Screening in the community to reduce fractures in older women (SCOOP): a randomised controlled trial
Screening in the community to reduce fractures in older women (SCOOP): a randomised controlled trial
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DOI：
10.1016/s0140-6736(17)32640-5
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发表时间：
2018-02-24
期刊：
影响因子：
168.9
通讯作者：
McCloskey, Eugene
中科院分区：
文献类型：
--
作者：
Shepstone, Lee;Lenaghan, Elizabeth;McCloskey, Eugene
背景 尽管有针对骨质疏松症和相关骨折的有效评估方法和药物，但英国目前并不提倡筛查骨折风险。我们测试了基于社区的筛查干预措施是否可以减少老年女性的骨折。方法我们对 70-85 岁的女性进行了一项双组随机对照试验，以将使用骨折风险评估工具 (FRAX) 的筛查计划与常规管理进行比较。女性是从英国七个地区的 100 名全科医生 (GP) 诊所中招募的：伯明翰、布里斯托尔、曼彻斯特、诺维奇、谢菲尔德、南安普顿和约克。我们排除了目前正在服用抗骨质疏松处方药的女性以及任何被认为不适合参加研究的个人（例如，已知的痴呆症、绝症或最近失去亲人）。主要结果是在 5 年内发生一次或多次骨质疏松症相关骨折的个体比例。在筛查组中，根据 FRAX 10 年髋部骨折概率，建议对被确定为髋部骨折高风险的女性进行治疗。预先指定的次要结局是至少发生一次髋部骨折、任何临床骨折或死亡的参与者的比例；以及筛查对焦虑和健康相关生活质量的影响。该试验在国际标准随机对照试验登记处注册，编号 ISRCTN 55814835。结果确定了 12 483 名符合条件的女性并参加了该试验，其中 6233 名女性在 2008 年 4 月 15 日至 2009 年 7 月 2 日期间被随机分配到筛查组。6233 名女性中，有 898 名（14%）建议接受治疗。与对照组相比，筛查组第一年末骨质疏松症药物的使用率更高（15% vs 4%），筛查高风险亚组的使用率尤其高（6 个月时为 78%）。筛查并没有降低所有骨质疏松相关骨折发生率的主要结局（风险比 [HR] 0.94，95% CI 0.85-1.03，p=0.178），也没有降低所有临床骨折的总体发生率（0.94，0.86-1.03，p=0.183），但筛查降低了髋部骨折的发生率（0.72， 0.59-0.89，p=0.002）。没有证据表明死亡率、焦虑水平或生活质量存在差异。 解释 英国老年女性骨折风险的系统性、基于社区的筛查计划是可行的，并且可以有效减少髋部骨折。
Background Despite effective assessment methods and medications targeting osteoporosis and related fractures, screening for fracture risk is not currently advocated in the UK. We tested whether a community-based screening intervention could reduce fractures in older women.Methods We did a two-arm randomised controlled trial in women aged 70-85 years to compare a screening programme using the Fracture Risk Assessment Tool (FRAX) with usual management. Women were recruited from 100 general practitioner (GP) practices in seven regions of the UK: Birmingham, Bristol, Manchester, Norwich, Sheffield, Southampton, and York. We excluded women who were currently on prescription anti-osteoporotic drugs and any individuals deemed to be unsuitable to enter a research study (eg, known dementia, terminally ill, or recently bereaved). The primary outcome was the proportion of individuals who had one or more osteoporosis-related fractures over a 5-year period. In the screening group, treatment was recommended in women identified to be at high risk of hip fracture, according to the FRAX 10-year hip fracture probability. Prespecified secondary outcomes were the proportions of participants who had at least one hip fracture, any clinical fracture, or mortality; and the effect of screening on anxiety and health-related quality of life. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN 55814835.Findings 12 483 eligible women were identified and participated in the trial, and 6233 women randomly assigned to the screening group between April 15, 2008, and July 2, 2009. Treatment was recommended in 898 (14%) of 6233 women. Use of osteoporosis medication was higher at the end of year 1 in the screening group compared with controls (15% vs 4%), with uptake particularly high (78% at 6 months) in the screening high-risk subgroup. Screening did not reduce the primary outcome of incidence of all osteoporosis-related fractures (hazard ratio [HR] 0.94, 95% CI 0.85-1.03, p=0.178), nor the overall incidence of all clinical fractures (0.94, 0.86-1.03, p=0.183), but screening reduced the incidence of hip fractures (0.72, 0.59-0.89, p=0.002). There was no evidence of differences in mortality, anxiety levels, or quality of life.Interpretation Systematic, community-based screening programme of fracture risk in older women in the UK is feasible, and could be effective in reducing hip fractures.