BPSU study - Severe chronic fatigue syndrome / myalgic encephalitis (CFS/ME)

This BPSU study will collect information on all young people aged between five and 16 years who receive a diagnosis of severe Chronic Fatigue Syndrome or Myalgic Encephalitis (CFS/ME). The study aims to explore how many young people across the UK and Ireland have severe CFS/ME, the length of time from symptom onset to diagnosis and how the condition is managed in clinical services.

Lead investigators

Professor Esther Crawley
Centre of Child and Adolescent Health, University of Bristol
1-5 Whiteladies Road
Bristol BS8 1NU
Email: esther.crawley@bristol.ac.uk

About the study

Children with chronic fatigue syndrome or myalgic encephalitis (CFS/ME) have persistent disabling fatigue for at least three months. The fatigue is made worse by activity and is not relieved by rest. Children with CFS/ME have other symptoms including muscle aches, headaches, and poor concentration.

Children with severe CFS/ME are only able to leave their house occasionally (if at all). They have severe fatigue and often severe pain and many require help with daily activities such as eating and washing. At the moment, we do not know how often children develop severe CFS/ME or what treatment they receive. This means the NHS cannot organise treatment for them.

In this study, we will ask every children’s doctor in the UK whether they have seen a child that month with severe CFS/ME. We will then ask the doctor about their symptoms, how disabled they are and how long they have been unwell. We want to know what treatment children with severe CFS/ME get and we will ask doctors what treatment children were offered and what treatment they received. We also want to know whether children with severe CFS/ME get better and we will go back to doctors after a year to find out what happened to children in terms of treatment offered and whether they got better (or not).

You can download the protocol card, including references, below.

Case definition

Children aged 5 to 16 years who has been given a clinical diagnosis of CFS/ME with fatigue that is so severe that they are unable to attend school for more than one hour a week during the last 6 weeks of the school term. 

Notes: 

  1. If a child has had CFS/ME for a long period of time, they should be reported when the paediatrician becomes aware that they are not attending school. 
  2. School includes hospital school but not home tuition. 
  3. If a paediatrician is providing assessment during the school holidays or shortly after the school holidays, they should consider whether the child is able to attend school for more than one hour (or do a similar activity) during the last 6 weeks.

Reporting instructions

Please report any cases seen within the last month that meet the case definition.

Duration

February 2019 to February 2020 (13 months of surveillance). Follow-up until February 2021 (12 month follow-up).

Funding

The study is funded by The National Institute for Health Research (Senior Research Fellowship, SRF-2013-06-013) and a grant from the Royal United Hospitals Bath NHS Foundation Trust.

Approval

This study has been approved by South West – Central Bristol REC (REC reference: 18/SW/0051); has been granted Section 251 HRA-CAG permission (CAG Reference: 18/CAG/0051); and has been granted Public Benefit and Privacy Panel for Health and Social Care (PBPP) approval in Scotland (PBPP reference: 1718-0341).

Privacy information

University of Bristol (UB) is the sponsor and data controller for this research study. The Data Protection Officer, Henry Stuart at UB can be contacted at henry.stuart@bristol.ac.uk.

The study team at UB will use information from medical records for medical research. We will collect information about children with a new diagnosis of CFS/ME unable to attend school for more than one hour a week during the last 6 weeks of the school term from the doctors who are looking after them. Doctors will not provide names and addresses to the study team but they will provide details like sex, ethnic group, date of birth and NHS/CHI number. Doctors will complete questionnaires using information from medical records. If you want access to the information in your child’s medical records, then you should contact your child’s NHS hospital or doctor. We cannot withdraw or remove personal information from the study as this would make the research invalid. After the study finishes, UB will securely store information for 20 years, then anonymise or destroy it. Under the EU General Data Protection Regulation, the legal basis for processing this information is for the performance of a task carried out in the public interest. You can find out how the study uses personal information by contacting Professor Esther Crawley (esther.crawley@bristol.ac.uk).

If you wish to complain about the use of personal information, then you should contact the Information Commissioner's Office.