HTA Core Model Handbook

Version 2.2, published 8 Apr 2016

This Handbook is the main source for instructions on using the HTA Core Model. The Handbook has during autumn 2015 undergone a major revision since its previous version (1.5, published in April 2014). Most content has been rewritten and included in two completely new user guides, one for using the Model in HTA projects and another for using the HTA Core Model Online. Practical instructions and key documentation are both included in the following table. Definitions for terms and concepts, as well as a brief introduction to the domains of HTA is available below the table.

Instructions and key documentation

DocumentDescriptionFormat(s)Producer
HTA Core Model User GuideA general introduction to the HTA Core Model and practical guidance for HTA projects. Basic reading for anyone using the Model.PDFJA2/WP8
HTA Core Model Online User GuidePractical guidance for using the HTA Core Model Online.PDFJA2/WP8
Methodological Standards and ProceduresPractical guidance for project groups working on a core HTA (i.e. a "full assessment")PDFJA2/WP4
Procedure Manual for Rapid REAsPractical guidance for project groups working on rapid relative effectiveness assessments. Separate versions are available for pharmaceuticals (pdf) and other technologies (pdf). PDFJA2/WP5
Overview of HTA Core Model training materialsKey documentation used in HTA Core Model training. Particularly aimed for new users of the Model. The majority of the material can be used for self-learning.PDFJA2/WP8
HTA Core ModelAll Model documentation (including earlier versions) is available here.HTML, PDF and DOCXJA2/WP8
Assessment element tablesKey information regarding the assessment elements included in various model applications is available in separate tables. Locate the application you are interested in here and choose the respective link "Assessment elements [pdf]". PDFJA2/WP8
LicenceAll users of the HTA Core Model should adhere to the Licence. Instructions and documentPDFJA2/WP8
Policy for the HTA Core Model and core HTA informationPolicies that steer the use of the HTA Core Model and core HTA information. Project managers of EUnetHTA projects, as well as users of core HTA information should read some of the contents. Instructions and documentPDFJA2/WP8

Terms and concepts

The following terms and concepts are used in the HTA Core Model and its derivatives and applications.

Application of the HTA Core Model: Different kinds of technologies (e.g. surgical interventions or pharmaceuticals) may require different questions to be asked in an assessment and the answers to the questions may require different research methods. An application of the HTA Core Model is built for assessing a specific kind of health technology. Different applications all draw from the same pool of assessment elements, but not all elements are used in all applications. Separate applications may exist for different types of assessments (e.g. full vs. rapid assessment).

Assessment element: The basic unit of the model. Defines a piece of information that describes the technology or the consequences or implications of its use, or any other aspect relevant for the assessment, such as the patients and the disease for which it is applied. Each assessment element contains an "issue", which is a question that should be answered in an HTA. Not all issues, however, are relevant to all technologies/settings/projects, and hence their relevance is considered separately for each assessment. Elements are defined through a combination of domain, topic and issue.

Collection: Core HTA information published in a standardized format. Each collection contains a) a set of question-answer pairs (e.g. as result cards in which each research question is answered in a concise manner), b) general content (e.g. summary, introduction and discussion) that combines the questions and answers (or result cards) into a coherent information package, and c) optional appendices that enable inclusion of additional information to the results without crowding the result cards' content. Appendices may also be relevant to one or more domains (these are respectively called domain-level and collection-level appendices).

Core HTA information: Any information on a technology that has been produced following the ontology and the common reporting structure of the HTA Core Model. This information has high potential for being shareable and transferable knowledge.

Core HTA: An actual assessment that a) has been conducted using the HTA Core Model and b) has considered all core elements of all 9 domains. Some elements may be defined as irrelevant, but such exclusions should be documented.  A core HTA contains a summary chapter that draws together key findings of various domains, but does not make recommendations regarding the use of technology. Through the wide scope, focus on core elements and the summary, a core HTA gives an overview of a technology that is likely to be useful in the European context. A core HTA can be used as a basis for producing local HTA reports that take into account local circumstances (e.g. epidemiology, organisation, resources, values). A core HTA is published as a collection within the HTA Core Model Online.

Domain: A wide perspective within which technology is considered. It provides an angle of viewing the use, consequences and implications of technology. A standard set of domains is used in the HTA Core Model. See also Topic and Issue.

Element card: Each assessment element is connected in the Model to an element card, which provides tangible information on the element and its relations to other elements. A card may provide advice on how to answer the question defined by the element. Two characteristics within a card (importance and transferability) define whether an element is a "core element" or "non-core element". While assessment elements are generic (i.e. one element can belong to several applications of the HTA Core Model), element cards are application-specific (i.e. the cards describing an element within different applications may be different).

HTA Core Model: A methodological framework for joint production and sharing of HTA information. The Model consists of three components: 1) an ontology containing a set of generic questions that define the contents of an HTA, 2) methodological guidance that assists in answering the questions and 3) a common reporting structure that enables standardised reporting of HTAs.

Issue: An even more specific area of consideration within any of the topics. One topic typically consists of several issues, but it may also contain only one issue. An issue is always expressed as a question that can be answered through answering one or more research questions. See also Domain and Topic.

Result card: After a question deriving from an assessment element has been answered through appropriate research, the answer can be recorded in a result card. The information should be in a concise form, fitting into 1 or 2 pages. More extensive materials (e.g. long texts or large tables) can be added as appendices, which can be relevant to one or more result cards.

Structured HTA information: Information on any aspect of health technology created through answering the issues defined in the assessment elements of the HTA Core Model.

Topic: A more specific area of consideration within the domains. One domain is divided into several topics. Similar topics may be addressed within more than one domain. See also Domain and Issue.

Domains of HTA

The HTA Core Model employs a multidisciplinary view of HTA. Any technology that is being assessed is considered through domains, each of which provides a wide framework for the analysis. Brief definitions of the domains follow. More detailed information on domains is available in the actual Model applications.

Health problem and current use of technology (CUR)

Domain describes the health problem and target population to be intervened with the technology under assessment; the epidemiology and the burden of disease on individuals and the society. It describes the availability, patterns of use, life cycle, and regulatory status, as well as the alternatives to the technology. It is essential background information for core HTA investigators in other domains as well as for those who read and utilise a core HTA.

Description and technical characteristics of technology (TEC)

Domain gives an overview of what the technology is, when it was developed and for what purposes, who will be using the technology, in what manner, and at which level of health care. The material requirements, premises, equipment and staff, are described, as well as the training and information needs the new technology brings along.

Safety (SAF)

Safety domain describes the direct and indirect harms of a technology for patients, staff and environment, and how to reduce the risk of harms. There is usually a spectrum of known and unknown harms, which can be intended or unintended, of different seriousness, and dose or time dependent.

Clinical effectiveness (EFF)

Domain describes the spectrum and amount of beneficial health effects and quality of life that is expected through the use of the technology. In diagnostic technologies the test accuracy and beneficial changes in management are considered as outcomes of indirect effectiveness as well. Proven effectiveness and safety of a technology is fundamental, considering further assessment and the potential use of the technology.

Costs and economic evaluation (ECO)

Domain identifies, measures, values and compares the costs and outcomes of technologies being considered to inform value-for-money judgments about the intervention and priority-setting between different health technologies. The issues deal with resource utilization, unit costs, indirect costs, outcomes/consequences, and incremental cost-effectiveness of the technology.

Ethical analysis (ETH)

Domain considers prevalent social and moral norms and values relevant for the technology in question. Ethical questions are addressed both with regard to the technology itself and with regard to the consequences of implementing or not implementing a health technology. In addition, the moral and ethical issues inherent in the entire HTA process are identified and evaluated.

Organisational aspects (ORG)

Domain focuses on the delivery models of the technology, analysing processes, resources, management and cultural issues within variety of stakeholders, in the intra- and inter-organisational and health care system level. Understanding organisational aspects may reveal essential challenges and barriers in implementing health technologies.

Patient and social aspects (SOC)

Domain focuses on the patients' and his or her significant others' considerations, worries and experiences before, during and after the implementation of the technology. It describes how the technology molds diverse social arenas and is molded by these arenas where the patients use it (hospitals, general practitioner, everyday life, homes, schools, and workplace), and what specific meanings people give to the technology. The domain was renamed from ‘Social aspects’ to ‘Patient and social aspects’ in version the HTA Core Model version 3.0.

Legal aspects (LEG)

Domain scrutinizes aspects of basic rights of patients, such as autonomy, informed consent, privacy and confidentiality, and legal requirements, such as authorisation, guarantee, and regulation of market. The European Union is producing ever more health technology related legislation. Harmonisation of national legislation is likely to occur in the health care sector, as the patients and professionals are allowed free movement within Europe. Proper knowledge of relevant legal questions has often relevant legal consequences in decision making.

Version history

Version

Date

Main changes

2.28 Apr 2016
  • Overview of Training Materials included
2.126 Jan 2016
  • New version of User Guide included
  • Definition of core HTA information udpated

2.0

4 Dec 2015
  • First version of completely revised Handbook