Title: Measuring Health in Children with CFS/ME: Refinement, application and evaluation of new PROM (PEACH) in routine practice.
Funder: Department of Health and Social Care

Abstract: Background: Paediatric Chronic Fatigue Syndrome or Myalgic Encaphalistis (CFS/ME) is disabling and relatively common (1-2% of teenagers). We need to improve treatment but need a well developed Patient Reported Outcome Measure (PROM) to do this. Clinical services and randomised controlled trials use a variety of PROMs but they are largely of poor quality with limited relevance to children s experience of CFS/ME. We have completed the first stage in developing a child-centred measure: Prom Evaluating Adolescent and Child cHronic fatigue (PEACH). However, this contains 63 questions and is too long to be used. Aims: Create a high quality, relevant, acceptable child-reported PROM for paediatric CFS/ME called PEACH-Short form (PEACH-SF). Objective 1: Refine PEACH-63 to construct PEACH-SF. Objective 2: Check the acceptability and relevance of PEACH-SF. Objective 3: Evaluate the quality, validity, acceptability, reliability and responsiveness of PEACH-SF. Methods: Phase 1: Objective 1. Refining PEACH-63. We will recruit 313 children from the Bath Specialist paediatric CFS/ME service and the London Specialist paediatric service to complete PEACH-63 once. This will provide data on >250 children. We will collect questionnaire data online and use both traditional and modern psychometric analyses to perform psychometric evaluation. We will describe measurement data quality, the internal structure of the measure, identify those questions which contribute best which will enable us to reduce the number of questions producing PEACH-short form (PEACH-SF), of approximately 20 questions. Objective 2: We will check the acceptability and relevance of PEACH-SF by interviewing participants (approximately 10) on whether we have retained content and face validity. We will observe approximately 10 children and young people complete PEACH-SF using Usability Testing Software and we will discuss PEACH-SF with the CFS/ME Young Peoples Advisory Group. Phase 2 (Field test 2) Objective 3. We will recruit a further 313 children and young people (ensuring we have data on >250) to complete PEACH-SF ( approximately 20 questions) at baseline, 2 weeks later (to check temporal stability) and 6 months later (to check measurement responsiveness). We will collect the Clinical Global Improvement Scale (CGI, 1 item) at both time points and the SF-36 physical function short form at 6 months. Timelines for delivery: Month 10: Field testing 1 complete. Month 14: PEACH-SF complete. Month 28: Field testing 2 complete. Month 31: Psychometric analyses complete and PEACH-SF ready for use. Impact and Dissemination: Short term impact &ndash; improved clinical care as PEACH-SF will be used immediately at the end of this study. Medium to long term impact &ndash; improved research in paediatric CFS/ME leading to improved treatments. Dissemination: To ensure PEACH-SF is used throughout the NHS, we will work with the British Association for CFS/ME to disseminate to paediatric CFS/ME services, and the AHSN to disseminate to paediatric services and inform NICE. We will publish, and work with the press office to ensure researchers and the public are aware of PEACH-SF.

Lay abstract: Aims: To make a short questionnaire that measures symptoms and disability in children and young people (YP) who have Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME). Background: CFS/ME is a relatively common condition which affects at least 1 to 2% of children and YP in the UK. Symptoms can have a big effect on the child or YPs life, and include: headaches, muscle pain and problems concentrating. Some will also be anxious and low. Treatment and research is difficult because we do not have a good way to measure the symptoms and impact of CFS/ME on the life of the child or YP. This means it is hard to know if they get better with treatment. We have developed the PEACH questionnaire, or Patient Reported Outcome Measure (PROM), that children and YP with CFS/ME think is a good way to measure their symptoms and disability. However, PEACH is too long (63 questions) and we need to check that it works before we can use it in the NHS or in research studies. Methods: The study has two stages: Stage 1: We will ask 313 children and YP with CFS/ME to answer PEACH so we can work out which questions we can remove to make it shorter. When we have a shorter version (about 20 questions), we will ask around 10 children and YP to answer it, and then talk to them to check the shortened PEACH asks all the important questions and is easy to answer. Stage 2: We will then check the short-form PEACH (PEACH-SF) works by testing it in a second group of 313 children with CFS/ME at three separate times (when they first come to clinic, then after 2 weeks and after 6 months). At the second and third time points, the children and YP will also be asked if their symptoms have changed since the last time and we will also measure how it affects their daily lives using a standard questionnaire called the SF-36. We will then check that the PEACH-SF can measure if their symptoms change. Patient involvement: Our CFS/ME Young People's Advisory Group helped us develop PEACH. They will test each version, and advise us on if the shorter version still works. They will help us understand the results and help with recruitment in each stage. Dissemination: PEACH will be useful to all clinical CFS/ME services, and help researchers test new treatments. We will publish the results in peer reviewed journals, present information about PEACH at national and international meetings for paediatricians and share information using our clinical networks and through our Young People's Advisory Group.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: DISPUTED AETIOLOGY AND OTHER