Dictionary of Evidence-based Medicine.pdf

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Dictionary of Evidence-based Medicine 3 play the winner. In a trial using this design, the next patient is allocated to the same treatment as the last one if it was successful and to the other treatment otherwise (Sen S (1997) Statistical issues in drug development. John Wiley, Chicago). Administrative analysis In a clinical trial, monitors are normally appointed to ensure that progress is being made according to plans. Patient enrolment, event rates and/or safety profile of the drug are checked to ensure that they are broadly as expected. Such analyses, which do not involve any formal statistical analyses, are referred to as administrative analyses. Adverse drug reaction (ADR) For marketed medicinal products, an adverse reaction to a drug is a noxious and unintended response which can plausibly be attributed to the drug at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or modification of physiological function. The definition is broadened to include any dose of the drug when dealing with preapproval clinical experience since at that stage the normal dose of the drug has yet to be defined. An ADR is said to be unexpected if its nature or severity is not consistent with the applicable product information. If the ADR is life-threatening or leads to death then it is clearly serious. The term 'life-threatening' is itself used when the ADR leads to hospitalization or prolongation of hospital stay, results in persistent or significant disability or in a congenital anomaly or birth defect. Note that the descriptor 'serious' is not synonymous with 'severe'. The latter refers to intensity of the experience (e.g. severe headache) rather than to its prognostic significance (Edward IR et al. (1994) Harmonisation in pharmacovigilance. Drug Safety. 10: 93-102 and see Type A reaction). Adverse event An adverse event is any untoward occurrence in any subject given a pharmaceutical product, irrespective of whether or not a causal relationship can be established. The term is used synonymously with 'adverse experience'. An adverse event is said to be serious if it is life-threatening or leads to death (Edward IR et al. (1994) Harmonisation in pharmacovigilance. Drug Safety. 10: 93-102).
4 Dictionary of Evidence-based Medicine Advisory Committee on Borderline Substances The Advisory Committee on Borderline Substances (ACBS) is a nonstatutory body of experts representing medical, pharmaceutical and dietetic opinion, first set up in 1971 to advise UK health ministers whether particular unlicensed substances, preparations or items (foods, dietary supplements and toiletries) should be treated as drugs which are prescribable at the expense of the National Health Service (paragraph 43 of Schedule 2 to the NHS (General Medical Services) Regulations 1992). The chairman and members of the Committee are appointed by the UK Secretary of State for Health and three other members are appointed by the Secretaries of State for Wales, Scotland and Northern Ireland. The Committee's terms of reference include ensuring that substances, preparations or items which have a therapeutic use in the treatment of disease in the community can be provided as economically as possible under the NHS. Products which the Committee recommends may be regarded as drugs are published in the Drug Tariff and in the British 'National Formulary. Although the list has no legal force, it is widely followed by both health authorities and prescribers in the community (GPs). The ACBS also advises the ministers on which products should not be prescribed at NHS expense either because they have not demonstrated a therapeutic use in treating disease in the community or because they do not meet a need as economically as possible. Such products are added to a negative list or blacklist (Schedule 10 to the NHS (General Medical Services) Regulations 1992) and GPs are legally barred from prescribing them at NHS expense though not on private prescriptions. The blacklist is given at part XVIIIA of the Drug Tariff. This blacklist also includes recommendations made by other committees, notably the Advisory Committee on NHS Drugs, and agreed by ministers. Age-specific rate (see Specific rate) Allocative efficiency (see under Efficiency) Allostasis Allostasis is the ability to achieve stability of body systems through change. Allostasis is essential to survival and is provided through the coordinated responses of the autonomic nervous system, the hypothalamicpituitary axis, the cardiovascular system, the metabolic system and the immune system (McEwen BS (1998) Protective and damaging effects of
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Page 4 and 5: Preface This book was conceived at
Page 6 and 7: A Ability to pay Ability to pay is
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Page 14 and 15: B Balanced design In an experiment,
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Figure 9 Concept of externality Dic
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G Game theory Game theory, first de
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I ICD (see International Classifica
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K Keynes, John Maynard (1883-1946)
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M Macroeconomics Macroeconomics is
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N N of I trial An N of 1 trial is a
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o OBM (see Opinion-based medicine)
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Figure 25 Measuring quality of life
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S Scarcity Scarcity is often referr
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T TDM (see Therapeutic drug monitor
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u Unique value effect This term is
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Z Z variate A random variable which
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