RNHRD NHS FT Bath/University of Bristol Lightning Process pilot study in children 12 to 18 (SMILE study): Minutes of meeting of External Advisory Group held on 02.11.10
On 28 October, I submitted a requested for the following information under the FOI Act, from the University of Bristol:
1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.
2] The SMILE protocol document states on Page 7, under “Study management” that:
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.
Please provide the names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.
Today, I have received the following responses from the University’s Information Officer:
Details of collaborators/sponsors are included at sections A63 and A64 of the research ethics application, available online at:
from which I conclude that the only patient organisation involved in the planning/development of the SMILE pilot study has been the Association of Young people with ME (AYME).
There was a meeting of the External Advisory Group on 2nd November, the minutes of which are online at:
The membership of the group is included in these minutes.
Text of Minutes, appended, or open on ME agenda site here: SMILE Minutes 02.11.10
Agenda External Advisory Group: November 2nd 5pm – 6pm.
Stuart Logan (Chair) (SL), Exeter University
Jane Coad (JC), Coventry University
Jenny Ingram (JI), University of Bristol.
Kamal Patel (KP), Paediatrician, Brighton
Alison Wearden (AW), University of Manchester*
Mary-Jane Willows (MJ W), CEO AYME
Also Present: Esther Crawley (PI) (EC)
(*Ed: Dr Alison Wearden was PI for the FINE Trial. No representative of the Lightning Process appears to have been present.)
Everybody introduced themselves. EC outlined the study.
Review of study documentation
SL invited comments on the study documentation. SL said the aims and objectives were clear and it was good to see documentation on the web. This comment was endorsed by other members of the meeting.
1. There was a general discussion about what would happen if either the Lightning Practitioner or the child/family felt that a LP course was not appropriate after discussion. It was agreed that understanding about drop outs was part of the study.
2. There was a discussion that the PIS wasn’t clear on the qualifications or registration of the practitioners. EC agreed and suggested that an amendment was put forward to ethics to add further information on the PIS about this.
[Action] EC to draft amendment for PIS
3. AW asked whether groups would be feasible given the wide geographical area. EC replied that there were concerns about this but that was why a feasibility study was so important.
4. AW asked why the Chalder trial was not included in the reference list. EC replied that it was published after initial submission to Ethics.
5. JC suggested that the teenager PIS was clearer to read then the adult PIS and could be used for both.
EC informed the External Advisory Group that it was likely that FOI requests would be received
EC suggested that the minutes were put on to the website. This was agreed.
[Action] EC: Minutes to go on web
1. SL asked how the study was going to date. EC replied that recruitment was going well, parents and teenagers appeared to be enthusiastic and there was a higher recruitment rate then envisioned.
2. EC informed the group that she needed to respond to complaints made to NRES about the study. She suggested that she drafted a response, discussed this with co-applicants and sent the response to the External Advisory Group before submission. This was agreed.*
[Action] EC to draft response for NRES, show co-applicants and then send to External Advisory Group before submission.
Date of Next meeting – due in 6 months time
[Action] EC to doodle date
Response from Joan Kirkbride, National Research Ethics Service (complaint in response to ethical approval of SMILE Lighting Process pilot study in children), 8 November 2010
Progress on complaints to NRES (ethics approval of SMILE Lightning Process pilot study in children), 16 November 2010
1] SMILE – Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME): http://wp.me/p5foE-37x
2] Background to this issue: http://wp.me/p5foE-2Vt
3] All posts on Lightning Process pilot study in children issue: