Diagnostic and economic evaluation of new biomarkersfor Alzheimer's disease: the research protocol of a prospective cohort study Full Text
BMC Neurology, 08/20/2012
Handels RLH et al. – Several other multi–centre trials study the relative value of new biomarkers for early evaluation of AD and related disorders. The uniqueness of this study is the assessment of resource utilization and quality of life to enable an economic evaluation. The study results are generalizable to a population of patients who are referred to a memory clinic due to their memory problems.Methods
- In a cohort design 223 consecutive patients suspected of having a primary neurodegenerative disease are approached in four academic memory clinics and followed for two years.
- Clinical data and data on quality of life, costs and emerging biomarkers are gathered.
- Diagnostic test accuracy is determined by relating the clinical practice and new research criteria diagnoses to the reference diagnosis.
- The clinical practice diagnosis at baseline is reflected by a consensus procedure among experts using clinical information only (no biomarkers).
- The diagnosis based on the new research criteria is reflected by decision rules that combine clinical and biomarker information.
- The reference diagnosis is determined by a consensus procedure among experts based on clinical information on the course of symptoms over a two–year time period.
- A decision analytic model is built combining available evidence from different resources among which (accuracy) results from the study, literature and expert opinion to assess long–term cost–effectiveness of the emerging biomarkers.