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

doi:10.1136/archdischild-2017-313375

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

Research output: Contribution to journal › Article (Academic Journal) › peer-review

30 Citations (Scopus)

482 Downloads (Pure)

Abstract

OBJECTIVE: Investigate 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).

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

SETTING: Specialist paediatric CFS/ME service.

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

MAIN OUTCOME MEASURES: The 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.

RESULTS: We 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.

CONCLUSION: The 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.

Original language	English
Pages (from-to)	155-164
Number of pages	10
Journal	Archives of Disease in Childhood
Volume	103
Issue number	2
Early online date	20 Sept 2017
DOIs	https://doi.org/10.1136/archdischild-2017-313375
Publication status	Published - 19 Jan 2018

Research Groups and Themes

BTC (Bristol Trials Centre)
BRTC
Centre for Surgical Research

Keywords

Journal Article

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1136/archdischild-2017-313375

Full-text PDF (final published version)
This is the final published version of the article (version of record). It first appeared online via BMJ at http://adc.bmj.com/content/103/2/155 . Please refer to any applicable terms of use of the publisher.
Final published version, 1.37 MB

Handle.net

Persistent link

Embargoed Document

SMILE effectiveness & cost effectiveness accepted manuscript
Accepted author manuscript, 379 KB
Request copy

ConDuCT-II
Blazeby, J. (Principal Investigator)
1/04/14 → 31/03/19
Project: Research

SMILE trial public dataset
Crawley, E. (Creator), Garfield, K. (Creator) & Gaunt, D. (Creator), University of Bristol, 12 Apr 2019
DOI: 10.5523/bris.2c1pfur00h0p52c7s8cnpg31hb, http://data.bris.ac.uk/data/dataset/2c1pfur00h0p52c7s8cnpg31hb
Dataset
SMILE Trial
Garfield, K. (Creator), Gaunt, D. (Creator) & Crawley, E. (Creator), University of Bristol, 21 Sept 2017
DOI: 10.5523/bris.1myzti8qnv48g2sxtx6h5nice7, http://data.bris.ac.uk/data/dataset/1myzti8qnv48g2sxtx6h5nice7
Dataset

Dr Nicola J Mills
- Nicola.Millsbristol.acuk
- Bristol Medical School (PHS) - Senior Research Fellow
- Bristol Population Health Science Institute
- Cancer
Person: Academic , Member

Cite this

Crawley, E. M., Gaunt, D. M., Garfield, K., Hollingworth, W., Sterne, J. A. C., Beasant, L., Collin, S. M., Mills, N., & Montgomery, A. A. (2018). Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial. Archives of Disease in Childhood, 103(2), 155-164. https://doi.org/10.1136/archdischild-2017-313375

@article{4dc40d2eb49443709ce68332bc099ccd,

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

abstract = "OBJECTIVE: Investigate 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).DESIGN: Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.SETTING: Specialist paediatric CFS/ME service.PATIENTS: 12-18 year olds with mild/moderate CFS/ME.MAIN OUTCOME MEASURES: The 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.RESULTS: We 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.CONCLUSION: The 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.",

keywords = "Journal Article",

author = "Crawley, {Esther M} and Gaunt, {Daisy M} and Kirsty Garfield and William Hollingworth and Sterne, {Jonathan A C} and Lucy Beasant and Collin, {Simon M} and Nicola Mills and Montgomery, {Alan A}",

note = "{\textcopyright} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.",

year = "2018",

month = jan,

day = "19",

doi = "10.1136/archdischild-2017-313375",

language = "English",

volume = "103",

pages = "155--164",

journal = "Archives of Disease in Childhood",

issn = "0003-9888",

publisher = "BMJ Publishing Group",

number = "2",

}

Crawley, EM, Gaunt, DM , Garfield, K , Hollingworth, W , Sterne, JAC , Beasant, L , Collin, SM , Mills, N & Montgomery, AA 2018, 'Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial', Archives of Disease in Childhood, vol. 103, no. 2, pp. 155-164. https://doi.org/10.1136/archdischild-2017-313375

Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial. / Crawley, Esther M; Gaunt, Daisy M ; Garfield, Kirsty et al.
In: Archives of Disease in Childhood, Vol. 103, No. 2, 19.01.2018, p. 155-164.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome

T2 - randomised controlled trial

AU - Crawley, Esther M

AU - Gaunt, Daisy M

AU - Garfield, Kirsty

AU - Hollingworth, William

AU - Sterne, Jonathan A C

AU - Beasant, Lucy

AU - Collin, Simon M

AU - Mills, Nicola

AU - Montgomery, Alan A

PY - 2018/1/19

Y1 - 2018/1/19

N2 - OBJECTIVE: Investigate 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).DESIGN: Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.SETTING: Specialist paediatric CFS/ME service.PATIENTS: 12-18 year olds with mild/moderate CFS/ME.MAIN OUTCOME MEASURES: The 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.RESULTS: We 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.CONCLUSION: The 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.

AB - OBJECTIVE: Investigate 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).DESIGN: Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.SETTING: Specialist paediatric CFS/ME service.PATIENTS: 12-18 year olds with mild/moderate CFS/ME.MAIN OUTCOME MEASURES: The 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.RESULTS: We 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.CONCLUSION: The 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.

KW - Journal Article

U2 - 10.1136/archdischild-2017-313375

DO - 10.1136/archdischild-2017-313375

M3 - Article (Academic Journal)

C2 - 28931531

SN - 0003-9888

VL - 103

SP - 155

EP - 164

JO - Archives of Disease in Childhood

JF - Archives of Disease in Childhood

IS - 2

ER -

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

Abstract

Research Groups and Themes

Keywords

UN SDGs

Access to Document

Handle.net

Embargoed Document

Fingerprint

Projects

ConDuCT-II

Datasets

SMILE trial public dataset

SMILE Trial

Profiles

Dr Nicola J Mills

Cite this