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

Daisy Gaunt , Amberly Brigden, Chris Metcalfe, Maria Loades, Esther Crawley

Research output: Contribution to journalArticlepeer-review

2 Citations (SciVal)

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.
Original languageEnglish
Article numbere069110
Number of pages8
JournalBMJ Open
Volume13
Issue number8
Early online date24 Aug 2023
DOIs
Publication statusPublished - 24 Aug 2023

Bibliographical note

Funding: 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.

Data availability statement:
No data are available, due to lack of consent from participants to share data.

Keywords

  • Community child health
  • EPIDEMIOLOGY
  • PAEDIATRICS

ASJC Scopus subject areas

  • General Medicine

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