Associate Professor Melissa Mulraney Hi, I’m  Melissa Mulraney. I’m an Associate Professor of   Developmental Mental Health in the Department  of Paediatrics, at the University of Melbourne   in Australia. Today, I’m going to be speaking  about some work that we recently published,   where we developed a set of patient-centred  outcome measures for children and young people   with neurodevelopmental disorders. So,  just to give a brief overview of my talk,   I’ll start by describing what neurodevelopmental  disorders and measurement-based care are,   then I’ll introduce ICHOM, the organisation  that drove the development of the set. I’ll   then take you through how we developed the set,  describe the different components and then,   finally, provide some links to  resources and further information. So, neurodevelopmental disorders are conditions  that affect how the brain develops and functions.   They usually show up in early childhood and they  can affect things like how people learn, the way   that they behave and interact with the world  around them, as well as how they interact and   communicate with other people. There are a lot of  different types of neurodevelopmental disorders,   which depends on how brain development is affected  and what types of functions are affected. So,   I’ll just give a brief description of the  different categories of neurodevelopmental   disorders that you can see listed here, and  these are the categories that are included   in the DSM-5, which is the Diagnostic and  Statistical Manual of Mental Disorders. So, intellectual disabilities involve limitations  in intellectual functioning, so things like our   ability to learn, reason and problem solve, as  well as limitations in adaptive behaviour. So,   this is things like our everyday social and  practical skills, like being able to dress   ourselves independently. Communication disorders  affect a person’s ability to understand or apply   language and speech, and this can include things  like difficulties with speaking, listening,   reading, writing, or understanding language, and  an example of a communication disorder would be   a person who stutters. Autism spectrum disorder is  a condition that affects how a person communicates   and interacts with others. People with autism  may have trouble understanding social cues,   may engage in repetitive behaviours  and might have very focused interests. ADHD is a condition characterised by  persistent patterns of inattention,   so people have a lot of trouble  focusing or concentrating,   hyperactivity, which is excessive movement,  and impulsivity, so acting without thinking.   Specific learning disorders are difficulties  in specific areas of learning, like reading,   writing or maths. People who have a specific  learning disorder with impairments in reading   and spelling are often referred to as having  dyslexia. Specific learning disorders are not   due to a lack of intelligence or effort, but are  related to how our brain processes information.   And then, finally, motor disorders are conditions  that affect the nervous system and lead to   abnormal and involuntary movements. So, these can  include things like tics, tremors or problems with   co-ordination and balance. An example of a  motor disorder would be Tourette syndrome. Okay. Now, measurement-based care is a way of  using regular systematic assessments to track   a patient’s progress during treatment. So,  in simpler terms, that means that Doctors and   Therapists regularly check in on how a patient is  doing by using specific tools and questionnaires,   and this helps them see if the treatment is  working and make any necessary adjustments to   improve the care they’re giving their patients.  So, for example, in diabetes care, we know that   patients measure their blood sugar levels and  then adjust their medication accordingly. In   the context of neurodevelopmental disorders,  this might look like a parent completing a   brief questionnaire about their child’s  ADHD symptoms after starting medication,   and then this helps the Doctor decide whether  the medication dose needs to be adjusted. And we know that the use of measurement-based care  is associated with a number of positive outcomes,   so by regularly tracking a patient’s  progress using standardised tools,   healthcare providers can see what treatments  are working and make adjustments as needed,   and this leads to better and faster  improvements in patient health.   Measurement-based care enhances clinical  decision-making, through providing objective   data that helps Clinicians make more  informed decisions about treatment plans,   and this reduces the reliance on guesswork  and personal clinical judgement alone. When patients see their progress through  regular assessments, they often feel more   involved and motivated in their treatment, and  this can lead to better adherence to treatment,   as well as improved overall patient  satisfaction. Measurement-based care also   helps to show the effectiveness of treatments,  by providing clear evidence of patient progress,   and this is really important for justifying the  use of certain therapies, and in some contexts,   for securing funding or insurance coverage.  And then, finally, measurement-based care   can also help prevent deterioration, so regular  monitoring can catch early signs that a patient’s   condition is worsening, and this allows for early,  timely interventions to prevent further decline. Okay. Now, before I go on to describe  our research, I’m just going to speak   a little bit about ICHOM, the organisation  who drove the development of our set. So,   ICHOM stands for International Consortium  for Health Outcomes Measurement. They’re   a nonprofit organisation with a vision  of improving health and safe equitable   healthcare through measurement-based care,  ensuring that the outcomes which matter most   to patients are being tracked. ICHOM aims  to standardise and drive global adoption   of patient-centred outcomes measurement  as the benchmark for health and value. Okay. So, ICHOM sets end up being a set of  around ten to 15 outcomes that matter most   to the people with a particular condition, and  this usually includes symptoms of the condition,   as well as impacts on functioning and quality  of life. The sets are designed to be mostly   patient-reported outcomes, but most sets also  include some Clinician-reported outcomes. As   well as the outcomes, a set will include something  that’s called ‘case-mix variables’. Now, these are   things that are not likely to change as a result  of treatment for the condition, but they’ll   probably impact either treatment effectiveness  or the choice of which treatment to use.   So, case-mix variables might include things like a  person’s gender, or if they were born prematurely. The sets also include recommended  measurement tools, so, for example,   a particular questionnaire might be recommended  to measure quality of life. And this ensures that,   as much as possible, the same tools are used  in different healthcare settings worldwide,   which makes it easier to compare outcomes  across services. Lastly, the sets include   recommended measurement timepoints, and again,  this makes comparisons between services a lot   more relevant, because patient outcomes can  be compared at similar stages of treatment. So, how are they developed? ICHOM sets  are developed by an international working   group that consists of a core Research  Team, including ICHOM representatives,   a Working Group Chair, who’s a renowned  expert in the field, and a Research Fellow,   who’s also an expert in the field, but generally  a bit more junior in their career than the Chair.   So, for the neurodevelopmental disorder set,  I was the Research Fellow. As well as the core   Research Team, there’s a selection  of experts from around the globe,   including Researchers and Clinicians who  work diresh – directly with patients with   the conditions. And then, finally, the working  group includes lived experience representatives. So, what happens in the process is the Research  Team compiles – or the core Project Team compiles   evidence to present to the working group, who then  vote on various aspects of the set in an iterative   process, until agreement is reached on final  recommendations. And when choosing measurement   tools, the working group prioritise measures that  have evidence of strong psychometric properties,   so that means these are measures that can reliably  measure what it is that they’re supposed to be   measuring. Working groups also prioritise  measures that have low administrative burden,   so that it’s not too difficult or time consuming  for patients and Clinicians to complete,   wherever possible tools that are free from cost  and that are translated into multiple languages. Okay. So, for the neurodevelopmental disorders,   the working group is shown on the slide here,  and consisted of 27 experts from 12 countries,   and this included Clinicians and Researchers,  as well as two lived experience representatives.   Now, I know the font here is quite  small, but as you can see on the map,   we had representatives from most areas around the  globe, and the core Project Team co-ordinated and   facilitated the work and undertook supporting  research, but didn’t vote on the surveys. So, the set was developed through the process  that’s depicted on this slide. So, the working   group participated in nine video conferences and  eight surveys, between March 2021 and June 2022.   During the video conferences, the working group  discussed the results of research presented by the   Project Team, and then a modified Delphi process  was undertaken to make decisions. So, what this   means is that members were given a survey where  they voted on how important different aspects   were. If 80% of the group agreed that something  was essential, it was included, and if 80% agreed   that it was not important, then it was excluded.  Anything else that didn’t meet those thresholds   was discussed in a subsequent video conference and  then went through to a second round of voting, and   if necessary, a third round. So, the working group  voted on the scope of the set, outcomes and their   measurement, as well as a selection of case-mix  variables and timepoints for measurement, and I’ll   describe each of those steps in turn. And then the  set also went through an open review period, where   it was distributed to professionals and service  users for external feedback and validation. Okay. So, here you can see the final scope of  the set, and there were just a couple of key   things that I wanted to speak about in relation  to this. So, we made the decision to define   neurodevelopmental cor – disorders according  to the categories you can see here, so ADHD,   motor disorders, communication disorders  and specific learning disorders. Although   the working group agreed that a set of outcome  measures for neurodevelopmental disorders should   include autism, a separate ICHOM set had already  been developed specific to autism, so we didn’t   want to duplicate this work. The working group  also decided to exclude intellectual disabilities,   and this is based on the understanding  that the goal was to develop a standard   set of patient-reported outcome measures  reflecting treatment outcomes, and intellectual   abilities are really not very well measured  through patient-reported measures. In fact,   most measures of intellectual ability are  very time consuming and costly, and need to   be administered by a Psychologist, so they’re  not really feasible for a project like this. All treatment approaches and modalities were  considered in scope, and the age range for   the set was three to 20 years. We set the upper  limit at 20 rather than 18, because the working   group thought that it was really important to  capture the transition into young adulthood,   especially since a lot of youth health services  around the world include adults – include clients   who are in early adulthood. We excluded adults  older than 20 because a lot of the relevant   outcomes change from childhood to adulthood. So,  for example, in adulthood, work-related outcomes   become more important and education-related  outcomes less so. We did recommend to ICHOM that   they consider developing a separate set for  adults with neurodevelopmental disorders. Okay. So, moving to outcomes and measurement, the  working group decided on a broad outcome domain of   core symptoms, which vary according to diagnosis.  And on this slide, you can see the chosen core   symptom outcomes for each disorder, as well as the  tools recommended to measure them. So, I just want   to remind you again here, when choosing measures,  we prioritised those with evidence of strong   psychometric properties, with low administration  burden, wherever possible free of cost, and   translated into multiple languages. So, for ADHD  symptoms, we recommend using either the SNAP-IV,   ADHD Rating Scale-5, or Vanderbilt. And these  three measures are pretty directly comparable,   because the measurement of core ADHD symptoms  in these tools maps directly onto diagnostic   criteria and response format is the same. So,  we didn’t feel comfortable recommending one   tool above another, because they’re essentially,  equivalent in their measurement of ADHD symptoms. For communication disorders, we recommend the  Children’s Communication Checklist-2, to assess   language and social communication difficulties,  and the Intelligibility in Context Scale for   speech sound difficulties. We weren’t able to  identify an appropriate patient-report measure   for fluency difficulties, so while it’s not  included as part of the core set, we do recommend   that where possible, fluency difficulties should  be assessed using the Speech Naturalness Scale.   Core symptom outcomes for motor disorders include  fine and gross motor skills and co-ordination,   for which we recommend the Developmental  Co-ordination Disorder Questionnaire,   and motor disorders can also include vocal and  motor tic frequency and severity, for which we   recommend the Yale Global Tic Severity Scale. And  then, finally, specific learning disorder outcomes   include reading accuracy and comprehension,  global maths ability and global writing ability,   all of which can be assessed using the  Colorado Learning Disabilities Questionnaire. Our second broad outcome domain was  impact, functioning and quality of life,   and while we recognise that educational outcomes  are really important, they’re generally assessed   through education rather than health services, so  we weren’t actually able to find an appropriate   patient-report measure, and so when – we can’t  make a recommendation of a tool at this time.   The KIDSCREEN-10 was chosen to track quality of  life outcomes and activities of daily living,   with the Clinician-reported Developmental  Disability-CGAS recommended to complement   the KIDSCREEN for activities of daily living.  We chose the KIDSCREEN-10 over longer versions   of this scale, both to reduce burden and  also, increase consistency across sets. So,   for example, the set for anxiety and depression  in children and young people also recommend   the KIDSCREEN-10. For assessment of caregiver  burden, the Family Strain Index is recommended. The final broad domain we included is  common co-existing problems, and this   wheel here just depicts the three broad domains  with their component outcomes within. And then,   as you can see, three of the six included  outcomes under common co-existing problems   are the focus of existing ICHOM sets.  So, for these issues, we recommend   the measures used in the corresponding  set. For emotional lability and reactivity,   aggression and irritability, the Affective  Reactivity Index and the SNAP-IV are recommended,   with the Children’s Sleep Habits  Questionnaire for sleep problems. Okay. Now, the next few slides will go through the  case-mix variables that we included in the set.   So, just to remind you, case-mix variables  are things that are not likely to change   as a result of treatment but will probably  impact treatment effectiveness or decisions   about what treatment to use. So, we agreed that  services should record demographic information,   baseline health status, clinical and historical  factors and treatment-related factors. You can   see here on the slide the demographic factors  that we included. In relation to treatment,   we recommend intervention type and setting be  included. This might include things like what   type of medication or psychotherapy,  and whether it’s being delivered in   a hospital or community setting. In  terms of disorder-specific factors,   we included ADHD subtype, and for specific  learning disorders, whether the child’s   first language is the same as the predominant  local language spoken where they’re living. A large number of baseline health status,  clinical and historical factors were included,   as you can see here on the slide, but many of  these are measured by the Current View tool   and so, can actually be recorded quite quickly  and easily by services. Now, I’ll just pause for   a moment to give you a chance to read through  these, before I go onto the next slide [pause]. So, finally, the timepoints for measurement, and  we recognise that these are likely to vary quite   considerably across services and Clinicians. So,  the timepoints that we’re recommending here are   really minimum timepoints for measuring outcomes  and case-mix variables, but we encourage measuring   outcomes as frequently as is needed to best  inform clinical decision-making. So, outcomes   should be measured at least every six months, or  in the cases of changes to medication, they should   be measured prior to initiation or change of a  medication, as well as at the end of titration. So, to summarise, the neurodevelopmental  disorders set has been completed and is   freely available for download and implementation.  I’ve included here the direct link to the webpage   that you can download it from. You do need to  sign up for an ICHOM Connect account before   you’ll be able to download the materials,  but these accounts are free to set up. So,   the set includes 12 outcomes across the domains  of core symptoms, impact, functioning and   quality of life and common co-existing  problems, with 14 recommended measures. One point that I wanted to touch on before  finishing up today, is that we did have a   lot of difficulty selecting measures for some of  the outcomes. When we were doing our research,   we found that very few of the tools had  evidence that they were sensitive to change,   and for some outcomes, we weren’t actually  able to locate any appropriate measures,   or patient-reported outcome measures, so in some  instances, we couldn’t make a recommendation,   and in others we’ve recommended  Clinician-reported outcomes. So,   it’s really important, as we continue to work  towards our patient-centred measurement-based   care, that appropriate psychometrically sound  patient-reported outcome measures are developed,   to make sure that we can properly measure  all outcomes of importance to service users. Finally, I’d just really like to thank everyone  who contributed to the development of the set,   including the working group members, the  reference group members, the core Project Team,   our patients and professionals who  participated in the open review survey,   and the NHS England for funding  the set development. Thank you.