Award Title: Remote Extra-clinic Monitoring of ADHD In the NHS (REMAIN) Study
Funder: Department of Health and Social Care

Abstract: Research questions: Will an integrated multi-modal digital health monitoring system (DHMS), linked with electronic health records(EHR), improve the monitoring of treatment effectiveness and adverse effects in children with Attention Deficit Hyperactivity Disorder (ADHD)? Will it enhance long-term outcome evaluation for ADHD services? Background: Since the 1990's, use of UK ADHD stimulant medication has increased 34-fold, and is currently being prescribed to 1-in-200 children. Current management of ADHD is challenging:	Overstretched NHS ADHD clinics cannot meet National guidance on clinical monitoring schedules. 	Data collection methods for monitoring treatment effectiveness and adverse effects rely on postal returns from teachers/parents, which are inefficient, provide low returns and hinder informed decision making. 	ADHD rating scales which assess intervention effectiveness are very subjective. Low inter-rater agreement is common, and susceptible to nocebo and placebo effects, which hinders safe and effective practice.Systematic reviews show that monitoring symptoms and adverse effects can be improved by online web-applications, and we have developed an online system called Me_health_e. ADHD rating subjectivity could be addressed using wearables to provide objective measures of activity and sleep, combined with online neuropsychological tests of attention and impulsivity. No NHS mental health services have integrated these approaches within a user-designed DHMS; the added benefits for these DHMS in assessing treatment effectiveness and safety above current approaches need clarifying. Objectives & timelines The main aim: To investigate if a user-designed DHMS can improve the quality of information available for monitoring treatment effectiveness and safety in childhood ADHD treatment? Objective - this will be addressed using five evolving workstreams (WS 1-5), incorporating research synthesis (WS1) qualitative (WS2,5), epidemiological (WS3-4) and computational techniques (WS3-4)	WS1: Systematic review to understand the theoretical models and evaluate the most effective approaches to monitor symptom tracking and adverse outcomes in ADHD and other long-term paediatic conditions using DHMS. (months 1-6); 	WS2: Qualitative study to optimise the usability of ADHD symptom tracking and adverse effects monitoring. Bringing together multiple stakeholders (parents, children, academics, clinicians, engineers, NHS system engineers) to co-design, plan and implement changes to the objective measurement devices, Me_Health_e system and, and improve the feasibility of WS3 protocol (months 6-18) 	WS3: A prospective cohort study to examine the feasibility and drug target validity of symptom tracking and adverse effects monitoring in ADHD via adapted Me_Health_e and objective measurement systems (wearables and online neuropsychological performance tests) in non-clinic settings at home and school. (months 18-38). 	WS4: A data-linkage study to nest the WS3 cohort into EHR and linked school data to evaluate representativeness of WS3 cohort and their long-term outcomes (months 38-60).Impacts: Creation of the first validated DHMS for both subjective and objective data collection in home/school settings; ready for trial evaluation in the NHS to its test impact on ADHD treatment effectiveness, adherence and reduction of adverse effects. Cost-savings beyond improving ADHD outcomes, include reduce caregiver, teacher and clinician burden. Provides proof of principle of this DHMS as a secure NHS pipeline to enhance patient reported outcomes which can be readily extended to monitoring other long-term health conditions

Lay Abstract: One in twenty-five children have Attention Deficit Hyperactivity Disorder (ADHD). To receive a diagnosis, children need to have severe and chronic problems with inattention, impulsivity and hyperactivity, both at school and home. These problems are debilitating, and studies have shown they can dramatically affect people throughout their life: preventing them doing well at school, holding down friendships, and later on, jobs, relationships, and maintaining their health. Medication can help. Nearly half of children diagnosed with ADHD in NHS child and adolescent mental health services (CAMHS) are offered medication at primary school age. They work by reducing the main symptoms of ADHD. However, when children start medications, specialist CAMHS doctors need to monitor carefully how well a child responds. Each child is different. If doctors prescribe too much ADHD medication or increase doses too quickly, side-effects like poor sleep, poor appetite, headaches, and mood changes can make things worse. Give too little, or too slow, a child's ADHD symptoms and their difficulties remain. There are several major problems with how ADHD is managed. Current ways of checking for side-effects or whether the medication works are too awkward to use efficiently. The NHS aims to be paperless, but parents and teachers are often asked to fill out paper-based questionnaires via the post. These rarely get back to the doctor and enter a child's health record. This creates difficulties, as doctors need this information to check medications are working. National guidance recommends regular questionnaire checks, and appointments when starting ADHD medications. Doctors say everyone is too overstretched to meet these recommendations. Another problem is that teachers and parents assess the same children differently, and disagree about what behaviours are due to a child's ADHD symptoms. For doctors, these disagreements make prescribing the right dose difficult, as they cannot determine who may be more accurate. Finally, clinicians and family want to know that ADHD treatments help their child later on. Information is not collected once children leave NHS care, so clinical services cannot show parents that their treatment can make long-term differences at school or home. I am proposing a research project which tackles these issues using digital technologies. The REMAIN study will build and test an innovative digital system which aims to make completing questionnaires on ADHD symptoms and medication side-effects much easier. It also tests whether wrist-based activity trackers(wearables) and online attention tests, provide a better way of checking medication effects. To ensure the digital systems I develop, are engaging and user-friendly, this study will put specialist healthcare designers alongside children with ADHD, caregivers, clinicians, teachers, data-scientists to try and create the most user-friendly health monitoring system in the NHS. We will all work together to select the best features home/school based online ADHD system; finding the ideal way to integrate online-questionnaires, wearable and online psychological tests. After this, I will build the system using commercial partners, who specialise in tech development within these areas. I will then test whether the system works in NHS practice. I will recruit families with children with ADHD before they start medications, and see whether families and doctors like using the new system. I will test the activity and attention data to see whether it changes as we would expect during medication increases. I will then link this information electronic health records, hospital and education record to see whether it can help us understand the effect of ADHD treatments over the long-term.If by the end of this fellowship, I aim to be ready to test the digital system in randomised trial, and eventually offer it across the NHS.

Research Activity Codes: 6.1 PHARMACEUTICALS;7.3 MANAGEMENT AND DECISION MAKING;8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health Categories: MENTAL HEALTH