Evaluation of a new outcome measure for children with CFS/ME
Research type
Research Study
Full title
Measuring health in children with CFS/ME: Refinement, application and evaluation of a new PROM in routine practice.
IRAS ID
281461
Contact name
Jenny Ingram
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
Research Summary
Aims: To finalise and evaluate 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 relatively common affecting at least 1 to 2% of children and YP in the UK. Treatment and research is difficult because we do not have a good way to measure the symptoms and impact of CFS/ME on YP. This means it is hard to know if they get better with treatment. We have developed a new questionnaire, or Patient Reported Outcome Measure (PROM) in collaboration with children and YP with CFS/ME. However, the questionnaire is currently too long and we need to evaluate it and check that it works before we can use it in the NHS or in research studies.
Methods:
The study has two stages:
Stage 1 (Field Test 1): We will ask 313 children and YP with CFS/ME to complete the new questionnaire to work out which questions we can remove to make it shorter. When we have a shorter version, we will ask around 20 children what they think about it to check the shortened version includes the important questions and is easy to answer.
Stage 2 (Field Test 2): We will then check the short-form questionnaire 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 new questionnaire can measure if their symptoms change.Summary of results
To make a short questionnaire that measures symptoms and disability in children and young people (CYP) with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
Background: ME/CFS affects around 1-2% of CYP in the UK. Treatment and research is difficult because we do not have a good way to measure the impact on CYP and if they get better with treatment. We developed a questionnaire - the Paediatric Outcome Measure for ME (POMME) - with CYP with ME/CFS to measure how they feel and what can or cant do. However, it was too long and we needed to reduce it and test it to check it worked properly.
Methods:
Stage 1: We asked 229 CYP with ME/CFS to complete POMME. We tested it to make it shorter, and asked CYP with ME/CFS if the questionnaire still included the things that were important to them.
Stage 2: We asked a further 152 CYP with ME/CFS to complete the short POMME at two separate times: at a clinic appointment and after two weeks.Key findings:
In Stage 1, we made a short version of POMME (23 questions). Stage 2 made a final version with 21 questions which is ready to be used in the NHS and to help researchers test new treatments.Dissemination:
We will tell clinicians and researchers about the measure by publishing the results in an academic journal and through the British Association for Clinicians in ME/CFS (BACME).Patient involvement: Our ME/CFS Young People's Advisory Group helped us develop POMME and write the patient information leaflets. They told us we missed out important questions which we put into POMME after stage 1.
Conclusions:
POMME helps CYP with ME/CFS describe how they feel and what they can and cannot do in their daily lives and includes the things that really matter to them.REC name
Wales REC 1
REC reference
20/WA/0136
Date of REC Opinion
22 May 2020
REC opinion
Further Information Favourable Opinion