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Global Assessment Measures for Assessing Efficacy in Dementia Drug Trials

Published online by Cambridge University Press:  02 December 2014

Kenneth Rockwood
Kenneth Rockwood*
Affiliation:
The Division of Geriatric Medicine, Dalhousie University, Halifax, NS, Canada
*
Division of Geriatric Medicine, Dalhousie University, 1421-5955 Veterans' Memorial Lane, Halifax, Nova Scotia, B3H 1C6, Canada.
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Abstract

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The use of judgment-based global measures of clinical treatment effects has a long history in the regulatory approval of drugs for the treatment of dementia. This paper reviews current use of these measures, noting several practical difficulties with their implementation. Importantly, global measures have usually yielded general estimates of drug effects similar to psychometric test batteries, even though correlations between global and psychometric measures at the individual patient level is modest. Like psychometric tests, global measures can tell us that some clinically detectable effect is present but often yield only limited evidence about what those effects might be. Steps should be taken to improve the specificity of treatment effect description and to incorporate patient/caregiver preferences in global measures about disease treatment in dementia.

Résumé:

RÉSUMÉ:

D'un point de vue historique, des mesures globales des effets du traitement fondées sur le jugement ont été utilisées pour l'approbation de médicaments pour traiter la démence. Cet article revoit l'utilisation actuelle de ces mesures tout en signalant plusieurs difficultés pratiques associées à leur application. Il est important de noter que les mesures globales ont habituellement fourni des estimés généraux des effets thérapeutiques qui sont semblables aux batteries de tests psychométriques, même si la corrélation entre les mesures globales et psychométriques au niveau individuel est modeste. Comme les tests psychométriques, les mesures globales peuvent indiquer qu'il y a certains effets cliniques qui sont détectables, mais elles fournissent souvent des données limitées sur ce que pourraient être ces effets. La spécificité de la description des effets du traitement et l'intégration des préférences du patient/soignant devraient être améliorées dans les mesures globales du traitement de la démence.

Type
Original Articles
Information
Canadian Journal of Neurological Sciences , Volume 34 , Issue S1 , March 2007 , pp. S52 - S56
Copyright
Copyright © The Canadian Journal of Neurological 2007

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