PP385 Using Common Data Models And Data Networks For Evidence Generation In Health Technology Assessment

2020 ◽  
Vol 36 (S1) ◽  
pp. 32-32
Author(s):  
Seamus Kent ◽  
Jacoline Bouvy
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Healthcare Delivery ◽  
Health Technology ◽  
Data Models ◽  
Medical Decision ◽  
Data Networks ◽  
Common Data Model ◽  
Analytical Tools ◽  
Evidence Generation

IntroductionDifferences between healthcare datasets in structure, content, and coding systems are widely recognized as significant barriers to generating robust evidence for regulatory and medical decision making. As a result, there is a growing interest in using common data models embedded within large data networks. By standardizing the structure, contents, and semantics of disparate healthcare databases, common data models like the Observational and Medical Outcomes Partnerships common data model (OMOP-CDM) enable multidatabase studies to be undertaken at speed and in a transparent way. To date, little attention has been given to their potential role in health technology assessment (HTA).MethodsWe identify the uses of observational data in generating evidence in HTA, some common analytical challenges faced in their estimation, and the infrastructural, technical, and data reusability constraints that limit its wider use. We discuss where and how the OMOP-CDM could overcome these barriers in relation to different types of evidence requirements.ResultsThe OMOP-CDM increases the interoperability of otherwise disparate datasets, allowing reliable evidence to be generated from multidatabase studies at speed and transparently. The current analytical tools are best suited for clinical characterization and population-level effect estimation. Further developments to these tools are required to support analyses common in HTA like parametric survival modeling. Differences in costing methods as well as the structure of healthcare delivery between countries may limit the feasibility and value of standardization.ConclusionsThe OMOP-CDM has the potential to support reliable and timely evidence generation in HTA. The analytical tools should be further developed to support common HTA use cases.

PP14 Development Of The European Network For Health Technology Assessment Standards Tool For Registries In Health Technology Assessment

2018 ◽  
Vol 34 (S1) ◽  
pp. 70-70
Author(s):  
Emmanuel Gimenez Garcia ◽  
Mireia Espallargues ◽  
Jae Long ◽  
Maja Valentic ◽  
Irena Guzina ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Good Practice ◽  
Health Technology ◽  
Registry Data ◽  
European Network ◽  
Real World Data ◽  
The Third ◽  
Evidence Quality ◽  
Evidence Generation

Introduction:Bridging gaps between registry-holders, Health Technology Assessment (HTA) producers and users is one of the aims of the European Network for HTA (EUnetHTA) Joint Action 3. In this context, a post-launch evidence generation tool is being developed, including a quality standards tool for registries in HTA. The standards tool for registries in HTA will enable, among others, registry owners to consistently collect high quality registry data, and HTA agencies to use proper registry data collected by others as evidence for their assessments. The objective is to present the first draft version of the tool structure, which is going to be piloted during the forthcoming months.Methods:A review and description of the currently available first version (November 2017) sections, items and criteria for HTA studies.Results:The tool is divided in three sections; “Methodological Information”, “Essential Standards” and “Additional Requirements”. The first section enables users to analyze not only the ability of the registry to answer to research questions but also to check the registry transparency. The second section encloses the essential elements of good practice and evidence quality (therefore all of them must be met before an HTA report can use the registry data). Finally, the third section includes elements of good practice and evidence quality useful to consider in planning and evaluating registries for specific purposes. Although suggestions are defined, the third section item requirements could depend on the individual HTA agency perspectives and needs.Conclusions:There is a clear growing availability and requirement for real world data for health technology assessment. A piloted and robust registry standards tool for HTA can provide a relevant basis to improve both the evidence generation but also to make more trustful and excellent evaluations.

scholarly journals Web-based toolkit to facilitate European collaboration on evidence generation on promising health technologies

2009 ◽  
Vol 25 (S2) ◽  
pp. 68-74 ◽  
Author(s):  
Fabienne Quentin ◽  
Cédric Carbonneil ◽  
Céline Moty-Monnereau ◽  
Elena Berti ◽  
Wim Goettsch ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Information Sharing ◽  
Technology Assessment ◽  
Web Site ◽  
Health Technology ◽  
Web Based ◽  
Health Technologies ◽  
European Collaboration ◽  
Evidence Generation ◽  
The Web

Background: Several countries have developed policy frameworks allowing timely access to promising health technologies on the condition that additional evidence is generated. However, an important barrier to evidence generation is the lack of structured collaboration among health technology assessment (HTA) agencies.Objectives: One of the aims of Work Package 7 (WP7) of the European network for Health Technology Assessment (EUnetHTA) Project was to determine the types of structured collaboration that could facilitate evidence generation and to develop a Web-based toolkit to support such collaboration.Methods: Collaboration modalities were defined by all WP7 Partners. Initial emphasis was on information sharing. Standardized forms for information sharing were developed and tested. An information technology development phase followed with the creation of the Web-based toolkit (Web site).Results: Three levels of collaboration were agreed on: (i) sharing information, (ii) coordinated action, and (iii) joint action. The Web site allows access to structured and standardized forms for requesting information, posting information in response to a request, and posting information spontaneously. An online database contains all of the information requested or posted. Pilot tests on twenty-one promising technologies were satisfactory.Conclusions: This new Web site for sharing information on evidence generation should help countries reach robust decisions on the timely adoption of promising health technologies. It will only become fully operational if EUnetHTA Partners supply relevant, accurate, and updated information, and regularly use the Web site.

Devolving Healthcare Delivery to Regional Health Authorities: Is Health Technology Assessment Prepared to Follow?

2003 ◽  
Vol 16 (1) ◽  
pp. 24-31 ◽  
Author(s):  
Bernhard R. Gibis ◽  
Don Juzwishin
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Healthcare Delivery ◽  
Health Technology ◽  
General Information ◽  
Regional Health ◽  
Face To Face ◽  
Healthcare Environment ◽  
Health Authorities ◽  
Regional Health Authorities

Since the establishment of health technology assessment units in the latter 1980s, Canada has witnessed an unprecedented transformation of the governance, management and service delivery of its healthcare system. In Alberta, this transformation culminated in the establishment of regional health authorities that provide integrated healthcare to Albertans. With the shift of responsibility for healthcare delivery from the provincial to the regional level, the Alberta Heritage Foundation for Medical Research HTA unit recognized that for health technology assessment to continue to be relevant, it must follow this change. Four steps were taken to refocus the unit's scope: a thorough analysis of the healthcare environment; face-to-face interviews with the chief executive officers of the regions; the development of a framework for HTA in the regions; and the organization of a conference on evidence-based decision making. These steps were helpful in bringing HTA to the attention of regional decision makers. A formal, analytical assessment of the regional healthcare environment, provision of general information (through the framework and conference) and individual information (through face-to-face interviews) enabled a proactive engagement with regions. However, to meet the demands and needs of a population that expects comprehensive coverage that delivers “state of the art” diagnostics and treatments, the efficacy and effectiveness of interventions can sometimes be of subordinate importance.

HEALTH TECHNOLOGY ASSESSMENT IN GREECE

2000 ◽  
Vol 16 (2) ◽  
pp. 429-448 ◽  
Author(s):  
Lycurgus Liaropoulos ◽  
Daphne Kaitelidou
Keyword(s):  
Cost Effectiveness ◽  
Private Sector ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Social Insurance ◽  
Healthcare Delivery ◽  
Health Technology ◽  
Policy Formulation ◽  
Public Hospitals ◽  
Legal Provisions

In 1983 a health reform aimed to assure universal coverage and equity in the distribution of services in Greece. The reform implied state responsibility for the financing and delivery of services and a reduction of the private sector. The model was a Bismarckian scheme for social insurance. However, healthcare delivery remains fragmented and uncoordinated and the private sector is getting stronger. The dominant payment system is fee-for-service for the private sector and administered prices and salaries for public hospitals and social insurance funds. The many insurers have their own eligibility requirements, validation procedures, etc. Coverage of services by social security funds, probably among the most comprehensive in Europe, is determined more on historical and political grounds than on efficiency or cost-effectiveness. The system is plagued by problems, including geographical inequalities, overcentralization, bureaucratic management, poor incentives in the public sector, open-ended financing, inefficient use of hospital beds, and lack of cost-effectiveness. There are no specific legal provisions for the control of health technology. Technologies are introduced without standards or formal consideration of needs. There are no current efforts to control health technology in Greece. However, health technology assessment (HTA) has gained increasing visibility. In 1997 a law provided for a new government agency responsible for quality control, economic evaluation of health services, and HTA. The hope is that the new law may introduce evaluation and assessment elements into health policy formulation and assure that cost effectiveness, quality, and appropriate use of health technology will receive more attention.

scholarly journals CONSIDERING EQUITY IN HEALTH TECHNOLOGY ASSESSMENT: AN EXPLORATORY ANALYSIS OF AGENCY PRACTICES

2015 ◽  
Vol 31 (5) ◽  
pp. 314-323 ◽  
Author(s):  
Dimitra Panteli ◽  
Julia Kreis ◽  
Reinhard Busse
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Vertical Equity ◽  
Equity In Health ◽  
Increased Risk ◽  
Legal Contexts ◽  
Analytical Tools ◽  
Agency Practices ◽  
Equity Perspective

Objectives: Equity is one of the founding principles in most healthcare systems. Financial constraints entail an increased risk of exacerbating inequities and a greater need for evidence-based decisions. It is, therefore, both important and timely to enquire how equity can be addressed in health technology assessment (HTA) practice. We aimed to explore related practices from a broad range of HTA agencies, identify exemplary approaches and common concerns, and offer insights for future considerations.Methods: HTA agencies for which both methodological guides and HTA reports were publicly available were selected from an initial comprehensive pool. Information was extracted on issues ranging from a general commitment to fairness to specific measures targeting both methodological and process-related elements.Results: Methodological documents and ninety-eight reports from nineteen agencies were analyzed. Our findings indicate that equity was not a standard consideration in HTA report production. The nature of specific approaches and the amount of resources invested into including an equity perspective varied considerably. Specific measures (e.g., appropriate information sources, analytical tools, and schemes) were mentioned by almost half of the agencies analyzed. Albeit sporadic, both horizontal and vertical equity considerations were identified in included HTA reports.Conclusions: While varying legal contexts and institutional principles can lead to different interpretations of equity at the decision point, a combination of methodological and process-related practices could contribute to more equity-sensitive evaluations, especially in conjunction with enhanced dissemination of existing methodological tools. Networking initiatives on behalf of existing collaborating platforms could play an important role in this direction.

PP32 Joint Early Dialogs Between Medical Device Regulation and Health Technology Assessment

2019 ◽  
Vol 35 (S1) ◽  
pp. 43-43
Author(s):  
Petra Schnell-Inderst ◽  
Claudia Wild
Keyword(s):  
High Risk ◽  
Health Technology Assessment ◽  
Medical Device ◽  
Technology Assessment ◽  
Health Technology ◽  
European Medicines Agency ◽  
Scientific Advice ◽  
Market Approval ◽  
Evidence Generation ◽  
Medical Device Regulation

IntroductionIn Europe, the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) that entered into force 2017 will have to be applied until 2020 and 2022, respectively. Under the old regulation, there was a large gap between evidence requirements for market approval and market access for high risk (class IIb and III) medical devices (MD). The MDR/IVDR will require appropriate clinical investigations for these MD classes. Despite the different purpose of market approval and surveillance and reimbursement decisions, there are possible synergies with regard to evidence generation, for example, design of pivotal trials and post-launch evidence generation with observational data. In the MDR, early scientific advice can be provided by expert panels of the European Commission if requested by MD developers. For medicinal products, the European network for Health Technology Assessment (EUnetHTA) has established joint early dialogs (JED) of HTA agencies with the European Medicines Agency and manufacturers. A similar approach might be possible with the Medical Device Coordination Group (MDCG). The objective was to explore possible synergies for JED with the MDCG and EUnetHTA.MethodsIn 2018, EUnetHTA established a task force for HTA and MDR/IVDR. A workshop, which will explore possible synergies and activities on JED as well as the viewpoints of stakeholders will be held in May 2019. Participants will be Directorate-Generals GROW (Internal Market, Industry, Entrepreneurship and SME) and SANTE (Health and Food Safety), EUnetHTA members assessing MD, representatives of national competent authorities, Team Notified Bodies, MedTech Europe, patient representatives and academia.ResultsA report on the presentations, the results of the discussion, and next steps in a possible collaboration will be presented.ConclusionsJoint early scientific advice to manufacturers on the European level for evidence generation by HTA agencies and the MDCG has the potential to streamline evidence generation in the life cycle of high risk MD.

scholarly journals Health technology assessment in Singapore

2009 ◽  
Vol 25 (S1) ◽  
pp. 234-240 ◽  
Author(s):  
Keng Ho Pwee
Keyword(s):  
Health Care ◽  
Public Sector ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Healthcare Delivery ◽  
Community Support ◽  
Good Health ◽  
Health Technology ◽  
Regulation System ◽  
Standard Drug

The Republic of Singapore is an island city-state in Southeast Asia. Its population enjoys good health and the Singapore Ministry of Health's mission is to promote good health and reduce illness, ensure access to good and affordable health care, and pursue medical excellence. This is achieved through a healthcare system that includes both private and public sector elements. The financing philosophy of Singapore's healthcare delivery system is based on individual responsibility and community support. Health care in Singapore is financed by a combination of taxes, employee medical benefits, compulsory health savings, insurance, and out-of-pocket payment. The capability for health technology assessment in Singapore was developed concurrently with its medical device regulation system in the 1990s. The first formal unit with health technology assessment (HTA) functions was established in September 1995. Today, HTA features in decision making for the Standard Drug List, licensing of medical clinics, the Health Service Development Programme, healthcare subsidies, and policy development. The public sector healthcare delivery clusters have also recently started health services research units with HTA functions. Singapore is organizing the 6th Health Technology Assessment International (HTAi) Annual Meeting in June 2009. Bringing this prestigious international conference to Asia for the first time will help raise awareness of HTA in the region.

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