Below is an a-z list and brief definition of some technical terms that we use when describing our work. If you have read a word or phrase on the website that you do not know, check to see if it is on this list.

Find more clinical research terms in the glossary on the NIHR website.

If there are any other terms you would like us to include here, please email us at: nihr.newcastle.mic@newcastle.ac.uk

A

ABHI

The Association of British HealthTech industries (ABHI) represent the HealthTech industry to groups such as governments, healthcare systems and regulators.

Adoption phase

At this point the new test is commercially available and can be used in the population. Further research may be undertaken to examine the acceptance of the test by potential users of the technology.

AHSN

There are 15 Academic Health Science Networks (AHSNs) across England that were established by NHS England to spread innovation. Each AHSN works across a distinct geography to serve the population in the region.

AI

Artificial Intelligence (AI) is a type of computer science which focuses on the ability of a digital computer or computer-controlled robot to perform tasks commonly associated with intelligent beings such as visual perception, speech recognition and decision-making.

Analytical validity study

Analytical validity studies examine the test’s performance and its ability to accurately and reliably measure a biomarker of interest in a sample.

Applied research

Applied research aims to find solutions to an immediate and specific practical problem.

B

Basic research

Basic research aims to improve knowledge and understanding, rather than finding a solution to a specific practical problem.

Biomarker

Biomarkers (short for biological markers) are a broad range of measures which capture what is happening in the body. They are often examined to study a normal or abnormal process, a condition or disease.

BIVDA

The British In Vitro Diagnostic Association (BIVDA) represent is the manufacturers and distributors of In Vitro Diagnostics products in the UK to groups including politicians, policymakers and media.

C

Care pathway

A care pathway outlines the sequence of interactions a patient experiences as they move through a healthcare system with the symptoms of a particular medical condition.

Care pathway analysis

Uses methods such as examining surveys, interviews, focus group discussions, research papers and guideline documents. This helps to identify scenarios where a new diagnostic could improve patient care.

Chief investigator

The chief investigator (CI) is the person who takes overall responsibility for the design, conduct and reporting of a clinical study.

Clinical research

Clinical research aims to find out the causes of human illness and how it can be treated and prevented. It can involve research on patient samples and information from patient records, surveys and interviews.

Clinical utility study

Clinical utility studies measure the likelihood that a test will result in benefits to the patient and clinical practice. For example this could include changes to treatment and reduced time in hospital.

Clinical validity study

Clinical validity studies examine the test’s ability to identify individuals with a defined clinical condition within a given population. In most cases these studies will examine the diagnostic accuracy of the test.

Confidence interval

A measurement of the uncertainty around the main finding of a statistical analysis. Wider intervals indicate lower precision and narrow intervals indicate greater precision.

Cost effectiveness

Measures the cost implications of achieving health benefits in terms of ‘QALYs’ (Quality-Adjusted Life Years) which incorporate both extra life achieved and improvements in quality of life. This can help decision-makers assess whether the introduction of a new test should be recommended.

Cost effectiveness analysis

An economic analysis that views effects in terms of overall health specific to the problem, and describes the costs for some additional gain (e.g. cost per additional stroke prevented).

D

Data

Data is the information collected through research. It can include written information, numbers, sounds and pictures.

Data analysis

Data analysis involves examining research data. It involves identifying patterns and drawing out the main themes, and is often done with specialist computer software.

DHSC

The Department of Health and Social Care (DHSC) is the UK government department supporting ministers in leading the nation’s health and social care. DHSC funds the NIHR.

Diagnostic accuracy study

A diagnostic accuracy study examines how well a new test correctly identifies or rules out a medical condition. This done through benchmarking it against the current reference standard that is used in clinical practice. Through these studies we can measure the sensitivity, specificity, positive predictive value and negative predictive value of the new test.

Diagnostic test

A diagnostic test is a medical device that helps to determine whether a person has a medical condition or not.

Diffusion phase

The test is used widely and routinely in practice. For example, it may be described in policy documents.

Digital health

The use of information and communications technologies to manage illnesses and health risks.

DxNE

Diagnostics North East (DxNE) is a network of organisations based in North East England who support the development, evaluation and adoption of diagnostics for better patient outcomes.

E

Evaluation phase

This involves assessing whether an innovation such as a new test is achieving its aims. It can be evaluated as it goes along or right at the end. The results of evaluations can help with decision-making and planning.

Evaluation studies

The test is assessed in a controlled environment, such as a laboratory, to ensure that it produces reliable results. The invention will then be examined to see how it performs in practice and whether it adds any benefits.

Evidence synthesis

Evidence synthesis uses techniques to combine quantitative and qualitative data. From this we can gather the best evidence for use in healthcare.

F

False negative

A false negative is where the test makes a mistake and incorrectly categorises a person with the condition as not having the condition.

False positive

A false positive is where the test makes a mistake and incorrectly identifies a person without the condition as having the condition.

Feasibility studies

Feasibility studies are pieces of research done before a main study in order to answer the question “Can this study be done?”. They are used to estimate important parameters that are needed to design the main study.

G

Gold standard

The method, procedure, or measurement that is widely accepted as being the best available, against which new innovations should be compared.

H

Health economic analysis

Comparison of the costs and outcomes of alternative healthcare tests, treatments, medical technologies and services.

HealthTech

Health Technology (HealthTech) is an internationally recognised term that covers any method used by those working in health services to promote health, prevent and treat disease and improve long-term care.

I

i4i

The NIHR Invention for Innovation (i4i) Programme supports the development of medical devices in areas of existing or emerging patient need.

Implementation

Implementation involves putting research findings into practice. This means using research findings to make appropriate decisions and changes to health and social care policy and practice.

Index test

A new diagnostic test that is evaluated and benchmarked against a reference standard in a diagnostic accuracy study. Ideally the reference standard will be the gold standard.

Innovate UK

Innovate UK provides money and support to organisations to make new products and services. It is a non-departmental public body and is part of UK Research and Innovation (UKRI).

Invention phase

Basic research into new technologies and approaches. At this stage research needs to be undertaken to demonstrate how the invention could be used to address a health and social care challenge.

IVD

An In Vitro Diagnostic (IVD) is a diagnostic test performed outside of the body on a clinical sample taken from the patient (e.g., blood or urine).

L

Lay summary

A lay summary is a brief summary that has been written for non-experts or so called “lay” members of the public. It should be written in plain English, avoid the use of jargon and explain any technical terms.

M

Machine learning

An application of AI that enables systems to learn and improve from experience without being explicitly programmed.

Medical device

All products, except medicines, that are used in healthcare to diagnose, prevent, monitor or treat illness or disability. For example, a device might be a pacemaker, X-ray machine or blood pressure monitor.

MedTech

Medtech, short for “medical technology,” is an umbrella term that covers all technologies used for medical purposes. This includes digital technologies as well as medical devices.

Meta analysis

Combining data from multiple independent studies. This might be undertaken in evidence synthesis studies.

Methodologist

A researcher who applies methodology and its principles. They may use a quantitative research approach, a qualitative research approach or a blended “mixed methods” approach.

Methodology

The term methodology describes how research is done. It covers how information is collected and analysed as well as understanding which method, set of methods or best practices should be applied to the research question.

MHRA

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the competent authority for the UK. It is responsible for ensuring that medicines and medical devices work and are acceptably safe.

MIC

The 11 NIHR MedTech and In Vitro Diagnostic Co-operatives (MICs) build expertise and capacity in the NHS to develop new medical technologies and provide evidence on IVD tests.

MRC

Medical Research Council (MRC) is a non-departmental government body. It is the main UK Government source of funds for biomedical and early stage clinical research. It is part of UK Research and Innovation (UKRI).

Multicentre study

A study conducted at several geographical sites. Studies are sometimes conducted among several collaborating institutions, rather than at a single institution. Particularly when large numbers of participants are needed.

N

NHS

The National Health Service (NHS) is a government-funded medical and healthcare system that everyone living in the UK can use without being asked to pay the full cost of the service.

NICE

The National Institute for Health and Clinical Excellence (NICE) is an executive non-departmental public body of the Department of Health in England. It recommends which treatments should be provided by the NHS.

NIHR

The National Institute for Health and Care Research (NIHR) is a UK government agency which funds research into health and care including the MICs. It is funded by DHSC.

NPV

The negative predictive value (NPV) uses the prevalence of a condition to determine the likelihood that following a negative test result, that individual will truly not have that medical condition. When the prevalence of a condition is low the NPV increases because there will be more true negatives for every false negative.

P

PICO

The PICO framework is used by researchers to develop a research question:
P for Patient, problem or population we intend to study.
I for Intervention. The new index test result we plan to investigate.
C for Comparison. The control/reference standard result used to measure the index test performance.
O for Outcome we anticipate from the intervention/index test.
We produce a PICO document for new projects which are reviewed by our management team.

Pilot studies

Pilot studies are smaller versions of the main study. They examine whether the components of the main study can all work together. They may test whether recruitment and follow-up assessments all run smoothly.

PPI

Patient and Public Involvement (PPI). In research, PPI takes various forms, from involvement of public contributors in a priority setting, representation on committees, and as reviewers.

PPV

The positive predictive value (PPV) uses the prevalence of a condition to determine the likelihood that following a positive test result, that individual will truly have that medical condition. When the prevalence of a condition is low the PPV decreases because there will be more false positives for every true positive.

Prevalence

The number of people with a condition in the population that is being tested at a particular point in time.

Principal investigator

The principal investigator (PI) is the person at each study site who is responsible for the day to day running of the research project. When there is one site for the study the PI may also be the chief investigator (CI).

Protocol

The plan or set of steps to be followed in a study.

Q

Qualitative research

Uses methods like surveys, focus groups and interviews to explore and understand people’s beliefs, experiences, attitudes or behaviours. This research collects data such as interview transcripts, or notes from focus groups.

Quantitative research

Uses methods to collect data in the form of numbers. This could include measuring the accuracy of a diagnostic test in a particular patient population.

R

Reference standard

The reference standard is the test or combination of tests that is considered the best available method for categorising people in a diagnostic accuracy study as having or not having a medical condition. Ideally this is the gold standard.

S

Sample size

The number of participants analysed in a clinical study. The sample size should be adequate to detect a clinically important difference if one exists and produce accurate results without any scientific and ethical issues.

SBRI

The Small Business Research Initiative (SBRI) Healthcare is an NHS England & NHS Improvement funding programme supported by the AHSN and targeted at SMEs and early stage businesses.

Sensitivity

This is a measure of a test’s ability to correctly identify people who do have the medical condition (true positives). A test with sensitivity of 95% would mean that 5 in 100 people who have a condition would test negative (false negative). They have a condition, but the test says that they don’t.

SME

In the UK a company qualifies as an SME (small or medium-sized enterprise) if it meets two out of three criteria: it has fewer than 250 employees; it has a turnover of less than £25M, it has gross assets of less than £12.5M.

Specificity

This is a measure of a test’s ability to correctly identify people who do not have the disease (true negatives). A specificity of 95% means that 5 in 100 people who do not have a condition would test positive (false positive). They do not have a condition, but the test says that they do.

Statistical analysis

Statistical analysis uses a set of mathematical rules to analyse quantitative data. It assesses whether differences seen between two groups of people in a clinical study is likely to be a reliable finding or simply due to chance.

Systematic review

A review of a clearly formulated question that may use statistical methods to identify, select, and critically appraise relevant research. The review may also collect and analyse data from the studies that are included in the review.

T

Technology assessment review

A systematic assessment of an intervention (or group of interventions), usually undertaken for organisations such as NICE.

Translational research

Research aimed at translating or converting basic research into practical applications that directly benefit humans. Therefore translational research can be considered a type of applied research.

TRL

Technology readiness levels (TRLs) are a method for estimating the maturity of technologies. They were developed at the National Aeronautics and Space Administration (NASA) during the 1970s.

True negative

A true negative is a result where the test correctly identifies someone as not having a medical condition.

True positive

A true positive is a result where the test correctly identifies someone as having a medical condition.