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PLOS ONE issues Expression of Concern on PACE

May 03, 2017

The journal PLOS ONE has issued an Expression of Concern about the PACE trial paper it published in 2012.

“Several readers have raised concerns about some of the analyses reported in the article and made requests for the data underlying this study,” said the journal yesterday.

Referring to the paper Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis, the journal’s editors have contacted its authors to request certain data, in line with PLOS ONE’s clear policy on data sharing.

The authors have offered to release aggregated data, but have reservations about the individual-level patient data.

PLOS ONE says, “In spite of requests to the authors and Queen Mary University of London, we have not yet received confirmation that an institutional process compatible with the existing PLOS data policy at the time has been developed or implemented for the independent evaluation of requests for data from this study. We conclude that the lack of resolution towards release of the dataset is not in line with the journal’s editorial policy and we are thus issuing this Expression of Concern to alert readers about the concerns raised about this article.”

The journal has also published a statement from Prof Peter White and his co-authors of the paper, who say that they “disagree with the Expression of Concern about our health economic paper that PLOS ONE has issued and do not accept that it is justified.”

Action for M.E.’s Board of Trustees met last week to consider a number of issues relating to the PACE trial. We will communicate the outcome of this as soon as it has been agreed by our Board.

What is an Expression of Concern?

Blogging about the issue of potentially problematic science papers earlier this year, Retraction Watch defines Expression of Concerns as “rare but important signals in the scientific record. Neither retractions nor corrections, they alert readers that there may be an issue with a paper, but that the full story is not yet clear.”

After contacting PLOS ONE about this particular Expression of Concern, Retraction Watch also reports that it asked if the journal planned to retract the paper if its authors do not provide the data requested.

PLOS ONE said, “For now, we have exhausted the options to make the data available in accordance with our policy at the time, but PLOS still seeks a positive outcome to this case for all parties. It is our intention to update this notice when a mechanism is established that allows concerns about the article’s analyses to be addressed while protecting patient privacy. PLOS has not given the authors a deadline.”

Data sharing in clinical research

PLOS ONE has also published a more detailed blog detail by its Managing Editor and Editor-in-Chief about the challenges and opportunities relating to data sharing in clinical research.

Referring specifically to the PACE trial paper published in the journal, they say, “What lies at the heart of the complexity of this case, and the question of data availability for clinical data in general, is the tension between encouraging open science and the duty to protect those who generously contribute towards public benefit by participating in clinical research. There is a need for mechanisms and policies to address the different challenges related to confidentiality and these will require input from all stakeholders to maximize responsible data sharing and reuse.”