Evidence map›Paper›PMID 28931531›Full record

Trial reportArchives of disease in childhood2018

Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.

Esther M Crawley, Daisy M Gaunt, Kirsty Garfield, William Hollingworth, Jonathan A C Sterne, Lucy Beasant, Simon M Collin, Nicola Mills, Alan A Montgomery

RetractedErratum issuedOpen access · hybridAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Archives of disease in childhood, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
3.1field-weighted citation impact, top 8% 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

23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Recent research in myalgic encephalomyelitis/chronic fatigue syndrome: an evidence map.Health technology assessment (Winchester, England) · 2025
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Observational
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Management of chronic fatigue syndrome/myalgic encephalomyelitis in a pediatric population: A scoping review.Journal of child health care : for professionals working with children in the hospital and community · 2020
    Article
  17. Article
  18. Article
  19. Editor's note on correction to CrawleyArchives of disease in childhood · 2019
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Esther M CrawleyCentre for Child and Adolescent Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol.
Daisy M GauntBristol Medical School: Population Health Sciences, University of Bristol, Bristol.
Kirsty GarfieldBristol Medical School: Population Health Sciences, University of Bristol, Bristol.
William HollingworthBristol Medical School: Population Health Sciences, University of Bristol, Bristol.
Jonathan A C SterneBristol Medical School: Population Health Sciences, University of Bristol, Bristol.
Lucy BeasantCentre for Child and Adolescent Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol.
Simon M CollinCentre for Child and Adolescent Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol.
Nicola MillsBristol Medical School: Population Health Sciences, University of Bristol, Bristol.
Alan A MontgomeryBristol Randomised Trials Collaboration, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol.
University of Bristol · GBAt Bristol · GBUniversity of Nottingham · GB

Funding

Department of Health SRF-2013-06-013Medical Research Council MR/K023233/1Medical Research Council MR/K025643/1Medical Research Council MR/L004933/1Medical Research Council MR/L004933/2
6 · The paper itself

Abstract

objectiveInvestigate the effectiveness and cost-effectiveness of the Lightning Process (LP) in addition to specialist medical care (SMC) compared with SMC alone, for children with chronic fatigue syndrome (CFS)/myalgic encephalitis (ME).

designPragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.

settingSpecialist paediatric CFS/ME service. PATIENTS: 12-18 year olds with mild/moderate CFS/ME.

main outcome measuresThe primary outcome was the the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS) at 6 months. Secondary outcomes included pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.

resultsWe recruited 100 participants, of whom 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5(95% CI 4.5 to 20.5), p=0.003) and this improved further at 12 months (15.1 (5.8 to 24.4), p=0.002). At 6 months, fatigue and anxiety were reduced, and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm. Results were similar following multiple imputation. SMC+LP was probably more cost-effective in the multiple imputation dataset (difference in means in net monetary benefit at 12 months £1474(95% CI £111 to £2836), p=0.034) but not for complete cases.

conclusionThe LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME. TRIAL REGISTRATION NUMBER: ISRCTN81456207.

Indexed as

Psychotherapy, GroupAdolescentClinical ProtocolsCombined Modality TherapyCost-Benefit AnalysisFatigue Syndrome, ChronicFemaleHumansMaleTreatment Outcomeadolescent healthchronic fatigue syndromeRCT

Identifiers

PMID28931531
PMCPMC5865512
OpenAlexW2758408552

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.