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Abstract
Objectives: Paediatric myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is relatively common and disabling, but little is known about the factors associated with outcome. We aimed to describe the number and characteristics of young people reaching the 10-point minimal clinically important difference (MCID) of SF-36-Physical Function Subscale (SF-36-PFS) and to investigate factors associated with reaching the MCID.
Design: Prospective observational cohort study.
Setting: A specialist UK National Health Service ME/CFS service, Southwest England; recruitment between March 2014 and August 2015.
Participants: 193 eligible patients with ME/CFS aged 8–17 years reported baseline data. 124 (65%) and 121 (63%) with outcome data at 6 and 12 months, respectively.
Outcome: measures SF-36-PFS (primary outcome). Chalder Fatigue Questionnaire, school attendance, visual analogue pain scale, Hospital Anxiety and Depression Scale, Spence Young People Anxiety Scale, Clinical Global Impression scale and EQ-5D-Y (secondary).
Results: At 6 months 48/120 (40%) had reached the MCID for SF-36-PFS. This had increased to 63/117 (54%) at 12 months. On the Clinical Global Impressions, 77% and 79% reported feeling either a little better, much better or very much better. Those with worse SF-36-PFS at baseline assessment were more likely to achieve the MCID for SF-36-PFS at 6 months (odds ratio 0.97, 95% confidence interval 0.96 to 0.99, p value 0.003), but there was weaker evidence of effect at 12 months (OR 0.98, 95% CI 0.97 to 1.00, p value 0.038). No other factors at baseline were associated with the odds of reaching the MCID at 6 months. However, at 12 months, there was strong evidence of an effect of pain on MCID (OR 0.97, 95% CI 0.95 to 0.99, p value 0.001) and SF-36-PFS on MCID (OR 0.96, 95% CI 0.94 to 0.98, p value 0.001).
Conclusions: 40% and 54% of young people reached the MCID at 6 and 12 months, respectively. No factors at assessment (other than SF-36-PFS at 6 months, and pain and SF-36-PFS at 12 months) are associated with MCID of SF-36-PFS at either 6 or 12 months. Further work is needed to explore the most appropriate outcome measure for capturing clinical meaningful improvement for young people with ME/CFS.
Design: Prospective observational cohort study.
Setting: A specialist UK National Health Service ME/CFS service, Southwest England; recruitment between March 2014 and August 2015.
Participants: 193 eligible patients with ME/CFS aged 8–17 years reported baseline data. 124 (65%) and 121 (63%) with outcome data at 6 and 12 months, respectively.
Outcome: measures SF-36-PFS (primary outcome). Chalder Fatigue Questionnaire, school attendance, visual analogue pain scale, Hospital Anxiety and Depression Scale, Spence Young People Anxiety Scale, Clinical Global Impression scale and EQ-5D-Y (secondary).
Results: At 6 months 48/120 (40%) had reached the MCID for SF-36-PFS. This had increased to 63/117 (54%) at 12 months. On the Clinical Global Impressions, 77% and 79% reported feeling either a little better, much better or very much better. Those with worse SF-36-PFS at baseline assessment were more likely to achieve the MCID for SF-36-PFS at 6 months (odds ratio 0.97, 95% confidence interval 0.96 to 0.99, p value 0.003), but there was weaker evidence of effect at 12 months (OR 0.98, 95% CI 0.97 to 1.00, p value 0.038). No other factors at baseline were associated with the odds of reaching the MCID at 6 months. However, at 12 months, there was strong evidence of an effect of pain on MCID (OR 0.97, 95% CI 0.95 to 0.99, p value 0.001) and SF-36-PFS on MCID (OR 0.96, 95% CI 0.94 to 0.98, p value 0.001).
Conclusions: 40% and 54% of young people reached the MCID at 6 and 12 months, respectively. No factors at assessment (other than SF-36-PFS at 6 months, and pain and SF-36-PFS at 12 months) are associated with MCID of SF-36-PFS at either 6 or 12 months. Further work is needed to explore the most appropriate outcome measure for capturing clinical meaningful improvement for young people with ME/CFS.
| Original language | English |
|---|---|
| Article number | e069110 |
| Number of pages | 8 |
| Journal | BMJ Open |
| Volume | 13 |
| Issue number | 8 |
| Early online date | 24 Aug 2023 |
| DOIs | |
| Publication status | Published - 24 Aug 2023 |
Bibliographical note
Funding: EC was funded by a National Institute of Health Research (NIHR) SeniorResearch Fellowship (SRF-2013-06-013). AB was funded by the National Institute
for Health Research (NIHR Doctoral Research Fellowship, DRF-2017-10-169). ML
was funded by the National Institute for Health Research (NIHR Doctoral Research
Fellowship, DRF-2016-09-021). DG was funded by the National Institute for Health
Research (NIHR Doctoral Fellowship NIHR300219). This report is independent
research.
Data availability statement:
No data are available, due to lack of consent from participants to share data.
Funding
EC runs the specialist ME/CFS service of the data reported, has received one grant from Medical Research Council, multiple grants from the UK National Institute for Health Research (NIHR) and is an unfunded medical advisor to the Sussex & Kent ME/CFS Society. CM was a co-applicant on two UK NIHR grants in ME/CFS. The other authors declare no competing interests. EC was funded by a National Institute of Health Research (NIHR) Senior Research Fellowship (SRF-2013-06-013). AB was funded by the National Institute for Health Research (NIHR Doctoral Research Fellowship, DRF-2017-10-169). ML was funded by the National Institute for Health Research (NIHR Doctoral Research Fellowship, DRF-2016-09-021). DG was funded by the National Institute for Health Research (NIHR Doctoral Fellowship NIHR300219). This report is independent research. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
| Funders | Funder number |
|---|---|
| Medical Research Council | |
| National Institute for Health and Care Research | DRF-2017-10-169, DRF-2016-09-021, SRF-2013-06-013, NIHR300219 |
Keywords
- Community child health
- EPIDEMIOLOGY
- PAEDIATRICS
ASJC Scopus subject areas
- General Medicine
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- 1 Finished
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Doctoral Research Fellowship: Depression in Paediatric Chronic Fatigue Syndrome (CFS/ME)
Loades, M. (PI)
National Institute for Health Research
1/10/16 → 28/02/22
Project: Central government, health and local authorities