Note: new answers added to the Q&A page of the MEGA site
[as the page displayed on 14 December 2016] are being interspersed amongst the original answers.
So if you are checking the site periodically for new Questions and Answers you may need to skim all of them in order to spot newly added ones. They are not numbered or dated.
I have highlighted my own Qs in red. And note, a potentially undisclosed PAG membership.
Not good.
http://www.megaresearch.me.uk/qanda/
Q & A page:
NEW QUESTION What is the plan to address the clearance of the MEGA study by an NHS Ethics Board/Committee or similar independent body?
As with all studies involving human subjects, the appropriate ethical permissions will have to be sought. The funders will not permit a study to be funded or proceed unless they are in place.
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NEW QUESTION Many people with ME/CFS do not have contact with specialist NHS ME/CFS clinics. So only using the clinics to recruit is likely to give an unrepresentative sample. How will the researchers address this?
For this application we need to be as sure as possible, with limited funds, that those who are included, using post-exertional malaise as an essential criterion, have ME/CFS. We know that up to 50% of those referred to specialist ME/CFS services do not have ME/CFS. If we accepted patients from other clinics into MEGA, we would need to pay for them to be seen by a specialist ME/CFS doctor if they were to be included in this application. We will not have the funds to do this at this early stage. Recruiting from the NHS Specialist services does not stop patients from other clinics being referred in to the specialist services.
In the future, we would like to apply for additional funding to collect samples from patients who are not part of the NHS clinics. We can either apply for funding for them to be seen by a ME/CFS specialist or we may look at using these samples without specialist review in studies, for example, in replication studies.
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NEW QUESTION I have recovered enough from ME/CFS to work full-time and be physically active – would my data be of use, and if so how can I be include in the study?
This will be decided later. It is possible that we will use patients who have recovered for the genetic studies (as genes don’t change). However, we would want to be sure that they had ME/CFS.
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NEW QUESTION Profs George Davey Smith and Chris Ponting have explained the need for a large sample size of 10,000 in order to produce statistically significant results for studies of this type. However, it also seems possible – indeed probable – that people diagnosed with ME/CFS may include those suffering from a number of different illnesses. If, say, people who are severely affected and do not get better were suffering from a different illness to others with the same diagnosis, how many of those people would it be necessary to include in the study in order for that illness to be accurately differentiated using the methods you propose?
The study is powered on investigating the association of genes with ME/CFS. It will not be powered to investigate the association of genes with other conditions. However, as we are collecting samples that will allow us to look at all the -omics from genes to metabolites, we will be able to investigate different biological pathways in sub-groups of ME/CFS as well as different illnesses. All of this will require additional funding in the future and is a long way away. The number required will depend on the investigation planned and the strength of the genetic association.
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NEW QUESTION It is good to see that you propose for all participants to have post-exertional malaise – how do you define post-exertional malaise?
This will be defined at a later stage.
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NEW QUESTION Will people who meet the NICE criteria for ME/CFS but who have additional related problems (eg. POTs, hypotension, fibromyalgia, IBS) will be included in the MEGA study?
These people will be included.
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UPDATED QUESTION What data will you collect?
We will collect symptom data on all patients to allow us to identify which patients will be identified as having ME/CFS using different diagnoses. We will also include data on fatigue, disability and
co-morbid anxiety/depression. We would like to collect detailed data on pain. How much data we collect will depend on what our Patient Advisory Groups say will be acceptable to consenting patients and how much funding we get. We are concerned about placing demands on patients by asking too many questions so the Patient Advisory Group will be asked to monitor and advise on the limits for patient assessment by questions and other assays.
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NEW QUESTION Will you be measuring orthostatic intolerance?
We would like to but this depends on whether the additional costs are perceived by the funders as being justified.
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NEW QUESTION Will you use the Bell Disability Scale?
We haven’t decided yet. This will be decided at a later stage and will depend in part on whether this is perceived by the funders as being justified.
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NEW QUESTION Are you quantifying the physical functional capacity of donors?
How we define physical function will be decided at a later stage.
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UPDATED QUESTION How will this study work with/use the existing UK ME/CFS Biobank of tissue samples?
The existing biobank does not have enough patients to answer the questions that we want to answer. In addition, we need all the patients to be recruited using the same criteria in the first instance. We also need additional biobanks to replicate the work. Researchers should have access to multiple biobanks.
We believe that collaboration is very important, particularly in terms of replication. The MEGA data and samples will be available to other researchers to use. We hope we will be able to test whether results from MEGA are replicated in other studies.
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NEW QUESTION Why is a new patient advisory group for the children’s arm of MEGA not being recruited is the same way as the adults Patient Advisory Group?
Recruiting a children and young people’s Patient Advisory Group presents considerable challenges, as this patient group and their parents and carers frequently do not have the capacity and/or time to be part of such a group. So the MEGA team have decided to use an existing group, funded by the National Institute for Health Research as part of work being done at the University of Bristol. The group has been running for three years, with new participants recruited each year. Members are children, young people, parents, carers and young adults who had ME/CFS as a child, all of whom have expressed an interest in helping research, and they have contributed to and advised on a wide variety of projects including qualitative and epidemiological studies.
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NEW QUESTION Why has the recruitment of the Patient Advisory Group been done on such a short time scale?
We wanted people with M.E. to have input into the application from the very beginning. The first draft of an application will be submitted in January. This has very little detail on the science, but we need to get the costs right. We want to involve people with M.E. in those decisions. The Patient Advisory Group will not be expected to make decisions on every detail of the application at this stage because we are only seeking feedback on whether the funders are interested in an application of this nature.
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NEW QUESTION Can you provide assurances that all applications will be passed on to the selection process?
Action for M.E. is administering the MEGA Patient Advisory Group application process and as such will pass on all applications received by the deadline to the recruitment panel. No-one at Action for M.E. is involved in decision-making about who will and will not be recruited, and the applications will be anonymised before being sent to the decision-making panel, comprising representatives from the ME Association and ME Research UK and a scientist from the MEGA team, Prof Paul Little.
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NEW QUESTION Does the MEGA Team intend to publish the names of those who have accepted a seat on the Patient Advisory Group and by what date does MEGA anticipate publishing the confirmed membership list?
We will discuss this with the Patient Advisory Group and publish names if they are willing for us to do so.
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NEW QUESTION Does MEGA project have a Steering Group overseeing the project?
A Steering or Oversight Group has not been established as there is as yet no project to oversee. If MEGA is funded, this will be established in due course.
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