SMILE – Specialist Medical Intervention and Lightning Evaluation documents

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


See also previous ME agenda post:

“Unethical” Lightning Process pilot study in children receives ethics approval

Update: Key documents

3] SMILE Research Protocol

Open here: smprotv6final

29] Research Ethics  Application Form

Open here: recfrmrfs

University of Bristol website  

Source: Protocol document


SMILE – Specialist Medical Intervention and Lightning Evaluation

What is SMILE?

SMILE is a feasibility study to see whether it is possible 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 study will also look at how we should measure outcomes and the health economic impact on the families of young people with CFS/ME.

Young people will be observed completing the questionnaires that we use to look at how unwell they are before they see us and what happens to them after an intervention. We will also talk to young people and their parents to understand what they think about the questionnaires and to determine the most acceptable and sensitive ones to use. This study is the first to work out which questionnaires we should be using to understand outcome in paediatric CFS/ME.

Frequently Asked Questions

Why is research in children needed?

Over 250 children a year already attend Lightning Process training. It is important that people know whether it is safe and effective or not. We need high quality research to answer these questions. If SMILE can recruit enough people to participate in the study then further research could look at whether it is helpful or not.

Should research be done in children before adults?

Children have the right to research particularly in illnesses which are different to adults. CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children.

How will the safety of those involved in SMILE be monitored?

The safety and wellbeing of people involved in any research project, not just the SMILE project, is of the utmost importance. There is an Independent Advisory Group to oversee, and monitor this research. All participants will be carefully monitored and regularly reviewed in the specialist CFS/ME service. Young people taking part can opt out of the trial at any point.

How can we take part in the study?

Young people are eligible if they are between 12 and 18 years of age, have CFS/ME and are from the region covered by the Bath/Bristol specialist CFS/ME service. Young people are recruited at assessment so you will not be eligible if you have already been seen by the service.

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 have 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 can be found in the following documents:

Smile Study Documents

[Ed: I have numbered these documents for ease of reference – they are not numbered on the University of  Bristol website.]

Note: some of the documents on this page are in PDF format. In order to view a PDF you will need Adobe Acrobat Reader

1] SMILE Information sheet for teenagers August 2010 [pdf (150kb)]

Open here: infoshtteensv4aug10

2] SMILE Information sheet for parents September 2010 [pdf (147kb)]

Open here: infoshtprntsv7sept10

3] SMILE Protocol Final July 2010 [pdf (170kb)]

Open here: smprotv6final

4] SMILE Under 16 assent to contact July 2010 [pdf (109kb)

Open here: u16asscv4july10

5] SMILE 16 to 18 consent to contact July 2010 [pdf (110kb)]

Open here: 16to18confinaljuly10

6] SMILE Parental consent to contact 10 May 2010 [pdf (111kb)]

Open here: parconsv310may10

7] SMILE Under 16 assent to study July 2010 [pdf (112kb)]

Open here: u16asscv4july10

8] SMILE 16 to 18 consent to study July 2010 [pdf (110kb)]

Open here:  16to18constjuly10final

9] SMILE Parental consent to study 10 May 2010 [pdf (113kb)]

Open here: parconssv310may10

10] SMILE teenager consent/assent to teenager interview August 2010 [pdf (110kb)]

Open here: tcontinvv5aug10

11] SMILE Parental consent to child interview 10 May 2010 [pdf (111kb)]

Open here: parconcinv10may10

12] SMILE Parental consent to parental interview 10 May 2010 [pdf (109kb)]

Open here: parconinvv310may10

13] SMILE Consent to record intervention for participants, parents and those delivering interventions July 2010 [pdf (110kb)]

Open here: conrecintjuly10final

14] SMILE Lightning process assessment form July 2010 [pdf (159kb)]

Open here: lipcassfrmv2july10

15] SMILE letter to GP 10 May 2010 [pdf (49kb)]

Open here: letgpv110may10

16] SMILE WPAI [pdf (135kb)]

Open here: wpai

17] SMILE Health resource use questionnaire 10 May 2010 [pdf (232kb)]

Open here: healthresuseq

18] SMILE SF-36 [pdf (165kb)]

Open here: smilesf36

19] SMILE Interview topic guide 10 May 10 [pdf (178kb)]

 Open here: topgdev210may10

Correspondence with Ethics Documents

20] Initial covering letter to NREC 20th May 2010 [pdf (75kb)]

Open here: covlet20may10

21] NREC Letter 14th June 2010 [pdf (108kb)]

Open here: let14jun

22] NREC Letter 19th July 2010 [pdf (272kb)]

Open here: let19july

23] Covering letter in reply to NREC 28th July 2010 [pdf (159kb)]

Open here: letrep28july

24] NREC Letter 13th August 2010 [pdf (72kb)]

Open here: let13aug

25] Letter re meeting notes in reply to NREC 19th August 2010 [pdf (45kb)]

Open here: letmetn19aug

26] Second covering letter reply to NREC 20th August 2010 [pdf (109kb)]

Open here: seclet20aug10

27] Letter in reply to NREC 13th September 2010 [pdf ( 80kb)]

Open here: let13sep

28] NREC Approval letter 14th September 2010 [pdf (213kb)]

Open here: applet14sep10

29] REC Form [pdf (353kb)]

Open here: recfrmrfs