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ecological study Study comparing the extent of disease and exposure in different populations; interpretation of associations between disease and exposure may result in ecological fallacy. economic analysis syn. pharmacoeconomic study; overall term for analyses such as cost/effectiveness a., cost/utility a., and quality of life studies; outcomes measured are e.g. direct medical costs such as payments for drugs, treatments, laboratory and other medical services, direct non-medical costs (related to illness) such as payments for transportation or housekeeper, indirect costs such as lost of earnings due to morbidity and mortality, and intangible costs such as those associated with pain and suffering; examples for cost-effective medical decisions are vaccinations against viral infections or introduction of inhaled steroids for asthma treatment which decreased overall treatment costs by 22%; some health authorities require economic data to support product application and reimbursement by the national formularies e.g. Australia (since January 1993) and Canada (“Ontario Guidelines”, since 1994), European regulatory authorities are expected to follow (guidelines under development e.g. in Italy, Spain, UK, US); in France, cost/effectiveness and quality of life are decisive criteria for determining prices and reimbursement; economic evaluations may be seen differently by authorities, (e.g. Australia favorises evaluations where indirect costs are excluded); in monetary terms, the contribution of a subject living in a OECD country with a life expectancy of 25 years to the gross national product was estimated by the world trade bank (1995) to amount to 20.000$, contrary to 333$ of a subject of the third world with a life expectancy of 15 years; → see also health care costs, marginal costs, time trade-off, willingness to pay. ecotoxicity Potential toxic effects of man-made chemicals upon the environment; → see also toxicity. EC type-examination (of a medical device) Procedure “whereby a notified body ascertains and certifies that a representative sample of the production covered fulfils the relevant provisions of the Council Directive 93/42/EEC”; → see also ec type-examination certificate. EC type-examination certificate (of a medical device) Document issued by an authority summarizing the conclusions of an inspection, the conditions of validity and the data needed for identification of the type of devices approved. The relevant parts of the documentation must be annexed to the certificate. A copy is kept by the notified body; → see also ec type-examination. EC verification Procedure whereby the manufacturer or his authorized representative established in the European Community
ecv