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针对65岁及以上慢性下腰痛且代表性不足人群的针灸试验的招募与保留

Recruitment and Retention for an Acupuncture Trial in an Underrepresented 65 and Older Population With Chronic Low Back Pain.

作者信息

Teets Ray Y, Nielsen Arya, Mah Donna, Beyrouty Matthew, Handel Marsha J, Justice Morgan, Jyung Hyowoun, Eng Carolyn M, DeBar Lynn L

机构信息

Institute for Family Health, New York, NY, USA.

Department of Family Medicine & Community Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

出版信息

Glob Adv Integr Med Health. 2025 May 9;14:27536130251340921. doi: 10.1177/27536130251340921. eCollection 2025 Jan-Dec.

Abstract

BACKGROUND

The consequences of health disparities in underrepresented populations persist with increased disease burden and reduced access to care. Even with inclusion mandates, underserved populations are poorly represented across trials. This article describes recruitment and retention efforts of an underrepresented population in a large NIH-funded trial.

METHODS

The BackInAction (BIA) study is a pragmatic, multi-site, three-arm, parallel-groups randomized controlled trial testing the effectiveness of acupuncture needling for reducing back pain-related disability among 800 older adults (≥65 years) with chronic low back pain. The Institute for Family Health (IFH), an FQHC in New York City, one of four BIA sites, provides primary care to largely underrepresented patients. The IFH recruitment goal was 123 participants. PCPs were oriented to trial referral, clinical research coordinators worked as navigators, and electronic health records (EHR) mechanisms were adapted to allow seamless communication between trial acupuncturists and the research team.

RESULTS

IFH met its goal of 123 trial participants with sociodemographic (22.8% ≥ 75 yrs of age, 72.4% female, 59.4% reported having at least some college education, 62.6% reported an annual household income of less than $25 000) and ethnic/racial diversity (39.0% Hispanic, 35.6% Black, 22.0% White non-Hispanic, 26.8% Spanish-speaking). IFH study withdrawal rate was 12.2% with 18.7% missingness in follow-up data rates at the trial's 6-month primary endpoint.

CONCLUSION

The IFH site team successfully recruited and retained diverse participants through trusted connections with the study population, building on experience with acupuncture research, engaging PCPs, study team members, primary care clinical sites and EHR communication options.

摘要

背景

在代表性不足的人群中,健康差异的后果持续存在,疾病负担加重,获得医疗服务的机会减少。即使有纳入规定,在各项试验中,服务不足人群的代表性仍然很低。本文描述了在一项由美国国立卫生研究院资助的大型试验中,针对代表性不足人群的招募和保留工作。

方法

“重返行动”(BIA)研究是一项务实的、多中心、三臂、平行组随机对照试验,旨在测试针刺疗法对800名患有慢性下背痛的老年人(≥65岁)减轻背痛相关残疾的有效性。纽约市的家庭健康研究所(IFH)是一家联邦合格健康中心,也是BIA的四个研究地点之一,主要为代表性不足的患者提供初级医疗服务。IFH的招募目标是123名参与者。初级保健医生接受了试验转诊培训,临床研究协调员担任导航员,并调整了电子健康记录(EHR)机制,以便试验针灸师与研究团队之间进行无缝沟通。

结果

IFH达到了招募123名试验参与者的目标,这些参与者具有社会人口统计学特征(22.8%年龄≥75岁,72.4%为女性,59.4%报告至少接受过一些大学教育,62.6%报告家庭年收入低于25000美元)和种族/民族多样性(39.0%为西班牙裔,35.6%为黑人,22.0%为非西班牙裔白人,26.8%说西班牙语)。在试验的6个月主要终点,IFH研究的退出率为12.2%,随访数据缺失率为18.7%。

结论

IFH研究地点团队通过与研究人群建立可信赖的联系,利用针灸研究经验,让初级保健医生、研究团队成员、初级保健临床地点和EHR沟通选项参与进来,成功招募并保留了多样化的参与者。

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