By Dr. med. Dr. phil. Gerhard Nahler (auth.)
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Propranolol, verapamil) . floor effect opp. CEILINGEFFEcr; effects, especially SCORES measured, cannot go beyond a predefined lowest level; therefore observations will accumulate and form a rather inhomogenous group. flow chart syn. ) to be taken during different visits of a CLINICAL TRIAl.. follow-up protocol see CONTINUATION STUDY. Fontaine's stages Describe peripheral arterial occlusive disease (PAOD); I = asymptomatic, circulatory reserve is adequate, merely slight changes in the vessel wall; II = circulatory reserve is compromised, IIa walking distance> 200 m (5 km / h), IIb walking distance < 200 m; III = rest pain due to inadequate compensation; IV = necroses, typically in distal regions as toe and foot, with or without rest pain ; Doppler ultrasound pressures over malleolar arteries ar e less than 50mm Hg .
In Aus tra lia and Cana d a, but not by th e FDA); see also DELTA VALUE. g. /e. of weight loss progr ams, cos t of means of avoid ing an in fant d eath per year of life ga ine d); most appropriate for co m pa riso n of treatments not pr oducing an equ ivalen t likelihood of clini cal out come; cosl/effectiven ess data ar e increasingly used to facilitate reg ulatory approval, justify pri cing and influen ce REIMBURSEMENT; Australia and Can ada request eco no mic data to support product ap plicatio n and reimbursem ent listing since 1993, in Fran ce CEA and QUALITYOF LIFE data ar e explicit criteria for deter mining prices and reimbursem ent; it is likely that other European authorities will follow.
Extension protocol see CONTINUATION STUDY . external audit see AUDIT. extra incidence rate in non-vaccinated groups (EIRnv) Paramete r used in vaccination studies in order to assess EFFICACY of a vaccine ; usua lly compare d with the in cidence ra te in vaccinated groups; see also EPIDEMIO LO GY, EXT RA I NCID ENCE RATE IN DATA INTENT-To-TREAT PRINCIPL E; VACCINATED GROUPS, I NCID ENCE RATE. extra incidence rate in vaccinated groups (EIRv) Increased ra te of a disease in a vaccinated population ; see also EXTRA INCIDENCE RATE IN NON-VACCI NAT ED GROUPS, INCIDENCE RATE.
Dictionary of Pharmaceutical Medicine by Dr. med. Dr. phil. Gerhard Nahler (auth.)