FITNET-NHS: Frequently Asked Questions

Q. How do you know whether someone actually has CFS/ME?

A. A child has CFS/ME if they have fatigue that is disabling, has lasted more than 3 months, and is not explained by other illnesses (for example thyroid disease). A lot of teenagers have fatigue, but CFS/ME is different because it is disabling. Patients with CFS/ME also have other symptoms. One of the most helpful to make a diagnosis is "post exertional malaise" which is an increase in fatigue (and other symptoms) after exertion. 

Q. What will the study entail?

A. Children will be randomised to receive either Activity Management or FITNET-NHS.

Those who get Activity Management will receive information on managing activities and sleep. They will have three Skype calls (one assessment and two follow up) with CFS specialist occupational therapists (OTs) to understand and provide advice on sleep and activity. The specialist OT will hand over care to the local GP or paediatrician but will provide support to them with up to three phone calls.

Those who receive FITNET-NHS (and their parents) will be given information and then work through 19 interactive modules (psycho-education and CBT). Children will be asked to do homework (answer questions and complete diaries). CBT-trained therapists will make appointments with children and their parents to review homework and support behaviour change.

Q. Why does this have to be such a large study?

A. We are hoping to recruit 734 children and young adults. About 30% of children with CFS/ME also have low mood or anxiety. This large sample size will allow us to know if this treatment will work for those with CFS/ME and depression or anxiety. This is an important group of patients for whom there is little treatment available. 

Q. How long will this study take?

A. The project was funded May 2016 and is set to open to recruitment on 1 November 2016. We hope to publish the results in May 2022 but it will depend on how long it takes us to recruit 734 children. We have estimated that this may take 42 months.

Q. How can children and young people access this study?

A. Children and young people need to be referred to the Bath Specialist Paediatric CFS/ME Service by their GP. To be eligible for this study, they need to have been assessed by a Paediatrician, have had their screening blood tests done (see NICE guidance for more information). This is to make sure other causes of fatigue have been excluded. 

Q. Will children and young people with co-morbid conditions (such as diabetes) be able to take part in the study?

A. Children and young people with CFS/ME and other illnesses can take part as long as the illnesses do not explain their fatigue.
 

Q. How many children and young people will be recruited to the study with post-exertional malaise?

A. Post-exertional malaise is part of the study eligibility criteria so children and young people can only be recruited if they have post-exertional malaise. 
 

Q. Can patients from Scotland, Wales and Northern Ireland enter the FITNET-NHS study?

A. The Bath Specialist Paediatric CFS/ME Service has always accepted referrals from Scotland, Wales and Northern Ireland but, as with all patients, the funding must be sorted for treatment (not for the research costs which are funded for). In England this is straightforward and patients can be referred through "Choose and Book". 
 
We hope to talk to the commissioners in Scotland, Wales and Northern Ireland to try and sort a similar solution for those wanting to access FITNET-NHS in these areas. 
 
At the moment, if you live in either Scotland, Wales or Northern Ireland and would like your child to be considered for FITNET-NHS, please talk to your GP and paediatrician about referral to the Bath Specialist CFS/ME service. We recommend you discuss with your GP and paediatrician the process of applying for funding for your child to get treatment. We cannot guarantee that they will fund any treatment that we offer.
 

Q. Can I take part in the study if I am an adult with CFS/ME (18 years and older)?

A. The study is only for children aged 11-17 years old. However, there are a number of specialist CFS/ME services for adults: ME Association

Q. Can I take part in the study if I have left school and I am working? 

A. No, the Bath Specialist Paediatric CFS/ME Service will only accept referrals from patients who are still doing (or should be doing) GCSEs and A levels at school or college. If you have left school and are working, you need to be referred to an adult specialist CFS/ME service. 

Q. What will happen at the end of the study?

A. If it FITNET-NHS is effective and is good value for money, we will be able to continue delivering FITNET-NHS to patients at the end of the trial. There is little roll out involved because it can be delivered from the same trust by the same therapists. 

Q. What will happen to the results from this study?

A. The FITNET-NHS study will published in the HTA Journal part of the NIHR Journals Library in 2022, providing an important and permanent record for research funded by the National Institute for Health Research. All of the journals are freely available to search, view and download from the NIHR Journals Library website.

NIHR report authors are expected to publish results in other high-quality peer-reviewed journals as part of their dissemination strategy. The NIHR has had a policy on open access since 2006. 

Q. What did the Dutch FITNET trial show? 

A. The Dutch FITNET trial showed that FITNET, compared with usual care, greatly accelerated the rate of recovery from CFS/ME. The biggest difference was seen after 6 months, when almost two thirds of teenagers who had received FITNET recovered, compared with less than 10% of teenagers who received 'usual care'. The precise numbers were 63% (42/67) compared with 8% (5/64). 'Recovery' meant that participants' fatigue, physical function and school attendance had to cross certain thresholds, and participants also had to rate themselves as being completely recovered or feeling much better.
 

Q. But didn't the Dutch teenagers recover anyway, whether or not they received FITNET?

A. The important thing here is that teenagers who didn't recover in the 'usual care' arm were able to get FITNET. This means that we might not expect any difference at long term follow up.  Actually, at 2-4 years, 64% of teenagers who had been allocated to FITNET had recovered compared with 53% who had been allocated to 'usual care', but the trial was probably too small to provide statistical evidence in support of this difference. It should be noted that around half of the 'usual care' group chose to do FITNET after the 6-month trial had ended. Also, 'usual care' could include individual or group-based rehabilitation programs, face-to-face cognitive behavioural therapy, and graded exercise therapy with a physical therapist, so FITNET was not being compared with 'no treatment'.
 

Q. So what difference did FITNET make to Dutch teenagers with CFS/ME? 

A. Perhaps the best summary of FITNET is to say that it greatly accelerated the rate of recovery. This can clearly be seen in the figure below, which shows the much more rapid recovery achieved by FITNET. As the Dutch researchers said, "This shortened recovery period is crucial during adolescence, when school attendance and social contacts are crucial for social and academic development."
  FITNET LTFU graph
© 2013 by American Academy of Pediatrics
 

Q. Who is funding the research?

A. The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (14/192/109).  The study proposal was submitted through the NIHR HTA Programme’s researcher-led workstream (http://www.nets.nihr.ac.uk/programmes/hta/funding-streams) by Dr Esther Crawley.

Q. Why has this research been funded?

A. Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) affects 1-2% of young people, most of whom do not have access to treatment. This research is investigating whether FITNET-NHS is effective and cost effective. This is because we need to be able to offer treatment to children and young people with CFS/ME who cannot access local specialist treatment. If FITNET-NHS is effective and cost-effective, we will able to offer treatment for children throughout the NHS wherever they live. 

Q. What is the process for commissioning research?

A. The NIHR HTA Programme researcher-led work stream funds research questions proposed directly by researchers. Applications are usually assessed using a two stage process. All research proposals are assessed at each stage by the HTA Board whose members are appointed for their expertise. External expert opinion is also obtained from a number of national experts in the field.

The HTA Programme funds independent research about the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS. The board looks at whether the study is designed to achieve its objectives in an appropriate, feasible and ethical manner, whether successful completion of the project would lead to a reduction in uncertainty and whether the research would result in measurable health gains for patients and/or wider benefits for the NHS. They will also judge whether the proposal is methodologically and scientifically robust and if the team expected to carry out the research have the necessary skills, experience, project management and infrastructure for success.

Q. What level of funding has been provided for this study?

A. The HTA as agreed to fund this study at a cost of £994,430.

Q. Will children without post exertional malaise be recruited?

A. Post exertional malaise is what we consider to be a definig symptom. Checking that children have post exertional malaise is part of our recruitment pathway. More details of this can be found in the protocol.

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