bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP141 Legal Governance: How Does Law Circumscribe The Social Role Of Health Technology Assessment?
Authors: Bernier Louise , Legault Georges-Auguste , Daniel Charles-Etienne , Bédard Suzanne Kocsis , Béland Jean-Pierre , Bellemare Christian , Dagenais Pierre , Gagnon Hubert , Parent Monelle , Patenaude Johane 
Published: January 2018

INTRODUCTION:One of the barriers of integrating ethics in Health Technology Assessment (HTA) relates to the social role of HTA (1). The aim of this study is to provide a better understanding of the way by which law circumscribes the social role of HTA. Our hypothesis: HTA's social role is embedded within a mixed governance based on hard law and soft law.METHODS:Three HTA agencies were conveniently selected for our study: Haute Autorité de santé (HAS) (France), National Institute for Health and Care Excellence (NICE) (United Kingdom) and Institut national d'excellence en santé et en services sociaux (INESSS) (Québec, Canada). Our analysis of the legal, administrative and procedural documents relating to the existence and assessment processes of these three agencies is guided by the following criteria:
1.The normative strength of the documents (categories of hard law or soft law) (2)2.The definition of the agencies’ social role (1)3.The integration of ethics in the agencies’ mandate.RESULTS:Hard law contributes to establish a general mandate and some legal legitimacy for these agencies. Soft law, grounded in the HTA producers' practices, plays a major role in the legal governance of HTA. Our results demonstrate that these agencies existing practices seem to circumscribe their social role further than their constitutive laws. In this context, social actors become responsible to define, structure and operationalize the implementation of HTA.In addition, the legal framework (hard law) through which HTA unfolds does not clearly support its structural and social role. Despite existing legal frameworks, the normative legitimacy of HTA is not entirely established, as it depends on soft law. Taken altogether, this maintains a persisting conceptual vagueness in HTA governance.CONCLUSIONS:The social role of HTA should be defined either through modifying existing legislations (hard law) or through harmonization of the agencies internal policies and regulations (soft law). Such legal initiatives would help clarify the aims of HTA evaluations: assessments (scientific) or appraisal (value-laden), and therefore give a clearer indication on how best to integrate ethics in HTA.
PP147 Physician And Patient Reported Anxiety And Depression In Hemophilia
Authors: Jacob Ian , Camp Charlotte , O'Hara Jamie , Skinner Mark , Walsh Shaun 
Published: January 2018

INTRODUCTION:Anxiety and depression are major drivers of health-related quality of life, adherence to therapy, and motivation to self-manage chronic conditions. A number of studies have shown rates of anxiety and depression to be higher among individuals with hemophilia compared to that of the general population (1). As the primary point of care for persons with hemophilia, hematologists are well-placed to assess the mental health state of their patients (2). The aim of this study is to explore physician- and patient-reported rates of anxiety and depression among a cohort with severe hemophilia.METHODS:Data were drawn from the Cost of Haemophilia across Europe – a Socioeconomic Survey (CHESS), a cost-of-illness study in severe hemophilia A and B across five European countries (France, Germany, Italy, Spain, and the UK) (3). Physicians provided clinical and sociodemographic information for 1,285 adult patients, 551 of whom completed corresponding questionnaires, including EuroQol EQ-5D-3L. We compared the self-reported EQ-5D with physician reports of anxiety and depression.RESULTS:Across the five countries, physicians recorded a diagnosis of anxiety disorder in 189 patients (15 percent; range 4 percent-28 percent) and depression in 178 patients (14 percent; range 10 percent-28 percent). Seventy-three patients (6 percent) recorded comorbid anxiety and depression. Forty-six percent of patients with anxiety and 58 percent of patients with depression were receiving some form of treatment for their condition.Within the EQ-5D measure, 42 percent of individuals recorded problems with anxiety or depression, with 6 percent of patients reporting “extreme” anxiety or depression. Twenty-two percent of individuals with a self-reported problem were not recorded with a corresponding diagnosis by their hematologist; 39 percent of patients reporting “extreme” anxiety or depression were absent of any physician-reported diagnosis.CONCLUSIONS:Anxiety and depression are notable conditions within the hemophilia community, particularly so among those with severe condition. The mental health of individuals with hemophilia is an important aspect in ensuring therapy adherence and overall wellbeing and should be considered as part of a multidisciplinary approach to management of the condition.
PP148 Development And Evaluation Of A Tool Supporting Prescription Behavior
Authors: Lorenzoni Valentina , Ferrari Vincenzo , Freschi Cinzia , Turchetti Giuseppe 
Published: January 2018

INTRODUCTION:The increasing complexity of decision-making in clinical practice and the financial pressure requires clinicians to develop some background about the economic consequences of their decisions and to become more and more managers of pre-defined budgets. The present work aims at describing a simple technology solution that could support prescription decisions and illustrates the results of a preliminary assessment of the tool in a sample of professionals. The solution has been developed to allow informed decision-making in the prescription of oral anti-diabetic drugs (OADs) in type II diabetes mellitus (T2DM) patients by supporting prescriptive appropriateness.METHODS:The tool developed is compatible with many kinds of hardware architectures and the most diffused web browsers. The system allows real-time reproduction of economic evaluation of the different therapeutic options for the management of T2DM patients. Assessment of “ease to use” and “usefulness” of the tool was performed in a convenience sample of clinicians and pharmacists through a specific questionnaire.RESULTS:The tool was developed to compare dipeptidyl-peptidase inhibitors (DPP4i) with sulfonylureas, as second line therapy, for T2DM patients. The tool has a user-friendly Graphical User Interface allowing users to quickly and easily select the therapeutic options to compare, choosing geographical context, perspective of analysis, and changing some model parameters. Feedbacks obtained from thirty-three different professionals were generally positive for the “ease to understand information offered”, “ease of introduction of the tool to support usual working activity”, “usefulness within the usual working activity”.CONCLUSIONS:The study showed that the introduction of the tool as a support for clinicians in optimizing their practice could satisfy unmet needs of professionals by supporting informed prescriptive appropriateness in the choice of OADs as it allows to consider diabetes drug related costs in a comprehensive way. The routinely use of the tool developed could become a solution helping clinicians in the management of several diseases.
PP156 New Information And Communication Technologies And Hospitals' Design
Authors: Alves Eduardo , Bezerra Benefran 
Published: January 2018

INTRODUCTION:The hospital's design today must be prepared for changes resulting from the incorporation of new information and communication technologies (ICT) (1). These will affect non-finalistic (warehouse, archive), diagnostic support (laboratory and image) and finalistic activities (emergency, surgical center, clinics) (2). The Health Technology Assessment (HTA) is fundamental in the dimension of the impact of each technology on the structure of healthcare facilities (HCF). In this way, this work intends to evaluate the trends of impact of the new ICT on hospitals’ structure.METHODS:The main technologies under discussion in Management of HCF in Brazillian Health Regulatory Agency were raised. From this survey an impact matrix was built with hospital environmental design and the trends of adequacy of its space.RESULTS:ICT that tend to decrease the physical space are: electronic health record for the archive, use of digital imaging for radiology, Radio-Frequency Identification (RFID) for the warehouse, point of care and automated laboratory equipment for clinical laboratories.ICT that tend to increase physical space are: Telemedicine for the surgical center, Internet of Things - IoT for Intensive Care Units, beds for emergency and hospitalization.The technologies that present an undefined tendency in relation to physical space are: automatic dispensers of drugs for nursing posts.The use of database servers and the need for network points are still undefined due to the use of Wi-Fi technology and cloud storage. However, it's possible to increase use of electricity and the internet.CONCLUSIONS:It is concluded that the new ICT will have an impact on the planning and building of the future HCF (3). The designs of today's buildings should consider this trend so that the future reality is adequate and the regulatory requirements about HCF should be able to consider it.
PP166 From An Institutional Strategic Plan To A Knowledge Transfer Tool For Health Technology Assessment: Case Of Drug-eluting Stents
Authors: Poder Thomas , Erraji Jihane , Coulibaly Lucien , Koffi Kouamé , Fisette Jean-Francois , Dagenais Pierre , Déry Véronique 
Published: January 2018

INTRODUCTION:Knowledge transfer (KT) of Health Technolgy Assessment (HTA) results presents numerous challenges, one being the lack of time of busy decision makers. Our hospital-based HTA unit is now part of a large network comprising 100 installations. To bridge the gap between complex HTAs and even more limited time by executive officers and managers, we needed to develop a new approach to deliver effectively key HTA messages. We initiated a new strategy with a report on drug-eluting stent (DES). DES may have the potential to eradicate restenosis and the necessity to perform multiple revascularization procedures subsequent to percutaneous coronary intervention (PCI). However, the technology is expensive and some concerns about safety remain. The second generation of DES stents show promising results in terms of efficacy and safety.METHODS:We conducted a systematic review of meta-analyses comparing bare-metal stents (BMS) with second generation DES. Data extracted were used to perform a cost-benefit analysis for our organization. Main findings were illustrated in relation to the strategic plan of our institution.RESULTS:As compared to BMS, the second generation of DES is very effective and potentially leads to huge savings. Safety is improved as regard to myocardial infarction, but not to mortality. For our institution, the use of second-generation DES has the potential to reduce waiting lists for a PCI. In an effort to improve clarity of the results and increase knowledge transfer among managers, we developed a new communication strategy involving the six axes considered as strategic by our Chief Executive Officer, namely: university mission, judicious use of resources, accessibility and quality of care and services, to build for and with the staff, and to act for and with the patient and his family. This led to a smart visual scheme directly showing the results in terms of what is important for our hospital. This initiative was very appreciated by managers.CONCLUSIONS:Using our institutional strategic plan to communicate our results allowed a greater visibility of HTA activities and was greatly appreciated by managers. This will help in disseminating our results locally and in promoting the utility of HTA.
VP05 Comprehensive Evaluation Of An Evolving Transcatheter Technology
Authors: Lambert Laurie , Azzi Leila , Désy François , Vutcovici Maria , Boothroyd Lucy , Brière Anabèle , Bogaty Peter , de Guise Michèle 
Published: January 2018

INTRODUCTION:Our cardiovascular evaluation unit is mandated to evaluate transcatheter aortic valve implantation (TAVI) in the province of Québec. In 2012, it was recommended that only patients at too high risk for surgery receive TAVI. In partnership with our six hospital TAVI programs, we have measured indicators of structure, process and outcomes since 2013. We are collaborating with multidisciplinary clinical experts to update recommendations for optimal use. Herein, we present the evolving portrait of TAVI in Québec and identify priority issues.METHODS:Clinical data were collected and analyzed for all TAVI performed from 1 April 2013 to 31 March 2016. Regular site feedback was provided. A systematic review of recent guidelines and randomized trials facilitated the interpretation of “real world” results and formulation of provincial quality standards.RESULTS:Provincial TAVI volume increased from 294 in 2013–14 to 340 in 2014–15, and to 360 in 2015–16. Patient age and sex distribution remained relatively constant over time (median age 83 years; 47 percent female). However, the median predicted risk of operative mortality (STS score) decreased in the latest period [6 percent (Interquartile Range, IQR: 4–9) versus 7 percent (IQR: 4–9) versus 4 percent (IQR: 3–7)], suggesting TAVI is increasingly being performed in lower-risk patients. Clinical documentation and processes of care generally improved. Thirty-day mortality decreased (6.1 percent versus 4.1 percent versus 2.8 percent). The literature review identified two central issues: TAVI futility in patients who are too sick and apparent non-inferiority of TAVI compared with surgical valve replacement in medium-risk patients.CONCLUSIONS:Our province-wide TAVI evaluation indicates improving processes and outcomes. Patient selection remains the key in our universal healthcare system, with the need to minimize futile and costly therapy and offer TAVI to those most likely to benefit. Continued monitoring of clinical practice and newly-established quality standards, in close collaboration with clinical teams, remains essential to promote optimal use of this evolving technology.
VP07 Collaboratively Modelling The Impact Of Interventions Retrospectively
Authors: Bache Gordon , Tatla Sukh , Simpson Deborah 
Published: January 2018

INTRODUCTION:A conventional approach to communicating value is to model the budget impact of a medicine and the associated formulations in which it is available to be prescribed. However, such an approach does not demonstrate the actual realization of the proposed impact. This abstract outlines an approach to presenting retrospective data back to healthcare professionals (HCP) that blends assumptions and real-world data. For illustrative purposes, we present the results of an application of the model for subcutaneously delivered trastuzumab in an anonymized trust in Yorkshire and Humber.METHODS:The authors developed a model that examined one calendar year (from April 2014) of redistributed sales data for both the intravenous and subcutaneous formulations of trastuzumab for every National Health Service (NHS) trust in England. A series of baseline assumptions (1) were used to model the resource impact of different formulations such as chair time, HCP time, pharmacy preparation time, consumables, wastage, and other considerations. Impacts were estimated at the individual attendance level and scaled to the caseload. These baseline assumptions could then be overwritten by the individual trust using local data.RESULTS:The site delivered approximately 985 doses of subcutaneous trastuzumab over a period of 12 months from April 2014, which represented about 76 percent of the total number of doses delivered. Chair time is estimated to have reduced by 22 minutes per attendance, resulting in a total saving of 361hours. HCP administration time is estimated to have reduced by 23 minutes per attendance, resulting in a total saving of 378 hours based on changing 985 IV doses to SC therapy.CONCLUSIONS:Blending real data and assumptions to provide a retrospective assessment of actual benefits realized back to HCPs is a powerful tool for demonstrating real-world value at both an individual trust and system level.
VP32 Improving The Efficiency Of Early Awareness For Non-Drugs In Spain
Authors: Gutiérrez-Ibarluzea Iñaki , Varela-Lema Leonor , Baños Elena , Luengo-Matos Setefilla , Llanos Aurora , Polo-Desantos Mar , Prieto Isabel , Ruiz Melquiades , Juarez Celia , Asua José , Molina-Lopez Teresa 
Published: January 2018

INTRODUCTION:Early awareness and alert systems (EAAS) try to anticipate the impact of new technologies in the healthcare systems. Spain, which has a decentralized health system with public provision and universal health coverage, has been a pioneer in establishing EAAS activities. From 2006 a network of regional agencies coordinated EAAS activities. Taking into account the individual agencies scarce resources and in order to improve efficiency, this collaboration decided to distribute tasks when identifying and early assessment of new and emerging health technologies. The aim was to inform the common benefit package of the Spanish public health system.METHODS:Four out of eight Spanish Health Technology Assessment (HTA) agencies had EAAS in Spain (AETS-Carlos III Institute; AETSA-Andalusia; Avalia-t-Galicia; Osteba-Basque Country). Each agency has taken care of different sources for the identification of new and emerging non-drug health technologies: industry and innovator contacts, health expert networks, mass media and EAAS databases. Members of the network used the same filtration criteria to reach the final list. The system will run in parallel to a biannual identification process in major databases.RESULTS:In 2016, the network identified and filtered sixty-three technologies: ten by mass media; five by health experts; thirty-five other EAAS and thirteen by direct contact with industry and innovators. Main represented specialties were: endocrinology (seven); gynecology and obstetrics (six); cardiology and cardiac surgery (five); emergency medicine (four); dermatology (three) and pneumology (three). Technologies were grouped by specialty in order to inform the different commissions that discuss inclusion in the Spanish Benefit Package. Specialty monographs will be published to inform stakeholders.CONCLUSIONS:The approach is feasible, and increases the capacity of individual agencies to address the needs of the national and regional systems by improving their efficiency. There is a need to previously define the methods and the criteria that will be used for the identification and filtration.
VP61 Patients Views Of Health Technology Assessment At The National Institute Of Health And Care Excellence (NICE): Enhancing Involvement Opportunities
Authors: Thomas Lizzie , Livingstone Heidi , Leng Gillian 
Published: January 2018

INTRODUCTION:The National Institute for Health and Care Excellence (NICE) medicines health technology assessments (HTAs) involve patients throughout (1): scoping the topic, evidence submission, attending committee as ‘patient experts’, consultation and appeal. A 2013 Health Select Committee report stated “It is important for the credibility of NICE and for the decisions that it makes that the patient voice is effectively and openly represented in all its work” (2). We thus wished to build on previous evaluation projects with more formal research into the views of patient organizations and individual patient experts on their involvement. We additionally sought to explore barriers to involvement.METHODS:The research was a collaboration between staff from three teams at NICE: public involvement, market research, and HTA committee support. A mix of interviews, focus groups and surveys was used to gather feedback – from patients and organizations who have engaged with NICE, but also those who had not, plus NICE committee chairs and staff. Facilitators and barriers to involvement were investigated, along with attitudes towards process and support. We used qualitative thematic analysis alongside quantitative methods.RESULTS:Key findings were that patients and patient organizations mostly:
•hold favourable opinions of NICE•have a good understanding of process and expectations•remain unsure of the impact of their inputs.Improvements identified include clarifying communications, language and roles. Plus increasing transparency of decision making and patient impact.CONCLUSIONS:The research findings and action plan, although specific to NICE, hopefully can inform others in the wider HTA ecosystem. Resources developed will be shared with Health Technology Assessment International (HTAi) networks, including updated correspondence templates and new videos explaining decision making in lay language. The research further adds to discussions around appropriate use of patient organizations scarce resources, and how best to feedback to participants and demonstrate impact of patient involvement.
VP63 National Institute For Health And Care Excellence (NICE) Technology Appraisal Patient Expert Feedback: 15 month analysis
Authors: Kastoryano Chloe , Thomas Lizzie , Livingstone Heidi , Leng Gillian 
Published: January 2018

INTRODUCTION:The National Institute for Health and Care Excellence (NICE) has a formal policy stating patients, carers and citizens are involved throughout each Health Technology Assessment (HTA). One key way patient/carer organizations are involved is by nominating patient experts to participate in appraisal committee meetings.A NICE 2014 report (1) on Patient Experts experiences identified a need to routinely survey Patient Experts. This has been ongoing since October 2015. This study highlights key findings, including new recommendations and whether previous concerns have been addressed.METHODS:We refined the 2012 survey to be routinely sent to all patient experts that attended a NICE technology appraisal committee meeting. Between October 2015 and December 2016 this online survey was sent to eighty-eight patient experts. After analysis the findings were compared to the previous report to identify whether concerns have been addressed and whether new recommendations should be considered.RESULTS:There was a response rate of 47 percent (n = 41). Quantitative results and qualitative quotes demonstrate that patient experience varies widely. Key findings from the new data revealed that patient experts feel supported by the Public Involvement Programme, however would welcome more opportunities to speak. Notable improvements since 2012 include favourable opinions of support documents and the Chair more regularly introducing themselves to the patient expert before the meeting. Some experts still find the paperwork cumbersome and find the meetings very technical.CONCLUSIONS:Progress has been made since 2012, but further improvements could facilitate even more effective patient involvement. We continue to routinely measure experiences to identify and address evolving issues. Some tensions remain between NICE's remit and processes, and patients expectations of these. The findings, although specific to NICE, hopefully can feed into other patient involvement developments in the wider HTA ecosystem.