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.
RCT Entities:
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.
Authors: Edward J D Webb; David Meads; Ieva Eskyte; Natalie King; Naila Dracup; Jeremy Chataway; Helen L Ford; Joachim Marti; Sue H Pavitt; Klaus Schmierer; Ana Manzano Journal: Patient Date: 2018-08 Impact factor: 3.883
Authors: Jeri Burtchell; Daisy Clemmons; Joann Clemmons; Tim Sabutis; Adeline Rosenberg; Jennifer Graves; Michael L Sweeney; John Kramer; Marina Ziehn; Brandon Brown; Jamie L Weiss; Ahmed Z Obeidat Journal: Neurol Ther Date: 2022-05-24
Authors: Elena Álvarez-Rodríguez; César Manuel Sánchez-Franco; María José Pérez-Haro; Laura Bello-Otero; Marta Aguado-Valcarcel; Inés González-Suárez Journal: PLoS One Date: 2022-05-13 Impact factor: 3.752
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: France Légaré; Rhéda Adekpedjou; Dawn Stacey; Stéphane Turcotte; Jennifer Kryworuchko; Ian D Graham; Anne Lyddiatt; Mary C Politi; Richard Thomson; Glyn Elwyn; Norbert Donner-Banzhoff Journal: Cochrane Database Syst Rev Date: 2018-07-19