bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP04 Lessons Learnt When Implementing A Health Technology Assessment Institution In Costa Rica
Authors: Gutiérrez-Ibarluzea Iñaki , Cercone James , Bronstein Daniel , Tacsan Luis , Morales Pablo , Sancho Ana Eduviges , Benguria-Arrate Gaizka , Llorca Fernando 
Published: January 2018

INTRODUCTION:Faced with increasing financial challenges to the single-payer social security system and constitutional challenges supporting all citizen's right to health, Costa Rica has endeavored to introduce Health Technology Assessment (HTA) to ensure sustainability and promote the timely introduction of technology innovations in the health system. The Ministry of Health initiated a process to establish an independent, external institution providing leadership in the process of HTA.METHODS:Based on a survey developed by REDETSA/PAHO (HTA Network of the Americas/Pan American Health Organization), an inclusive method of stakeholders participation was used to analyze the strengths, weaknesses, opportunities and threats regarding the implementation of an HTA entity. This was combined with qualitative research methods, market access situation analysis and the review of coverage and provision processes to define the elements for the new HTA institution. The “in-depth” interviews extended to manufacturers, ministry representatives, services providers, purchasers, patients and citizens representatives, judiciary court, professional colleges, academia and non-governmental organizations (NGOs). Analysis of the professional competencies required for the HTA institution was carried out based on best practice analysis of international HTA institutions.RESULTS:The implementation of an HTA unit in Costa Rica was identified by all the actors as crucial to ensuring the health system's sustainability. Costa Rica's health system is based on all citizens right to health and all inputs required delivering health services, judicialization and access to health care have become a big issue. Two main issues were identified as essential to implement an HTA institution: the establishment of a clear framework to provide legal and financial support and the need to have sufficient independence from the Ministry and the Social Security, including maximum transparency and methodological robustness.CONCLUSIONS:The business model for the new HTA institution should consider the participation of all the interested actors. The HTA institution should bridge the gap between technology regulation and health technology management and aim to improve both processes. It should also provide third party independent evidence to inform the constitutional court around health care claims.
OP28 Health Apps: A Proposed Framework To Guide Clinical Risk Assessment
Authors: van Velthoven Michelle Helena , Powell John , Wyatt Jeremy 
Published: January 2018

INTRODUCTION:Globally, health systems are struggling with reliably appraising the safety and efficacy of rapidly changing digital health interventions whilst allowing useful innovations to be rapidly adopted. Assessment and regulation of the large number of health apps should be proportional to their clinical risk, but there is large uncertainty about suitable criteria to assess risk (1). We aimed to identify criteria for assessing clinical risks associated with different types of health apps.METHODS:Our work builds on previous studies that identified some of the risks that health apps can pose and contextual factors that can moderate these risks (2,3). This work is grounded in a review of existing literature; wide consultation of stakeholders; participation in multi-agency policy discussion; and sense-checking successive versions of the framework that evolved over time. We combined different risk domains for apps (technical safety, usability, intervention quality, and engagement) with their functions (learning, behaviour and cognition change, communication, record keeping, and clinical decision support).RESULTS:We developed a comprehensive generic risk framework that app users, developers, commissioners, regulators and other stakeholders worldwide can use to guide assessment of the likely risks posed by a specified health app in a specific context. We also propose questions that should help determine whether these risks have been addressed.CONCLUSIONS:Apps are very promising in health care but are very numerous, complex, rapidly evolving and with overlapping functions. A rigorous risk framework should help stakeholders to deal with the large quantity of health apps, classify and manage clinical risks, and improve patient safety by applying generic risk assessment criteria. Further work is needed to test and develop the criteria we propose, especially as apps that integrate different functions are emerging, which will make risk assessment more complex.
OP37 Can Local Ultra-Orphan Patient Evidence Shape Global Understanding?
Authors: Livingstone Heidi , Upadhyaya Sheela , Thomas Lizzie , Leng Gillian 
Published: January 2018

INTRODUCTION:Written patient evidence is submitted to the National Institute for Health and Care Excellence (NICE) by patient organizations and their nominated patient experts. We reviewed the impact that patient evidence had on the committee's decision making. This local learning can help generate global opportunities for Health Technology Assessment (HTA) bodies and patient groups to further develop their understanding and methodology about how patient evidence can support HTA decision making for ultra-orphan conditions.METHODS:There were two phases.Phase one was an online questionnaire about the impact of patient evidence on the committee's decision making for ultra-orphan HTA evaluations. It was sent to the committee chair, lay committee members and selected other committee members.Phase 2 developed the initial questionnaire findings using in-depth interviews with the committee chair and the lay members. These gained further understanding of the impact of patient evidence and the themes raised.RESULTS:Key findings showed patient evidence was helpful to understand the:
•Burden of disease•Patient population•Likely uptake of new medicines•Impact on carers.For ultra-orphan conditions, where other forms of evidence are scarcer, patient evidence is fundamental to understanding patient needs, the impact of the disease, patient population and preferences.CONCLUSIONS:Patient evidence was useful for the committee in different ways; it provided the committee with new evidence and it helped the committee understand and interpret the evidence submitted by others. Both are key to committee decision making. It was clear that due to the very small patient population, patient groups knew the patient population, their stage of disease, and their preferences in detail.The findings will be used to inform an updated patient submission template for ultra-orphan HTAs, and supporting guide. These will be available on the NICE website and offered to the HTAi Interest Group on Patient and Citizen Involvement so they can be shared globally.
OP38 Improving The Patient Centricity Of Value Assessments: A Rubric
Authors: Perfetto Eleanor , Oehrlein Elisabeth , Boutin Marc , Reid Sarah , Gascho Eric 
Published: January 2018

INTRODUCTION:Value frameworks, analogous to Health Technology Assessment (HTA) internationally, have emerged in the United States to aid stakeholders in assessing the value of new treatments. Since patient perspectives on value may differ significantly from other stakeholders, formalized procedures to involve patients in their work have been created. Despite these efforts, concerns persist that patient involvement is insufficient or “rhetoric.” To assist in this effort, the National Health Council (NHC) created a rubric to aid decision makers in improving the patient centricity of their value assessments.METHODS:A convenience sample of twenty-eight organizations was invited to participate in a roundtable discussion. Participants discussed experiences with value frameworks; debated and thematically grouped hallmark patient-centeredness characteristics; and developed illustrative examples of the characteristics. These materials were organized into the rubric, and subsequently vetted via multi-stakeholder peer review.RESULTS:Participants agreed upon six key domains of patient centeredness: partnership (patients are involved in every step of development/dissemination processes), transparency (assumptions/inputs are disclosed in an understandable, timely way), inclusiveness (perspectives drawn from broad range of stakeholders), diversity (differences in subpopulations, trajectory of disease, and stage of a life should be accounted for), outcomes (includes those that patients have identified as important), and data (variety of credible data sources are used allowing for timely incorporation of new information and account for the diversity of patient populations and patient-centered outcomes). The Rubric describes each domain and includes illustrative examples of how patient engagement/centeredness can be operationalized through direct and indirect pathways.CONCLUSIONS:The NHC Rubric is a first step toward creating patient-centered value assessments that patients and their families can rely on. It is intended to assist all stakeholders, especially the patient community, in assessing the level of patient centeredness and engagement in a given framework or model. It can be a guide to support developers in conceptualizing plans for meaningfully engaging patients.
OP43 Unconventional Health Technology Assessment Use: Diagnosis Of Likely Emerging Tropical Diseases
Authors: Lafarge Jean-Charles , David Denis-Jean , Morin-Surroca Michèle 
Published: January 2018

INTRODUCTION:The increase in travelers and refugees combined with global warming may soon lead to the development of tropical diseases such as Schistosoma or Strongyloides infections in some European countries.Those intestinal parasites may persist for decades with subclinical infections or low-grade disease with nonspecific manifestations. In the presence of immunosuppression, strongyloidiasis can rapidly evolve into life-threatening disseminated disease, whereas chronic schistosomiasis can lead to complications causing future morbidity and death.Currently in France, an update of diagnostic tests reimbursed for those tropical diseases is ongoing to fully cover diagnostic needs.Our aim was to assess the clinical relevance of tests used in schistosomiasis’ or strongyloidiasis’ diagnosis and include the most relevant in the national list of reimbursed tests.METHODS:The assessment involves a critical analysis of national and international guidelines identified by a systematic literature search, and stakeholders’ views.RESULTS:This work identifies several autochthonous outbreaks of those diseases in France; such as urogenital schistosomiasis that occurred in Corsica, in summer 2013. Also it enlightens the increase of strongyloides serological tests performed in the past years. Those facts prove the potential development of those infections in Europe.It underlines that, serology is the first diagnostic test line for most cases and is more sensitive than stool microscopy which represents however the final diagnostic investigation to confirm the intestinal infection.It confirms the main indications of those two diagnostic tools.It relies on a tropical infectious disease expert network including the French army health service. They have brought further clarification of diagnostic tests clinical relevance for travelers or autochthonous cases.CONCLUSIONS:This new use of Health Technology Assessment has allowed updating and listing the relevant diagnostic tools which might be crucial to better follow those diseases and it may help the health system to face the increase of tropical infections.
OP44 Cost-Effectiveness Of Hepatitis C Virus Screening In Swiss Prisons Using Rapid Tests
Authors: Girardin François , Hearmon Natalie , Castro Erika , Negro Francesco , Perard Rodolphe , Schnyder Anita , Eddowes Lucy , Gétaz Laurent , Wolff Hans 
Published: January 2018

INTRODUCTION:This study explored the cost-effectiveness of expanding Hepatitis C Virus (HCV) screening and subsequent treatment in Swiss custodial settings, given the availability of rapid antibody saliva tests (Oraquick®) and dried blood spot tests (semi-quantitative viremia and viral genotype), and recent therapeutic advances which have higher cure rates and shorter treatment courses (1).METHODS:A comprehensive strategy offering screening to all detainees was compared to the current setup of screening high-risk individuals (for example, from endemic countries, active or former injecting drug users). A decision tree simulated the diagnosis pathway, and results from a Markov model were included to predict treatment effects and natural progression over a lifetime time-horizon. Input data were derived from clinical studies, literature reviews, custodial health services and expert opinion (2). The net monetary benefit (NMB) and incremental cost-effectiveness ratio (ICER) of comprehensive compared to current screening were calculated. Deterministic and probabilistic sensitivity analyses were performed to explore parameter uncertainty and whether variations informed by expert opinion changed the cost-effectiveness of comprehensive screening.RESULTS:At a willingness-to-pay threshold of CHF100,000 (USD99,500) per Quality-Adjusted Life-Year (QALY), comprehensive screening had an 83 percent probability of being cost-effective, with a corresponding NMB of CHF33,451,972 (USD33,284,712) and ICER of CHF7,168/QALY (USD7,132/QALY). Results were most sensitive to the QALYs gained from the treatment model (both treatment and no treatment arms), respective HCV prevalence in the current and comprehensive screening populations, treatment initiation rates, and screening offer acceptance rates. Compared to the current practice of screening high-risk individuals, comprehensive screening is likely to be cost-effective due to the increase in testing rates, which were conservatively estimated in this study. Furthermore, comprehensive HCV screening of prisoners may prove more cost-effective in countries where prisoners are not routinely screened.CONCLUSIONS:Comprehensive screening programs could be considered in prison units with a large proportion of high-risk individuals and where detainees are incarcerated for enough time to complete a treatment course during their sentence.
OP46 Addressing National Health Service (NHS) Priorities: Medtech Innovation Briefings
Authors: Herz Naomi , Macmillan Thomas , Goddard Kate , Chalkidou Anastasia 
Published: January 2018

INTRODUCTION:Medtech innovation briefings (MIBs) are intended to support National Health Service (NHS) decision makers and staff who are considering using new innovative medical devices and in-vitro diagnostics. MIBs are produced in support of the NHS 5-Year Forward View, specifically to accelerate innovation in new treatments and diagnostics. This project aimed to evaluate the extent to which published MIBs address national priorities set by NHS England, including in six clinical areas: cancer, mental health, dementia, diabetes, learning disabilities, and maternity.METHODS:Data was extracted from eighty-seven MIBs downloaded from the National Institute for Health and Care Excellence (NICE) website including: study design, amount of evidence, date of CE mark, population, cost, manufacturer, device class, publication date, and category of conditions and disease (as prescribed by NICE). Descriptive analysis was done for each variable and frequency tables were produced for MIBs by disease category.RESULTS:Cardiovascular disease (n = 19) and cancer (n = 12) were the two most common conditions addressed by MIB-evaluated devices. The four medical conditions with the fewest MIBs (n = 1 each) were: diabetes, liver conditions, neurological conditions, and fertility, pregnancy and childbirth. Of the eighty-five MIBs with stated device classifications, just over half were Class IIa and IIb devices and 18 percent were in-vitro diagnostics. The earliest original CE mark was 1997, and approximately half of the devices obtained or updated their CE mark after 2010.CONCLUSIONS:Chronic conditions such as cancer, cardiovascular disease, and diabetes accounted for 89 percent of total deaths in the UK in 2014, thus, the most commonly published MIBs aptly address these issues. However, MIBs are lacking in five out of six NHS priority areas. There is opportunity for innovative technologies to be reviewed via MIBs and alternative NICE pathways in the areas of diabetes, maternity, mental health, and learning disabilities and dementia.
OP55 Health Technology Assessment In Children And Adolescents: Adolescent Preferences For Child Health Utility 9D Health States
Authors: Ratcliffe Julie , Chen Gang , Huynh Elisabeth , Xu Frank , Stevens Katherine , Brazier John , Swait Joffre 
Published: January 2018

INTRODUCTION:Preference-based measures of health-related quality of life play a key role in the calculation of Quality-Adjusted Life Years (QALYs) for Health Technology Assessment (HTA). The Child Health Utility 9D (CHU9D) is a new preference-based instrument designed specifically for application in children and adolescents (aged 7 to 17 years). This study aimed to compare Chinese and Australian adolescent population preferences for CHU9D health states using profile case best worst scaling (BWS) methods.METHODS:Fifty CHU9D health states (blocked into five survey versions) were generated for valuation using a fractional factorial design. Study participants were recruited through an online panel company in Australia, and through primary and secondary schools in China. A latent class modelling framework was adopted for econometric analysis.RESULTS:A total of 1,982 respondents (51 percent female) in Australia and 902 respondents (43 percent female) in China provided useable survey responses. Latent class analysis indicated the existence of preference heterogeneity for both population groups. In the Australian sample, respondents in Class I placed the most importance on the mental health dimensions of the CHU9D (for example, Worried and Annoyed) and the least importance on daily activities (for example, Activities, Daily routine, Sleep), whilst respondents in Class II placed equal weights on all attributes. In the Chinese sample, respondents in Class I placed the most importance on the Activities dimension of the CHU9D and the least importance on the Annoyed dimension, whist Class II placed the most importance on the Schoolwork dimension and the least importance on Pain.CONCLUSIONS:This study has provided important cross-country insights into the use of profile case BWS methods to elicit health state preferences with young people for application in HTA in children and adolescents. The differential latent classes identified between Australia and China highlights the necessity to derive country-specific adolescent scoring algorithms for the CHU9D instrument for application in HTA.
OP69 Hospital-based Health Technology Assessment Is Applicable To Investment Decision-Making Process
Authors: Ikonen Tuija , Lähteenmäki Heli 
Published: January 2018

INTRODUCTION:Hospital mangers need information for decision making (1). Hospital-based health technology assessment (HTA) methods were tested out to support the budget planning of investments for a new building to be constructed for diagnostic and teaching units at a publicly funded tertiary care university hospital. The hospital board nominated an ad hoc working group to reassess all investment proposals for devices, equipment and furniture for the diagnostic or teaching units that intended to move into the new building. The need for assessment was obliged when the submitted proposals of the units exceeded two-fold the initially allocated investment budget.METHODS:Depending on the level of expenditure, all proposals were assessed by one of the following processes: (i) Proposals over EUR250,000 were evaluated by three to five person expert groups using multi-domain assessment adapting Hospital-based HTA-principles; (ii) Proposals between EUR50,000 and EUR250,000 were returned to the units for miniHTA-assessments by clinicians who submitted the initial proposals and (iii) All proposals below EUR50,000 were prioritized by the units to cut the expenditure by at least 25 percent, with a special emphasis on synergistic use of devices and equipment among the units.RESULTS:The expert groups suggested significant reductions to the proposals, including the withdrawal of a Magnetic Resonance Imaging (MRI)-unit considered to be suboptimally located. Furthermore, the need for a new scanner was declined by promoting adherence to evidence-based diagnostic guidelines and more efficient utilization of existing scanners. Self-assessed MiniHTAs revealed proposals that were unnecessary or the specifications for devices needed re-adjustments. Prioritization revealed excess numbers of devices, for instance the number of cold storage appliances could be reduced. Altogether, the investment proposals were cut by over EUR3.8 million to reach the initial budgetary allocation.CONCLUSIONS:Innovative and flexible usage of hospital-based HTA methodology can be applied to budget planning and evaluation of investment proposals to support decision making. Based on encouraging results, hospital-based HTA was accepted to become a part of hospital strategy as a tool for the annual investment planning.
OP93 Conditional Financing In Health Technology Assessment Practice: The Dutch Experience
Authors: Makady Amr , Nijmeijer Hugo , van Veelen Ard , de Boer Anthonius , Hillege Hans , Klunger Olaf , Goettsch Wim 
Published: January 2018

INTRODUCTION:In 2007, the National Healthcare Institute (ZIN) initiated conditional financing (CF) of expensive hospital drugs as an example of conditional reimbursement schemes (CRS). CF is a 4-year procedure encompassing initial HTA assessment (T = 0) followed by additional data collection via outcomes research (separately assessing appropriate use & cost-effectiveness in routine practice) and re-assessment (T = 4). This study aims to review performance and experiences with CF in the Netherlands to date.METHODS:All dossiers for drugs that underwent the full CF procedure were reviewed. Using a standardized data abstraction form, two researchers independently extracted information on procedural, methodological and decision-making aspects (that is, related to implemented outcomes research, evidence assessment and appraisal). A scoring algorithm was used to assess all three aspects.RESULTS:Fourty-seven candidates were nominated for CF; fourty-four underwent T = 0 assessments and eleven T = 4 assessments. The procedure extended beyond 4 years for 10/11 candidates. For the eleven candidates, applicants clearly defined study designs and data collection methods for outcomes research proposals addressing 16/22 research questions posed in T = 0 reports. ZIN provided discussion points and recommendations regarding research proposals for 18/22 research questions. Applicants implemented recommendations fully in 8/22 cases and partially in 12/22. Sufficient data was available at T = 4 to answer 15/22 research questions posed at T = 0. However, discussion points remained regarding implemented outcomes research for all eleven candidates at T = 4. ZIN advised to continue reimbursement for nine candidates and to stop reimbursement for two. For six of the nine candidates, reimbursement was continued on the basis of conditions relating to additional evidence generation beyond T = 4.CONCLUSIONS:Theoretically, CF provides a valuable option for enabling quick but conditional access to medicines in the Netherlands. However, procedural, methodological and decision-making considerations related to scheme design and implementation may affect its value in decision-making practice.