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试验的困境:从招募 777 名老年人参加针对行动障碍的社区、小组式积极老龄化干预试验(REACT)中学到的经验。

The Tribulations of Trials: Lessons Learnt Recruiting 777 Older Adults Into REtirement in ACTion (REACT), a Trial of a Community, Group-Based Active Aging Intervention Targeting Mobility Disability.

机构信息

Department for Health, University of Bath, UK.

School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, UK.

出版信息

J Gerontol A Biol Sci Med Sci. 2020 Nov 13;75(12):2387-2395. doi: 10.1093/gerona/glaa051.

Abstract

BACKGROUND

Challenges of recruitment to randomized controlled trials (RCTs) and successful strategies to overcome them should be clearly reported to improve recruitment into future trials. REtirement in ACTion (REACT) is a United Kingdom-based multicenter RCT recruiting older adults at high risk of mobility disability to a 12-month group-based exercise and behavior maintenance program or to a minimal Healthy Aging control intervention.

METHODS

The recruitment target was 768 adults, aged 65 years and older scoring 4-9 on the Short Physical Performance Battery (SPPB). Recruitment methods include the following: (a) invitations mailed by general practitioners (GPs); (b) invitations distributed via third-sector organizations; and (c) public relations (PR) campaign. Yields, efficiency, and costs were calculated.

RESULTS

The study recruited 777 (33.9% men) community-dwelling, older adults (mean age 77.55 years (SD 6.79), mean SPPB score 7.37 (SD 1.56)), 95.11% white (n = 739) and broadly representative of UK quintiles of deprivation. Over a 20-month recruitment period, 25,559 invitations were issued. Eighty-eight percent of the participants were recruited via GP invitations, 5.4% via the PR campaign, 3% via word-of-mouth, and 2.5% via third-sector organizations. Mean recruitment cost per participant was £78.47, with an extra £26.54 per recruit paid to GPs to cover research costs.

CONCLUSIONS

REACT successfully recruited to target. Response rates were lower than initially predicted and recruitment timescales required adjustment. Written invitations from GPs were the most efficient method for recruiting older adults at risk of mobility disability. Targeted efforts could achieve more ethnically diverse cohorts. All trials should be required to provide recruitment data to enable evidence-based planning of future trials.

摘要

背景

招募随机对照试验(RCT)面临挑战,应明确报告克服这些挑战的成功策略,以提高未来试验的招募率。英国的 REtirement in ACTion(REACT)是一项多中心 RCT,招募身体机能有下降风险的老年人参加为期 12 个月的团体运动和行为维持计划或最低限度的健康老龄化对照干预。

方法

招募目标是 768 名年龄在 65 岁及以上、短体适能表现测试(SPPB)评分为 4-9 的成年人。招募方法包括:(a)全科医生(GP)寄发邀请;(b)通过第三方组织分发邀请;(c)公共关系(PR)活动。计算了收益、效率和成本。

结果

该研究招募了 777 名(33.9%为男性)居住在社区的老年人(平均年龄为 77.55 岁(标准差为 6.79),平均 SPPB 评分为 7.37(标准差为 1.56)),95.11%为白人(n=739),并广泛代表了英国贫困五分位数。在 20 个月的招募期间,共发出 25559 份邀请。88%的参与者通过 GP 邀请招募,5.4%通过 PR 活动招募,3%通过口碑招募,2.5%通过第三方组织招募。每位参与者的平均招募成本为 78.47 英镑,向 GP 支付的额外招募费用为每位 26.54 英镑,以支付研究费用。

结论

REACT 成功达到了目标。响应率低于最初的预测,招募时间表需要调整。GP 发出的书面邀请是招募有身体机能下降风险的老年人的最有效方法。有针对性的努力可以招募到更多种族多样化的队列。所有试验都应被要求提供招募数据,以便为未来的试验提供基于证据的规划。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b354/7662171/9f0cc2e8bc44/glaa051_fig1.jpg

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