Talk:PACE trial
I worry that the previously neutral, encyclopedic tone of this page has become increasingly skeptical. I think it's better to keep tone neutral and slowly build argument in the appropriate sections (e.g., criticism, controversy) rather than editorializing from the start. We hope for a broad audience, including readers who might find an approach with a strong perspective less credible. For example, the "findings" section contains several implicit and explicit critiques that should be probably be saved for the "criticisms" section. It's important to let the reader first learn what it is that the PACE trial actually says before presenting the criticism and controversy --JenB (talk) 21:55, 6 March 2016 (PST)
This may be helpful: https://en.wikipedia.org/wiki/Wikipedia:Neutral_point_of_view It doesn't mean that we can't include all the criticisms and all the controversy, but the sections that are for describing what the PACE trial said and found should be kept neutral and state just those facts – to be refuted in the following sections. --JenB (talk) 22:14, 6 March 2016 (PST)
'I think this page needs a little more narrative (paragraphs rather than bullets). Most notably, it's missing a section about what the trial actually found. It's nearly all controversy and statements against. There is also no information about how the PACE trial authors and Simon Wessely have defended the work or what their position and point of view are. It's important to include to understand the whole picture. Lastly, even if you are going to do a list of quotes from lot of different people, there needs to be an introductory paragraph to that section that explains what hte key criticisms were. Otherwise it's a lot to read and interpret. I am not deleting what comes later in terms of lists of resources but I am trying to include more context up top on the key findings of the trial and key criticisms before launching into the politics/controversy --JenB (talk) 12:11, 13 February 2016 (PST)
Content to add==[edit source | reply | new]
We should include links to the SMC "expert opinions" for each of the papers.Olliec (talk) 04:38, 29 November 2015 (PST)
We should include a link to a full copy (hosted where?) of the PACE "Manual for Therapists" (are there separate manuals for CBT/GET?). PACE web site copies deleted. Olliec (talk) 04:38, 29 November 2015 (PST)
And perhaps include notable quotes from the papers/manuals like this https://twitter.com/batteredoldbook/status/670579432483090433/photo/1 Olliec (talk) 04:38, 29 November 2015 (PST)
We should also add notable criticisms from Malcolm Hooper, not sure yet where to find them. Olliec (talk) 04:39, 6 December 2015 (PST)
More links to consider using as references: Invest in ME criticism http://www.investinme.org/IIME-Newslet-1511-01.htm RetractionWatch response re recent paper data release refusal http://retractionwatch.com/2015/12/12/weekend-reads-what-do-phds-earn-does-peer-review-work-collaborations-dark-side/ https://jcoynester.wordpress.com/2015/12/12/formal-request-to-plos-one-to-issue-an-expression-of-concern-for-pace-cost-effectiveness-study/ https://dl.dropboxusercontent.com/u/23608059/PACE%20F325-15%20-%20Prof.%20James%20Coyne%20-%20Response-2.pdf http://www.ncbi.nlm.nih.gov/pubmed/22870204#cm22870204_13300 https://en.wikipedia.org/wiki/Chronic_fatigue_syndrome_treatment#PACE_trial Olliec (talk) 03:16, 13 December 2015 (PST)
Another Coyne FoI blog to add https://jcoynester.wordpress.com/2015/12/13/why-i-dont-know-how-plos-will-respond-to-authors-refusal-to-release-data/ Olliec (talk) 02:18, 14 December 2015 (PST)
PLOS response to data request. http://www.plosone.org/annotation/listThread.action?root=87754 and Coyne blog about it. https://jcoynester.wordpress.com/2015/12/15/plos-one-response-to-concerns-about-kings-college-refusal-to-share-pace-data/ Olliec (talk) 06:10, 15 December 2015 (PST)
Consider including this chart of the PACE data (by patients, who?). https://twitter.com/Katiissick/status/676317109685587968?s=09 Olliec (talk) 06:26, 15 December 2015 (PST)
More from Jonathan Edwards, https://twitter.com/sandwichpickle/status/676789963917275136/photo/1 Olliec (talk) 08:43, 15 December 2015 (PST)
Chronology from Malcolm Hooper http://www.meactionuk.org.uk/PACE-Trial-Complaint-Chronology-FINAL.htm Olliec (talk) 08:36, 16 December 2015 (PST)
=[edit source | reply | new]
These are the main PACE trial papers, published to date:
2007 Published protocol: 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. http://www.biomedcentral.com/1471-2377/7/6
2011 Main PACE trial paper: 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; PACE trial management group. 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. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract
2012 Cost-effectiveness analysis (Includes employment and welfare benefits data): McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: A cost-effectiveness analysis. PLoS ONE 2012; 7:e40808. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0040808
2013 [Alleged] "Recovery" paper: White PD, Johnson AL, Goldsmith K, Chalder T, Sharpe MC. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine 2013; 43:2227-35. http://journals.cambridge.org/abstract_S0033291713000020
2013 Statistical Analysis Plan: Walwyn R, Potts L, McCrone P, Johnson AL, DeCesare JC, Baber H, Goldsmith K, Sharpe M, Chalder T, White PD. A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan. Trials 2013; 14:386. http://www.trialsjournal.com/content/14/1/386
2014 Adverse events and deterioration: Dougall D, Johnson A, Goldsmith K, Sharpe M, Angus B, Chalder T, White P. Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome. J Psychosom Res. 2014; 77:20-6. http://www.sciencedirect.com/science/article/pii/S0022399914001883
2015 Mediation Analysis (contains the fitness step test results): Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial. Chalder T, Goldsmith KA, White PD, Sharpe M, Pickles AR. (2015) Lancet Psychiatry 2015; 2:141–52 http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366%2814%2900069-8/abstract
2015 Two Year Follow Up. Sharpe M, Goldsmith KA, Johnson AL, Chalder T, Walker J, White PD. Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial. Published Online: 27 October 2015. DOI: http://dx.doi.org/10.1016/S2215-0366(15)00317-X | http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00317-X/fulltext
There are also some minor PACE-related papers:
Lawn T, Kumar P, Knight B, Sharpe M, White PD. (2010) Psychiatric misdiagnoses in patients with chronic fatigue syndrome. JRSM Short Rep. 1:28.
Cella M, Sharpe M, Chalder T. (2011) Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale. J Psychosom Res. 71:124-8.
Cella M, White PD, Sharpe M, Chalder T. (2013) Cognitions, behaviours and co-morbid psychiatric diagnoses in patients with chronic fatigue syndrome. Psychological Medicine 43:375-380. doi:10.1017/S0033291712000979
Bourke JH, Johnson AL, Sharpe M, Chalder T, White PD. (2014) Pain in chronic fatigue syndrome; response to rehabilitative treatments in the PACE trial. Psychological Medicine 44:1545-52 doi:10.1017/S0033291713002201
Cox D, Burgess M, Chalder T, Sharpe M, White P, Clark L. (2013) Training, supervision and therapists' adherence to manual-based therapy. International Journal of Therapy and Rehabilitation 20:180-186.
Have moved Kennedy quotes here as not cited and need more work before can be considered for inclusion.
Angela Kennedy, sociologist and author[edit source | reply | new]
Angela Kennedy has made specific critiques of PACE regarding the following areas: [1][2]
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.
Olliec (talk) 02:46, 4 March 2016 (PST)
I have reinstated the above summary. It was not in order to completely remove a person's contributions to PACE critique from the main page indefinitely, especially as no clear reason for 'improvement' has been given, and my contribution to PACE critique has been treated differently to others cited here. User:Angela Kennedy
Thanks, Suelala! I've just been through doing a few tweaks and adding a load of references.
minor suggestions:
- use a piped link to allow hyperlink in lower-case, and display text in mixed case, for Cognitive Behavioral Therapy, Graded Exercise Torture, Adaptive Pacing Therapy, etc [I'm afraid I couldn't get my head around this!]
There's plenty more to say about PACE but this is all I can manage and I have to move onto other things now, though I aim to print it off and check again for errors.
Thanks for your help!
Sasha, the last half of the text has been deleted, from 'Controversy' onward - including Requests from Scientists, Petitions, Open Letters, Quotes, FOI requests, etc. is this what you intended ? --Suelala (talk) 00:52, 8 March 2016 (PST)
Hi Sue - I don't understand what you mean but I see you've found me elsewhere - let's carry on the conversation there! :)
Today I have reverted three recent edits to the page (see in View History) as the oldest of those three edits deleted most of the page content. The edits since then have been reverted and lost, but they still show in the log so can be manually re-applied. Please be careful when editing (use Preview) to make sure the page remains intact. Olliec (talk) 02:04, 8 March 2016 (PST)
Media section (Sasha, 9 Mar 2016)
Just doing a sweep-through to remove my editorialising (that was me in those early sections, sorry!) from the front end. With those particular spectacles on, I see there's some stuff in the Media section that's critical of some of the media coverage (the Chalder comment, the alteration of the Telegraph article, the SMC) and I wondered where the best place is to introduce the controversy over the media coverage.
I think that now that there's some media coverage supporting patients' criticism (e.g. WSJ), that should be included.
Don't know how to handle this issue but wanted to raise it for the the folks dealing with this section.
Research and treatment section (Sasha, 9 Mar 2016)
This section also goes into criticism and goes beyond PACE to a wider consideration and critique of the Oxford studies. I think it's better to narrow the focus back to PACE and to mention that PACE is the reason the NICE guidelines are on the static list.
But in case people disagree, I'm parking the text I'm replacing with the original:
Research and treatment[edit source | reply | new]
The PACE trial dominates clinical policy in the United Kingdom and other countries, both in government funded health care[3] and private medical insurance.[4]
Because the Oxford criteria definition of CFS is very broad (requiring six months of fatigue but not necessarily any other symptoms), PACE and other studies that use it are seen as muddying the research evidence-base by including patients with other conditions. It is for this reason that a 2015 report by the U.S. National Institutes of Health called for the Oxford definition to be retired, stating "continuing to use the Oxford definition may impair progress and cause harm".[5]
PACE and other Oxford-definition studies have an impact on how ME/CFS patients are treated clinically through their impact on "evidence-based" clinical guidelines. For instance, in the U.K., the primary NHS treatment recommendations (the NICE guidelines[3]) are for cognitive behavioral therapy (CBT) and graded exercise therapy (GET), based largely on the results of Oxford-definition studies. In the U.S., these studies have led a number of medical education providers, including the CDC, to recommend CBT and GET and/or to link poor prognosis to a patient's belief that the disease is organic.
This impact of PACE and other Oxford-definition studies on clinical guidelines is still seen even though the 2015 Institute of Medicine report on ME/CFS stated that the disease is not psychological and is characterized by a systemic intolerance to even trivial activity. For example, UpToDate's clinical guidelines recommend the IOM criteria for diagnosis but PACE-style CBT and GET for treatment, even though such treatment would be inappropriate for patients diagnosed by the IOM criteria.[6]
- ↑ Summary of my specific concerns about PACE with annotated bibliography
- ↑ Summary of my specific concerns about PACE with annotated bibliography
- ↑ 3.0 3.1 Cite error: Invalid
<ref>tag; no text was provided for refs namedNICEguideCG53 - ↑ Cite error: Invalid
<ref>tag; no text was provided for refs namedSwissRe2011 - ↑ "NIH P2P: Advancing the Research on Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome", National Institutes of Health, USA, 9 Dec 2014. (broken link - see copy in google cache : https://webcache.googleusercontent.com/search?q=cache:MS4x7xhmPusJ:https://prevention.nih.gov/docs/programs/mecfs/ODP-P2P-MECFS-FinalReport.pdf)
- ↑ "Treatment of chronic fatigue syndrome (systemic exertion intolerance disease)", UpToDate, 26 Feb 2016.
