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Implementation Analysis
 

In close interaction with patient representatives, we develop a concept to evaluate and support the implementation of the Clinical Decision Support System (CDSS; compare Research Project CDSS) and its impact on patient well-being, its acceptance by patients, medical professionals, and important stake holders (e. g., hospital administrations, health insurance companies, regulatory entities) as well as its economic impact and potential cost-effectiveness. This research project, therefore, pursues two main goals:

Firstly, we evaluate the cost implications and cost-effectiveness of the personalized treatment approach bymaking long-term projections based on decision modeling, in addition to a trial-based short-term health-economic evaluation. By this approach, we identify factors influencing cost-effectiveness under routine conditions and over a relevant time horizon.

Secondly, we establish validity, usability, acceptance, risk profile, and patient benefit of the CDSS asking two questions: 1. How reproducible are the model predictions and which variance do they show when the model is applied in different centers under different conditions on different populations? 2. How usable and safe is the CDSS when applied by clinical staff in daily routine and how well is it accepted? We expect to generate quantitative, statistically significant data on the risk/benefit profile, which will provide sufficient evidence to decide on the potential for certification of the CDSS as medical device.

Representatives from Alpha1 Deutschland e. V., the German association for individuals with Alpha1-antitrypsin deficiency, participate in all steps of the socio-economical analysis, provide guidance on desirable outcomes, and important criteria from the patients’ perspective.

People involved

Principal Investigators

Prof. Dr. Rolf Holle

Institute for Medical Information Processing, Biometry, and Epidemiology (IBE)
Ludwig-Maximilians-Universität München

Tina Schleicher

LabVantage Biomax

Postdoctoral Researcher

Dr. Tobias Niedermaier

Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE)
Ludwig-Maximilians-Universität München

Patients' Representative

Marion Wilkens

Gesellschaft für Alpha 1-Mangel-Erkrankte e. v. (Alpha 1 Deutschland e. V.)