• Nina Rieckmann, Christoph Schwarzbach, Marc Nocon, Stefanie Roll, Christoph Vauth, Stefan N Willich, and Wolfgang Greiner.
• Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin, Berlin, Deutschland.
• GMS Health Technol Assess. 2009 Jan 1;5:Doc01.

IntroductionToday there are approximately one million people with dementia in Germany. If current demographic trends continue, this number is likely to rise substantially in the coming years. In the older population, dementia is the most frequent reason for long-term care. Because most forms of dementia cannot be cured, the aim of treatment is to delay disease progression and to maintain functioning and quality of life.Research QuestionsWhat is the evidence on different approaches to the long-term usual care of patients with dementia in terms of common endpoints such as quality of life, and social behaviour? How is the cost-effectiveness of these concepts to be evaluated? Which ethical, social, or legal issues are discussed in this context?MethodsBased on a systematic literature review, we include randomized, controlled studies that had at least 30 participants and investigated one or more of the following approaches of dementia care: validation therapy/emotion-oriented usual care, ergotherapy, sensory stimulation, relaxation techniques, reality orientation therapy, and reminiscence therapy. Studies had to be published after 1996 (after 1990 for the economic part) in English or German.ResultsA total of 20 studies meet the inclusion criteria. Of these, three focus on validation therapy/emotion-oriented usual care, five on ergotherapy, seven on different kinds of sensory stimulation, two on reality orientation, two on reminiscence therapy, and one on a type of relaxation technique. There are no significant differences between the intervention and control groups in two of the three studies on validation therapy or emotion-oriented usual care, in two of the five studies on ergotherapy, in three of the seven studies on sensory stimulation, in both of the two studies on reminiscence therapy, and in the one study on relaxation. In the remaining ten studies, seven report some positive results in favour of the respective interventions, and three studies (ergotherapy, aroma therapy, and music/massage) report positive effects with respect to all of the endpoints measured. Six publications present economic results for usual-care-concepts. One study reports additional costs of 16 GBP (24.03 Euro (2006)) per patient per week for occupational therapie. Two publications declare incremental cost of 24.30 USD (25.62 Euro (2006)) per mini-mental-state-examination-(MMSE)-point gained per month respectively 1,380,000 ITL (506.21 Euro (2006)) per MMSE-point gained. Two publications focus on mixed interventions. One study reports the additional costs of an activity program (1.13 USD (1.39 Euro (2006)) per day per patient) and the other additional time for the usual care for mobile demented patients (average of 45 minutes per day per patient). WITH RESPECT TO ETHICAL AND SOCIAL ASPECTS THE DISCUSSION FOCUSSES ON THE PROBLEM OF AUTONOMY: dementia does not necessarily mean inability to decide over the participtation in studies. Legal questions address the financial situation of patients, the organisation of their care and the legal representation of dementia patients.DiscussionOnly a few studies on the nursing interventions considered in this report are methodologically robust. Most of the studies have a small number of participants and show substantial differences in terms of their inclusion criteria, implementation, and endpoints. THIS HETEROGENEITY IS REFLECTED IN THE RESULTS: in half of the studies, the interventions have no positive effects compared to the control group. The other half of the studies reports some positive effects with regard to specific endpoints. All of the economic studies are, from a methodologial and a thematic standpoint, not suitable to answer the questions raised. Ethical, social and legal aspects are discussed but not systematically analysed.ConclusionThe studies conducted to date do not provide sufficient evidence of neither efficacy nor cost-effectiveness for any of the nursing interventions considered in the present HTA. However, lack of evidence does not mean lack of efficacy. Instead, more methodologically sound studies are needed. Particullary desireable are studies reflecting the framework of dementia care in Germany. This holds also for the healtheconomic evaluations of the chosen interventions.

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