Response: Sharpe, Goldsmith and Chalder fail to restore confidence in the PACE trial findings

BMC Psychol. 2019 Mar 26;7(1):19. doi: 10.1186/s40359-019-0296-x.

Abstract

In a recent paper, we argued that the conclusions of the PACE trial of chronic fatigue syndrome are problematic because the pre-registered protocol was not adhered to. We showed that when the originally specific outcomes and analyses are used, the evidence for the effectiveness of CBT and graded exercise therapy is weak. In a companion paper to this article, Sharpe, Goldsmith and Chalder dismiss the concerns we raised and maintain that the original conclusions are robust. In this rejoinder, we clarify one misconception in their commentary, and address seven additional arguments they raise in defence of their conclusions. We conclude that none of these arguments is sufficient to justify digressing from the pre-registered trial protocol. Specifically, the PACE authors view the trial protocol as a preliminary plan, subject to honing and improvement as time progresses, whereas we view it as a contract that should not be broken except in extremely unusual circumstances. While the arguments presented by Sharpe and colleagues inspire some interesting reflections on the scientific process, they fail to restore confidence in the PACE trial's conclusions.

Keywords: Chronic fatigue syndrome; Clinical trial; Cognitive behavioral therapy; Graded exercise therapy; Methodology; Myalgic encephalomyelitis.

Publication types

  • Comment

MeSH terms

  • Cognitive Behavioral Therapy
  • Dissent and Disputes
  • Exercise Therapy
  • Fatigue Syndrome, Chronic*
  • Humans
  • Treatment Outcome