Schein Jeff, Cloutier Martin, Gauthier-Loiselle Marjolaine, Catillon Maryaline, Yu Louise, Libchaber Beatrice, Wang Yuxi, Childress Ann
Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA.
Analysis Group, Inc., Montréal, Quebec, Canada.
J Child Adolesc Psychopharmacol. 2025 Feb;35(1):49-60. doi: 10.1089/cap.2024.0061. Epub 2024 Oct 7.
To assess quality of life and outcomes associated with adverse effects (AEs) in pediatric patients receiving pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD) and their parents/caregivers. An online survey was conducted (10/13/2023-10/20/2023) among parents/caregivers recruited from Dynata's U.S. panel who lived with a pediatric patient (6-17 years) currently treated for ADHD. Patient and parent/caregiver characteristics and outcomes were descriptively reported. Patients were considered to have AEs if they experienced symptoms/complications in the past 30 days that appeared, worsened, or remained unchanged after initiating their latest ADHD treatment. Regression analyses were used to estimate correlations between the number of AEs and key outcomes, including patients' health-related quality of life (HRQoL; based on the Pediatric Quality of Life Inventory) and parents/caregivers' work and activity impairments (based on Work Productivity and Activity Impairment: Caregiver) and mental health (based on Patient Health Questionnaire-4). A total of 401 parents/caregivers from all U.S. regions completed the survey (caregiver median age: 38 years, 58.9% female; patient median age: 11 years; 37.7% female). In the 30 days prior to data collection, 66.8% of patients had AEs (overall mean: 1.2 AEs), with insomnia/sleep disturbances and decreased appetite/weight loss being the most frequently reported (14.2% and 11.7%, respectively). The number of AEs was significantly correlated with reduced patient's HRQoL (including reduced physical, emotional, and school functioning), increased parent/caregiver's work and activity impairment, and a higher likelihood of parents/caregivers having generalized anxiety disorder or major depressive disorder, respectively (all < 0.001). AEs are common among pediatric patients receiving pharmacological treatment for ADHD and are associated with poorer quality of life and outcomes in pediatric patients and their parents/caregivers. Therapies with better safety profiles may help improve patient's HRQoL and parent/caregiver outcomes.
评估接受注意力缺陷多动障碍（ADHD）药物治疗的儿科患者及其父母/照顾者的生活质量以及与不良反应（AE）相关的结果。在2023年10月13日至20日期间，对从Dynata美国小组招募的与一名目前正在接受ADHD治疗的儿科患者（6 - 17岁）同住的父母/照顾者进行了一项在线调查。对患者及父母/照顾者的特征和结果进行了描述性报告。如果患者在开始最新的ADHD治疗后的过去30天内出现、加重或症状未改变的症状/并发症，则被认为有AE。采用回归分析来估计AE数量与关键结果之间的相关性，包括患者的健康相关生活质量（HRQoL；基于儿童生活质量量表）以及父母/照顾者的工作和活动障碍（基于工作效率和活动障碍：照顾者）和心理健康（基于患者健康问卷 - 4）。共有来自美国所有地区的401名父母/照顾者完成了调查（照顾者中位年龄：38岁，58.9%为女性；患者中位年龄：11岁；37.7%为女性）。在数据收集前的30天内，66.8%的患者有AE（总体平均：1.2次AE），其中失眠/睡眠障碍和食欲减退/体重减轻是最常报告的（分别为14.2%和11.7%）。AE的数量分别与患者HRQoL降低（包括身体、情感和学校功能降低）、父母/照顾者工作和活动障碍增加以及父母/照顾者患广泛性焦虑障碍或重度抑郁症的可能性更高显著相关（均P < 0.001）。AE在接受ADHD药物治疗的儿科患者中很常见，并且与儿科患者及其父母/照顾者较差的生活质量和结果相关。具有更好安全性的治疗方法可能有助于改善患者的HRQoL和父母/照顾者的结果。
