International Psychogeriatrics



Consensus statement

International Psychogeriatric Association consensus statement on defining and measuring treatment benefits in dementia


Cornelius Katona a1c1 1 , Gill Livingston a2 1 , Claudia Cooper a3 1 , David Ames a4 1 , Henry Brodaty a5 1 , Edmond Chiu a6 1 and on behalf of the Consensus Group 1
a1 World Federation of Societies of Biological Psychiatry, Professor and Dean, Kent Institute of Medicine and Health Sciences, University of Kent, Canterbury, U.K.
a2 World Federation of Societies of Biological Psychiatry, Professor of Psychiatry for Older People, Centre for Ageing and Mental Health Science, University College London, London, U.K.
a3 Centre for Ageing and Mental Health Science, University College, London, U.K.
a4 University of Melbourne Academic Unit for Psychiatry of Old Age, Kew, Australia
a5 Primary Dementia Collaborative Research Centre, University of New South Wales, Sydney, Australia
a6 University of Melbourne Academic Unit for Psychiatry of Old Age, Kew, Australia

Article author query
katona c   [PubMed][Google Scholar] 
livingston g   [PubMed][Google Scholar] 
cooper c   [PubMed][Google Scholar] 
ames d   [PubMed][Google Scholar] 
brodaty h   [PubMed][Google Scholar] 
chiu e   [PubMed][Google Scholar] 

Abstract

Current symptomatic treatments for dementia have only modest efficacy. Assessing meaningful benefits in this variably progressive syndrome is complex and difficult. This consensus statement was generated by an international group representing caregivers, organizations and professionals with expertise in dementia.

We recommend the statement of clear, pre-defined diagnostic and severity criteria and outcome measures, which include functional and executive capacity, in treatment trials. Outcomes can include effects on people with dementia (PWD) with regard to cognition, behavioral and psychological symptoms, quality of life, global assessments, and activities of daily living, and must be tailored to the education and culture of the participants. Outcomes can also appropriately encompass effects on caregivers. New instruments may be needed, as validation of many existing measures has been in relatively homogenous populations. Treatment goals can be to prevent dementia emerging, or in those with established dementia to slow deterioration, and to postpone, stabilize or improve symptoms. Comparisons between treatment groups should be on the basis of clinically relevant measures with both risk and benefit reported for all participants regardless of whether or not they continue to receive treatment throughout the trial. Characterization of any groups that respond well to treatment has been unsuccessful to date, but may be facilitated in the future by measurement of putative biomarkers. Despite considerable recent progress and several ‘candidate’ biomarkers, none is yet satisfactory for determining diagnosis, severity, progression or prediction of response.

To provide meaningful data, economic analyses should use up-to-date, country-specific data. Health economic measures should be incorporated as secondary outcomes in all Phase 3 trials since health systems are concerned with cost-effectiveness as well as clinical outcome. Health utility measures are not, however, validated satisfactorily in dementia, thus calling into question previous health economic analyses. While current drugs appear to reduce the amount of family caregiver time required by PWD, these costs fall in the main on older individuals who often exert little political leverage, rather than on society at large. Traditionally, elderly people have been marginalized in the political process. The growth in the older population across the world, and their potential for increasing political empowerment may lead to a radical re-evaluation of the economics of treatment in dementia.

(Published Online March 27 2007)


Key Words: dementia; treatment; randomized controlled trials; outcomes; measurement; caregivers; biomarkers; Alzheimer's disease; health economics; culture.

Correspondence:
c1 Correspondence should be addressed to: Professor C. Katona, Kent Institute of Medicine and Health Sciences, University of Kent, Canterbury CT2 7PD, U.K. Phone: +44 (0) 1227 824063; Fax: +44 (0) 1227 824054. Email: c.katona@kent.ac.uk.


Footnotes

1 Members of the consensus group are listed in Appendix 1.