Christoph Heesen1, Ingo Kleiter2, Sven G Meuth3, Julia Krämer3, Jürgen Kasper4, Sascha Köpke5, Wolfgang Gaissmaier6. 1. Institut für Neuroimmunologie und Multiple Sklerose (INIMS), Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 2046 Hamburg, Germany. Electronic address: heesen@uke.uni-hamburg.de. 2. Department of Neurology, St. Josef-Hospital, Ruhr-University-Bochum, Gudrunstr. 56, 44791 Bochum, Germany. 3. Department of Neurology, Neurology Clinic and Institute of Translational Neurology, Westfälische Wilhelms University, Albert Schweizer Campus 1, 48149 Münster, Germany. 4. Department of Health and Caring Sciences, Faculty of Health Sciences, University of Tromsø, Hansine Hansens veg 18, 9019 Tromsø, Norway. 5. Institute of Social Medicine, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, 23538 Lübeck, Germany. 6. Department of Psychology, University of Konstanz, Universitätsstraße 10, 78464 Konstanz, Germany.
Abstract
BACKGROUND: Natalizumab (NAT) is associated with the risk of progressive multifocal leukoencephalopathy (PML). Risk stratification algorithms have been developed, however, without detectable reduction of PML incidence. OBJECTIVE: To evaluate to which extent patients and physicians understand and accept risks associated with NAT treatment. METHODS: Prospective observational cohort study in German MS centers (n=73) among NAT-treated MS patients (n=801) and their neurologists (n=99). Patients included in this study had mean disease duration of 10.2years and a mean NAT treatment duration of 24months. RESULTS: More than 90% of patients and physicians voted for shared decision making or an informed choice decision making approach. Patients and physicians perceived a similar threat from MS as serious disease and both overestimated treatment benefits from NAT based on trial data. Men perceived MS more severe than women and perception of seriousness increased with age in both groups and in patients as well with increasing disability. Although patients evaluated their PML risk higher, their risk acceptance was significantly higher than of their neurologists. Risk stratification knowledge was good among neurologists and significantly lower among patients. CONCLUSION: While patients and physicians seem to have realistic risk perception of PML and knowledge of risk stratification concepts, the threat of MS and the perception of treatment benefits may explain the ongoing high acceptance of PML risk.
BACKGROUND:Natalizumab (NAT) is associated with the risk of progressive multifocal leukoencephalopathy (PML). Risk stratification algorithms have been developed, however, without detectable reduction of PML incidence. OBJECTIVE: To evaluate to which extent patients and physicians understand and accept risks associated with NAT treatment. METHODS: Prospective observational cohort study in German MS centers (n=73) among NAT-treated MS patients (n=801) and their neurologists (n=99). Patients included in this study had mean disease duration of 10.2years and a mean NAT treatment duration of 24months. RESULTS: More than 90% of patients and physicians voted for shared decision making or an informed choice decision making approach. Patients and physicians perceived a similar threat from MS as serious disease and both overestimated treatment benefits from NAT based on trial data. Men perceived MS more severe than women and perception of seriousness increased with age in both groups and in patients as well with increasing disability. Although patients evaluated their PML risk higher, their risk acceptance was significantly higher than of their neurologists. Risk stratification knowledge was good among neurologists and significantly lower among patients. CONCLUSION: While patients and physicians seem to have realistic risk perception of PML and knowledge of risk stratification concepts, the threat of MS and the perception of treatment benefits may explain the ongoing high acceptance of PML risk.
Authors: Anne Christin Rahn; Alessandra Solari; Heleen Beckerman; Richard Nicholas; David Wilkie; Christoph Heesen; Andrea Giordano Journal: Int J MS Care Date: 2020-12-28
Authors: Hiba El Masri; Treasure M McGuire; Christine Dalais; Mieke van Driel; Helen Benham; Samantha A Hollingworth Journal: J Med Libr Assoc Date: 2022-04-01