Dx Revision Watch
Suzy Chapman Owner of Dx Revision Watch
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- 3,061
- Location
- UK
FOI response: U of Bristol: 17 June 2010: Chapman
Preamble:
The whole issue of the commissioning and regulation of practitioners who might eventually be administering LP within NHS in the future, certainly needs our consideration, but I can only focus, at the moment, on this pilot, what is going to be done with these children and whether it can be halted.
From 3 March press release:
"The study will involve in depth interviews with the patients and their parents, and the primary outcome measure will be school attendance after six-months. It is hoped that over 90 children aged between eight and 18 and their families will be involved in the study. They will be recruited after assessment by the specialist team at the Min."
From AYME Link:
"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."
So we don't yet know what Dr Crawley and her team and the two LP advisors (I have the name of one of these, and the other may be Phil Parker, himself) intend to do to these children via the pilot.
All that is known at the moment, is what has been said in the press release and in the AYME Link article. One interpretation (by a health services researcher) is that the pilot won't be splitting the group into a "treatment group" and a control group - that is they won't be comparing, for example, a "usual specialist care" group v an LP or hybrid version of LP group.
I have had some contact with a Regional Manager for the National Research Ethics Service. I have been advised that there does not appear to be a formal mechanism for forcing a review of a decision to approve a study. (We do know that the study is still in the process of obtaining approval.)
Universities appear to have some system for lodging complaints about research undertaken under their auspices - but whether this is restricted to those directly involved in a study or includes members of the public/stakeholders not personally involved in the study, remains to be established.
In addition to the two FOIs I submitted, I put in a third enquiry to U of Bristol's research ethics office solely for the names of the ethics committee(s) responsible for granting approval for this pilot. I asked for this enquiry to be dealt with separately from the FOI but they would not comply by identifying the names of the committees outside the FOI procedure. In the FOI, the names of the committees are being withheld on the grounds that:
"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."
An additional FOI submitted by Ciaran Farrell did not produce any further information other than copies of two letters relating to the funders. A letter dated, 24 November 2009, sets out that the grant awarded by the Ashden Trust of 44,000 is being awarded in three annual instalments of 14,667 in years 09/10, 10/11, 11/12 subject to satisfactory annual reports on the progress of the grant.
The study also incorporates "the first study on health economic cost of this condition in children". It is not established by which date the LP part of the study is due for completion.
Note that this was a preliminary request for information. Selected questions may be resubmitted at a later date and additional questions may be also be submitted depending on whether ethics approval is granted and what material is published by the study leads. I do not consider that all the requests made below are likely to be covered by the material which is said to be intended for publication at some point in the future.
Submitted 16 May 2010; fulfilled 17 June 2010
Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning ProcessTM 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): See press release:
http://www.rnhrd.nhs.uk/index_sub_menus/news/documents/FINALRNHRDCFS_ME_fundingfeb10.pdf
2] Project Collaborator(s): See press release
3] Collaborating Institution(s): See press release
4] Names of individuals acting in advisory capacities in relation to the application of the Phil Parker Lightning ProcessTM
a) to inform the project research group:
b) to inform children and their parents during the pilot study recruitment process or following recruitment:
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.
5] Names of individuals responsible for administering the Phil Parker Lightning ProcessTM to study participants as instructors/trainers/coaches if administering the Lightning Process 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.]
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.
6] Any Identification or Reference code assigned to the Project:
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.
7] Project's Public Title:
Project's Scientific Title:
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.
Ethics Approval
8] Has the pilot project received research ethics approval and on what date was approval granted:
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.
9] Any reference numbers attached to a) the application for approval and b) approval:
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.
10] Names of Research Ethics Committee(s) responsible for granting approval:
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.
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:
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.
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.
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.
12] Study
Please provide copies of:
a) Research purpose and rationale
b) Research aims and objectives
c) Study design
d) Protocol document (where applicable)
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.
13] Through what means will potential study participants be identified and recruited:
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.
14] Participants - inclusion criteria (please also state which CFS/ME criteria will be used eg Oxford Criteria, Fukuda/CDC Criteria):
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.
15] Participants - exclusion criteria:
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.
16] Target number of participants and Age range:
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.
Continued in next post/
Preamble:
The whole issue of the commissioning and regulation of practitioners who might eventually be administering LP within NHS in the future, certainly needs our consideration, but I can only focus, at the moment, on this pilot, what is going to be done with these children and whether it can be halted.
From 3 March press release:
"The study will involve in depth interviews with the patients and their parents, and the primary outcome measure will be school attendance after six-months. It is hoped that over 90 children aged between eight and 18 and their families will be involved in the study. They will be recruited after assessment by the specialist team at the Min."
From AYME Link:
"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."
So we don't yet know what Dr Crawley and her team and the two LP advisors (I have the name of one of these, and the other may be Phil Parker, himself) intend to do to these children via the pilot.
All that is known at the moment, is what has been said in the press release and in the AYME Link article. One interpretation (by a health services researcher) is that the pilot won't be splitting the group into a "treatment group" and a control group - that is they won't be comparing, for example, a "usual specialist care" group v an LP or hybrid version of LP group.
I have had some contact with a Regional Manager for the National Research Ethics Service. I have been advised that there does not appear to be a formal mechanism for forcing a review of a decision to approve a study. (We do know that the study is still in the process of obtaining approval.)
Universities appear to have some system for lodging complaints about research undertaken under their auspices - but whether this is restricted to those directly involved in a study or includes members of the public/stakeholders not personally involved in the study, remains to be established.
In addition to the two FOIs I submitted, I put in a third enquiry to U of Bristol's research ethics office solely for the names of the ethics committee(s) responsible for granting approval for this pilot. I asked for this enquiry to be dealt with separately from the FOI but they would not comply by identifying the names of the committees outside the FOI procedure. In the FOI, the names of the committees are being withheld on the grounds that:
"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."
An additional FOI submitted by Ciaran Farrell did not produce any further information other than copies of two letters relating to the funders. A letter dated, 24 November 2009, sets out that the grant awarded by the Ashden Trust of 44,000 is being awarded in three annual instalments of 14,667 in years 09/10, 10/11, 11/12 subject to satisfactory annual reports on the progress of the grant.
The study also incorporates "the first study on health economic cost of this condition in children". It is not established by which date the LP part of the study is due for completion.
Note that this was a preliminary request for information. Selected questions may be resubmitted at a later date and additional questions may be also be submitted depending on whether ethics approval is granted and what material is published by the study leads. I do not consider that all the requests made below are likely to be covered by the material which is said to be intended for publication at some point in the future.
Submitted 16 May 2010; fulfilled 17 June 2010
Pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning ProcessTM 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): See press release:
http://www.rnhrd.nhs.uk/index_sub_menus/news/documents/FINALRNHRDCFS_ME_fundingfeb10.pdf
2] Project Collaborator(s): See press release
3] Collaborating Institution(s): See press release
4] Names of individuals acting in advisory capacities in relation to the application of the Phil Parker Lightning ProcessTM
a) to inform the project research group:
b) to inform children and their parents during the pilot study recruitment process or following recruitment:
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.
5] Names of individuals responsible for administering the Phil Parker Lightning ProcessTM to study participants as instructors/trainers/coaches if administering the Lightning Process 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.]
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.
6] Any Identification or Reference code assigned to the Project:
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.
7] Project's Public Title:
Project's Scientific Title:
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.
Ethics Approval
8] Has the pilot project received research ethics approval and on what date was approval granted:
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.
9] Any reference numbers attached to a) the application for approval and b) approval:
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.
10] Names of Research Ethics Committee(s) responsible for granting approval:
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.
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:
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.
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.
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.
12] Study
Please provide copies of:
a) Research purpose and rationale
b) Research aims and objectives
c) Study design
d) Protocol document (where applicable)
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.
13] Through what means will potential study participants be identified and recruited:
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.
14] Participants - inclusion criteria (please also state which CFS/ME criteria will be used eg Oxford Criteria, Fukuda/CDC Criteria):
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.
15] Participants - exclusion criteria:
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.
16] Target number of participants and Age range:
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.
Continued in next post/