C Wild1, S Mathis, B Guba, G Gartlehner. 1. Ludwig Boltzmann Institut für Health Technology Assessment, Garnisongasse 7/20, 1090 Wien, Osterreich. Claudia.wild@hta.lbg.ac.at
Abstract
BACKGROUND: In Austria, Rheopheresis for non-exudative age-related macular degeneration (AMD) has been proposed for inclusion into the benefit catalogue. Decisions on the inclusion of new medical interventions in reimbursement schemes or benefit catalogues are increasingly based on systematic reviews of clinical studies and their patient-relevant results. MATERIAL AND METHODS: A systematic literature search in five databases identified two randomised clinical trials (RCTs). A systematic analysis of the evidence based on the critical appraisal of the RCTs was carried out. RESULTS: Both RCTs, having a total of 238 included patients, show that to date, evidence for the effectiveness of Rheopheresis for AMD is not available, and predictions for exact indications cannot be made. The bigger RCT showed no effect at all, and the smaller one showed a small effect with questionable clinical relevance. CONCLUSION: Available clinical data suggest considering Rheopheresis an experimental intervention. Its inclusion in the benefit catalogue is not recommended.
BACKGROUND: In Austria, Rheopheresis for non-exudative age-related macular degeneration (AMD) has been proposed for inclusion into the benefit catalogue. Decisions on the inclusion of new medical interventions in reimbursement schemes or benefit catalogues are increasingly based on systematic reviews of clinical studies and their patient-relevant results. MATERIAL AND METHODS: A systematic literature search in five databases identified two randomised clinical trials (RCTs). A systematic analysis of the evidence based on the critical appraisal of the RCTs was carried out. RESULTS: Both RCTs, having a total of 238 included patients, show that to date, evidence for the effectiveness of Rheopheresis for AMD is not available, and predictions for exact indications cannot be made. The bigger RCT showed no effect at all, and the smaller one showed a small effect with questionable clinical relevance. CONCLUSION: Available clinical data suggest considering Rheopheresis an experimental intervention. Its inclusion in the benefit catalogue is not recommended.
Authors: Michael Janusz Koss; Peter Kurz; Theoharis Tsobanelis; Walter Lehmacher; Cordula Fassbender; Reinhard Klingel; Frank H J Koch Journal: Graefes Arch Clin Exp Ophthalmol Date: 2009-07-23 Impact factor: 3.117