一项针对老年人预防跌倒的多方面足病治疗干预措施的队列随机对照试验（REFORM试验）。
Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).
作者信息
Cockayne Sarah, Adamson Joy, Clarke Arabella, Corbacho Belen, Fairhurst Caroline, Green Lorraine, Hewitt Catherine E, Hicks Kate, Kenan Anne-Maree, Lamb Sarah E, McIntosh Caroline, Menz Hylton B, Redmond Anthony C, Richardson Zoe, Rodgers Sara, Vernon Wesley, Watson Judith, Torgerson David J
机构信息
York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, United Kingdom.
出版信息
PLoS One. 2017 Jan 20;12(1):e0168712. doi: 10.1371/journal.pone.0168712. eCollection 2017.
BACKGROUND
Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.
DESIGN
Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness.
RESULTS
In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained.
CONCLUSION
There was a small reduction in falls. The intervention may be cost-effective.
TRIAL REGISTRATION
ISRCTN ISRCTN68240461.
背景
跌倒是老年人发病的主要原因。多方面的足病治疗干预可能会降低跌倒风险。本研究评估了这样一种干预措施。
设计
在英格兰和爱尔兰进行的实用队列随机对照试验。1010名参与者被随机分组（493人分到干预组，517人分到常规护理组），分别接受：足病治疗干预，包括足部和踝关节锻炼、足部矫形器，以及必要时的新鞋，还有一份预防跌倒宣传册；或者常规足病治疗加一份预防跌倒宣传册。主要结局是随机分组后12个月内每位参与者自我报告的跌倒发生率。次要结局包括：跌倒者及报告多次跌倒者的比例、首次跌倒时间、害怕跌倒、法恩斯沃思活动指数、老年抑郁量表、足部疼痛、健康相关生活质量以及成本效益。
结果
在初步分析中，干预组有484名（98.2%）参与者，对照组有507名（98.1%）参与者。干预组的跌倒发生率有小幅降低，但无统计学意义（调整后的发生率比为0.88，95%置信区间为0.73至1.05，p = 0.16）。经历跌倒的参与者比例较低（49.7%对54.9%，调整后的优势比为0.78，95%置信区间为0.60至1.00，p = 0.05），经历两次或更多次跌倒的比例也较低（27.6%对34.6%，调整后的优势比为0.69，95%置信区间为0.52至0.90，p = 0.01）。干预组的足部疼痛有所增加（p = 0.02）。其他结局无统计学显著差异。该干预措施成本更高，但在健康相关生活质量方面略有益处（平均质量调整生命年（QALY）差异为0.0129, 95%置信区间为 -0.0050至0.0314），并且在每获得一个QALY的成本阈值为30,000英镑时，具有65%的成本效益概率。
结论
跌倒发生率有小幅降低。该干预措施可能具有成本效益。
试验注册号
ISRCTN ISRCTN68240461
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