Update: PLOS One affirms my (and anyone else’s) right to PACE data published there

plos oneA prominent notice has appeared on the PLOS One article

McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, et al. (2012) Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis. PLOS ONE 7(8): e40808. doi: 10.1371/journal.pone.0040808

PLOS ONE notice: Update on follow up

Posted by PLoS_ONE_Group on 07 Mar 2016 at 17:08 GMT

PLOS ONE is actively following up on requests for the data from this study and we are writing to provide an update on the current status.

The journal policy that applies to this article requires authors to share the data underlying the study upon request, provided that the release of the data does not compromise the confidentiality of participants in human-subjects research. The data policy that was in effect at the time of the publication of the article did not require the release of the data upon publication or a statement on how the data would be made available.

We have now carefully assessed the study and sought advice from two editorial board members, who have provided guidance on the data necessary to replicate the cost-effectiveness analyses reported in the article, and thus we have established which data we would expect the authors to share in the context of the analyses presented in this PLOS ONE article. We have contacted the authors to request the release of the data, which include individual patient-level data underlying tables in the article. Our follow-up is ongoing as we engage with the authors and assess requirements to ensure that the confidentiality of patient data collected as part of the clinical trial is not compromised.

My November 13, 2015 request was:

Dear Professor McCrone:

I have read with interest your 2012 article in PLOS One, “Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome…”

I am interested in reproducing your empirical results, as well as conducting some additional exploratory sensitivity analyses.

Accordingly, and consistent with PLOS journals’ data sharing policies, I ask you to kindly provide me with a copy of the dataset in order to allow me to verify the substantive claims of your article through reanalysis.  I can read files in SPSS, XLS[x], or any reasonable ASCII format.

Thank you in advance. I look forward to your response.

As I understand the announcement, PLOS is affirming my right to data needed to reproduce analyses reflected in six tables:

  • Table 1. Baseline demographic and clinical data.
  • Table 2. Service use and lost employment at baseline and follow-up.
  • Table 3. Service costs at baseline and follow-up.
  • Table 4. N (%) receiving welfare benefits or other financial payments.
  • Table 5. EQ-5D utilities and QALYs accrued during follow-up period.
  • Table 6. Cost-effectiveness results from healthcare and societal perspectives, 0–52 weeks.

I am also assisting in the patient response to FOIA Tribunal case (QMUL-PACE vs ICO & Matthees) for The Lancet data.

It is my understanding that:

Sufficiently anonymised or de-identified data which poses no significant risk of re-identification is not classified as exempted personal or confidential data under the UK’s Freedom of Information Act (FOIA) or Data Protection Act (DPA), including individual patient data.

My request in no way received special treatment by the PLOS One administration. Anyone else could make a request for data.The processing of my request and the commitment of PLOS should now streamline the procedure.

For more background see

UK government: Risk of reputational damage to investigators not an excuse for withholding data

Further insights into war against data sharing: Science Media Centre’s letter writing campaign to UK Parliament

A call for the unconditional release of the PLOS One PACE data Part 1

Recognizing when “protecting patient privacy” is mere excuse for not sharing data

King’s College London stalls some more, reiterating refusal to release the PACE trial data

PLOS One response to concerns about King’s College refusal to share PACE data

Why I don’t know how PLOS will respond to authors’ refusal to release data