutively, the proposed innovative framework introducing value-based incentives for implantable medical devices will be instrumental in enabling access to quality health care to poor patients. These strategies follow the principles of value-based care and will go a long way in achieving better health outcomes for the population. The scientific initiative has been made possible with the support of St. Jude Medical India Pvt Ltd. (now Abbott).
PP24 Methodological Frameworks And Assessment Domains For Digital Health Technology Assessment: Scoping Review And Thematic Analysis
Authors: Segur-Ferrer Joan , Moltó-Puigmartí Carolina , Pastells-Peiró Roland , Vivanco-Hidalgo Rosa Maria 
Published: December 2023

IntroductionExperts highlight the need to reconsider the frameworks used in health technology assessment (HTA) in order to cover the particularities of digital health technologies (DHT). However, there is a large heterogeneity in the literature about terminologies and definitions. Our objective was to identify the methodological frameworks used worldwide for HTA of DHT and generate a proposal of domains to consider in the assessment through a thematic analysis, a qualitative data analysis method that consists of identifying, analysing and reporting patterns across the data.MethodsMethodological frameworks were identified through a scoping review (ScR) in accordance with the PRISMA extension for ScR. We searched five different databases for peer-reviewed and grey literature published between 2011 and 2021. The retrieved references were screened using Rayyan by two authors in a single-blind manner. References included were analyzed thematically by three reviewers using ATLAS.ti.ResultsThe systematic search retrieved 3,061 references (2,238 unique), of which 26 were included. These, in turn, synthesized 102 frameworks designed for the assessment of DHT. The included documents contained a wide variety of items to consider in HTA of DHT and often used different wording to refer to similar concepts. Through the thematic analysis, we reduced this heterogeneity. Specifically, in the first analysis phase we established 176 provisional codes related to different assessment domains. In the second one, these codes were grouped in 86 descriptive themes that, in turn, were clustered in the third phase in 61 analytical themes. The latter were organized through a vertical hierarchy of three levels: level 1 (13 domains), level 2 (38 dimensions), and level 3 (11 sub-dimensions).ConclusionsThere is a need to reconsider the frameworks and assessment domains used for HTA of DHT. Our thematic analysis of 26 references led to the definition of 13 domains, 38 dimensions and 11 sub-dimensions to consider in HTA of DHT. From our perspective, thematic analysis is the most appropriate method to identify assessment items for HTA of DHT from literature.
PP26 Critical Review Of The Reimbursement Process For Software As A Medical Device And Challenges In South Korea
Authors: Kwon Soontack , Han Seung Jin , Kim Kyung-Hoon 
Published: December 2023

IntroductionThe global artificial intelligence (AI) healthcare market is predicted to grow rapidly. Various technologies for AI-based Software as Medical Device (SaMD) have been developed, and demand for their health insurance reimbursement coverage is increasing. Reimbursement policies for new medical technologies need to be thoroughly examined, despite their role in stimulating the market. The reason is that health insurance finance can have significant impact on the entire country, including patients, providers, and industry.MethodsBased on guidelines for applying Korea’s innovative medical technologies, especially AI-based imaging medical technology, to health insurance, we examined outcome factors such as procedures and benefits. After the guidelines’ publication in 2019, we examined their impact on the medical device market through changes in the number of clinical trials and identified cases in which health insurance was listed.ResultsThe process of registering SaMD’s health insurance occurs in accordance with the existing medical technology evaluation system, and it can take up to 460 days from application to approval. If new technologies, including SaMDs demonstrate significant improvement in diagnostic capabilities and cost-effectiveness compared to existing practices, separate health insurance claims are available. Since the scheme’s announcement in 2019, items approved for SaMD clinical trials have increased (2018: ‘n=4; 2020: n=44; 2021: n=37). However, as of November 2022, only one was listed for health insurance benefits (VUNO Med-DeepBrain®), and one case was not listed on benefits but was recognized for its innovation and entered the market on the premise of suspending the health technology assessment process and accumulating real-world data (VUNO Med-DeepCARS®).™ DeepBrain® is a deep learning-based image reading technology costing about KRW80,000 (USD60) higher than conventional brain-magnetic resonance imaging and readings.ConclusionsThe number of SaMDs attempting clinical trials is increasing, but there is a low number of cases of reimbursement because most technologies are often classified as existing technologies and do not receive additional compensation. Since SaMD continuously is developed by accumulating data and feedback, a flexible system that can reflect this is required.
PP38 Immersion in water during childbirth: A survey to the Spanish National Health System
Authors: Reviriego-Rodrigo Eva , Ibargoyen-Roteta Nora , Carreguí-Vilar Soledad , Mediavilla-Serrano Luis , Uceira-Rey Sonia , Iglesias-Casás Susana , Martín-Casado Ana María , Toledo-Chávarri Ana , Ares-Mateos Gonzalo , Montero-Carcaboso Sonia , Castelló-Zamora Belén , Burgos-Alonso Natalia , Moreno-Rodríguez Anai , Hernández-Tejada Naiara , Koetsenruyter Carmen , Gutiérrez-Ibarluzea Iñaki 
Published: December 2023

IntroductionCertain doubts about immersion in water during birth mainly regarding the safety of the infant, warrant analysis of the data to determine whether immersion in water during childbirth is safe and effective. The aim is to describe the situation regarding the use of water immersion during childbirth in hospitals of the Spanish National Health System across Spanish Autonomous Regions and Cities.MethodsA questionnaire was developed to assess the use of water immersion on maternity wards of National Health System hospitals. The survey was reviewed by several categories of health professionals and stakeholders. The online questionnaire was distributed via email. A database was created using the Microsoft Excel 365® computer program. Quantitative results were described through percentages and frequency distributions. In the case of free responses, a content analysis was performed, coding the responses into different categories.ResultsRegarding the status of water birth in Spain, the availability of the option of water birth varies across hospitals of the National Health System. Forty-six hospitals in 13 autonomous regions indicated that they had birthing pools on their delivery wards. Among these hospitals, 20 percent reported having more than 10 years of experience in water births, 45 percent between five and 10 years and 35 percent less than five years. Of the 46 responses received, 78 percent of the hospitals indicated that there was a demand for information on waterbirth by pregnant women. Regarding the existence of criteria for the adequate selection of pregnant women who could opt for immersion in water during childbirth, 89 percent of the hospitals indicated that these did exist, while 11 percent indicated that they did not have agreed criteria for the selection of candidates for water birth.ConclusionsThe availability of the option of water birth varies in hospitals across the Spanish National System. All the hospitals that have birthing pools offer them in the first stage of labor (dilation), while 32 percent also use them in the pushing stage and 15 percent during delivery of the placenta. It would be advisable to have standardized protocols and training to ensure the possibility that all pregnant women, regardless of their place of residence, can safely opt for water immersion during childbirth with satisfactory results.