AYME welcomes ethical approval of Bath/Bristol Lightning Process pilot study in children (SMILE)

AYME welcomes ethical approval of Bath/Bristol Lightning Process pilot study in children (SMILE)

November 1, 2010 by Suzy Chapman

Shortlink: http://wp.me/p5foE-3cq

In the November edition of LINK Newsletter (Issue 40), the Association of Young People with M.E. (AYME) has welcomed the decision by South West 2 Research Ethics Committee to grant ethical approval for the controversial pilot study around the application of the Lightning Process in children as young as 12.

Lead researcher for the SMILE study (Specialist Medical Intervention and Lightning Evaluation), Dr Esther Crawley,  is AYME’s Medical Consultant.

To date, no rigorous RCTs have been undertaken into the safety, acceptability, short and long-term efficacy of the Lightning Process in adults.

In a joint press release issued in August, two national ME patient organisations – The ME Association and The Young ME Sufferers Trust –  condemned the study as “unethical” and called for the project to be abandoned.

In a position statement issued in March, Action for M.E. had said it saw “no reason to oppose this pilot study”.

But in August, Sir Peter Spencer, CEO of Bristol based Action for M.E., disclosed that “Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.”

Sir Peter Spencer is a non-executive director of the Royal National Hospital for Rheumatic Diseases, NHS Foundation Trust – Dr Esther Crawley’s employer and the hospital where this research study is being undertaken.

The study hopes to recruit around 90 children aged between 12 to 18 and is expected to start this month. Half the patient cohort will undergo a three day course of the Lightning Process.

According to the NHS REC IRAS application form, the SMILE study Protocol and other SMILE study documents published on the University of Bristol website in September:

Ethical issues   The Lightning Process is popular with over 250 children with CFS/ME attending courses each year. There is therefore an urgent need to study this intervention properly.”

“There are currently no reported studies investigating the effectiveness or side effects of the Lightning Process in children. As with all interventions, proper evaluation is necessary if it is to be brought into mainstream practice.”

“CFS/ME is different in children and adults with different risk factors [15-17], course and outcome [18]. It is therefore not possible to complete a study in adults and extrapolate the results to children.”

“The need for doing a study properly evaluating the Lightning Process came from patients and service users. Representatives from the Association of Young people with ME (AYME) have read, and suggested changes to the protocol and methodology. Service users publicized the research project and are keen to disseminate the findings.”

“The PIS [Participant Information Sheet] follows the NRES recommended layout and has adopted the NRES recommendations for children. We have also tested the PIS on healthy teenagers who reported that it was clear to read. Members of the patient charity AYME have scrutinised the PIS and also felt it was clear to read.”

“Healthy teenagers have scrutinized the patient information sheets and consent forms. The Chief Executive of AYME will be on the External Advisory Group.”

“As this is only a feasibility study, participants will not be individually informed of the outcome. However, the results from the feasibility study will be disseminated through patient charities.”

In a response to the ME Association, published on 28 October, Joan Kirkbride, Head of Operations, NRES (National Research Ethics Service), has written:

“Given that this treatment is currently available, ME Association survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning), we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion.”

I have submitted a FOI request, due for fulfilment on or before 25 November, for the provision of:

1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.

2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.

AYME LINK Issue 40

www.aymelink.org

November 2010

Association of Young People with M.E.

Research study to investigate a chronic childhood condition

A favourable Ethical opinion has been given to a feasibility study which will see if it is possible to look at two different approaches to the intervention and treatment of chronic fatigue syndrome/ME (CFS/ME) in children.

The project called SMILE (Specialist Medical Intervention and Lightning Evaluation) aims to find out if it is feasible 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 research team will be led by AYME’s medical advisor, Dr Esther Crawley, Consultant Senior Lecturer in the University of Bristol’s Centre for Child and Adolescent Health and Consultant Paediatrician at the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust and is funded by the Linbury Trust and the Ashden Trust.

AYME is aware that there are concerns from families about The Phil Parker Lightning Process®.

However, around 250 children a year are already receiving the treatment, and it seems clear that large numbers will continue to do so. Many of the families that AYME supports have asked us about LP and it has been frustrating for us to be able to give them only limited information.

We therefore, welcome this feasibility study to see whether a future study is possible. In addition, AYME is pleased to see the study group are looking at how much health resources young people with ME use and are also investigating the measures clinicians use to look at outcome. If the study is successful, not only will the team be able to apply for funding for a larger study to look at effectiveness, but they will also have a lot of data on the cost of CFS/ME as well as what we need to measure in future research.

It is important to realise that only a larger study in the future will be able to investigate whether LP is effective or not which will enable children and young people and their parents and carers and to make an informed choice about LP. The study is using a mixture of interview techniques to understand what young people think about both interventions, including actually observing and comparing both interventions in order to understand more about them. The fact that all young people will be closely monitored by both the clinical and research team is reassuring.

Esther Crawley said: “We are doing this study because so many young people with ME and their families asked us for this. We are very grateful we can now go ahead and start to answer some of the questions they have been asking”.

The Phil Parker Lightning Process® is an intervention that is used for a variety of conditions including CFS/ME 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.

Phil Parker, designer of the Lightning Process said: “It is vitally important that all interventions that could assist children with CFS/ME to return to school and improve their health are explored”.

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 has 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, including frequently asked questions can be found at the URL:

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

 

Key SMILE documents

SMILE Research Protocol

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smilestudydocuments/smprotv6final.pdf

Open here: smprotv6final

Research Ethics  Application Form

http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/correspondencewithethics/recfrmrfs.pdf

Open here: recfrmrfs

All published SMILE documents here:

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

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