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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
William
Brown
william.brown@doctors.org.uk
Will
Brown
wb255@cam.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Demyelinating diseases of the central nervous systemDiseases of myoneural junction and muscle
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This study is about people with neuroimmunological conditions. These include multiple sclerosis (MS),neuromyelitis optica (NMO) and myasthenia gravis. A neuroimmunological condition is one where the body’s own immune system becomes “mis-programmed” and attacks the brain,spinal cord,nerves or muscles. These conditions are common and cause significant disability.
Treatments exist,but we do not know how best to treat people with these conditions. Finding this out has previously used trials.
But trials have problems:
• trials don’t have enough participants to answer “who needs which drug and when”
• trials recruit participants that are not representative of people seen in NHS clinics (for example people with other medical problems)
• most people are not given the chance to be in a trial: doctors and nurses are often too busy to know what trials are open. It is hard for people with neuroimmunological conditions to find out what trials are going on and whether they are eligible.
As a result,trial conclusions are not applicable to many people in the ‘real world’.
To know how best to treat people in clinics,‘real world’ data needs to be collected and studied. Fortunately,this data is already in hospital records (e.g. facts from clinics,results from blood tests and MRI scans). But this is not happening. This is because clinicians don’t have time to either enter the data into registries (we are resolving this in a separate project) or to seek participants’ consent. As a result,registries contain the bare minimum information from only 1% of people with neuroimmunological conditions in the UK. We can’t answer the important questions until this is fixed.
And we need to make it easier for people to hear about trials.
The solution: a simple,quick consent form that patients can complete from home. This single form takes about 3 minutes to complete,and empowers patients to consent to:
1. Three different registries
2. Other approved research being done at their hospital
3. Be informed about trials if they meet the ‘entry’ criteria. If a person is found to be eligible,they will be sent the trial Information Sheet. And they will receive the contact details of trial staff if they wish to participate or find out more.
The form,called CONSENTOR,will:
• Transform registries: they will have enough data to answer the biggest questions.
• Speed up trial recruitment.
• Make trials and registries more representative of people in NHS clinics.
The unified consent form will be promoted by the teams working at clinics; and by charities (e.g. MS Society).
We hope to encourage as many people as possible to complete the consent form by ensuring that:
• the form can be completed online or on paper;
• the form is presented in multiple languages;
• a child-friendly version of the form is available for those under 16 years old (with a separate agreement form for the parent or guardian to complete);
• the form can be completed by relatives or staff if physical impairments,illiteracy or computer access preclude a willing person completing it;
• people who lack mental capacity can participate if their relative or guardian believes they would wish to (and completes a declaration form).
CONSENTOR has been guided by those with lived experience of these conditions. A patient group at the Cambridge NIHR biomedical campus did a detailed document review. The UK MS Society Research Network has also provided invaluable document feedback. Oversight is provided by the Scientific Leadership Committee,which will include two people with lived experience of these conditions.
We will measure the recruitment rates at each site using a summary of numbers recruited (including which components they have consented to),and request feedback from participants. This feedback cycle will be repeated at regular intervals to understand and optimise recruitment.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
There are no exclusion criteria
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Will
Brown
wb255@cam.ac.uk
William
Brown
william.brown@doctors.org.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST and funded by NIHR Academy .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 58929
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