Objective: To develop a strategy for the evaluation of unanticipated treatment effects in pharmacological therapy of Alzheimer’s disease.
Design: Randomized, controlled trial of galanatamine.
Materials and Methods: Videotaped patient-carer interviews, analyzed systematically using ATLAS-TI qualitative software.
Results: Understanding therapeutic effects in AD is complicated by the realization that the model of successful treatment is poorly specified. In the absence of a better specified model, the default understanding of what to look for as successful treatment is often disease reversal. More recent evidence, however, shows that this is an insensitive approach, and that many patients judged to have had treatment success have not, in fact, shown reversal of their disease symptoms. Instead, they manifest new combinations of symptoms and signs that do not correspond to recognized stages of AD. How to define the patterns that constitute successful treatment is an important challenge. One means of “looking for what you don’t know is there,” is to use open-ended measures, videotaped patient-carer interviews, and to analyze these interactions systematically. Each of these strategies is being followed in the VISTA trail. We report the design and methods of the study, and present information on the primary outcome (Goal Attainment Scaling). A technique for systematic qualitative analyses, using real-time, encrypted, web-based streaming and coding of video images will be presented.
Conclusion: A method of systematic qualitative analysis of videotaped patient/carer interviews allows for the detection of novel treatment effects. Their use in a double-blind, placebo-controlled trial allows for inferences about specific drug effects to be made.
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