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在一项减肥干预试验中招募和保留青少年和新兴成年人的经验。

Experiences with recruitment and retention of adolescents and emerging adults in a weight loss intervention trial.

机构信息

Johns Hopkins University, Baltimore, MD, USA.

Cicely Saunders Institute of Palliative Care, Policy & Rehabilitation, King's College, London, UK.

出版信息

Clin Trials. 2023 Oct;20(5):536-545. doi: 10.1177/17407745231167090. Epub 2023 Apr 27.

Abstract

BACKGROUND/AIMS: Efficient and effective participant recruitment is key for successful clinical research. Adolescent and emerging adult recruitment into clinical trials can be particularly challenging, especially when targeting underrepresented groups. This study aimed to determine the most successful recruitment strategies from those employed during a pediatric trial testing the efficacy of a behavioral intervention on adiposity and cardiovascular disease risk.

METHODS

We determined the effectiveness, cost, and diversity of the final research population by each recruitment method utilized in the EMPower trial, a randomized clinical trial designed to test the effect of a technology-delivered behavioral Healthy Lifestyle intervention on adiposity, blood pressure, and left ventricular mass among adolescents and emerging adults with overweight or obesity. Effectiveness was determined by respondent yield (RY; number of respondents/number contacted), scheduled yield (SY; number scheduled for a baseline visit/number of respondents), enrollment yield (EY; number enrolled/number of respondents), and retention (number completed/number enrolled). Cost-effectiveness of each recruitment method was calculated and demographics of participants recruited via each method was determined.

RESULTS

A minimum of 109,314 adolescents and emerging adults were contacted by at least one recruitment method (clinic, web-based, postal mailing, electronic medical record (EMR) messaging) leading to 429 respondents. The most successful strategies in terms of RY were clinic-based recruitment (n = 47, 61% RY), community web-postings (n = 109, 5.33% RY), and EMR messaging (n = 163, 0.99% RY); however, website, postal mailings, and EMR recruitment led to more successful SY and EY. Postal mailings were the most costly strategy to employ (US$3261/completed participant) with EMR messaging the second most costly (US$69/completed participant). Community web-postings were free of charge. Clinic-based recruitment did not add additional costs, per se, but did require a substantial amount of personnel time (63.6 h/completed participant). Final cohort diversity primarily came from postal mailings (57% Black) and EMR messages (50% female).

CONCLUSION

Electronic medical record messaging and web-based recruitment were highly successful and cost-effective strategies in a pediatric clinical trial targeting adolescents and emerging adults, but was less successful in recruiting a diverse cohort. Clinic recruitment and postal mailings, despite being costly and time-consuming, were the strategies that enrolled a greater proportion of underrepresented groups. While online forms of trial recruitment are growing in popularity, clinic-based recruitment and non-web-based strategies may be required to ensure participant diversity and representation.

摘要

背景/目的:高效且有效的参与者招募是临床研究成功的关键。招募青少年和新兴成年人参与临床试验可能极具挑战性,尤其是在针对代表性不足的群体时。本研究旨在确定在一项针对肥胖和心血管疾病风险的行为干预措施的儿科试验中所采用的最有效的招募策略。

方法

我们通过 EMPower 试验中使用的每种招募方法来确定最终研究人群的有效性、成本和多样性,该试验是一项随机临床试验,旨在测试一种通过技术传递的行为健康生活方式干预措施对超重或肥胖的青少年和新兴成年人的肥胖、血压和左心室质量的影响。有效性通过响应者产量(RY;响应者人数/联系人人数)、预定产量(SY;计划参加基线访视的人数/响应者人数)、入组产量(EY;入组人数/响应者人数)和保留率(完成人数/入组人数)来确定。计算了每种招募方法的成本效益,并确定了通过每种方法招募的参与者的人口统计学特征。

结果

通过至少一种招募方法(诊所、基于网络的、邮寄、电子病历(EMR)消息传递)联系了至少 109314 名青少年和新兴成年人,共产生了 429 名受访者。RY 方面最成功的策略是基于诊所的招募(n = 47,61% RY)、社区网络发布(n = 109,5.33% RY)和 EMR 消息传递(n = 163,0.99% RY);然而,网站、邮寄和 EMR 招募导致了更高的 SY 和 EY。邮寄是最昂贵的招聘策略(每位完成参与者 3261 美元),其次是 EMR 消息传递(每位完成参与者 69 美元)。社区网络发布是免费的。基于诊所的招募本身并没有增加额外的成本,但确实需要大量的人员时间(每位完成参与者 63.6 小时)。最终队列的多样性主要来自邮寄(57%黑人)和 EMR 消息(50%女性)。

结论

电子病历消息传递和基于网络的招募是针对青少年和新兴成年人的儿科临床试验中非常成功且具有成本效益的策略,但在招募多样化队列方面效果不佳。诊所招募和邮寄,尽管成本高且耗时,但它们是入组比例更大的代表性不足群体的策略。虽然在线形式的试验招募越来越受欢迎,但可能需要基于诊所的招募和非网络策略来确保参与者的多样性和代表性。

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