Benefit-risk perception of natalizumab therapy in neurologists and a large cohort of multiple sclerosis patients
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Benefit-risk perception of natalizumab therapy in neurologists and a large cohort of multiple sclerosis patients. / Heesen, Christoph; Kleiter, Ingo; Meuth, Sven G; Krämer, Julia; Kasper, Jürgen; Köpke, Sascha; Gaissmaier, Wolfgang.
in: J NEUROL SCI, Jahrgang 376, 07.03.2017, S. 181-190.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Benefit-risk perception of natalizumab therapy in neurologists and a large cohort of multiple sclerosis patients
AU - Heesen, Christoph
AU - Kleiter, Ingo
AU - Meuth, Sven G
AU - Krämer, Julia
AU - Kasper, Jürgen
AU - Köpke, Sascha
AU - Gaissmaier, Wolfgang
N1 - Copyright © 2017 Elsevier B.V. All rights reserved.
PY - 2017/3/7
Y1 - 2017/3/7
N2 - 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.
AB - 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.
KW - Journal Article
U2 - 10.1016/j.jns.2017.03.001
DO - 10.1016/j.jns.2017.03.001
M3 - SCORING: Journal article
C2 - 28431609
VL - 376
SP - 181
EP - 190
JO - J NEUROL SCI
JF - J NEUROL SCI
SN - 0022-510X
ER -