Talk:PACE trial

Content to add
To add reference from MSM about impact on bio research of the PACE trial http://www.sciencealert.com/chronic-fatigue-syndrome-low-energy-production-in-cells-metabolic-disease http://www.dailymail.co.uk/health/article-5058807/People-chronic-fatigue-syndrome-exhausted.html

Regarding the peer-reviewed papers criticizing the trial. It would be good to have all of them (or links to where they are on this page) in a single section that is linked to from the table of contents. (I came to check to see the size of the list and did not find the section.)

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)

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.

Narrative
'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)

Angela Kennedy
Have moved Kennedy quotes here as not cited and need more work before can be considered for inclusion.

Angela Kennedy, sociologist and author
Angela Kennedy has made specific critiques of PACE regarding the following areas: (ref: Summary of my specific concerns about PACE with annotated bibliography)

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


 * I copied over again as the citations did not come up correctly but now do. I am thinking that it is just a matter of formatting to look like all other authors and their information.  Perhaps saying "Items 1 through 8 discuss main points of citations." and then indented numbered bullets so that it is obvious the points are from the cited paragraphs.  Not sure if this was the issue or not but might be.--DxCFS (talk) 13:27, 21 April 2016 (PDT)


 * DxCFS (talk)I see. You are citing bullet points from your own blog post.  We all know what you state is true, but where are you drawing your conclusions on each bullet point.  I know they are really trying to stick to science and scientific conclusions because the future of correct publishing on the PACE trial and appeals in court depend on it.--DxCFS (talk) 13:44, 21 April 2016 (PDT)


 * I agree with DxCFS and Olliec's general points here. I believe all the others we've cited in that section either have medical credentials, journalistic credentials, or are publishing on behalf of ME/CFS organizations which they represent. I feel that any material we quote should meet one of those criteria. While I know Angela has done a fair bit of work for ME/CFS, I don't know if she actually does meet any of those criteria (Angela: please correct me if you do), and it's usually advised that a person should not substantially edit material that's about them or add material written by them (in short, they should not self-promote). I will fully admit that these criteria are not clearly outlined here, at least not that I'm aware of, but I think if we're going to keep any kind of neutrality to the article, the material published needs to come from an organization or medical/research professional, not just a well-known advocate. – Robin Hood  (talk)  18:22, 21 April 2016 (PDT)


 * I just noticed the section immediately below the one Angela's currently in about "citizen-scientists". Would that, perhaps, be a more appropriate section to list her under? We'd have to remove the word "patient" from the section heading, since she's an advocate and not a patient, though. Still, given the clear context of the section, I'd even say the current content and reference could go there, since that section clearly implies that the persons listed have no related credentials other than significant experience with the topic. The reference would also be appropriate in that context, since it's what she's written. – Robin Hood  (talk)  11:39, 22 April 2016 (PDT)


 * That seems appropriate RobinHood. Her page can also have this post and I assume it does. Whether these 8 posts are listed on this page or perhaps it can be stated there are 8 points as the Blog clearly outlines them.  Also, it isn't that she isn't correct in her conclusions, it would be helpful if the blog would show exactly how she came to those conclusions.  We have been stating points like these but no one cares unless we can show scientifically and statistically just why these claims are not so or have patient interviews listed and referenced even though PACE authors were not required to do the same scientifically, statistically or have patient interviews referenced.--DxCFS (talk) 16:01, 22 April 2016 (PDT)

The summary I've produced gives a list of various publications I've had about PACE, including my book, responses to articles that are there for all to see etc. which sets out key points I have made. In this respect I'm like most of the critics of PACE! If people want to read my points at length to adequately convey my points, then please do so. As regards 'citizen scientists'. I find this a strange division from the so-called 'medical credential' preoccupation. I have an academic qualification, and my field of research is the sociology of science. This does make me 'qualified' enough. By the logic of above comments, a GP with no knowledge of the PACE trial problems is more 'qualified' to be quoted than me, or Tom Kindlon for that matter. It's a flawed dichotomy. There should not be any division. People who have made key points should be listed in the same section. On top of this - I was one of the first people to critique the PACE trial. You need to be putting that history (and not just about me) in this frankly. Hooper, Margaret Williams, Jane Bryant, One Click etc. Angela Kennedy

Suggestions
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
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. Sasha Anonymous 09:08, 9 March 2016

Research and treatment section
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:


 * Note: text removed, as it can always be recovered from the article's history. – Robin Hood  (talk)  18:10, 21 April 2016 (PDT)

Neutrality
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)

Cleanup
I've attempted to clean this talk page up a bit. I haven't fully changed it to traditional talk-page format (due to overlapping edits, what appear to be deliberate insertions, requests for deletion, etc.) but it should be at least close to what the author(s) intended. The only significant change I made to content was to remove Sasha's copy of the "Research and treatment" section, as this can readily be recovered from the article history. On a lesser note, I removed a duplicate reference in the Angela Kennedy section and changed it to not be a reference, just so it's easier to deal with here on the talk page. I also changed multiple dashes as a separator to only four, since that will generate a separator line, regardless of page width. – Robin Hood  (talk)  18:10, 21 April 2016 (PDT)

Blog post on the involvement of many institutions
I thought this point made by Disabled in Tory Britain was valid but not certain where to post on the page. This is from the diary post Diary Day 116: Will Publishing The CFSME PACE Trial Data Topple The NHS?

''If that scenario happens, what will that mean for:

UK Medical Research Council Department of Health the Scottish Chief Scientist’s Office The Department for Work and Pensions The Wolfson Institute Queen Mary University 3 London hospitals 1 Oxford hospital 1 Edinburgh hospital The ethics committee who passed the research protocol?

''Look at that list…..take one long hard look. They worked together, not alone. They were one body, not separate. They were the partners that brough the PACE trial to its conclusion and the NHS worked on their recommendations.''

Will just leave this post here for now. : ) --DxCFS (talk) 08:45, 2 September 2016 (PDT)

NEUTRALITY
"Neutrality[edit] 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)"

'''AGREED! we need info that is convincing to the generally sceptic general public (I'm a CFS sufferer)'''