Metodologitermer på engelska
BASELINE (sv BASLINJE) – The initial assessment at the start of a ‘study’. The effect of an intervention (e.g. a new tablet) can be determined by comparing baseline scores to follow up scores.
BASIC SCIENTIFIC RESEARCH (sv GRUNDLÄGGANDE VETENSKAPLIG FORSKNING) - This term is usually used to differentiate studies involving real live patients (e.g. a trial of a new type of physiotherapy, clinical research) from work based in a test tube, in a laboratory (basic scientific research).
BIAS (sv BIAS) - Something that distorts a process. This process could be a meeting where a person’s views may be ‘biased’ favouring only one way of looking at things, or the process of some research itself where results are distorted, for example by only including patients who can attend hospital, some studies are biased and the results cannot be generalised to patients who are less mobile and cannot therefore attend hospital as outpatients.
BIOMEDICAL RESEARCH (sv BIOMEDICINSK FORSKNING) – Scientific research that relates and applies to clinical medicine.
BLINDED TRIAL (sv BLINDAD STUDIE) – The principle that if you don’t know what treatment you are on (maybe you get a placebo), you can’t influence the results. Single blind means that only the patient doesn’t know whether he or she gets the real drug or a placebo. Double blind means that neither the patient nor the clinician (doctor, nurse or researcher) knows.
CASE STUDY (sv FALLSTUDIE) – Research based on one or a few patients. Case studies may be very detailed and are a good way of finding out about rare conditions or illnesses.
CLINICALLY RELEVANT (sv KLINISKT RELEVANT) - A principle, fact or study that is directly applicable to patient care. May also refer to the magnitude of a treatment effect. For example a statistically significant treatment effect may or may not be clinically relevant.
CLINICAL TRIAL (sv KLINISK STUDIE) – see also: Case Study, Cohort Study, Randomised Clinical Trial (RCT) cf. Basic Scientific Research. Usually applied to studies that have direct applicability to patients and their care, or are carried out in patients, rather than in a laboratory.
CLINIMETRY (sv KLINIMETRI) – The science of clinical measurement.
COCHRANE (sv COCHRANE) - The Cochrane Collaboration is an international not-for-profit research organisation that aims to help people make informed decisions about health care. It is a registered charity in the United Kingdom. Its name derives from Archie Cochrane, a British epidemiologist, who drew attention to our great collective ignorance about the effects of health care. He recognised that people do not have ready access to reliable reviews of the available evidence.
COCHRANE CONSUMER NETWORK (CCN) (sv COCHRANE BRUKARNÄTVERK) – The CCN’s site contains a range of health care information, and information to help people understand health care research. It is also a resource for consumers and others who want to become involved in the Collaboration or other health research activities.
COCHRANE LIBRARY (sv COCHRANE-BIBLIOTEKET) - A collection of databases, published on disk, CD-ROM and the Internet and updated quarterly, containing the Cochrane Database of Systematic Reviews, the Cochrane Controlled Trials Register, the Database of Abstracts of Reviews of Effects, the Cochrane Review Methodology Database, and information about the Cochrane Collaboration.
COCHRANE REVIEW (sv COCHRANE-ÖVERSIKT) - A Cochrane Review is a systematic, up-to-date summary of reliable evidence of the benefits and risks of healthcare. Cochrane Reviews are intended to help people make practical decisions. For a review to be called a "Cochrane Review" it must be in the Parent Database maintained by the Cochrane Collaboration. The Parent Database is composed of modules of reviews submitted by Collaborative Review Groups (CRGs) registered with the Cochrane Collaboration.
The reviews contributed to one of the modules making up the Parent Database are referred by the editorial team of the CRG, as described in the CRG module. Reviewers adhere to guidelines published in the Cochrane Handbook. The specific methods used in a Review are described in the text of the review. Cochrane Reviews are prepared using Review Manager software provided by the Collaboration and adhere to a structured format that is described in The Cochrane Reviewers' Handbook.
COHORT STUDY (sv KOHORTSTUDIE) – A research method concerned with observing events involving a particular group of people over time (such as a group of patients’ progress in long term treatment) in order to provide information, which is useful for identifying longer-term strategies, and treatments that are effective.
CONTROL GROUP (sv KONTROLLGRUPP) – see: controlled study
CONTROLLED STUDY (sv KONTROLLERAD STUDIE) – Early in the development of clinical research it became clear that it can be very difficult to disentangle the real effect of an intervention or treatment from the natural background variation in the way patients feel. In other words patients may feel better or worse and it is nothing to do with the study treatment.
To address this problem, study designers often observe patients or volunteers who have not been given the active treatment and compare their progress with those that have. The former group is termed a control group and such a study a controlled study. To minimise bias such studies are often randomised (there is an equal chance of any individual being allocated to either the active or the control group) and (double or single blind) placebo controlled.
CROSS-SECTIONAL (sv TVÄRSNITT) – A cross-sectional study is an observational study, in which the observations (e.g. responses to a questionnaire) are made on a single occasion. Cross-sectional studies generally focus on a single group of people representative of the population of interest. Cross-sectional studies can be a useful way of getting a lot of information quickly but are not considered as powerful as ‘prospective (or longitudinal) studies in which patients or a disease process are/is followed over time.
DELPHI METHOD (sv DELPHI-METOD) - The Delphi Process is a means of reaching consensus through structured consultation between a group of people who may have very different perspectives and fields of expertise. It is particularly useful where there is little or no published information on the subject under consideration.
Unlike more familiar consultation methods such as steering groups, the Delphi Process doesn’t need participants to physically meet together and there is no limit on how many people can be involved. Since the process is anonymous, it avoids ‘power struggles’ because there is no opportunity for a strong individual to unduly influence the group and people can change their minds without losing face. The process also enables a combination of many opinions into a group response and can be completed in as short a time as possible.
To ensure anonymity, the Delphi Process uses questionnaires. These involve a number of statements to which participants respond using a ranking system. Reponses are analysed centrally and then fed back to all participants, enabling individuals to change their mind and re-rank their answers if they wish, in light of opinions expressed by the group. The process is repeated until consensus is reached. At the end, a statistical response is arrived at for each statement that equates to the strength of opinion felt by the group. The result can then be used as a benchmark for developing good practice.
DOMAIN (sv DOMÄN) – Broad area of measurement (e.g. physical function).
DOUBLE BLIND (sv DUBBELBLIND) - see: blinded trial
EFFECTIVENESS (sv EFFEKTIVITET) - The extent to which something actually works. In medicine this is a precise term and relates to the effect size (see below). Effectiveness of a specific treatment may be estimated from relevant research literature but many trials do not include patients with co-morbidity (there might be multiple exclusion criteria) and so the effect size may be less in a typical clinical setting.
EFFECT SIZE – SES (Standardized Effect Size) (sv EFFEKTSTORLEK – SES (standardiserad effektstorlek)) - A simple way to determine the degree of improvement (or otherwise) of a particular therapy after any placebo effect has been accounted for. The effect size is calculated as the ratio of the treatment effect (mean differences in treatment group minus differences in placebo group) to the pooled standard deviation of these differences.
EFFICACY (sv EFFEKT) - The extent to which a treatment improves outcomes under ideal circumstances, for example the maximum effect in patients who didn’t experience side effects and took all prescribed drugs.
EFFICIENCY (sv VERKNINGSGRAD) – (A statistical measure). The mean (average) change in the measure divided by the standard deviation (a statistical measure of spread) of the change.
EMPIRICAL (sv EMPIRISK) – A treatment derived from experiment and observation rather than theory. In practice this term applies to treatments based upon the individual’s clinician’s experience and judgement.
EVIDENCE BASED MEDICINE (sv EVIDENSBASERAD MEDICIN) - Evidence-Based Medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.
By individual clinical expertise we mean the proficiency and judgement that individual clinicians acquire through clinical experience and clinical practice. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. External clinical evidence both invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful, more accurate, more efficacious, and safer.
There are 4 levels of evidence which are broadly recognised:
- Controlled trials (RCT’s)
- Observational study
- Expert opinions
Lit: Sacket, D. et al. Evidence based medicine: what it is and what it isn't (Editorial). British medical journal 1996: 312:71-72
EXCLUSION CRITERIA (sv EXKLUSIONSKRITERIER) – Pre-defined factors that exclude a subject from a trial. For example: Clinical studies often exclude patients that would be unable to attend for review for any reason. Many studies exclude subjects of less than 18 years old.
FOCUS GROUP (sv FOKUSGRUPP) – A research method of gathering information from people while they are discussing a subject in small groups.
HAWTHORNE EFFECT (sv HAWTHORNE-EFFEKT) – This is based on a series of studies on the productivity of workers at factory which manipulated various conditions (e.g. pay, light levels, heating, rest breaks), but each change resulted on average over time in productivity rising, including eventually a return to the original conditions. This was true of each of the individual workers as well as the group mean. Clearly the variables the experimenters manipulated were not the only nor dominant causes of productivity. One interpretation was that the important effect here was the feeling of being studied.: it is this that is now referred to by “the Hawthorne effect”.
HYPOTHESIS (sv HYPOTES) – A proposed mechanism that might explain a known fact or observation. A hypothesis may be tested by a well-designed research protocol. Unlike a theory it is not supported by direct evidence, rather it is the question we are asking in our research study.
INCLUSION CRITERIA (sv INKLUSIONSKRITERIER) - The predefined characteristics that allow a subject to be entered for consideration for a trial. In a study of osteoarthritis, inclusion criteria might be determined as pain on most days of 1 month and definite radiographic evidence of osteoarthritis of the affected joint.
INFORMED CONSENT (sv INFORMERAT SAMTYCKE) – The decision by a person to give or not give permission for an action affecting them. The decision is based upon having all the information bearing on the situation including the advantages, disadvantages, and the various consequences involved.
LONGITUDINAL (sv LONGITUDINELL) – Measurements made repeatedly over a long period of time.
MEDLINE-REVIEW (sv MEDLINE-ÖVERSIKT) – National Library of Medicine’s premier bibliographic database. It contains 9 million records of bibliographic citations and author abstracts from approximately 3.900 current biomedical journals.
Direct access: http://www.annrheumdis.com
META-ANALYSIS (sv METAANALYS) – The process of combining the data from a number of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions addressing a particular issue. It aims to utilise the increased power of pooled data to clarify the state of knowledge on that issue. Meta analysis is often used in systematic reviews of effect studies of medical therapies to evaluate therapeutic effectiveness. The Cochrane Reviews are meta-analyses.
MINIMAL CLINICALLY IMPORTANT DIFFERENCE - MCID (sv MINSTA KLINISKT VIKTIGA SKILLNAD) - A minimal clinically important (or relevant) difference (MCID) can be defined as the smallest difference in score on an outcome measure (e.g. pain, disability, quality of life), which patients perceive as beneficial. This MCID can be used as a criterion to assess if a therapy has potential beneficial effects. (See Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials 1989;10:407–15
OUTCOME (sv RESULTAT) – The effect of treatment on a patient, which may be measured in a number of ways. Objective measures (outcomes) are independent of the opinion of the patient, e.g. X-rays, biological blood tests. More subjective outcomes are based on the experience or opinion by the patient, e.g. pain ratings or questionnaires on daily activities and health-related quality of life. Outcome expectancy is a belief that certain behaviour will lead to a certain outcome (e.g. pacing one’s lifestyle will lead to reduced fatigue) and is based on the patient’s knowledge of RA management.
PARADIGM (sv PARADIGM) - A way of thinking about a particular problem or issue. For example one paradigm for the management of a certain arthritis centres on early ‘aggressive’ drug treatment to improve the long-term outlook for patients.
PEER REVIEW (sv PEER REVIEW) – Research proposals and results are usually reviewed by a number of independent people who never the less have an interest in research, so that data, information and methods can be verified from a range of perspectives. Consumers often act as peer reviewers. They may not feel able to comment on the research method, but will have very valuable views about whether the research topic is an important one for consumers, and whether the research involves consumers in an appropriate way.
PLACEBO (sv PLACEBO) – A sham treatment. If the treatment is a tablet or capsule it will contain no active ingredient. The best placebos are identical to the real drug and help to maintain blinding in either single or double blind trials. Placebos are used to help separate the real effect of the active ingredient from any benefit (or side effects) that the subject may experience by chance or purely by the acting of taking tablets.
PROSPECTIVE STUDY (sv PROSPEKTIV STUDIE) – A study where patients are selected before any data collection starts.
PROTOCOL (sv PROTOKOLL) – The plan or set of steps to be followed in a study. A protocol for a systematic review for example should describe the rationale for the review, the objectives, and the methods that will be used to locate, select and critically appraise studies, and to collect and analyse data from the included studies.
QUALITATIVE RESEARCH (sv KVALITATIV FORSKNING) – Research that gathers information, which is varied, in-depth and rich. The information sought is about how something is perceived or experienced and not specifically about facts and figures. The emphasis is on the quality and depth of information. These data might be collected in the form of in-depth interviews or observations. The interviews are taped and the transcripts are systematically analysed to see what ideas emerge.
QUANTITATIVE RESEARCH (sv KVANTITATIV FORSKNING) – Deals with facts, figures and measurements, and produces data which can be readily analysed. Measurable data is gathered from a wide range of sources, and it is the analysis and interpretation of the relationships across this data that gives the information researchers are looking for. These data are collected using numbers, perhaps through answers to questionnaires. The numbers are then examined using statistical tests to see if the results have happened by chance.
RANDOMISED CONTROLLED TRIAL - (RCT) (sv RANDOMISERAD KONTROLLERAD STUDIE - (RCT)) (Synonym: randomised clinical trial) – An experiment in which investigators randomly allocate eligible people into (e.g. treatment and control) groups to receive or not to receive one or more interventions that are being compared. The results are assessed by comparing outcomes in the treatment and control groups.
RESPONSIVENESS (sv RESPONSIVITET) – The ability of an instrument (methods, questionnaire etc.) to measure a significant change in any assessment method over time.
RETROSPECTIVE STUDY (sv RETROSPEKTIV STUDIE) – A study where patients are selected then their medical records are used to find out what has happened to them.
SENSITIVITY (sv SENSITIVITET) – This is the opposite of specificity: the extent to which a test gives ‘abnormal’ outcomes in healthy people. A sensitive test gives only a few ‘false-negative’ outcomes. Sensitivity and specifity are interchangeable within one test by shifting the break off point.
SIGNIFICANT (sv SIGNIFIKANT) – What is a significant difference (improvement or change in disease activity)? It is important to know how many patients actually improved, i.e. is a good group result based on a large number of patients improving moderately, or on a small number of patients with a considerable improvement? In research, statistical tests will show whether a result arose by chance, or whether it is unlikely to have happened by chance and can therefore be said to be significant (eg a statistically significant change in pain on a new drug).
SMALLEST DETECTABLE DIFFERENCE – SDD (sv MINSTA DETEKTERBARA SKILLNAD – SDD)– that can be seen on an X-Ray. Used as a basis for measuring Minimal Clinically Important Difference (MCID).
SPECIFITY (sv SPECIFICITET) – A classical term in epidemiology, which means the extent to which a test gives ‘normal’ outcomes in healthy people. A specific test gives only a few ‘false-positive’ outcomes.
SYSTEMATIC REVIEW (sv SYSTEMATISK ÖVERSIKT) – A review of a clearly formulated question that uses systematic and explicit methods to identify, select and critically appraise relevant research, and to collect and analyse data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyse and summarise the results of the included studies. See also: Cochrane Review.
TREE APPROACH (sv TRÄDMETOD) – Using a branching algorithm to classify patients into different categories.
VALIDITY – (external) (sv VALIDITET – (extern)) – The extent to which the research findings can be generalised to the wider population of interest and applied to different settings. (Bowling, 1997).
VALIDITY – (internal) (sv VALIDITET – (intern)) – The ability of an instrument (method, questionnaire) to measure what it has to measure (or what we think or expect to measure). This is what is called “truth” in the Omeract filter. The validity of an instrument is not obvious. For example: patients with chronic conditions do have high scores on some depression questionnaires. Not because they are depressed, but as the results of questions like: “I always have a slow start in the morning”, “I often feel tired” and “I can’t do the same as before”. For this reason one has to conclude that such a questionnaire is not valid for RA patients.
VARIABLE (sv VARIABEL) – A variable is a factor you measure, such as pain, depression, disability, CRP.
Different variables are measured in different ways for example:
- Dichotomous or ‘yes/no’ answers (e.g. alive or dead)
- Continuous measurements (e.g. length can be 61cm or 61.25 cm or 61.257 cm)
- Discrete measures have to be whole numbers (e.g. number of children cannot be 1.6!)
- Categories such as blue or green, no pain or some pain
Variables can also be labelled as:
- Primary - the main question the study is asking (e.g. change in pain)
- Secondary – the next question you would like to ask (e.g. change in disability)
- Clinical – health status, e.g. pain, disability
- Demographic – details such as age, gender, education level
- Confounding – variables which might confuse your answer (e.g. there seems to be an association between alcohol and lung cancer. But this does not mean alcohol causes lung cancer. The link is really between smoking and lung cancer - alcohol confounds or confuses the issue because people who drink alcohol are more likely to smoke and therefore get lung cancer).
UNWEIGHTED (sv OVIKTAD) – All the information being used is given equal weight or importance. For example the score obtained from each single item of a questionnaire is given the same weight when summing up a total score.
WEIGHTED (sv VIKTAD) – The information being used is given different importance depending on the ‘weight’ assigned to each piece of information. For example the scores obtained from single items of a questionnaire may be multiplied with various predetermined factors in order to differentiate their importance when summing up a total score.