bluuebunny/crossref_metadata_2025_split huggingface dataset:
VP02 Are Journal Editors A Barrier To Publication Of Real World Evidence?
Authors: Oehrlein Elisabeth , Graff Jennifer , Perfetto Eleanor , Mullins C. Daniel , Dubois Robert , Anyanwu Chinenye , Onukwugha Ebere 
Published: January 2018

INTRODUCTION:Health technology assessment (HTA) bodies often rely heavily upon evidence from peer-review publications to inform their recommendations. Since journal editors attitudes likely influence the types of study designs that are accepted through the peer-review process and on to publication, journal editors serve as gatekeepers to translation of evidence, including real word evidence (RWE), into practice. Given past skepticism of RWE study designs, journal editors perceptions of and possible biases toward RWE are important to understand as they may impact dissemination and, therefore, uptake of research findings. The objective of this study was to examine current views of journal editors regarding the: (i) value of RWE studies and (ii) challenges editors face in managing, reviewing, and publishing RWE manuscripts.METHODS:Journal editors representing general medicine (GM), specialty medicine (SM), health policy/services research (HSR) were invited to participate in a telephone interview, a survey, and an in-person, roundtable discussion.RESULTS:In total, seventy-nine journals were approached, resulting in: 15 interviews (GM = 2; SM = 5; HSR = 8), 17 survey responses (GM = 2; SM = 6; HSR = 9) and 8 roundtable participants. RWE was viewed favorably by interviewed editors (n = 15). Characteristics of high-quality RWE manuscripts included: research question novelty/relevance, rigorous methodology, alignment of data with question, and the extent data-source advantages are optimized. Similar manuscript review processes and challenges were voiced for RWE and other study designs. HSR editors were more likely than SM or GM editors to participate, potentially indicating these researchers are more comfortable or interested in RWE. A possible study limitation was that editors favorable toward RWE may have been more likley to participate.CONCLUSIONS:Peer-review journal editors appear to have favorable views regarding RWE studies and can be accelerators to dissemination of RWE findings. However, they do report that studies and processes could be improved. One suggested improvement included a checklist for editors to speed rejections and improve communications with authors.
VP67 The Value Of The European Network For Health Technology Assessment (EUnetHTA) Outputs For National Health Technology Assessment: The French Experience
Authors: Guzina Irena , Meyer François 
Published: January 2018

INTRODUCTION:The French National Authority for Health (HAS) has participated in the work of the European Network for Health Technology Assessment (EUnetHTA) since its creation in 2006. HAS has been an active partner in most EUnetHTA activities, and the lead partner of specific work packages.METHODS:This report presents a summary of the main contribution of HAS to the two latest EUnetHTA projects (Joint Action (JA) 1 and Joint Action 2 (JA2)), their impact on national production, and Health Technology Assessment (HTA) doers feedback as to the opportunities and challenges of participating to the network and using its outputs.RESULTS:In JA 1 and JA 2 projects, HAS has: coordinated activities related to Early Dialogues and Additional Evidence Generation; coordinated the development of nine JA1 methodological guidelines for rapid relative effectiveness assessment (REA) of pharmaceuticals; participated in the production of two JA2 methodological guidelines; participated in the production of one JA1 and seven JA2 rapid REA reports, and two JA2 full HTAs.The national uptake of EUnetHTA outputs included entire adoptation of one REA report and adaptation of another. EUnetHTA templates and methodological guidelines have been taken into account when updating or developing national ones. Thanks to the network, HAS HTA doers could exchange on ongoing assessments with European colleagues, have enhanced their methodological know-how and enlarged their professional network.As for the challenges encountered, it turned out that the re-use of EUnetHTA reports for a technology of interest to HAS was not always possible, mainly due to discordances in deadlines or assessment questions between EUnetHTA and national productions.CONCLUSIONS:HAS has actively participated in different EUnetHTA projects since the network's creation. This collaboration has enabled HAS HTA doers, among others, to optimize national assessments and enhance their methodological know-how.
VP76 European Collaboration In Health Technology Assessment – Experiences And Possible Benefits
Authors: Mayer Julia , Ettinger Sabine , Nachtnebel Anna 
Published: January 2018

INTRODUCTION:Consistently high-quality health care is expected throughout Europe while concurrently, financial resources of member states are decreasing. National Health Technology Assessment (HTA) institutes are informing evidence-based reimbursement decisions in the national context, leading to redundancies in HTA production and tying up limited resources. Since 2006, the European Union project, the European Network for HTA (EUnetHTA) is aiming at enhancing the efficient use of HTA resources and facilitating transnational collaboration. Our aim is to present previous experience in joint assessment of medical devices. Furthermore, possible benefits of European collaboration for stakeholders will be discussed.METHODS:Processes and challenges of the completed EUnetHTA Joint Action (JA) 2 are summarized and discussed. Benefits, aims and opportunities of the ongoing EUnetHTA JA 3 are described.RESULTS:Six rapid assessments of medical devices, focusing on the assessment of effectiveness and safety, were published during EUnetHTA JA 2. Challenges in European medical device assessment encompass the choice of topics, the time point of assessments and the lack of European standards for systematic patient involvement. Characteristics of medical devices, like learning curves, call for monitoring them throughout their lifecycle.The benefit of European collaboration for stakeholders is manifold: uncertainty with regard to actual added value of a technology is minimized through Early Dialogues; harmonized and transparent assessment processes increase the quality of reports; work division among HTA organizations allows a resource-efficient assessment of a bigger amount of technologies; patient involvement ensures consideration of patient relevant endpoints.The importance of cross-border collaboration in HTA is shown in the continuation of the EUnetHTA project, which aims to sustainably strengthen international collaboration even after expiration of EU-funding.CONCLUSIONS:European collaboration in medical device assessment can ensure cross-border health care and efficient cooperation of national health systems. The focus should be set on a wide implementation of jointly established methods and quality standards. The European collaboration can lead to a concrete benefit for various stakeholders.
VP83 How To Identify Technologies Eligible For Health Technology Assessment: A Bottom-Up Approach
Authors: Maltoni Susanna , Camerlingo Maria Domenica , Negro Antonella , Palestini Luigi , Ragazzi Giovanni , Trimaglio Fabio 
Published: January 2018

INTRODUCTION:Governance of health technologies in Emilia-Romagna region, Italy, includes a local and a regional level. Medical devices (MDs) are requested by clinicians to hospital committees that may carry out an evaluation at local level or ask for a regional evaluation using Health Technology Assessment (HTA) methodology. Until the past year, committees weren't provided with a clear pathway to identify technologies for regional HTA evaluation. The aim of this study was to describe a bottom-up, shared approach to produce a tool with elements to be considered when judging if a technology is eligible for regional HTA or not.METHODS:To identify elements, we adopted a qualitative approach and the methodology of focus group (1,2) which consisted in starting from health professionals experience to build a shared knowledge. Two panels of stakeholders were convened, the first one comprising regional decision-makers deciding whether to reimburse and introduce a MD in Regional Health System; the second panel comprised regional clinicians that use, test and ask for MDs. Panels were asked to capture possible elements of MDs that should be considered for identifying the most promising and interesting ones for a regional HTA.RESULTS:The two panels (seventeen regional clinicians and twenty-two decision makers, respectively) had two operative meetings and worked in parallel. At the end of the second meeting, a draft of the tool with elements identified by both groups was built. Panels were asked to test the draft on few medical devices and identify possible tool's criticalities limiting transferability. Tool resulted user-friendly and complete, requiring no changes. The final version, approved by two panels convened together during the last meeting, reports thirty-two distinct items referred to five domains (that is, potential: innovativeness, clinical, economic, and organizational impact, environmental factors). Each item must be valued on a Likert scale. The tool will be applied on every MD requested by regional clinicians and before implementation it will be tested during a 6-month pilot phase beginning March 2017.CONCLUSIONS:The process was plain and feedback from stakeholders has been positive. The tool is expected to increase transparency and homogeneity in identifying technologies eligible for regional HTA.
VP89 Assessing mHealth: Proposal Of A New Framework
Authors: Puig Elisa Puigdomenech , Gómez Santiago , Carrión Carme , Almazan Cari , Espallargues Mireia 
Published: January 2018

INTRODUCTION:The use of health apps is rapidly increasing. They intend to promote health or to treat diseases; in some cases, substituting medical duties. No specific frameworks to assess mHealth solutions in a broad scope and in a comprehensive way have been identified. We aim to propose a framework for mHealth assessment.METHODS:The framework development was based on:
•Literature review to identify existing assessment models including the evaluation of health effects•Exploratory analysis with experts and user group discussions•Definition of the assessment model, following the domains of health technology assessment.RESULTS:Existing frameworks are mainly focused on certification criteria. Professionals and users agreed on the need to undertake mHealth assessments as to better inform user decisions. Assessments should be sensible to continuous changes of these technologies and be undertaken by independent organizations.The proposed framework offers a step-by-step process by which any mHealth solution can be categorized and analyzed, according to: (i) Risk classification matrix: combining intervention type and patient type, (ii) Users: patients, professionals, informal caregivers individually or all of these together and (iii) Integration: stand-alone, fully integrated.The model has four evaluation domains: technical maturity, risks, benefits and resources needed, including the commonly accepted evaluation perspectives: technical, contents, clinical/health, user perspective, organizational and socio-economic. Sub-domains are defined as: end-user, organization, healthcare system and community (society as a whole). Aspects to be assessed are selected according to the purpose of the evaluation (intended use / intended impact) and vary depending on the type of the mHealth solution: product or service.CONCLUSIONS:The mHealth assessment process is needed and should be: (i) continuous/iterative, providing timely conclusions and recommendations for improvement, (ii) inclusive/collaborative, involving all stakeholders,and (iii) constantly adapting to standards. The proposed framework is intended to support informed decisions when developing, integrating, selecting, recommending, or adopting mHealth solutions.
VP108 Environmental Sustainability In Hospitals Health Technology Assessment - A Survey
Authors: Tal Orna , Tal Shy-Lee , Azenkot Asaf , Mazuz Maya , Tzur Shirley 
Published: January 2018

INTRODUCTION:In the age of limited resources, hospital managers confront the need to strictly balance resource allocation at their disposal between drugs, wages, purchases and operation costs. This entails an endless search for creative pathways to efficiently merge the trends to preserve the environment.A “green” hospital is an entity that is planned, built and operated so as to minimize the ‘ecological footprint’: for example, saving energy by utilizing natural light; recycling water, paper or waste; and using insulation and soundproofing (1).‘Evidence-based environmental design’, a new approach to advanced building techniques, is gaining momentum worldwide. It synergizes with additional trends: promoting quality, improving potential utility, raising the accountability of hospital workers and involving the public and patients in overcoming health system dilemmas.The aim was to analyze the standpoints of professionals in health and architecture regarding environmental accountability, in comparison to public opinion, and enhance the dialogue between these three groups to create wise decision making toward improvements in the health system.METHODS:A structured questionnaire was prepared to examine environmental responsibility, focusing on hospital contours. The questionnaire was distributed among three groups to be completed anonymously: hospital employees (physicians and medical managers), professionals from the field of architecture and the general public. The distribution was via the internet and to the general public through a social network using the “snowball” mechanism.RESULTS:Distribution of the survey raised debates on the subject. We compared the views of 178 respondents (80 healthcare professionals, 47 from the field of architecture and 51 from the general public). Demographic and other criteria included age, gender, profession, priority setting, concepts of environmental responsibility and social values. Physicians prioritized economic factors as the main barrier (more than architects or the general public) and marked internal incentives as key factors. Environmental responsibility correlated with high quality of care and service among healthcare workers.CONCLUSIONS:Logistics and physical infrastructure interventions can enhance economic effectiveness. Moreso, they can initiate social and environmental responsibility and increase the level of confidentiality regarding the accountability of their managers towards quality-targeted work surroundings.
VP132 Cost Effectiveness Of A Predictive Risk Model In Primary Care
Authors: Snooks Helen , Porter Alison , Kingston Mark , Evans Bridie , Burge-Jones Deborah , Davies Jan , Hutchings Hayley , Watkins Alan , Whitman Shirley , Sewell Bernadette , Bailey-Jones Kerry , Dale Jeremy , Fitzsimmons Deborah , Harrison Jane , Heaven Martin , John Gareth , Lewis Leo , Philips Ceri , Williams Victoria , Warm Daniel , Russell Ian 
Published: January 2018

INTRODUCTION:Emergency admissions to hospital are a major financial burden on health services. In one area of the United Kingdom (UK), we evaluated a predictive risk stratification tool (PRISM) designed to support primary care practitioners to identify and manage patients at high risk of admission. We assessed the costs of implementing PRISM and its impact on health services costs. At the same time as the study, but independent of it, an incentive payment (‘QOF’) was introduced to encourage primary care practitioners to identify high risk patients and manage their care.METHODS:We conducted a randomized stepped wedge trial in thirty-two practices, with cluster-defined control and intervention phases, and participant-level anonymized linked outcomes. We analysed routine linked data on patient outcomes for 18 months (February 2013 – September 2014). We assigned standard unit costs in pound sterling to the resources utilized by each patient. Cost differences between the two study phases were used in conjunction with differences in the primary outcome (emergency admissions) to undertake a cost-effectiveness analysis.RESULTS:We included outcomes for 230,099 registered patients. We estimated a PRISM implementation cost of GBP0.12 per patient per year.Costs of emergency department attendances, outpatient visits, emergency and elective admissions to hospital, and general practice activity were higher per patient per year in the intervention phase than control phase (adjusted δ = GBP76, 95 percent Confidence Interval, CI GBP46, GBP106), an effect that was consistent and generally increased with risk level.CONCLUSIONS:Despite low reported use of PRISM, it was associated with increased healthcare expenditure. This effect was unexpected and in the opposite direction to that intended. We cannot disentangle the effects of introducing the PRISM tool from those of imposing the QOF targets; however, since across the UK predictive risk stratification tools for emergency admissions have been introduced alongside incentives to focus on patients at risk, we believe that our findings are generalizable.
VP146 A Comparative Assessment Of 3D/2D Laparoscopic Display Systems
Authors: Andellini Martina , Faggiano Francesco , Sabusco Francesca , Derrico Pietro , Ritrovato Matteo 
Published: January 2018

INTRODUCTION:The purpose of the study was to gather evidence on safety and overall effectiveness of performing laparoscopic surgery by using 3D versus 2D display systems in a variety of pediatric surgical procedures in order to efficiently support the final investment decision on the video system to be acquired.METHODS:A new methodology, that is, Decision-oriented HTA (DoHTA) (1) was applied to assess the technology on clinical, technical, organizational, economic, social, ethical and safety domains. A decision-tree covering all the relevant assessment aspects of 3D systems has been derived and weighted following the Analytic Hierarchy Process. Afterwards, another pairwise comparison list was set up to compare both alternative technologies with respect to every lowest indicator.RESULTS:DoHTA results of the 3D system has mainly forecast its impact on clinical efficacy and productivity within the specific context of use. The 3D system is particularly suitable in reducing the mean error rate, thanks to the stereoscopic depth cues which are lost in 2D vision (2,3) From the technical perspective, the analyses have indicated the reduction in median instrument path length, an enhancement of median motion smoothness, and the decrease in grasper frequency with the 3D display. However, the comparative cost analysis has pointed out that the 3D procedure cost was higher that its comparator.CONCLUSIONS:The assessment of the 3D visual system seems to reasonably satisfy the criteria of feasibility, clinical effectiveness and safety. However, the adoption of the 3D display system in surgical practice could involve increased hospital costs, mainly because of the initial cost of the technology. Indeed, based on the appreciation of the results of DoHTA, especially taking into account the positive technical and clinical features, we conclude that the 3D system may be a good alternative to the 2D system.
VP197 Sustainable Production Of Rapid Health Technology Assessments And Clinical Guidelines
Authors: Macpherson Karen , Thompson Lorna , Myles Susan 
Published: January 2018

INTRODUCTION:With increasing resource pressures on health systems, rapid developments in innovative technologies and limited numbers of skilled assessors, there is a need to establish sustainable methods to provide advice on healthcare technologies for decision makers. The European Network for Health Technology Assessment (EUnetHTA) has been testing an approach of collaborative production of rapid Health Technology Assessments (HTAs) and adaptation of these locally. The Scottish Health Technologies Group (SHTG) participated in two collaborative and adaptation projects to test whether this could save time and resource, whilst providing a product as robust and relevant as if developed locally. Concurrently the Scottish Intercollegiate Guidelines Network (SIGN) has been exploring ways to develop clinical guidelines more efficiently, including the use of rapid HTAs to inform recommendations.METHODS:Having established the relevance of the topics to NHS Scotland, SHTG participated as peer reviewers for EUnetHTA reviews on mitral valve repair and mechanical thrombectomy. On completion, SHTG summarized their content to fit with the well-accepted rapid review report format used in Scotland. Content was supplemented with a review of economic evidence, currently not included in the European reports, local epidemiological information and recently published studies. The thrombectomy report and associated Advice Statement were used by a small expert group to update a SIGN clinical guideline recommendation.RESULTS:Providing advice through adaptation proved feasible and acceptable to stakeholders. Limited time was saved because of the supplementary work undertaken, and lessons have been learned about what should and should not be done in future .The guideline recommendation was updated and made available more quickly than similar previous updates.CONCLUSIONS:Further such collaborations and adaptations will be pursued as this appears to be a sustainable approach for the future. The process could be aided by EUnetHTA publishing forward work plans and also by the inclusion of economic information, with details of the decision-making context provided, to allow assessment of its relevance locally.
Neuronal lysosomal dysfunction releases exosomes harboring APP C-terminal fragments and unique lipid signatures
Authors: Miranda André M. , Lasiecka Zofia M. , Xu Yimeng , Neufeld Jessi , Shahriar Sanjid , Simoes Sabrina , Chan Robin B. , Oliveira Tiago Gil , Small Scott A. , Di Paolo Gilbert 
Published: January 2018

AbstractDefects in endolysosomal and autophagic functions are increasingly viewed as key pathological features of neurodegenerative disorders. A master regulator of these functions is phosphatidylinositol-3-phosphate (PI3P), a phospholipid synthesized primarily by class III PI 3-kinase Vps34. Here we report that disruption of neuronal Vps34 function in vitro and in vivo impairs autophagy, lysosomal degradation as well as lipid metabolism, causing endolysosomal membrane damage. PI3P deficiency also promotes secretion of unique exosomes enriched for undigested lysosomal substrates, including amyloid precursor protein C-terminal fragments (APP-CTFs), specific sphingolipids, and the phospholipid bis(monoacylglycero)phosphate (BMP), which normally resides in the internal vesicles of endolysosomes. Secretion of these exosomes requires neutral sphingomyelinase 2 and sphingolipid synthesis. Our results reveal a homeostatic response counteracting lysosomal dysfunction via secretion of atypical exosomes eliminating lysosomal waste and define exosomal APP-CTFs and BMP as candidate biomarkers for endolysosomal dysfunction associated with neurodegenerative disorders.