Evidence map›Paper›PMID 32426159›Full record

ArticlePilot and feasibility studies2020

The feasibility and acceptability of an early intervention in primary care to prevent chronic fatigue syndrome (CFS) in adults: randomised controlled trial.

Hazel O'Dowd, Lucy Beasant, Jenny Ingram, Alan Montgomery, Will Hollingworth, Daisy Gaunt, Simon M Collin, Sarah Horne, Beth Jones, Esther Crawley

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 30% 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. 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

10 authors at 3 institutions in 1 country.

Hazel O'Dowd1CFS/NHS Bristol, The Lodge, Cossham Hospital, Lodge Road, Kingswood, Bristol, BS15 1LF UK.
Lucy Beasant2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.
Jenny Ingram2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.
Alan Montgomery3School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.
Will Hollingworth2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.
Daisy Gaunt4Bristol Randomised Trials Collaboration, Bristol Medical School, University of Bristol, Bristol, BS8 2PS UK.
Simon M Collin2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.
Sarah Horne5CFS/NHS Bristol, Cossham Hospital, Bristol, BS15 1LF UK.
Beth Jones5CFS/NHS Bristol, Cossham Hospital, Bristol, BS15 1LF UK.
Esther Crawley2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.
University of Bristol · GBCossham Hospital · GBUniversity of Nottingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis (ME)) is defined as fatigue that is disabling, is accompanied by additional symptoms and persists for ≥ 4 months. Treatment of CFS/ME aims to help patients manage their symptoms and make lifestyle adjustments. We do not know whether intervening early in primary care (< 4 months after onset of fatigue) can prevent the development of CFS/ME.

methodsThis was a feasibility randomised controlled trial with adults (age ≥ 18 years) comparing usual care with usual care plus an early intervention (EI; a combination of psycho-education and cognitive behavioural therapy, CBT). This study took place in fourteen primary care practices in Bristol, England and aimed to identify issues around recruitment and retention for a full-scale trial. It was not powered to support statistical analysis of differences in outcomes. Integrated qualitative methodology was used to explore the feasibility and acceptability of recruitment and randomisation to the intervention.

resultsForty-four patients were recruited (1 August 2012-November 28, 2013), falling short of our predicted recruitment rate of 100 patients in 8 months. Qualitative data from GPs showed recruitment was not feasible because it was difficult to identify potential participants within 4 months of symptom onset. Some referring GPs felt screening investigations recommended by NICE were unnecessary, and they had difficulty finding patients who met the eligibility criteria. Qualitative data from some participant interviews suggested that the intervention was not acceptable in its current format. Although the majority of participants found parts of the intervention acceptable, many reported one or more problems with acceptability. Participants who discontinued the intervention or found it problematic did not relate to the therapeutic model, disliked telephone consultations or found self-reflection challenging.

conclusionsA randomised controlled trial to test an early intervention for fatigue in adults in primary care is not feasible using this intervention and recruitment strategy.

trial registrationInternational Standard Randomised Controlled Trials, ISRCTN72645894. Retrospectively registered on 17 May 2013.

Indexed as

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)Early interventionFeasibilityPrimary careRandomised controlled trial

Identifiers

PMID32426159
PMCPMC7216523
OpenAlexW3026834450

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.