FINE Trial team remove raw data file: pressure from PACE Trial team?

[Sean]

This isn’t quite as bad as what the PACE authors did...

It's damn close.

 

[Yogi]

And a very interesting comment on Leonid Schneider's blog from johnthejack:

https://forbetterscience.wordpress....sed-patient-clinical-trial-data/#comment-1138

johnthejack
May 23, 2016 at 18:06

I have been in contact with Manchester University. Today I received an email that stated:

‘There has been no breach of the Data Protection Act. There has been a concern about whether the original patient consents for this project allowed for publication of data (even in anonymised form), but I believe that this is close to being resolved and that it is likely that the dataset will be returned to the PLOS site in the near future.’

Thanks very much @JohntheJack for contacting Manchester Uni and updating us all on Leonid's blog!! Cheers

 

[JohntheJack]

Thanks very much @JohntheJack for contacting Manchester Uni and updating us all on Leonid's blog!! Cheers

You're welcome. We'll see if they follow through. They do at least concede both that the data can be anonymized and that to share the data is not in their opinion a breach of the DPA.

 

[snowathlete]

Perhaps the thing to do is to look for papers from Manchester and QMUL where they publish data with similar consent forms and ask why they aren't being withdrawn.

Very good point. How many cases must there be that use the exact same forms...hundreds?....thousands? One assumes they are all going to be withdrawn in the next couple of days then.

Either that of they put the dataset back up and put an end to this bizarre development.

 

[Dolphin]

New thread

FINE Trial team restore raw data file!
http://forums.phoenixrising.me/index.php?threads/fine-trial-team-restore-raw-data-file.44963/

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0157199

Correction: Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome

• Lucy P. Goldsmith,
• Graham Dunn,
• Richard P. Bentall,
• Shôn W. Lewis,
• Alison J. Wearden

• Published: June 1, 2016
• http://dx.doi.org/10.1371/journal.pone.0157199

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0157199

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.

S1 Dataset. De-identified trial data.[/paste:font]
doi:10.1371/journal.pone.0157199.s001

(DTA)

References

1. 1. Goldsmith LP, Dunn G, Bentall RP, Lewis SW, Wearden AJ (2015) Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome. PLoS ONE 10(12): e0144623. doi:10.1371/journal.pone.0144623. pmid:26657793
2. 2. Goldsmith LP, Dunn G, Bentall RP, Lewis SW, Wearden AJ (2016) Correction: Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome. PLoS ONE 11(5): e0156120. doi:10.1371/journal.pone.0156120. pmid:27191956

Citation: Goldsmith LP, Dunn G, Bentall RP, Lewis SW, Wearden AJ (2016) Correction: Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome. PLoS ONE 11(6): e0157199. doi:10.1371/journal.pone.0157199

 

[worldbackwards]

Either that of they put the dataset back up and put an end to this bizarre development.

Which is, in it's way, an even more bizarre development. One shudders to think what it is exactly that they think they're doing. They look like a pack of fools.

 

[Scarecrow]

Which is, in it's way, an even more bizarre development. One shudders to think what it is exactly that they think they're doing. They look like a pack of fools.

That's certainly one way to look at it. But on the other hand you could argue that they behaved with caution when a potential problem was flagged up to them, investigated the issue and then restored the data when they were satisfied that there was no issue.

Compare the actions of the University of Manchester and their researchers with QMUL and theirs.

 

[BurnA]

So if they are satisfied the data is anonymised what is the PACE authors excuse ?

 

[Esther12]

So if they are satisfied the data is anonymised what is the PACE authors excuse ?

The release of their data will be much more embarrassing, so they're concerned about the privacy of participants.

 

[Denise]

Have others managed to download the dataset? (I have tried but thus far have been unsuccessful though it is likely because I am technologically challenged.)

Edit to clarify - I am trying to download the corrected dataset.
S1 Dataset. De-identified trial data.

 

[Sam Carter]

Have others managed to download the dataset? (I have tried but thus far have been unsuccessful though it is likely because I am technologically challenged.)

Edit to clarify - I am trying to download the corrected dataset.
S1 Dataset. De-identified trial data.

This is the download URL for the dataset, Denise.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4685991/bin/pone.0144623.s002.dta

Contrary to what Wearden et al wrote, the data were never removed from the web at any point.

 

[Denise]

This is the download URL for the dataset, Denise.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4685991/bin/pone.0144623.s002.dta

Contrary to what Wearden et al wrote, the data were never removed from the web at any point.

Thanks for the URL. What I would like to do is compare the original to the "corrected" set but I don't have the supporting software nor can I figure out how to download and convert it.

 

[Bob]

The file is available at: https://www.mediafire.com/?rvh3brmgoaznude

I'm attaching a PDF version of the file. However it is easier to read the spreadsheet version.

Just parking these links here for handy reference...

This is the FINE trial data, from PLOS One, converted from its original .dta file format.

The PLOS One data set is available as a .csv file (which can be opened in spreadsheet software such as Excell), here: https://www.mediafire.com/?rvh3brmgoaznude

And it's available as a PDF file, here: http://forums.phoenixrising.me/inde...ssure-from-pace-trial-team.44705/#post-726398


The data has now been officially republished in .dta format here:
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0157199
http://journals.plos.org/plosone/article/asset?unique&id=info:doi/10.1371/journal.pone.0157199.s001

 

[Sam Carter]

Thanks for the URL. What I would like to do is compare the original to the "corrected" set but I don't have the supporting software nor can I figure out how to download and convert it.

As best as I can tell the dataset hasn't been changed.

I compared the file I downloaded last year with one I downloaded tonight and they both have the same SHA-1 hash digest of 1ead6b2d5b4aa8ad69a951dbaf6bd9f499ec21ea which means they're identical (assuming I've done things correctly).