title: Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD-'Assessing QbTest Utility in ADHD' (AQUA): a randomised controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT02209116.
authors.affiliation: CLAHRC, University of Nottingham, Nottingham, UK.
authors.forename: Charlotte L
authors.initials: CL
authors.lastname: Hall
authors.affiliation: CLAHRC, University of Nottingham, Nottingham, UK.
authors.forename: Gemma M
authors.initials: GM
authors.lastname: Walker
authors.affiliation: CLAHRC, University of Nottingham, Nottingham, UK.
authors.forename: Althea Z
authors.initials: AZ
authors.lastname: Valentine
authors.affiliation: CLAHRC, University of Nottingham, Nottingham, UK.
authors.forename: Boliang
authors.initials: B
authors.lastname: Guo
authors.affiliation: CLAHRC, University of Nottingham, Nottingham, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Kaylor-Hughes
authors.affiliation: Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
authors.forename: Marilyn
authors.initials: M
authors.lastname: James
authors.affiliation: Division of Psychiatry & Applied Psychology, School of Medicine, University of Nottingham, Nottingham, UK.
authors.forename: David
authors.initials: D
authors.lastname: Daley
authors.affiliation: Department of Developmental Psychiatry, University of Nottingham, Queens Medical Centre, Nottingham, UK.
authors.forename: Kapil
authors.initials: K
authors.lastname: Sayal
authors.affiliation: Department of Developmental Psychiatry, University of Nottingham, Queens Medical Centre, Nottingham, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Hollis
mesh_terms: D000293:Adolescent; D001288:Attention; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis* / Q000628:therapy; D002648:Child; D003657:Decision Making; D003658:Decision Making, Computer-Assisted; D005260:Female; D006801:Humans; D008297:Male; D008603:Mental Health; D009043:Motor Activity; D011594:Psychometrics / Q000379:methods*; D011785:Quality Assurance, Health Care / Q000379:methods*; D016037:Single-Blind Method
keywords: ADHD; Continuous Performance Test (CPT); Diagnosis; QbTest; Treatment