The effect of disease modifying therapies on fatigue in multiple sclerosis
•Fatigue is a symptom with a serious impact on patients’ quality of life.•Inclusion of fatigue as an RCT outcome is crucial to understand the impact of DMTs.•Limited RCTs of DMTs assessed fatigue as an outcome.•The reporting of PROs of DMT trials assessing fatigue is suboptimal.•Carefully considerat...
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| Published in: | Multiple sclerosis and related disorders Vol. 79; p. 105065 |
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| Main Authors: | , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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01.11.2023
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| ISSN: | 2211-0348, 2211-0356, 2211-0356 |
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| Abstract | •Fatigue is a symptom with a serious impact on patients’ quality of life.•Inclusion of fatigue as an RCT outcome is crucial to understand the impact of DMTs.•Limited RCTs of DMTs assessed fatigue as an outcome.•The reporting of PROs of DMT trials assessing fatigue is suboptimal.•Carefully consideration should be given when interpreting the effect of DMTs on fatigue.
Fatigue is one of the most common and debilitating symptoms in people with multiple sclerosis (PwMS). Disease-modifying therapies (DMTs) are currently the gold standard in the treatment of MS and their effectiveness has been assessed through randomized clinical trials (RCTs). However, there is limited evidence on the impact of DMTs on fatigue in (PwMS). We conducted a systematic review to 1) understand whether fatigue is included as an outcome in MS trials of DMTs; 2) determine the effects on fatigue of treating MS with DMTs and 3) assess the quality of MS trials including fatigue as an outcome.
Two independent researchers systematically searched MEDLINE, EMBASE and ClinicalTrials.gov from 1993 to January 2023 for RCTs that measured fatigue as an outcome. Adherence to reporting standards was assessed with the Consolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO), while the risk of bias (RoB) was assessed with the RoB 2 tool by the Cochrane Handbook for Systematic Reviews of Interventions. The systematic review protocol was registered in PROSPERO (CRD42022383321).
The search strategy identified 130 RCTs of DMTs of which 7 (5%) assessed fatigue as an outcome. Of the 7 trials, only two presented statistically significant results. In addition, the reporting of fatigue among RCTs was suboptimal with a mean adherence to the CONSORT-PRO Statement of 36% across all trials. Of the 7 trials included, four were assessed as ‘high’ RoB..
Fatigue has a major impact on PwMS yet there is limited trial-based evidence on the impact of DMTs on fatigue. Assessment of fatigue as an outcome is underrepresented in trials of DMTs and the reporting of PRO trial data is suboptimal. Thus, it is imperative that MS researchers conduct RCTs that include fatigue as an outcome, to support clinicians and people with MS (PwMS) to consider the impact of the different DMTs on fatigue. |
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| AbstractList | Highlights•Fatigue is a symptom with a serious impact on patients’ quality of life •Inclusion of fatigue as an RCT outcome is crucial to understand the impact of DMTs •Limited RCTs of DMTs assessed fatigue as an outcome •The reporting of PROs of DMT trials assessing fatigue is suboptimal •Carefully consideration should be given when interpreting the effect of DMTs on fatigue •Fatigue is a symptom with a serious impact on patients’ quality of life.•Inclusion of fatigue as an RCT outcome is crucial to understand the impact of DMTs.•Limited RCTs of DMTs assessed fatigue as an outcome.•The reporting of PROs of DMT trials assessing fatigue is suboptimal.•Carefully consideration should be given when interpreting the effect of DMTs on fatigue. Fatigue is one of the most common and debilitating symptoms in people with multiple sclerosis (PwMS). Disease-modifying therapies (DMTs) are currently the gold standard in the treatment of MS and their effectiveness has been assessed through randomized clinical trials (RCTs). However, there is limited evidence on the impact of DMTs on fatigue in (PwMS). We conducted a systematic review to 1) understand whether fatigue is included as an outcome in MS trials of DMTs; 2) determine the effects on fatigue of treating MS with DMTs and 3) assess the quality of MS trials including fatigue as an outcome. Two independent researchers systematically searched MEDLINE, EMBASE and ClinicalTrials.gov from 1993 to January 2023 for RCTs that measured fatigue as an outcome. Adherence to reporting standards was assessed with the Consolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO), while the risk of bias (RoB) was assessed with the RoB 2 tool by the Cochrane Handbook for Systematic Reviews of Interventions. The systematic review protocol was registered in PROSPERO (CRD42022383321). The search strategy identified 130 RCTs of DMTs of which 7 (5%) assessed fatigue as an outcome. Of the 7 trials, only two presented statistically significant results. In addition, the reporting of fatigue among RCTs was suboptimal with a mean adherence to the CONSORT-PRO Statement of 36% across all trials. Of the 7 trials included, four were assessed as ‘high’ RoB.. Fatigue has a major impact on PwMS yet there is limited trial-based evidence on the impact of DMTs on fatigue. Assessment of fatigue as an outcome is underrepresented in trials of DMTs and the reporting of PRO trial data is suboptimal. Thus, it is imperative that MS researchers conduct RCTs that include fatigue as an outcome, to support clinicians and people with MS (PwMS) to consider the impact of the different DMTs on fatigue. Fatigue is one of the most common and debilitating symptoms in people with multiple sclerosis (PwMS). Disease-modifying therapies (DMTs) are currently the gold standard in the treatment of MS and their effectiveness has been assessed through randomized clinical trials (RCTs). However, there is limited evidence on the impact of DMTs on fatigue in (PwMS). We conducted a systematic review to 1) understand whether fatigue is included as an outcome in MS trials of DMTs; 2) determine the effects on fatigue of treating MS with DMTs and 3) assess the quality of MS trials including fatigue as an outcome.INTRODUCTIONFatigue is one of the most common and debilitating symptoms in people with multiple sclerosis (PwMS). Disease-modifying therapies (DMTs) are currently the gold standard in the treatment of MS and their effectiveness has been assessed through randomized clinical trials (RCTs). However, there is limited evidence on the impact of DMTs on fatigue in (PwMS). We conducted a systematic review to 1) understand whether fatigue is included as an outcome in MS trials of DMTs; 2) determine the effects on fatigue of treating MS with DMTs and 3) assess the quality of MS trials including fatigue as an outcome.Two independent researchers systematically searched MEDLINE, EMBASE and ClinicalTrials.gov from 1993 to January 2023 for RCTs that measured fatigue as an outcome. Adherence to reporting standards was assessed with the Consolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO), while the risk of bias (RoB) was assessed with the RoB 2 tool by the Cochrane Handbook for Systematic Reviews of Interventions. The systematic review protocol was registered in PROSPERO (CRD42022383321).METHODSTwo independent researchers systematically searched MEDLINE, EMBASE and ClinicalTrials.gov from 1993 to January 2023 for RCTs that measured fatigue as an outcome. Adherence to reporting standards was assessed with the Consolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO), while the risk of bias (RoB) was assessed with the RoB 2 tool by the Cochrane Handbook for Systematic Reviews of Interventions. The systematic review protocol was registered in PROSPERO (CRD42022383321).The search strategy identified 130 RCTs of DMTs of which 7 (5%) assessed fatigue as an outcome. Of the 7 trials, only two presented statistically significant results. In addition, the reporting of fatigue among RCTs was suboptimal with a mean adherence to the CONSORT-PRO Statement of 36% across all trials. Of the 7 trials included, four were assessed as 'high' RoB..RESULTSThe search strategy identified 130 RCTs of DMTs of which 7 (5%) assessed fatigue as an outcome. Of the 7 trials, only two presented statistically significant results. In addition, the reporting of fatigue among RCTs was suboptimal with a mean adherence to the CONSORT-PRO Statement of 36% across all trials. Of the 7 trials included, four were assessed as 'high' RoB..Fatigue has a major impact on PwMS yet there is limited trial-based evidence on the impact of DMTs on fatigue. Assessment of fatigue as an outcome is underrepresented in trials of DMTs and the reporting of PRO trial data is suboptimal. Thus, it is imperative that MS researchers conduct RCTs that include fatigue as an outcome, to support clinicians and people with MS (PwMS) to consider the impact of the different DMTs on fatigue.CONCLUSIONSFatigue has a major impact on PwMS yet there is limited trial-based evidence on the impact of DMTs on fatigue. Assessment of fatigue as an outcome is underrepresented in trials of DMTs and the reporting of PRO trial data is suboptimal. Thus, it is imperative that MS researchers conduct RCTs that include fatigue as an outcome, to support clinicians and people with MS (PwMS) to consider the impact of the different DMTs on fatigue. Fatigue is one of the most common and debilitating symptoms in people with multiple sclerosis (PwMS). Disease-modifying therapies (DMTs) are currently the gold standard in the treatment of MS and their effectiveness has been assessed through randomized clinical trials (RCTs). However, there is limited evidence on the impact of DMTs on fatigue in (PwMS). We conducted a systematic review to 1) understand whether fatigue is included as an outcome in MS trials of DMTs; 2) determine the effects on fatigue of treating MS with DMTs and 3) assess the quality of MS trials including fatigue as an outcome. Two independent researchers systematically searched MEDLINE, EMBASE and ClinicalTrials.gov from 1993 to January 2023 for RCTs that measured fatigue as an outcome. Adherence to reporting standards was assessed with the Consolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO), while the risk of bias (RoB) was assessed with the RoB 2 tool by the Cochrane Handbook for Systematic Reviews of Interventions. The systematic review protocol was registered in PROSPERO (CRD42022383321). The search strategy identified 130 RCTs of DMTs of which 7 (5%) assessed fatigue as an outcome. Of the 7 trials, only two presented statistically significant results. In addition, the reporting of fatigue among RCTs was suboptimal with a mean adherence to the CONSORT-PRO Statement of 36% across all trials. Of the 7 trials included, four were assessed as 'high' RoB.. Fatigue has a major impact on PwMS yet there is limited trial-based evidence on the impact of DMTs on fatigue. Assessment of fatigue as an outcome is underrepresented in trials of DMTs and the reporting of PRO trial data is suboptimal. Thus, it is imperative that MS researchers conduct RCTs that include fatigue as an outcome, to support clinicians and people with MS (PwMS) to consider the impact of the different DMTs on fatigue. |
| ArticleNumber | 105065 |
| Author | Cruz Rivera, Samantha Kamudoni, Paul Harlow, Danielle E Henke, Christian Calvert, Melanie J Dunne, Achille Aiyegbusi, Olalekan Lee Piani Meier, Daniela |
| Author_xml | – sequence: 1 givenname: Samantha orcidid: 0000-0002-1566-6804 surname: Cruz Rivera fullname: Cruz Rivera, Samantha email: s.rivera@bham.ac.uk organization: Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK – sequence: 2 givenname: Olalekan Lee surname: Aiyegbusi fullname: Aiyegbusi, Olalekan Lee organization: Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK – sequence: 3 givenname: Daniela surname: Piani Meier fullname: Piani Meier, Daniela organization: Ares Trading SA, Eysins, An affiliate of Merck KGaA, Switzerland – sequence: 4 givenname: Achille surname: Dunne fullname: Dunne, Achille organization: Merck KGaA, Darmstadt, Germany – sequence: 5 givenname: Danielle E surname: Harlow fullname: Harlow, Danielle E organization: EMD Serono, Billerica, Massachusetts, US – sequence: 6 givenname: Christian surname: Henke fullname: Henke, Christian organization: Merck KGaA, Darmstadt, Germany – sequence: 7 givenname: Paul surname: Kamudoni fullname: Kamudoni, Paul organization: Merck KGaA, Darmstadt, Germany – sequence: 8 givenname: Melanie J surname: Calvert fullname: Calvert, Melanie J organization: Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/37839365$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1177_13524585251349354 crossref_primary_10_1016_j_msard_2024_106214 crossref_primary_10_1002_ana_27034 crossref_primary_10_3390_brainsci14010004 crossref_primary_10_1186_s12958_024_01235_5 |
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| Keywords | Fatigue Patient-reported outcomes (PROs) Disease-modifying therapies (DMTs) patient-reported outcomes (PROs) fatigue disease-modifying therapies (DMTs) |
| Language | English |
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| Snippet | •Fatigue is a symptom with a serious impact on patients’ quality of life.•Inclusion of fatigue as an RCT outcome is crucial to understand the impact of... Highlights•Fatigue is a symptom with a serious impact on patients’ quality of life •Inclusion of fatigue as an RCT outcome is crucial to understand the impact... Fatigue is one of the most common and debilitating symptoms in people with multiple sclerosis (PwMS). Disease-modifying therapies (DMTs) are currently the gold... |
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| SubjectTerms | Disease-modifying therapies (DMTs) Fatigue Fatigue - drug therapy Fatigue - etiology Humans Multiple Sclerosis - complications Multiple Sclerosis - therapy Neurology Patient Reported Outcome Measures Patient-reported outcomes (PROs) Reference Standards Systematic Reviews as Topic |
| Title | The effect of disease modifying therapies on fatigue in multiple sclerosis |
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