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PACE data released to M.E. patient via FOI request

September 13, 2016

Queen Mary University of London (QMUL) announced on Friday that it has released anonymised data from the PACE trial to a patient with M.E. who requested it under the Freedom of Information Act.

The data was requested in March 2014 by Mr Alem Matthees, and the Information Commissioner ordered it to be released last October, a decision appealed by QMUL, resulting in a tribunal hearing in April. Its appeal was denied.

Mr Matthees requested baseline and 52-week follow-up scores on the SF-36 physical function scale, CFQ fatigue Likert and bimodal scales, Oxford criteria caseness, participant-and doctor-rated CGI scales and walking distance tests for all PACE trial participants, plus details of which treatment arm each individual was allocated to after randomisation.

We understand that it is his intention to now analyse this data.

Original protocol

The day before the data was released, the authors of the PACE trial published an analysis of primary outcomes using composite measures of improvement.

The authors say that, "as critics of the trial have requested that we also analyse the trial with the primary outcomes in the form outlined in the published protocol, we have done this as an analysis to see if this changes the trial’s conclusions […] All three of these outcomes are very similar to those reported in the main PACE results paper.”

An analysis of this published on #MEAction indicates that, on the basis of #MEAction’s calculations, 21% of patients who undertook graded exercise therapy (GET) as part of the trial would have been classed as “improvers” had the protocol not been changed during the trial. This compares to the 61% stated in the Lancet using protocol developed after the trial was under way. Results for those who were given cognitive behavioural therapy were similar to those for GET.

Action for M.E. comment

Alan Cook, Chair of Board of Trustees, Action for M.E., says, “As a point of principle, Action for M.E. supports the sharing of research data to enable replication and validation. Like a number of other organisations, I wrote to QMUL in February on behalf of Action for M.E. in support of the release of data related to the PACE trial.

“The Board are pleased to see that QMUL has now shared the data as instructed to do so by the Information Commissioner, and we await published analysis of it with considerable interest.

“Action for M.E. does not recommend any individual treatments or management approaches for people with M.E. Instead, we offer key information to allow people with M.E. to make informed decisions about their own care. This includes information about research into symptom-management approaches, and we will ensure that we keep this up to date in line with published, peer-reviewed evidence.”