Evidence map›Paper›PMID 37620254›Full record

Observational studyBMJ open2023

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

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 4 countries.

Daisy GauntPopulation Health Sciences, University of Bristol, Bristol, UK daisy.gaunt@bristol.ac.uk.
Amberly BrigdenDigital Health, School of Computer Science, Electrical and Electronic Engineering, University of Bristol, Bristol, UK.ORCID 0000-0002-7958-7881
Chris MetcalfePopulation Health Sciences, University of Bristol, Bristol, UK.ORCID 0000-0001-8318-8907
Maria LoadesCentre for Academic Child Health, University of Bristol, Bristol, UK.
Esther CrawleyCentre for Academic Child Health, University of Bristol, Bristol, UK.
University of Bristol · GB

Funding

Department of Health DRF-2016-09-021Department of Health DRF-2017-10-169Department of Health NIHR300219Department of Health SRF-2013-06-013
6 · The paper itself

Abstract

objectivesPaediatric 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.

designProspective observational cohort study.

settingA specialist UK National Health Service ME/CFS service, Southwest England; recruitment between March 2014 and August 2015.

participants193 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).

resultsAt 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).

conclusions40% 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.

Indexed as

Fatigue Syndrome, ChronicAdolescentChildEmotionsHumansPainProspective StudiesState MedicineCommunity child healthEPIDEMIOLOGYPAEDIATRICS

Identifiers

PMID37620254
PMCPMC10450087
OpenAlexW4386125387

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.