Re: People want to learn as much as possible from the PACE trial for chronic fatigue syndrome
01 October 2013
Peter D White
Professor of Psychological Medicine
T Chalder, M Sharpe, T Johnson, K Goldsmith
Barts and the London Medical School
St Bartholomew's Hospital, London EC1A 7BE
Tom Kindlon states that access to the committee minutes of the PACE trial is needed to “..to find out why outcome measures were changed”.1 We disagree.
First, the primary outcome measures were the same ones as described in the protocol – fatigue and physical disability.2 Second, details and explanations of independently approved changes to the scoring system and analysis of the outcomes are already in the public domain; both in the published papers and on the PACE trial website (
http://www.pacetrial.org/faq/).3,4
Third, his suggestion that there were problems in the reporting of harms is also incorrect.1 Unusually for a non-drug trial, we adopted the same stringent procedures as recommended by the European Union Clinical Trials Directive for Pharmacological Interventions. We measured safety by serious adverse reactions and events, non-serious adverse events, withdrawals from treatment because of worsening, self-rated global worsening, and a composite measure of serious deterioration.2,3 All adverse events were reviewed by an independent panel.
Finally, readers should know that the Information Tribunal’s unanimous judgement on the appeal was that: “The tribunal has no doubt that properly viewed in its context, this request should have been seen as vexatious - it was not a true request for information - rather its function was largely polemical.”5
PD White 1, T Chalder 2, M Sharpe 3, T Johnson 4, K Goldsmith 5
1 Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London,
2 Academic Department of Psychological Medicine, King's College London,
3 Department of Psychiatry, University of Oxford, Oxford, UK
4 MRC Clinical Trials Unit at UCL, London
5 Biostatistics Department, Institute of Psychiatry, King’s College London,
1. Kindlon T. People want to learn as much as possible from the PACE trial for chronic fatigue syndrome. BMJ 2013;347:f5731.
2. 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;7:6.
3. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O’Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M. 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.
4.W hite PD, Johnson AL, Goldsmith K, Chalder T, Sharpe MC. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med 2013;1-9, published online 31 Jan. doi:10.1017/S0033291713000020.
5. General Regulation Chamber (Information Rights) First Tier Tribunal. Mitchell versus Information Commissioner. EA 2013/0019.
http://www.informationtribunal.gov.uk/DBFiles/Decision/i1069/20130822%20....
Competing interests: PDW has done voluntary and paid consultancy work for the United Kingdom government and a reinsurance company. TC has received royalties from Sheldon Press and Constable and Robinson. MS has done voluntary and paid consultancy work for the United Kingdom government, has done consultancy work for an insurance company, and has received royalties from Oxford University Press. KAG and ALJ declare that they have no conflicts of interests.
