http://www.bmj.com/content/347/bmj.f5731
Chronic fatigue treatment trial
People want to learn as much as possible from the PACE trial for chronic fatigue syndrome
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5731
(Published 25 September 2013)
Cite this as: BMJ 2013;347:f5731
Drugs: CNS (not psychiatric) Infectious diseases Musculoskeletal syndromes Neuromuscular disease
Tom Kindlon, assistant chairperson1 Author Affiliations
tkindlon@maths.tcd.ie
One reason that the minutes are sought for the PACE (Pacing, Graded Activity, and Cognitive Behaviour Therapy—a Randomised Evaluation) trial, which looked at the effectiveness of treatments for chronic fatigue syndrome, is to find out why outcome measures were changed.1 None of the three primary outcomes were reported as in the protocol.2 The recovery criteria in the protocol were very different from what were reported on.2 3
Non-pharmacological therapies are less well regulated than pharmacological ones. For example, there is no equivalent to the yellow card system for adverse events seen with these therapies, so trial reporting becomes more important. Reporting of harms in trials of cognitive behavioural therapy and graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has generally been poor.4 Harms reporting in the PACE trial was improved but problems still remain.4 5
Outside of trials, people with ME/CFS have reported being made more ill by such interventions, but this has largely been ignored,4 which can make people frustrated.
This was an important trial: £5m (€6m; $8m) of taxpayers’ money was invested in it, and it was meant to be the definitive trial. It’s understandable that people want to get as much information from the trial as possible.
Notes
Cite this as: BMJ 2013;347:f5731
Footnotes
Competing interests: TK works in a voluntary capacity for the Irish ME/CFS Association.
References
1. Dyer C. College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules. BMJ2013;347:f5355. (30 August.)FREE Full Text
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 Neurol2007;7:6.CrossRefMedline
3. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M; PACE Trial Management Group. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med2013; published online 31 Jan.
4. Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bulletin of the IACFS/ME2011;19:59-111.
5. Kindlon T. The PACE trial in[/QUOTE]
chronic fatigue syndrome. Lancet2011;377:1833.Medline
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http://www.bmj.com/content/347/bmj.f5740
Letter
Chronic fatigue treatment trial
What’s the problem with sharing research committee’s discussions?
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5740 (Published 25 September 2013) Cite this as: BMJ 2013;347:f5740
Allan House, academic psychiatrist1
Author Affiliations
1University of Leeds, Leeds LS2 9LJ, UK
a.o.house@leeds.ac.uk
I struggle to see the logic here,1 mainly because I can’t think what would be minuted in a professionally conducted meeting that could not be shared later, once the usual conditions about third party information and data still being prepared for publication have been applied. The debate might move on with some specific, even if fictitious, examples.
Most people are (rightly) deeply suspicious about non-specific appeals to academic freedom or sensitivity of information as an explanation for opacity in public life.
Notes
Cite this as: BMJ 2013;347:f5740
Footnotes
Competing interests: None declared.
References
Dyer C. College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules. BMJ2013;347:f5355. (30 August.)
FREE Full Text
Chronic fatigue treatment trial
People want to learn as much as possible from the PACE trial for chronic fatigue syndrome
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5731
(Published 25 September 2013)
Cite this as: BMJ 2013;347:f5731
Drugs: CNS (not psychiatric) Infectious diseases Musculoskeletal syndromes Neuromuscular disease
Tom Kindlon, assistant chairperson1 Author Affiliations
tkindlon@maths.tcd.ie
One reason that the minutes are sought for the PACE (Pacing, Graded Activity, and Cognitive Behaviour Therapy—a Randomised Evaluation) trial, which looked at the effectiveness of treatments for chronic fatigue syndrome, is to find out why outcome measures were changed.1 None of the three primary outcomes were reported as in the protocol.2 The recovery criteria in the protocol were very different from what were reported on.2 3
Non-pharmacological therapies are less well regulated than pharmacological ones. For example, there is no equivalent to the yellow card system for adverse events seen with these therapies, so trial reporting becomes more important. Reporting of harms in trials of cognitive behavioural therapy and graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has generally been poor.4 Harms reporting in the PACE trial was improved but problems still remain.4 5
Outside of trials, people with ME/CFS have reported being made more ill by such interventions, but this has largely been ignored,4 which can make people frustrated.
This was an important trial: £5m (€6m; $8m) of taxpayers’ money was invested in it, and it was meant to be the definitive trial. It’s understandable that people want to get as much information from the trial as possible.
Notes
Cite this as: BMJ 2013;347:f5731
Footnotes
Competing interests: TK works in a voluntary capacity for the Irish ME/CFS Association.
References
1. Dyer C. College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules. BMJ2013;347:f5355. (30 August.)FREE Full Text
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 Neurol2007;7:6.CrossRefMedline
3. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M; PACE Trial Management Group. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med2013; published online 31 Jan.
4. Kindlon T. Reporting of harms associated with graded exercise therapy and cognitive behavioural therapy in myalgic encephalomyelitis/chronic fatigue syndrome. Bulletin of the IACFS/ME2011;19:59-111.
5. Kindlon T. The PACE trial in[/QUOTE]
chronic fatigue syndrome. Lancet2011;377:1833.Medline
-------------------------------------------------------------------------------------------------------------------------------------
http://www.bmj.com/content/347/bmj.f5740
Letter
Chronic fatigue treatment trial
What’s the problem with sharing research committee’s discussions?
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5740 (Published 25 September 2013) Cite this as: BMJ 2013;347:f5740
Allan House, academic psychiatrist1
Author Affiliations
1University of Leeds, Leeds LS2 9LJ, UK
a.o.house@leeds.ac.uk
I struggle to see the logic here,1 mainly because I can’t think what would be minuted in a professionally conducted meeting that could not be shared later, once the usual conditions about third party information and data still being prepared for publication have been applied. The debate might move on with some specific, even if fictitious, examples.
Most people are (rightly) deeply suspicious about non-specific appeals to academic freedom or sensitivity of information as an explanation for opacity in public life.
Notes
Cite this as: BMJ 2013;347:f5740
Footnotes
Competing interests: None declared.
References
Dyer C. College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules. BMJ2013;347:f5355. (30 August.)
FREE Full Text