The PACE trial missteps on pacing and patient selection.

Area of Science:

• Rehabilitation medicine
• Clinical trial methodology

Background:

• The Pacing, Activity, and Cognitive Therapy (PACE) trial aimed to evaluate adaptive pacing therapy for chronic fatigue syndrome.
• Concerns have been raised regarding methodological issues within the PACE trial.

Purpose of the Study:

• To critically assess the design and implementation of the adaptive pacing therapy intervention in the PACE trial.
• To examine the impact of patient selection criteria on the trial's outcomes.

Main Methods:

• Focused critique of the adaptive pacing therapy's composition.
• Analysis of patient selection ambiguity in the PACE trial.

Main Results:

• The PACE trial investigators failed to establish a valid adaptive pacing therapy intervention.
• Ambiguities in patient selection criteria significantly undermined the study's findings.

Conclusions:

• The methodological flaws in intervention design and patient selection render the PACE trial outcomes unreliable.
• Further research requires rigorous methodology for adaptive pacing therapy and clear patient selection.