Crawley: How to deal with anti-science BRS2017

slysaint

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slysaint

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Is/was this part of MAGENTA?

http://apcp.csp.org.uk/chronic-fatigue-syndrome-diagnosis-management-symptoms-children

"Caroline Grayson is a Consultant Paediatrician at the Great North Children’s Hospital (GNCH), Newcastle upon Tyne. Her job combines both acute and community paediatrics with close working with different members of the multidisciplinary team. She is also Named Doctor for child protection for the Trust."

"GNCH will be one of the pilot sites for a research trial led by Dr Esther Crawley , Consultant Paediatrician in Bath and Bristol looking at Graded Exercise Therapy in young people with CFS/ME compared to activity management and recruitment is expected to commence shortly."

"Caroline is grateful for the support and advice she has received from Dr Esther Crawley"

:vomit:
 
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Is/was this part of MAGENTA?

http://apcp.csp.org.uk/chronic-fatigue-syndrome-diagnosis-management-symptoms-children

"Caroline Grayson is a Consultant Paediatrician at the Great North Children’s Hospital (GNCH), Newcastle upon Tyne. Her job combines both acute and community paediatrics with close working with different members of the multidisciplinary team. She is also Named Doctor for child protection for the Trust."

"GNCH will be one of the pilot sites for a research trial led by Dr Esther Crawley , Consultant Paediatrician in Bath and Bristol looking at Graded Exercise Therapy in young people with CFS/ME compared to activity management and recruitment is expected to commence shortly."

"Caroline is grateful for the support and advice she has received from Dr Esther CrawlReplyey"

:vomit:
Looks like it is part of Magenta- with help from specialist physio

Jackie Young is currently the Operational Lead for Community Paediatric Physiotherapy and has been qualified as a physiotherapist since 1983. She specialised in paediatrics in 1992 working in Newcastle community paediatric services. She developed through the ranks to become the service manager in 2005, at the time for both physiotherapy and occupational therapy. This has given her extensive knowledge and experience in dealing with children with disabilities, strategic visions, service developments, working with partner organisations, and currently runs services that are both local and regional across the north east.



The community service is part of the Newcastle upon Tyne Hospitals NHS Foundation Trust. As a manager she has been able to support a strong research portfolio within her team and be part of new developments within the care of children with disabilities. Developing new services and treatment modalities, supported by medical teams.



Due to professional and personal experience she has developed a special interest in children with chronic fatigue and is currently developing the service along with Dr Caroline Grayson. They are hoping to become well established and to provide high levels of care and support for these young people who can have quite difficult times, and where recovery can be lengthy, particularly with the wrong approaches.



She is also going to be working with the Bath research team, along with Dr Grayson and Dr Esther Crawley, as Newcastle is one of the participating centres in the MAGENTA Trial, looking at GET therapy vs activity management, randomised control trial this year.

http://apcp.csp.org.uk/management-children-chronic-fatigue-syndrome
 

Esther12

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Valentijn

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Q: I have read that GET is harmful. Is that true?

A: No, so long as it is provided by appropriately trained healthcare professionals, as it is in this study. There is no evidence from research studies that GET is harmful. The most robust study to look at this was a review published in 2015 by a Cochrane Collaboration review group. In this review, the researchers looked at the data from all the trials investigating exercise therapies. They analysed data from 8 trials which included 1518 people. They concluded: “Exercise therapy was not found to worsen symptoms for people with CFS, while serious side effects were rare in all exercise and comparison groups”.
What a bunch of misleading bullshit. Can we complain to Bristol about their website deliberately misinforming people by leaving out key information regarding GET? In huge patient surveys, most of us report it causes harm, and Cochrane didn't have satisfactory data to establish if there's harm or not, so of course they couldn't conclude that it's harmful.
 
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What a bunch of misleading bullshit. Can we complain to Bristol about their website deliberately misinforming people by leaving out key information regarding GET? In huge patient surveys, most of us report it causes harm, and Cochrane didn't have satisfactory data to establish if there's harm or not, so of course the couldn't conclude that it's harmful.
I wonder if a complaint to the Child Protection Board is valid?
 

slysaint

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In huge patient surveys, most of us report it causes harm
This is why EC goes to great lengths to make out that 'Paediatric ME', or 'Adolescent CFS' or whatever she wants to call it at the time, is not the same as the adult variety.
What few of 'them' seem to have picked up on is that this is largely down to her means of diagnosis.
 

Revel

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This is why EC goes to great lengths to make out that 'Paediatric ME', or 'Adolescent CFS' or whatever she wants to call it at the time, is not the same as the adult variety.
Guess I'm still waiting to recover from my 'Adolescent CFS' then, even though I'm now 52, since nothing's changed for me so far. Did I miss the memo, at what point does this illness morph into the 'adult variety'? :confused:
 

Countrygirl

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I have been in conversation with a parent who is concerned that she is being pressurised against her will to enter her child for the FITNET trial. Perhaps they are finding it difficult to recruit their desired number of victims/participants.

I also recall reading in the study protocol that a parent of a child who fails to improve will be liable to investigation, a possibility of which the parents should be aware if they participate, but they are not, it appears. I have tried to find the document on line but it seems to have disappeared. A few months ago, based on the statement threatening the investigation of parents I wrote this short paragraph in a letter of concern:

We [a group of ME patients] are very concerned that severely ill children who fail to improve or deteriorate are re-diagnosed with Pervasive Refusal Syndrome at the instigation of Dr Crawley and subjected to highly damaging treatment resulting in serious and prolonged and potentially permanent deterioration while legal proceedings in some cases are taken against parents[15]. Indeed this possible scenario is inbuilt into the FITNET trial, an outcome of which future participants may not be aware. This is reprehensible.

The following is the text from the leaflet for that trial which participants are given which might be of interest. I have highlighted some of the statements that give concern.


How effective is FITNET-NHS for children and young adults with CFS/ME

Information Leaflet for Young People Aged 11-15 Years

We would like to invite you to take part in a research study which will tell us which of two treatments, FITNET-NHS and Activity Managements, is more effective at helping young people with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis. Before you decide whether you would like to take part, it is important for you to understand why the study is being done and what it will involve. The leaflet is divided into two parts. Part 1 tells you about the study and what will happen to you if you choose to take part. Part 2 gives details about how the study will be run. Please read this leaflet carefully. You can talk about it with your family, friends, doctor, or us. Ask us if there is anything you don’t understand or if you want more information. Take time to decide whether or not you want to join in. Thank you for reading this.

PART 1 Why are we doing the study?

We want to test whether a treatment called “FITNET-NHS”, which delivers cognitive behavioural therapy (CBT) for CFS/ME at home via the internet, is effective and value for money. CBT focuses on cognitive behavioural strategies to identify, challenge and change cognitive (thinking) processes. We want to compare this with another treatment for CFS/ME called Activity Management which will use video call (e.g. Skype).

In the first part of the study, we want to know whether young people, like you, will want take part in the study and whether young people think FITNET-NHS and Activity Management are acceptable treatments.
In the second part of the study, we want to see how effective FITNET-NHS and Activity Management are at treating young people with CFS/ME and measure the costs of each treatment.

Why have I been asked to take part?

You have been asked to take part in this study because you are aged between 11 and 17 years, have a diagnosis of CFS/ME, and do not have a specialist CFS/ME service close to your home.
If you are not able to attend telephone or online consultations required for the research study (e.g. you don’t have a phone line or internet/video call (e.g. Skype) access at home), you will not be able to take part.

Do I have to take part?

You do not have to take part in this study. If you agree to speak to the research nurse, they will explain more about the study. This will not commit you to taking part.
If you think that you might not want to take part in any of the treatments, you should not enter the study.
We hope that up to 734 young people and their parents/carers will take part in this study but it is up to you to decide whether or not you would like to take part.

FITNET-NHS IRAS ID: 211202

Participant Information Leaflet 11-15yrs_v3.0 Page 2 of 5 30/11//2016


If I agree to take part can I change my mind?

Yes. If you decide you would like to take part but change your mind later, we will continue to follow you up like we do other young people who are not part of the study unless you tell us you don’t want us to.
You can leave the study at any point and, if you would like us to, we will take out the information collected about you at any point before we carry out data analysis.
Leaving the study at any time will not affect the standard of medical care you will receive.

What will I be asked to do if I take part?

Before the treatment:
If you would like to hear more about the study, the research nurse will arrange a time to talk to you over the telephone. The research nurse will explain the study to you and your parents/carers, and answer any questions you may have. With your permission, this discussion will be audio-recorded and will last about 45 minutes, but you can talk for longer if you have more questions. The research nurse might ask you about how you felt when you were asked if you wanted to take part in this study.

If you want to take part in the study, you will be asked to fill in an on-line assent form to show us that you agree.
If you take part in this study, we need to make sure that participants in both groups are as similar as possible. This is the only way we can compare the groups and make sure the study is fair. You will therefore be allocated to either Activity Management or FITNET-NHS by a process of randomisation. Half of those taking part in the study will receive Activity Management and half will receive FITNET-NHS, so you will have a 50% chance of getting either treatment. Both treatments have been used before.

During the treatment:


You will receive treatment for your CFS/ME at home. Both groups will get lots of advice from members of Bath Specialist CFS/ME Service about how to improve your sleep and you will get treatment for your symptoms. You and your parents/carers will need to complete questionnaires at baseline, 3 months, 6 months and 12 months which will take you about 20 minutes each time.

We want to find out more about what you think about this study. A researcher may ask to meet with you or speak with you and your parents/carers over the phone to find out what you think about the study or the treatments. This discussion will be audio-recorded with your permission. This may last around 30 minutes. It is up to you if you want to do this or not.

In addition you will get either Activity Management or FITNET-NHS. Activity Management If you are in this group you will receive up to three video (e.g. Skype) calls. During the first video (e.g. Skype) call, you will have a detailed assessment of the activity you do. This will take around 90 minutes. This includes thinking activity such as school work, homework, time on the computer and screens, reading and hobbies that require concentration and physical activity such as walking or PE. We call this high energy activity. We will ask you to record your activity on paper or our iPhone app “ActiveME”. We will then help you find your “baseline” activity which is the average amount of activity that you can do each day. When you have found your baseline activity, we will provide follow up video (e.g. Skype) calls to help you increase this by 10-20% each week. Each follow up call usually takes around 60 minutes. This is called Activity Management.

FITNET-NHS IRAS ID: 211202

Participant Information Leaflet 11-15yrs_v3.0 Page 3 of 5 30/11//2016

FITNET-NHS If you are in this group both you and your parents will have to work through 19 interactive cognitive behavioural therapy (CBT) treatment modules on-line. Each module will take about 60 minutes to complete. These modules will explain what CBT is and how it works. CBT focuses on cognitive behavioural strategies to identify, challenge and change cognitive (thinking) processes. It also helps you develop treatment goals and discusses the role of your family in the treatment process. Your parents will also have to work through modules separately in which they will explore their beliefs and behaviours towards your CFS/ME and focus on their role as carers. The therapist will work with you and your parents and provide weekly online consultations to review homework and support you.

What is the difference between the two treatments?

Activity Management will mainly be working on activities that take up most of the day like school work, setting a baseline and trying to increase it. It does not focus on changing behaviours and thought processes. FITNET-NHS will try to focus on cognitive behaviour strategies to change thought processes to allow you to reach a goal which you have set for yourself.

Are there any disadvantages to taking part in this study?

You will need to spend time talking to a research nurse for about 10 minutes so we can understand if you are interested in the study. You and your parents/carers will need to arrange a time to talk on the phone to a research nurse about the study. This will take about 45 minutes.
If you take part, you will have to spend time completing the treatment. For Activity Management this will be about 90 minutes for the initial assessment and 60 minutes for each follow up call. For FITNET-NHS you will spend approximately 60 minutes on each on-line module. We think your parents will spend about 10 - 15 minutes on each module.
If you take part, you and your parents/carers will need to complete questionnaires at baseline, 3 months, 6 months and 12 months. We ask all young people to complete these questionnaires. These questionnaires will take you about 20 minutes each time.

You may not find the treatment you are offered helps you. Young people with CFS/ME can get worse even with the treatment offered and we do not know how many will get worse (or better) with either Activity Management or FITNET-NHS. This is why we are doing a study. Will I experience any side effects from taking part in this study?
We have used Activity Management and face-to face CBT in our service and are not aware of any side effects. A study of on-line CBT treatment for children with CFS/ME has also shown that there were no side effects.

What are the benefits of taking part in this study?

You may feel better from the treatment you are undergoing, but we cannot say this for certain. You may learn something about how a research trial works. Some young people with CFS/ME like to know that they are helping others with CFS/ME in the future. What will happen when the study stops?

After the study stops, you can continue to have medical care from your local team if you still need it. If you want to know the study results, let us know and we can send them to you.
FITNET-NHS IRAS ID: 211202
Participant Information Leaflet 11-15yrs_v3.0 Page 4 of 5 30/11//2016
PART 2 If you are still interested in taking part in this study, please read the information below before making your decision.

Consent
We have to be completely certain that you are happy to join this study, so we will ask you to sign an assent form. We will also ask you to sign one of these forms if you are happy for us to record discussions with you. Once you have signed the forms, you will still be free to stop the recording or leave the study at any point. Just tell us if this is the case. Whether or not you wish to take part, you will continue to receive the same care from the clinical team.

What will happen to the information you collect about me?

It is very important that all the information you give us is completely private. The conversations that you give us permission to record will be encrypted and password protected (so that only members of the study team can listen to them). They will be stored on a secure University of Bristol server.
We will use a research code to identify you. No name or personal information will be on the questionnaires we send you. All personal details that could identify you will be kept secure in locked cabinets in locked offices or password protected on secure NHS or University of Bristol computers.

We may use some of the things you say when we write about the study but we will take your name and any other information off so no one will know who was speaking. We would also like to keep the things you say so that other researchers can use it for research and teaching now, and in the future. We will check you are happy for us to use the things you say in this way. If you tell us something that makes us worried about your safety or the safety of those around you, we may have to discuss this with somebody else. This means, what you say would not be kept completely private if we were sufficiently concerned about you or those around you. We would do the same if you told us something in clinic.

What will happen if I feel unwell during the study?

If during the course of the study you start to feel unwell (e.g. if you feel anxious or depressed, or if you have a fever), you should speak to your parents and contact your local care providers (e.g. your GP or paediatrician). The research team provide specialist treatment for CFS/ME but cannot provide treatment for other problems you may have. If you do contact the CFS/ME research team about other concerns (e.g. feeling anxious or depressed), the research team will do their best to help. If they feel it’s appropriate they may pass the information on to your local care providers and try to inform you of other services which may help you. The CFS/ME research team may not be able to reply to your queries straight away (e.g. if you send the research team a message with concerns on a Saturday it may not be picked up until the Monday). This is why you should always speak to your parents and contact your GP if you have any concerns. Does everybody involved in the study have the right police checks?
Yes. All those working in the study have had police checks to make sure they are safe to work with children and young people.
FITNET-NHS IRAS ID: 211202
Participant Information Leaflet 11-15yrs_v3.0 Page 5 of 5 30/11//2016

Who will know that I am taking part in the study?

Your GP should know that you are taking part in this study so we will write to them to tell them which treatment you will be receiving in the study. What will happen to the results of the study?

This study will give us information on whether young people are interested in taking part in a study like this and whether they think the “Activity Management” and “FITNET-NHS” treatments are acceptable. It will also tell us how effective these treatments are at helping young people with CFS/ME and how much the treatments cost.

What if new information becomes available whilst I am in the study?

If new information becomes available, we will tell you about it and discuss whether you want to continue in the study. Who is organising and funding the study?
This research is organised by Professor Esther Crawley who leads the Bath Specialist CFS/ME Service and the CFS/ME Research team at the University of Bristol.
The study is funded by the government’s research fund - the National Institute of Health Research (NIHR) and is sponsored by the University of Bristol. What should I do if I have a problem with the study?
If you have any problems with this study, please speak to your parents/carers, Professor Esther Crawley, or any member of the clinical team that you know. Professor Crawley’s contact information can be found at the end of this information leaflet.
You can also complain to the NHS in the usual way through the Patient Advice and Liaison Services (PALS) on 01225 473424. Will I need to pay to be part of this study?
No. Ethical Approval
Ethical approval means that this study is safe to carry out on young people. The study has been approved by South West – Frenchay Research Ethics Committee. Who can I contact for further information? Prof Esther Crawley - Paediatric Consultant/Clinical Lead of the Paediatric CFS/ME Service Address: Paediatric CFS/ME Service, Children’s Centre, Royal United Hospital, Combe Park, Bath, BA1 3NG Tel: 01225 821340 Email: esther.crawley@bristol.ac.uk Or if you want to talk to somebody independent please contact: Jane Carter - Research Lead Address: RUH Bath NHS Foundation Trust, Combe Park, Bath, BA1 3NG Tel: 01225 465941 Email: jane.carter14@nhs.net

THANK YOU for taking the time to read this leaflet
 

user9876

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From the leaflet that @Countrygirl quoted
If during the course of the study you start to feel unwell (e.g. if you feel anxious depressed, or if you have a fever), you should speak to your parents and contact your local care providers (e.g. your GP or paediatrician). The research team provide specialist treatment for CFS/ME but cannot provide treatment for other problems you may have. If you do contact the CFS/ME research team about other concerns (e.g. feeling anxious or depressed), the research team will do their best to help.
This seems to imply that they don't have a way to monitor the safety of the intervention because they are saying if you feel unwell don't tell us tell your GP.

Of course they will then say it is safe because they have not looked for harms. Like they quote the cochrane review as saying GET is safe when most of the trials it quotes don't look at this and whilst the cochrane paper gives soundbites suggesting GET is safe they also have caveats around lack of information.
 
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Q: I have read that GET is harmful. Is that true?

A: No, so long as it is provided by appropriately trained healthcare professionals, as it is in this study.

That's just not true; I was made worse by GET from one-to-one care by the person who trains the NHS clinics!!! You can't get anymore appropriately trained than the one who wrote the flippin' guidelines. And it failed miserably and I was hung out to dry. This trial is a tragedy waiting to happen.
 

Countrygirl

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@Countrygirl wheres the bit about being investigated?
Hi @Jenny TipsforME :)

As I mentioned above, I read it last December in the study protocol which was online. I have spent some time searching for the same document today and it appears to have been vamooshed. I can only find very much abbreviated documents of FITNET. Maybe further investigation would unearth that version of the study protocol, but I don't have time right now and I am beginning to think, after spending so much time searching for it, that it may have been removed from the 'net or altered.
 

Countrygirl

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Q: I have read that GET is harmful. Is that true?

A: No, so long as it is provided by appropriately trained healthcare professionals, as it is in this study.

That's just not true; I was made worse by GET from one-to-one care by the person who trains the NHS clinics!!! You can't get anymore appropriately trained than the one who wrote the flippin' guidelines. And it failed miserably and I was hung out to dry. This trial is a tragedy waiting to happen.
I am sorry to hear that you were harmed, @jaybird1 .

Could you tell us more if you are up to doing that?,................. but not to worry if you don't want to.

Did you report it?
 
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I am sorry to hear that you were harmed, @jaybird1 .

Could you tell us more if you are up to doing that?,................. but not to worry if you don't want to.

Did you report it?
There's another thread here about a webinar by Jessica Bavinton on the use of GET; I've explained more over there. As it was provided by my work health insurance, and funding was cut as i didn't improve there wasn't anyone to complain to! That was a couple of years ago now sadly.
 

PhoenixDown

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Bristol.ac.UK said:
if you want to take part, but do not want to wear the acceleromenter that is fine.
Objective outcomes should be compulsory.

Bristol.ac.uk said:
Q: At the moment she doesn’t go to school, does this matter?

A: We don’t think you should be part of the trial if you are severely affected.
Interesting, let's hope she doesn't generalize the results to the severely affected.