Researchers have removed the previously openly available anonymised patient data of the clinical trial FINE from their publication in PLOS One. The correction, issued on May 18th 2016 states:
“S1 Dataset was published in error. The error was corrected in the XML and PDF versions of this article on May 9, 2016. Please download this article again to view the correct version”.
The now removed S1 dataset was previously described by the authors around Alison Wearden, professor of Health Psychology at the University of Manchester, in their Data Availability statement:
“The authors have prepared a dataset that fulfills requirements in terms of anonymity and confidentiality of trial participants, and which contains only those variables which are relevant to the present study. Data are available as Supplementary Information”.
FINE was a “randomised controlled trial of a nurse-led self-help treatment, versus supportive listening, versus treatment as usual for patients in primary care with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)”, performed at the University of Manchester. It was funded by the British Medical Research Council (MRC) and the UK Department of Health.
These new restrictive developments are very important. FINE is considered as a sister CFS/ME therapy trial of the PACE trial (on which I previously reported), where the sharing of anonymised patient data to non-collaborators was repeatedly denied by the King’s College London and Queen Mary University London, with the consequence that now the courts are expected to decide upon this issue of clinical data sharing. A judge has already decreed that certain documents associated with PACE trial are to be released (information and list with links are available from the website by the lawyer and CFS/ME activist Valerie Eliot Smith).
Unlike PACE, the FINE trial was processed rather transparently and was not accused of questionable protocol changes mid-trial or of reclassifying patients who were relatively healthy to begin with, as recovered thanks to the therapy. Before FINE was performed and published in the prestigious journal BMJ (Wearden et al, 2010), its protocol was made available in BMC Medicine (Wearden et al 2006). Further analysis of FINE data was published in the now corrected PLOS One article (Goldsmith et al, 2015). According to PLOS guidelines on data availability (which PACE authors ignored, with the resulting editorial note of concern), the authors of FINE trial originally made a subset of anonymised patient data publicly available. As Lisa Crawley, Records Officer at the Manchester University declared to my source, who also approached her about information on FINE:
“Please note that we have not released our entire dataset. The data which are available in association with the PLOS-One article entitled “Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome” comprise a small, anonymised subset of our dataset containing only variables relating to the analysis presented in the paper”.
Instead, interested parties will now have to contact the FINE researchers at the Manchester University directly. The corrected PLOS One paper now declares in its Data Availability statement:
“Our ethical permission did not expressly permit us to share patient data, even anonymised patient data, in a public forum. Data will be made available to bona fide researchers on application to the principal investigator, Alison Wearden or the trial statistician, Graham Dunn. Alison Wearden can be
contacted at: Alison.email@example.com. Graham Dunn can be contacted at: Graham.firstname.lastname@example.org.”
The original FINE patient consent form from 2004 is available here, it is also very similar to the patient consent form of PACE. The patients were not specifically deciding on allowing or prohibiting the open sharing of their anonymised patient data, but the form makes references to UK Data Protection Act from 1998, which may or may not prevent such data release.
The reasons as to why Wearden and her colleagues decided to remove already published anonymised CFS/ME patient data are unclear. I will provide updates should I receive further information.
Update 23.05.2016. I received this statement from Alison Weardon, indicating that the unclear formulation of the FINE trial patient consent form was indeed decisive for the removal of the anonymised dataset from public domain:
“We published the PLOS One paper on therapist effects and therapeutic alliance and provided a de-identified dataset containing the variables used in the analysis.
On 10th March, I received a freedom of information request for a copy of the patient consent form for the FINE trial. The request referred to the ongoing case relating to the PACE trial, and raised the issue of whether in fact we had been correct to make the data relating to the therapist paper open to the public. We did not request permission to do so in our trial consent form.
The dataset supplied to support the PLOS-One article was supplied in good faith and in the belief (still held) that no patient or therapist would be identifiable from it. The Freedom of Information request made me wonder if we had acted correctly, given our ethical permissions. In consultation with my co-authors and after discussing with various colleagues, I decided that it would be better to remove the dataset from public access (while still being prepared to supply it to bona-fide researchers). I wrote to PLOS-One on 18th April asking them whether it would be possible to do this.
The contents of the paper have not been retracted. The dataset has not been retracted. There is nothing wrong with either of them. The only issue is whether or not we were right in publishing this dataset given the consent that we had obtained from the trial participants“.
Update 2.07.2016. The previously removed S1 dataset is now back, hence the change to the title of this article. The Correction note from June 1st 2016 reads:
“The dataset originally included as S1 Dataset was removed in consideration of possible restrictions for the public availability of the data related to the wording of the original consent form for the trial. Upon consultation with the authors’ university it has been established that the file may be publicly shared as it reports de-identified data. Please view S1 Dataset here.
The Data Availability statement for the article is revised to read: The authors have prepared a dataset that fulfills requirements in terms of anonymity and confidentiality of trial participants, and which contains only those variables which are relevant to the present study. Data are available as Supporting Information”.