Lightning Process to be Evaluated in Research Study on Children

[Dx Revision Watch]

Hi Frances,

Thanks very much for making this available.

(In case some readers are not aware, AYME has issued no policy statement on this pilot. All the national patient organisations were contacted early on for position statements. Action for M.E., the ME Association jointly with The Young ME Sufferers Trust, and The 25% ME Group have issued statements; also Invest in ME and BRAME. But no statement from AYME.)

(Also for those who aren't aware, Dr Esther Crawley is the Medical Consultant to AYME. Earlier in this thread is an article on the study published in May, in AYME's Link newsletter.)

A couple of points to add to those of Angela's.

I note that the response from the "Grants and Projects Manager" is described as

"a personal response"

why is a spokesperson for AYME responding in a "personal" capacity?

Given that AYME will have received a number of requests for a position statement, and given that they are our largest UK children's and young person's patient organisation, they should have been prepared to issue a position statement.

"Mary-Jane takes very seriously my allegations that this would harm children and breach human rights, and so she keenly awaits the decision of the ethics panel; she believes that they will examine these points, including whether the research could feasibly be carried out on adults, and whether it would put participants at risk of harm.

Mary-Jane would also oppose the research if these were the case, but at the moment, she does not see grounds to doubt the good faith of the research team. "

So like Action for M.E., AYME chooses to defer to the views of an REC, when it is not known what information was set before the REC and what their understanding of LP is and when it is not generally known what the design and methods for this pilot are and how and by whom the intervention is going to be applied.

Dr Crawley is a Medical Advisor to AYME, it seems unlikely that AYME would not have sought to discuss the design of the pilot with her.

Why weren't AYME and The Young ME Sufferers Trust consulted about the project before an application for ethics approval was submitted in June?

(The application for funding had been submitted last year and funding was secured in November 09; the pilot was announced at the beginning of March, although at 6 September I was told that the pilot was study "is still at the final stage of the ethics procedure". Nothing received from U of Bristol FOI, today, by the way.)

"...many researchers have been discouraged by extremely negative and hostile reactions from a small part of the M.E. community."

Here we go again: so that's Bosely, White, Parry, Shepherd, Spencer, Holgate and now AYME.

Anyway, Frances, thank you for your persistance with AYME and for making this available.

Suzy

 

[Angela Kennedy]

Hi Suzy,

Yes.

It is absolutely astounding that AYME are prepared to defer in this way without ensuring ethical objections are made loud and clear.

I've also just noticed a major misrepresentation in Willow's assertion (I'm presuming Frances you've accurately reflected her comments here?):

"Mary-Jane would also oppose the research if these were the case, but at the moment, she does not see grounds to doubt the good faith of the research team."

This implies that any ethical objection to this trial is an accusatory calling of bad faith on the research team - an attack on their integrity! Of course, nothing of the sort has gone on, but Willows comment nevertheless constructs objections as such.

Speaking of the 'small hostile section of the community' meme - this also emerged in Gibson, didn't it? It was in relation to Simon Wessely's claims, and I think a more general comment? The same sort of language. Is this recurring theme a viral, unreflective use of banal and asinine soundbites? Or something more strategic?

 

[Dx Revision Watch]

...Speaking of the 'small hostile section of the community' meme - this also emerged in Gibson, didn't it? It was in relation to Simon Wessely's claims, and I think a more general comment? The same sort of language. Is this recurring theme a viral, unreflective use of banal and asinine soundbites? Or something more strategic?

I think there were around 7 references in the Gibson Report to "hostility".

http://twentysixsoldiersoflead.word...ughts-on-the-gibson-report-by-angela-kennedy/

More thoughts on the Gibson Report by Angela Kennedy

 

[Bob]

Hi,

I’m new to these forums, so I hope this works.

Hi kettles,
A big welcome to the forums to you...
You're doing great work here.

On 8th July I sent a letter to Dr. Esther Crawley regarding the proposed pilot study to look at how to recruit to a RCT of the Lightning Process on children. I have received no acknowledgement of the letter, nor any reply, despite a follow-up e-mail. I cc'd my letter to a number of the patient organisations (amongst other organisations). As of 12/8/10, I had received no reply from AYME, apart from an acknowledgement a few weeks before which said that their CEO was on annual leave, and that she would reply when she could; so, I e-mailed to ask if the CEO, Mary-Jane Willows, was back from annual leave. After many e-mails, and explanations, from AYME, I received a letter on 01/9/10.

Well done for getting a response... It seems that your persistence paid off. I also sent a letter outlining my concerns to various organisations including AYME, but I wasn't as persistent as you, and have never received a reply from any of them. I'm hoping that every little bit each of us does makes a small difference. And then there's Suzy (ME agenda), who makes a big difference.

Mary-Jane takes very seriously my allegations that this would harm children and breach human rights, and so she keenly awaits the decision of the ethics panel; she believes that they will examine these points, including whether the research could feasibly be carried out on adults, and whether it would put participants at risk of harm.

As has been discussed already, this is an ignorant thing to say... If the ethics committee hasn't been alerted to the nature of the Lightning Process, and its potential dangers for children with ME, then they simply won't have any insight into the dangers.

The ethics committee probably rely on the researchers to tell them about the nature of LP, the nature of ME, and the implications of treating ME with LP, and the dangers involved in training children to ignore their symptoms and to stop listening to their bodies, and the dangers of invalidating a child's experiences by telling them that they are ill purely because they want to be.

I'm sure the researchers didn't alert the ethics committee any of the potential dangers to the psychological and developmental welfare of the children... If the researchers understood, or cared about, the dangers, then they wouldn't be doing the research in the first place.

I'm sure that the ethics panel is completely ignorant about the nature of LP and has been told that it's a 'harmless' psychological therapy, and probably that it is similar to CBT (they would consider CBT to be a harmless therapy for people with ME)... I doubt if they understand that LP is a form of thought control, positive thinking or faith healing... or that it is more of a belief system than a therapy... or if they are aware of the inherent dangers involved in teaching children to ignore their symptoms and their feelings of ill-health... or of the dangers of telling children that they are not really ill, but that they are causing their own illness-behaviour due to a negative habitual thought pattern. As far as I am aware, the LP program is not based on any medical or scientific evidence.

I am in the process of trying to write a full explanation of the exact nature of LP, the nature of ME, why LP might adversely affect people with ME, why LP isn't suitable for treating anyone with ME and of the implications and dangers for 'training' children in LP.

I'm struggling to get it done because my foggy brain can't easily cope with writing.

Great work kettles... good to have you on board.

 

[Dx Revision Watch]

...I am following the thread with interest as my 12 year old has ME/CFS (as do I) and I am appalled that this "study" may be approved.

Apologies, Yawn, for missing your posting, last night. I'm sorry to hear that both you and your daughter are coping with this illness.

...You may have already answered this before - but who is it best to write to to add my concerns??

Early on, I contacted Action for M.E.; the ME Association; The Young ME Sufferers Trust; AYME; The 25% ME Group; Invest in ME; ME Research UK. (All except AYME and ME Research UK have now issued statements. The 25% ME Group were asked to forward my concerns and documents to their Medical Advisors, Dr Nigel Speight and Dr Byron Hyde and Simon has confirmed that he did so.)

Invest in ME issued an early opposition statement and eventually several national patient organisations followed suit (that is the ME Association with The Young ME Sufferers Trust in a joint press release, BRAME and the 25% ME Group). The joint press release unfortunately did not result in any coverage of the issue. If you were wanting to do some work on this issue, it would be useful to establish from all five organisations with whom their concerns have been raised beyond the confines of issuing position statements and publishing these on their websites, and in addition to the media recipients of the joint press release.

The ME Association have confirmed that they contacted Bill Davidson, Research Governance Manager, Department of Health, and received pretty much the same response that I had received from him. We also know that the ME Association has liaised with a number of Trading Standards Offices (though this is in connection with Lightning Process websites).

So it would be useful to know with whom these five organisations that have opposed the study have raised their concerns and what, if any, responses they have received.

I've concentrated, myself, mostly on submitting FOIs but other than the patient orgs, these are the people and organisations with whom I have raised my own concerns:

The Countess of Mar; Earl Freddie Howe (Parliamentary Under-Secretary of State for Quality); Lord Clement-Jones - all three are Patrons to the Young ME Sufferers Trust. (The Countess of Mar regretted that her health prevented her involvement in this issue; Earl Howe referred my concerns on to Bill Davidson, Research Governance Manager, Department of Health, who responded on his behalf; no response has been received yet from Lord Clement-Jones.)

Maria Robinson, South West Regional Manager, National Research Ethics Service, by email and telephone.

Annette Brooke, MP, Mid Dorset & North Poole (my own MP). Annette forwarded my concerns and enclosures to Rt Hon Andrew Lansley MP, Secretary of State for Health, Department of Health. Paul Burstow MP, Minister of State for Care Services, responded on behalf of the Secretary of State for Health, on 12 August.

Annette told me that she had tabled a Parliamentary question but that this was not processed in time before Parliament broke up for the summer recess. Once it has been confirmed whether the pilot has received ethics approval, I shall be discussing with Annette what other avenues might usefully be explored. Annette has been a member of a number of Parliamentary committees and standing committees relating to children's issues. Annette is also the Vice-Chair of the newly reformed APPG on ME, which meets in September for a planning meeting with an anticipated APPG meeting in November. The MEA has been given a copy of the letter of concerns raised with Mrs Brooke.

My concerns were also raised, indirectly, through the comprehensive FOI requests submitted in April to the RNHRD NHS FT Trust, Bath and the University of Bristol's FOI office, in May; then via a request for an internal review of the decision to withhold almost entirely all information under Clause 22(1)(a) of the FOI Act which was dealt with by their Director of Legal Services. A separate request for information submitted directly to a University of Bristol department was forwarded to Dr Esther Crawley by the recipient. Dr Crawley will also likely have a copy of the comprehensive request for information, though I have not sent her a copy, directly.

Much of the documentation I hold around the LP pilot and in relation to FOI requests is being shared with the ME Association Board of Trustees.

A Rapid Response to the BMJ was held back from publication by the editor.

I've done no work with journalists on this issue because my focus has been on obtaining information on the study design, methods etc and publishing this on my site and on other platforms.

I haven't approached Dr Crawley directly; those who have, for the most part, have reported that they have received no response. That is not acceptable from the lead investigator.

Nor have I approached the University or the RNHRD NHS FT Trust (other than via FOI offices for information). Some Universities have a department where concerns about research studies being undertaken under their auspices can be raised, but I have not established whether such a channel would be for complaints or concerns from research study participants or from members of the public who have concerns but who are not involved, themselves, in a study.

So these might be three avenues you may want to consider looking into.

Others are known to have approached the funders but have been referred back to Dr Crawley, the lead researcher.

Frances has told us that she has contacted a number of organisations, bodies and institutions and perhaps she might consider identifying those to whom her letter was sent.

There are likely to be others of whom I am not aware who have approached other individuals and organisations agencies or bodies.

It wasn't established until 27 August, in an FOI response, which Research Ethics Committee was responsible for reviewing the application. The RE committee met on 8 July but I am told that the application is "still at the final stage of the ethics procedure" and that I will be sent the URL as soon as the research protocol and other information is available on the University's website.

Dr Crawley had assured the FOI office that the research protocol would be published by the end of August - this hasn't happened. Whether this is due to a further delay by the ethics committee in reaching a decision or whether approval has now been obtained but the information hasn't been prepared yet for publication on the website, remains unclear.

However, there is no mechanism for putting material in front of an ethics committee and, apparently, no process through which a decision can be challenged by the public - and as I say, the committee met in July and a decision might be expected to have been handed down by now, or going through the final stage of the process (see Application Flowchart document: http://meagenda.files.wordpress.com/2010/08/apply_flowchart1.pdf )

So, until I've further discussed this with my MP, it's a little difficult to know how best we might proceed. I imagine (but this is unconfirmed) that we are likely to know within the next couple of weeks the outcome of the RE committee's deliberations and should also have more information on the study design itself.

But however this study is to be carried out I want to see it halted.

Suzy

 

[Dx Revision Watch]

For the record, two references to the Lightning Process pilot study in the summary of key points to emerge from two routine meetings of The ME Association Board of Trustees. These meetings took place at the MEA's Head Office in Buckingham on Monday, September 6 and on Tuesday, September 7 2010. This is a summary of the Board meetings - not the official minutes:


http://www.meassociation.org.uk/ind...ld-in-september-2010&catid=30:news&Itemid=161

Friday, 10 September 2010 23:59

[...]

PARLIAMENTARY MATTERS

APPG CS updated trustees on events that had taken place to set up a new APPG on ME following the General Election. This involved finding a new Chairman because Dr Des Turner had retired at the election, as well as finding a small group of other parliamentarians willing to take up the post of Treasurer, Secretary etc.

An inaugural meeting was held on 8 July - shortly before Parliament broke up for the long summer holidays. Those present agreed that David Amess MP would take on the role of Chairman. Other officers elected: Annette Brooke MP (Vice Chair); John Leech MP (Secretary) and Martin Vickers MP (Treasurer). A copy of the Minutes for this meeting can be found in July ME Essential magazine and on the MEA website. The current list of members of the new APPG can be found here.

A planning meeting was proposed for September but no date has yet been fixed.

Further details of the agenda, time, venue for the next full APPG will appear on the MEA website as soon as they become available. It is advisable to check with the MEA website the day before APPG meetings in case any late changes are made.

Neil Riley, Chairman of the MEA, wrote to Dr Des Turner to express our thanks for chairing the APPG and wishing him a happy retirement from Westminster.

The August MEA website poll asked people what they felt was the most important topic for the new APPG on ME to take on. Votes were as follows:

XMRV: 913
Benefits: 442
Medical Education: 274
MRC research: 100
NHS Services: 78
NICE guideline review: 74
Severely affected: 47
Children: 15
None: 7

These results have now been forwarded to David Amess, along with a summary of recent developments relating to benefits, research, NICE guidelines, Lightning Process research etc.

[...]

Lightning Process Trustees held a further discussion on a new research study that has been announced into the use of the Lightning Process. Costing 164,000, the feasibility study will investigate how children and adolescents could be involved in a randomised controlled trial that will assess the Lightning Process and compare it to specialist medical care. Not surprisingly, a number of concerns have been raised about the possible use of children and adolescents in this type of study and we are discussing this with our colleagues in other ME/CFS charities. As a result of these discussion the MEA and the Young ME Sufferers Trust (Tymes Trust) issued a joint statement of concern, which can be found here.

This was sent to the Department of Health with a request that it should be forwarded to the ethics committee that is dealing with the application. The DoH have refused to do so - a decision which we believe is unacceptable.

[...]

 

[Yawn]

Hi Suzy,

Many thanks for the info. I think what you are doing is just fantastic - so much work. But appreciated so much by all of us with children with ME/CFS.

Do we know how they are going to select the children if the study goes ahead? I am tempted to write and ask if it is possible to be included in the study - not to go ahead but just to see what sort of info they are going to give families beforehand and how they are going to oversee the "treatments" given?

 

[Dx Revision Watch]

PDFs of documents have been forwarded to Neil Riley (MEA) and Jane Colby (The Young ME Sufferers Trust):


http://www.dh.gov.uk/prod_consum_dh...@dh/@en/documents/digitalasset/dh_4058609.pdf

Governance arrangements for NHS Research Ethics Committees

Document type: Publication
Author: Department of Health
Published date: 3 August 2001
Primary audience: Professionals
Gateway reference: 2001
Pages: 34

This document provides a standards framework for the process of review of the ethics of all proposals for research in the NHS and Social Care which is efficient, effective and timely, and which will command public confidence. It sets out general standards and principles for an accountable system of Research Ethics Committees, working collaboratively to common high standards of review and operating process throughout the NHS. It should be read in conjunction with the Research Governance Framework for Health and Social Care.

---------------

http://www.dh.gov.uk/prod_consum_dh...@dh/@en/documents/digitalasset/dh_4122427.pdf

Research governance framework for health and social care: Second edition

Document type: Publication
Author: Department of Health
Published date: 24 April 2005
Primary audience: Professionals
Publication format: Electronic only
Gateway reference: 4747
Pages: 55
Supersedes/replaces:
Copyright holder: Crown

The Research Governance Framework for Health and Social Care (RGFHSC) sets out the broad principle of good research governance. The RGFHSC Annex is available separately.

Annex

http://www.dh.gov.uk/prod_consum_dh.../@dh/@en/documents/digitalasset/dh_088288.pdf

---------------

http://www.dh.gov.uk/prod_consum_dh.../@dh/@en/documents/digitalasset/dh_091186.pdf

Research governance in health and social care: NHS permission for research and development involving NHS patients (second edition)


Document type: Guidance
Author: Department of Health
Published date: 27 November 2008
Publication format: A4 electronic only
Gateway reference: 10923
Pages: 14
Supersedes/replaces:
Copyright holder: Crown

This document clarifies what primary care trusts need to consider before granting permission for research that involves NHS patients.

For research under the Clinical Trials Regulations, the NHS decision to give permission should normally be a formality, provided sponsors confirm who is authorised to act on their behalf, supply evidence that the project has received the favourable opinion of a research ethics committee, authorisation by the MHRA and independent expert review, and give details of provisions to cover any liabilities.

 

[Dx Revision Watch]

Hi Suzy,

Many thanks for the info. I think what you are doing is just fantastic - so much work. But appreciated so much by all of us with children with ME/CFS.

Do we know how they are going to select the children if the study goes ahead? I am tempted to write and ask if it is possible to be included in the study - not to go ahead but just to see what sort of info they are going to give families beforehand and how they are going to oversee the "treatments" given?

Hi Yawn,

Virtually all information about the design, methods, interventions, criteria, recruitment etc is being withheld under Clause 22(1)(a) of the FOI Act.

To virtually all questions I raised under FOI, the response was:

This information is intended for future publication when the study protocol and other related documents are published online. It is therefore exempt from disclosure under section 22(1)(a) of the Freedom of Information Act.

The study is currently going through the ethics approval procedure and this information is expected to be published around August / September 2010. We cannot see that there is any public interest in disclosing this information before that time.

Dr Crawley had told the U of Bristol office that the research protocol and other information about the pilot would be published on the University website by the end of August - this didn't happen.

But when the research protocol is published, this may include patient information sheets and consent forms, in addition to the research protocol. This material is unlikely to include all the information and documents I had requested, for example, copies of the applications for funding, copies of the application and all associated materials submitted to the REC - so I shall need to re-request these.

If the patient information literature and consent forms are not published I shall re-request these.

If you open this document, you can see what I asked and what responses I received on 17 June:

http://meagenda.files.wordpress.com/2010/07/foi-lightning-study-chapman-17-06-10.pdf


In this post here, is a copy of my request for an internal review of the decision to withhold virtually all information:

Response from the Director of Legal Services, University of Bristol, to request for an internal review of their FOI responses on the Bath/Bristol Lightning Process pilot study using ME and CFS children aged 8 to 18:

http://meagenda.wordpress.com/2010/...oi-lightning-process-pilot-study-in-children/

 

[Dx Revision Watch]

Extract:

http://www.dh.gov.uk/prod_consum_dh...@dh/@en/documents/digitalasset/dh_4058609.pdf

Governance arrangements for NHS Research Ethics Committees
July 2001


Elements of the review

9.7 The primary task of an REC lies in the ethical review of research proposals and their supporting documents, with special attention given to the nature of any intervention and its safety for participants, to the informed consent process, documentation, and to the suitability and feasibility of the protocol.

9.8 The Research Governance Framework makes it clear that the sponsor is responsible for ensuring the quality of the science. Paragraphs 2.3.1 and 2.3.2 state that:

“It is essential that existing sources of evidence, especially systematic reviews, are considered carefully prior to undertaking research. Research which duplicates other work unnecessarily or which is not of sufficient quality to contribute something useful to existing knowledge is in itself unethical.

All proposals for health and social care research must be subjected to review by experts in the relevant fields able to offer independent advice on

24

its quality. Arrangements for peer review must be commensurate with the scale of the research.”

9.9 Thus, protocols submitted for ethical review should already have had prior critique by experts in the relevant research methodology, who should also comment on the originality of the research. It is not the task of an REC to undertake additional scientific review, nor is it constituted to do so, but it should satisfy itself that the review already undertaken is adequate for the nature of the proposal under consideration.

9.10 If the committee is of the opinion that the prior scientific review commensurate with the scale of the research is not adequate (including adequate statistical analysis), it should require the applicant to re-submit the application having obtained further expert review.

9.11 In addition to considering prior scientific review, RECs need to take into account the potential relevance of applicable laws and regulations. It is not the role of the REC to offer a legal opinion, but it may advise the applicant and the host NHS body whenever it is of the opinion that further expert legal advice might be helpful to them.

Requirements for a favourable opinion

9.12 Before giving a favourable opinion, the REC should be adequately reassured about the following issues, as applicable:

9.13 Scientific design and conduct of the study:

a. the appropriateness of the study design in relation to the objectives of the study, the statistical methodology (including sample size calculation where appropriate), and the potential for reaching sound conclusions with the smallest number of research participants

b. the justification of predictable risks and inconveniences weighed against the anticipated benefits for the research participants, other present and future patients, and the concerned communities

c. the justification for use of control arms in trials, (whether placebo or active comparator), and the randomisation process to be used

d. criteria for prematurely withdrawing research participants

e. criteria for suspending or terminating the research as a whole

f. the adequacy of provisions made for monitoring and auditing the conduct of the research, including the constitution of a data safety monitoring committee (DSMC)

g. the adequacy of the research site, including the supporting staff, available facilities, and emergency procedures. For multi-centre research, these

25

locality issues will be considered separately from the ethical review of the research proposal itself

h. the manner in which the results of the research will be reported and published.

9.14 Recruitment of research participants

a. the characteristics of the population from which the research participants will be drawn (including gender, age, literacy, culture, economic status and ethnicity) and the justification for any decisions made in this respect

b. the means by which initial contact and recruitment is to be conducted

c. the means by which full information is to be conveyed to potential research participants or their representatives

d. inclusion criteria for research participants

e. exclusion criteria for research participants.

9.15 Care and protection of research participants

a. the safety of any intervention to be used in the proposed research

b. the suitability of the investigator(s)’s qualifications and experience for ensuring good conduct of the proposed study

c. any plans to withdraw or withhold standard therapies or clinical management protocols for the purpose of the research, and the justification for such action

d. the health and social care to be provided to research participants during and after the course of the research

e. the adequacy of health and social supervision and psychosocial support for the research participants

f. steps to be taken if research participants voluntarily withdraw during the course of the research

g. the criteria for extended access to, the emergency use of, and/or the compassionate use of study products

h. the arrangements, if appropriate, for informing the research participant’s general practitioner, including procedures for seeking the participant’s consent to do so

i. a description of any plans to make the study product available to the research participants following the research

26

j. a description of any financial costs to research participants

k. the rewards and compensations (if any) for research participants (including money, services and/or gifts)

l. whether there is provision in proportion to the risk for compensation/treatment in the case of injury/disability/death of a research participant attributable to participation in the research; the insurance and indemnity arrangements

m. the nature and size of any grants, payments or other reward to be made to any researchers or research hosts

n. circumstances that might be lead to conflicts of interest that may affect the independent judgement of the researcher(s).

9.16 Protection of research participants’ confidentiality

a. a description of the persons who will have access to personal data of the research participants, including medical records and biological samples

b. the measures taken to ensure the confidentiality and security of personal information concerning research participants

c. the extent to which the information will be anonymised

d. how the data/samples will be obtained, and the purposes for which they will be used

e. how long the data/samples will be kept

f. to which countries, if any, the data/samples will be sent

g. the adequacy of the process for obtaining consent for the above.

9.17 Informed consent process

a. a full description of the process for obtaining informed consent, including the identification of those responsible for obtaining consent, the time-frame in which it will occur, and the process for ensuring consent has not been withdrawn

b. the adequacy, completeness and understandability of written and oral information to be given to the research participants, and, when appropriate, their legally acceptable representatives

c. clear justification for the intention to include in the research individuals who cannot consent, and a full account of the arrangements for obtaining consent or authorization for the participation of such individuals

27

d. assurances that research participants will receive information that becomes available during the course of the research relevant to their participation (including their rights, safety and well-being)

e. the provisions made for receiving and responding to queries and complaints from research participants or their representatives during the course of a research project.

9.18 Community considerations

a. the impact and relevance of the research on the local community and on the concerned communities from which the research participants are drawn

b. the steps which had been taken to consult with the concerned communities during the course of designing the research

c. the extent to which the research contributes to capacity building, such as the enhancement of local healthcare, research, and the ability to respond to public health needs

d. a description of the availability and affordability of any successful study product to the concerned communities following the research

e. the manner in which the results of the research will be made available to the research participants and the concerned communities.

Expedited review

9.19 RECs shall establish any procedures necessary for the expedited review of research proposals. (See Section B). These procedures, which should be described in full in the Standard Operating Procedures, should specify the following:

a. the nature of the applications, amendments, and other considerations that will be eligible for expedited review

b. the quorum requirements for expedited review

c. the status of decisions (e.g. whether requiring confirmation by the full REC or not)

 

[Dx Revision Watch]

Unethical Lightning Process pilot study in children receives ethics approval

“Unethical” Lightning Process pilot study in children receives ethics approval

Shortlink: http://wp.me/p5foE-36W

Update on the Dr Esther Crawley led Royal National Hospital for Rheumatic Diseases (RNHRD) NHS FT, Bath/University of Bristol Lightning Process pilot study for children aged 8 to 18 [1].

For background to this pilot study 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


“Unethical”

A pilot study on the controversial Lightning Process using children as young as eight [Ed: now raised to 12] has received the go ahead from a South West Region Research Ethics Committee (REC), despite widespread public concern and condemnation by two UK national patient organisations.

In August, ME patient charities, The ME Association and The Young ME Sufferers Trust, issued a joint press release describing the study as “unethical” and calling for it to be abandoned [2].

The organisations said:

“We are issuing this joint statement due to widespread public concern, together with our own serious reservations, about a forthcoming study of the psychologically-based Lightning Process on children.

“The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged eight to 18 with ME/CFS into a randomised controlled trial (RCT) comparing the Lightning Process with specialist medical care.

“It is planned that over 90 children aged between eight and eighteen and their families will be involved in the study.

“The Medical Research Council (MRC) produces specific guidelines for research involving vulnerable patient groups [3].

“The document ‘MRC Medical Research Involving Children’ is quite clear on this issue. It poses the question: ‘Does the research need to be carried out with children?’ In answer, the MRC states: ‘Research involving children should only be carried out if it cannot feasibly be carried out on adults.’

“The ME Association and The Young ME Sufferers Trust do not believe that it is ethically right to use children in trialling an unproven and controversial process such as the Lightning Process…

“…We cannot approve of a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated ‘process’ with adults.”​

Today, information received from University of Bristol Information Rights Officer, Matthew Morrison, confirms that the pilot study has now been granted ethics approval. Recruitment to the study, which is being funded by the Linbury Trust and the Ashden Trust, was scheduled to start in September.


What has been published?

A large number of documents are published today on the University of Bristol website.

Information on accessing the research protocol and other published material can be found in the next post.

SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)

Shortlink: http://wp.me/p5foE-37x



Advertising Standards Authority (ASA) ruling

In June, ME agenda reported that Alastair Gibson, who had previously identified himself as one of two Lightning Process coaches involved with the NHS study, was the subject of an Advertising Standards Authority (ASA) ruling [10].

The ASA upheld a complaint about unsubstantiated claims made for the efficacy of the Lightning Process in ME and CFS in an advertisement for Mr Gibson’s “Withinspiration” company.

At least one Lightning Process company has made changes to the wording on its website following the ME Association’s discussions with Trading Standards.

Currently, the ASA’s remit does not extend to website content but from May 2011, the ASA will broaden its remit and will be able to consider complaints about:

• Advertisers’ own marketing communications on their own websites and;

• Marketing communications in other non-paid-for space under their control, such as social networking sites like Facebook and Twitter.​

On 1 September, the Advertising Standards Authority issued a news release setting out its extended remit:

Landmark agreement extends ASA’s digital remit (Lightning Process pilot study in children)



Department of Health responses

Concerns about the pilot study have been taken up with Earl Howe (Parliamentary Under-Secretary of State for Quality). Earl Howe is a Patron to The Young ME Sufferers Trust. An unsatisfactory response was received from Bill Davidson, Research Governance Manager, Department of Health, on 30 August, who responded on behalf of Earl Howe.

In July, Annette Brooke, MP, Mid Dorset & North Poole forwarded my concerns and documents to the Rt Hon Andrew Lansley MP, Secretary of State for Health, Department of Health. Paul Burstow MP, Minister of State for Care Services, responded briefly on behalf of the Secretary of State for Health, on 12 August.

Mrs Brooke is Vice-chair of the newly reformed APPG on ME (Acting chair, David Amiss, MP).

The ME Association had also written to the Department of Health requesting that their joint press release be forwarded to the ethics committee reviewing the application. The DoH refused to do so – a decision which the ME Association considered unacceptable.

The name of the South West Research Ethics Committee, which had met to review the application on 8 July, was identified on 27 August in a response to my request for information under the Freedom of Information Act. The contact details for this regional RE committee chair have been passed to the ME Association.

The South West Regional Manager for the National Research Ethics Service (NRES) confirmed to me, in May, that there is apparently no process through which REC decisions might be challenged by the public.



References:

[1] Press Release, University of Bristol, 2 March 2010

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

[3] MRC Guidelines Medical Research Involving Children (Nov 2004, revised Aug 2007)

[4] Request for information under FOI and FOI Office responses

[5] Action for M.E. article on Lightning Process, InterAction magazine, March 2007

[6] Patient Survey 2008, Action for M.E. and AYME

Patient Survey May 2010, ME Association

[7] LP Doesn’t Work for ME: Personal accounts from LP “trainees”

Letter: Lightning process for ME didn’t work for me

Personal account of Lightning Process technique as applied to patient with ME

Personal account of Lightning Process as applied to patients with ME and MS

[8] Sample Lightning Process application form

[9] ASA adjudication against “Withinspiration”

[10] RNHRD Bath Chronic Fatigue Syndrome/ME Service for Children & Young People

[11] Lightning Process website

 

[Dx Revision Watch]

SMILE Specialist Medical Intervention and Lightning Evaluation documents

Please note that I only received this material this afternoon and have not yet had time to go through any of the material published.


SMILE Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study children [now aged 12 to 18] with CFS and ME)

Shortlink: http://wp.me/p5foE-37x

See also previous ME agenda post:

Unethical Lightning Process pilot study in children receives ethics approval: http://wp.me/p5foE-36W


University of Bristol website

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html

SMILE Specialist Medical Intervention and Lightning Evaluation

What is SMILE?

SMILE is a feasibility study to see whether it is possible to recruit young people into a study to compare specialist medical treatment with specialist medical treatment plus the Lightning Process for young people with chronic fatigue syndrome or ME (CFS/ME).

The study will also look at how we should measure outcomes and the health economic impact on the families of young people with CFS/ME.

Young people will be observed completing the questionnaires that we use to look at how unwell they are before they see us and what happens to them after an intervention. We will also talk to young people and their parents to understand what they think about the questionnaires and to determine the most acceptable and sensitive ones to use. This study is the first to work out which questionnaires we should be using to understand outcome in paediatric CFS/ME.

Frequently Asked Questions

Why is research in children needed?

Over 250 children a year already attend Lightning Process training. It is important that people know whether it is safe and effective or not. We need high quality research to answer these questions. If SMILE can recruit enough people to participate in the study then further research could look at whether it is helpful or not.

Should research be done in children before adults?

Children have the right to research particularly in illnesses which are different to adults. CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children.

How will the safety of those involved in SMILE be monitored?

The safety and wellbeing of people involved in any research project, not just the SMILE project, is of the utmost importance. There is an Independent Advisory Group to oversee, and monitor this research. All participants will be carefully monitored and regularly reviewed in the specialist CFS/ME service. Young people taking part can opt out of the trial at any point.

How can we take part in the study?

Young people are eligible if they are between 12 and 18 years of age, have CFS/ME and are from the region covered by the Bath/Bristol specialist CFS/ME service. Young people are recruited at assessment so you will not be eligible if you have already been seen by the service.

What ethical review has SMILE received?

The study has been scrutinised by the South West 2 Research Ethics Committee whose role it is to ensure that research is safe and ethically sound. The ethics committee have looked in detail at the study design, and all associated documentation and suggested improvements to the readability and accessibility of the patient information leaflets and consent forms which have been adopted.

The SMILE study is compliant with Good Clinical Practice Guidelines, Research Governance Framework, Medical Research Council guidelines, Royal College of Paediatrics and Child Health guidelines for the conduct of trials and has been approved by an ethics committee.

Further information about this research project can be found in the following documents:

Smile Study Documents

Note: some of the documents on this page are in PDF format. In order to view a PDF you will need Adobe Acrobat Reader

SMILE Information sheet for teenagers August 2010 [pdf (150kb)]

http://www.bristol.ac.uk/ccah/resea...e/smilestudydocuments/infoshtteensv4aug10.pdf

SMILE Information sheet for parents September 2010 [pdf (147kb)]

http://www.bristol.ac.uk/ccah/resea.../smilestudydocuments/infoshtprntsv7sept10.pdf

SMILE Protocol Final July 2010 [pdf (170kb)]

http://www.bristol.ac.uk/ccah/resea...fatigue/smilestudydocuments/smprotv6final.pdf

SMILE Under 16 assent to contact July 2010 [pdf (109kb)

http://www.bristol.ac.uk/ccah/resea...tigue/smilestudydocuments/u16asscv4july10.pdf

SMILE 16 to 18 consent to contact July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/resea.../smilestudydocuments/16to18confinaljuly10.pdf

SMILE Parental consent to contact 10 May 2010 [pdf (111kb)]

http://www.bristol.ac.uk/ccah/resea...igue/smilestudydocuments/parconsv310may10.pdf

SMILE Under 16 assent to study July 2010 [pdf (112kb)]

http://www.bristol.ac.uk/ccah/resea...atigue/smilestudydocuments/u16assv4july10.pdf

SMILE 16 to 18 consent to study July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/resea...milestudydocuments/16to18constjuly10final.pdf

SMILE Parental consent to study 10 May 2010 [pdf (113kb)]

http://www.bristol.ac.uk/ccah/resea...gue/smilestudydocuments/parconssv310may10.pdf

SMILE teenager consent/assent to teenager interview August 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/resea...tigue/smilestudydocuments/tcontinvv5aug10.pdf

SMILE Parental consent to child interview 10 May 2010 [pdf (111kb)]

http://www.bristol.ac.uk/ccah/resea...gue/smilestudydocuments/parconcinv10may10.pdf

SMILE Parental consent to parental interview 10 May 2010 [pdf (109kb)]

http://www.bristol.ac.uk/ccah/resea...ue/smilestudydocuments/parconinvv310may10.pdf

SMILE Consent to record intervention for participants, parents and those delivering interventions July 2010 [pdf (110kb)]

http://www.bristol.ac.uk/ccah/resea.../smilestudydocuments/conrecintjuly10final.pdf

SMILE Lightning process assessment form July 2010 [pdf (159kb)]

http://www.bristol.ac.uk/ccah/resea...ue/smilestudydocuments/lipcassfrmv2july10.pdf

SMILE letter to GP 10 May 2010 [pdf (49kb)]

http://www.bristol.ac.uk/ccah/resea...atigue/smilestudydocuments/letgpv110may10.pdf

SMILE WPAI [pdf (135kb)]

http://www.bristol.ac.uk/ccah/resea.../chronic-fatigue/smilestudydocuments/wpai.pdf

SMILE Health resource use questionnaire 10 May 2010 [pdf (232kb)]

http://www.bristol.ac.uk/ccah/resea...fatigue/smilestudydocuments/healthresuseq.pdf

SMILE SF-36 [pdf (165kb)]

http://www.bristol.ac.uk/ccah/resea...nic-fatigue/smilestudydocuments/smilesf36.pdf

SMILE Interview topic guide 10 May 10 [pdf (178kb)]

http://www.bristol.ac.uk/ccah/resea...tigue/smilestudydocuments/topgdev210may10.pdf



Correspondence with Ethics Documents

Initial covering letter to NREC 20th May 2010 [pdf (75kb)]

http://www.bristol.ac.uk/ccah/resea...ue/correspondencewithethics/covlet20may10.pdf

NREC Letter 14th June 2010 [pdf (108kb)]

http://www.bristol.ac.uk/ccah/resea...fatigue/correspondencewithethics/let14jun.pdf

NREC Letter 19th July 2010 [pdf (272kb)]

http://www.bristol.ac.uk/ccah/resea...atigue/correspondencewithethics/let19july.pdf

Covering letter in reply to NREC 28th July 2010 [pdf (159kb)]

http://www.bristol.ac.uk/ccah/resea...gue/correspondencewithethics/letrep28july.pdf

NREC Letter 13th August 2010 [pdf (72kb)]

http://www.bristol.ac.uk/ccah/resea...fatigue/correspondencewithethics/let13aug.pdf

Letter re meeting notes in reply to NREC 19th August 2010 [pdf (45kb)]

http://www.bristol.ac.uk/ccah/resea...gue/correspondencewithethics/letmetn19aug.pdf

Second covering letter reply to NREC 20th August 2010 [pdf (109kb)]

http://www.bristol.ac.uk/ccah/resea...ue/correspondencewithethics/seclet20aug10.pdf

Letter in reply to NREC 13th September 2010 [pdf ( 80kb)]

http://www.bristol.ac.uk/ccah/resea...fatigue/correspondencewithethics/let13sep.pdf

NREC Approval letter 14th September 2010 [pdf (213kb)]

http://www.bristol.ac.uk/ccah/resea...ue/correspondencewithethics/applet14sep10.pdf

REC Form [pdf (353kb)]

http://www.bristol.ac.uk/ccah/resea...atigue/correspondencewithethics/recfrmrfs.pdf

 

[Mithriel]

How will the safety of those involved in SMILE be monitored?

The safety and wellbeing of people involved in any research project, not just the SMILE project, is of the utmost importance. There is an Independent Advisory Group to oversee, and monitor this research. All participants will be carefully monitored and regularly reviewed in the specialist CFS/ME service. Young people taking part can opt out of the trial at any point.

And how much faith can we put in that when anything goes for these people?

This is monstrous.

Mithriel

 

[Dx Revision Watch]

SMILE Protocol Flow Chart

Source: SMILE Protocol Final July 2010 [pdf (170kb)]


http://www.bristol.ac.uk/ccah/resea...fatigue/smilestudydocuments/smprotv6final.pdf

 

[Yawn]

"Should research be done in children before adults?

Children have the right to research particularly in illnesses which are different to adults. CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children."

Is this the sole reason for being able to undertake the study on children??? I am confused in how the ilness of ME/CFS is different in children to adults?

As a sufferer myself and having a child with CFs the patterns seem very similar to me!

Some adults seem to improve and make good recoveries, so do some children - others both adults and children do not??

I would really like a professional to clarify how the illness differs in children.

 

[kettles]

I've also just noticed a major misrepresentation in Willow's assertion (I'm presuming Frances you've accurately reflected her comments here?):

"Mary-Jane would also oppose the research if these were the case, but at the moment, she does not see grounds to doubt the good faith of the research team."

This implies that any ethical objection to this trial is an accusatory calling of bad faith on the research team - an attack on their integrity! Of course, nothing of the sort has gone on, but Willows comment nevertheless constructs objections as such.

Speaking of the 'small hostile section of the community' meme - this also emerged in Gibson, didn't it? It was in relation to Simon Wessely's claims, and I think a more general comment? The same sort of language. Is this recurring theme a viral, unreflective use of banal and asinine soundbites? Or something more strategic?

Hi Angela,

Yes, it is almost the same as the original sentence. I have not changed any key words or phrases.

Best wishes,

Frances

 

[kettles]

Hi kettles,
A big welcome to the forums to you...

Hi Bob,

Thanks for your welcome , and thanks also for writing letters about this to AYME and others.

I agree with everything you said about the letter from AYME. I'm putting all these points in my reply (which hasn't gone yet unfortunately - just going so slow since deterioration, such a pain!). Now that the study has ethics approval (so terrible), I think I can say even more. Well done on the explanation you are writing too, I shall look forward to reading it - and am with you about the foggyness!

Best wishes,
Frances

 

[kettles]

Action for M.E.

20 August 2010

Facebook Wall

Action for M.E. is very concerned that the Lightning Process is being given to children in the UK without having been formally evaluated for effectiveness and safety.

Although the MRC ethics guide says that research involving children shoul...d only be carried out if it cannot feasibly be carried out on adults, there are exceptions eg. studies which aim to increase understanding of child health or shed light on a disease, its natural history and possibilities of prevention.

Before any research is approved, an ethics committee scrutinises the proposals to ensure that the rules about research involving children are satisfied. The committee also ensures that proper safety systems are in place and include safety monitoring by an independent committee.

As long as the ethics committee gives its approval, the charity supports proposals to investigate whether it is possible to set up a controlled trial to look at the Lightning Process and how it compares with current treatments for M.E./CFS in children.

Dr Esther Crawley is a Consultant Paediatrician specialising in CFS/M.E. and a leading researcher in the field. Together with Dr Margaret May and Dr Alan Emond, Dr Crawley has recently published new research on phenotypes of CFS/M.E. in children in the journal Archives of Disease in Childhood.

They showed that there appear to be three different phenotypes: musculoskeletal (the main symptoms being muscle and joint pain), migraine and sore throat. None of the phenotypes were associated with age or length of illness suggesting that they did not merely reflect deconditioning. The lack of association with symptoms of depression or anxiety (with the exception of the migraine phenotype) also suggests that they are unlikely to reflect mood disorders.

I know this is a terribly late post, sorry, I haven't been able to finish it 'til now.


Although the MRC guidelines are useful, it should be noted that as this study is not MRC funded, the GMC and RCPCH guidelines should also be taken into account, as these are universal guidelines; the GMC and RCPCH guidelines both state that research should not be carried out on children if it can be feasibly carried out on adults, and they do not give the same exceptions that the MRC guidelines do .

--------------------------

The GMC guidelines (0-18 years guidance: Research) state:

"37. Children or young people should be involved in research only when research on adults cannot provide the same benefits. They can be involved in research that has either:

a. potential benefits for children or young people generally, as long as the research does not go against their best interests or involves only minimal or low risk of harm (this would be research that involves, for example, asking questions or taking blood samples, the assessment of the risk depending on the view of the child or young person), or

b. potential therapeutic benefits for them that outweigh any foreseeable risks, which should be kept as low as possible."

-------------------------

The RCPCH guidelines (Guidelines for the ethical conduct of medical research involving children) state:

"Research with children should be undertaken only if work with adults is clearly not feasible"

-------------------------

Perhaps AFME should also acquaint themselves with the GMC and RCPCH guidelines.

 

[fred]

From the XMRV Press Releases page on Facebook.

A template letter for challenging the trial protocol document and also email addresses to use, viz:

Bath Min Hospital (where Dr Esther Crawley works)
Press Officer emma.mooney@rnhrd.nhs.uk
FAO Peter Franklyn, Chairman of Bath Min Hospital

University of Bristol Centre for Child and Adolescent Health (which is supporting the trial)

Director of the Centre: Professor Alan Emond
alan.emond@bristol.ac.uk

Deputy Director: Professor Elizabeth Towner
cdemlt@bristol.ac.uk

Ashden Trust and Linbury Trust (which are providing the 164k funding)
Sainsburys Family Trust Executive: Jo.Temple@sfct.org.uk

MPs sitting on the All Parliamentary Group on ME (27 addresses provided)

http://www.facebook.com/topic.php?uid=112160662164471&topic=139

 

[Wildcat]

In 2002 Phil Parker was advertising his 'Lightning' as a 'Dynamic New NLP Pattern Seminar' and as a new 'Self Coaching Strategy'.

There was NO MENTION of Lightning being a cure for the serious physical Neuro Immune Disease Mylagic Encephalomyelitis in Phil Parkers advertising for his 'Lightning Self Coaching Strategy'.


~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~


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http://health.groups.yahoo.com/group/hypnosis-hypnotherapy-UK/message/3888


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