Precision Link Biobank, Boston Children's Hospital, 300 Longwood Ave, Boston, MA 02115, United States.
Harvard T.H Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States.
Contemp Clin Trials. 2023 Feb;125:107044. doi: 10.1016/j.cct.2022.107044. Epub 2022 Dec 5.
eHealth interventions using active video games (AVGs) offer an alternative method to help children exercise, especially during a pandemic where options are limited. There is limited data on costs associated with developing and implementing such interventions.
We quantified the costs of delivering an eHealth RCT intervention among minority children during COVID-19.
We categorized the total trial cost into five subcategories: intervention material development, advertising and recruitment, intervention delivery, personnel salaries, and COVID-19-related equipment costs.
The total RCT cost was $1,927,807 (Direct: $1,227,903; Indirect: $699,904) with three visits required for each participant. The average cost per participant completing the RCT (79 participants/237 visits) was $24,403 (Direct: $15,543; Indirect: $8860). Due to no-shows and cancellations (198 visits) and dropouts before study completion (61 visits; 56 participants), 496 visits had to be scheduled to ensure complete data collection on 79 participants. If all 496 visits were from participants completing the three-visit protocol, that would correspond to 165 participants, bringing the average cost per participant down to $11,684 (Direct: $7442; Indirect: $4242). Of the subcategories, intervention material development accounted for the largest portion, followed by personnel salaries. While the direct COVID-19-specific cost constituted <1% of the entire budget, the indirect effects were much larger and significantly impacted the trial.
RCTs typically involve significant resources, even more so during a pandemic. Future eHealth intervention investigators should budget and plan accordingly to prepare for unexpected costs such as recruitment challenges to increase flexibility while maximizing the intervention efficacy.
使用积极视频游戏(AVG)的电子健康干预措施提供了一种帮助儿童锻炼的替代方法,尤其是在疫情期间,选择有限的情况下。关于开发和实施此类干预措施的相关成本,数据有限。
我们量化了在 COVID-19 期间为少数族裔儿童提供电子健康 RCT 干预的成本。
我们将总试验成本分为五个子类别:干预材料开发、广告和招募、干预交付、人员工资和与 COVID-19 相关的设备成本。
总 RCT 成本为 1927807 美元(直接成本:1227903 美元;间接成本:699904 美元),每个参与者需要进行三次访问。完成 RCT 的每位参与者的平均成本(79 名参与者/237 次访问)为 24403 美元(直接成本:15543 美元;间接成本:8860 美元)。由于未出席和取消(198 次访问)以及研究完成前(61 次访问;56 名参与者)辍学,必须安排 496 次访问以确保对 79 名参与者进行完整的数据收集。如果所有 496 次访问均来自完成三访协议的参与者,则对应 165 名参与者,将每位参与者的平均成本降低至 11684 美元(直接成本:7442 美元;间接成本:4242 美元)。在子类别中,干预材料开发占比最大,其次是人员工资。虽然直接针对 COVID-19 的特定成本构成整个预算的 <1%,但间接影响要大得多,并且对试验产生了重大影响。
RCT 通常需要大量资源,尤其是在疫情期间。未来的电子健康干预研究人员应该相应地预算和计划,以应对招募挑战等意外成本,提高灵活性,同时最大限度地提高干预效果。