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Lightning Process to be Evaluated in Research Study on Children

Discussion in 'General ME/CFS News' started by Jenny, Mar 4, 2010.

  1. Bob

    Bob

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    Ethics Committees


    I have come across two ethics committees which might be involved in the Lightning Process medical trial: One for the University of Bristol, and one for the Hospital. I don't know if permission was (or will be) needed from each.


    University of Bristol, Faculty of Medicine and Dentistry - Committee for Ethics

    It seems that the research is being carried out within the University of Bristol's Faculty of Medicine and Dentistry (http://www.bris.ac.uk/fmd/).
    This faculty has its own Committee of Ethics... The Faculty of Medicine and Dentistry Committee for Ethics (FMDCE). Here is its webpage, with a list of its committee members:
    http://www.bris.ac.uk/fmd/fec/

    The Faculty's Committee for Ethics' webpage links to a University webpage entitled "Research Ethics - Policy and Procedure" which outlines the university's ethical policy:
    http://www.bristol.ac.uk/red/support/governance/ethics/ethics.html

    Their ethical policy includes the following:

    The Hospital

    The press release says that research study is based at this hospital:
    Royal National Hospital for Rheumatic Diseases NHS Foundation Trust
    www.rnhrd.nhs.uk
    So they might have their own Ethics Committee.

    * The NHS 'Research Ethics Committees' (REC's)

    The NHS has an umbrella website for its 'Research Ethics Committees' (REC's)...
    The NHS National Research Ethics Service:
    http://www.nres.npsa.nhs.uk/
  2. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    Thanks for the additional information and links, Bob. The regional office I am waiting on a response from is:

    http://www.nres.npsa.nhs.uk/contacts/office-addresses/
    West Midlands, South West, South Central and South East

    which is listed on the

    NHS National Research Ethics Service site:
    http://www.nres.npsa.nhs.uk/

    The Press Release (also attached at foot of post) says:

    "The funding has been awarded to a research team led by Dr Esther Crawley, Consultant Paediatrician at the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust"

    One of the LP coaches apparently to be involved in the study is

    Alastair Gibson
    http://www.withinspiration.co.uk/index.php


    Attached Files:

  3. fred

    fred The game is afoot

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    @Suzy - do you suppose there is any substance in Tony Golding implying that ethics approval is still pending or is he being either disingenuous or simply ignorant of the facts?
  4. Bob

    Bob

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    Fred, if I understand the situation correctly... so far funding has been given only to the pilot project...
    If the main research study goes ahead, I would imagine that it will have to get separate approval... I think that's what he is referring to.
  5. fred

    fred The game is afoot

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    Can funding not come before ethics approval? And, presumably, the pilot study requires ethics approval.
  6. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    @ Fred

    Tony Golding had written:

    It wasn't clear to me whether he was referring to the planned pilot into the feasibility of conducting a trial or to any trial which might result out of the planned pilot.

    I asked:


    which TG chose not to answer (clarifying only that he posted on FB in a personal capacity). So I asked him again:


    to which he replied:

    Note that he does not say that what he had been commenting on was any trial that might result out of the planned pilot - not the pilot, per se.

    I replied:

    He's made no further comment.

    Mr Golding is/was a Trustee/Director of Action for M.E. I very much doubt that he would know what the status is regarding approval of the pilot.

    The FOI will include a request for:

    The names of the Research Ethics Committee(s) responsible for approval
    Date of approval
    Ethics Approval Code Number

    So we will have this information in three or four weeks. (The pilot is not scheduled to start until September 10.)

    My understanding is that separate approval would be required for any trial resulting out of the pilot and I would imagine that (particularly as the study involves children) the pilot would need ethics approval.

    Whether it's practice to secure funding (and announce in a Press Release that funding has been secured) while ethics approval is pending, I cannot say.

    I could contact RNHRD informally and ask what the status is, prior to compiling a complex FOI request, but I think it is preferable to keep the information altogether in the form of a formal response issued by the office that deals with requests for information under FOIA.

    There is a register for research trials, but this study does not appear to be on the register; there may be a number of reasons for this: it may not be practice to submit a pilot of this nature to the register or it may be too early for it to appear on a register.
  7. fred

    fred The game is afoot

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    Thank you, Suzy. Very clear.
  8. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    I wrote:

    I am advised by a health services researcher that it is quite normal to announce you've successfully applied for funding for a project to design a pilot or trial, which will need subsequent ethics approval before it can take place.
  9. Dolphin

    Dolphin Senior Member

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    Yes, I know this grant isn't directly associated with the fellowship but I think the fellowship means she may do less clinical hours and so has to find research projects involving children to occupy herself (a study on LP involving adults wouldn't qualify). That was the point (as well as the main point of my message was to praise the point that studies shouldn't be done on children unless they couldn't be done on adults was a very important point to highlight)
  10. Min

    Min Senior Member

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    from Invest in ME Newsletter March/April 2010




    "Lightning Process - The Falsehood of Magical Medicine

    When ME biomedical research and researchers have been starved of funding by the UK Medical Research Council it is particularly galling to hear that the charity AYME's medical advisor, Esther Crawley, is to receive 160,000 from the Linbury Trust and the Ashden Trust to look at the psycho-therapy which is the Lightning process [http://www.bristol.ac.uk/ccah/news/2010/22.htmldresthercrawley].
    Not only is this a waste of scarce resources but children aged 8-18 are to be used to perform this study. There are many stories of the damage this series of courses can do to patients - a business enterprise which is unregulated, has no valid research into the "theory" behind it which really warrants funding of it (certainly not in preference to the funding of biomedical research into ME) and for which anyone can seemingly attend a few courses and set up a business, with no medical training.

    This reminds us of a similar psychological approach to ME which that same charity discussed in a conference in 2005 - Reverse Therapy (RT) - with their then medical advisor, child psychiatrist Dr Derek Proudlove, who reported on his successful pilot study on RT. Five years on and children with ME are still ill but now we have another expensive training programme attracting the attention of another medical advisor.

    We thought to check the definition of a pyramid business - "A successful pyramid scheme combines a fake yet seemingly credible business with a simple-to-understand yet sophisticated-sounding money-making formula which is used for profit".

    Those who subscribe to organisations who market, advocate or advertise businesses under the guise of treatments for vulnerable and chronically ill people might reflect on the policy of the charity they are supporting.

    If this training programme really needs research then why not start with adults who can give informed consent - and why not test it on a well known patient group with clear biomarkers such as diabetics or MS patients to see if these patients stop "doing" diabetes or MS after three days of training. Why are ME patients always the target for therapy businesses? If there is funding available for research into ME then why not direct it to biomedical research?"
  11. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    FOI request 16.04.10

    On 16 April, I submitted a request for information under FOIA in relation to the Dr Esther Crawley led LP pilot study. I will update when I have received a response which is due for fulfilment within 20 working days of receipt. It may be necessary to submit a further response based on information provided.

    _________________________________________________

    To: info@rnhrd.nhs.uk Royal National Hospital for Rheumatic Diseases, Upper Borough Walls, Bath BA1 1RL

    Re: Request for information under the Freedom of Information Act

    Date: 16 April 2010

    Requested by: [Full contact details redacted]

    _________________________________________________

    I should be pleased if an acknowledgement of receipt of this request for information could be issued, together with any reference number assigned to this request.


    I request the following information under the Act in relation to the study:

    RNHRD NHS FT/University of Bristol:

    Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children.



    1] Principal Investigator(s):

    2] Project Collaborator(s):

    3] Collaborating Institution(s):

    4] Individuals acting in advisory capacities in relation to the application of the Phil Parker Lightning Process to

    a) inform the project research group:
    b) inform children and their parents during pilot study recruitment process or following recruitment:

    5] Individuals responsible for administering the Phil Parker Lightning Process to study participants as instructors/trainers/coaches if this forms part of the pilot study:

    [Lightning Process instructor/trainer/coach, Alastair Gibson, has already identified himself, on his website, as "one of the two practitioners working with the NHS" on this study.]

    6] Any Identification or Reference code assigned to the Project:

    7] Project's Public Title:
    Project's Scientific Title:


    Ethics Approval

    8] Has the pilot project received research ethics approval and on what date was approval granted:

    9] Any reference numbers attached to a) the application and b) approval:

    10] Research Ethics Committee(s) responsible for granting approval:

    11] If ethics approval has not yet been granted, what is the status of any application for approval and which Research Ethics Committee(s) will be responsible for approval:

    Please provide copies of applications for research ethics approval for the study, including any accompanying documentation that forms part of the application for example, questionnaires, interview protocol.


    Study

    12] Please provide copies of:

    Research purpose and rationale
    Study design
    Research aims and objectives
    Protocol document (where applicable)


    13] Through what means will potential study participants be identified and recruited:

    14] Participants - inclusion criteria (please also state which CFS/ME criteria will be used eg Oxford CFS Criteria, Fukuda CDC Criteria):

    15] Participants - exclusion criteria:

    16] Target number of participants and Age range:


    17] Please provide copies of patient information material to be provided to children and parents, including consent forms.

    If no patient information material has been prepared at this stage, by what date is it anticipated that patient information will be available:

    Are children to be provided with work books, diary/activity charts, manuals or other materials for completion/use during the study, and who will be responsible for their production and content:

    Are slide/PowerPoint presentations to be used as a) part of the recruitment process b) during the study, and who will be responsible for their production and content:


    18] Anticipated recruitment process start date:

    19] Anticipated project start date:

    20] Anticipated project completion date:


    Funding

    21] Sources of funding:

    22] Sponsor details (where applicable):

    23] Please provide copies of the funding application documents.


    24] It is understood that the Phil Parker Lightning Process is delivered commercially to adults, young people and children by "instructors/trainers/coaches" on a one-to-one basis or in a group setting, usually over a period of three consecutive days.

    It is understood that prior to acceptance into a "Seminar" or "training program", an application form is completed by or on behalf of the applicant to enable the "instructor/trainer/coach" to assess whether the applicant is "ready" to undertake the program and that in some cases, a telephone assessment is also carried out by the "instructor/trainer/coach" to further assess the applicant's "readiness" and suitability to undertake the training program.

    It is understood that the Lightning Process application form anticipates that the applicant will be prepared to sign up in agreement with certain beliefs and commitments in order to demonstrate their degree of "readiness" to undertake the sessions and their commitment to continue to practice the "training" once the sessions have been completed.

    It is understood that in order to assess suitability for the program, applicants are requested to indicate medical or mental health conditions, pre-existing conditions and past or present diagnoses as part of the application process.


    a) No rigorous controlled trials have been published on the application of the Lightning Process in adults. What data has been used in order to establish that overall the likely benefits of the research outweigh any risks to the participants?

    With reference to the document "MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)" sections 4.1 and 4.3, what is the rationale for undertaking a pilot study in children when rigorous controlled trials have yet to be undertaken and results published on the application of Lightning Process in adults?

    b) During the recruitment process, what information will be given to children and their parents/guardians about the Lightning Process and what will be expected of them throughout the study, in order that parents and children considered competent to give consent, themselves, or to assent with their parents/guardians' consent, are fully informed of likely benefits and any potential risks?

    c) If the pilot project is designed to involve some or all participants allocated to the Phil Parker Lightning Process arm of the study to receive Lightning Process training/instruction in some form, is the training program being specifically adapted for this study in children or is it to be delivered in the same format as would be delivered commercially by Phil Parker franchised trainers/coaches to children and young people?

    If the training program or instruction is being adapted specifically for the study, in what ways will it differ from that provided commercially by Phil Parker franchised trainers/coaches?

    d) Will children or their parents/guardians be expected to sign up in agreement with certain beliefs and commitments in order to demonstrate the child's "readiness" to undertake the program?

    If so, what beliefs and commitments will they be expected to sign up to and at what point in the recruitment process would agreement with beliefs and commitments be sought?

    For the purposes of the study, how will "readiness" be defined, by whom, and what tools will be used to assess or determine a child's "readiness"?

    e) If selection for and participation in the study does not involve the signing up in agreement with certain beliefs and commitments, either by the child or by their parents/guardians on their behalf, through what means are children to be assessed for suitability for and potential to benefit from the application of the Lightning Process?

    f) By what means will it be determined that undergoing the training program would not be detrimental to a child's current health status, as a patient diagnosed with CFS/ME?

    What safeguards will be put in place to avoid the potential for exacerbation of existing symptoms or the development of new symptoms whilst undertaking the sessions, in-between sessions and in the weeks and months following completion of the program?

    What support will be given to children and their families if a child were to experience exacerbation of existing symptoms or develop new symptoms as a result of participating in the program or as a result of practicing the instructions in-between sessions or in the weeks and months following completion of the program?

    g) It is understood that the Lightning Process is being marketed by some franchised "instructors/trainers/coaches" as a process that should be effective for all participants in resolving their symptoms if a) they are "ready" to undertake the process and b) they carry out the instructions properly. This might be considered to place a considerable burden of responsibility on a vulnerable research group and their families in terms of compliance and outcome.

    What consideration has been given to the issue of power imbalances where participants (or their families) may feel obliged to please or comply with the researcher's requests or with "instructor/trainer/coach" requests while the program is being delivered, and beyond, throughout the life of the project?

    By what means will it be determined that undergoing the "process" will not be detrimental to the child's psychological well-being or impact negatively on the family dynamic if the child failed to gain benefit from the program, or if the child were to experience set-back or significant relapse during or following the program, or if apparent improvement or resolution of symptoms/disability following the program were short-lived?

    What safeguards will be put in place in order to protect the child's psychological well-being?

    h) In what setting will the Lightning Process be delivered and will it be delivered in one-to-one sessions or in a group setting?

    Would a parent, family member or other individual in loco parentis be permitted to accompany a child while sessions are being delivered?

    i) How will participants who fail to complete the program (for whatever reason) be accounted for in the results and will the results include data on the various reasons for withdrawal from the study?

    j) The press release published on 02 March 2010 states that the primary outcome measure will be "school attendance after six-months".

    Are any other outcomes measures being recorded such as the child or young person's ability to complete comparable amounts of homework assignments as their peer group, ability to participate in normal family/social activities outside school hours, resume hobbies, sporting activities, requirement for rest/sleep outside school hours etc?

    k) Prior to recruitment to the study or following recruitment, will prospective participants undergo any assessment of fitness/physical functioning or other physiological assessment, or psychological assessment? Please specify.

    Will participants be re-assessed following the study and will these assessments be recorded as outcome measures?

    [Request ends]
  12. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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  13. fred

    fred The game is afoot

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    From the above:

    "J. I would also love to see objective, randomized, controlled studies of adults using the LP. These kinds of studies are, however, very expensive to perform. This is where public funding could help out and this is where a strong lobby could be helpful."

    Agreed. Controlled studies of *adults*, not children. And adults who are selected using the Canadian criteria and which represent a broad cross section of symptoms and severity, not just the ones who Mr Parker deems will 'benefit most' from his training programme. And a study which follows the patients for two years post training to understand the longevity of any effect.

    I heard two alarming stories recently: one that an LP trainer told a patient that Parker doesn't 'do' ME any more but has moved on to cancer; and that Parker states that the LP has 100% success with children. Indeed, there is one such 'Lazarus' story local to me.
  14. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    Action for M.E. InterAction magazine

    Caveat: I maintain a subscription to Action for M.E. only because as a site owner, I need to receive their magazine and newsletters in order to keep an eye on what they are up to - not because I support their policies, the way they operate or the way in which the organisation is governed.

    Yesterday I received InterAction 72 Summer 2010.

    There are four pages of readers' letters. On page 43, a third of the page has given a platform for Phil Parker "LP inventor responds to your letter".

    On the same page is a letter from Lyn White, a former NHS nurse, now a Reverse Therapist.

    Ms White's letter is headed "Why I believe in RT", and is written in response, apparently, to comments in a previous copy of InterAction (unhelpfully, no issue number has been given). The letter offers "reduced fee places for people with no household income (apart from benefits) and who are keen to give RT a go..."

    Basically, a free ad for both LP and RT.

    Elsewhere in the magazine, there are two ads for LP coaches. One on page 17 for the 3 day programme at "Swallows Retreat" in Henfield; the other, a half page ad on page 28 for LP courses in London, Bournemouth, Belfast and Southampton (with Alastair Gibson who has said on his website that he is one of two LP coaches involved with the proposed RNHRD NHS FT Bath pilot study) and with another LP coach in London, Bromley and Kent.

    I have a dental appointment this morning, but I will scan a copy of Phil Parker's letter later.

    Suzy
  15. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    AYME Link, Issue 37, May 10: First steps in researching Lightning Process

    AYME (Association of Young People with ME)

    http://www.ayme.org.uk/

    AYME Link, Issue 37, May 2010.

    First steps in researching Lightning Process

    AYME's medical advisor, Dr Esther Crawley, will lead a research team at the Royal National Hospital for Rheumatic Diseases (often called the Min) in Bath, looking into interventions and treatment options for ME. This is thanks to successful funding of 164,000 from the Linbury Trust and the Ashden Trust.

    This is an interesting piece of research as it will be looking into whether it is possible to research two different approaches which both aim to treat ME in children: Phil Parker's Lighting Process (LP) and specialist medical care - which is generally found in the specialist ME clinics.

    At this stage, Dr Crawley's team will carry out a pilot project to investigate if it is possible to recruit to a randomized, controlled trial looking at both approaches. It will only show whether a larger scale piece of research is a viable project.

    This will be the first study of its kind in this area. If successful at this stage, the team hopes to establish a basis for a larger multicentre research project.

    Dr Crawley's specialist Paediatric ME/CFS service at the Min is the largest regional paediatric service in the UK and also provides services nationally. The team currently provides assessment and treatment for over 200 children from across the UK and Western Europe each year. Approximately ten per cent of the children referred into the service are housebound and assessed at home.
    The Phil Parker Lightning Process (R) is an intervention that is used for a variety of conditions including ME/CFS and has been developed from osteopathy, coaching and neuro-linguistic programming. It is a three-day training programme run by registered practitioners* and designed to teach individuals a new set of techniques for improving life and health.


    The research study will begin in September 2010 and will involve in-depth interviews with the patients and their parents, with the primary outcome measure being school attendance after six-months. It is hoped that over 90 children and their families will be involved in the study. They will be recruited after assessment by the specialist team at the Min.

    If the full research goes ahead Lightening [sic] Process will be under scrutiny for the first time, meaning that what happens during the process can be studied and evaluated and compared to other sorts of ME treatment. The study is only a small percentage of the total grant funding raised this year by the Bath/Bristol team for ME/CFS research and is being done because young people and adults asked for it to be done.

    Research is also being done on aetiology. The team have also just put in for a huge grant to look at genetics.

    Dr Crawley told CHEERS: "There is so much research in lots of different areas. Research on treatment is important. At the moment, we are not comparing treatments but seeing if we can recruit into a trial to see if we could investigate treatments in the future.

    "Lots of people are using LP. It's important to know whether it is helping or not. It is also important to know if there are significant side effects."

    Dr Crawley added: "As well as all of this, we will also use this study to start looking at which outcomes are the best for children. At the moment, no research has looked at those and it is important to find out from young people how best to measure outcome."

    ----------

    *Ed: Registered with and licenced by Phil Parker's company. Unregulated.
  16. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    AfME InterAction Readers write: [Phil Parker] LP inventor responds to your letters

    Transcribed via OCR: some errors and omissions may remain.

    Action for M.E. magazine InterAction 72 Summer 2010 Page 43

    Letters
    Readers write

    LP inventor responds to your letters


    We believe that M.E. is a physical illness and our approach is based on the Ramsey definition of 'a multi system disease' and on the understanding that the body and mind are interrelated and interact with each other. Since its development 10 years ago, the Lightning Process has helped thousands of people reclaim their lives and health. Although often misunderstood as a treatment or therapy, the Lightning Process is a training programme and therefore does not suit everyone.

    The Lightning Process is a journey which starts with an assessment and preparation prior to the 3 day seminar. Following the training there are support structures including follow up coaching and 'Building Your Future' seminars designed to ensure they continue to benefit from the Process.

    Only practitioners on the Lightning Process Register can deliver the Process and we have over 100 practitioners, between them working in 14 countries including consultants, doctors and physiotherapists. All Registered Practitioners are trained by me to ensure they have the necessary skills to deliver the Lightning Process. Only once they have completed all the courses and passed stringent written and practical exams are they included on the Register. Practitioners are then required to maintain their skills with supervision, continuing professional development and to abide by our strict codes of conduct.

    The Lightning Process is continuously evolving to incorporate the latest findings within the fields of personal development and medical theories, and to meet client expectations from feedback received. We are currently involved in the design of Randomised Controlled Trials working with renowned researchers from both medical and academic fields as we are committed to evidence based research.

    Phil Parker
    Lightning Process


    On the same page of the "Readers write" section

    Action for M.E. magazine InterAction 72 Summer 2010 Page 43

    Why I believe in RT

    As a Reverse Therapist. I would like to respond to comments made in a previous InterAction. I believe M.E. is a physical condition, caused by an alarm response in the hypothalamus, leading to neurological and hormonal changes in the body. People with neurological, hormonal and gastrointestinal symptoms, as well as fatigue, recover with Reverse Therapy (RT); testimonials are available. Participation in clinical trials would be welcome. I worked in the NHS as an RGN and RSCN until I lost my job through M.E. After recovery I trained with Dr Eaton, the founder of RT. I attend regular training events and conferences to update my skills, and I have a clinical supervisor. There are at least three medically trained doctors working as Reverse Therapists.

    I have reduced fee places for people with no household income (apart from benefits) and who are keen to give RT a go. I am motivated by a genuine desire to teach people the skills they need to get and stay well so they can get on with their lives. I understand that people with M.E. can be fed up and frustrated because of the illness and the way they have been treated. I believe that RT does offer real hope of recovery - or I wouldn't do it.

    Lyn White
    lynwhite@reverse-therapy.com
    07942 044 800
  17. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    Dr Crawley told CHEERS:
    But they plan to undertake a pilot study on a vulnerable patient group with a view to a larger trial on a vulnerable patient group when no rigorous controlled trials into the safety and efficacy of the application of LP in adults have been undertaken!
  18. oerganix

    oerganix Senior Member

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    I wonder whether a "scientific" study such as this can take into consideration the significant side effect of having a "trainee" be required to say the opposite of what they feel, if they feel bad, terrible, misable, sick, exhausted, in pain, etc. Permitting not a whisper of negative outcomes from the mouths of these children cannot be healthy. For the children's sake, I sure hope they select only the least sick, those less likely to be damaged by overdoing.

    The press release says:
    "At this stage, Dr Crawley's team will carry out a pilot project to investigate if it is possible to recruit to a randomized, controlled trial looking at both approaches. " (Refers to patients from "ME clinics" getting "specialist medical care" and those to be enrolled in the LP "training".)

    I thought at first glance that those ME clinic kids were to be the controls, but looking more closely, I'm not sure that's what she said. Just what does "a randomized, controlled trial looking at both approaches" actually mean?

    To be randomized and controlled, there would have to be a group of ME kids who aren't getting either "treatment" or "training", right? Are they going to have 3 groups then? One for LP, one from the ME clinics and one not receiving any treatment or training? With LP "trainers" getting to cherry-pick their participants because we all know the "trainee" has to have her/his mind right and be malleable in order to be accepted into the "training" in the first place; with the ME clinic patients being drawn from a pool of patients where the diagnosis excludes most physical symptoms and includes a host of mental ones; and a third group...defined how? Oxford criteria?
  19. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    The only information about the pilot study currently in the public domain is in the press release.

    Until we have responses from the FOI request, we do not have any other details about the study design, what criteria will be used, patient selection methods, how the allocation to the various arms of the study will be carried out - this is covered within the FOI.

    So it's not known whether, for the purpose of this pilot study, a control group receiving no interventions will be used or how the "Process" is to be applied during the study, that is, consistent with how it is usually applied commercially - over the course of 3 days, or in a modified form.

    So until we have more details of the study design, exclusions etc, we don't know what participants will be subjected to, how long participants will have been ill for, whether children who are severely affected will be included, and data like school attendance prior to the start of the study, duration of illness prior to the start of the study may not be known until after the study is completed.

    Several years ago, a small study was undertaken by Trudie Chalder using a cohort from KCL looking at CBT and family therapy. After the trial was underway, some children were administered antidepressants on the grounds that it would have been unethical to withhold treatment to those considered in need of medication. In my view, that introduced a potential confounder.

    It's not known whether participants in this study will be recruited who are simultaneously taking supplements, antidepressants, medication for pain, sleep etc or who have already been following whatever form of intervention their local service for children with ME and CFS provides, which is likely to be multidisciplinary. So various specialities may already have a stake in the child's care - GP, paediatrician, OT, Nurse specialist, psychiatry, family therapist. Children are referred to paediatricians or their local CFS service more rapidly than an adult might be offered a referral to a CFS service.

    Also, some of these children may not be attending mainstream school at all. Because of the requirement for children to attend school, children who are out of school due to ill health are monitored by community paediatricians (aka "School Doctors"), as well as their GPs and their hospital based paediatricians, Education Welfare Officers, Local Education Authorities, sometimes social services, sometimes Child and Adolescent Mental Health Services and NHS Family Therapy.

    When a young person reaches 17 or 18 and transfers to adult care, it is easier for the young person to opt out of interventions. But younger children with CFS and ME are going to be under the care of a GP and a paediatrician who may want to see that child in outpatients as frequently as every three to six months as well as seeing the community paed, in between. You cannot opt out of this level of monitoring since the signatures of community paeds or paediatricians are required to sanction a child's absence from school, to obtain and maintain the provision of LEA home tuition, and to obtain special arrangements for the sitting of exams at home, or with extra time or with an amanuensis.

    Because of the shadow of social services intervention, hassle with EWOs and LEAs it is not that easy for parents and for children considered competent to give informed consent, to reject pharmaceuticals and other interventions. So children and young people are perhaps more likely to be already receiving interventions like antidepressants, medication for sleep, pain etc and whatever else their local CFS service offers. I would not expect that participants would necessarily be expected to stop all other interventions for the duration of the study, whatever that is going to involve them in, and that isn't clear at the moment.

    I put in a revised FOI last night to the University of Bristol which I will post in the next message. Further questions can be submitted later if necessary.
  20. Dx Revision Watch

    Dx Revision Watch Suzy Chapman dxrevisionwatch.com

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    UK
    FOI: University of Bristol: LP pilot study, children 8 to 18 years

    Edit: The 20 working day deadline is 15th June 2010


    To: Information Rights Officer, University of Bristol freedom-information@bris.ac.uk

    Re: Request for information under the Freedom of Information Act

    Date: 16 May 2010

    Requested by: Name and contact details redacted

    ______________________________________________________________________________

    I should be pleased if an acknowledgement of receipt of this request for information could be issued, together with any reference number assigned to this request.

    I request the following information under the Act in relation to the study:

    RNHRD NHS FT/University of Bristol:

    Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process TM and specialist medical care in CFS/ME in children. Project to incorporate study on health economic cost of CFS/ME in children.

    1] Principal Investigator(s):

    2] Project Collaborator(s):

    3] Collaborating Institution(s):

    4] Names of individuals acting in advisory capacities in relation to the application of the Phil Parker Lightning Process TM

    a) to inform the project research group:

    b) to inform children and their parents during the pilot study recruitment process or following recruitment:

    5] Names of individuals responsible for administering the Phil Parker Lightning Process TM to study participants as instructors/trainers/coaches if administering the Lightning Process TM forms part of the pilot study:

    [Lightning Process TM instructor/trainer/coach, Alastair Gibson, has already identified himself, on his website, as "one of the two practitioners working with the NHS" on this study.]

    6] Any Identification or Reference code assigned to the Project:

    7] Project's Public Title:
    Project's Scientific Title:


    Ethics Approval

    8] Has the pilot project received research ethics approval and on what date was approval granted:

    9] Any reference numbers attached to a) the application for approval and b) approval:

    10] Names of Research Ethics Committee(s) responsible for granting approval:

    11] If ethics approval has not yet been granted, what is the status of any application for approval and which Research Ethics Committee(s) would be responsible for approval:

    Please provide copies of applications for research ethics approval for the study, including any accompanying documentation that forms part of the application, for example, questionnaires, interview protocol.


    12] Study

    Please provide copies of:

    a) Research purpose and rationale
    b) Research aims and objectives
    c) Study design
    d) Protocol document (where applicable)



    13] Through what means will potential study participants be identified and recruited:

    14] Participants - inclusion criteria (please also state which CFS/ME criteria will be used eg Oxford Criteria, Fukuda/CDC Criteria):

    15] Participants - exclusion criteria:

    16] Target number of participants and Age range:

    17] Anticipated recruitment process start date:

    18] Anticipated study start date:

    19] Anticipated study completion date:

    20] Funding

    a) Value of grant awarded by the Linbury Trust:
    b) Value of grant awarded by the Ashdon Trust:
    c) Any other sources of funding for the pilot study:

    21] Sponsor details (where applicable):

    22] Please provide copies of the funding application documents.

    23] Please provide copies of patient information material to be provided to children and parents, including consent forms.

    If not all patient information material has been prepared at this stage, by what date is it anticipated that patient information will be available?

    Are slide/PowerPoint presentations to be used as a) part of the recruitment process b) during the study, and who will be responsible for their content and production?

    Are participants to be provided with work books, diary/activity charts, manuals or other materials for completion/use during either arm of the study, and who will be responsible for their content and production?

    24] What treatments/interventions will be available to children and young people assigned to receive "specialist medical care" if this forms part of the pilot study?

    25] Will the study include interviews with children, young people and their families where the child/young person has already undertaken the Lightning Process?


    26] With reference to content on the Phil Parker Lightning Process TM website and on the websites of Phil Parker Lightning Process TM licensed practitioners, it is understood that the Lightning Process TM is delivered commercially to adults, young people and children by "instructors/trainers/coaches" on a one-to-one basis or in a group setting, usually over a period of three consecutive days.

    It is understood that prior to acceptance into a "Seminar" or "training program", an application form is completed by or on behalf of the applicant to enable the practitioner to assess whether the applicant is "ready" to undertake the program and that in some cases, a telephone assessment is also carried out by the practitioner to further assess the applicant's "readiness" and suitability to undertake the "training program".

    It is understood that the Lightning Process TM application form anticipates that the applicant will be prepared to sign up in agreement with certain beliefs and commitments in order to demonstrate their degree of "readiness" to undertake the sessions and their commitment to continue to practice the "training" once the sessions have been completed.

    It is understood that in order to assess suitability for the program, applicants are requested to indicate medical or mental health conditions, pre-existing conditions and past or present diagnoses as part of the application process.


    a) No rigorous controlled trials have been undertaken on the application of the Lightning Process TM in adults with CFS or ME.

    Study participants are considered a vulnerable patient group. What data has been used in order to establish that overall the likely benefits of the research outweigh any risks to the participants?

    With reference to the document "MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)" sections 4.1 and 4.3, what is the rationale for undertaking a pilot study in children when rigorous controlled trials have yet to be undertaken and results published on the application of the Lightning Process TM in adults with CFS or ME?

    b) During the recruitment process, what information will be given to children and their parents/guardians about the Lightning Process TM and what is going to be required of the children throughout the study, in order that children considered competent to give consent, or to assent with their parents/guardians' consent, and their parents/guardians, are fully informed of likely benefits and any potential risks?

    c) If the pilot project is designed to involve some or all participants allocated to the Lightning Process TM arm of the study to receive Lightning Process TM training/instruction in some form, is the training program being specifically adapted for this study in children and young people or is it to be delivered in the same format as would be delivered commercially by Phil Parker licensed practitioners to children and young people?

    If the training program or instruction is being adapted specifically for the study, in what ways will it differ from that provided commercially by Phil Parker licensed practitioners?

    d) Will children or their parents/guardians be expected to sign up in agreement with certain beliefs and commitments in order to demonstrate the child's "readiness" to undertake the program?

    If so, what beliefs and commitments will children and/or their parents/guardians be expected to sign up to and at what point in the recruitment process would agreement with beliefs and commitments be sought?

    For the purpose of the study, how will "readiness" be defined, by whom, and what tools will be used to assess or determine a child's "readiness" to undertake the program?

    e) If selection for and participation in the study does not involve the signing up in agreement with certain beliefs and commitments, either by the child or by their parent/guardian, on their behalf, through what means are children to be assessed for suitability for and potential to benefit from the application of the Lightning Process?

    f) By what means will it be determined that undergoing the training program would not be detrimental to a child's current health status, as a patient diagnosed with CFS or ME?

    What safeguards will be put in place to avoid the potential for exacerbation of existing symptoms or the development of new symptoms whilst undertaking the sessions, in-between sessions and in the weeks and months following completion of the program?

    What support will be given to children and their families if a child were to experience exacerbation of existing symptoms or develop new symptoms as a result of participating in the program or as a result of practicing the instructions in-between sessions or in the weeks and months following completion of the program?

    g) It is understood that the Lightning Process TM is being marketed by some Phil Parker licensed practitioners as a process that should be effective for all participants in resolving their symptoms if

    a) they are "ready" to undertake the process and
    b) they carry out the instructions properly.

    This might be considered to place a considerable burden of responsibility on a vulnerable research group and their families in terms of compliance and outcome.

    What consideration has been given to the issue of power imbalances where participants (or their families) may feel obliged to please or comply with the researcher's requests or with an "instructor/trainer/coach's" requests while the program is being delivered, and beyond throughout the life of the project?

    By what means will it be determined that undergoing the "process" will not be detrimental to the child's psychological well-being or impact negatively on the family dynamic if the child were unable to complete the program and withdrew from the study, or if the child failed to gain benefit from the program, or if the child were to experience set-back or significant relapse or exacerbation of symptoms during or following the program, or if an apparent improvement or resolution of symptoms/disability following the program proved to be short-lived?

    What safeguards will be put in place in order to protect the child's psychological well-being?

    h) In what setting will the Lightning Process TM be delivered and will it be delivered in one-to-one sessions or in a group setting?

    Would a parent, family member or other individual in loco parentis be permitted to accompany a child while sessions are being delivered?

    i) How will participants who fail to complete the program (for whatever reason) be accounted for in the results and will the results include data on the various reasons for withdrawal from the study?

    j) The press release published on 02 March 2010 states that the primary outcome measure will be "school attendance after six-months".

    What other outcome measures will be recorded?

    Other than school attendance after six months, are other outcome measures being recorded such as the child or young person's ability to complete comparable amounts of homework assignments as their peer group, ability to participate in normal family/social activities outside school hours, resume hobbies, sporting activities, requirement for rest/sleep outside school hours etc?

    k) Will monitoring of participants' school attendance and level of functioning be undertaken beyond the six month point? Please specify at what intervals.

    l) Prior to recruitment to the study or following recruitment, will prospective participants undergo any assessment of fitness/physical functioning or other physiological assessment, or psychological assessment? Please specify which assessment tools will be used.

    Will participants be re-assessed following the study and will these assessments be recorded as outcome measures?

    [Request ends]

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