Interventional procedures programme manual

22 Glossary

Abstract (of a published study)
A summary (introduction) of a published study. Abstracts of published studies can usually be retrieved through literature search engines.

Abstract (conference)
A summary of an as‑yet unpublished study presented at a scientific conference. Although such abstracts may be retrievable through literature search engines, they are not peer reviewed and the study is not always subsequently published in full. If it is published in full, the content may differ from the original conference abstract.

Adverse event
An undesirable outcome experienced by a person while they are taking (a) drug(s), or having any other treatment or intervention, regardless of whether or not the event is suspected to be related to or caused by the drug, treatment or intervention.

Audit
The evaluation of clinical performance against standards or through comparative analysis, aimed at informing service management.

Bias
Systematic (as opposed to random) deviation of the results of a study from the 'true' results caused by the way the study is designed or conducted.

Case report
An uncontrolled observational study involving an intervention and outcome in a single patient.

Case series
Reports of several patients with a given condition, usually covering the course of the condition and the response to treatment. There is no comparison (control) group of patients.

CE Mark
A CE Mark indicates that the manufacturer of a medical device complies with the relevant European Union Directive on safety, quality and performance.

Cochrane Library
A regularly updated electronic collection of evidence‑based medicine databases, including the Cochrane Database of Systematic Reviews.

Commentary
Commentary obtained by the public involvement team that refers to patient opinion about an interventional procedure.

Comparator
An alternative treatment against which the intervention under appraisal is compared. The comparator could be standard treatment (including, on occasions, expectant management or no intervention) or a sham procedure.

Confidence interval
The confidence interval is a way of expressing how certain we are about the findings from a study, using statistics. It gives a range of results that is likely to include the 'true' value for the population. A wide confidence interval indicates a lack of certainty about the true effect of the test or treatment – often because a small group of patients has been studied. A narrow confidence interval indicates a more precise estimate (for example, if a large number of patients have been studied).

Consultee
An individual who, or organisation that, submits a response to an interventional procedure consultation document.

Control
An explicitly defined comparator against which the effects of an intervention are compared in a clinical study.

Critical appraisal
The process of assessing and interpreting evidence by systematically considering its validity, results and relevance.

Developer
A team set up by NICE to develop NICE guidelines for a particular area. It may be a team within NICE, or in an organisation contracted by NICE to develop guidelines. The team includes administrators, coordinators and project managers who provide administrative and management support to the Committee, plan and schedule the work, arrange meetings, and liaise with stakeholders and all other people and organisations contributing to guideline development.

Diagnostics assessment programme
The diagnostics assessment programme focuses on the evaluation of innovative medical diagnostic technologies to make sure that the NHS is able to adopt clinically- and cost‑effective technologies rapidly and consistently.

Device
A piece of equipment used for diagnostic or therapeutic purposes, sometimes along with (a) pharmaceutical agent(s).

Effectiveness (clinical)
An effective procedure is one that, compared with other interventions, produces benefits that patients value in routine use. To be considered effective, the procedure must have been assessed in more standard clinical settings than is the case for efficacy.

Efficacy
An efficacious procedure is one that produces a desirable outcome in research conditions.

EMBASE
Excerpta Medica database. A European database of medical and health research.

EmTree
The controlled vocabulary used for EMBASE and other similar databases.

Evidence
Information on which a decision or guidance is based, from a range of sources and methodologies, but mostly from peer‑reviewed publications.

Evidence summary table (in overview)
A summary in a tabular format of the design, methods, results and brief critical appraisal of the studies judged to be most valid and relevant in relation to the interventional procedure of interest.

External Assessment Centres
NICE commissions 4 External Assessment Centres to help develop its guidance. They help the interventional procedures programme develop systematic reviews when they are needed.

Follow-up
Observation of patients taking part in a clinical study over a period of time to measure outcomes under investigation.

Generalisability
The extent to which the results of a study relating to a particular patient population or context hold true for other patient populations or different contexts.

Guideline Committee
A group of healthcare professionals, patients, carers and technical staff who develop the recommendations for a NICE guideline. The developer responsible for the guideline recruits a Guideline Committee to work on it. They also oversee the evidence review team, who review the evidence and support the Guideline Committee. The Committee writes draft guidance, and then revises it after a consultation with organisations registered as stakeholders.

Guidance Executive
The Executive and Centre Directors of NICE, delegated by the NICE Board to issue guidance on its behalf.

Healthcare Improvement Scotland
Healthcare Improvement Scotland is the body responsible for improving the quality of healthcare in Scotland by setting standards, monitoring performance and providing advice, guidance and support to NHS Scotland on effective clinical practice and service improvements.

Health technology assessment
Independent research about the effectiveness, costs and broader impact of healthcare (treatments and tests) for people who plan, provide or have care in the NHS. The Health Technology Assessment (HTA) programme is part of the National Institute for Health Research (NIHR).

Indication
A condition or disease that may make a patient eligible for a particular treatment or procedure.

Inclusion criteria (literature review)
Explicit criteria used to decide which studies should be considered as potential sources of evidence.

'In confidence' material

Information (for example, the findings of a research project) defined as 'confidential' because its public disclosure could affect the commercial interests of a particular company ('commercial in confidence') or the academic interests of a research or professional organisation ('academic in confidence').

Information for the public
A document issued by NICE for patients and carers that summarises the recommendations in NICE guidance in everyday language.

Interventional procedure
A procedure used for diagnosis or treatment that involves incision, puncture or entry into a body cavity, or the use of ionising, electromagnetic or acoustic energy.

Interventional Procedures Advisory Committee (IPAC)
The Committee is responsible for advising NICE on the safety and efficacy of interventional procedures.

Interventional procedures guidance
Guidance on the use of an interventional procedure based on current evidence of its safety and efficacy, issued by NICE after consultation has ended and the Committee has met to discuss comments received at consultation.

Learning curve
The process by and time during which an individual surgeon or surgical team achieves proficiency in a particular surgical procedure. It relates mostly to complex and difficult procedures that need subspecialty expertise and skills.

List of notified procedures
The list of interventional procedures notified to NICE, posted on NICE's website.

Medicines and Healthcare products Regulatory Agency (MHRA)
The MHRA is the national competent authority responsible for regulating medical devices on the UK market. It has a statutory responsibility to investigate incidents involving medical devices and powers to prosecute manufacturers when it can be shown that there has been a serious breach of the Medical Devices Regulations. Because some new interventional procedures involve devices, the work of the MHRA and NICE may occasionally overlap. The MHRA's senior officer responsible for medical aspects of device regulation is a member of the Committee and the 2 organisations are in regular contact.

Medical technologies evaluation programme
The medical technologies evaluation programme aims to promote the timely and consistent adoption or new or novel medical technologies that have the potential to offer benefits to patients or the NHS. It does this by identifying technologies, producing NICE advice or guidance, and helping generate evidence.

Medline
An online, open‑access, searchable electronic database produced by the United States National Library of Medicine (NLM).

MeSH
Medical subject headings; the controlled vocabulary used for indexing content in Medline and certain other databases.

Meta-analysis
A statistical technique for combining (pooling) the results of more than 1 study addressing the same question and reporting on the same outcomes to produce a summary result. The aim is to derive more accurate and clear information from a large data pool. Meta‑analysis is generally more likely than the individual trials to reliably confirm or refute a hypothesis.

NIHR Horizon Scanning Research & Intelligence Centre
The NIHR Horizon Scanning Research & Intelligence Centre aims to provide advance notice of new and emerging technologies that might need urgent evaluation, consideration of clinical and cost effectiveness, or modification of clinical guidance.

NICE Pathways
NICE Pathways are interactive topic‑based diagrams that aim to provide users with a way to quickly navigate all NICE guidance recommendations on a particular topic.

Non-randomised controlled study
Any study of an intervention compared with another intervention (whether looking at harm or benefit) that does not use randomisation to allocate patients to comparison groups.

Operator
The individual clinician who does a procedure – s/he may be a surgeon, interventional radiologist, radiotherapist, interventional physician, etc.

Outcome (clinical)
The clinical effect that results from exposure to a healthcare intervention.

Overview
A document produced by NICE to inform the Committee about an interventional procedure. It contains information on the indications for the procedure, a description of the procedure, a summary of key points from a rapid review of the literature, and a summary of commentary by the specialist advisers.

p value
The p value is a statistical measure that is used to indicate whether or not an effect is statistically significant.

Patient commentary

The written information patient commentators provide about their personal experience of a procedure.

Patient commentator

Patient commentators are individuals who have either had a procedure or are the carer of someone who has. Patient commentators complete a questionnaire to provide information to the Committee about their personal experience of a procedure.

Patient group, patient organisation
Terms used to cover patient, carer, community and other lay organisations, including those that represent people from groups protected by equalities legislation.

Patient-focused outcome
Any health outcome that is directly meaningful to the patient (for example, survival, mortality, morbidity, quality of life). Such outcomes should be distinguished from surrogate outcomes.

PICO (population, intervention, comparator, outcome)
A structured approach for developing review questions about interventions. The PICO framework divides each question into 4 components: the population, the intervention(s), the comparator(s) and the outcome(s).

Placebo (sham procedure)
An inactive substance or interventional procedure that the effects of an active drug or interventional procedure is compared against in a study.

Public involvement programme
The public involvement programme advises NICE on patient and carer involvement, and identifies patient and carer organisations interested in contributing to its work programme. It promotes effective patient and carer input by providing training and support to patient organisations and individual patients, carers and lay members who contribute to NICE's work.

Randomised controlled trial (RCT)
A comparative study in which patients are allocated randomly to intervention and control groups, and are followed up to examine differences in outcomes between the groups.

Rapid review
A review of the literature that is systematic but not exhaustive (for example, not including direct contact with study authors, or manual searches of journals).

Register
A type of database for observations and related information about a group of patients, a disease or an intervention for the purpose of analysis.

Risk
The proportion of participants experiencing the adverse event of interest.

Search strategy
The combination of terms used to identify studies in an electronic database such as Medline.

Serious adverse event
An adverse event resulting in death, hospitalisation, prolongation of a hospital stay or long‑term loss of function.

Specialist adviser
A person nominated by a relevant professional organisation to advise the interventional procedures programme about notified procedures.

Stakeholder
An individual or organisation with an interest in the interventional procedures programme's activities and outputs.

Surrogate outcome
An outcome measure that is not of direct clinical importance but may be associated with patient‑focused clinical outcomes, such as 1 based on imaging findings or measurement of a biochemical marker. It should be distinguished from a patient‑focused outcome.

Systematic review
A review that summarises the evidence on a clearly formulated review question according to a predefined protocol, using systematic and explicit methods to identify, select and appraise relevant studies, and to extract, analyse, collate and report their findings. It may or may not use statistical meta‑analysis.

Technology appraisal programme
The technology appraisal programme at NICE makes recommendations on the clinical and cost effectiveness of new and existing medicines and treatments within the NHS in England, such as medicines, medical devices, diagnostic techniques, surgical procedures and health promotion activities.

Technical team
Members of the interventional procedures programme team with responsibility for the technical aspects of the assessment process, including scoping of the topic, selecting and analysing the evidence that forms the basis of the overview and advising on technical aspects in the consultation documents.

Validity
Whether a test or study actually measures what it aims to measure. Internal validity shows whether study or test is appropriate for the question, for example, whether a study of exercise among gym members measures the amount of exercise people do at the gym not simply whether people join. External validity shows whether findings can be generalised to other settings or populations.