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Research paper
Evidence-based patient information programme in early multiple sclerosis: a randomised controlled trial
  1. Sascha Köpke1,2,3,
  2. Simone Kern4,
  3. Tjalf Ziemssen4,
  4. Martin Berghoff5,
  5. Ingo Kleiter6,
  6. Martin Marziniak7,
  7. Friedemann Paul8,9,
  8. Eik Vettorazzi10,
  9. Jana Pöttgen2,
  10. Korbinian Fischer2,
  11. Jürgen Kasper2,3,11,
  12. Christoph Heesen2
  1. 1Institute of Social Medicine, University of Lübeck, Lübeck, Germany
  2. 2Department of Neurology, Institute for Neuroimmunology and Clinical MS Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  3. 3Unit of Health Sciences and Education, MIN Faculty, University of Hamburg, Hamburg, Germany
  4. 4Department of Neurology, MS-Center Dresden, University Clinic Carl Gustav Carus, Dresden, at the Dresden University of Technology, Dresden, Germany
  5. 5Department of Neurology, Justus Liebig University Giessen, Giessen, Germany
  6. 6Department of Neurology, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany
  7. 7Department of Neurology, University of Münster, Münster, Germany
  8. 8NeuroCure Clinical Research Center and Experimental and Clinical Research Center, Charité University Medicine Berlin and Max Delbrueck Center for Molecular Medicine, Berlin, Germany
  9. 9Department of Neurology, Clinical and Experimental Multiple Sclerosis Research Center, Charité University Medicine Berlin, Berlin, Germany
  10. 10Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  11. 11Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  1. Correspondence to Dr Sascha Köpke, University of Lübeck, Institute for Social Medicine and Epidemiology, Ratzeburger Allee 160, Lübeck D-23538, Germany; sascha.koepke{at}


Objective To evaluate the efficacy of an evidence-based patient information programme aiming to increase informed choice in patients with early multiple sclerosis (MS).

Background Patients with early MS face a number of uncertainties concerning diagnosis, prognosis and effectiveness of immunotherapy. Prior studies suggest that evidence-based patient information combined with group education can promote informed choice in MS patients.

Methods A 12-month, six-centre, double-blind randomised controlled clinical trial with 192 patients with a diagnosis of confirmed relapsing-remitting MS or clinical isolated syndrome in Germany. A 4-h interactive evidence-based educational programme was compared with a 4-h MS-specific stress management programme. The primary endpoint was informed choice after 6 months comprising risk knowledge and congruency between attitude towards immunotherapy and actual immunotherapy uptake. Secondary endpoints included autonomy preference, decision autonomy, decisional conflict and satisfaction, anxiety and depression, and number of immunotherapies.

Results For the primary endpoint, a significant difference was shown with 50 of 85 (59%) participants in the intervention group achieving informed choice after 6 months compared with 18 of 89 (20%) in the control group (OR 0.2 (95% CI 0.1 to 0.4), p<0.001). Four weeks after the intervention, more participants in the intervention group showed good risk knowledge (difference between groups 39% (95% CI 26% to 53%), p<0.001). There were no significant differences between groups for attitude towards immunotherapy and for immunotherapy uptake. There were trends towards increased autonomy preference after the intervention and increased adherence to immunotherapies in the intervention group.

Conclusions The intervention significantly increased informed choice and relevant risk knowledge without negative side effects.

  • Multiple Sclerosis

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