Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-10-15 DOI:10.1016/j.cct.2024.107715

Cristina Palacios, Julia Leone, Priscilla Clayton, Jacqueline Hernandez, María Angélica Trak-Fellermeier, Alison Macchi, Daniela Ramirez-Roggio, Yivani Cobo, Shanelle Bautista, Jeneene Connelly, Malik Elington, Jorge Romero, Rodolfo Galvan

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引用次数: 0

Abstract

Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment strategies used in this trial. Methods: The recruitment plan included “Traditional” (mailings, flyers, posters, visits, snowball, etc.) or “Online” (email campaigns, social media, website, etc.) strategies. All strategies led to the pre-screening online form, which asked how they learned about the study. This analysis includes the number of pre-screenings and enrollment (consents signed), ineligibility, socio-demographics, and costs per strategy. Differences were analyzed using ANOVA or chi-square. Results: 649 individuals completed the pre-screening; 37.1 % came from “Traditional”, 46.7 % from “Online”, 2.6 % from “Other”, and 13.6 % from “Unknown” strategies. The most successful strategies were related to Florida International University (posting flyers around campus and email campaigns). The main reasons for ineligibility were obesity (38.9 %) or outside the age range (22.7 %). A total of 48.4 % of the children enrolled came from “Traditional”, 50.2 % from “Online”, and 1.4 % from “Other” strategies. The cost per screened participant was $1112 for “Traditional” and $512 for “Online” strategies, and the cost per enrolled participant was $2704 for “Traditional” and $1454 for “Online” strategies. The highest costs were staff salary. Conclusion: “Online” strategies were more effective and had a lower implementation cost than “Traditional” strategies, although these were also important in achieving the recruitment goal. Future pediatric trials should consider some of these strategies and their costs.

ClinicalTrials.gov registry number: NCT02916862

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MetA-Bone试验中采用的招募策略的效果和成本，该试验是一项随机临床试验，旨在测试在儿童中补充为期一年的可溶性玉米纤维的效果

背景：招募儿童参与临床试验非常具有挑战性。我们设计了一项招募计划，招募健康儿童（9-14 岁）参加一项试验，测试补充玉米可溶性纤维对骨质的 1 年影响。我们评估了该试验所采用的招募策略的有效性和成本。方法：招募计划包括 "传统"（邮寄、传单、海报、访问、滚雪球等）或 "在线"（电子邮件宣传、社交媒体、网站等）策略。所有策略都指向预选在线表格，其中询问他们是如何了解到这项研究的。本分析包括预选和注册（签署同意书）人数、不合格人数、社会人口统计以及每种策略的成本。差异分析采用方差分析或卡方检验。结果649 人完成了预筛选；37.1% 来自 "传统 "策略，46.7% 来自 "在线 "策略，2.6% 来自 "其他 "策略，13.6% 来自 "未知 "策略。最成功的策略与佛罗里达国际大学有关（在校园内张贴传单和电子邮件宣传）。不符合条件的主要原因是肥胖（38.9%）或超出年龄范围（22.7%）。共有 48.4% 的儿童通过 "传统"、50.2% 通过 "在线 "和 1.4% 通过 "其他 "策略报名。传统 "策略和 "在线 "策略每筛选一名参与者的成本分别为 1112 美元和 512 美元，"传统 "策略和 "在线 "策略每招收一名参与者的成本分别为 2704 美元和 1454 美元。成本最高的是员工工资。结论与 "传统 "策略相比，"在线 "策略更有效，实施成本更低，尽管这些策略对于实现招募目标也很重要。未来的儿科试验应考虑这些策略及其成本：NCT02916862

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.