PMID- 37620254
OWN - NLM
STAT- MEDLINE
DCOM- 20230828
LR  - 20230828
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 13
IP  - 8
DP  - 2023 Aug 24
TI  - Investigating the factors associated with meaningful improvement on the SF-36-PFS 
      and exploring the appropriateness of this measure for young people with ME/CFS 
      accessing an NHS specialist service: a prospective cohort study.
PG  - e069110
LID - 10.1136/bmjopen-2022-069110 [doi]
LID - e069110
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Gaunt, Daisy
AU  - Gaunt D
AD  - Population Health Sciences, University of Bristol, Bristol, UK 
      daisy.gaunt@bristol.ac.uk.
FAU - Brigden, Amberly
AU  - Brigden A
AUID- ORCID: 0000-0002-7958-7881
AD  - Digital Health, School of Computer Science, Electrical and Electronic 
      Engineering, University of Bristol, Bristol, UK.
FAU - Metcalfe, Chris
AU  - Metcalfe C
AUID- ORCID: 0000-0001-8318-8907
AD  - Population Health Sciences, University of Bristol, Bristol, UK.
FAU - Loades, Maria
AU  - Loades M
AD  - Centre for Academic Child Health, University of Bristol, Bristol, UK.
AD  - Department of Psychology, University of Bath, Bath, UK.
FAU - Crawley, Esther
AU  - Crawley E
AD  - Centre for Academic Child Health, University of Bristol, Bristol, UK.
LA  - eng
GR  - SRF-2013-06-013/DH_/Department of Health/United Kingdom
GR  - DRF-2017-10-169/DH_/Department of Health/United Kingdom
GR  - DRF-2016-09-021/DH_/Department of Health/United Kingdom
GR  - NIHR300219/DH_/Department of Health/United Kingdom
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20230824
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - Humans
MH  - Child
MH  - Adolescent
MH  - *Fatigue Syndrome, Chronic
MH  - Prospective Studies
MH  - State Medicine
MH  - Emotions
MH  - Pain
PMC - PMC10450087
OTO - NOTNLM
OT  - Community child health
OT  - EPIDEMIOLOGY
OT  - PAEDIATRICS
COIS- Competing interests: 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.
EDAT- 2023/08/25 00:41
MHDA- 2023/08/28 07:16
PMCR- 2023/08/24
CRDT- 2023/08/24 22:03
PHST- 2023/08/28 07:16 [medline]
PHST- 2023/08/25 00:41 [pubmed]
PHST- 2023/08/24 22:03 [entrez]
PHST- 2023/08/24 00:00 [pmc-release]
AID - bmjopen-2022-069110 [pii]
AID - 10.1136/bmjopen-2022-069110 [doi]
PST - epublish
SO  - BMJ Open. 2023 Aug 24;13(8):e069110. doi: 10.1136/bmjopen-2022-069110.