Dictionary of Evidence-based Medicine.pdf

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Dictionary of Evidence-based Medicine 23 Clinical phase The clinical phase in the development of a therapeutic drug refers to the interval from submission of an investigational new drug (IND) application for a new chemical entity (NCE) to submission of a new drug licence application (NDA). Clinical practice guidelines Clinical practice guidelines are systematically developed statements to help clinicians and patients to make rational decisions about the most appropriate health care for specific clinical circumstances. Information that one would expect from such guidelines includes: (i) a statement of objective including the targeted health problem and the main reasons for developing recommendations concerning the problem being addressed; (ii) the practice options that were considered; (iii) the main clinical and economic consequences identified as potential outcomes; (iv) the evidence used, including the methods used for systematically collecting the information and its synthesis; (v) the persons and methods used for assigning utilities or values to the potential outcomes; (vi) the benefits, harm and costs that are expected to result from implementation of the guidelines; (vii) methods used to validate the guidelines such as external review and auditing; (viii) identification of sponsors to make explicit any potential conflict of interest; (ix) date of the latest revision of the guideline (Committee to Advise the Public Health Service on Clinical Practice Guidelines. Institute of Medicine. Field MJ, Lohr KN (eds) (1990) Clinical practice guidelines: directions for a new program. National Academy Press, Washington DC). Clinical reasoning Clinical reasoning refers to the inductive and deductive reasoning which a clinician undertakes when dealing with a patient's health problem. The reasoning is based on clinical experience, tradition, education and intuition. However, there is increasing recognition that these have to be supplemented with quantitative diagnostic reasoning for optimum outcome. For this reason, clinical reasoning is now often broken down into discrete steps for the purpose of research: (i) history taking and physical examination leading to tentative diagnoses; (ii) ordering of appropriate diagnostic tests to provide additional data; (iii) integration of clinical and diagnostic test data; (iv) evaluation of alternative course of action; (v) incorporation of patient preferences in the selection of the most appropriate course of action (Goldman L (1991) Quantitative aspects of clinical reasoning. In: Wilson
24 Dictionary of Evidence-based Medicine JD, Braunwald E, Isselbacher KJ et al. (eds) Harrison's principles of internal medicine. McGraw-Hill, New York). Clinical trial A clinical trial can be defined as any study undertaken to evaluate the clinical effects of an intervention on humans or animals. The control under which such studies are undertaken varies. For estimating efficacy of an intervention, the double-blind, randomized, controlled trial (double-blind RCT) is generally regarded as being the gold standard. In such a trial, one intervention is compared against another, which may be a placebo, to provide a control. Neither the investigator nor the subjects know which treatment is being assigned to whom (i.e. both are blinded) and the assignments are randomized (i.e. subjects are assigned using a validated randomization method). In some instances, it may not be possible for practical or ethical reasons to blind the subjects and/or the investigators (e.g. surgical interventions) and open trials are then resorted to. Randomization may also be on the basis of non-validated allocation schemes such as alternate patient assignments. Such allocations are referred to as quasirandomization in recognition of the fact that they are less robust. In interpreting the results of clinical trials, it is therefore important to critically assess the designs used. Recently, recommendations have been made on the reporting of clinical trials to ensure that readers have all the information to hand to make a critical appraisal (see CONSORT statement). Clinimetrics Clinimetrics is a term proposed by AR Feinstein to define 'the domain concerned with indexes, rating scales, and other expressions that are used to describe or measure symptoms, physical signs and other distinctly clinical phenomena in clinical medicine (Feinstein AR (1987) Clinimetrics. Yale University Press, New Haven). The term is regarded as being synonymous with clinical outcomes research by some authors. Cluster randomization A cluster randomized study is one in which a group of subjects is randomized to the same treatment together. An example is when children in some schools are given one vaccine and those of other schools given another and the protection offered compared. The essential feature of studies with cluster randomization is that the unit of analysis is the experimental unit (school, in this case). In analysing such studies, a common approach
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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
Page 12 and 13: Figure I Audit: Clinical audit cycl
Page 14 and 15: B Balanced design In an experiment,
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Page 72 and 73: 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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