Developing a PROM for Children with CFS/ME: Cognitive Interviews
Research type
Research Study
Full title
Developing a Patient Reported Outcome Measure (PROM) for Children with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). Cognitive Interviews with Children.
IRAS ID
194846
Contact name
Roxanne Parslow
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
This study will: Evaluate whether children understand and interpret questions in a new paediatric CFS/ME Patient Reported Outcome Measure (PROM)/ questionnaire the way that was intended.
Design: Cognitive interviews
Recruitment: 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 and are mild to moderately affected (not housebound).
We will recruit children at assessment and follow up.
Cognitive Interviews: In the cognitive interview process, patients are asked to say what they are thinking as they work through the questionnaire—to think aloud and then they will be asked open ended semi structured interview questions about how they make sense of questionnaire items. Cognitive interviews will take up to 30 minutes.
Analysis: Interviews will be audio-recorded and transcribed. We will use thematic analyses in an iterative process. The results will inform the development of the PROM.REC name
West of Scotland REC 3
REC reference
16/WS/0011
Date of REC Opinion
25 Jan 2016
REC opinion
Further Information Favourable Opinion