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PACE 10 year follow-up: feasibility study

Dolphin

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http://www.hra.nhs.uk/news/research-summaries/pace-10-year-follow-up-feasibility-study/

Research Summaries
PACE 10 year follow-up: feasibility study
PACE 10 year follow-up: feasibility study

Full title PACE trial 10 year follow-up: feasibility study

Research type
Research study

IRAS ID
214164

Contact Name
Peter D White

Contact Email
p.d.white@qmul.ac.uk

Sponsor organisation
Queen Mary University of London

Eudract number

ISRCTN number

Clinicaltrials.gov identifier

Additional reference number fields
54285094, ISRCTN; MREC/02/7/89, MREC West Midlands

Research summary


This study will test the feasibility of undertaking a 10-year postal questionnaire follow-up of participants who took part in the PACE trial.

This trial tested treatments for chronic fatigue syndrome and the main results were published in the Lancet.

We wish to find out: how healthy participants are now, whether they have had any other illnesses since leaving the trial, how they are functioning, their economic status, how they view the concept of recovery, and whether they would be willing to participate in a qualitative study about their illness and current health.

For this feasibility study we will use a random sample of 60 participants from two of the original five PACE trial centres.

We will use original information provided for address details, as well as trace participants using their NHS numbers, and send questionnaires in the post.

The questionnaires will include the original primary outcomes, a global health measure and measures of overall functioning.

We will ask information about any new illnesses suffered since leaving the trial.

Finally we will ask participants’ how they feel about having their data shared anonymously with other researchers and the general public.

A return rate of 75% (45/60) returned questionnaires will deem a full 10-year follow-up study feasible.

REC Name
London - South East Research Ethics Committee
REC Reference 16/LO/2167
REC Opinion
Favourable Opinion

Date of REC Opinion 3 January 2017
 

Esther12

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Who wouldn't trust White to run this appropriately?

Last time they were talking about a 5 year feasability study. Now 10?

Odd, as QMUL are trying to use White's retirement to avoid releasing PACE info:

I am afraid that we estimate to provide the information would exceed the appropriate limit as defined by the Freedom of Information and Data Protection (Appropriate Limit) Regulations 2004. For your information this is £450, calculated as the estimated cost of one person spending 18 hours in determining whether the information is held, then locating, retrieving and extracting the information. Section 12 of the Freedom of Information Act 2000 therefore makes provision for public authorities to refuse such requests. As the Chief Investigator has retired we have no one qualified to locate, retrieve and extract the information requested.
https://www.whatdotheyknow.com/request/cfs_a_small_of_the_objective_phy_2#incoming-1026722
 

Valentijn

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The time to ask patients how they feel about sharing anonymous data is when they join the trial. Because patients and researchers do not have the right to prevent their anonymous data from being analyzed, unless patients completely withdraw consent.

Grow up, White. You lost, open data won. Get over it and move on with life. Enough of the hissy fits and posturing.
 

Hutan

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I don't understand why they would bother with a sample of 60 rather than sending forms out to everyone they can trace.
The smaller the sample, the better the opportunity for manipulation of the patient selection.

This study will test the feasibility of undertaking a 10-year postal questionnaire follow-up of participants who took part in the PACE trial.
Although, to be fair, the proposal is for a feasibility study that, if successful, presumably would be extended later to the rest of the participants.

I'd love to see a study of all the participants done by an independent party. Failing that, I wonder if the MEA would be up for collaborating, even with White, to ensure the questions asked are sensible? @charles shepherd

[Edit:
Date of REC Opinion 3 January 2017
Perhaps the feasibility study has been completed already?]

White must really feel very sure that we are all fruitloops (who just need to get over our fear of physical activity and attachment to being ill) and that CBT and GET cured plenty of people to keep pursuing this.
 

user9876

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Although, to be fair, the proposal is for a feasibility study that, if successful, presumably would be extended later to the rest of the participants.
This is why I wonder what the point is of doing the feasibility system. Once all the questionnaires are collated and a system for tracking addresses is designed why not just do it for everyone involved.

The smaller the sample, the better the opportunity for manipulation of the patient selection.
I wondered if it would allow them to avoid a follow up. They spun the 2.5 year one so wouldn't expect any better results for 10 years.
 

Hutan

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This is why I wonder what the point is of doing the feasibility system.
Well, you carefully choose your small sample so as to be quite confident of a good result. Then you can publish the small study and win more years of NICE support.

Then, after having basked in the glory for a good while, if you've noticed that some of the questions don't give quite the right outcome, you can tweak them a bit or quietly drop them before applying them to the wider, less carefully selected sample.;)
 

lilpink

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I think it would be reasonable to expect that any follow up should be designed and carried out by a completely independent group of researchers.
Yes..if there was ever any sense that such work could provide anything useful at all. As we know the PACE Trial has been a load of old cack from its inception & so it would be insane for funding to prolong its death throes further. You can't make a silk purse from a sows ear, and the PACE Trial is a poor infected pus-filled ear of the sort that should be swiftly amputated and buried.
 

Large Donner

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The time to ask patients how they feel about sharing anonymous data is when they join the trial. Because patients and researchers do not have the right to prevent their anonymous data from being analyzed, unless patients completely withdraw consent.

Grow up, White. You lost, open data won. Get over it and move on with life. Enough of the hissy fits and posturing.
I can just see them claiming all 60 are fully recovered but no one wants their data shared.