Part 2: What to look for in a Special Issue of Journal of Health Psychology concerning the PACE trial

Part 2: What to look for in the Special Issue of Journal of Health Psychology concerning the PACE trial

In a continuation of the last blog post, this one provides brief summaries and links to eight additional contributions to the special issue of Journal of Health Psychology. These articles include a reply to the PACE investigators’ response from Keith Geraghty, a defense of the trial from some friends and supporters (Petrie and Weinman) of the PACE investigators, and a commentary from Susanna Agardy on the conflicts of interest in this defense.

special issue spread

Apologies to the authors and readers for my not indicating yesterday that there were an additional eight summaries coming. Because of all the uncertainty about whether the special issue would be published on schedule or blocked, yesterday’s blog post was uploaded at the last minute and incomplete.

When the effort to block publication of the special issue failed, the PACE investigators got criticism posted at Science Media Centre. One commentary was attributed to anonymous sources at Oxford University and simply parroting things that the PACE investigators themselves have been saying all along. Another commentary was from Malcolm MacLeod, a former colleague of Michael Sharpe at University of Edinburgh, who also authored a paper with him. McLeod claims to have read the issue and found nothing of substance there. That was an amazing feat, because the Science Media Centre posted this critique only minutes before the special issue was available. We might conclude that McLeod is a speed reader. Judging from the superficiality of his comments, it could simply be a matter of his not having read the special issue

Who would’ve thought that a special issue of Journal of Health Psychology could garner such publicity?

McLeod also indiscreetly disclosed that he was a member of a committee advising PLOS One on whether to release to me the data from an article on the PACE trial. Availability of the data had been promised as a condition for publishing in PLOS One. Yet, over a year after my request, it has still not been provided. However the PLOS One article now prominently features an Expression of Concern, which often precedes a retraction. Regardless, McLeod’s disclosure cast doubt on the integrity of the decision-making process at PLOS One, given his obvious conflict of interest.

As a critic of the PACE trial from the United States, I noticed early on that I was dealing with a tight close-knit network, strongly interconnected with the British establishment, a real charmed circle. The opposition to the publication of the special issue of Journal of Health Psychology and the PACE investigators’ access to resources like Science Media Centre and placement of an article in The Times and who served as go-to sources put this network on public display.

However, the brouhaha and the foiled effort to block publication of the special issue and this extraordinary attentionin the media has  paradoxically generated considerable buzz about the special issue that would otherwise not have. We appreciate all the publicity we can get and we hope the PACE investigators will bring on some more. But for now, check out the brief summaries below and click on the links to the open access articles.

Special thanks to blogger John Peters for having put together these links and summaries.

 Eight articles from the Special Issue

Distress signals: Does cognitive behavioural therapy reduce or increase distress in chronic fatigue syndrome/myalgic encephalomyelitis?   Keith R Laws

Reducing the psychological distress associated with chronic fatigue syndrome/myalgic encephalomyelitis is seen as a key aim of cognitive behavioural therapy. Crucially, the claim by National Institute of Clinical Excellence that cognitive behavioural therapy reduces distress in chronic fatigue syndrome/myalgic encephalomyelitis is not only at odds with what patients repeatedly report in surveys, but with their own gold-standard randomised controlled trial and meta-analytic data.

Cognitive behaviour therapy and objective assessments in chronic fatigue syndrome Graham McPhee

Most evaluations of cognitive behavioural therapy to treat people with chronic fatigue syndrome/myalgic encephalomyelitis rely exclusively on subjective self-report outcomes to evaluate whether treatment is effective. A review of studies incorporating objective measures suggests that there is a lack of evidence that cognitive behavioural therapy produces any improvement in a patient’s physical capabilities or other objective measures such as return to work.

 PACE trial claims for recovery in myalgic encephalomyelitis/chronic fatigue syndrome – true or false? It’s time for an independent review of the methodology and results Charles Bernard Shepherd

Patient evidence has repeatedly found cognitive behaviour therapy is ineffective and graded exercise therapy can make the condition worse. The PACE trial methodology has been heavily criticised by clinicians, academics and patients. A re-analysis of the data has cast serious doubts on the recovery rates being claimed. The trust of patients has been lost. The medical profession must start listening to people with myalgic encephalomyelitis/chronic fatigue syndrome if trust is going to be restored.

The PACE trial: It’s time to broaden perceptions and move on Keith J Petrie, John Weinman

Differing beliefs about the causes of chronic fatigue syndrome still influence how scientific studies in this area are accepted and evaluated. Causal beliefs about chronic fatigue syndrome and a modern version of Cartesian dualism are important in understanding the reaction to the PACE trial. Science is incremental. An unfortunate outcome of the PACE controversy and intimidation of researchers may be less research in the area. It is time to move on from criticism and collect more data on effective treatments.

Defense of the PACE trial is based on argumentation fallacies Steven Lubet

In defense of the PACE trial, Petrie and Weinman employ a series of misleading or fallacious argumentation techniques, including circularity, blaming the victim, bait and switch, non-sequitur, setting up a straw person, guilt by association, red herring, and the parade of horribles. These are described and explained.

Chronic fatigue syndrome patients have no reason to accept the PACE trial results: Response to Keith J Petrie and John Weinman Susanna Agardy

Petrie and Weinman’s urging to accept the findings of the PACE trial is unreasonable in view of the failure of PACE to achieve evidence of recovery. The Institute of Medicine describes chronic fatigue syndrome not as psychological but as a serious, chronic, systemic disease, with post-exertional malaise as its main feature which inhibits exercise. Linking debate about PACE with intimidation of researchers is unjustifiable and damaging to patients.

Further commentary on the PACE trial: Biased methods and unreliable outcomes Keith J Geraghty

The PACE authors respond that ‘Dr Geraghty’s views are based on misunderstandings and misrepresentations of the PACE trial’. This article draws on expert commentaries to further detail the critical methodological failures and biases identified in the PACE trial, which undermine the reliability and credibility of the major findings to emerge from this trial.

PACE-GATE: An alternative view on a study with a poor trial protocol Bart Stouten

The controversies surrounding the effectiveness of cognitive behavioural therapy and graded exercise therapy for chronic fatigue syndrome are explained using Cohen’s d effect sizes rather than arbitrary thresholds for ‘success’. This article shows that the treatment effects vanish when switching to objective outcomes. The preference for subjective outcomes by the PACE trial team leads to false hope. This article provides a more realistic view, which will help patients and their doctors to evaluate the pros and cons.