Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK.
Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh.
Health Technol Assess. 2021 May;25(34):1-114. doi: 10.3310/hta25340.
Falls and fractures are a major problem.
To investigate the clinical effectiveness and cost-effectiveness of alternative falls prevention interventions.
Three-arm, pragmatic, cluster randomised controlled trial with parallel economic analysis. The unit of randomisation was the general practice.
Primary care.
People aged ≥ 70 years.
All practices posted an advice leaflet to each participant. Practices randomised to active intervention arms (exercise and multifactorial falls prevention) screened participants for falls risk using a postal questionnaire. Active treatments were delivered to participants at higher risk of falling.
The primary outcome was fracture rate over 18 months, captured from Hospital Episode Statistics, general practice records and self-report. Secondary outcomes were falls rate, health-related quality of life, mortality, frailty and health service resource use. Economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit.
Between 2011 and 2014, we randomised 63 general practices (9803 participants): 21 practices (3223 participants) to advice only, 21 practices (3279 participants) to exercise and 21 practices (3301 participants) to multifactorial falls prevention. In the active intervention arms, 5779 out of 6580 (87.8%) participants responded to the postal fall risk screener, of whom 2153 (37.3%) were classed as being at higher risk of falling and invited for treatment. The rate of intervention uptake was 65% (697 out of 1079) in the exercise arm and 71% (762 out of 1074) in the multifactorial falls prevention arm. Overall, 379 out of 9803 (3.9%) participants sustained a fracture. There was no difference in the fracture rate between the advice and exercise arms (rate ratio 1.20, 95% confidence interval 0.91 to 1.59) or between the advice and multifactorial falls prevention arms (rate ratio 1.30, 95% confidence interval 0.99 to 1.71). There was no difference in falls rate over 18 months (exercise arm: rate ratio 0.99, 95% confidence interval 0.86 to 1.14; multifactorial falls prevention arm: rate ratio 1.13, 95% confidence interval 0.98 to 1.30). A lower rate of falls was observed in the exercise arm at 8 months (rate ratio 0.78, 95% confidence interval 0.64 to 0.96), but not at other time points. There were 289 (2.9%) deaths, with no differences by treatment arm. There was no evidence of effects in prespecified subgroup comparisons, nor in nested intention-to-treat analyses that considered only those at higher risk of falling. Exercise provided the highest expected quality-adjusted life-years (1.120), followed by advice and multifactorial falls prevention, with 1.106 and 1.114 quality-adjusted life-years, respectively. NHS costs associated with exercise (£3720) were lower than the costs of advice (£3737) or of multifactorial falls prevention (£3941). Although incremental differences between treatment arms were small, exercise dominated advice, which in turn dominated multifactorial falls prevention. The incremental net monetary benefit of exercise relative to treatment valued at £30,000 per quality-adjusted life-year is modest, at £191, and for multifactorial falls prevention is £613. Exercise is the most cost-effective treatment. No serious adverse events were reported.
The rate of fractures was lower than anticipated.
Screen-and-treat falls prevention strategies in primary care did not reduce fractures. Exercise resulted in a short-term reduction in falls and was cost-effective.
Exercise is the most promising intervention for primary care. Work is needed to ensure adequate uptake and sustained effects.
Current Controlled Trials ISRCTN71002650.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 34. See the NIHR Journals Library website for further project information.
跌倒和骨折是一个重大问题。
研究替代跌倒预防干预措施的临床效果和成本效益。
三臂、实用、群组随机对照试验，同时进行平行的经济分析。随机单位是全科医生诊所。
初级保健。
年龄≥70 岁的人。
所有诊所都向每位参与者寄发了一份建议传单。随机分配到积极干预组（运动和多因素跌倒预防）的诊所使用邮寄问卷筛查参与者的跌倒风险。对有更高跌倒风险的参与者进行积极治疗。
主要结局是 18 个月内骨折发生率，通过医院发病统计、全科医生记录和自我报告进行捕获。次要结局是跌倒发生率、健康相关生活质量、死亡率、虚弱和卫生服务资源使用。经济评估以每质量调整生命年的增量成本和增量净货币效益表示。
在 2011 年至 2014 年期间，我们随机分配了 63 家全科医生诊所（9803 名参与者）：21 家诊所（3223 名参与者）接受建议，21 家诊所（3279 名参与者）接受运动，21 家诊所（3301 名参与者）接受多因素跌倒预防。在积极干预组中，6580 名参与者中有 5779 名（87.8%）回复了邮寄的跌倒风险筛查问卷，其中 2153 名（37.3%）被归类为有更高跌倒风险，并邀请他们接受治疗。运动组的干预参与率为 65%（697 名中的 657 名），多因素跌倒预防组为 71%（762 名中的 712 名）。总体而言，9803 名参与者中有 379 名（3.9%）发生骨折。建议和运动组之间（发生率比 1.20，95%置信区间 0.91 至 1.59）或建议和多因素跌倒预防组之间（发生率比 1.30，95%置信区间 0.99 至 1.71）的骨折发生率没有差异。18 个月的跌倒发生率没有差异（运动组：发生率比 0.99，95%置信区间 0.86 至 1.14；多因素跌倒预防组：发生率比 1.13，95%置信区间 0.98 至 1.30）。在 8 个月时，运动组的跌倒率较低（发生率比 0.78，95%置信区间 0.64 至 0.96），但在其他时间点没有差异。有 289 名（2.9%）死亡，各治疗组之间没有差异。在预先指定的亚组比较或仅考虑高跌倒风险的意向治疗分析中，均未观察到效果。运动组的预期质量调整生命年最高（1.120），其次是建议组和多因素跌倒预防组，分别为 1.106 和 1.114 个质量调整生命年。运动相关的 NHS 成本（3720 英镑）低于建议（3737 英镑）或多因素跌倒预防（3941 英镑）。尽管治疗组之间的增量差异较小，但运动组优于建议组，而建议组又优于多因素跌倒预防组。运动相对于价值 30000 英镑/质量调整生命年的治疗的增量净货币效益适中，为 191 英镑，而多因素跌倒预防的增量净货币效益为 613 英镑。运动是最具成本效益的治疗方法。没有报告严重不良事件。
骨折发生率低于预期。
初级保健中的筛检和治疗跌倒预防策略并未降低骨折发生率。运动导致短期跌倒减少，且具有成本效益。
运动是初级保健最有前途的干预措施。需要开展工作以确保充分参与并维持效果。
当前对照试验 ISRCTN71002650。
该项目由英国国家卫生研究所（NIHR）卫生技术评估计划资助，将在；第 25 卷，第 34 期。有关该项目的更多信息，请访问 NIHR 期刊库网站。
