Investigator bias and the PACE trial, by Steven Lubet in Journal of Health Psychology[Published online: 7 March 2017]
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.”
Extract: Viewed in this light, Geraghty’s proposal is persuasive. By virtue of their own experience, the PACE investigators were confident in the effectiveness of CBT and GET as ME/CFS treatments. Their earlier public statements— attributing ME/CFS symptoms to “false cognitions”— certainly appeared to dispose them toward a result. Coupled with their mid-trial revision of certain outcome measures—in a direction favorable to their own theories of improvement and recovery—it is reasonable to conclude that non-blinded trials of CBT/GET should be designed and overseen by investigators with no preexisting stake in the outcome.
Overview by Family physician Dr Mark Vink from the Netherlands:
Assessment of Individual PACE Trial Data: in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome, Cognitive Behavioral and Graded Exercise Therapy are Ineffective, Do Not Lead to Actual Recovery and Negative Outcomes may be Higher than Reported in Neurol Neurobiol 3(1) 2017 (full article)
news.com.au article by Jason Murphy, 17 jan 2017: How Alem Matthees’ letter helped solve Chronic Fatigue Syndrome mystery
The PACE trial missteps on pacing and patient selection, by Prof Leonard A Jason in Journal of Neurology and Neurobiology, 10 January 2017
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. [full article available on payment, excerpts available here]
Do more people recover from chronic fatigue syndrome with cognitive behaviour therapy or graded exercise therapy than with other treatments? by M. Sharpe, T. Chalder, A. L. Johnson, K. A. Goldsmith & P. D. White in Fatigue: Biomedicine, Health & Behavior [Published online: 15 Feb 2017]
Abstract: Wilshire et al. suggest that we have overestimated the number of patients that recover from chronic fatigue syndrome (CFS) after receiving a course of either cognitive behaviour therapy (CBT) or graded exercise therapy (GET), as reported in a secondary analysis of outcome data from the Pacing, graded Activity and Cognitive behavior therapy; a randomized Evaluation (PACE) trial. We provide counter-arguments to this view.
Quick thoughts blog post, 20 Dec 2016, by James Coyne: Simon Wessely: Why PACE investigators aren’t keen on handing over the PLOS One data to Coyne
Undark podcast no.8, 31 Oct 2016: Worse Than the Disease
Prof David Tuller discusses a therapy commonly prescribed for chronic fatigue syndrome — one for which supporting research is now unravelling.
Undark case studies, 27 Oct 2017, by Prof David Tuller: Worse Than the Disease [9000+ words]
Studies on Cognitive Behavioral Therapy and Graded Exercise Therapy for ME/CFS are misleading, by Sten Helmfrid (Assoc. Prof. of Physics, Member of the Swedish ME Association)
This is a translation of an article published in Socialmedicinsk tidskrift, Stockholm,
Sweden, on September 28 2016. Link to the original article in Swedish:
Citation: Helmfrid S. Studier av kognitiv beteendeterapi och gradvis ökad träning vid ME/CFS är missvisande. Soc Med Tidskr. 2016;93(4):433–44.
