Malow Beth A, Galion Anjalee, Lu Frances, Kennedy Nan, Lawrence Colleen E, Tassone Alison, O'Neal Lindsay, Wilson Travis M, Parker Robert A, Harris Paul A, Neumeyer Ann M
Sleep Disorders Division, Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.
Division of Pediatric Neurology, Department of Pediatrics, University of California Irvine - Children's Hospital of Orange County, Orange, CA, USA.
J Clin Transl Sci. 2021 Jun 14;5(1):e138. doi: 10.1017/cts.2021.798. eCollection 2021.
The use of online platforms for pediatric healthcare research is timely, given the current pandemic. These platforms facilitate trial efficiency integration including electronic consent, randomization, collection of patient/family survey data, delivery of an intervention, and basic data analysis.
We created an online digital platform for a multicenter study that delivered an intervention for sleep disorders to parents of children with autism spectrum disorder (ASD). An advisory parent group provided input. Participants were randomized to receive either a sleep education pamphlet only or the sleep education pamphlet plus three quick-tips sheets and two videos that reinforced the material in the pamphlet (multimedia materials). Three measures - Family Inventory of Sleep Habits (FISH), Children's Sleep Habits Questionnaire modified for ASD (CSHQ-ASD), and Parenting Sense of Competence (PSOC) - were completed before and after 12 weeks of sleep education.
Enrollment exceeded recruitment goals. Trial efficiency was improved, especially in data entry and automatic notification of participants related to survey completion. Most families commented favorably on the study. While study measures did not improve with treatment in either group (pamphlet or multimedia materials), parents reporting an improvement of ≥3 points in the FISH score showed a significantly improved change in the total CSHQ ( = 0.038).
Our study demonstrates the feasibility of using online research delivery platforms to support studies in ASD, and more broadly, pediatric clinical and translational research. Online platforms may increase participant inclusion in enrollment and increase convenience and safety for participants and study personnel.
鉴于当前的疫情，利用在线平台进行儿科医疗保健研究正合时宜。这些平台有助于提高试验效率，包括电子同意、随机分组、收集患者/家庭调查数据、提供干预措施以及进行基本数据分析。
我们为一项多中心研究创建了一个在线数字平台，该研究为自闭症谱系障碍（ASD）儿童的家长提供睡眠障碍干预措施。一个家长咨询小组提供了意见。参与者被随机分为仅接受一份睡眠教育手册，或接受睡眠教育手册加上三张快速提示单和两段强化手册内容的视频（多媒体材料）。在进行12周睡眠教育前后，完成了三项测评——睡眠习惯家庭问卷（FISH）、针对ASD修改的儿童睡眠习惯问卷（CSHQ-ASD）以及育儿胜任感问卷（PSOC）。
入组人数超过了招募目标。试验效率得到了提高，尤其是在数据录入以及与调查完成情况相关的参与者自动通知方面。大多数家庭对该研究给予了积极评价。虽然两组（手册组或多媒体材料组）的研究测评指标在治疗后均未改善，但报告FISH评分提高≥3分的家长在CSHQ总分上的变化有显著改善（P = 0.038）。
我们的研究证明了使用在线研究交付平台来支持ASD研究以及更广泛的儿科临床和转化研究的可行性。在线平台可能会增加参与者的入组率，并提高参与者和研究人员的便利性与安全性。
