Dictionary of Evidence-based Medicine.pdf

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Dictionary of Evidence-based Medicine 77 9 In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely given informed consent, preferably in writing. 10 When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship. 11 In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian. 12 The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with. 17 Medical research combined with professional care (clinical research) 1 In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, re-establishing health or alleviating suffering. 2 The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods. 3 In any medical study, every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method. 4 The refusal of the patient to participate in a study must never interfere with the physician-patient relationship.
78 Dictionary of Evidence-based Medicine 5 If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I, 2). 6 The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient. Ill Non-therapeutic biomedical research involving human subjects (non-clinical biomedical research) 1 In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out. 2 The subjects should be volunteers - either healthy persons or patients for whom the experimental design is not related to the patient's illness. 3 The investigator or the investigating team should discontinue the research if in his/her or their judgement it may, if continued, be harmful to the individual. 4 In research on man, the interests of science and society should never take precedence over considerations related to the well-being of the subject. Heterogeneity In the literature on evidence-based medicine, heterogeneity refers to nonhomogeneous treatment effects (statistical heterogeneity) or patient groups (clinical heterogeneity) across trials. The latter and differences in treatment protocols will contribute to statistical heterogeneity (Thompson SG (1995) Why sources of heterogeneity in meta-analysis should be investigated. In: Chalmers I, Altaian DG (eds) Systematic reviews. BMJ Publishing Group, London). HMO (see Health maintenance organizations) Human capital method In economics, human capital is defined generally as the level of skills and knowledge which the workforce has as a result of education and training.
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Dictionary of Evidence-based Medici
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Preface This book was conceived at
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A Ability to pay Ability to pay is
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Figure I Audit: Clinical audit cycl
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B Balanced design In an experiment,
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Page 72 and 73: G Game theory Game theory, first de
Page 86 and 87: I ICD (see International Classifica
Page 94 and 95: K Keynes, John Maynard (1883-1946)
Page 100 and 101: M Macroeconomics Macroeconomics is
Page 112 and 113: N N of I trial An N of 1 trial is a
Page 116 and 117: 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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