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
Abstract Background Multiple 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...
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | BMC Neurology |
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| Online Access: | https://doi.org/10.1186/s12883-023-03090-0 |
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| author | Nathan Y. Chu Kaitlyn E. Watson Yazid N. Al Hamarneh Lily Yushko Ross T. Tsuyuki Penelope Smyth |
| author_facet | Nathan Y. Chu Kaitlyn E. Watson Yazid N. Al Hamarneh Lily Yushko Ross T. Tsuyuki Penelope Smyth |
| author_sort | Nathan Y. Chu |
| collection | DOAJ |
| description | Abstract Background Multiple 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. Methods A 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. Discussion This 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 registration This trial is registered at the National Institutes of Health United States National Library of Medicine, ClinicalTrials.gov NCT04979546 . Registered on July 28, 2021. |
| first_indexed | 2024-04-10T17:18:03Z |
| format | Article |
| id | doaj.art-290f41f554a747d69215601193cbd3de |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-04-10T17:18:03Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj.art-290f41f554a747d69215601193cbd3de2023-02-05T12:16:26ZengBMCBMC Neurology1471-23772023-02-0123111010.1186/s12883-023-03090-0Evaluating the impact of patient-reported outcome measures on depression and anxiety levels in people with multiple sclerosis: a study protocol for a randomized controlled trialNathan Y. Chu0Kaitlyn E. Watson1Yazid N. Al Hamarneh2Lily Yushko3Ross T. Tsuyuki4Penelope Smyth5Department of Medicine, Division of Neurology, University of AlbertaEPICORE (Epidemiology Coordinating and Research) Centre, Department of Medicine, University of AlbertaEPICORE (Epidemiology Coordinating and Research) Centre, Department of Medicine, University of AlbertaEPICORE (Epidemiology Coordinating and Research) Centre, Department of Medicine, University of AlbertaEPICORE (Epidemiology Coordinating and Research) Centre, Department of Medicine, University of AlbertaDepartment of Medicine, Division of Neurology, University of AlbertaAbstract Background Multiple 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. Methods A 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. Discussion This 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 registration This trial is registered at the National Institutes of Health United States National Library of Medicine, ClinicalTrials.gov NCT04979546 . Registered on July 28, 2021.https://doi.org/10.1186/s12883-023-03090-0Multiple sclerosisPatient-reported outcome measuresPatient satisfactionDepressionAnxietyHADS |
| spellingShingle | Nathan Y. Chu Kaitlyn E. Watson Yazid N. Al Hamarneh Lily Yushko Ross T. Tsuyuki Penelope Smyth 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 Multiple sclerosis Patient-reported outcome measures Patient satisfaction Depression Anxiety HADS |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Multiple sclerosis Patient-reported outcome measures Patient satisfaction Depression Anxiety HADS |
| url | https://doi.org/10.1186/s12883-023-03090-0 |
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