PACE trial authors’ reply to letter by KindlonBMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5963 (Published 15 October 2013) Cite this as: BMJ 2013;347:f5963
- P D White, professor of psychological medicine1,
- T Chalder, professor of cognitive behavioural psychotherapy2,
- M Sharpe, professor of psychological medicine3,
- T Johnson, senior statistician4,
- K Goldsmith, clinical trials unit statistician5
- 1Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
- 2Academic Department of Psychological Medicine, King’s College London, London, UK
- 3Department of Psychiatry, University of Oxford, Oxford, UK
- 4Medical Research Council Clinical Trials Unit at UCL, London, UK
- 5Biostatistics Department, Institute of Psychiatry, King’s College London, London, UK
Kindlon states that access to the committee minutes of the PACE (Pacing, Graded Activity, and Cognitive Behaviour Therapy—a Randomised Evaluation) trial is needed “to find out why outcome measures were changed.”1 We disagree.
Firstly, the primary outcome measures were the same as those described in the protocol—fatigue and physical disability.2
Secondly, details and explanations of independently approved changes to the scoring system and analysis of the outcomes are already in the public domain—in the published papers and on the PACE trial website (www.pacetrial.org/faq/).3 4
Thirdly, 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 judgment 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
Cite this as: BMJ 2013;347:f5963
Competing interests: PDW has done voluntary and paid consultancy work for the UK 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 UK government, has done consultancy work for an insurance company, and has received royalties from Oxford University Press. KG and TJ declare that they have no conflicts of interests.