Tag: PACE trial critique

Cognitive behaviour therapy and objective assessments in chronic fatigue syndrome

Abstract:

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. Few studies have used measures appropriate to assessing whether cognitive behavioural therapy changes in more objective measures. 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. Future studies of chronic fatigue syndrome/myalgic encephalomyelitis should include some objective assessments as primary outcomes. If this is to include activity monitors, we first need a sound baseline dataset.

Source: McPhee G. Cognitive behaviour therapy and objective assessments in chronic fatigue syndrome. J Health Psychol. 2017 Aug;22(9):1181-1186. doi: 10.1177/1359105317707215. Epub 2017 Jun 19. https://www.ncbi.nlm.nih.gov/pubmed/28805529

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: Kirke KD. PACE investigators’ response is misleading regarding patient survey results. J Health Psychol. 2017 Aug;22(9):1168-1176. doi: 10.1177/1359105317703787. Epub 2017 May 11. https://www.ncbi.nlm.nih.gov/pubmed/28805528

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: Goudsmit E, Howes S. Bias, misleading information and lack of respect for alternative views have distorted perceptions of myalgic encephalomyelitis/chronic fatigue syndrome and its treatment. J Health Psychol. 2017 Aug;22(9):1159-1167. doi: 10.1177/1359105317707216. Epub 2017 May 29. https://www.ncbi.nlm.nih.gov/pubmed/28805527

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: Wilshire C. The problem of bias in behavioural intervention studies: Lessons from the PACE trial. J Health Psychol. 2017 Aug;22(9):1128-1133. doi: 10.1177/1359105317700885. Epub 2017 Mar 23. https://www.ncbi.nlm.nih.gov/pubmed/28805526

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

Abstract:

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.

Source: Stouten B. PACE-GATE: An alternative view on a study with a poor trial protocol. J Health Psychol. 2017 Aug;22(9):1192-1197. doi: 10.1177/1359105317707531. Epub 2017 May 12. https://www.ncbi.nlm.nih.gov/pubmed/28805525

PACE trial authors continue to ignore their own null effect

Abstract:

Protocols and outcomes for the PACE trial were changed after the start of the trial. These changes made substantial differences, leading to exaggerated claims for the efficacy of cognitive behavior therapy and graded exercise therapy in myalgic encephalomyelitis/chronic fatigue syndrome. The small, self-reported improvements in subjective measures cannot be used to say the interventions are effective, particularly in light of the absence of objective improvement. Geraghty’s criticism of the trial was reasonable and supported by the evidence.

Source: Vink M. PACE trial authors continue to ignore their own null effect. J Health Psychol. 2017 Aug;22(9):1134-1140. doi: 10.1177/1359105317703785. Epub 2017 Apr 27. https://www.ncbi.nlm.nih.gov/pubmed/28805519

The PACE trial missteps on pacing and patient selection

Abstract:

As others have pointed out a variety of complicating factors with the PACE trial (e.g. changing outcome criteria), I will limit my remarks to issues that involve the composition of adaptive pacing therapy and issues involving patient selection. My key points are that the PACE trial investigators were not successful in designing and implementing a valid pacing intervention and patient selection ambiguity further compromised the study’s outcomes.

Source: Jason LA. The PACE trial missteps on pacing and patient selection. J Health Psychol. 2017 Aug;22(9):1141-1145. doi: 10.1177/1359105317695801. Epub 2017 Feb 1. https://www.ncbi.nlm.nih.gov/pubmed/28805518

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