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Clinical Trial

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A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. (ICH E6)

Glossary of clinical trial related terms

The difference in event rates between two groups (one subtracted from the other) in a comparative study.

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

Someone other than a health professional who is involved in caring for a person with a medical condition.

The extent to which an intervention produces an overall health benefit in routine clinical practice.

Clinical/test utility in its narrowest sense refers to the ability of a screening or diagnostic test to prevent or ameliorate adverse health outcomes such as mortality, morbidity, or disability through the adoption of efficacious treatments conditioned on test results. A screening or diagnostic test alone does not have inherent utility; because it is the adoption of therapeutic or preventive interventions that influences health outcomes, the clinical utility of a test depends on effective access to appropriate interventions

(also known as follow-up, incidence, longitudinal, or prospective study): An observational study in which a defined group of people (the cohort) is followed over time. Outcomes are compared in subsets of the cohort who were exposed or not exposed (or exposed at different levels) to an intervention or other factor of interest.

Two or more diseases or conditions occurring at the same time, such as depression and anxiety.

The range within which the ‘true’ values (for example, size of effect of an intervention) are expected to lie with a given degree of certainty (for example, 95% or 99%). (Note: confidence intervals represent the probability of random errors, but not systematic errors or bias).

Concurrent validity is demonstrated where a test correlates well with a measure that has previously been validated. The two measures may be for the same construct, or for different, but presumably related, constructs.

Techniques that aim to reach an agreement on a particular issue. Formal consensus methods include Delphi and nominal group techniques, and consensus development conferences. In the development of clinical guidelines, consensus methods may be used where there is a lack of strong research evidence on a particular topic. Expert consensus methods will aim to reach agreement between experts in a particular field.

An economic evaluation that compares alternative options for a specific patient group looking at a single effectiveness dimension measured in a non-monetary (natural) unit. It expresses the result in the form of an incremental cost-effectiveness ratio.

Criterion or concrete validity is the extent to which the measures are demonstrably related to concrete criteria in the ‘real’ world. This type of validity is often divided into ‘concurrent’ and ‘predictive’ subtypes. The term ‘concurrent validity’ is reserved for demonstrations relating a measure to other concrete criteria assessed simultaneously. ‘Predictive validity’ refers to the degree to which any measure can predict future concrete events. These variables are often represented as ‘intermediate’ and ‘ultimate’ criteria.

Critical care is now used as a term that encompasses intensive care or intensive therapy; units providing such care are referred to as intensive care (ICU) or intensive therapy (ITU) units respectively and synonymously, and what used to be called high dependency care provided in HDUs.

Cronbach’s alpha will generally increase when the correlations between the items in a test increase. For this reason the coefficient is also called the internal consistency or the internal consistency reliability of the test.

DSM-IV is published by the American Psychiatric Association and provides diagnostic criteria for mental disorders. It is used in the United States, United Kingdom and in varying degrees around the world, by clinicians, researchers, psychiatric drug regulation agencies, health insurance companies, pharmaceutical companies and policy makers.

DSM-IV is published by the American Psychiatric Association and provides diagnostic criteria for mental disorders. It is used in the United States, United Kingdom and in varying degrees around the world, by clinicians, researchers, psychiatric drug regulation agencies, health insurance companies, pharmaceutical companies and policy makers.

Technique developed to assess both costs and consequences of alternative health strategies and to provide a decision-making framework.

A group of healthcare professionals, patients, carers and members of the Short Clinical Guidelines Technical Team who develop the recommendations for a clinical guideline. The group writes draft guidance, and then revises it after a consultation with organisations registered as stakeholders.

The degree to which the results of a study or systematic review can be extrapolated to other circumstances, particularly routine healthcare situations in the NHS in England and Wales.

A term used to illustrate the variability or differences between studies in the estimates of effects.

Used to assess the consistency of results across items within a test.

Used to assess the degree to which different raters/observers give consistent estimates of the same phenomenon.

Kappa coefficient is a statistical measure of inter-rater reliability. It is generally thought to be a more robust measure than simple percent agreement calculation because kappa takes into account the agreement occurring by chance.

The proportion of patients with negative test results who are correctly diagnosed.

Phenomenology is one of many types of qualitative research that examines the lived experiences of humans. Phenomenological researchers hope to gain understanding of the essential ‘truths’ (that is, essences) of a phenomenon as experienced by people.

Includes muscle loss, muscle weakness, joint pain, loss of bone, sensory problems, swallowing and communication problems.

Include anxiety, depression, post-traumatic stress disorder, post-traumatic stress symptoms and cognitive dysfunction.

The proportion of people with a positive test result who actually have the disease.

A purposive sample is one which is selected by the researcher subjectively. The researcher attempts to obtain a sample that appears to him/her to be representative of the population and will usually try to ensure that a range from one extreme to the other is included.

Research concerned with subjective outcomes relating to social, emotional and experiential phenomena in health and social care.

The QALY is a single measure of health related quality of life that takes into account both the quantity and quality of life provided by the intervention.

A comparative study in which participants are randomly allocated to intervention and control groups and followed up to examine differences in outcomes between the group.

Also known as risk ratio; the ratio of risk in the intervention group to the risk in the control group. The risk (proportion, probability or rate) is the ratio of people with an event in a group to the total in the group. A relative risk (RR) of 1 indicates no difference between comparison groups. For undesirable outcomes, an RR that is less than 1 indicates that the intervention was effective in reducing the risk of that outcome.

A receiver operating characteristic (ROC), or simply ROC curve, is a graphical plot of the sensitivity versus (100% – specificity) for a binary classifier system as its discrimination threshold is varied. ROC analysis provides tools to select possibly optimal models and to discard suboptimal ones independently from (and before specifying) the cost context or the class distribution. ROC analysis is related in a direct and natural way to cost/benefit analysis of diagnostic decision making.

The proportion of people classified as positive by the gold standard who are correctly identified by the study test.

The proportion of people classified as negative by the gold standard who are correctly identified by the study test.

Research that summarises the evidence on a clearly formulated question according to a pre-defined protocol using systematic and explicit methods to identify, select and appraise relevant studies, and to extract, collate and report their findings. It may or may not use statistical meta-analysis.

Tracheotomy and tracheostomy are surgical procedures on the neck to open a direct airway through an incision in the trachea (the windpipe). 3.1.2 Abbreviations

Confidence interval

Grading of Recommendations Assessment, Development and Evaluation

Intensive care unit

Negative predictive value

Not significant

Odds ratio

Positive predictive value

Quality-adjusted life year

Quality Assessment of Studies of Diagnostic Accuracy included in Systematic Reviews

Randomised controlled trial

Relative risk

Standard deviation


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