Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
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AYME's involvement with the SMILE study
Not for forwarding or republishing elsewhere
Because I have been focussing on the forthcoming ICD-11 Revision September/October iCAMP meeting and Alpha Draft, this last few days, I have only just started going through the LP pilot study documents that were published towards the end of last week, on the University of Bristol website.
There are 29 documents in all which can also be downloaded in PDF format from ME agenda site:
SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)
ME agenda Shortlink: http://wp.me/p5foE-37x
University of Bristol website:
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html
Some brief notes:
The acronym "SMILE" is cringeworthy.
From Page 6 of the NHS REC Application Form Reference: 10/H0206/32: [Document 29 on ME agenda site]
http://www.bristol.ac.uk/ccah/resea...atigue/correspondencewithethics/recfrmrfs.pdf
The Phil Parker Lightning Process is a trademarked intervention that is used for a variety of conditions including CFS/ME. In 2009, over 250 children attended groups to access the Lightning process as an intervention for paediatric CFS/ME. The Lightning Process has been developed from osteopathy, life coaching and Neurolinguistic programming (NLP). The intervention includes three group sessions on consecutive days. Families currently pay approximately 620 to attend the Lightning Process course.
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.
*Ed: Nor any rigorous RCTs in adults, either.
From the NHS REC Application Form Reference: 10/H0206/32: [Document 29 on ME agenda site]
Application dated 24 June 2010
http://www.bristol.ac.uk/ccah/resea...atigue/correspondencewithethics/recfrmrfs.pdf
[...]
Give details of involvement, or if none please justify the absence of involvement.
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.
Healthy teenagers have scrutinized the patient information sheets and consent forms. The Chief Executive of AYME will be on the External Advisory Group.
---------------
From Page 7 of the Final Protocol Document: [Document 3 on ME agenda site]
Final Protocol dated July 2010
http://www.bristol.ac.uk/ccah/resea...fatigue/smilestudydocuments/smprotv6final.pdf
Study management
The study will be monitored by a Trial Monitoring Group which will meet every 4 to 6 weeks. The trial Monitoring Group will consist of: Dr Esther Crawley (PI), a member of the BRTC as well as applicants on the grant.
An External Advisory Group will also meet: prior to the study starting, by phone conference 6 monthly and at the end of the study. This will be an independent group and will include experts in CFS/ME, including a representative from the Association of Young people with ME (AYME) and the Lightning Process.
It's not yet known who the "CFS/ME experts" are who comprise the External Advisory Group. I shall be requesting that their names are identified when I put in another request for the information and documents I had requested in May, but which have not been provided within the documents now published on the U of Bristol website (which includes the funding application forms and associated documentation).
So AYME had been invited to scrutinize the methods and protocol and Mary Jane Willows (CEO, AYME) has a seat on the study's External Advisory Group.
And while patient organisations, advocates and parents of YPWME were trying to establish just what is going to be done to these children under the auspices of the NHS Bath and U of Bristol, and while Dr Crawley (lead researcher) was failing to respond to communications, AYME were sitting on knowledge of the study design and methods and providing input.
In May, AYME had published an article on the study in its restricted circulation Link Newsletter. Note that at that point, it had already been announced by the research team's press release, by local media coverage and on the sites of some LP practitioners, that the age range for the study would be 8 to 18. The REC Application, dated 24 June 10, and the Final Protocol, dated July 10, specify under Inclusion/Exclusion Criteria an age range of 12 to 18 years.
Note that in the AYME Link article [1], Dr Crawley is reported as stating:
"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."
But under "2. Select one category from the list below" on Page 1 of the REC Application application it gives the study category as:
Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
even though for half of the projected 90 odd cohort, a course of Lightning Process, administered over three days is to be applied as an intervention (the LP + specialist medical care arm).
And from the REC Application:
RISKS, BURDENS AND BENEFITS
...children attending either arm may not benefit from the interventions. This is true for specialist medical treatment as well the specialist medical care plus the Lightning Process. Both interventions include a burden attending outpatient appointments or group sessions respectively. In addition, there is the added burden of qualitative interviews to examine the view points of participants and their families before and after the interventions.
[...]
The course is 3 sessions on 3 consecutive days. Each session is 3 hours 45 minutes long. Group sessions include 4 to 5 young people between 12 – 18 years of age who live within the region covered by the CFS/ME service. During the group, children and young people will have a theory session and a practical session. The theory session will include taught elements on the stress response, how the mindbody interacts and how thought processes can be helpful and negative. The language used by young people will be discussed and in some cases challenged. Young people will be encouraged to think about what they may be able to take responsibility for and change. The taught sessions are followed by a group discussion.
The practical session is used to put some of the skills learnt into practise. Young people identify a goal they wish to achieve (such as standing for longer) and are then given alternative ways to think about and prepare for this. This involves using different cognitive (thinking) strategies before and whilst the goal is attempted. Young people are also asked to identify a goal in which they can practise the strategies in the afternoon or evening. This goal will usually be short but could be an activity that is up to 30 minutes long. The LP Practitioner will then arrange two follow up phone calls
[...]
RESEARCH PROCEDURES, RISKS AND BENEFITS
A22. What are the potential risks and burdens for research participants and how will you minimise them?
For all studies, describe any potential adverse effects, pain, discomfort, distress, intrusion, inconvenience or changes to lifestyle. Only describe risks or burdens that could occur as a result of participation in the research. Say what steps would be taken to minimise risks and burdens as far as possible.
We do not believe there are any risks of being part of this study. There is however a burden for study participants.
Some parents will be interviewed on three occasions. Children and young people will be interviewed once. We have tried to reduce this by ensuring that interviews are conducted at a place and time that is convenient for parents and the young person (usually in the home). In addition, feedback from parents from a previous study suggested that interviews were welcome as parents are keen to discuss their experiences of this illness.
There is an additional burden of extra inventories for children (5 minutes more at each assessment) and one extra time point. We have tried hard to minimise the questions asked and included follow up at the time they normally receive follow up as part of service evaluation. Inventories are self completed at home and completion can therefore be spread out over several days if necessary.
We have excluded young people who are severely affected from this study as we feel the burden of this study would be excessive for them. We will only recruit young people who will be able to manage this extra burden.
So, no potential risks to study participants have been identified by Dr Crawley in the REC Application Form, only the potential "burden" of interviews, questionnaire completion and inventories. So the potential for PEM, short or long term exacerbation of symptoms, relapse etc has been played right down, to the extent that it is not mentioned at all.
A copy of the Lightning Process Assessment Form where "...they are asked to identify their goals and describe what they learnt from reading the book [about the Lightning Process]" has been included in the documents provided: [Document 14 on ME agenda site] but I have not had time to go through this yet.
Note also that the "cost effectiveness" of LP is also to be evaluated as part of the study.
http://www.bristol.ac.uk/ccah/resea...ue/smilestudydocuments/lipcassfrmv2july10.pdf
Open PDF here: View attachment lipcassfrmv2july.pdf
------------------
[No URL for this]
[1] 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."
[Ends]
Not for forwarding or republishing elsewhere
Because I have been focussing on the forthcoming ICD-11 Revision September/October iCAMP meeting and Alpha Draft, this last few days, I have only just started going through the LP pilot study documents that were published towards the end of last week, on the University of Bristol website.
There are 29 documents in all which can also be downloaded in PDF format from ME agenda site:
SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)
ME agenda Shortlink: http://wp.me/p5foE-37x
University of Bristol website:
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/smile.html
Some brief notes:
The acronym "SMILE" is cringeworthy.
From Page 6 of the NHS REC Application Form Reference: 10/H0206/32: [Document 29 on ME agenda site]
http://www.bristol.ac.uk/ccah/resea...atigue/correspondencewithethics/recfrmrfs.pdf
The Phil Parker Lightning Process is a trademarked intervention that is used for a variety of conditions including CFS/ME. In 2009, over 250 children attended groups to access the Lightning process as an intervention for paediatric CFS/ME. The Lightning Process has been developed from osteopathy, life coaching and Neurolinguistic programming (NLP). The intervention includes three group sessions on consecutive days. Families currently pay approximately 620 to attend the Lightning Process course.
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.
*Ed: Nor any rigorous RCTs in adults, either.
From the NHS REC Application Form Reference: 10/H0206/32: [Document 29 on ME agenda site]
Application dated 24 June 2010
http://www.bristol.ac.uk/ccah/resea...atigue/correspondencewithethics/recfrmrfs.pdf
[...]
Give details of involvement, or if none please justify the absence of involvement.
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.
Healthy teenagers have scrutinized the patient information sheets and consent forms. The Chief Executive of AYME will be on the External Advisory Group.
---------------
From Page 7 of the Final Protocol Document: [Document 3 on ME agenda site]
Final Protocol dated July 2010
http://www.bristol.ac.uk/ccah/resea...fatigue/smilestudydocuments/smprotv6final.pdf
Study management
The study will be monitored by a Trial Monitoring Group which will meet every 4 to 6 weeks. The trial Monitoring Group will consist of: Dr Esther Crawley (PI), a member of the BRTC as well as applicants on the grant.
An External Advisory Group will also meet: prior to the study starting, by phone conference 6 monthly and at the end of the study. This will be an independent group and will include experts in CFS/ME, including a representative from the Association of Young people with ME (AYME) and the Lightning Process.
It's not yet known who the "CFS/ME experts" are who comprise the External Advisory Group. I shall be requesting that their names are identified when I put in another request for the information and documents I had requested in May, but which have not been provided within the documents now published on the U of Bristol website (which includes the funding application forms and associated documentation).
So AYME had been invited to scrutinize the methods and protocol and Mary Jane Willows (CEO, AYME) has a seat on the study's External Advisory Group.
And while patient organisations, advocates and parents of YPWME were trying to establish just what is going to be done to these children under the auspices of the NHS Bath and U of Bristol, and while Dr Crawley (lead researcher) was failing to respond to communications, AYME were sitting on knowledge of the study design and methods and providing input.
In May, AYME had published an article on the study in its restricted circulation Link Newsletter. Note that at that point, it had already been announced by the research team's press release, by local media coverage and on the sites of some LP practitioners, that the age range for the study would be 8 to 18. The REC Application, dated 24 June 10, and the Final Protocol, dated July 10, specify under Inclusion/Exclusion Criteria an age range of 12 to 18 years.
Note that in the AYME Link article [1], Dr Crawley is reported as stating:
"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."
But under "2. Select one category from the list below" on Page 1 of the REC Application application it gives the study category as:
Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
even though for half of the projected 90 odd cohort, a course of Lightning Process, administered over three days is to be applied as an intervention (the LP + specialist medical care arm).
And from the REC Application:
RISKS, BURDENS AND BENEFITS
...children attending either arm may not benefit from the interventions. This is true for specialist medical treatment as well the specialist medical care plus the Lightning Process. Both interventions include a burden attending outpatient appointments or group sessions respectively. In addition, there is the added burden of qualitative interviews to examine the view points of participants and their families before and after the interventions.
[...]
The course is 3 sessions on 3 consecutive days. Each session is 3 hours 45 minutes long. Group sessions include 4 to 5 young people between 12 – 18 years of age who live within the region covered by the CFS/ME service. During the group, children and young people will have a theory session and a practical session. The theory session will include taught elements on the stress response, how the mindbody interacts and how thought processes can be helpful and negative. The language used by young people will be discussed and in some cases challenged. Young people will be encouraged to think about what they may be able to take responsibility for and change. The taught sessions are followed by a group discussion.
The practical session is used to put some of the skills learnt into practise. Young people identify a goal they wish to achieve (such as standing for longer) and are then given alternative ways to think about and prepare for this. This involves using different cognitive (thinking) strategies before and whilst the goal is attempted. Young people are also asked to identify a goal in which they can practise the strategies in the afternoon or evening. This goal will usually be short but could be an activity that is up to 30 minutes long. The LP Practitioner will then arrange two follow up phone calls
[...]
RESEARCH PROCEDURES, RISKS AND BENEFITS
A22. What are the potential risks and burdens for research participants and how will you minimise them?
For all studies, describe any potential adverse effects, pain, discomfort, distress, intrusion, inconvenience or changes to lifestyle. Only describe risks or burdens that could occur as a result of participation in the research. Say what steps would be taken to minimise risks and burdens as far as possible.
We do not believe there are any risks of being part of this study. There is however a burden for study participants.
Some parents will be interviewed on three occasions. Children and young people will be interviewed once. We have tried to reduce this by ensuring that interviews are conducted at a place and time that is convenient for parents and the young person (usually in the home). In addition, feedback from parents from a previous study suggested that interviews were welcome as parents are keen to discuss their experiences of this illness.
There is an additional burden of extra inventories for children (5 minutes more at each assessment) and one extra time point. We have tried hard to minimise the questions asked and included follow up at the time they normally receive follow up as part of service evaluation. Inventories are self completed at home and completion can therefore be spread out over several days if necessary.
We have excluded young people who are severely affected from this study as we feel the burden of this study would be excessive for them. We will only recruit young people who will be able to manage this extra burden.
So, no potential risks to study participants have been identified by Dr Crawley in the REC Application Form, only the potential "burden" of interviews, questionnaire completion and inventories. So the potential for PEM, short or long term exacerbation of symptoms, relapse etc has been played right down, to the extent that it is not mentioned at all.
A copy of the Lightning Process Assessment Form where "...they are asked to identify their goals and describe what they learnt from reading the book [about the Lightning Process]" has been included in the documents provided: [Document 14 on ME agenda site] but I have not had time to go through this yet.
Note also that the "cost effectiveness" of LP is also to be evaluated as part of the study.
http://www.bristol.ac.uk/ccah/resea...ue/smilestudydocuments/lipcassfrmv2july10.pdf
Open PDF here: View attachment lipcassfrmv2july.pdf
------------------
[No URL for this]
[1] 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."
[Ends]
