https://orcid.org/0000-0001-9978-0198
Abstract
Purpose
Shared decision-making is critical in multiple sclerosis (MS) due to the uncertainty of the disease trajectory over time and the large number of treatment options with differing efficacy, safety and administration characteristics. The aim of this study was to assess patients’ decisional conflict regarding the choice of a disease-modifying therapy and its associated factors in patients with mid-stage relapsing-remitting multiple sclerosis (RRMS).
Methods
A multicenter, non-interventional study was conducted. Adult patients with a diagnosis of RRMS (2017 revised McDonald criteria) and disease duration of 3 to 8 years were included. The level of uncertainty experienced by a patient when faced with making a treatment choice was assessed using the 4-item Decisional Conflict Scale. A battery of patient-reported and clinician-rated measures was administered to obtain information on symptom severity, illness perception, illness-related uncertainty, regret, MS knowledge, risk taking behavior, preferred role in the decision-making process, cognition, and self-management. Patients were recruited during routine follow-up visits and completed all questionnaires online using electronic tablets at the hospital. A multivariate logistic regression analysis was conducted.
Results
A total of 201 patients were studied. Mean age (Standard deviation) was 38.7 (8.4) years and 74.1% were female. Median disease duration (Interquartile range) was 6.0 (4.0–7.0) years. Median EDSS score was 1.0 (0–2.0). Sixty-seven (33.3%) patients reported a decisional conflict. These patients had lower MS knowledge and more illness uncertainty, anxiety, depressive symptoms, fatigue, subjective symptom severity, a threatening illness perception, and poorer quality of life than their counterparts. Lack of decisional conflict was associated with MS knowledge (Odds ratio [OR]=1.195, 95% CI 1.045, 1.383, p=0.013), self-management (OR=1.049, 95% CI 1.013, 1.093, p=0.018), and regret after a healthcare decision (OR=0.860, 95% CI 0.756, 0.973, p=0.018) in the multivariate analysis.
Conclusion
Decisional conflict regarding the selection of a disease-modifying therapy was a common phenomenon in patients with mid-stage RRMS. Identifying factors associated with decisional conflict may be useful to implement preventive strategies that help patients better understand their condition and strengthen their self-management resources.
Acknowledgments
The authors are most grateful to all patients, neurologists, and nurses participating in the study. This manuscript has not been previously published and is not under consideration elsewhere. The abstract of this paper was presented at the 77th American Academy of Neurology (AAN) Annual Meeting as a poster presentation with interim findings (Poster P2-6.008; Denver, USA; Neurology. 2024;102 (17 Supplement 1) https://www.neurology.org/doi/10.1212/WNL.0000000000204450
Author Contributions
All authors made a significant contribution to the work reported, whether in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all of these areas; all took part in drafting, revising or critically reviewing the article; all gave final approval of the version to be published; all have agreed on the journal to which the article has been submitted; and all agree to be accountable for all aspects of the work.
Disclosure
Julia Sabin received honoraria for lecturing, consulting or travel expenses from Biogen, Merck, Teva, Novartis, BMS, Janssen, Almirall, Roche and Sanofi. Jesús Martín-Martínez served on scientific advisory boards and/or received speaking honoraria, research funding and support to attend scientific meetings from Biogen, Merck, Novartis, Roche and Teva. Francisco Javier Barrero received compensation for consulting services and speaking honoraria from Almirall, Biogen, Genzyme, Merck, Novartis, Roche, Sanofi and Teva. Ana Alonso received compensation for consulting services from Biogen, BMS, Sanofi, Roche, Janssen and Novartis; and speaking honoraria from Biogen, BMS, Sanofi, Roche, Janssen, Merck, Almirall and Novartis. José Luis Sánchez-Menoyo received support to attend scientific meetings from Novartis, Merck, and Biogen; speaking honoraria from Biogen, Novartis, Sanofi, Merck, Almirall, Bayer and Teva; and participated in clinical trials from Biogen, Merck and Roche. Laura Borrega received compensation for consulting services, speaking honoraria and support to attend scientific meetings from Bayer, Celgene, Biogen, Sanofi, Merck, Novartis, Roche, Almirall and Teva. Monserrat Gómez-Gutiérrez received honoraria as speaker from Biogen, BMS, Janssen, Merck, Mylan, Novartis, Roche, Sanofi and Bial. Sara Eichau received consulting fees and lecture honoraria from Biogen, Novartis, Sanofi, Merck, Roche and Almirall. Carmen Calles received compensation for consulting services, speaking honoraria and support to attend scientific meetings and courses from Merck, Teva, Sanofi, Novartis, Biogen, Roche, and BMS. Eva Fernández-Díaz received honoraria and travel expenses for participation in scientific meetings and advisory boards from Almirall, Biogen, Merck, Roche and Sanofi. Olga Carmona received honoraria for speaker services and advisory boards from Sanofi, Roche, Janssen and Merck. Aida Orvíz received research grants, travel support, advisory activities or honoraria for speaking engagements from Almirall, Biogen, BMS, Merck, Mylan, Novartis, Roche, Sanofi, and Teva. Ana López-Real received speaker and consultation fees, and congress travel support from Biogen, Janssen, Merck, Novartis, Roche and Sanofi. Amelia Mendoza received research grants, travel support or honoraria for speaking engagements from Biogen, Merck, Novartis, Roche, Sanofi, and Teva. Eduardo Agüera received speaking honoraria from Roche, Novartis, Merck, Sanofi and Biogen. Elisa Salas and Jorge Maurino are employees of Roche Farma Spain. The authors report no other conflicts of interest in this work.