PACE trial documents

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This page gives an overview of the main PACE trial documents. These include the PACE trial's full protocol, therapist manuals, participant newsletters and meeting minutes of the trial steering committee and trial management group.

Protocol[edit | edit source]

Manuals[edit | edit source]

For therapists[edit | edit source]

For participants[edit | edit source]

For doctors[edit | edit source]

Newsletters[edit | edit source]

Trial Steering Committee[edit | edit source]

1. Trial Steering Committee Meeting 22nd Apr 2004
2. Trial Steering Committee Meeting 27th Sep 2004
3. Trial Steering Committee Meeting 29th Jun 2005
4. Trial Steering Committee Meeting 23rd Jan 2006
5. Trial Steering Committee Meeting 17th Jul 2006
6. Trial Steering Committee Meeting 27th Jun 2007
7. Trial Steering Committee Meeting 9th Apr 2008
8. Trial Steering Committee Meeting 29th Apr 2009
9. Trial Steering Committee Meeting 10th Sep 2010.

Trial Management Group[edit | edit source]

MInutes from the trial managment group were obtained through a Freedom of Information request. For more information see the following thread on the forum Science for ME: "PACE trial TSC and TMG minutes released."

Draft minutes of PACE team meeting of 7.6.02

Other documents[edit | edit source]

Freedom of information requests for PACE trial data[edit | edit source]

This section gives an overview of several Freedom of Information (FOI) requests regarding the PACE-trial. This inventory is not exhaustative and it is possible that several FOI requests are not yet listed below.

Neil Riley for the ME Association[edit | edit source]

Mr. Courtney: recovery rates[edit | edit source]

Alem Matthees: Selected data on PACE Trial participants[edit | edit source]

Ann Sheridan: data for the 6 minute walking test[edit | edit source]

Graham McPhee: data for the fitness test[edit | edit source]

Robin Ellis destroyal of raw data[edit | edit source]

Kathryn Dickenson objective data[edit | edit source]

Other FOI requests[edit | edit source]

2011[edit | edit source]

2012[edit | edit source]

2013[edit | edit source]

2014[edit | edit source]

2015[edit | edit source]

2016[edit | edit source]

2017[edit | edit source]

2018[edit | edit source]

Information Commissioner's Office Decision notices[edit | edit source]

This section gives an overview of several Information Commissioner's Office (ICO) decision notices. This inventory however is not exhaustative and it is possible that several ICO rulings are not yet listed below.

First tier tribunal appeals[edit | edit source]

PACE trial published papers[edit | edit source]

Main papers[edit | edit source]

Year Journal Content Full reference
2007 BMC Neurology Protocol White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol. 2007 Mar 8;7:6.
2011 The Lancet Main results 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 Mar 5;377(9768):823-36. 
2012 PLOS ONE Cost-effectiveness McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS One. 2012;7(8):e40808. 
2013 Psychological Medicine Recovery rates White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013 Oct;43(10):2227-35. 
2013 Trials Statistical analysis plan 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 Nov 13;14:386. 
2014 Journal of Psychosomatic Research Adverse events Dougall D, Johnson A, Goldsmith K, Sharpe M, Angus B, Chalder T, White P. Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome. J Psychosom Res. 2014 Jul;77(1):20-6. 
2015 Lancet Psychiatry Mediation analysis Chalder T, Goldsmith KA, White PD, Sharpe M, Pickles AR. Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial. Lancet Psychiatry. 2015 Feb;2(2):141-52. 
2015 Lancet Psychiatry Long term follow-up Sharpe M, Goldsmith KA, Johnson AL, Chalder T, Walker J, White PD. Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial. Lancet Psychiatry. 2015 Dec;2(12):1067-74. 

Other PACE trial papers[edit | edit source]

Year Journal Content Full reference
2010 JRSM Open Psychiatric misdiagnoses Lawn T, Kumar P, Knight B, Sharpe M, White PD. Psychiatric misdiagnoses in patients with chronic fatigue syndrome. JRSM Short Rep. 2010 Sep 6;1(4):28. 
2011 Journal of Psychosomatic Research Testing the Work and Social Adjustment Scale Cella M, Sharpe M, Chalder T. Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale. J Psychosom Res. 2011 Sep;71(3):124-8. 
2013 BJPsych Bulletin History and planning of the PACE trial White PD, Chalder T, Sharpe M. The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial. BJPsych Bull. 2015 Feb;39(1):24-7.
2013 Psychological Medicine Cognitions and co-morbid psychiatric diagnoses Cella M, White PD, Sharpe M, Chalder T. Cognitions, behaviours and co-morbid psychiatric diagnoses in patients with chronic fatigue syndrome. Psychol Med. 2013 Feb;43(2):375-80. 
2013 International Journal of Therapy and Rehabilitation Training and supervision of therapists Cox D, Burgess M, Chalder T, Sharpe M, White P, Clark L. Training, supervision and therapists' adherence to manual-based therapy. Int J Rehabil Res. 2013;20(4):180-186.
2014 Psychological Medicine Pain Bourke JH, Johnson AL, Sharpe M, Chalder T, White PD. Pain in chronic fatigue syndrome: response to rehabilitative treatments in the PACE trial. Psychol Med. 2014 May;44(7):1545-52.
2016 Journal of Psychosomatic Research The use of complementary and alternative treatments Lewith G, Stuart B, Chalder T, McDermott C, White PD. Complementary and alternative healthcare use by participants in the PACE trial of treatments for chronic fatigue syndrome. J Psychosom Res. 2016 Aug;87:37-42.
2017 Psychological Medicine Analysis of subgroups Williams TE, Chalder T, Sharpe M, White PD. Heterogeneity in chronic fatigue syndrome - empirically defined subgroups from the PACE trial. Psychol Med. 2017 Jun;47(8):1454-1465.

For more information on the PACE trial publications and documents, visit the discussion on the webforum Science for ME.

Myalgic encephalomyelitis (ME) - A disease often marked by neurological symptoms, but fatigue is sometimes a symptom as well. Some diagnostic criteria distinguish it from chronic fatigue syndrome, while other diagnostic criteria consider it to be a synonym for chronic fatigue syndrome. A defining characteristic of ME is post-exertional malaise (PEM), or post-exertional neuroimmune exhaustion (PENE), which is a notable exacerbation of symptoms brought on by small exertions. PEM can last for days or weeks. Symptoms can include cognitive impairments, muscle pain (myalgia), trouble remaining upright (orthostatic intolerance), sleep abnormalities, and gastro-intestinal impairments, among others. An estimated 25% of those suffering from ME are housebound or bedbound. The World Health Organization (WHO) classifies ME as a neurological disease.

Cognition - Thought processes, including attention, reasoning, and memory.

The information provided at this site is not intended to diagnose or treat any illness.
From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history.