Publication of the international psychogeriatric association consensus statement on defining and measuring treatment benefits in dementia

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In the 2006 Editorial comment in this section of Current Opinion in Psychiatry[1], we referred to a consensus conference to be held from 31 October to 1 November 2006 at Canterbury, UK, to develop a consensus statement on defining and measuring treatment benefits in dementia.
The successful outcome of this consensus conference is evidenced by the publication of such a consensus statement in International Psychogeriatrics, the official publication of the International Psychogeriatric Association [2••]. Key papers that underpinned the discussion at this conference are published along with the statement.
Perhaps the most relevant contribution came from two caregivers, Nurock and Wojciechowska [3], who opened the presentation with their personal views of what outcomes and benefits are important to them as caregivers. A more academic paper by Brodaty [4] included an extensive list of potential instruments and recommendations for measuring caregiver outcomes.
The heterogeneity of sampling in dementia clinical trials was highlighted by Folstein [5], who recommended a reduction of such heterogeneity by the administration of a risk factor inventory for patient allocation or selection of drug responders. An overview of the biological markers as potential outcome measures by Takeda et al.[6] raised the future possibility of surrogate markers.
Rabins and Black [7] highlighted the critical construct of health-related quality of life (QOL) and the strength and limitations of QOL research, and advocated QOL as a core outcome in trials of antidementia therapies. Behavioural and psychological symptoms of dementia or neuropsychiatric symptoms constitute a major challenge in caring for people with dementia. Lyketsos [8] proposed that an important advance might come through empirical characterisation of clinically meaningful changes in neuropsychiatric symptoms (behavioural and psychological symptoms of dementia) by examining their relationships with dementia care burden, disability, QOL, caregiver stress, and resource utilisation.
Global measures found support from Reisberg [9] who provided, in his lengthy paper, a detailed examination of the utility of such measures in assessing treatment response in incipient and progressive Alzheimer disease.
As the majority of people with dementia live in the less developed countries, the paper by Chiu and Lam [10] remind us that biological markers might not be a practical outcome due to cost and unacceptability. The area of QOL, through improvement in behavioural and psychological symptoms of dementia, may be useful. Further work in less developed countries is needed to establish the practical applicability, acceptability, cost, and utility of any outcome measures.
This discussion was followed by a cogent and thoughtful paper by Rockwood [11], who raised the issue of functional outcomes as being most prized by patients and their caregivers and physicians. Such outcome measures are not always sensitive to change, however, so that we are left with a challenge regarding how best to improve sensitivity to change in these measures to make them more useful.
In this era of health economics as a central driver of healthcare policy, the two papers on the economic outcomes in dementia treatment by Knapp [12] and Wimo [13] are instructive in setting the issues in a political/policy context. These two papers [12,13] are important reading for all clinicians and policy makers involved in the care of people with dementia.
Finally, Broich [14], from the European regulatory agency, provided a clear outline of the regulatory environment and the requirements for the approval of any new medicinal products for symptomatic improvement or disease modifying effects in patients with dementia. Broich [14] provided a reality-based regulatory framework for the consideration of treatment benefits required for obtaining regulatory support.

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