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The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial

  • Peter D. White (a1), Trudie Chalder (a2) and Michael Sharpe (a3)
Summary

The PACE trial was a four-arm trial of specialist medical care, compared with specialist medical care with a supplementary therapy: adaptive pacing therapy, cognitive–behavioural therapy or graded exercise therapy, for patients with chronic fatigue syndrome. The trial found that both cognitive–behavioural and graded exercise therapies were more effective than either of the other two treatments in reducing fatigue and improving physical disability. This paper describes the design, conduct and main results of the trial, along with a description of the challenges that had to be overcome in order to produce clear answers to the clinically important questions the trial posed.

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Copyright
This is an open-access article published by the Royal College of Psychiatrists and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Corresponding author
Correspondence to Peter D. White (p.d.white@qmul.ac.uk)
Footnotes
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Declaration of interest

P.D.W. has carried out voluntary and paid consultancy work for the UK Government and a reinsurance company. T.C. has received royalties from Sheldon Press and Constable and Robinson. M.S. has carried out voluntary and paid consultancy work for the UK Government, consultancy work for an insurance company and has received royalties from Oxford University Press.

Footnotes
References
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1 World Health Organization The ICD-10 Classification of Mental and Behavioural Disorders: Clinical Descriptions and Diagnostic Guidelines. WHO, 1992.
2 Wojcik, W, Armstrong, D, Kanaan, R. Is chronic fatigue syndrome a neurological condition? A survey of UK neurologists. J Psychosom Res 2011; 70: 573–4.
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5 Cox, DL, Burgess, M, Chalder, T, Sharpe, M, White, PD, Clark, L. Training, supervision and therapists' adherence to manual based therapy. Int J Ther Rehabil 2013; 20: 180–6.
6 Sharpe, MC, Archard, LC, Banatvala, JE, Borysiewicz, LK, Clare, AW, David, A, et al. A report – chronic fatigue syndrome: guidelines for research. JRSM 1991; 84: 118–21.
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8 National Task Force. Report on Chronic Fatigue Syndrome (CFS), Post Viral Fatigue Syndrome (PVFS), Myalgic Encephalomyelitis (ME). Westcare, 1994.
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10 White, PD, Goldsmith, KA, Johnson, AL, Potts, L, Walwyn, R, DeCesare, JC, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011; 377: 823–36.
11 McCrone, P, Sharpe, M, Chalder, T, Knapp, M, Johnson, AL, Goldsmith, KA, et al. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS ONE 2012; 7: e40808.
12 White, PD, Johnson, AL, Goldsmith, K, Chalder, T, Sharpe, MC. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med 2013; 43: 227–35.
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18 ME Association. MEA calls for PACE trial to be scrapped. ME Essential, July 2004: 91: 34.
19 Smith, C, Wessely, S. Unity of opposites? Chronic fatigue syndrome and the challenge of divergent perspectives in guideline development. J Neurol Neurosurg Psychiatry 2014; 85: 214–9.
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22 Hansard. PACE trial: Chronic fatigue syndrome/myalgic encephalomyelitis. Question for short debate. 6th February, 2013, Columns GC65–82 (www.publications.parliament.uk/pa/ld201213/ldhansrd/text/130206-gc0001.htm130206114000195).
23 Walwyn, R, Potts, L, McCrone, P, Johnson, AL, DeCesare, JC, Baber, H, et al. A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan. Trials 2013; 14: 386.
24 Association of Young people with ME. The PACE trial results – an analysis by Vivienne Parry, OBE. Link 2011; 42: 13.
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BJPsych Bulletin
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The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial

  • Peter D. White (a1), Trudie Chalder (a2) and Michael Sharpe (a3)
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