Glossary: General

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Abstract

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

Academic In Confidence

See ‘In Confidence Material’.

Access

The extent to which people are able to receive the information, services or care they need.

Appraisal

See ‘Technology appraisal (single and multiple)’.

Appraisal of Evidence

Formal assessment of the quality of research evidence and its relevance to the topic being considered. It is assessed according to predetermined criteria.

Assay

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

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.

Care Pathway

Care pathways are sometimes described as ‘integrated care pathways’ (ICP) and are a tool and a concept, that embed guidelines, protocols and locally agreed, evidence-based, patient-centred, best practice, into everyday use for the individual patient. An ICP aims to have:

  • The right people,
  • Doing the right things,
  • In the right order,
  • At the right time,
  • In the right place,
  • With the right outcome,
  • All with attention to the patient experience

Care Programme Approach (CPA)

The care programme approach is a systematic assessment of a patient’s health and social care needs, a care plan, a key worker and a regular review of progress.

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.

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 Governance

A system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish.

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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.

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Commercial In Confidence

See ‘In Confidence Material’.

Commissioning

The process used by health services and local authorities to: identify the need for local services; assess this need against the services and resources available from public, private and voluntary organisations; decide priorities; and set up contracts and service agreements to buy services. As part of the commissioning process, services are regularly evaluated.

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.

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Comorbidity

More than one medical/psychiatric condition present.

Comparability

Similarity of groups in terms of characteristics likely to affect study results (such as health status or age).

Comparator

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

Confidentiality Disclosure Agreement (CDA/NDA)

A Confidentiality Disclosure Agreement (CDA, also known as non-disclosure agreement; NDA) is a legal contract between at least two parties that outlines confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to or by third parties.

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.

Cost-Benefit Analysis

One of the tools used to carry out an economic evaluation. The costs and benefits are measured using the same monetary units (for example, pounds sterling) to see whether the benefits exceed the costs.

Cost-Consequence Analysis

One of the tools used to carry out an economic evaluation. This compares the costs (such as treatment and hospital care) and the consequences (such as health outcomes) of a test or treatment with a suitable alternative. Unlike cost-benefit analysis or cost-effectiveness analysis, it does not attempt to summarise outcomes in a single measure (such as the quality-adjusted life year) or in financial terms. Instead, outcomes are shown in their natural units (some of which may be monetary) and it is left to decision-makers to determine whether, overall, the treatment is worth carrying out.

Cost-Effectiveness Analysis

Cost-effectiveness analysis assesses the cost of achieving a benefit by different means. The benefits are expressed in non-monetary terms related to health, such as symptom-free days, heart attacks avoided, deaths avoided or life years gained (that is, the number of years by which life is extended as a result of the intervention).

Cost-Minimisation Analysis

One of the tools used to carry out an economic evaluation. Cost-minimisation analysis compares the costs of different interventions that provide the same benefits. If they are equally effective, only the costs are compared and the cheapest intervention will provide the best value for money. In practice, there are relatively few cost-minimisation analyses because it is rare for 2 healthcare interventions to provide exactly the same benefits.

Cost-Utility Analysis

One of the tools used to carry out an economic evaluation. The benefits are assessed in terms of both quality and duration of life, and expressed as quality-adjusted life years (QALYs).

CSD

Commissioning Support Documents.

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-Analytic Model

A model of how decisions are or should be made. This could be one of several models or techniques used to help people to make better decisions (for example, when considering the trade-off between costs, benefits and harms of diagnostic tests or interventions).

Detailed Advice Document (DAD)

A detailed advice document is the document produced by the HTA body (e.g. NICE, SMC) providing final advice on whether a medicine is accepted for routine use, not recommended for use or accepted for restricted use.

Discounting

Costs and perhaps benefits incurred today have a higher value than costs and benefits occurring in the future. Discounting health benefits reflects individual preference for benefits to be experienced in the present rather than the future. Discounting costs reflects individual preference for costs to be experienced in the future rather than the present.

Drugs and Therapeutics Committee (D&TC)

A local formulary decision-making groups that is hospital (secondary care) based.

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.

Economic Modelling

A way to estimate the costs and effects of an intervention over periods of time on patient groups not covered in a clinical trial or other research.

Electronic Health Record (EHR)

The term EHR is used to describe the record of patient’s overall health and healthcare. It combines information about patient contacts with primary health care and information associated with the elements of care held in EPRs.

Electronic Patient Record (EPR)

A record of a patient’s personal details (name, date of birth, etc.) their diagnosis or condition and details about the treatment/assessments undertaken by a clinician. Typically, it covers the care provided, mainly by one organisation.

Evaluation

An assessment of an intervention (for example, a treatment, service, project, or programme) to see whether it achieves its aims.

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 healthcare and other professionals and/or patients).

Evidence Statement

A brief summary of the key findings from a review of evidence that has been used as the basis for a recommendation in a guideline.

External Reference Pricing

External reference pricing is a method used by some countries to set drug prices based on the prices of medicines in other countries. For example, Ireland has a basket of 9 external reference states that it uses to influence the prices set for its pharmaceutical industry.

Hazard Ratio

A measure of effect produced by a time-to-event survival analysis. This represents the increased instantaneous rate with which one group is likely to experience the outcome of interest.

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.

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.

Indication

The defined use of a technology as licensed by the European Medicines Agency (EMA) or the European Commission as well as specific bodies in each country such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

Lead Team

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

Local Health Boards (LHB)

An administrative unit within the National Health Service in Wales. There are 7 LHBs which plan, secure and deliver healthcare services in their areas, replacing the 22 LHBs and the 7 NHS Trusts.

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Marketing Authorisation

An authorisation to market a medicinal product from the European Medicines Agency (EMA) or the European Commission or from additional bodies specific to each countries such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

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Marketing Authorisation Holder (MAH)

The MAH stands for the company in whose name the marketing authorisation has been granted. This party has responsibility for all aspects of the product, including quality and compliance with the conditions of the marketing authorisation.

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Master Services Agreement (MSA)

The master services agreement (MSA) is a document agreed between two parties that sets out standard terms that apply to all the transactions entered into between those parties. Each time that a transaction is entered into, the terms of the MSA do not need to be re-negotiated and apply automatically.

Named Patient Programs (NPP)

Named patient programs (NPP) provide controlled, pre-approval access to drugs in response to requests by physicians on behalf of specific, or “named”, patients before those medicines are licensed in the patient’s home country.

Through these programs, patients are able to access drugs in late-stage clinical trials or approved in other countries for a genuine, unmet medical need, before those drugs have been licensed in the patient’s home country.

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Organisation for Economic Cooperation and Development (OECD)

The Organisation for Economic Cooperation and Development (OECD) is a group of 36 member countries that discuss and develop economic and social policy. OECD countries are democratic countries that support free market economies.

Orphan

A term designated to rare diseases and drugs that treat such diseases. The prevalence of the condition must not exceed 5 in 10,000 in order to be classified as an orphan within the EU but may vary in other non-EU countries.

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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.

Over-the-Counter (OTC)

OTC drugs are medicines sold directly to a consumer without a prescription, from a healthcare professional.

Parallel Trade

Parallel trade imports a patented product from an EU Member States with low prices and then sold in higher-priced Member States where the patent holder also markets that product but without the authorisation of the patent holder.

Policy Working Group (PWG)

The purpose of the Policy Working Group (PWG) is to educate national leaders, organisations and agencies on the shared values, priorities, recommendations and contributions to bettering healthcare.

PPP

Preliminary policy proposal.

Prescription Only Medicine (POM)

Medicines which can only be sold to patients with a valid prescription.

Primary Care

Primary care is the day-to-day healthcare given by a health care provider outside of hospitals. It is typically the first point of contact for and includes a range of services provided by GPs, nurses, health visitors, midwives and other healthcare professionals and allied health professionals such as dentists, pharmacists and opticians. It includes community clinics, health centres and walk-in centres.

Quality Adjusted Life Year (QALY)

The quality life adjusted year (QALY) is a tool used to work out how much benefit a patient might get from a medicine in terms of the increase in the length of their life weighted according to how high the quality of the life is. A QALY of 1 is equivalent to one year of perfect health.

Real-World Evidence (RWE)

Real-world evidence provides significant insight into how a drug or drug class performs or is used in real-world medical settings.

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.

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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.

Secondary Care

Secondary care is healthcare provided in hospitals. It includes accident and emergency departments, outpatient departments, antenatal services, genitourinary medicine and sexual health clinics.

SMEs

Small and medium-sized enterprises.

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.

Systematic Literature Review (SLR)

See ‘Systematic Review‘.

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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 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‘.

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Ultra-Orphan

The term given to drugs that are used to treat extremely rare diseases that are chronically debilitating or life-threatening, with a prevalence of less than 1 in 50,000.

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