Glossary: Glossary UK

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Abstract

A summary of a study, which may be published alone or as an introduction to a full scientific paper.

All Wales Medicines Strategy Group (AWMSG)

The AWMSG is the Welsh health technology appraisal (HTA) body,  a statutory advisory Welsh Assembly-sponsored public body which aims to provide advice on medicines management and prescribing to the Welsh Government’s Minister for Health and Social Services in an effective, efficient and transparent manner.

Appraisal

See ‘Technology appraisal (single and multiple)‘.

Appraisal Committee

An independent committee that develops NICE’s guidance on using drugs or treatments in the NHS (called technology appraisal guidance). It is made up of healthcare professionals and NHS managers, researchers, lay representatives, and people who work for drug companies and medical equipment manufacturers.

Appraisal Consultation Document (ACD)

The ACD sets out the Appraisal Committee’s provisional recommendations to NICE on how the technology should be used in the NHS in England.

It is the Appraisal Committee’s draft guidance on using a drug (or group of drugs) or treatment in the NHS (called technology appraisal guidance). The manufacturer and organisations who have been invited as consultees and commentators can comment on this draft guidance.

The ACD will include any restrictions in the event that a restrictive recommendation has been made by NICE.

Area Drugs and Therapeutics Committee (ADTC)

Committees responsible for providing advice to the regional NHS boards in Scotland on the use of medicines to meet the needs of the patients in that health board area. There are 14 regional health boards in Scotland.

Assay

A diagnostic test to measure the concentration or level of a particular analytic.

Assessment Group

An independent assessment group commissioned by the NHS Research and Development Health Technology Assessment (HTA) programme to produce an independent review of the evidence for technologies being appraised within the multiple technology appraisal (MTA) process.

Assessment Protocol

The assessment protocol is derived from the scope of the appraisal, taking into account consultation responses to the draft scope and comments from organisations attending the scoping workshop. It forms the basis of the assessment report during an appraisal following the MTA process.

Assessment Report

A critical review of the clinical and cost effectiveness of a health technology or technologies being appraised within the multiple technology appraisal (MTA) process. It is prepared by the Assessment Group. To prepare the report, the Assessment Group carries out a review of the published literature and the submissions from manufacturers and sponsors.

Association of British HealthTech Industries (ABHI)

The ABHI is an industry association for the medical technology sector in the UK.

Association of the British Pharmaceutical Industry (ABPI)

The ABPI is the trade association for more than 90 companies in the UK producing prescription medicines for human use.

British In Vitro Diagnostics Association (BIVDA)

The national industry association for companies with major involvement and interest in the in vitro diagnostics (IVD) industry.

Carer

In this guide the term ‘carer’ refers to a person who provides unpaid care by looking after a relative, friend or partner who needs support because of ill health, frailty or disability.

Centre Director

The Director of the Centre for Health Technology Evaluation is responsible for the delivery of the technology appraisal programme. The Director is also responsible for ensuring that appraisals are conducted in accordance with the published appraisal process and methodology.

Citizens Council

A group of 30 people drawn from all walks of life who bring the public’s views to NICE decision-making. The Citizens Council tackles challenging questions about values, such as fairness and need.

Clinical Effectiveness

The extent to which an intervention produces an overall health benefit, taking into account beneficial and adverse effects, in routine clinical practice. It is not the same as efficacy.

Clinical Specialist

In technology appraisals, clinical specialists act as expert witnesses to the Appraisal Committee. They are selected on the basis of specialist expertise and personal knowledge of the technology and/or other treatments for the condition. They provide a view of the technology within current clinical practice, and insights not typically available in the published literature.

Commentator

An organisation that engages in the appraisal process but is not asked to prepare a submission dossier. Commentators are invited to comment on the draft scope document, the assessment report and the appraisal consultation document (ACD). They receive the final appraisal determination (FAD) for information only. These organisations are manufacturers of comparator technologies, Healthcare Improvement Scotland (HIS), the relevant National Collaborating Centre, related research groups, and other groups when appropriate.

Committee Papers

The committee papers that are issued and published with an appraisal consultation document (ACD) or a final appraisal document (FAD) include all of the evidence seen by the Appraisal Committee. It is made up of the ERG report, written submissions, and the personal statements of patient experts and clinical specialists, as well as comments received on the ERG report. For second and subsequent committee meetings they will also include consultation comments and responses.

Comparator

The standard intervention against which the intervention under appraisal is compared. The comparator can be no intervention, for example best supportive care.

CONSORT Statement (Consolidated Standards of Reporting Trials)

The CONSORT Statement is a set of evidence-based recommendations for improving the reporting of randomised controlled trials. A flow diagram and checklist allow readers to understand how to conduct a study and assess the validity of the results.

Consultation

The period during guidance development when stakeholders or interested members of the public can comment on draft guidance. For guidelines and technology appraisals, there is also a consultation on the draft scope.

Consultee

An organisation that participates in a technology appraisal. Consultees can comment on the draft scope, the Assessment Report and the appraisal consultation document (ACD) during the consultation process. Consultee organisations can nominate clinical specialists, commissioning experts and patient experts to present their personal views to the Appraisal Committee. All consultees are given the opportunity to appeal against the final appraisal determination (FAD).

Cost Effectiveness

How well a technology works in relation to how much it costs.

Decision Problem

The decision problem describes the proposed approach to be taken in the sponsor’s submission of evidence to answer the question in the scope. This includes the population, intervention, comparator(s), outcomes, cost analysis, subgroup analysis and any special considerations.

Decision Support Unit (DSU)

The Decision Support Unit helps the technical team at NICE to meet the information needs of the Appraisal Committee. This is achieved by providing support, as required, to the technical team and the Evidence Review Group. The objective of the Decision Support Unit is to enhance the delivery of robust information to support Appraisal Committee decision-making. The Decision Support Unit is a multidisciplinary team, expert in methods of health technology appraisal and capable of providing advice and high-quality analyses to decision-makers within very tight deadlines.

Department for International Trade (DIT)

The department for international trade (DIT) is a UK Government department working with businesses based in the United Kingdom to assist their success in international markets, and with overseas investors looking to the UK as an investment destination.

Formerly known as UKTI.

Department of Health and Social Care (DHSC)

The Department of Health and Social Care (DHSC) is responsible for standards of healthcare in the UK, including the NHS. The Department sets the strategic framework for adult social care and influences local authority spending on social care. The Department is also responsible for promoting and protecting the public’s health, taking the lead on issues like environmental hazards to health, infectious diseases, health promotion and education, the safety of medicines, and ethical issues.

Economic Evaluation

An economic evaluation is used to assess the cost effectiveness of healthcare interventions (that is, to compare the costs and benefits of a healthcare intervention to assess whether it is worth doing). The aim of an economic evaluation is to maximise the level of benefits – health effects – relative to the resources available. It should be used to inform and support the decision-making process; it is not supposed to replace the judgement of healthcare professionals.

There are several types of economic evaluation: cost-benefit analysis, cost-consequence analysis, cost-effectiveness analysis, cost-minimisation analysis and cost-utility analysis. They use similar methods to define and evaluate costs but differ in the way they estimate the benefits of a particular drug, programme or intervention.

Economic Model

An explicit mathematical framework that is used to represent clinical decision problems. It incorporates evidence from a variety of sources so that the costs and health outcomes can be estimated.

Enterprise Ireland

Enterprise Ireland is the government organisation responsible for the development of Irish-owned businesses and securing new export sales in global markets.

European Medicines Agency (EMA)

The EMA is a decentralised agency of the European Union responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

Evidence

Information on which a decision or guidance is based. Evidence is obtained from a range of sources, including randomised controlled trials, observational studies and expert opinion (of clinical professionals and/or patients/carers).

Evidence Review Group (ERG)

An independent assessment group commissioned by the NHS Research and Development Health Technology Assessment (HTA) programme to produce an independent assessment of the evidence submitted by the manufacturer or sponsor of a technology being appraised within the single technology appraisal (STA) process.

Evidence Review Group report

A critical assessment of the evidence submitted by the manufacturer of a technology being appraised within the single technology appraisal (STA) process. It is prepared by the Evidence Review Group.

Final Appraisal Determination (FAD)

The FAD sets out the Appraisal Committee’s final recommendations to NICE on how the technology should be used in the NHS in England.

Guidance Executive

A team comprising the Executive Directors and Centre Directors at NICE who are responsible for approving the final appraisal determination before publication.

Health Products Regulatory Authority (HPRA)

Formerly known as the Irish Medicines Board (IMB), the regulatory body in Ireland whose role it is to protect and enhance public and animal health by regulating medicines, medical devices and other health products.

Health Technology

Any method used by those working in health services to promote health, prevent and treat disease, and improve rehabilitation and long-term care. Technologies in this context are not confined to new drugs or medical technologies.

Health-Related Quality of Life

A combination of a person’s physical, mental and social wellbeing.

Healthcare Improvement Scotland (HIS)

The national healthcare improvement organisation for Scotland. The SMC is part of HIS.

HIS has a key role in supporting healthcare providers to make sure that their services meet these expectations and continually improve the healthcare the people of Scotland receive.

In Confidence Material

Information (for example, the findings of a research project) defined as ‘confidential’ because its public disclosure could have an impact on the commercial interests of a particular company or the academic interests of a research or professional organisation, or the policy interests of government.

Incremental Cost-Effectiveness Ratio (ICER)

The ratio of the difference in the mean costs of a technology compared with the next best alternative to the differences in the mean outcomes.

Invasive Device

A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

Lead Team

Members of the Appraisal Committee asked to introduce individual appraisals at committee meetings.

Medical Device Liaison Officer (MDLO)

This person’s primary role is to encourage the effective reporting of adverse incidents.

Medical Devices Directive (MDD)

The Medical Device Directive is intended to harmonise the laws relating to medical devices within the European Union.

Medical Research Council (MRC)

The Medical Research Council is a publicly funded government agency responsible for co-ordinating and funding medical research in the United Kingdom.

Medical Technologies Advisory Committee

An independent committee with 2 roles: selecting medical technologies for evaluation by other NICE guidance programmes and developing medical technologies guidance itself.

Medical Technologies Evaluation Programme (MTEP)

MTEP is a programme to identify medical technologies that could offer benefits to patient or the NHS. Manufacturers notify NICE about possible topics. The Medical Technologies Advisory Committee selects products for evaluation. It may carry out the evaluation itself or refer the topic to be evaluated by another NICE programme – usually technology appraisals, interventional procedures, diagnostics, and sometimes guidelines.

Medical Technologies Guidance

Guidance produced by the Medical Technologies Advisory Committee on technologies that it evaluates. Medical technologies may also be evaluated by other NICE programmes, and usually result in diagnostics guidance or technology appraisal guidance.

Medicines and Healthcare Products Regulatory Agency (MHRA)

The Executive Agency of the Department of Health and Social Care (DHSC). It protects and promotes public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.

Multicentre Investigation

A clinical investigation, conducted according to a single clinical investigation plan, which takes place at different investigation sites.

National Assembly for Wales

The National Assembly for Wales is the democratically elected body that represents the interests of Wales and its people, makes laws for Wales, and holds the Welsh Government to account.

National Health Service (NHS)

The NHS is the name commonly used to refer to the publicly funded healthcare systems of the UK.

National Institute for Health and Care Excellence (NICE)

NICE are a public body of the Department of Health and Social Care (DHSC) in the UK which provides national guidance and advice to improve health and social care. NICE also develop guidance, standards and information on high quality health and social care.

National Institute for Health Research – Health Technology Assessment Programme (NIHR HTA)

The National Institute for Health Research – Health Technology Assessment (NIHR HTA) is part of the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton. The NIHR HTA coordinates the Health Technology Assessment (HTA) Programme on behalf of the NIHR. The aim of the HTA Programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way.

NHS Scotland

NHS Scotland is the publicly funded healthcare system in Scotland. Health and social care policy and funding are the responsibility of the Health and Social Care Directorates of the Scottish Government.

Outcome

A measure of the possible results of a treatment with a preventive or therapeutic intervention. Outcome measures can be either intermediate or final end points.

Palliative Therapy

To relieve the pain and treat a disease as far as possible, but not cure it completely.

Patient Access Scheme (PAS)

A scheme where an agreement is reached between a pharmaceutical company and the NHS in order to reduce the costs of a medicine and improve its cost-effectiveness. This can enable patients to receive access to cost-effective, innovative medicines.

Patient Access Scheme Assessment Group (PASAG)

The Patient Access Schemes (PAS) advisory group in Scotland. PASAG review and advise NHS Scotland on the feasibility of proposed PAS for implementation. It operates separately from the SMC to maintain the integrity and independence of the assessment process.

Patient Access Scheme Liaison Unit (PASLU)

PASLU is the Patient Access Schemes (PAS) advisory group in England. Part of the NICE Centre for Health Technology Evaluation that coordinates the review and evaluation of PAS proposals and produces guidance to the Department of Health and Social Care (DHSC).

Patient Access Scheme Wales Group (PASWG)

PASWG is the Patient Access Schemes (PAS) advisory group in Wales, which aids the reviewing process for PAS applications made to the All Wales Medicines Strategy Group (AWMSG) within the Health Technology Appraisal (HTA) process.

Patient Experts

Acts as an expert witness to the Appraisal Committee. Patient experts have used the technology either personally or as part of a representative group. They provide a view on the risks and benefits of the technology from personal experience as a patient or carer, and an understanding of the wider range of patient and/or carer views.

Pharmaceutical Price Regulation Scheme (PPRS)

The 2014 PPRS was a non-contractual scheme that was replaced on 1 January 2019 by the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (Voluntary Scheme). The parties to this agreement were the Department of Health and Social Care (DHSC), acting on behalf of the health departments of England, Wales, Scotland and Northern Ireland, and the Association of the British Pharmaceutical Industry (ABPI). The purpose of the scheme was to ensure that safe and cost-effective medicines were available on the NHS in England.

Public Health Wales NHS Trust

Public Health Wales was established as an NHS Trust on 1 October 2009. The Trust incorporates the functions and services previously provided by the National Public Health Service for Wales, the Wales Centre for Health, the Welsh Cancer Intelligence and Surveillance Unit, and the Congenital Anomaly Register and Information Service for Wales. Its statutory functions cover a broad range of public health, health protection, screening, health intelligence and research services.

Public Involvement Programme (PIP)

The PIP is the team at NICE that supports and develops public involvement across NICE’s work programme. A PIP Public Involvement Adviser is assigned to each appraisal and supports patient and carer consultee organisations, their representatives, and individual patients or carers throughout the appraisal. The PIP public involvement adviser also supports the lay members of the Appraisal Committees and supplies the patient and carer group information for the ‘Information for the public’.

Redacted

If documents contain confidential information, it must be redacted. ‘Academic in confidence’ and ‘commercial in confidence’ information should be replaced with asterisks and then highlighted in black.

Remit

This is the brief the Department of Health and Social Care (DHSC) gives to NICE when it formally refers a technology for appraisal. Typically, the remit outlines the disease, the patients and the technologies that will be covered by the appraisal.

Scope

Provides a detailed framework for the appraisal and defines the disease, the patients and the technologies that will be covered by the appraisal. The questions the appraisal aims to address are also part of the scope.

Scottish Medicines Consortium (SMC)

A consortium of stakeholders from NHS Boards and Area Drug and Therapeutic Committees (ADTCs) with representation derived from across NHS Scotland. The SMC provides advice to all NHS Boards and their ADTCs about the status of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. All new products must undergo an SMC evaluation within 3 months of launch.

Sponsor

A sponsor is a pharmaceutical company who may not manufacture the technology being appraised but holds the marketing authorisation.

Summary of Product Characteristics (SPC)

The SPC provides information for healthcare professionals on how to use medicines safely and effectively. The SPC does not give general advice on the treatment of particular medical conditions.

Surgically Invasive

An invasive device which penetrates inside the body, other than through an established body orifice, with the aid or in the context of a surgical operation.

Systematic Review

Research that summarises the evidence on a clearly formulated question according to a predefined protocol. Systematic and explicit methods to identify, select and appraise relevant studies, and to extract, collate and report their findings are used. Statistical meta-analysis may or may not be used.

Technology Appraisal (Single: STA; Multiple: MTA)

The process of developing recommendations on the use of new and existing health technologies within the NHS in England. A multiple technology appraisal will normally cover more than 1 technology, or 1 technology for more than 1 indication. A single technology appraisal covers a single technology for a single indication.

Technology Assessment (TA)

The process of evaluating the clinical, economic and other evidence relating to the use of a technology and to formulate guidance on its use. See ‘HTA‘.

Technology Transfer Office (TTO)

Technology transfer, also called transfer of technology (TOT), is the process of transferring skills, knowledge, technologies, methods of manufacturing, samples of manufacturing and facilities among governments or universities and other institutions to ensure that scientific and technological developments are accessible to a wider range of users who can then further develop and exploit the technology into new products, processes, applications, materials or services.

Terminated Appraisal

The single technology appraisal process relies on manufacturers or sponsors submitting evidence, in line with NICE’s specification. Occasionally, they do not make a submission or the submission does not meet the specification. The appraisal is therefore terminated and NICE asks NHS organisations to take into account the reasons why the manufacturer or sponsor did not make an evidence submission when making local decisions on whether to offer the treatment.

Welsh Health Specialised Services Committee (WHSSC)

The Welsh Health Specialised Services Committee (WHSSC) is responsible for the joint planning of Specialised and Tertiary Services on behalf of Local Health Boards (LHBs) in Wales. Every year, WHSSC receives money from the LHBs to pay for specialised healthcare for everyone who lives in Wales and is entitled to NHS care.

The WHSSC was established to ensure that the population of Wales has fair and equitable access to the full range of specialised services. In establishing WHSSC to work on their behalf, the seven LHBs recognised that the most efficient and effective way of planning these services was to work together to reduce duplication and ensure consistency.

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