Tag: PACE trial critique

Bias, misleading information and lack of respect for alternative views have distorted perceptions of myalgic encephalomyelitis/chronic fatigue syndrome and its treatment

Abstract:

The PACE trial is one of the most recent studies evaluating cognitive behavioural therapy and graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome. These interventions are based on a model which assumes that symptoms are perpetuated by factors such as misguided beliefs and a lack of activity. Our analysis indicates that the researchers have shown significant bias in their accounts of the literature and may also have overstated the effectiveness of the above treatments. We submit that their approach to criticisms undermines the scientific process and is inconsistent with best practice.

Source: Ellen Goudsmit, Sandra Howes. Bias, misleading information and lack of respect for alternative views have distorted perceptions of myalgic encephalomyelitis/chronic fatigue syndrome and its treatment. Jounral of Health Psychology. http://journals.sagepub.com/doi/abs/10.1177/1359105317707216?journalCode=hpqa

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: David Tuller. Once again, the PACE authors respond to concerns with empty answers. Journal of Health Psychology. First Published April 27, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317703788 (Full article)

PACE investigators’ response is misleading regarding patient survey results

Abstract:

The PACE investigators’ citation of a patient survey might mislead readers into thinking that the experience of people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) supports PACE findings. In fact, patient survey evidence directly contradicts the results of the PACE trial. A review of survey data published between 2001 and 2015 reveals that for most patients, graded exercise therapy leads to worsening of symptoms, cognitive behavioural therapy leads to no change in symptoms, and pacing leads to improvement. The experience of people with ME/CFS as reflected in surveys is a rich source of information, made more compelling by the consistency of results. Consequently, patient survey evidence can be used to inform practice, research and guidelines. Misrepresentation of patient experience must be vigorously challenged, to ensure that patients and health professionals make decisions about therapies based on accurate information.

Source: Karen D. Kirke. PACE investigators’ response is misleading regarding patient survey results. Journal of Health Psychology. First Published May 11, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317703787 (Full article)

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: Keth R. Laws. Distress signals: Does cognitive behavioural therapy reduce or increase distress in chronic fatigue syndrome/myalgic encephalomyelitis? Journal of Health Psychology.  First Published May 17, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317710246 (Full article)

Studies on Cognitive Behavioral Therapy and Graded Exercise Therapy for ME/CFS are misleading

Abstract:

There have been a number of studies on Cognitive Behavioral Therapy (CBT) and Graded Exercise Therapy (GET) for ME/CFS based on a treatment model where the disease is perpetuated by cognitive processes. Although the studies are flawed and the model lacks scientific support, the treatments are described as evidence based. The studies are non-blinded and rely on subjective outcomes. There are no objective measures of adherence. The diagnostic criteria vary, and the participating patients often have one or several psychiatric diagnoses apart from suffering from chronic fatigue. The underlying model has no theoretical foundation and is at odds with physiological findings. Surveys suggest that the efficacy of CBT is no better than placebo and that GET is harmful. Therefore, cognitive behavioral therapy and graded exercise therapy for ME/CFS are not evidence based.

 

Source: Sten Helmfrid. Studies on Cognitive Behavioral Therapy and Graded Exercise Therapy for ME/CFS are misleading.

This is a translation of an article published in Socialmedicinsk tidskrift, Stockholm, Sweden, on September 28 th , 2016. http://socialmedicinsktidskrift.se

Academic paper: Studies on Cognitive Behavioral Therapy and Graded Exercise Therapy for ME/CFS are misleading. Available from: https://www.researchgate.net/publication/309351210_Studies_on_Cognitive_Behavioral_Therapy_and_Graded_Exercise_Therapy_for_MECFS_are_misleading [accessed Apr 2, 2017].

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: Tom Kindlon. Do graded activity therapies cause harm in chronic fatigue syndrome? Journal of Health Psychology. March 20, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317697323 (Full article)

 

The problem of bias in behavioural intervention studies: Lessons from the PACE trial

Abstract:

Geraghty’s recent editorial on the PACE trial for chronic fatigue syndrome has stimulated a lively discussion. Here, I consider whether the published claims are justified by the data. I also discuss wider issues concerning trial procedures, researcher allegiance and participant reporting bias. Cognitive behavioural therapy and graded exercise therapy had modest, time-limited effects on self-report measures, but little effect on more objective measures such as fitness and employment status. Given that the trial was non-blinded, and the favoured treatments were promoted to participants as ‘highly effective’, these effects may reflect participant response bias. In non-blinded trials, the issue of reporting biases deserves greater attention in future.

 

Source: Carolyn Wilshire. The problem of bias in behavioural intervention studies: Lessons from the PACE trial. Journal of Health Psychology. First published date: March-23-2017. http://journals.sagepub.com/doi/full/10.1177/1359105317700885 (Full article)

 

PACE team response shows a disregard for the principles of science. Journal of Health Psychology

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: Jonathan Edwards. PACE team response shows a disregard for the principles of science. Journal of Health Psychology. First published date: March-28-2017. http://journals.sagepub.com/doi/full/10.1177/1359105317700886 (Full article)

 

Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial

Abstract:

BACKGROUND: Publications from the PACE trial reported that 22% of chronic fatigue syndrome patients recovered following graded exercise therapy (GET), and 22% following a specialised form of CBT. Only 7% recovered in a control, no-therapy group. These figures were based on a definition of recovery that differed markedly from that specified in the trial protocol.

PURPOSE: To evaluate whether these recovery claims are justified by the evidence.

METHODS: Drawing on relevant normative data and other research, we critically examine the researchers’ definition of recovery, and whether the late changes they made to this definition were justified. Finally, we calculate recovery rates based on the original protocol-specified definition.

RESULTS: None of the changes made to PACE recovery criteria were adequately justified. Further, the final definition was so lax that on some criteria, it was possible to score below the level required for trial entry, yet still be counted as ‘recovered’. When recovery was defined according to the original protocol, recovery rates in the GET and CBT groups were low and not significantly higher than in the control group (4%, 7% and 3%, respectively).

CONCLUSIONS: The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments.

 

Source: Carolyn Wilshire, Tom Kindlon, Alem Matthees & Simon McGrath. Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial. Fatigue: Biomedicine, Health & Behavior Volume 5, 2017 – Issue 1. http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1259724 (Full article)

 

PACE trial claims of recovery are not justified by the data: a rejoinder to Sharpe, Chalder, Johnson, Goldsmith and White (2017)

Abstract:

Background: Recently, we critically evaluated the claim from the PACE trial that cognitive behavioural therapy (CBT) and graded exercise therapy (GET) can lead to recovery from chronic fatigue syndrome (CFS). We showed that the trial’s definition of recovery was so loose it failed to capture the term’s core meaning. Also, this definition was substantially loosened very late in the trial, in ways that favoured the study hypotheses. The investigators do not acknowledge any of these criticisms and stand by their original analyses.

Purpose: To examine the arguments advanced in defence of PACE’s recovery claims.

Methods: Drawing on various sources of evidence, we consider three major arguments raised in defence of PACE’s recovery claims: (1) that since there is no agreed definition of recovery, it comes down to a matter of opinion; (2) that the original definition was ‘too stringent’; and (3) the revised definition generates results that align with previous studies.

Results: We find that: (1) ‘recovery’ is a strong claim, which implies evidence a return to health, and that the trial’s final definition did not preserve this core meaning; (2) there is no evidence to suggest that the original protocol-specified definition was ‘too stringent’; (3) absolute recovery rates from other studies are not a legitimate source of support for the recovery definition used.

Conclusions: The PACE trial provides no evidence that CBT and GET can lead to recovery from CFS. The recovery claims made in the PACE trial are therefore misleading for patients and clinicians.

 

Source: Carolyn Wilshire, Tom Kindlon & Simon McGrath. PACE trial claims of recovery are not justified by the data: a rejoinder to Sharpe, Chalder, Johnson, Goldsmith and White (2017). Fatigue: Biomedicine, Health & Behavior. Volume 5, 2017 – Issue 1. http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1299358