Questions for Action for M.E. (Lightning Process pilot study in children)

Questions for Action for M.E. (proposed Lightning Process pilot study in children with CFS and ME aged 8 to 18)

Shortlink: http://wp.me/p5foE-31X

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

For joint ME charity opposition statement and press release see:

Joint Press Release and statement: ME Association and The Young ME Sufferers Trust

Update @ 24 August

I have received a response from Sir Peter Spencer, this afternoon.

Sir Peter writes that [Action for M.E.’s] position derives from their detailed reading of the MRC Ethics Guide for medical research involving children and from their understanding of the role of any ethics committee in satisfying itself that appropriate independent arrangements are in place to ensure patient safety.

That Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.

That [Action for M.E.] does, of course, want to see research into LP in adults too – but as children are already seeing LP practitioners, before the process has been subject to research published in respected peer-reviewed journals, [they] can see a case for investigating if it is feasible within the Ethics Guide to set up a controlled trial.

 

I have written, today, to Action for M.E. requesting clarification of what information they have relied on when formulating their position on this controversial RNHRD NHS FT, Bath/University of Bristol Lightning Process pilot study.

Action for M.E. has now issued two position statements on this proposed Lightning Process pilot study for children.

Although funding for the study had been secured last November and a press release published in early March, by 17 June, the research team were still waiting on an ethics committee decision.

According to information posted on Action for M.E.’s Facebook site on 23 August, the project’s lead researcher, Dr Esther Crawley, has apparently confirmed that the pilot is still waiting to receive ethics approval.

University of Bristol Information Rights Officer and the Director of Legal Services had already confirmed to me (on 10 and 17 August) that the project lead had given assurances that “information requested will be published on the University’s website by the end of this month” and that “the published information will include the research protocol and related material, including  information about the ethics approval process”.

It appears then that Dr Crawley is very confident her project will be approved.

The University FOI office has told me that I will be notified when the material is published. 

A request for information and documents relating to the application for approval and the approval process timeline is due for fulfilment on or before 31 August.  Information requested of the National Research Ethics Service can be read in this posting:

Freedom of Information requests: South West Strategic Health Authority and National Research Ethics Service

To: Policy Officer; Heather Walker, Communications Manager; Sir Peter Spencer, CEO

Sent: Monday, August 23, 2010 4:18 PM
Subject: Query on position statements

This is a query in relation to Action for M.E.’s two published position statements on the proposed Lightning Process pilot study for children.

It was reported, back in March, by the regional Bristol newspaper:

http://www.thisisbath.co.uk/news/Money-Min-children-s-study/article-1885785-detail/article.html

“Money for Min children’s study
Thursday, March 04, 2010, 15:29

“A project looking into a chronic childhood condition has been given a £164,000 boost.

[…]

“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.

“The system is derived from osteopathy, neuro-linguistic programming and life coaching.

“Its creator, osteopath Phil Parker said: “We are thrilled to have the opportunity to collaborate on this exciting and groundbreaking research with Dr Crawley and her team.”

———

As you are aware, the University of Bristol’s FOI office is withholding virtually all information and documents under FOIA Clause 22(1)(a). Some limited documents relating to the funders have been made available.

When the University of Bristol issued its press release published on 2 March 2010 announcing the Lightning Process pilot study, the study had not, at that point, obtained ethics approval.

At 17 June, the University FOI Office confirmed that the study was still going through the ethics approval procedure and that information requested was expected to be published around August/September 2010.

I am recently advised by the FOI Office that Dr Crawley has assured them that information around the study and the research protocol is now planned to be published by the end of August. It is unconfirmed, but this suggests that the study may now have received approval.

So there is very little information in the public domain about the study design and methods.

The only information that is currently publicly available is:

1] The press release announcing the study on 2 March:
http://www.rnhrd.nhs.uk/index_sub_menus/news/documents/FINALRNHRDCFS_ME_fundingfeb10.pdf

2] The media article in “This is Bath” (URL above).

3] An article in the May issue of AYME’s Link Newsletter (a copy can be provided but no URL).

4] The information that Alastair Gibson is one of two LP practitioners involved with the NHS study (was on his website in March but has since been removed).

The “This is Bath” article states:

“The team will be carrying out a three-day trial using the Phil Parker Lightning Process, which is designed to teach people a new set of techniques for improving life and health.”

In five months, this has not been corrected by the lead researcher if this information is misleading.

The press release states that the primary outcome measure will be “school attendance after six-months”.

It seems unlikely, then, that the pilot participants and their families are going to be subjected solely to the application of “in-depth interviews”.

To date, there is virtually no information in the public domain about the proposed study design and methods and the research protocol is not expected to be published until the end of this month.

a) What is Action for M.E.’s understanding of what will be applied to the children during the life of the pilot study and by whom?

Where has it obtained the information on which it has based its decision to support this pilot study and to support any decision by the ethics committee(s) to grant a “favourable opinion”, ie, to approve the application?

b) Would Action for M.E. please set out what information it has relied upon in order to inform its position on this pilot and whether the organisation has made any approaches to the researchers or to any other body to obtain information about the proposed study over and above the press release, and what was the outcome of any approaches made?

Sincerely,

Suzy Chapman
_____________________

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