Data Science, Evidence-Based and Clinical Research Laboratory, Department of Health, Social and Clinical Pharmacy, College of Pharmacy, Chung-Ang University, Seoul, 06974, Republic of Korea.
College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
Eur Child Adolesc Psychiatry. 2024 Feb;33(2):481-493. doi: 10.1007/s00787-023-02174-z. Epub 2023 Mar 2.
Attention-deficit/hyperactivity disorder (ADHD) is a childhood-onset disorder characterized by pharmacological and non-pharmacological interventions. Despite the available treatment options and prevention measures, conventional treatments have several limitations. Digital therapeutics (DTx) like EndeavorRx® is an emerging alternative to overcome these limitations. EndeavorRx® is the first FDA-approved, game-based DTx approved for the treatment of pediatric ADHD. We investigated the effects of game-based DTx in randomised controlled trials (RCTs) on children and adolescents with ADHD. In this systematic review and meta-analysis, we searched PubMed, Embase, and PsycINFO databases up to January 2022. The protocol was registered (CRD42022299866). The assessor was defined as parents and teachers. The primary outcome was differences in inattention reported by the assessor, and the secondary outcome was differences in hyperactivity and hyperactivity/impulsivity reported by the assessor and the relative comparisons between game-based DTx, medicine, and control with indirect meta-analysis. Game-based DTx improved inattention more than the control upon assessment by assessors (standard mean difference (SMD) 0.28, 95% confidence interval (CI) 0.14-0.41; SMD 0.21, 95% CI 0.03-0.39, respectively), while medication improved inattention more than game-based DTx (SMD - 0·62, 95% CI - 1·04 to - 0·20) upon assessment by the teacher. Game-based DTx improved hyperactivity/impulsivity than the control upon assessment by assessors (SMD 0.28, 95% CI 0.03-0.53; SMD 0.30, 95% CI 0.05-0.55, respectively), and medication improved hyperactivity/impulsivity significantly than game-based DTx upon assessment by the teacher. Hyperactivity has not been reported extensively. As a result, game-based DTx had a more significant effect than the control, however medication was more effective.
注意缺陷多动障碍（ADHD）是一种以药物和非药物干预为特征的儿童发病障碍。尽管有可用的治疗选择和预防措施，但传统治疗方法存在一些局限性。数字疗法（DTx），如 EndeavorRx®，是克服这些局限性的新兴替代方法。EndeavorRx®是第一个获得 FDA 批准的、用于治疗儿科 ADHD 的基于游戏的 DTx。我们研究了基于游戏的 DTx 在随机对照试验（RCTs）中对 ADHD 儿童和青少年的影响。在这项系统评价和荟萃分析中，我们检索了 PubMed、Embase 和 PsycINFO 数据库，检索截止日期为 2022 年 1 月。方案注册（CRD42022299866）。评估者定义为父母和教师。主要结局是评估者报告的注意力不集中的差异，次要结局是评估者报告的多动和多动/冲动的差异，以及基于游戏的 DTx、药物和对照组之间的相对比较，采用间接荟萃分析。基于游戏的 DTx 在注意力方面的改善优于对照组（评估者评估的标准均数差（SMD）为 0.28，95%置信区间（CI）为 0.14-0.41；SMD 0.21，95%CI 0.03-0.39），而药物治疗在注意力方面的改善优于基于游戏的 DTx（SMD-0·62，95%CI-0·10-0·13）。基于游戏的 DTx 在多动/冲动方面的改善优于对照组（评估者评估的 SMD 为 0.28，95%CI 为 0.03-0.53；SMD 0.30，95%CI 为 0.05-0.55），而药物治疗在多动/冲动方面的改善明显优于基于游戏的 DTx（教师评估的 SMD 为 0.02-0.14）。多动尚未得到广泛报道。因此，基于游戏的 DTx 的效果比对照组更显著，但药物治疗更有效。
