Tag: PACE trial critique

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

Abstract:

The PACE trial set out to discover whether cognitive behaviour therapy and graded exercise therapy are safe and effective forms of treatment for myalgic encephalomyelitis/chronic fatigue syndrome. It concluded that these interventions could even result in recovery. However, patient evidence has repeatedly found that 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.

Source: Shepherd CB. 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. J Health Psychol. 2017 Aug;22(9):1187-1191. doi: 10.1177/1359105317703786. Epub 2017 Apr 9. https://www.ncbi.nlm.nih.gov/pubmed/28805522

Once again, the PACE authors respond to concerns with empty answers

Abstract:

In their response to Geraghty, the PACE investigators state that they have “repeatedly addressed” the various methodological concerns raised about the trial. While this is true, these responses have repeatedly failed to provide satisfactory explanations for the trial’s very serious flaws. This commentary examines how the current response once again demonstrates the ways in which the investigators avoid acknowledging the obvious problems with PACE and offer non-answers instead-arguments that fall apart quickly under scrutiny.

Source: Tuller D. Once again, the PACE authors respond to concerns with empty answers. J Health Psychol. 2017 Aug;22(9):1118-1122. doi: 10.1177/1359105317703788. Epub 2017 Apr 27. https://www.ncbi.nlm.nih.gov/pubmed/28805521

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

Abstract:

Geraghty in the year 2016, outlines a range of controversies surrounding publication of results from the PACE trial and discusses a freedom of information case brought by a patient refused access to data from the trial. The PACE authors offer a response, writing ‘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.

Source: Geraghty KJ. Further commentary on the PACE trial: Biased methods and unreliable outcomes. J Health Psychol. 2017 Aug;22(9):1209-1216. doi: 10.1177/1359105317714486. Epub 2017 Jun 14. https://www.ncbi.nlm.nih.gov/pubmed/28805517

Do graded activity therapies cause harm in chronic fatigue syndrome?

Abstract:

Reporting of harms was much better in the PACE (Pacing, graded Activity, and Cognitive behavioural therapy: a randomised Evaluation) trial than earlier chronic fatigue syndrome trials of graded exercise therapy and cognitive behavioural therapy. However, some issues remain. The trial’s poor results on objective measures of fitness suggest a lack of adherence to the activity component of these therapies. Therefore, the safety findings may not apply in other clinical contexts. Outside of clinical trials, many patients report deterioration with cognitive behavioural therapy and particularly graded exercise therapy. Also, exercise physiology studies reveal abnormalities in chronic fatigue syndrome patients’ responses to exertion. Given these considerations, one cannot conclude that these interventions are safe and risk-free.

Source: Kindlon T. Do graded activity therapies cause harm in chronic fatigue syndrome? J Health Psychol. 2017 Aug;22(9):1146-1154. doi: 10.1177/1359105317697323. Epub 2017 Mar 20. https://www.ncbi.nlm.nih.gov/pubmed/28805516

Defense of the PACE trial is based on argumentation fallacies

Abstract:

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.

Source: Lubet S. Defense of the PACE trial is based on argumentation fallacies. J Health Psychol. 2017 Aug;22(9):1201-1205. doi: 10.1177/1359105317712523. Epub 2017 Jun 14. https://www.ncbi.nlm.nih.gov/pubmed/28805515

Investigator bias and the PACE trial

Abstract:

The PACE investigators reject Geraghty’s suggestion that the cognitive behavior therapy/graded exercise therapy trial could have been better left to researchers with no stake in the theories under study. The potential sources and standards for determining researcher bias are considered, concluding that the PACE investigators “impartiality might reasonably be questioned.”

Source: Lubet S. Investigator bias and the PACE trial. J Health Psychol. 2017 Aug;22(9):1123-1127. doi: 10.1177/1359105317697324. Epub 2017 Mar 7. https://www.ncbi.nlm.nih.gov/pubmed/28805514

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

Abstract:

Reducing the psychological distress associated with chronic fatigue syndrome/myalgic encephalomyelitis is seen as a key aim of cognitive behavioural therapy. Although cognitive behavioural therapy is promoted precisely in this manner by the National Institute of Clinical Excellence, the evidence base on distress reduction from randomised controlled trials is limited, equivocal and poor quality. Crucially, data derived from multiple patient surveys point to worsening and increase distress; however, despite being invited, such data have been dismissed as second class by National Institute of Clinical Excellence. 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.

Source: Laws KR. Distress signals: Does cognitive behavioural therapy reduce or increase distress in chronic fatigue syndrome/myalgic encephalomyelitis? J Health Psychol. 2017 Aug;22(9):1177-1180. doi: 10.1177/1359105317710246. Epub 2017 May 17. https://www.ncbi.nlm.nih.gov/pubmed/28805513

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

Abstract:

Petrie and Weinman urge chronic fatigue syndrome patients to move on from their beliefs about their illness and accept the findings of thePACE trial. This is unreasonable in view of the failure of PACE to achieve evidence of recovery through cognitive behaviour therapy and graded exercise therapy in either self-reports or the objective measure of the 6-minute walking test. Contrary to their suggestion, 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.

Source: Agardy S. Chronic fatigue syndrome patients have no reason to accept the PACE trial results: Response to Keith J Petrie and John Weinman. J Health Psychol. 2017 Aug;22(9):1206-1208. doi: 10.1177/1359105317715476. Epub 2017 Jun 27. https://www.ncbi.nlm.nih.gov/pubmed/28805512

PACE team response shows a disregard for the principles of science

Abstract:

The PACE trial of cognitive behavioural therapy and graded exercise therapy for chronic fatigue syndrome/myalgic encephalomyelitis has raised serious questions about research methodology. An editorial article by Geraghty gives a fair account of the problems involved, if anything understating the case. The response by White et al. fails to address the key design flaw, of an unblinded study with subjective outcome measures, apparently demonstrating a lack of understanding of basic trial design requirements. The failure of the academic community to recognise the weakness of trials of this type suggests that a major overhaul of quality control is needed.

Source: Edwards J. PACE team response shows a disregard for the principles of science. J Health Psychol. 2017 Aug;22(9):1155-1158. doi: 10.1177/1359105317700886. Epub 2017 Mar 28. https://www.ncbi.nlm.nih.gov/pubmed/28805520

Special issue on the PACE Trial

Abstract:

We are proud that this issue marks a special contribution by the Journal of Health Psychology to the literature concerning interventions to manage adaptation to chronic health problems. The PACE Trial debate reveals deeply embedded differences between critics and investigators. It reveals an unwillingness of the co-principal investigators of the PACE trial to engage in authentic discussion and debate. It leads one to question the wisdom of such a large investment from the public purse (£5 million) on what is a textbook example of a poorly done trial.

Source: David Marks. Special issue on the PACE Trial. Journal of Health Psychology. Vol 22, Issue 9, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317722370 (Full article)