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]
