- Acute trust
A trust is an NHS organisation responsible for providing a group of healthcare services. An acute trust provides hospital services (but not mental health hospital services which are provided by a mental health trust).
- Afferent nerve
Nerve carrying sensory nerve impulses from a peripheral receptor towards the central nervous system.
- Anterior colporrhaphy
Vaginal operation for the treatment of cystocele (anterior vaginal wall prolapse). Involves plication of the fascia between vaginal and bladder walls. With the addition of plication of the fascia beneath the urethra, it has commonly been used for treatment of stress incontinence. Can be used as an additional procedure for prolapse repair along with a continence procedure.
- Antimuscarinic drugs
Class of pharmacological agents acting on neuromuscular junctions in the autonomic nervous system, used for overactive bladder syndrome.
- Applicability
The extent to which the results of a study or review can be applied to the target population for a clinical guideline.
- Appraisal of evidence
Formal assessment of the quality of research evidence and its relevance to the clinical question or guideline under consideration, according to predetermined criteria.
- Best available evidence
The strongest research evidence available to support a particular guideline recommendation.
- Bias
Influences on a study that can lead to invalid conclusions about a treatment or intervention. Bias in research can make a treatment look better or worse than it really is. Bias can even make it look as if the treatment works when it actually does not. Bias can occur by chance or as a result of systematic errors in the design and execution of a study. Bias can occur at various stages in the research process, for example in the collection, analysis, interpretation, publication or review of research data. For examples, see selection bias, performance bias, information bias, confounder or confounding factor, publication bias.
- Bimanual examination
Vaginal examination carried out using the examiner's fingers of one hand in the vagina and of the other hand on the abdomen. Allows the description of observed and palpable anatomical abnormalities and the assessment of pelvic floor muscle function.
- Biofeedback
The technique by which information about a normally unconscious physiological process is presented to the patient and/or the therapist as a visual, auditory or tactile signal.
- Bladder diary
A diary that records voiding times and voided volumes, leakage episodes, pad usage and other information such as fluid intake, degree of urgency, and degree of incontinence. See also frequency–volume chart.
- Bladder pain
Pain felt suprapubically or retropubically. Usually increases with bladder filling and may persist after voiding.
- Bladder training
Bladder training (also described as bladder retraining, bladder drill, bladder re-education, bladder discipline) actively involves the individual in attempting to increase the interval between the desire to void and the actual void.
- Blinding or masking
The practice of keeping the investigators or subjects of a study ignorant of the group to which a subject has been assigned. For example, a clinical trial in which the participating patients or their doctors are unaware of whether they (the patients) are taking the experimental drug or a placebo (dummy treatment). The purpose of ‘blinding’ or ‘masking’ is to protect against bias. See also double-blind (DB) study, single-blind study.
- Body mass index (BMI)
A person's weight in kilogrammes divided by the square of their height in metres. Overweight is defined as a BMI of 25 or more, and obese as 30 or more.
- Case–control study
A study that starts with the identification of a group of individuals sharing the same characteristics (for example people with a particular disease) and a suitable comparison (control) group (such as people without the disease). All subjects are then assessed with respect to things that happened to them in the past, for example things that might be related to getting the disease under investigation. Such studies are also called retrospective as they look back in time from the outcome to the possible causes.
- Case report (or case study)
Detailed report on one patient (or case), usually covering the course of that person's disease and their response to treatment.
- Case series
Description of several cases of a given disease, usually covering the course of the disease and the response to treatment. There is no comparison (control) group of patients.
- Causal relationship
Describes the relationship between two variables whenever it can be established that one causes the other. For example, there is a causal relationship between a treatment and a disease if it can be shown that the treatment changes the course or outcome of the disease. Usually randomised controlled trials are needed to ascertain causality. Proving cause and effect is much more difficult than just showing an association between two variables. For example, if it happened that everyone who had eaten a particular food became sick and everyone who avoided that food remained well, then the food would clearly be associated with the sickness. However, even if leftovers were found to be contaminated, it could not be proved that the food caused the sickness – unless all other possible causes (such as environmental factors) had been ruled out.
- Clinical audit
A systematic process for setting and monitoring standards of clinical care. Whereas ‘guidelines’ define what the best clinical practice should be, ‘audit’ investigates whether best practice is being carried out. Clinical audit can be described as a cycle or spiral. Within the cycle there are stages that follow a systematic process of establishing best practice, measuring care against specific criteria, taking action to improve care, and monitoring to sustain improvement. The spiral suggests that as the process continues, each cycle aspires to a higher level of quality.
- Clinical effectiveness
The extent to which a specific treatment or intervention, when used under usual or everyday conditions, has a beneficial effect on the course or outcome of disease compared with no treatment or other routine care. (Clinical trials that assess effectiveness are sometimes called management trials.) Clinical ‘effectiveness’ is not the same as efficacy.
- Clinical governance
A framework through which NHS organisations are accountable for both continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.
- Clinical impact
The effect that a guideline recommendation is likely to have on the treatment, or treatment outcomes, of the target population.
- Clinical importance
The importance of a particular guideline recommendation to the clinical management of the target population.
- Clinical question
This term is sometimes used in guideline development work to refer to the questions about treatment and care that are formulated in order to guide the search for research evidence. When a clinical question is formulated in a precise way, it is called a focused question.
- Clinical trial
A research study conducted with patients which tests out a drug or other intervention to assess its effectiveness and safety. Each trial is designed to answer scientific questions and to find better ways to treat individuals with a specific disease. This general term encompasses controlled clinical trials and randomised controlled trials.
- Clinician
A healthcare professional providing patient care, e.g. doctor, nurse, or physiotherapist.
- Cluster
A group of patients, rather than an individual, used as the basic unit for investigation. See also cluster design and cluster randomisation.
- Cluster design
Cluster designs are those where research subjects are not sampled or selected independently, but in a group. For example a clinical trial where patients in a general practice are allocated to the same intervention; the general practice forming a cluster. See also cluster and cluster randomisation.
- Cluster randomisation
A study in which groups of individuals (such as patients in a GP surgery or on a hospital ward) are randomly allocated to treatment groups. For example, in a smoking cessation study of two different interventions – leaflets and teaching sessions – each GP surgery within the study would be randomly allocated to administer one of the two interventions. See also cluster and cluster design.
- Cochrane Collaboration
An international organisation in which people find, appraise and review specific types of studies called randomised controlled trials. The Cochrane Database of Systematic Reviews contains regularly updated reviews on a variety of health issues and is available electronically as part of the Cochrane Library.
- Cochrane Library
The Cochrane Library consists of a regularly updated collection of evidence-based medicine databases including the Cochrane Database of Systematic Reviews (reviews of randomised controlled trials prepared by the Cochrane Collaboration). The Cochrane Library is available on CD-ROM and the internet.
- Cohort
A group of people sharing some common characteristic (for example patients with the same disease), followed up in a research study for a specified period of time.
- Cohort study
An observational study that takes a group (cohort) of patients and follows their progress over time in order to measure outcomes such as disease or mortality rates and make comparisons according to the treatments or interventions that patients received. Thus, within the study group, subgroups of patients are identified (from information collected about patients) and these groups are compared with respect to outcome, such as comparing mortality between one group that received a specific treatment and one group that did not (or between two groups that received different levels of treatment). Cohorts can be assembled in the present and followed into the future (a ‘concurrent’ or ‘prospective’ cohort study) or identified from past records and followed forward from that time up to the present (a ‘historical’ or ‘retrospective’ cohort study). Because patients are not randomly allocated to subgroups, these subgroups may be quite different in their characteristics and some adjustment must be made when analysing the results to ensure that the ,comparison between groups is as fair as possible.
- Co-morbidity
Co-existence of a disease or diseases in the people being studied in addition to the health problem that is the subject of the study.
- Confidence interval (CI)
A way of expressing certainty about the findings from a study or group of studies, using statistical techniques. A confidence interval describes a range of possible effects (of a treatment or intervention) that are consistent with the results of a study or group of studies. A wide confidence interval indicates a lack of certainty or precision about the true size of the clinical effect and is seen in studies with too few patients. Where confidence intervals are narrow they indicate more precise estimates of effects and a larger sample of patients studied. It is usual to interpret a ‘95%’ confidence interval as the range of effects within which we are 95% confident that the true effect lies.
- Confounder or confounding factor
Something that influences a study and can contribute to misleading findings if it is not understood or appropriately dealt with. For example, if a group of people exercising regularly and a group of people who do not exercise have an important age difference, then any difference found in outcomes about heart disease could be due to one group being older than the other rather than due to the exercising. Age is the confounding factor here and the effect of exercising on heart disease cannot be assessed without adjusting for age differences in some way.
- Consensus methods
A variety of techniques that aim to reach an agreement on a particular issue. Formal consensus methods include Delphi and nominal group techniques. In the development of clinical guidelines, consensus methods may be used where there is a lack of strong research evidence on a particular topic.
- Consensus statement
A statement of the advised course of action in relation to a particular clinical topic, based on the collective views of a body of experts.
- Considered judgement
The application of the collective knowledge of a guideline development group to a body of evidence, to assess its applicability to the target population and the strength of any recommendation that it would support.
- Consistency
The extent to which the conclusions of a collection of studies used to support a guideline recommendation are in agreement with each other. See also homogeneity.
- Conservative management
Treatment or management strategies that do not involve surgery.
- Control group
A group of patients recruited into a study that receives no treatment, a treatment of known effect, or a placebo (dummy or sham treatment), in order to provide a comparison for a group receiving an experimental treatment, such as a new drug.
- Controlled clinical trial
A study testing a specific drug or other treatment involving two (or more) groups of patients with the same disease. One (the experimental group) receives the treatment that is being tested, and the other (the comparison or control group) receives an alternative treatment, a placebo (dummy treatment) or no treatment. The two groups are followed up to compare differences in outcomes to see how effective the experimental treatment was. A controlled clinical trial where patients are randomly allocated to treatment and comparison groups is called a randomised controlled trial.
- Correlation coefficient
A measure of the degree of linear association between two variables. A significant association does not imply causation.
- Cost–benefit analysis
A type of economic evaluation where both costs and benefits of healthcare treatment are measured in the same monetary units. If benefits exceed costs, the evaluation would recommend providing the treatment.
- Cost–consequence analysis
A limited form of economic evaluation that considers costs alongside consequences (or outcomes) without calculating an incremental cost effectiveness ratio.
- Cost effectiveness
Value for money. A specific healthcare treatment is said to be ‘cost effective’ if it gives a greater health gain than could be achieved by using the resources in other ways.
- Cost effectiveness analysis
A type of economic evaluation comparing the costs and the effects on health of different treatments. Health effects are measured in ‘health related units’, for example the cost of preventing one additional heart attack.
- Cost–utility analysis
A special form of cost effectiveness analysis where health effects are measured in quality adjusted life years. A treatment is assessed in terms of its ability to both extend life and to improve the quality of life.
- Crossover study design
A study comparing two or more interventions in which the participants, upon completion of the course of one treatment, are switched to another. For example, for a comparison of treatments A and B, half the participants are randomly allocated to receive them in the order A, B and half to receive them in the order B, A. A problem with this study design is that the effects of the first treatment may carry over into the period when the second is given. Therefore a crossover study should include an adequate ‘wash-out’ period, which means allowing sufficient time between stopping one treatment and starting another so that the first treatment has time to ‘wash out’ of the patient's system.
- Cross-sectional study
The observation of a defined set of people at a single point in time or time period – a snapshot. (This type of study contrasts with a longitudinal study, which follows a set of people over a period of time.)
- Cystocele
Herniation (protrusion) of the bladder through the wall of the vagina.
- Cystometric (bladder) capacity
Bladder volume at the end of the filling phase of cystometry.
- Cystometry
Cystometry is the measurement of intravesical pressure that can be carried out through a single recording channel (simple cystometry) or, more commonly, by multichannel cystometry, which involves the synchronous measurement of both bladder and intra-abdominal pressures by means of catheters inserted into the bladder and the rectum or vagina. The aim is to replicate the patient's symptoms by filling the bladder and observing pressure changes or leakage caused by provocation tests. See also urodynamics.
- Data set
A list of required information relating to a specific disease.
- Decision analysis
Decision analysis is the study of how people make decisions or how they should make decisions. There are several methods that decision analysts use to help people to make better decisions, including decision trees.
- Decision tree
A decision tree is a method for helping people to make better decisions in situations of uncertainty. It illustrates the decision as a succession of possible actions and outcomes. It consists of the probabilities, costs and health consequences associated with each option. The overall effectiveness or overall cost effectiveness of various actions can then be compared.
- Declaration of interest
A process by which members of a working group or committee ‘declare’ any personal or professional involvement with a company (or related to a technology) that might affect their objectivity, for example if their position or department is funded by a pharmaceutical company.
- Delphi method
A technique used for the purpose of reaching an agreement on a particular issue, without the participants meeting or interacting directly. It involves sending participants a series of postal questionnaires asking them to record their views. After the first questionnaire, participants are asked to give further views in the light of the group feedback. The judgements of the participants are statistically aggregated, sometimes after weighting for expertise. See also consensus methods.
- De novo
New onset.
- Detrusor overactivity (DO)
An urodynamic observation characterised by involuntary detrusor contractions during the filling phase of cystometry that may be spontaneous or provoked. See also urodynamics.
- Diagnostic study
A study to assess the effectiveness of a test or measurement in terms of its ability to accurately detect or exclude a specific disease.
- Dominance
A term used in health economics describing when an option for treatment is both less clinically effective and more costly than an alternative option. The less effective and more costly option is said to be ‘dominated’.
- Double-blind (DB) study
A study in which neither the subject (patient) nor the observer (investigator/clinician) is aware of which treatment or intervention the subject is receiving. The purpose of blinding is to protect against bias.
- Economic evaluation
A comparison of alternative courses of action in terms of both their costs and consequences. In health economic evaluations the consequences should include health outcomes.
- Effectiveness
See clinical effectiveness.
- Efferent nerve
Nerve carrying motor impulses from the central nervous system to a peripheral effector.
- Efficacy
The extent to which a specific treatment or intervention, under ideally controlled conditions (for example in a laboratory), has a beneficial effect on the course or outcome of disease compared with no treatment or other routine care.
- Elective
Name for clinical procedures that are regarded as advantageous to the patient but not urgent.
- Electrical stimulation
The application of electrical current to stimulate the pelvic viscera or their nerve supply.
- Electromyography (EMG)
Recording of neuromuscular function from an electrode within or in proximity to a muscle. Feedback tool for pelvic floor muscle recruitment.
- Empirical
Based directly on experience (observation or experiment) rather than on reasoning alone.
- Epidemiology
Study of diseases within a population, covering the causes and means of prevention.
- Evidence based
The process of systematically finding, appraising and using research findings as the basis for clinical decisions.
- Evidence-based clinical practice
Evidence-based clinical practice involves making decisions about the care of individual patients based on the best research evidence available rather than basing decisions on personal opinions or common practice (which may not always be evidence based). Evidence-based clinical practice therefore involves integrating individual clinical expertise and patient preferences with the best available evidence from research.
- Evidence table
A table summarising the results of a collection of studies that, taken together, represent the evidence supporting a particular recommendation or series of recommendations in a guideline.
- Exclusion criteria
See selection criteria.
- Experimental study
A research study designed to test whether a treatment or intervention has an effect on the course or outcome of a condition or disease – where the conditions of testing are to some extent under the control of the investigator. Controlled clinical trials and randomised controlled trials are examples of experimental studies.
- Experimental treatment
A treatment or intervention (such as a new drug) being studied to see whether it has an effect on the course or outcome of a condition or disease.
- External validity
The degree to which the results of a study hold true in non-study situations, for example in routine clinical practice. May also be referred to as the generalisability of study results to non-study patients or populations.
- Extrapolation
The application of research evidence based on studies of a specific population to another population with similar characteristics.
- Focused question
A study question that clearly identifies all aspects of the topic that are to be considered while seeking an answer. Questions are normally expected to identify the patients or population involved, the treatment or intervention to be investigated, what outcomes are to be considered, and any comparisons that are to be made. For example, do insulin pumps (intervention) improve blood sugar control (outcome) in adolescents with type 1 diabetes (population) compared with multiple insulin injections (comparison)? See also clinical question.
- Frail older women
Women with with multiple comorbidities, functional impairments such as walking or dressing difficulties and any degree of cognitive impairment.
- Frequency
Increased daytime frequency is the complaint by the patient that he/she voids too often by day. See also nocturia.
- Frequency–volume chart (FVC)
A chart that records voided volumes and times of voiding (day and night) for at least 24 hours. See also bladder diary.
- Generalisability
The extent to which the results of a study hold true for a population of patients beyond those who participated in the research. See also external validity.
- Gold standard
A method, procedure or measurement that is widely accepted as being the best available. Also called a reference standard.
- Good practice point (GPP)
Recommended good practice based on the expert experience of the guideline development group (and possibly incorporating the expertise of a wider reference group). A guideline development group may produce a ‘good practice point’ (rather than an evidence-based recommendation) on an important topic when there is a lack of research evidence.
- Grade of recommendation
A code (for example A, B, C) linked to a guideline recommendation, indicating the strength of the evidence supporting that recommendation.
- Grey literature
Reports that are unpublished or have limited distribution, and are not included in bibliographic retrieval systems.
- Guideline
A systematically developed tool that describes aspects of a patient's condition and the care to be given. A good guideline makes recommendations about treatment and care, based on the best research available, rather than opinion. It is used to assist clinician and patient decision making about appropriate health care for specific clinical conditions.
- Guideline recommendation
Course of action advised by the guideline development group on the basis of their assessment of the supporting evidence.
- Haematuria
The presence of blood in the urine. Macroscopic haematuria is visible to the naked eye, while microscopic haematuria is only visible with the aid of a microscope.
- Health economics
A branch of economics that studies decisions about the use and distribution of healthcare resources.
- Health technology
Health technologies include medicines, medical devices such as artificial hip joints, diagnostic techniques, surgical procedures, health promotion activities (such as the role of diet versus medicines in disease management) and other therapeutic interventions.
- Health technology appraisal
A health technology appraisal, as undertaken by NICE, is the process of determining the clinical and cost effectiveness of a health technology. NICE health technology appraisals are designed to provide patients, health professionals and managers with an authoritative source of advice on new and existing health technologies.
- Heterogeneity
A lack of homogeneity. The term is used in meta-analyses and systematic reviews when the results or estimates of effects of treatment from separate studies seem to be very different – in terms of the size of treatment effects or even to the extent that some indicate beneficial and others suggest adverse treatment effects. Such results may occur as a result of differences between studies in terms of the patient populations, outcome measures, definition of variables or duration of follow-up.
- Hierarchy of evidence
An established hierarchy of study types, based on the degree of certainty that can be attributed to the conclusions that can be drawn from a well conducted study. Well-conducted randomised controlled trials (RCTs) are at the top of this hierarchy. (Several large statistically significant RCTs that are in agreement represent stronger evidence than one small RCT.) Well-conducted studies of patients' views and experiences would appear at a lower level in the hierarchy of evidence.
- Homogeneity
This means that the results of studies included in a systematic review or meta-analysis are similar and there is no evidence of heterogeneity. Results are usually regarded as homogeneous when differences between studies could reasonably be expected to occur by chance. See also consistency.
- Idiopathic
Having no defined cause.
- Incidence
The probability of developing the disease or condition under study during a defined time period, usually 1 year.
- Inclusion criteria
See selection criteria.
- Information bias
Pertinent to all types of study and can be caused by inadequate questionnaires (such as difficult or biased questions), observer or interviewer errors (such as lack of blinding), response errors (for example lack of blinding if patients are aware of the treatment they receive) and measurement error (such as a faulty machine).
- Intention-to-treat (ITT) analysis
An analysis of a clinical trial where patients are analysed according to the group to which they were initially randomly allocated, regardless of whether or not they had dropped out, fully complied with the treatment, or crossed over and received the alternative treatment. Intention-to-treat analyses are favoured in assessments of clinical effectiveness as they mirror the non-compliance and treatment changes that are likely to occur when the treatment is used in practice.
- Internal validity
Refers to the integrity of the study design.
- International Continence Society (ICS)
Multidisciplinary scientific group concerned with all aspects of urinary and faecal incontinence in all patient groups.
- Intervention
Healthcare action intended to benefit the patient, such as drug treatment, surgical procedure or psychological therapy.
- Interventional procedure (IP)
A procedure used for diagnosis or treatment that involves making a cut or hole in the patient's body, entry into a body cavity or using electromagnetic radiation (including X-rays or lasers). NICE has the task of producing guidance about whether specific interventional procedures are safe enough and work well enough for routine use.
- Intrinsic sphincter deficiency (ISD)
Incompetence of the urethral sphincter mechanisms usually associated with severe stress incontinence symptoms, due to inherent weakness of the sphincter itself, as opposed to the more common problem of impaired urethral support (hypermobility).
- Introitus
Entrance into the vagina.
- Kappa score or rating
A measure of agreement between two individuals or variables, where 1 indicates perfect agreement.
- ‘Knack’
A conscious contraction of pelvic floor muscle preceding rises in intraabdominal pressure, for example with cough. Also called ‘counterbracing’.
- Level of evidence (evidence level, EL)
A code (for example 1++, 1+) linked to an individual study, indicating where it fits into the hierarchy of evidence and how well it has adhered to recognised research principles.
- Literature review
A process of collecting, reading and assessing the quality of published (and unpublished) articles on a given topic.
- Longitudinal study
A study of the same group of people at more than one point in time. (This type of study contrasts with a cross-sectional study, which observes a defined set of people at a single point in time.)
- Masking
See blinding.
- Meta-analysis
Results from a collection of independent studies (investigating the same treatment) are pooled using statistical techniques to synthesise their findings into a single estimate of a treatment effect. Where studies are not compatible, for example because of differences in the study populations or in the outcomes measured, it may be inappropriate or even misleading to statistically pool results in this way. See also systematic review and heterogeneity.
- Methodological quality
The extent to which a study has conformed to recognised good practice in the design and execution of its research methods.
- Methodology
The overall approach of a research project; for example the study will be a randomised controlled trial, of 200 people, over 1 year.
- Mixed urinary incontinence (MUI)
Involuntary leakage associated with urgency and also with exertion, effort, sneezing or coughing.
- Multicentre study
A study where subjects were selected from different locations or populations, such as a cooperative study between different hospitals or an international collaboration involving patients from more than one country.
- Multivariate analysis
An analysis where the effects of many variables are considered. It can select a subset of variables that significantly contribute to the variable in the outcome.
- Negative predictive value (NPV)
The proportion of people with a negative test result who do not have the disease (where not having the disease is indicated by the ‘gold’ standard test being negative).
- Nocturia
The complaint of having to wake at night one or more times to void. See also frequency.
- Nocturnal enuresis
Urinary incontinence occurring during sleep. The term enuresis itself is synonymous with incontinence and, where it is intended to denote incontinence during sleep, it should always be qualified with the adjective ‘nocturnal’.
- Nominal group technique
A technique used for the purpose of reaching an agreement on a particular issue. It uses a variety of postal and direct contact techniques, with individual judgements being aggregated statistically to derive the group judgement. See also consensus methods.
- Non-experimental study
A study based on subjects selected on the basis of their availability, with no attempt having been made to avoid problems of bias.
- Non-systematic review
See review.
- Objective measure
A measurement that follows a standardised procedure that is less open to subjective interpretation by potentially biased observers and study participants.
- Observation
Observation is a research technique used to help understand complex situations. It involves watching, listening to and recording behaviours, actions, activities and interactions. The settings are usually natural but they can be laboratory settings, as in psychological research.
- Observational study
In research about diseases or treatments, this refers to a study in which nature is allowed to take its course. Changes or differences in one characteristic (such as whether or not people received a specific treatment or intervention) are studied in relation to changes or differences in other(s) (for example whether or not they died), without the intervention of the investigator. There is a greater risk of selection bias than in experimental studies.
- Odds ratio (OR)
Odds are a way of representing probability, especially familiar for betting. In recent years odds ratios have become widely used in reports of clinical studies. They provide an estimate (usually with a confidence interval) for the effect of a treatment. Odds are used to convey the idea of ‘risk’ and an odds ratio of 1 between two treatment groups would imply that the risks of an adverse outcome were the same in each group. For rare events the odds ratio and the relative risk (which uses actual risks and not odds) will be very similar. See also relative risk and risk ratio.
- Off-label prescribing
When a drug or device is prescribed outside its specific indication, to treat a condition or disease for which it is not specifically licensed.
- Oxford grading system
A system for assessing pelvic floor muscle contraction, where 0 = no contraction, 1 = flicker, 2 = weak, 3 = moderate, 4 = good, 5 = strong.
- Outcome
The end result of care and treatment and/or rehabilitation. In other words, the change in health, functional ability, symptoms or situation of a person, which can be used to measure the effectiveness of care/treatment/rehabilitation. Researchers should decide what outcomes to measure before a study begins; outcomes are then assessed at the end of the study.
- Overactive bladder (OAB) syndrome
Urgency, with or without urge urinary incontinence, usually with frequency and nocturia. OAB wet is where (urge) incontinence is present and OAB dry is where incontinence is absent.
- Pad test
A diagnostic method used to detect and quantify urine loss based on weight gain of absorbent pads during a set time period.
- Peer review
Review of a study, service or recommendations by those with similar interests and expertise to the people who produced the study findings or recommendations. Peer reviewers can include professional and/or patient/carer representatives.
- Pelvic floor muscle training (PFMT)
Repetitive selective voluntary contraction and relaxation of specific pelvic floor muscles.
- Pelvic organ prolapse (POP)
Descent of one or more of the anterior vaginal wall, the posterior vaginal wall and the apex, or the vault of the vagina towards or through the vaginal introitus.
- Pelvic organ prolapse quantification (POP-Q)
A method for classifying the stage of prolapse, in which six specific vaginal sites (A, Ba, C, D, Bp, Ap) and the vaginal length are measured in centimetres from the introitus.
- Performance bias
Systematic differences in care provided apart from the intervention being evaluated. For example, if study participants know they are in the control group they may be more likely to use other forms of care; people who know they are in the experimental group may experience placebo effects, and care providers may treat patients differently according to what group they are in. Masking (blinding) of both the recipients and providers of care is used to protect against performance bias.
- Perineometer
A device for measuring the strength of pelvic floor muscle contraction. Used as a form of biofeedback during treatment, or to measure treatment outcome.
- Pilot study
A small-scale ‘test’ of the research instrument. For example, testing out (piloting) a new questionnaire with people who are similar to the population of the study, in order to highlight any problems or areas of concern, which can then be addressed before the full-scale study begins.
- Placebo
Placebos are fake or inactive treatments received by participants allocated to the control group in a clinical trial that are indistinguishable from the active treatments being given in the experimental group. They are used so that participants are ignorant of their treatment allocation in order to be able to quantify the effect of the experimental treatment over and above any placebo effect due to receiving care or attention.
- Placebo effect
A beneficial (or adverse) effect produced by a placebo and not due to any property of the placebo itself.
- Point estimate
A best single estimate (taken from research data) for the true value of a treatment effect or other measurement. For example, researchers in one clinical trial take their results as their best estimate of the real treatment effect – this is their estimate at their point in time. The precision or accuracy of the estimate is measured by a confidence interval. Another clinical trial of the same treatment will produce a different point estimate of treatment effect.
- Positive predictive value (PPV)
The proportion of people with a positive test result who have the disease (where having the disease is indicated by the ‘gold’ standard test being positive).
- Post-void residual urine (PVR)
The volume of urine left in the bladder immediately after voiding.
- Power
See statistical power.
- Prevalence
The probability of experiencing a symptom or having a condition or disease within a defined population at a defined time point.
- Primary care
Health care delivered to patients outside hospitals. Primary care covers a range of services provided by GPs, nurses and other healthcare professionals, dentists, pharmacists and opticians.
- Primary care trust (PCT)
A primary care trust is an NHS organisation responsible for improving the health of local people, developing services provided by local GPs and their teams (called primary care) and making sure that other appropriate health services are in place to meet local people's needs.
- Primary surgery for stress UI
Surgery for stress urinary incontinence undertaken in a woman who has not previously undergone surgery for this condition.
- Probability
How likely an event is to occur, such as how likely a treatment or intervention will alleviate a symptom.
- Prognostic factor
Patient or disease characteristics, for example age or co-morbidity, that influence the course of the disease under study. In a randomised trial to compare two treatments, chance imbalances in variables (prognostic factors) that influence patient outcome are possible, especially if the size of the study is fairly small. In terms of analysis these prognostic factors become confounding factors. See also prognostic marker.
- Prognostic marker
A prognostic factor used to assign patients to categories for a specified purpose, for example for treatment or as part of a clinical trial, according to the likely progression of the disease. For example, the purpose of randomisation in a clinical trial is to produce similar treatment groups with respect to important prognostic factors. This can often be achieved more efficiently if randomisation takes place within subgroups defined by the most important prognostic factors. Thus if age was very much related to patient outcome then separate randomisation schemes would be used for different age groups. This process is known as stratified random allocation.
- Prompted voiding
Prompted voiding teaches people to initiate their own toileting through requests for help and positive reinforcement from carers. It has been used in institutionalised patients with cognitive and mobility problems. They are asked regularly if they wish to void and only assisted to the toilet when there is a positive response.
- Prospective study
A study in which people are entered into the research and then followed up over a period of time with future events recorded as they happen. This contrasts with studies that are retrospective.
- Protocol
A plan or set of steps that defines appropriate action. A research protocol sets out, in advance of carrying out the study, what question is to be answered and how information will be collected and analysed. Guideline implementation protocols set out how guideline recommendations will be used in practice by the NHS, both at national and local levels.
- Publication bias
Studies with statistically significant results are more likely to get published than those with non-significant results. Meta-analyses that are exclusively based on published literature may therefore produce biased results.
- P value
If a study is done to compare two treatments then the P value is the probability of obtaining the results of that study, or something more extreme, if there really was no difference between treatments. (The assumption that there really is no difference between treatments is called the ‘null hypothesis’.) Suppose the P value was 0.03. What this means is that if there really was no difference between treatments then there would only be a 3% chance of getting the kind of results obtained. Since this chance seems quite low we should question the validity of the assumption that there really is no difference between treatments. We would conclude that there probably is a difference between treatments. By convention, where the value of P is below 0.05 (i.e. less than 5%) the result is seen as statistically significant. Where the value of P is 0.001 or less, the result is seen as highly significant. P values just tell us whether an effect can be regarded as statistically significant or not. In no way do they relate to how big the effect might be, for which we need the confidence interval.
- Quality adjusted life years (QALYs)
A measure of health outcome which looks at both length of life and quality of life. QALYs are calculated by estimating the years of life remaining for a patient following a particular care pathway and weighting each year with a quality of life score (on a zero to one scale). One QALY is equal to 1 year of life in perfect health, or 2 years at 50% health, and so on.
- Quantitative research
Research that generates numerical data or data that can be converted into numbers, such as clinical trials or the national census that counts people and households.
- Quasi experimental study
A study designed to test whether a treatment or intervention has an effect on the course or outcome of disease. It differs from a controlled clinical trial and a randomised controlled trial in that: (a) the assignment of patients to treatment and comparison groups is not done randomly, or patients are not given equal probabilities of selection; or (b) the investigator does not have full control over the allocation and/or timing of the intervention, but nonetheless conducts the study as if it were an experiment, allocating subjects to treatment and comparison groups.
- Random allocation or randomisation
A method that uses the play of chance to assign participants to comparison groups in a research study, such as by using a random numbers table or a computer-generated random sequence. Random allocation implies that each individual (or each unit in the case of cluster randomisation) being entered into a study has the same chance of receiving each of the possible interventions.
- Randomised controlled trial (RCT)
A study to test a specific drug or other treatment in which people are randomly assigned to two (or more) groups, with one (the experimental group) receiving the treatment that is being tested and the other (the comparison or control group) receiving an alternative treatment, a placebo (dummy treatment) or no treatment. The two groups are followed up to compare differences in outcomes to see how effective the experimental treatment was. (Through randomisation, the groups should be similar in all aspects apart from the treatment they receive during the study.)
- Rectocele
Herniation (protrusion) of the rectum into the vagina.
- Relative risk (RR)
A summary measure that represents the ratio of the risk of a given event or outcome (for example an adverse reaction to the drug being tested) in one group of subjects compared with another group. When the ‘risk’ of the event is the same in the two groups the relative risk is 1. In a study comparing two treatments, a relative risk of 2 would indicate that patients receiving one of the treatments had twice the risk of an undesirable outcome than those receiving the other treatment. Relative risk is sometimes used as a synonym for risk ratio.
- Reliability
Reliability refers to a method of measurement that consistently gives the same results. For example, someone who has a high score on one occasion tends to have a high score if measured on another occasion very soon afterwards. With physical assessments it is possible for different clinicians to make independent assessments in quick succession – and if their assessments tend to agree then the method of assessment is said to be reliable.
- Retrospective study
A retrospective study deals with the present/past and does not involve studying future events. This contrasts with studies that are prospective.
- Review
A summary of the main points and trends in the research literature on a specified topic. A review is considered non-systematic unless an extensive literature search has been carried out to ensure that all aspects of the topic are covered and an objective appraisal made of the quality of the studies.
- Risk ratio (RR)
Ratio of the risk of an undesirable event or outcome occurring in a group of patients receiving experimental treatment compared with a comparison (control) group. The term relative risk is sometimes used as a synonym for risk ratio.
- Royal Colleges
In the UK medical/nursing world the term Royal Colleges, as for example in ‘The Royal College of … ’ refers to organisations that usually combine an educational standards and examination role with the promotion of professional standards.
- Sample
A part of the study's target population from which the subjects of the study will be recruited. If subjects are drawn in an unbiased way from a particular population, the results can be generalised from the sample to the population as a whole
- Sampling
Refers to the way participants are selected for inclusion in a study.
- Scottish Intercollegiate Guidelines Network (SIGN)
SIGN was established in 1993 to sponsor and support the development of evidence-based clinical guidelines for the NHS in Scotland.
- Secondary care
Care provided in hospitals.
- Secondary surgery for stress UI
Surgery for stress urinary incontinence undertaken in a woman who has previously undergone surgery for this condition.
- Selection bias
Selection bias has occurred if the characteristics of the sample differ from those of the wider population from which the sample has been drawn or if there are systematic differences between comparison groups of patients in a study in terms of prognosis or responsiveness to treatment.
- Selection criteria
Explicit standards used by guideline development groups to decide which studies should be included and excluded from consideration as potential sources of evidence.
- Sensitivity
In diagnostic testing, this refers to the chance of having a positive test result given that you have the disease. 100% sensitivity means that all those with the disease will test positive, but this is not the same the other way around. A patient could have a positive test result but not have the disease – this is called a ‘false positive’. The sensitivity of a test is also related to its negative predictive value (true negatives) – a test with a sensitivity of 100% means that all those who get a negative test result do not have the disease. To fully judge the accuracy of a test, its specificity must also be considered.
- Short form 36 (SF-36)
A generic multipurpose 36-item survey that measures eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
- Single-blind (SB) study
A study in which either the subject (patient/participant) or the observer (clinician/investigator) is not aware of which treatment or intervention the subject is receiving.
- Specialist
A specialist is any healthcare professional who has received appropriate training to be able to provide the particular range of specialist services he or she undertakes, and who works within the context of an integrated, multidisciplinary continence team. Particular service profiles will differ from one place to another.
- Specific indication
When a drug or a device has a specific remit to treat a specific condition and is not licensed for use in treating other conditions or diseases.
- Specificity
In diagnostic testing, this refers to the chance of having a negative test result given that you do not have the disease. 100% specificity means that all those without the disease will test negative, but this is not the same the other way around. A patient could have a negative test result yet still have the disease – this is called a ‘false negative’. The specificity of a test is also related to its positive predictive value (true positives) – a test with a specificity of 100% means that all those who get a positive test result definitely have the disease. To fully judge the accuracy of a test, its sensitivity must also be considered.
- Stamey grading of urinary incontinence
Grade 1: urine loss only with coughing/sneezing/lifting heavy objects.
Grade 2: urine loss with minimal activities, such as walking or rising from sitting position.
Grade 3: totally incontinent in upright position.
- Standard deviation (SD)
A measure of the spread, scatter or variability of a set of measurements. Usually used with the mean (average) to describe numerical data.
- Statistical power
The ability of a study to demonstrate an association or causal relationship between two variables, given that an association exists. For example, 80% power in a clinical trial means that the study has a 80% chance of ending up with a P value of less than 5% in a statistical test (i.e. a statistically significant treatment effect) if there really was an important difference (e.g. 10% versus 5% mortality) between treatments. If the statistical power of a study is low, the study results will be questionable (the study might have been too small to detect any differences). By convention, 80% is an acceptable level of power. See also P value.
- Stress test
A clinical test for the demonstration of stress urinary incontinence. The woman is asked to cough while the observer visualises the external urethral meatus. The test may be undertaken either after filling to a known volume, or prior to micturition, the volume being recorded thereafter. It may be undertaken supine or standing.
- Stress urinary incontinence (SUI)
The complaint of involuntary leakage on effort or exertion or on sneezing or coughing.
- Structured interview
A research technique where the interviewer controls the interview by adhering strictly to a questionnaire or interview schedule with pre-set questions.
- Study checklist
A list of questions addressing the key aspects of the research methodology that must be in place if a study is to be accepted as valid. A different checklist is required for each study type. These checklists are used to ensure a degree of consistency in the way that studies are evaluated.
- Study population
People who have been identified as the subjects of a study.
- Study quality
See methodological quality.
- Study type
The kind of design used for a study. Randomised controlled trials, case–control studies and cohort studies are all examples of study types.
- Subject
A person who takes part in an experiment or research study.
- Survey
A study in which information is systematically collected from people (usually from a sample within a defined population).
- Systematic
Methodical, according to plan; not random.
- Systematic error
Refers to the various errors or biases inherent in a study. See also bias.
- Systematic review
A review in which evidence from scientific studies has been identified, appraised and synthesised in a methodical way according to predetermined criteria. May or may not include a meta-analysis.
- Systemic
Involving the whole body.
- Target population
The people to whom guideline recommendations are intended to apply. Recommendations may be less valid if applied to a population with different characteristics from the participants in the research study – for example in terms of age, disease state, social background.
- Tertiary centre
A major medical centre providing complex treatments which receives referrals from both primary and secondary care. Sometimes called a tertiary referral centre. See also primary care and secondary care.
- Timed voiding
Timed voiding (scheduled, routine or regular toileting) is a passive toileting assistance programme that is initiated and maintained by a caregiver, for example for patients who cannot participate in independent toileting. Toileting is fixed by time or event, on a regular schedule, or a schedule to match the patient's voiding pattern.
- Trust
A trust is an NHS organisation responsible for providing a group of healthcare services. An acute trust provides hospital services. A primary care trust buys hospital care on behalf of the local population, as well as being responsible for the provision of community health services.
- Urethral competence
The ability of the urethral sphincter mechanisms to retain urine in the bladder at all times other than during normal micturition.
- Urethral hypermobility
Incompetence of the urethral sphincter mechanisms usually associated with stress incontinence symptoms, due to failure of urethral support.
- Urethral pain
Pain felt in the urethra and the patient indicates the urethra as the site.
- Urgency urinary incontinence (UUI)
Involuntary urine leakage accompanied by or immediately preceded by urgency (formally known as urge urinary incontinence).
- Urgency
The complaint of a sudden compelling desire to pass urine which is difficult to defer.
- Urgency-frequency syndrome
Another name for overactive bladder.
- Urinary incontinence (UI)
The complaint of any involuntary urinary leakage.
- Urodynamics (UD)
The term ‘urodynamics’ encompasses a number of varied physiological tests of bladder and urethral function that aim to demonstrate an underlying abnormality of storage or voiding. The term is often used loosely to mean multichannel cystometry. See also cystometry and uroflowmetry. Videourodynamics involves synchronous radiographic screening of the bladder with multichannel cystometry and is so called because originally the information was recorded to videotape. Ambulatory urodynamics involves multichannel cystometry carried out with physiological bladder filling rates and using portable recording devices that enable to patient to remain ambulant during the test.
- Urodynamic stress urinary incontinence (USI)
The demonstration of involuntary leakage of urine during increased abdominal pressure but in the absence of detrusor contraction during filling cystometry.
- Uroflowmetry
Uroflowmetry entails a free-flow void into a recording device that provides the practitioner with information about the volume of urine passed, and the rate of urine flow.
- Validity
Assessment of how well a tool or instrument measures what it is intended to measure. See also external validity and internal validity.
- Variable
A measurement that can vary within a study, such as the age of participants. Variability is present when differences can be seen between different people or within the same person over time, with respect to any characteristic or feature that can be assessed or measured.
- Voiding dysfunction
The term is not formally defined but is used to indicate objective evidence of abnormal voiding. This is usually based on a combination of diminished urine flow rate, abnormal flow pattern, raised detrusor voiding pressure and the presence of postmicturition residual urine. It is often, but not always, associated with symptoms of voiding difficulty (hesitancy, straining, poor or intermittent urinary stream) and/or post-micturition symptoms (sensation of incomplete emptying, postmicturition dribble).