Hall Charlotte L, Walker Gemma M, Valentine Althea Z, Guo Boliang, Kaylor-Hughes Catherine, James Marilyn, Daley David, Sayal Kapil, Hollis Chris
CLAHRC, University of Nottingham, Nottingham, UK.
Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
BMJ Open. 2014 Dec 1;4(12):e006838. doi: 10.1136/bmjopen-2014-006838.
The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current 'gold standard' ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome.
This multisite randomised controlled trial will recruit young people (aged 6-17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice.
The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval.
NCT02209116.
英国国家卫生与临床优化研究所（NICE）发布的注意缺陷多动障碍（ADHD）指南指出，青少年需要获得基于最佳证据的护理，以改善治疗效果。当前ADHD诊断评估的“金标准”是将临床观察与家长、教师及自我主观报告相结合。在常规临床实践中，可能无法获取来自多个信息提供者的报告，或者这些报告相互矛盾，从而导致诊断不确定性和延误。增加注意力和活动的客观测试可能有助于减少诊断不确定性，并减少启动治疗的延误，进而改善治疗效果。本试验旨在研究为临床医生提供注意力、冲动性和活动水平的客观报告是否能实现更早、更准确的临床诊断，并改善患者治疗效果。
这项多中心随机对照试验将招募在英格兰各地儿童和青少年心理健康服务机构（CAMHS）及社区儿科诊所被转介进行ADHD诊断评估的青少年（6至17岁）。通过QbTest对常规临床评估进行补充，QbTest包括连续性能测试（CPT）和活动的红外运动跟踪。参与者将被随机分为两个研究组之一：QbOpen（临床医生可立即获取QbTest报告）；QbBlind（报告在研究结束前 withheld）。主要结局指标是诊断时间和诊断准确性。次要结局指标包括临床医生的诊断信心和常规临床结局指标。将进行成本效益分析，并对将QbTest纳入常规实践的可行性和可接受性进行定性评估。
该研究的结果将为决策者、临床医生和管理人员提供有关将QbTest纳入青少年ADHD常规诊断评估的可行性、可接受性、临床效用和成本效益的信息。研究结果将提交至同行评审期刊发表。该研究已获得伦理批准。
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