Dictionary of Evidence-based Medicine.pdf

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Dictionary of Evidence-based Medicine 69 Generic substitution When drugs lose their patent, manufacturers other than the innovator company can supply alternative bioequivalent products (generic equivalents). To reduce drug costs, health care providers and hospitals may permit the supply of such products when prescribers request the innovator's branded product (generic substitution). In the UK, under the National Health Service, generic substitution is not allowed in general practice with the emphasis being placed on generic prescribing instead. When a prescriber orders a drug generically, then the pharmacist can supply any generic equivalent. In the hospital service, generic substitution is common but needs to be agreed on by the appropriate drug and therapeutic committees. Geometric mean The geometric mean is the antilogarithm of log x where Any base can be used provided the same base is used for both the log and antilog steps. The geometric mean is often used in summarizing pharmacokinetic data such as the ratio of area under the blood concentration-time curves for the products being compared because of their non-normal distribution. Geometric series A geometric series is a sequence of numbers in which consecutive terms differ from each other by a constant ratio r whose modulus is smaller than one. Such a series of n terms can be written as a, ar 2 , ar 2 , ar 3 ..., ar"- 1 where I r I
70 Dictionary of Evidence-based Medicine Global measures In the assessment of perception, a global measure is one where the person makes a single assessment about the overall value of an intervention on his or her own status. Two types of global measures are often used in healthrelated quality of life assessments: (i) preference measures by which the subjects express a judgement about how much they would be prepared to sacrifice in order to achieve perfect health; (ii) rating scales by which patients rate their health status using categorical descriptive labels or analogue (continuous) scales. All rating scales are usually anchored so that the two ends of the scales refer to perfect health and as good as dead. States of health worse than death may be assigned negative values, particularly in community-derived scales. In preference measurements, what is being traded for perfect health can be years of life, risk of death or money. The method is then referred to as time trade-off, standard gamble or willingness to pay respectively. Global values using both preference measures and rating scales can be transformed to a utility scale ranging from 0 to 1. These utilities can then be used for quality-adjusting life-years to yield QALYs, a basic unit in cost utility analyses. Gold standard The term 'gold standard' in measurement scale development or pharmacoeconomic evaluation refers to the comparator which is generally regarded to be the best available. For example, in the survey of health status, the SF-36 form is often regarded as the gold standard. Therefore when developing or proposing a new form, it is expected that any validation would include the concurrent use of SF-36. Good clinical practice Good clinical practice for the conduct of a clinical trial defines what needs to be done before, during and after completion of the trial to ensure full accountability. The steps required for GCP are defined in a guideline issued by the International Conference on Harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use. While the health ministries of different countries will have their own criteria, the ICH guideline summarizes the consensus views of regulatory authorities in the USA, the European Community and Japan after wide-ranging consultation with interested parties such as the pharmaceutical industry. Issues such as informed consent, ethics committee approval, randomization list, subject enrolment log and reporting of adverse drug reactions are
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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
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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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