Tuesday, May 17, 2011

Lancet's editorial and nine letters: PACE trial's White and colleagues formed their opinion about the intended outcome before the trial began

by tonybritton on May 17, 2011:

From The Lancet online, 17 May 2011.


Patients’s power and PACE

Once every few years, we publish a paper that elicits an outpouring of consternation and condemnation from individuals or groups outside our usual reach. The latest topic to have caused such a reaction is chronic fatigue syndrome (CFS), and—more specifically—Peter White and colleagues’ randomised PACE trial published on March 5, this year.

In the PACE trial, White and colleagues set out to answer a question that has long troubled the CFS community: are the treatments recommended by clinical guidelines—ie, cognitive behaviour therapy and graded exercise therapy—really the best option for patients with CFS? The trial’s findings showed that, compared with specialist medical care alone, both treatments were associated with significant improvements in self-rated fatigue and physical function (the primary outcomes) after 52 weeks.

The response to the trial’s publication was swift and damning. “When is the Lancet going to retract this fraudulent study?” demanded a Facebook group. A 43-page complaint (now available via Wikipedia) branded the trial “unethical and unscientific”. There were 44 formal letter submissions, eight of which we publish today, together with a response from White and colleagues.

Many of the letters critique the definitions of secondary outcomes, question protocol changes, and express concern over generalisability. But one cannot help but wonder whether the sheer anger and coordination of the response to this trial has been born not only from the frustration many feel about a disabling condition, but also from an active campaign to discredit the research. White and colleagues have been accused of having “formed their opinion about the intended outcome” before the trial began. This view is unjustified and unfair. The researchers should be praised for their willingness to test competing ideas and interventions in a randomised trial. The evidence might even suggest that it is the critics of the PACE trial who have formed their opinions first, ignoring the findings of this rigorously conducted work. Read more>>

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