220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

62effensures and declares that the medical devices which have beensubject to conformity examinations and tests (among other things,examination of every product or statistical control of products byrandom sampling) conform to the type described in the EC typeexaminationcertificate.effect Result of a drug or treatment on a specific pharmacological orbiological parameter; → see also effectiveness, efficacy.effectiveness Therapeutic utility of a drug or treatment when usedby the public at large under uncontrolled, real world conditions,e.g. survival in cancer; → see also cost-effectiveness, effect,efficacy.effectiveness analysis → see intent-to-treat analysis.effect modifier Variable which increases or weakens an effect, but –in contrast to confounders – does not bias the overall estimateof exposure-outcome associations (e.g. living/hygienic conditions,immune status for developing tuberculosis in addition to exposureto Mycobacterium tuberculosis); → see also learning effect,placebo effect.effect size Differences in outcome measurements between two ormore groups, e.g. in standard deviation units, which then areusually calculated by dividing the differences in post-treatmentscores between the groups by the standard deviation of the controlgroup scores; in “pre-post” evaluations the difference betweenpre- and post-mean scores is divided by the pretreatment standarddeviation; in broad terms, e.s. above placebo (or no treatment) of2.0 are associated with large treatment benefits obviousto most of the observers; 5–10 subjects will normally be sufficientto generate significant results; → see also q-value, sample sizeestimation.effect size (SRM) Calculated by dividing the mean change by thestandard deviation of the baseline score; emphasizes the magnitudeof change; → see analysis, standardized response mean.efficacy Individual (in contrast to effectiveness) therapeutic orpharmacological result of a drug or treatment in a controlled clinicalsituation; assessment of e. needs (EC): “specification of the effectparameters to be used, description of how e. are measured andrecorded, times and periods of e. recording, description of specialanalyses and/or tests to be carried out (pharmacokinetic, clinical,laboratory, radiological, etc.)”; e. measurements should be doneby objective criteria, and subjective rating such as from “mark-