Hayes Sara, Galvin Rose, Kennedy Catriona, Finlayson Marcia, McGuigan Christopher, Walsh Cathal D, Coote Susan
University of Limerick, School of Allied Health, Ageing Research Centre, Health Research Institute, Limerick, Ireland.
University of Limerick, Department of Clinical Therapies, Faculty of Education and Health Sciences, Castletroy, Limerick, Ireland.
Cochrane Database Syst Rev. 2019 Nov 28;11(11):CD012475. doi: 10.1002/14651858.CD012475.pub2.
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.
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.
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).
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.
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.
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.
多发性硬化症(MS)是中枢神经系统最常见的疾病之一,最近的患病率估计表明,MS在全球直接影响230万人。最近一项荟萃分析报告称,MS患者的跌倒率为56%。临床指南未概述针对MS患者跌倒干预的循证方法。需要有关MS跌倒预防干预措施有效性的综合信息。
本综述的目的是评估旨在减少MS患者跌倒的干预措施的有效性。具体目标包括比较:(1)跌倒预防干预措施与对照措施;(2)不同类型的跌倒预防干预措施。
我们检索了Cochrane中枢神经系统多发性硬化症和罕见病小组试验注册库、Cochrane对照试验中心注册库(2018年第9期);医学期刊数据库(PubMed)(1966年至2018年9月12日);Embase数据库(EMBASE.com)(1974年至2018年9月12日);护理及相关健康文献累积索引(EBSCOhost)(1981年至2018年9月12日);拉丁美洲和加勒比卫生科学信息数据库(Bireme)(1982年至2018年9月12日);ClinicalTrials.gov;以及世界卫生组织国际临床试验注册平台;心理学文摘数据库(1806年至2018年9月12日);以及物理治疗证据数据库(1999年至2018年9月12日)。
我们选择了旨在减少MS患者跌倒的干预措施的随机对照试验或半随机试验。我们纳入了将跌倒预防干预措施与对照措施或不同类型的跌倒预防干预措施进行比较的试验。主要结局包括:跌倒率、跌倒风险、每人跌倒次数和不良事件。
两位综述作者筛选研究以进行选择、评估偏倚风险并提取数据。我们使用率比(RaR)和95%置信区间来比较组间跌倒率。对于跌倒风险,我们根据每组跌倒者的数量使用风险比(RR)和95%CI。
在纳入的13项试验中,共有839名MS患者(12至177人)被随机分组。参与者的平均年龄为52岁(36至62岁)。女性参与者的比例在59%至85%之间。研究纳入了所有类型MS的患者。大多数试验将运动干预与无干预或不同类型的跌倒预防干预措施进行了比较。我们纳入了两项比较:(1)跌倒预防干预措施与对照措施;(2)跌倒预防干预措施与另一种跌倒预防干预措施。测试的最常见干预措施是单一运动干预、单一教育干预、功能性电刺激以及运动加教育。纳入研究的偏倚风险不一,9项研究在其方法的一个或多个方面显示出高偏倚风险。关于运动与对照对跌倒率(率比为0.68;95%CI为0.43至1.06;极低质量证据)、跌倒者数量(风险比为0.85;95%CI为0.51至1.43;低质量证据)和不良事件(风险比为1.25;95%CI为0.26至6.03;低质量证据)的影响,证据尚不确定。没有关于运动与对照比较的生活质量结局的数据。跌倒干预措施与对照措施之间的大多数其他比较表明,对于所有主要结局,没有证据表明任何一组有效果。对于不同跌倒预防干预措施的比较,各研究中干预类型的异质性使得无法合并数据。关于次要结局,有证据表明与对照相比,运动干预措施对平衡功能有效果,标准化均数差为0.50(95%CI为0.09至0.92),对自我报告的活动能力有效果,标准化均数差为16.30(95%CI为9.34至23.26),对客观活动能力有效果,标准化均数差为0.28(95%CI为0.07至0.50)。次要结局未根据GRADE标准进行评估,结果必须谨慎解释。
关于MS跌倒预防干预措施效果的证据稀少且不确定。证据基础显示偏倚风险不一,证据的确定性极低到低。有一些证据支持运动干预措施可改善平衡功能和活动能力。然而,必须谨慎解释,因为这些次要结局未根据GRADE标准进行评估,且结果代表的是少数研究的数据。需要进行强有力的随机对照试验来检验多因素跌倒干预措施对跌倒结局的有效性。