Sara Hayes1, Rose Galvin2, Catriona Kennedy3, Marcia Finlayson4, Christopher McGuigan5, Cathal D Walsh6, Susan Coote2. 1. University of Limerick, School of Allied Health, Ageing Research Centre, Health Research Institute, Limerick, Ireland. 2. University of Limerick, Department of Clinical Therapies, Faculty of Education and Health Sciences, Castletroy, Limerick, Ireland. 3. Robert Gordon University, School of Nursing and Midwifery, Garthdee Road, Aberdeen, UK, AB10 7QG. 4. Queen's University, School of Rehabilitation Therapy, 31 George Street, Kingston, ON, Canada. 5. St. Vincent's University Hospital & University College Dublin, Department of Neurology, Elm Park, Dublin, Ireland. 6. Department of Mathematics and Statistics, Health Research Institute (HRI) and MACSI, University of Limerick, Ireland.
Abstract
BACKGROUND: Multiple sclerosis (MS) is one of the most prevalent diseases of the central nervous system with recent prevalence estimates indicating that MS directly affects 2.3 million people worldwide. Fall rates of 56% have been reported among people with MS in a recent meta-analysis. Clinical guidelines do not outline an evidence-based approach to falls interventions in MS. There is a need for synthesised information regarding the effectiveness of falls prevention interventions in MS. OBJECTIVES: The aim of this review was to evaluate the effectiveness of interventions designed to reduce falls in people with MS. Specific objectives included comparing: (1) falls prevention interventions to controls and; (2) different types of falls prevention interventions. SEARCH METHODS: We searched the Trials Register of the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group, Cochrane Central Register of Controlled Trials (2018 Issue 9); MEDLINE (PubMed) (1966 to 12 September 2018); Embase (EMBASE.com) (1974 to 12 September 2018); Cumulative Index to Nursing and Allied Health Literature (EBSCOhost) (1981 to 12 September 2018); Latin American and Caribbean Health Science Information Database (Bireme) (1982 to 12 September 2018); ClinicalTrials.gov; and World Health Organization International Clinical Trials Registry Platform; PsycINFO (1806 to 12 September 2018; and Physiotherapy Evidence Database (1999 to 12 September 2018). SELECTION CRITERIA: We selected randomised controlled trials or quasi-randomised trials of interventions to reduce falls in people with MS. We included trials that examined falls prevention interventions compared to controls or different types of falls prevention interventions. Primary outcomes included: falls rate, risk of falling, number of falls per person and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors screened studies for selection, assessed risk of bias and extracted data. We used a rate ratio (RaR) and 95% confidence interval to compare falls rate between groups. For risk of falling, we used a risk ratio (RR) and 95% CI based on the number of fallers in each group. MAIN RESULTS: A total of 839 people with MS (12 to 177 individuals) were randomised in the 13 included trials. The mean age of the participants was 52 years (36 to 62 years). The percentage of women participants ranged from 59% to 85%. Studies included people with all types of MS. Most trials compared an exercise intervention with no intervention or different types of falls prevention interventions. We included two comparisons: (1) Falls prevention intervention versus control and (2) Falls prevention intervention versus another falls prevention intervention. The most common interventions tested were exercise as a single intervention, education as a single intervention, functional electrical stimulation and exercise plus education. The risk of bias of the included studies mixed, with nine studies demonstrating high risk of bias related to one or more aspects of their methodology. The evidence was uncertain regarding the effects of exercise versus control on falls rate (RaR of 0.68; 95% CI 0.43 to 1.06; very low-quality evidence), number of fallers (RR of 0.85; 95% CI 0.51 to 1.43; low-quality evidence) and adverse events (RR of 1.25; 95% CI 0.26 to 6.03; low-quality evidence). Data were not available on quality of life outcomes comparing exercise to control. The majority of other comparisons between falls interventions and controls demonstrated no evidence of effect in favour of either group for all primary outcomes. For the comparison of different falls prevention interventions, the heterogeneity of intervention types across studies prohibited the pooling of data. In relation to secondary outcomes, there was evidence of an effect in favour of exercise interventions compared to controls for balance function with a SMD of 0.50 (95% CI 0.09 to 0.92), self-reported mobility with a SMD of 16.30 (95% CI 9.34 to 23.26) and objective mobility with a SMD of 0.28 (95% CI 0.07 to 0.50). Secondary outcomes were not assessed under the GRADE criteria and results must be interpreted with caution. AUTHORS' CONCLUSIONS: The evidence regarding the effects of interventions for preventing falls in MS is sparse and uncertain. The evidence base demonstrates mixed risk of bias, with very low to low certainty of the evidence. There is some evidence in favour of exercise interventions for the improvement of balance function and mobility. However, this must be interpreted with caution as these secondary outcomes were not assessed under the GRADE criteria and as the results represent data from a small number of studies. Robust RCTs examining the effectiveness of multifactorial falls interventions on falls outcomes are needed.
BACKGROUND: Multiple sclerosis (MS) is one of the most prevalent diseases of the central nervous system with recent prevalence estimates indicating that MS directly affects 2.3 million people worldwide. Fall rates of 56% have been reported among people with MS in a recent meta-analysis. Clinical guidelines do not outline an evidence-based approach to falls interventions in MS. There is a need for synthesised information regarding the effectiveness of falls prevention interventions in MS. OBJECTIVES: The aim of this review was to evaluate the effectiveness of interventions designed to reduce falls in people with MS. Specific objectives included comparing: (1) falls prevention interventions to controls and; (2) different types of falls prevention interventions. SEARCH METHODS: We searched the Trials Register of the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group, Cochrane Central Register of Controlled Trials (2018 Issue 9); MEDLINE (PubMed) (1966 to 12 September 2018); Embase (EMBASE.com) (1974 to 12 September 2018); Cumulative Index to Nursing and Allied Health Literature (EBSCOhost) (1981 to 12 September 2018); Latin American and Caribbean Health Science Information Database (Bireme) (1982 to 12 September 2018); ClinicalTrials.gov; and World Health Organization International Clinical Trials Registry Platform; PsycINFO (1806 to 12 September 2018; and Physiotherapy Evidence Database (1999 to 12 September 2018). SELECTION CRITERIA: We selected randomised controlled trials or quasi-randomised trials of interventions to reduce falls in people with MS. We included trials that examined falls prevention interventions compared to controls or different types of falls prevention interventions. Primary outcomes included: falls rate, risk of falling, number of falls per person and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors screened studies for selection, assessed risk of bias and extracted data. We used a rate ratio (RaR) and 95% confidence interval to compare falls rate between groups. For risk of falling, we used a risk ratio (RR) and 95% CI based on the number of fallers in each group. MAIN RESULTS: A total of 839 people with MS (12 to 177 individuals) were randomised in the 13 included trials. The mean age of the participants was 52 years (36 to 62 years). The percentage of women participants ranged from 59% to 85%. Studies included people with all types of MS. Most trials compared an exercise intervention with no intervention or different types of falls prevention interventions. We included two comparisons: (1) Falls prevention intervention versus control and (2) Falls prevention intervention versus another falls prevention intervention. The most common interventions tested were exercise as a single intervention, education as a single intervention, functional electrical stimulation and exercise plus education. The risk of bias of the included studies mixed, with nine studies demonstrating high risk of bias related to one or more aspects of their methodology. The evidence was uncertain regarding the effects of exercise versus control on falls rate (RaR of 0.68; 95% CI 0.43 to 1.06; very low-quality evidence), number of fallers (RR of 0.85; 95% CI 0.51 to 1.43; low-quality evidence) and adverse events (RR of 1.25; 95% CI 0.26 to 6.03; low-quality evidence). Data were not available on quality of life outcomes comparing exercise to control. The majority of other comparisons between falls interventions and controls demonstrated no evidence of effect in favour of either group for all primary outcomes. For the comparison of different falls prevention interventions, the heterogeneity of intervention types across studies prohibited the pooling of data. In relation to secondary outcomes, there was evidence of an effect in favour of exercise interventions compared to controls for balance function with a SMD of 0.50 (95% CI 0.09 to 0.92), self-reported mobility with a SMD of 16.30 (95% CI 9.34 to 23.26) and objective mobility with a SMD of 0.28 (95% CI 0.07 to 0.50). Secondary outcomes were not assessed under the GRADE criteria and results must be interpreted with caution. AUTHORS' CONCLUSIONS: The evidence regarding the effects of interventions for preventing falls in MS is sparse and uncertain. The evidence base demonstrates mixed risk of bias, with very low to low certainty of the evidence. There is some evidence in favour of exercise interventions for the improvement of balance function and mobility. However, this must be interpreted with caution as these secondary outcomes were not assessed under the GRADE criteria and as the results represent data from a small number of studies. Robust RCTs examining the effectiveness of multifactorial falls interventions on falls outcomes are needed.
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Authors: Sara Hayes; Rose Galvin; Catriona Kennedy; Marcia Finlayson; Christopher McGuigan; Cathal D Walsh; Susan Coote Journal: Cochrane Database Syst Rev Date: 2019-11-28