Evaluating the impact of patient-reported outcome measures on depression and anxiety levels in people with multiple sclerosis: a study protocol for a randomized controlled trial

BMC Neurology

Study Protocol

Penelope Smyth¹  Nathan Y. Chu¹  Lily Yushko²  Kaitlyn E. Watson²  Yazid N. Al Hamarneh³  Ross T. Tsuyuki⁴ 

[1] Department of Medicine, Division of Neurology, University of Alberta, 7-132B Clinical Sciences Building, 8440 112 Street NW, T6G 2B7, Edmonton, AB, Canada;EPICORE (Epidemiology Coordinating and Research) Centre, Department of Medicine, University of Alberta, Edmonton, AB, Canada;EPICORE (Epidemiology Coordinating and Research) Centre, Department of Medicine, University of Alberta, Edmonton, AB, Canada;Department of Pharmacology, University of Alberta, Edmonton, AB, Canada;EPICORE (Epidemiology Coordinating and Research) Centre, Department of Medicine, University of Alberta, Edmonton, AB, Canada;Department of Pharmacology, University of Alberta, Edmonton, AB, Canada;Department of Medicine, University of Alberta, Edmonton, AB, Canada;

关键词: Multiple sclerosis;    Patient-reported outcome measures;    Patient satisfaction;    Depression;    Anxiety;    HADS;    Healthcare delivery;   

DOI  :  10.1186/s12883-023-03090-0

 received in 2022-10-03, accepted in 2023-01-25,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundMultiple sclerosis (MS) is a chronic disease affecting multiple functional aspects of patients’ lives. Depression and anxiety are common amongst persons with MS (PwMS). There has been an interest in utilizing patient-reported outcome measures (PROMs) to capture and systematically assess patient’s perceptions of their MS experience in addition to other clinical measures, but PROMs are not usually collected in routine clinical practice. Therefore, this study aims to systematically incorporate periodic electronically administered PROMs into the care of PwMS to evaluate its effects on depression and anxiety.MethodsA randomized controlled trial will be conducted with patients allocated 1:1 to either intervention or conservative treatment groups. Patients in the intervention group will complete PROMs at the start of the study and then every 6 months for 1 year, in addition to having their MS healthcare provider prompted to view their scores. The conservative treatment group will complete PROMs at the start of the study and again after 12 months, and their neurologist will not be able to view their scores. For both groups, pre-determined critical PROM scores will trigger an alert to the patient’s MS provider. The difference in change in Hospital Anxiety and Depression Scale score between the intervention and conservative treatment groups at 12 months will be the primary outcome, along with difference in Consultation Satisfaction Questionnaire and CollaboRATE scores at 12 months, and proportion and type of healthcare provider intervention/alerts initiated by different PROMs as secondary outcomes.DiscussionThis study will determine the feasibility of utilizing PROMs on an interval basis and its effects on the psychological well-being of PwMS. Findings of this study will provide evidence on use of PROMs in future MS clinical practice.Trial registrationThis trial is registered at the National Institutes of Health United States National Library of Medicine, ClinicalTrials.gov NCT04979546. Registered on July 28, 2021.

【 授权许可】

CC BY   
© The Author(s) 2023

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