PACE Trial Results: An Update

Purpose: This document, authored by Margaret Williams on June 9, 2011, critiques a misleading claim published in a Comment by Bleijenberg and Knoop about the PACE trial. It documents efforts to correct the assertion that 30% of PACE trial participants “recovered” following Cognitive Behavioral Therapy (CBT) and Graded Exercise Therapy (GET). The aim is to ensure transparency and accuracy in the interpretation of PACE trial results.

Key Points:

1. Misrepresentation of Recovery Rates
   • Highlights how the Comment inaccurately claimed a 30% recovery rate, which was based on a “normal range” definition that set thresholds low enough for participants to still meet trial entry criteria despite being labeled as “recovered.”
   • Notes this misrepresentation could lead to a gross misunderstanding of the PACE trial results by readers and researchers.
2. Critique of Peer Review and Editorial Oversight
   • Raises concerns about failures in the peer review and editorial processes at The Lancet, allowing such claims to be published.
   • References medical statistician Professor Martin Bland’s call for correcting potentially incorrect conclusions to prevent their uncritical citation.
3. Response from The Lancet
   • Documents communication between Professor Hooper and Zoe Mullan, a Senior Editor at The Lancet, which resulted in an agreement to correct the misleading claim in the Comment.
   • Notes The Lancet acknowledged that recovery rates would be reported in a separate publication by White et al., and confirmed a correction would be issued.
4. Advocacy for Transparency
   • Emphasizes the importance of ensuring accurate reporting and interpretation of trial results to uphold scientific integrity and prevent misinformation.
   • Recognizes the efforts of Professor Hooper in addressing and rectifying inaccuracies in influential medical literature.

Target Audience:

• Researchers and Clinicians: Individuals relying on accurate data to inform research or treatment strategies.
• Advocates and Patients: Those seeking transparency and accountability in ME/CFS research reporting.
• Journal Editors and Policymakers: Stakeholders responsible for maintaining ethical standards in research publication and dissemination.

Overall Outcome: This update reinforces the need for transparency and critical oversight in research publication. By addressing the misrepresentation in the PACE trial Comment, it advocates for ethical and accurate communication of findings to support evidence-based care for ME/CFS.