Williams Laura, Hall Charlotte L, Brown Susan, Guo Boliang, James Marilyn, Franceschini Matilde, Clarke Julie, Selby Kim, Vijayan Hena, Kulkarni Neeta, Brown Nikki, Sayal Kapil, Hollis Chris, Groom Madeleine J
School of Medicine, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, UK.
Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Pilot Feasibility Stud. 2021 Mar 16;7(1):68. doi: 10.1186/s40814-021-00788-1.
Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD.
This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6-15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2-4 weeks and 8-10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed.
Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47-65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (- 5.85, 95% CI - 10.33, - 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases.
The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV.
ClinicalTrials.gov, NCT03368573 , prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593 , retrospectively registered, 10th April 2018.
注意力缺陷多动障碍(ADHD)的药物治疗应受到密切监测以确保达到最佳效果。利用计算机化的ADHD症状评估来辅助药物监测的兴趣日益浓厚。本研究的目的是评估一项随机对照试验(RCT)的可行性和可接受性,该试验旨在评估一种此类计算机化评估——量化行为(Qb)测试,作为ADHD药物管理一部分的疗效。
这项在儿童和青少年心理健康及社区儿科环境中进行的可行性多中心RCT招募了6至15岁被诊断为ADHD且开始使用兴奋剂药物治疗的参与者。参与者被随机分为两组之一:实验组(Qb测试方案),参与者在基线时完成一次Qb测试,并在用药后进行两次随访Qb测试(分别在2 - 4周和8 - 10周后);对照组,参与者接受常规治疗,包括至少两次随访咨询。在每个时间点完成家长、教师和临床医生评定的症状及整体功能的测量。临床医生记录治疗决策过程并获取卫生经济学指标。使用多层次模型对数据进行分析,并对参与者(儿童及其家长)和临床医生就他们的经历进行访谈,对所得数据进行主题分析。
44名儿童和青少年被随机分组。照顾者和教师完成研究结局测量的比例从基线时的52%至78%,到随访时的47% - 65%。参与者报告完成问卷很有用。SNAP - IV注意力不集中得分显示干预组比对照组有更大幅度的降低(-5.85,95%可信区间 -10.33,-1.36)。对干预的参与率从基线时的100%,降至随访1时的78%和随访2时的57%。然而,只有37%的Qb测试是在正确时间段内进行的。访谈数据突出显示临床医生和家长赞赏Qb测试的客观性。临床医生评论说所需的额外时间和资源意味着对所有病例使用Qb测试是不可行的。
试验设计和方案似乎是可行且可接受的,但可通过修改Qb测试时间段和数据收集方法来改进。做出这些改变后,该方案可能适合进行全面试验。添加Qb测试可能会改善SNAP - IV所测量的症状结局。
ClinicalTrials.gov,NCT03368573,前瞻性注册,2017年12月11日;以及ISRCTN,ISRCTN69461593,回顾性注册,2018年4月10日。