Investigating outcome in children with CFS/ME
Research type
Research Study
Full title
Investigating Outcome in children with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)
IRAS ID
146840
Contact name
Esther Crawley
Contact email
Sponsor organisation
Royal National Hospital for Rheumatic Diseases
Research summary
This study will: define recovery in paediatric CFS/ME; investigate how many children recover after accessing a specialist service; when they recover and what factors predict recovery.
Design: Longitudinal cohort and focus groups.
LONGITUDINAL COHORT: We will recruit children attending a specialist CFS/ME service in the Bath/Bristol area. Children will be eligible if they have a diagnosis of CFS/ME and are between 8 and 18 years old. Participants will be asked to complete follow up questionnaires at 6, 12 and 24 months either using paper questionnaires (currently used clinically) or completing questionnaires on-line.
FOCUS GROUPS: We will run focus groups (3 for children, 3 for their parents and 1 for clinicians) to define recovery and outcome. The focus groups will explore how recovery should be defined and what the smallest difference in fatigue and disability is beneficial. This will allow us to define the Minimum Clinically Important Difference (MCID) used to calculate how many are participants are need in trials. For the focus groups, we want children who have and have not recovered. We will therefore recruit children (and their parents) at assessment and we will therefore also contact children who have been discharged from the Bath/Bristol service and invite them to take part in the focus groups. Children will be eligible for the focus groups if they are have a diagnoses of CFS/ME and are age 12 to 18. We will recruit clinicians from the British Association for CFS/ME. Focus groups will be run in either Bath or Bristol, will last between one and two hours with a break in the middle.
Analysis: Focus groups will aim to reach consensus. The definition of recovery will be used to define recovery in the longitudinal cohort.REC name
North West - Preston Research Ethics Committee
REC reference
14/NW/0170
Date of REC Opinion
17 Mar 2014
REC opinion
Favourable Opinion