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J Health Psychol. 2017 Aug;22(9):1106-1112. doi: 10.1177/1359105316675213. Epub 2016 Nov 1.

'PACE-Gate': When clinical trial evidence meets open data access.

Author information

1
The University of Manchester, UK.

Abstract

Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.

KEYWORDS:

chronic fatigue syndrome; clinical trials; cognitive behavioural therapy; psychotherapy; treatment

PMID:
27807258
DOI:
10.1177/1359105316675213
[Indexed for MEDLINE]

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