bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP49 A Systematic Review Of The Activities Of Early Advice, Early Dialogue, Scientific Advice By HTA Doers
Authors: Ibargoyen-Roteta Nora , Benguria-Arrate Gaizka , Galnares-Cordero Lorea , Guevara Claudia , De la Hoz Siegler Ilich Herbert , Chacon Kelly Rocio , Low Eduardo , Otte Maximiliam , Dauben Hans Peter , Gutierrez-Ibarluzea Iñaki 
Published: December 2022

IntroductionThere is a range of activities that health technology assessment (HTA) doers have started to improve the process of generation of required evidence for new technologies, and the alignment of regulatory and reimbursement processes that retard the access to patients to them. Different organizations call those processes early advice, early dialogue, or scientific advice to those activities.MethodsWe performed a systematic review of the activities named scientific advice (SA), early advice (EA) and early dialogue (ED). Major databases and HTA organizations were explored. The protocol and search strategy were published in PROSPERO. The selection of final articles and documents was done in pairs, and when discrepancies were found a third person resolved with the consensus of the others. A matrix was used to define the commonalities and differences of the described processes.ResultsWe initially retrieved 949 documents, after the analysis of duplications and the full text reading of the selected ones, we finally selected 39 documents and described: the type of technologies, the process, the stakeholders, the duration, the costs, and the impact. Big HTA agencies such as the Canadian Agency for Drugs and Technologies in Health (CADTH) or the National Institute for Health and Care Excellence (NICE) included EA or SA among their portfolio of activities as well as networks (European Network for HTA (EUnetHTA) or smaller agencies such as HTA Wales or Basque Office for HTA (Osteba) among others. The type of activity, the process, duration, purpose and costs differ among HTA doers.ConclusionsThere is a need to define what we meant when we are talking about SA, ED, and EA. In fact, regulators used the same processes with different purposes. Our systematic review and the lessons learnt from the European-funded SAFENMEDTECH project will propose a detailed framework that can be useful to better understanding the needs of each of the involved parties and how to make the processes involved more efficient.
OP71 PriTec Tool 2: Adaptation For Selection Of Technologies To Be Assessed For Inclusion Into The Health Care System
Authors: Lema Leonor Varela , Maceira-Rozas Maria , Puñal-Riobóo Janet , Faraldo-Vallés Maria José 
Published: December 2022

IntroductionThe PriTec Tool is an automatically executable multicriteria web application developed in 2009 by the Galician Health Knowledge Agency (avalia-t; ACIS) for the prioritization of technologies susceptible of post-introduction observation or obsolescence. Currently, the tool has been updated and improved to support the selection process of technologies to be assessed for inclusion into the National Public Health Care Portfolio. The aim of this work is to present the updated version of the tool (PriTec Tool 2) with the new functionalities.MethodsThe development of the tool was based on a mixed-method approach, comprising a systematic review, followed by a five-step process: (i) development of the preliminary proposal of prioritization criteria and domains; (ii) contextualization and validation of the criteria and domains by a multidisciplinary group of key stakeholders; (iii) assessment of validity, reliability and suitability of criteria; (iv) weighting of domains; and (v) evaluation of applicability, reliability and reproducibility of the tool.ResultsThe tool consists of 15 criteria categorized in 5 domains. The web application ranks the technologies through automatic computation of the weighted average of the different criteria and generates a comparative analysis of the individual or working group results. The application allows access to different options: working groups, case studies or technology comparison. It allows for individual prioritizations or managing working groups. When applied to prioritize the Spanish Network of Health Technology Assessment (HTA) Agencies yearly workplan it achieved an intraclass correlation coefficient of 0.71 (95% confidence interval 0.62, 0.88).ConclusionsThe updated PriTec Tool-2 can be very useful to guide decision-making regarding the assessments that would be mostly needed to ensure health, equity and sustainability. The tool stands out for its simplicity and ease of application. It is acknowledged that the tool could be of great interest to policy makers, HTA bodies and other health decision-makers worldwide.
OP74 Assessing Public Confidence Towards COVID-19 Vaccines Through Social Media Insights Leveraged Using Artificial Intelligence Techniques
Authors: Green Rhiannon , Lanyi Kate , Marshall Christopher , Craig Dawn 
Published: December 2022

IntroductionIn areas where public confidence is low and there is a lack of understanding around behaviors, such as COVID-19 vaccine hesitancy, there is a need to explore novel sources of evidence. When leveraged using artificial intelligence (AI) techniques, social media data may offer rich insights into public concerns around vaccination. Currently, sources of ‘soft-intelligence’ are underutilized by policy makers, health technology assessment (HTA) and other public health research agencies. In this work, we used an AI platform to rapidly detect and analyze key barriers to vaccine uptake from a sample of geo-located tweets.MethodsAn AI-based tool was deployed using a robust search strategy to capture tweets associated with COVID-19 vaccination, posted from users in London, United Kingdom. The tool’s algorithm automatically clustered tweets based on key topics of discussion and sentiment. Tweets contained within the 12 most populated topics with negative sentiment were extracted. The extracted tweets were mapped to one of six pre-determined themes (safety, mistrust, under-representation, complacency, ineffectiveness, and access) informed using the World Health Organization’s 3Cs vaccine hesitancy model. All collated tweets were anonymized.ResultsWe identified 91,473 tweets posted between 30 November 2020 and 15 August 2021. A sample of 913 tweets were extracted from the twelve negative topic clusters. Of these, 302 tweets were coded to a vaccine hesitancy theme. ‘Safety’ (29%) and ‘mistrust’ (23%) were the most commonly coded themes; the least commonly coded was ‘under-representation’ (3%). Within the main themes, adverse reactions, inadequate assessment, and rushed development of the vaccines as key findings. Our analysis also revealed widespread sharing of misinformation.ConclusionsUsing an AI-based text analytics tool, we were able to rapidly assess public confidence in COVID-19 vaccination and identify key barriers to uptake from a corpus of geo-located tweets. Our findings support a growing body of evidence and confidence surrounding the use of AI tools to efficiently analyze early sources of soft-intelligence evidence in public health research.
OP80 ‘Green Metrics’ - Incorporating Environmental Dimensions In Health Technology Assessment
Authors: Schuitmaker-Warnaar Tjerk Jan , Fruytier Sevgi , Gunn Callum 
Published: December 2022

IntroductionClimate change as the result of human action and the risks it poses to human health are well established. In healthcare there is increasing attention to climate and environmental impacts of the use of medical and health technologies. As part of a lifecycle approach, health technology assessment (HTA) needs to take climate and environmental impacts into account. In 2020, the new definition of HTA added the dimension ‘environmental aspects’, with which the value of health technologies can be determined and assessed in terms of their impact on the environment. This led several HTA organizations to explore opportunities for including environmental impacts in HTA procedures. It is, however, yet unclear how many researchers and HTA organizations are already working on this sustainability dimension, in what way, with which (international) partners, and what they have achieved as of now. Furthermore, the complex relations between the climate crisis, environmental pollution, health and care are difficult to trace, and methods are scarce. In HTA, there is an increasing need for outcome measures that, in addition to clinical utility, effectiveness, efficiency or satisfaction, also quantify the environmental impact of medical interventions (i.e., green metrics).MethodsWe report on (i) a scoping of international (research) groups and (HTA) organizations that are working on green metrics; (ii) a literature review into the state of affairs with regard to metrics and methods; and (iii) an impact analysis of possible future inclusion of green metrics in HTA procedures. We supplemented a review of (grey) literature with interviews with HTA organizations pioneering with green metrics, and we have conducted a review of available scientific literature, yielding examples of incorporation of environmental aspects into HTA and reports on practical implications.ResultsCarbon dioxide emissions and pollution by the health sector are currently being explored as green metrics. Differences between direct and indirect environmental impacts complicate the evaluation.ConclusionsGreen metrics should eventually make it possible to assess sustainability in healthcare as part of a lifecycle approach.
OP82 Patient Involvement In Health Technology Assessment
Authors: Kulembekova Lyazzat , Kosherbayeva Lyazzat , Hailey David , Tabarov Adlet , Imanbekova Anar 
Published: December 2022

IntroductionPatients are increasingly involved in the decision-making process for health technology assessment (HTA), but the question of at what stage they can be involved is still controversial. In Kazakhstan, the HTA process began in 2010. Over the past 2 years, implementation of a project to develop a priority-setting tool based on evidence-informed deliberative processes has made it possible to discuss the participation of patients in HTA. We explored the possibilities of participation of patients or a patient-oriented group in the HTA process.MethodsStructured interviews were held with eight people with interests in HTA. Two were representatives of universities, two from a patient-oriented group, two experts in HTA, and two physicians. Interviews were held online by mobile phone or Zoom for 25–30 minutes. Question structures were formed based on the report ‘Patient Involvement in Health Technology Assessment in Europe 2010’. Seven stages were considered.ResultsAll participants partially or completely agreed with the involvement of patients at the HTA stages of identification and prioritization. One or two did not agree with their involvement at the HTA assessment, information production, internal and external review, and diffusion and dissemination stages. Challenges for patient involvement in HTA can be related to other commitments for patients and their carers, lack of financial affordability, conflict of interest, and lack of capacity of the HTA agency to involve them. Five participants agreed on challenges for patients to being meaningfully involved in decision-making on health technologies. These included understanding which institution makes the decisions, finding an interlocutor within the decision-making body, and understanding the decision-making process. Other issues were technical and language difficulties, lack of commitment from decision-makers and the legal or policy framework for patient involvement in HTA decision-making.ConclusionsPatients can participate in HTA, but the HTA agency must first prepare and agree on the level of patient participation, and develop measures to reduce barriers such as language difficulties, and patient obligations.
OP84 Cost Consequence Analysis: A Potential Framework To Incorporate Patient Preferences Into Health Technology Assessment And Reimbursement Decisions
Authors: Whitty Jennifer , Marsh Kevin , Low Eric , Shah Koonal , Dzingina Mendwas 
Published: December 2022

IntroductionPatient preferences (PPs) are an important source of evidence in health technology assessment (HTA). However, a methodological framework to achieve their integration in decision-making is lacking. We aim to investigate the potential role of evaluative frameworks to integrate PP evidence into HTA and decision-making.MethodsWe undertook a scoping review to identify potential methodological frameworks to consider PP evidence in HTA and evidence of the acceptability of these frameworks for decision-makers. We searched PubMed, Cochrane, and the grey literature to identify relevant studies, reports, or guidance documents. We restricted our search to the use of PP rather than patient experience data and excluded articles solely relating to deliberative approaches.ResultsFrameworks identified as having the potential to integrate PP evidence included cost-utility analysis, cost-consequence analysis (CCA), the efficiency-frontier approach, and multi-criteria decision analysis. All have been used in various HTA contexts, but not necessarily for inclusion of PP evidence. Distinct benefits and challenges of integrating PP data were identified for each framework. These included the theoretical basis of the frameworks, their ability to consider non-health as well as health outcomes, and their ability to separate outcomes based on PPs from outcomes based on population preferences. There is limited evidence and no consensus on the application of these frameworks to consider PPs in HTA or on their acceptability for decision-makers. However, CCA has the advantage that it is both based on economic decision theory and it leaves patient preferences disaggregated from population preferences in an HTA.ConclusionsThe frameworks identified in this review offer potential approaches to systematically and transparently integrate PPs into HTA and decision-making. Based on the review findings, we propose a research agenda to explore the potential of CCA in particular. We anticipate that our findings will augment the recommendations of the Innovative Medicines Initiative PREFER project, which are expected to report in 2022.
OP88 Drawing Lines In The Sand: How Do We Define The Scope Of Analysis In HTA And Economic Evaluation?
Authors: Richardson Marina , Miller Fiona , Daneman Nick , Sander Beate 
Published: December 2022

IntroductionWe explore how the scope of analysis is defined in health technology assessment (HTA) and economic evaluation and consider the potential implications of these decisions.MethodsThe scope of analysis, including decisions about which methods and domains of HTA to include in the assessment, which costs, and health outcomes are most meaningful, and which comparators are the most relevant are typically informed by the needs of the decision-maker. We undertook two systematic scoping reviews to assess: (i) to what extent systems thinking is considered in literature-based technology assessments; and (ii) how the scope of the analysis is defined in economic evaluation using Clostridioides difficile infection as an exemplar. We synthesized the findings from these reviews and offer three key observations for future research and exploration in the field of HTA.ResultsOur scoping reviews found that the scope of analysis in economic evaluations typically focus on single interventions, often ignoring upstream and downstream interventions. Similarly, published technology assessments have narrowly defined and inconsistent scopes of analysis, with limited consideration of indirect health and non-health impacts. Three key observations for the field of HTA include: (i) economic evaluations focus on the value of single heath interventions. A focus on a single health intervention may simplify the analysis; however, will this siloed decision-making lead to optimal health resource allocation? (ii) published assessments have inconsistently defined scopes of analysis. A decision problem that focuses on the needs of the decision-maker is practical; however, will inconsistencies in perspectives across assessments create unfair conceptualizations of value? (iii) HTA is technology-focused, not patient-focused. A technology-focused HTA system aligns with the technology diffusion process; however, does this move us away from the patient-centered mandate of HTA?ConclusionsThe dynamic nature of HTA leads to many conceptualizations of value. Considering the potential implications of narrowly defined, inconsistent, and technology-focused scopes of analyses may have consequences on achieving a patient-centered high-quality health system.
OP92 Impact Of Real-World Evidence On Health Technology Assessment And National Guidance For Interventional Procedures: A UK Perspective
Authors: Mandava Lakshmi , Powell John , Harris Kevin , Chalkidou Anastasia 
Published: December 2022

IntroductionThe National Institute for Health and Care Excellence (NICE) interventional procedures programme (IPP) issues guidance on the safety and efficacy of new interventional procedures (IPS). The IPP considers a range of evidence from randomized controlled trials (RCTs) to case series to make final recommendations. Real-world evidence (RWE) can provide additional information on long-term outcomes and patient population characteristics that are not easily captured by RCTs. This study explores the impact of RWE in complementing RCTs on long-term safety and efficacy for national guidance development.MethodsWe review the impact of RWE in IPS guidance (IPG) updates and change in guidance recommendations in the last 5 years. This is done by analyzing NICE guidance updates and supporting evidence. A range of RWE was considered in the supporting evidence, for example, registries and clinical audits.ResultsThe addition of RWE evidence to IPP guidance update has led to significant changes in the recommendations. For example, in one recent IPG, standard arrangements recommendation based on short-term RCT evidence was changed to a research recommendation when RWE showed an increase in long-term adverse effects. In another recent IPG update, special arrangements recommendation based on short-term RCT evidence was changed to a research recommendation when RWE reported long-term inferior efficacy and safety for the new intervention compared to current standard of care. A complete overview of results of the last 5 years will also be presented at the meeting.ConclusionsThese findings indicate that increased availability of RWE in HTA has the potential to impact national guidance recommendations. In addition, it shows how RWE can fill the evidence base gaps created by RCTs. Such data can confirm or contradict the findings of RCTs, or generate questions needing further research, or support disinvestment in non-effective technologies.
PP05 Effect Modifiers In Indirect Treatment Comparisons: Guidance Is Needed To Ensure An Unbiased Identification In Decision-Making
Authors: Freitag Andreas , Gurskyte Laura , Rizzo Maria , Sarri Grammati 
Published: December 2022

IntroductionUnadjusted effect modifiers (EM) in indirect treatment comparisons (ITC) can produce biased and uncertain results in health technology assessments (HTA). Even though research on advanced ITC methods to adjust for EMs has attracted much attention, less emphasis has been placed on how these EMs are identified and assessed in the first place. This is surprising given the evidence-based approach underpinning all analyses supporting HTAs. To address this gap, our aim was to identify what HTA guidance exists on the selection process for EMs, and how the selection of EMs has been justified in the context of published ITCs.MethodsA pragmatic review of HTA guidance documents was conducted in 2021 to describe current requirements for the selection of EMs for ITCs. A supplementary Embase and Medline search was conducted to identify primary research on ITCs published between 2015-2021 presenting information on how EMs were selected to inform these analyses.ResultsOur review found that guidance on this topic focusses on developing and testing different methodologies to adjust for EMs. No detailed guidance was identified in any of the reviewed HTAs, although the National Institute for Health and Care Excellence (NICE) briefly mentioned that companies should identify EMs through a topical review or expert discussions. Similar findings were also revealed through the database search; few published ITCs included information on the EM selection process which was either based on evidence highlighted in the literature or findings from prior trial subgroup analyses. No reference to a systematic identification of EMs was found.ConclusionsTo fill the guidance gap identified in our review an extension of current ITC guidelines (including those from HTA bodies) is needed, including (i) indication on how EMs should be identified through systematic reviews, (ii) a quantitative assessment of the EM distribution and (iii) formal expert elicitation prior to the selection of ITC methods. Without these additional steps, ITC results may be biased, potentially negatively impacting decision-making and ultimately patient care.
PP10 Impact Of COVID-19 On The Management Of Breast Cancer In Italy: The Perspectives Of Patients And Coordinators
Authors: Di Brino Eugenio , Laurita Roberta , Cicchetti Americo 
Published: December 2022

IntroductionBreast Units (BU) represent an opportunity to adequately manage and improve quality of care for patients with breast cancer. The presence of specific national guidelines should promote safe and good quality, integrated care. In fact, the presence of a multidisciplinary team of specialists whose workflows follow specific guidelines, set to the highest European standards, should ensure that patients in Breast Units receive appropriate care at diagnosis and throughout the course of the disease.MethodsTwo surveys were developed and administered to Breast Unit coordinators and patients throughout Italy. The surveys investigated the provision of healthcare services and the implementation of a new organizational model over two time periods: the first wave of the coronavirus disease 2019 (COVID-19) pandemic from March 2020 to August 2020 and the second wave from September 2020 to December 2020. The surveys aimed to assess the continuity of care during the pandemic from the clinician and patient perspective.ResultsPatients observed a reduction in the postponement of care between the first wave of COVID-19 and the second wave. Some services were delayed, particularly in the second wave where a large number of services were not rescheduled. Management of the COVID-19 pandemic resulted in many healthcare professionals being reallocated to other duties and hospital departments. The effect of this was particularly relevant for both patients and clinicians, with few healthcare professionals having the capacity to focus on conditions other than COVID-19. In the first wave of the pandemic 42 percent of professionals were redeployed, compared with 27 percent in the second wave.ConclusionsThis study demonstrates how COVID-19 affected the care of patients with breast cancer in Italy. Patients and coordinators from Breast Units across the country highlighted many important aspects that should be considered when assessing the effects of the COVID-19 pandemic on the entire healthcare system in order to be better prepared for future pandemics.