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Titolo:
Design issues for drug epidemiology
Autore:
McMahon, AD; MacDonald, TM;
Indirizzi:
Univ Glasgow, Robertson Ctr Biostat, Glasgow G12 8QQ, Lanark, Scotland Univ Glasgow Glasgow Lanark Scotland G12 8QQ ow G12 8QQ, Lanark, Scotland Univ Dundee, Med Monitoring Unit, Dundee DD1 9SY, Scotland Univ Dundee Dundee Scotland DD1 9SY oring Unit, Dundee DD1 9SY, Scotland
Titolo Testata:
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
fascicolo: 5, volume: 50, anno: 2000,
pagine: 419 - 425
SICI:
0306-5251(200011)50:5<419:DIFDE>2.0.ZU;2-S
Fonte:
ISI
Lingua:
ENG
Soggetto:
CLINICAL-TRIALS; COMPARATOR GROUPS; SELECTION; PRINCIPLES; EFFICACY; COHORT; RISK; PHARMACOEPIDEMIOLOGY; PHARMACOVIGILANCE; PARADIGM;
Keywords:
drug epidemiology; pharmacoepidemiology; study design;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
62
Recensione:
Indirizzi per estratti:
Indirizzo: McMahon, AD Univ Glasgow, Robertson Ctr Biostat, Boyd Orr Bldg, Glasgow G12 8QQ, Lanark, Scotland Univ Glasgow Boyd Orr Bldg Glasgow Lanark Scotland G12 8QQ and
Citazione:
A.D. McMahon e T.M. MacDonald, "Design issues for drug epidemiology", BR J CL PH, 50(5), 2000, pp. 419-425

Abstract

Despite the difficulties involved in designing drug epidemiology studies, these studies are invaluable for investigating the unexpected adverse effects of drugs. The aim of this paper is to discuss various aspects of study design, particularly those issues that are not easily found in either textbooks or review papers. We have also compared and contrasted drug epidemiology with the randomized controlled trial (RCT) wherever possible. Drug epidemiology is especially useful in the many situations where the RCT is not suitable, or even possible. The study base has to be defined before the appropriate cohort of subjects is assembled. If all of the cases are identified, then a referent sample of controls may be assembled by random sampling of the study base. If all of the cases cannot be assembled, a hypothetical secondary base may need to be created. Preferably, only new-users of the drug should be included, and the risk-ratio will be different for acute users andchronic users. Studies will usually only be possible when researching the unintended effects of drugs. It is difficult to study efficacy because of confounding by indication. In occasional circumstances it may be possible tostudy efficacy (examples are given). Discussion of the dangers of designing with generalisability in mind is provided. Additionally, the similaritiesin study design between drug epidemiology and the RCT are discussed in detail, as well as the design-characteristics that cannot be shared between the two methods.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/01/20 alle ore 03:38:38