PACE trial documents

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

 * PACE trial protocol: Final version 5.0, 01.02.2006

For therapists

 * Cox et al. 2004. Manual for Therapists Adaptive Pacing Therapy (APT) for CFS/ME.


 * Burgess & Chalder, 2004. Manual for Therapists Cognitive Behavioral Therapy (CBT) for CFS/ME.


 * Bavinton et al. 2004. Manual for Therapists Graded Exercise Therapy (GET) for CFS/ME.

For participants

 * Cox et al. 2004. Manual for Participants Adaptive Pacing Therapy (APT) for CFS/ME.


 * Burgess & Chalder, 2004. Manual for Participants Cognitive Behavioral Therapy (CBT) for CFS/ME.


 * Bavinton et al. 2004. Manual for Participants Graded Exercise Therapy (GET) for CFS/ME.

For doctors

 * Murphy et al. 2004. Manual for doctors standardised specialist medical care (SSMC).

Newsletters

 * Participants' newsletter Issue 1 June 2006


 * Participants' newsletter Issue 2 March 2007


 * Participants' newsletter Issue 3 December 2008


 * Participants' newsletter Issue 4 February 2011

Trial Steering Committee

 * 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
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
 * TMG meeting 1


 * TMG meeting 2


 * TMG meeting 3


 * TMG meeting 4


 * TMG meeting 5


 * TMG meeting 6


 * TMG meeting 7


 * TMG meeting 8


 * TMG meeting 9


 * TMG meeting 10


 * TMG meeting 11


 * TMG meeting 12


 * TMG meeting 13


 * TMG meeting 14


 * TMG meeting 15


 * TMG meeting 16


 * TMG meeting 17


 * TMG meeting 18


 * TMG meeting 19


 * TMG meeting 20


 * TMG meeting 21


 * TMG meeting 22


 * TMG meeting 23


 * TMG meeting 24


 * TMG meeting 25


 * TMG meeting 26


 * TMG meeting 27


 * TMG meeting 28


 * TMG meeting 29


 * TMG meeting 30


 * TMG meeting 31


 * TMG meeting 32


 * TMG meeting 33

Other documents

 * Full Trial Consent Form


 * invitation to join the PACE trial


 * Guidance for researchers requesting access to data from the PACE trial
 * HRA The PACE trial and the Commitee's inquiry on research integrity
 * Analysis of primary outcomes using composite measures of improvement
 * FAQ answered by the PACE team.

Freedom of information requests for PACE trial data
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

 * PACE Trial – text of joint letter calling for more information. The ME Association, the Young ME Sufferers Trust and the West Midlands ME Groups Consortium. 24 May 2011.


 * Response from Paul Smallcombe of Queen Mary University of London to Neil Riley of the ME Association. PACE trial data. 16 June 2011.

Mr. Courtney: recovery rates

 * FOI request from Mr. Courtney to Medical Research Council. Request for raw data from the PACE Trial. 15 May 2011.


 * FOI request from Mr. Courtney to Queen Mary Unversity of London. Request for raw data from the PACE Trial. 9 June 2011.


 * FOI Request from Mr. Courtney to Queen Mary University of London. Request for deterioration rates for PACE Trial. 29 March 2012


 * FOI request from Mr. Courtney to Queen Mary University of London. PACE Trial: Recovery Rates and Positive Outcome Rates. 26 Ocotober 2012.
 * FOI request from Mr. Courtney to Queen Mary University of London. The PACE Trial - the 'normal range' data analysis. 4 November 2012.


 * FOI request from Mr. Courtney to Queen Mary University of London. PACE Trial: Recovery Rates and Positive Outcome Rates (repeat request). 23 October 2013.
 * FOI request from Mr. Courtney to Queen Mary University of London. PACE Trial: Recovery Rates and Positive Outcome Rates (repeat request) 29 October 2013.

Alem Matthees: Selected data on PACE Trial participants

 * FOI request from Alem Matthees to Queen Mary University of London. Selected data on PACE Trial participants. 24 March 2014.

Ann Sheridan: data for the 6 minute walking test

 * FOI request from Anne Sheridan to Queen Mary University of London. 6min walking test data - Recovered patients in PACE trial. 3 September 2013.


 * FOI request from Anne Sheridan to Queen Mary University of London. Raw data for 6mwt. 30 May 2014.


 * FOI request from Anna Sheridan to Queen Mary University of London. Raw 6mwt Data after treatment. 1 November 2015

Graham McPhee: data for the fitness test

 * FOI request from Graham McPhee to Queen Mary University of London. Fitness data for PACE trial. 29 June 2015.

Robin Ellis destroyal of raw data

 * FOI request from Robin Ellis to Queen Mary University London. PACE trial raw data. 22 July 2016.

Kathryn Dickenson objective data

 * FOI request from Kathryn Dickenson to Queen Mary University of London. CFS - PACE what story does the objective data tell? 5 May 2017.


 * FOI request from Kathryn Dickenson to Queen Mary University of London. CFS - PACE trial objective data enable comparison with patients own objective data. 6 May 2017.


 * FOI request from Kathryn Dickenson to Queen Mary University of London. CFS - PACE where is the objective data? 6 June 2017.
 * FOI request from Kathryn Dickenson to Medical Research Council. CFS - PACE permission to drop more than 50% objective outcome measures. 7 June 2017.
 * FOI request from Kathryn Dickenson to Medical Research Council. CFS - a small % of the objective physical and physiological data from PACE trial. 13 June 2017.
 * FOI request from Kathryn Dickenson to Queen Mary University of London. CFS - a small % of the objective physical and physiological data from PACE trial (6 minute walk test already in public domain). 27 July 2017.
 * FOI request from Kathryn Dickenson to Queen Mary University of London. CFS- a request for even less objective info from the PACE trial just the STEP test results at baseline and 52 weeks. 7 Augustus 2017.
 * FOI request from Kathryn Dickenson to Queen Mary University of London. CFS- the volume of objective data was narrowed down many times how was it determined it would take more than 18 hours to provide the data. 6 September 2017.
 * FOI request from Kathryn Dickenson to Queen Mary University of London. CSF- did DWP authorise the dropping of objective measures of physical capacity. 12 September 2017.

2011

 * FOI request from D. Benyon to Department for Work and Pensions. Part funding of the PACE trial by the DWP. 2 March 2011.

2012

 * FOI request from Peter Kemp to Medical Research Council. The PACE Trial. White, et al. 2011. 14 October 2012.

2014

 * FOI request from Alem Matthees to Queen Mary University of London. Timing of changes to PACE Trial recovery criteria. 26 April 2014.

2015

 * FOI request from Robin Ellis to Queen Mary University of London. PACE results for CFS - do they apply to people with the neurological disorder, ME? 18 December 2015.

2016

 * FOI request from Peter Kemp to  Medical Research Council. When were the MRC informed that the PACE Trial Primary Outcome Measures of 'Positive Outcome' and 'Recovery' were eliminated from the Research Protocol. 6 September 2016.
 * FOI request from John Slater to  Department for Work and Pensions. Funding for Queen Mary University of London "PACE Trial" FOIA case. 3 October 2016.
 * FOI request from Dave to King's College London. Action as a result of the admission the PACE analysis was misleading? 8 November 2016.
 * FOI request from Dave to University of Oxford. Any actions resulting from misleading PACE publications? 8 November 2016.
 * FOI request from Dave to Queen Mary University of London. Action as a result of the admission the PACE analysis was misleading? 8 November 2016.
 * FOI request from George Jenson to King's College London. CFS - Changing RCT outcomes to get desired results- Any harrassment/threats actually happen?- PACE what do they think now? _Were any expert exercise physiologists involved in the GET program? 15 November 2016.
 * FOI request from George Jenson to University of Edingbrough. CFS - Micheal Sharpe - Action after his admission that the PACE trial's results were "cooked" and misleading. 18 November 2016.
 * FOI request from George Jenson to  Oxford University Hospitals NHS Trust. 18 November 2016.
 * FOI request from Freda Fogget to Queen Mary University of London. Fraudulent action by QMUL.1 December 2016.
 * FOI request from George Jenson to Department of Health and Social Care. CFS correspondence on the Department's view of the PACE trial. 13 December 2016.

2017

 * FOI request from Dave to Queen Mary University of London. CFS- misleading and poor quality trial design and results - remedies. 30 March 2017.
 * FOI request from Freda Frogget to  Medical Research Council. CFS - how was 5 million pounds spent on the PACE trial and the 2/3millions on the FINE trial. 22 May 2017.
 * FOI request from Kathryn Dickenson to Queen Mary University of London. CFS- What physical/physiological entry and outcome data did PACE authors undertake to collect, to "win" 5 million pounds. 5 July 2017.

2018

 * FOI request from G. Ryan to Department for Work and Pensions. DWP funding of PACE trial. 24 February 2018.
 * FOI request from G. Ryan to Department of Health and Social Care. DoHSC funding of PACE trial. 24 February 2018.
 * FOI request from G. Ryan to Medical Research Council. MRC funding of the PACE trial. 13 March 2018.
 * FOI request from G. Ryan to Queen Mary University of London. Funding of PACE trial. 20 March 2018.
 * FOI request from George Jenson to Department of Health and Social Care. CFS - NIHR investigators misrepresenting the effectiveness of CBT and GET for people with CFS. 18 November 2018.

Information Commissioner's Office Decision notices
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.
 * ICO Decision notice. Jan 9, 2013. Reference FS50458231.
 * ICO Decision notice. Jan 9, 2013. Reference FS50463661.
 * ICO Decision notice. 23 January 2014. Reference FS50514995.
 * ICO Decision notice. 18 Mach 2015. Reference FS50558352.
 * ICO Decision notice. 1 February 2018. Reference FS50673373.
 * ICO Decision notice. 20 February 2018. Reference FS50687719.
 * ICO Decision notice. 14 March 2018. Reference FS50696884.
 * ICO Decision notice. 23 May 2018. Reference FS50721768.
 * ICO Decision notice. 17 October 2018. Reference FS50735928.
 * ICO Decision notice. 7 November 2018. Reference FS50748585.
 * ICO Decision notice. 13 December 2018. Reference FS50742225.

First tier tribunal appeals

 * First tier tribunal. Appeal Number EA/2013/0019. Appelant: John Mitchell. Respondent: The Information Commissioner. Second Respondent: Queen Mary University of London.
 * First tier tribunal. Appeal Number EA/2015/0269. Appelant: Queen Mary University of London. Respondent: The Information Commissioner. Second Respondent: Alem Matthees.

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