bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP223 A Semi-Automated Process To Monitor The Clinical Development And Regulatory Approval Pathway Of Innovative Medicines
Authors: Wilkins Georgina , Zanghelini Fernando , Brooks Kieran , Ogunbayo Oladapo 
Published: December 2021

IntroductionEarly identification of innovative medicines is crucial for timely health technology assessment (HTA) and efficient patient access. The National Institute for Health Research Innovation Observatory (NIHRIO) identifies, monitors and notifies key HTA stakeholders in England of ‘technologies’ (innovative medicines) within three to five years of regulatory approval. Increasing numbers of innovative medicines and significant uncertainties in clinical and regulatory pathways are major challenges in the monitoring and notification process. An active monitoring framework using pre-defined predictive criteria has previously been developed. This framework provides a standardized and consistent process, but is highly resource-intensive, requiring manual review of individual records.MethodsUsing the previous active monitoring framework, a scoring matrix was calculated and used to prioritize individual technologies using available data in the NIHRIO database: estimated regulatory timelines, regulatory awards/designations, innovative medicine type (for example gene therapies) and clinical trial phase, completion dates and results. A threshold for automatic and manual reviewing of technologies was developed and tested by NIHRIO analysts.ResultsThe scoring system identified approximately ninety percent of technologies meeting the threshold for semi-automated reviewing. The review period for these technologies are set automatically according to predefined criteria depending on data availability. The review periods are updated automatically until the record reaches the threshold that triggers manual reviewing. The remaining ten percent had estimated regulatory timelines necessitating the need for manual reviewing and early engagement with companies to verify regulatory timelines and/or notify HTA stakeholders.ConclusionsPreliminary analysis indicates that each technology is routinely and automatically updated. The semi-automatic updating represents a significant improvement in the efficiency of the monitoring of the large volume of technologies on the NIHRIO database. Ongoing work is being undertaken to further refine, pilot and test the system.This project is funded by the NIHR [(HSRIC-2016-10009)/Innovation Observatory]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
OP227 Exploring The Value Of Soft-Intelligence: A Case Study Using Twitter To Track Mental Health During The COVID-19 Pandemic
Authors: Marshall Christopher , Lanyi Kate , Green Rhiannon , Wilkins Georgina , Pandey Savitri , Craig Dawn 
Published: December 2021

IntroductionThere is increasing pressure to rapidly shape policies and inform decision-making where robust evidence is lacking. This work aimed to explore the value of soft-intelligence as a novel source of evidence. We deployed an artificial intelligence based natural language platform to identify and analyze a large collection of UK tweets relating to mental health during the COVID-19 pandemic.MethodsA search strategy comprising a list of terms relating to mental health, COVID-19 and the lockdown was developed to prospectively identify relevant tweets via Twitter's advanced search application programming interface. We used a specialist text analytics platform to explore tweet frequency and sentiment across the UK and identify key topics of discussion for qualitative analysis. All collated tweets were anonymized.ResultsWe identified 380,728 tweets from 184,289 unique users in the UK from 30 April to 4 July 2020. The average sentiment score was fifty-two percent, suggesting overall positive sentiment. Tweets around mental health were polarizing, discussed with both positive and negative sentiment. For example, some people described how they were using the lockdown as a positive opportunity to work on their mental health, sharing helpful strategies to support others. However, many people expressed the damaging impact the pandemic (and resulting lockdown) was having on their mental health, including worsening anxiety, stress, depression, and loneliness.ConclusionsThe results suggest that soft-intelligence is potentially a useful source of evidence. The approach taken to identify and analyze this data may offer an efficient means of establishing key insights from the ‘public voice’ relating to critical health issues. However, there are still various limitations to consider concerning the technology and representativeness of the data. Future work to explore this type of evidence further, and how it might formally support decision-making processes, is recommended.This project is funded by the NIHR [(HSRIC-2016-10009)/Innovation Observatory]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
OP242 Patient-based Evidence: A Comparison Of The Views Of Patient And Clinical Engagement Participants And Committee Members
Authors: Hems Sharon , Taylor Louise , Jones Jan , Holmes Eileen 
Published: December 2021

IntroductionThe Scottish Medicines Consortium (SMC) conducts early health technology assessment (HTA) of new medicines on behalf of NHSScotland. Evidence from patients and carers on end-of-life and orphan medicines is gathered during Patient and Clinician Engagement (PACE) meetings. The output is a consensus statement describing a medicine's added value from the perspective of patients/carers and clinicians, which is used by SMC committee members in decision-making. This study compared the importance of factors in the PACE statement to PACE participants and committee members.MethodsA survey of ninety-eight PACE participants (consisting of forty-two patient group (PG) representatives and fifty-six clinicians) investigated the importance of quality of life (QoL) themes (family/carer impact, health benefits, tolerability, psychological benefit, hope, normal life, treatment choice and convenience) identified from an earlier thematic analysis of PACE statements. The findings from PG representatives and clinicians were compared, and the overall results were further compared with those from a previous survey of committee members (n = 26).ResultsAmong PACE participants who responded (twenty-six PG representatives and fourteen clinicians), 100 percent rated ‘health benefits’ and ‘ability to take part in normal life’ as important / very important. ‘Convenience of administration’ and ‘treatment choice’ received the lowest rating with fifteen percent and nineteen percent respectively of PG representatives versus seven percent of clinicians rating each as very important. ‘Hope for the future’ received the most diverse response with fifty-eight percent of PG representatives and fourteen of clinicians rating this as very important.In general, PACE participants rated importance of QoL themes higher than committee members (n = 21) but the rank order was similar. Differences between the proportion of PACE participants and committee members who rated themes important/very important was greatest for ‘treatment choice’ (sixty-seven percent versus twenty percent respectively) and ‘hope for the future’ (eighty-two percent versus fifty-three percent).ConclusionsThe findings demonstrate some alignment between PACE participants’ and committee members’ responses, supporting the value of the PACE output in decision-making. Areas for further research are highlighted.
OP248 A Minimum Data-Set For Left Ventricular Assist Device On Destination Therapy: Cross-Border Collaboration Pilot On Real World Data
Authors: Varela-Lema Leonor , Puñal-Rioboo Janet , Faraldo Vallés María José 
Published: December 2021

IntroductionThe European Health Technology Assessment Network (EUnetHTA) Work Package 5B1, is focused on testing the levels of cross-border collaboration on real world data for supporting reimbursement/pricing decision-making. Within this Work Package, we are conducting a pilot on Left Ventricular Assist Device on destination therapy in collaboration with the National Institute for Health and Care Excellence (NICE, UK), the Belgian Health Care Knowledge Centre (KCE, Belgium) and the Italian National Agency for Regional Health Services (AGENAS, Italy). This pilot aims to define the minimum data set for gathering and sharing high quality registry data on key uncertainties found at the time of the health technology assessment (HTA). Furthermore, the pilot will assess the feasibility of carrying out a common analysis or reusing this data for National or Joint Reassessments.MethodsEvidence gaps were based on the four national assessments. Collaborating partners were responsible for agreeing on the key outcomes and proposing the minimum dataset to be registered. European clinical experts and patients rated and prioritized the dataset using a two round Delphi technique (not relevant, important but not critical; critical). The dataset will confirm the basis for the Spanish LVAD registry, implemented at the national health service level to inform inclusion into the healthcare portfolio.ResultsThe key outcomes agreed upon by agencies relate to safety, effectiveness, satisfaction and acceptability of the patient and cost-effectiveness, budget impact and organizational impact. Expert cardiologists and cardiac surgeons representing the European and Spanish Society, among others, participated in the prioritization of basic data. The final dataset is expected by December 2020.ConclusionsThe variation in the quality and definition of outcome measures for measuring key evidence gaps reduces the utility of registries for HTA, making it difficult to compare, link, and aggregate data across countries. The EUnetHTA pilot is intended to offer a model for cross-border collaboration on real world data for supporting the decision-making process for pricing and reimbursement.
OP256 Recognising The Broader Value Of Vaccines In Health Technology Assessment: Worth A Shot?
Authors: Neri Margherita , Brassel Simon , Steuten Lotte 
Published: December 2021

IntroductionThe COVID-19 pandemic shows that the impact of effective vaccines extends well beyond vaccinated individuals and healthcare systems. Yet, these externalities are not typically considered in health technology assessments (HTA) which may underestimate vaccines’ broader value. We explored to what extent future vaccines relevant to England might exhibit such broader value.MethodsWe compared the ten value elements of an existing vaccine evaluation framework to the value elements considered in England according to the Joint Committee on Vaccine and Immunisation (JCVI) and the National Institute for Health and Care Excellence's (NICE) guidelines. Using literature and expert opinion we then explored, for a selection of ten vaccines with an expected UK-launch within five years, on which value elements each vaccine might potentially show added value.ResultsUp to five of ten value elements are unlikely to be considered by JCVI or NICE, including patient and carer productivity, enablement value, impact on antimicrobial resistance and transmission value. Of vaccines studied, 100 percent will potentially generate value on at least one broader value element that is currently ignored; 60 percent to 80 percent may increase vaccinee/patient or carer productivity respectively.ConclusionsThere is a substantial gap between value generation and value recognition of vaccines in HTA in England. This might lead to undervaluation and underutilization of vaccines, leaving societies more vulnerable than needed when faced with infectious diseases.
OP267 Evidence for Health Technology Assessment: The Capability Approach
Authors: Rijke Wouter , Vermeulen Anneke , Blom Helen , Willeboer Krista , Mylanus Emmanuel , Langereis Margreet , van der Wilt Gert Jan 
Published: December 2021

IntroductionHealthcare services, such as cochlear implants and subsequent rehabilitation, aim to increase valuable activities and opportunities of those affected. Their impact may be inferred from the extent that they protect or restore capability, which reflects the real freedoms that people have to be or do things they have reason to value. Capability emerges from the dynamic interaction between available resources, individual, social, and environmental conversion factors, and functionings. This model sets the informational requirements of the capability approach.MethodsOn the basis of interviews with thirty-three hearing impaired children and thirty hearing peers, information on capability elements (values, resources, conversion factors, and functionings) was collected. Qualitative results were triangulated with standardized clinical audiological and psycholinguistic quantitative measures.ResultsHearing impaired children and their hearing peers concurred in terms of the doings and beings they valued, but differed in terms of conversion factors to realize capability. Parents of hearing impaired children played a more upfront role, hearing impairment predominated many areas of life, and communicating through hearing aids required more energy than was usually acknowledged by the people around them.ConclusionsThe capability approach offers opportunities not only to assess impact of technology on dimensions that are important to patients, but also to better understand the mechanisms that are involved in value generation.
OP305 A Systematic Approach To Include Ethical Aspects In Health Technology Assessments – Experiences And Evaluation
Authors: Ramsay Karin Willbe 
Published: December 2021

IntroductionThe Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) is commissioned to assess ethical aspects in their health technology assessment (HTA) reports, in addition to effects and health economic aspects of the examined interventions. For this purpose, a framework for systematic evaluation of ethical aspects of healthcare technologies has been developed and used at SBU since 2014. With seven years of practice, we decided it was time to evaluate experiences from using the ethical framework and consider possible adjustments to improve future use.MethodsSBU reports in the time period 2014–2020 were systematically screened for ethical content. Focus group meetings with users of the framework (mainly HTA project managers) were held where opinions regarding usability and possible obstacles were collected. A revised version of the document was sent for consultation to relevant stakeholders (possible users, reviewers and recipients) in order to collect additional views.ResultsOf fifty-eight HTA reports produced in the time frame, ethical aspects were evaluated in fifty-five reports (ninety-five percent), and in most cases, the framework had been used as support. In twenty-one cases (thirty-six percent), a professional ethicist had been engaged in the work. In twelve cases (twenty-one percent), ethical aspects were presented in the main conclusions of the report. Opinions from users and reviewers revealed that the framework was generally regarded as a helpful tool, but problems regarding interpretation of specific questions were highlighted and subjected to revision.ConclusionsThe ethical framework is a valuable tool for systematic and transparent identification and discussion of ethical aspects in the HTA context, and it has been well implemented at SBU. A systematic approach to assess ethical aspects can facilitate the communication and dissemination of ethical aspects as principal results from the HTA project.
OP339 Virtual COVID Ward: The Use Of Telehealth In The Emergency Response To COVID-19
Authors: Rezgui Abdel Hakim , Harkness Rosemary , Law Hou , Thomson David , Towns Rebecca 
Published: December 2021

IntroductionWith unprecedented times, comes accelerated change. Hospitals in our region have begun to facilitate safe discharge for COVID-19 patients in the form of “The virtual COVID ward”. This has enabled patients to be monitored safely in the community using pulse oximetry, Florence (a telehealth mobile app) and remote consultations. Our objective is to expand upon this model by providing home oxygen therapy for these patients facilitated by telemedicine.MethodsPatients were discharged with an oxygen concentrator if they had an oxygen requirement equal to or less than four litres/minute. Fraction of inspired oxygen needed to be stable and an early warning score of less than four was also required. Once admitted, the Florence app and daily remote consultations were crucial to closely monitor the patient's clinical status. The patient was instructed to enter oxygen saturations and heart rate into the app four times daily. The app would then alert our team if any patients observations deteriorate, triggering immediate assessment.ResultsWe have discharged ninety patients to the virtual ward, fifty-six of these with home oxygen. The average age was fifty-seven and the Clinical Frailty Score ranged between one and six. At present, ten patients have been re-admitted, four with increasing oxygen requirements, and six with unrelated symptoms. Two patients had oxygen concentrators installed at home after we were alerted to their desaturation by the Florence App. The re-admission rate is eleven percent, which mirrors that of other virtual wards (who do not provide home oxygen). In total, the ward has saved the trust 627 hospital inpatient ‘days’. Patients report increased satisfaction at playing a meaningful role in monitoring their own healthcare using the app.ConclusionsOur novel model of supported discharge with oxygen therapy using telehealth demonstrates that it is possible to manage such patients, safely, in the community. Other trusts could utilise this model to reduce inpatient bed occupancy. Looking to the future, could telehealth be utilised further to facilitate other “Virtual wards” in the community?
OP443 Evaluating The Value Of Endovascular Innovations For Aortic Valve Replacement Through Clinical Benefits, Patient-reported Outcomes And Resource Consumption.
Authors: Pinar Eduardo , de Lara Juan García , Hurtado José , Robles Miguel , Leithold Gunnar , Martí-Sánchez Belén , Cerezales Mónica , Cuervo Jesús 
Published: December 2021

IntroductionThe use of most recent Transcatheter aortic valve implants (TAVI) in the treatment of symptomatic severe aortic stenosis (SAS) is evolving with expanded indications from inoperable/high-risk to intermediate and low risk patients. Consequently, TAVI outcomes must be monitored to highlight its value under real-world conditions. Our aim was to prospectively evaluate TAVI (SAPIEN 3) outcomes in terms of patient's health-related quality of life (HRQoL), clinical outcomes, and healthcare resource utilization (HRU).MethodsAn observational prospective study including all consecutive patients with SAS undergoing a transcatheter valve implantation with Edwards SAPIEN 3 valve (transfemoral access) was conducted in full accordance with clinical guidelines from the European Society of Cardiology. Patients were evaluated before the intervention (baseline), at discharge, and after one, six and twelve months from the implant. A thoughtful and systematic evaluation of patients’ HRQoL (EQ-5D 5L, the Short Form-36 Health Survey -SF-36- and the Kansas City Cardiomyopathy Questionnaire -KCCQ-), clinical endpoints (that is, cardiovascular mortality, and rates of stroke, major bleeding, myocardial infarction, and re-hospitalization), echocardiographic measurements, and HRU (that is, Length of stay-LOS- in ward/intensive care unit -ICU-) was implemented. Multivariate regression models were applied to test outcomes while controlling key risk factors (that is, patient’ severity at baseline).ResultsA total of seventy-six patients (fifty percent female, fifty-five percent of intermediate-high risk) with a mean age of 82.1 ± 4.78 years were included. Implant success was 97.34% and cardiovascular death was 2.6% at one year. Significant reductions in mean and maximum gradients were achieved and maintained during follow-up. Mean LOS in ward (5.2 ± 4.0days) and ICU (0.22 ± 0.64 days) were low. Statistically significant improvements were detected in the KCCQ overall summary scores, EQ-5D, and SF-36 (Physical component summary) - all adjusted - p < 0.05 - after the intervention.ConclusionsTAVI represents a safe and effective innovation for SAS with clinical benefits translated into significant improvements in terms of HRQoL. Besides, the low HRU provides new insights for health-economic modelling and the optimization of limited resources of special importance under current pandemic situation.
PP100 Characteristics To Consider In A Knowledge Translation Theory, Model Or Framework For Health Technology Reassessment
Authors: Esmail Rosmin , Hanson Heather M. , Holroyd-Leduc Jayna , Niven Daniel J. , Clement Fiona M. 
Published: December 2021

IntroductionHealth technology reassessment (HTR) is a structured evidence-based assessment of an existing technology in comparison to its alternatives. The process results in the following four outputs: (i) increased use; (ii) decreased use; (iii) no change; or (iv) de-adoption. However, implementing these outputs remains a challenge. Knowledge translation (KT) can be applied to implement findings from the HTR process. This study sought to identify which characteristics of KT theories, models, and frameworks (TMFs) could be useful, specifically for decreasing the use of or de-adopting a technology.MethodsA qualitative descriptive approach was used to ascertain the perspectives of international KT and HTR experts on the characteristics of KT TMFs for decreasing the use of or de-adopting a technology. One-to-one semi-structured interviews were conducted. Interviews were audio recorded and transcribed verbatim. Themes and sub-themes were deduced from the data through framework analysis using the following five distinctive steps: familiarization; identifying an analytic framework; indexing; charting; and mapping and interpretation. Themes and sub-themes were also mapped to existing KT TMFs.ResultsThirteen experts participated. The following three themes emerged as ideal characteristics of a KT TMF: (i) principles foundational for HTR: evidence-based, high usability, patient-centered, and ability to apply to micro, meso, and macro levels; (ii) levers of change: characterized as positive, neutral, or negative influences for changing behavior; and (iii) steps for knowledge to action: build the case for HTR, adapt research knowledge, assess context, select, tailor, and implement interventions, and assess impact. The Consolidated Framework for Implementation Research had the greatest number of ideal characteristics.ConclusionsApplication of KT TMFs to the HTR process has not been clearly established. This is the first study to provide an understanding of characteristics within KT TMFs that could be considered by users undertaking projects to decrease or de-adopt technologies. Characteristics to be considered within a KT TMF for implementing HTR outputs were identified. Consideration of these characteristics may guide users in choosing which KT TMF(s) to use when undertaking HTR projects.