Risk perception in natalizumab-treated multiple sclerosis patients and their neurologists

Abstract

Background: Natalizumab is associated with the potentially life-threatening side-effect progressive multifocal leukoencephalopathy (PML). Little is known about patients’ and physicians’ risk estimates and attitudes towards natalizumab treatment.

Methods: Consecutive natalizumab-treated patients (n = 69) and neurologists (n = 66) in two centres and cooperating private practices received an evidence-based three-page information leaflet about natalizumab-associated PML and an evaluation sheet.

Results: After reading the information, patients were significantly more likely than physicians to intend continuation of natalizumab treatment and willing to accept higher risks of PML: 49% of physicians would stop treatment at a PML risk of 2 : 10,000 or lower, while only 17% of patients would do so (p < 0.001). This difference could not be explained by risk calculation abilities or lack of understanding. Both groups overestimated natalizumab treatment effects.

Conclusion: Patients had a significantly worse perception of multiple sclerosis as a malignant disease. We conclude that patients were willing to accept a higher risk of PML than neurologists. Coherent with their perception of risks and benefits, patients were also more willing to continue treatment. Open information about treatment-related risks is appreciated and might support shared decision making.

Keywords

multiple sclerosis natalizumab progressive multifocal leukoencephalopathy risk perception shared decision making

Get full access to this article

View all access options for this article.

References

Filippini G. , Munari L. , Incorvaia B. , Ebers GC , Polman C. , D’Amico R. , et al. Interferons in relapsing remitting multiple sclerosis: a systematic review. Lancet 2003; 361: 545-552.

Whiting P. , Harbord R. , Main C. , Deeks JJ , Filippini G. , Egger M. , et al. Accuracy of magnetic resonance imaging for the diagnosis of multiple sclerosis: systematic review. BMJ 2006; 332: 875-884.

Heesen C. , Kasper J. , Kopke S. , Richter T. , Segal J. and Muhlhauser I.

Informed shared decision making in multiple sclerosis - inevitable or impossible?

J Neurol Sci 2007; 259: 109-117.

Rothwell PM , McDowell Z. , Wong CK and Dorman PJ Doctors and patients don’t agree: cross-sectional study of patients’ and doctors’ perceptions and assessments of disability in multiple sclerosis . BMJ 1997; 314: 1580-1583.

Heesen C. , Kolbeck J. , Gold SM , Schulz H. and Schulz KH Delivering the diagnosis of MS - results of a survey among patients and neurologists . Acta Neurol Scand 2003; 107: 363-368.

Kasper J. , Kopke S. , Muhlhauser I. and Heesen C. Evidence-based patient information about treatment of multiple sclerosis - a phase one study on comprehension and emotional responses. Patient Educ Couns 2006; 62: 56-63.

O’Connor AM , Wennberg JE , Legare F. , Llewellyn-Thomas HA , Moulton BW , Sepucha KR , et al. Toward the ‘tipping point’: decision aids and informed patient choice . Health Aff (Millwood) 2007; 26: 716-725.

Polman CH , O’Connor PW , Havrdova E. , Hutchinson M. , Kappos L. , Miller DH , et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006; 354: 899-910.

Rudick RA , Stuart WH , Calabresi PA , Confavreux C. , Galetta SL , Radue EW , et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis . N Engl J Med 2006; 354: 911-923.

10.

Major EO Progressive multifocal leukoencephalopathy in patients on immunomodulatory therapies. Annu Rev Med 2010; 61: 35-47.

11.

PML Inzidenz [online]. Available at: http://tysabri.de/index.php?inhalt=tysabri.pmlinzidenz. (accessed June 2010).

12.

Gold R. , Hartung H. , Hohlfeld R. , et al. Therapy of multiple sclerosis with monoclonal antibodies. Results and recommendations of a Symposium of the Medical Advisory Board of the German MS Society. Aktuelle Neurologie 2009; 36: 334-344.

13.

Gigerenzer G. , Gaissmaier W. , Kurz-Milcke E. , Schwartz L. and Woloshins S. Helping doctors and patients make sense of health statistics. Psychol Sci Public Interest 2007; 8: 53-96.

14.

Bunge M. , Muhlhauser I. and Steckelberg A. What constitutes evidence-based patient information? Overview of discussed criteria. Patient Educ Couns 2010; 78: 316-328.

15.

GMC ‘Consent: patients and doctors making decisions together’ , Available at: http://www.gmc-uk.org/static/documents/content/Consent_2008.pdf (accessed January 2010).

16.

Kurtzke JF Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983; 33: 1444-1452.

17.

Schwartz LM , Woloshin S. and Welch HG Can patients interpret health information? An assessment of the medical data interpretation test. Med Decis Making 2005; 25: 290-300.

18.

Boeije HR and Janssens Acjw. ‘It might happen or it might not’: how patients with multiple sclerosis explain their perception of prognostic risk. Soc Sci Med 2004; 59: 861-868.

19.

Johnson FR , Ozdemir S. , Mansfield C. , Hass S. , Miller DW , Siegel CA , et al. Crohn’s disease patients’ risk-benefit preferences: serious adverse event risks versus treatment efficacy. Gastroenterology 2007; 133: 769-779.

20.

Shaffer V. and Hulsey L. Are patient decision aids effective? Insight from revisiting the debate between correspondence and coherence theories of judgment. Judgment Decis Mak 2009; 4: 141-146.

21.

Hauser SL and Johnston SC Balancing risk and reward: the question of natalizumab. Ann Neurol 2009; 66: A7-A8.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.30 MB

0.05 MB