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Clinical trial calls patients "recovered" with worse health than required to qualify for the trial

Accepted submission by Anonymous Coward at 2016-01-06 12:32:13
Science

What is the PACE trial?

This large-scale trial is the first in the world to test and compare the effectiveness of four of the main treatments currently available for people suffering from chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME). These are adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and standardised specialist medical care (see below). All of the treatments offer ways for patients to deal with and improve the symptoms of CFS/ME and its effects on disability.

http://www.wolfson.qmul.ac.uk/current-projects/pace-trial#overview [qmul.ac.uk]

It has been discovered that the threshold used to determine who was allowed to join the trial was higher than that to qualify as recovered. Patients who got worse after treatment were then categorized as improved:

If the standard formula is used on a population-based survey with scores clustered toward the healthier end, the result is an expanded “normal range” that pushes the lower threshold even lower, as happened with the PACE physical function scale. And in PACE, the threshold wasn’t just low–it was lower than the score required for entry into the trial. This score, of course, already represented severe disability, not “recovery” or being “back to normal”—and certainly not a “strict criterion” for anything.

http://www.virology.ws/2015/11/04/trial-by-error-continued-did-the-pace-study-really-adopt-a-strict-criterion-for-recovery/ [virology.ws]


Original Submission