Tuesday, 11 October 2016

Summary of my specific concerns about PACE with annotated bibliography

(Note this was first published on my 'PACE Complaint Documents' blog on 10 February 2016. I am placing here for ease of reference for others).


Summary of my specific concerns about PACE with annotated bibliography

This is a summary of my specific concerns about the PACE trial and its methodology, which differs to a degree to many of the other concerns currently being aired. This does not mean I do not share those other concerns. I do. but my own concerns here are more specific to other problems in PACE methodology, and provide additional fundamental reasons why the PACE trial methodology needs a critical review with a view to possible retraction. I actually believe all published PACE papers should be retracted because their 'findings' are unsafe: a consequence of the many methodological flaws of the trial. By 'unsafe' I mean both scientifically unsound and, actually more importantly, dangerous to patients.

It must be said that some of these concerns listed here have been present since at least 2004, and remain, borne out by newer evidence as it became available when the PACE trial paper was published. Others are newer concerns that arose as the paper was published and other flaws became evident.

The methodological and ethical problems I have identified are as follows:


1. Serious risks to clinical patient safety caused by unsound claims made about the efficacy of CBT and GET following the PACE trial;

2. Gross discrepancies between research and clinical cohorts, and how clinical patients (and the physiological dysfunction associated with them) appear to have been actively excluded from PACE and other research by the research group involved in PACE, which has, ironically, caused serious resulting risks to clinical patient safety in the UK in particular;

3. Related to the above, gross discrepancies in how various sets of patient criteria were used (and/or rejected), including but not limited to a changing of the London criteria by PACE authors from its original state, a set of criteria which was already controversial and problematic to start with for a number of reasons;

4. Failure of the PACE trial authors to acknowledge the range and depth of scientific literature documenting serious physiological dysfunction in patients given diagnoses of ME or CFS, and how CBT and GET approaches may endanger patients in this context;

5. The inclusion of major mental illnesses in the research cohort;

6. The distortion by PACE trial researchers of 'pacing' from an autonomous flexible management strategy for patients into a therapist led Graded Activity approach;

7. The post hoc dismissal of adverse outcomes as irrelevant to the trial, in direct contradiction to what is scientifically known about the physiological dysfunctions of people given diagnoses of Myalgic Encephalomyelitis or Chronic Fatigue Syndrome;

8. The instability of 'specialist medical care' as a treatment category, and the lack of any sound category of 'control' group.

ANNOTATED BIBLIOGRAPHY

1. Regarding my concerns about PACE's (and other projects') studied ignoring of the Canadian Guidelines:

http://bmj.bmjjournals.com/cgi/eletters/bmj.38301.587106.63v1

Also my response "Problems in the PACE Trial" (13 November 2007)
to the White et al paper "Protocol for the PACE trial":

https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments

See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html

See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.

2. Regarding the problems of the London Criteria in particular:

Online exchange with Ellen Goudsmit following my response "Problems in the PACE Trial" (13 November 2007)
to the White et al paper "Protocol for the PACE trial":

https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments

See also an online discussion on Phoenix Rising:

http://forums.phoenixrising.me/index.php?threads/pace-trial-and-the-criteria-for-m-e-used.10766/

See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html


3. Regarding the problems around criteria used generally:

http://bmj.bmjjournals.com/cgi/eletters/bmj.38301.587106.63v1

https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments

http://forums.phoenixrising.me/index.php?threads/pace-trial-and-the-criteria-for-m-e-used.10766/

http://forums.phoenixrising.me/index.php?threads/pace-study-and-oxford-criteria.8880/

See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html

See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.

4. Regarding PACE and/or other research excluding ME patients (a neurological disease according to WHO ICD-10) with neurological dysfunction (and signs of physical illness) from research:

http://forums.phoenixrising.me/index.php?threads/pace-trial-and-the-criteria-for-m-e-used.10766/

http://forums.phoenixrising.me/index.php?threads/pace-study-and-oxford-criteria.8880/

http://forums.phoenixrising.me/index.php?threads%2Fpoll-swollen-lymph-nodes-did-you-have-these-before-getting-me-cfs-or-did-they-only-appear-after.9250%2F

See also: "RE: Authors Response" (Angela Kennedy replied to Anthony_Cleare on 13 Jan 2010 at 23:18 GMT)

http://www.plosone.org/annotation/listThread.action?root=1669

See also: Questions about 'CFS' and 'ICF' selection criteria of cohort' Response to Byrnes et al ('Expression in
Peripheral Blood Leukocytes in Monozygotic Twins Discordant for Chronic Fatigue: No Evidence of a
Biomarker' PLoS ONE 4(6): e5805 2009) 3 January 2011.
http://www.plosone.org/annotation/listThread.action?root=3801

See also: "'Cost-effectiveness' is irrelevant when safety has not even been addressed in the PACE trial 02 Aug 2012 at 11:35 GMT in response to McCrone et al "Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis"

http://www.plosone.org/annotation/listThread.action?root=52481

See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html

See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.


5. Regarding claims to safety and efficacy:

http://www.plosone.org/annotation/listThread.action?root=52481

http://bmj.bmjjournals.com/cgi/eletters/bmj.38301.587106.63v1

See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-regarding.html

See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.


6. Regarding the failure to address the biomedical evidence available detailing serious organic physiological dysfunction in patients who receive a 'CFS' or 'ME' diagnosis:

https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments

See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-

7. Other points:

https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6/comments

See also my complaint to the Lancet: http://pacedocuments.blogspot.co.uk/2011/04/complaint-to-editor-of-lancet-

See also my book "Authors of our own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (2012) Market Rasen: The Village Digital Press, especially chapters 2, 4, and 6.

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