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New Research Studies Posted at CFS/ME Registry

Discussion in 'General ME/CFS News' started by mlapenna, Sep 7, 2018.

  1. mlapenna

    mlapenna Established Member (Voting Rights)

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    Good day everyone
    I know this might be out of reach but if you have the energy to participate in CFS/ME related research studies, I have 23 active studies that are currently recruiting participants. Last year I started https://cfsme-registry.info, a global registry of individuals suffering from CFS/ME to provide them with active studies. I personally contact the lead researcher to confirm recruitment. Over 500 individuals have signed up so far. The time will come when promising therapies need to be tested in large scale studies that require thousands of participants. The FAQs page answers many questions about this initiative. However, I am always open to your comments and questions.
    Thank you and have a restful day
    Mike Lapenna
    michael.lapenna@cfsme-registry.info
     
  2. NelliePledge

    NelliePledge Moderator Staff Member

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    if You’re including every study does that mean you’re supporting recruitment to FITNET?
     
  3. Peter Trewhitt

    Peter Trewhitt Senior Member (Voting Rights)

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    This sounds like a very valuable exercise and one I want to support (I plan to look at registering with the CFS/ME registry), but @NelliePledge raises an interesting point about whether including a study would be seen as an endorsement. Especially as we have witnessed over recent years here in the UK that the ethical approval system does not always work for ME/CFS studies.

    The continued use of the Oxford Criteria makes participating in studies using it a waste of time and energy for subjects given the results can not be meaningfully interpreted as actually having any implication for ME. A significant number of researchers, particularly those invested in the BPS model seem to have problems distinguishing between the symptom of chronic fatigue linked to many conditions and the specific condition Chronic Fatigue Syndrome. However it is not reasonable to expect all potential research subjects to be aware of the implications of the different research definitions of ME/CFS.

    At least one relatively recent study, namely Prof Crawford's School Absence study, avoided ethical aproval entirely on spurious grounds, even though there were serious potential ethical risks involved. In this example children and their parents/guardians could hardly be expected to understand the technical problems in its oversight without more information than that available from the research team, especially given prolonged school absence leaves parents/guardians fearing the risk of prosecution making them less likely to question what was happening.

    Then there are the studies, primarily associated with promoting excercise, usually in the form of GET, that carry serious risk of real and lasting harm to participants. Given the relevant researchers' biased understanding of the nature of ME and their failure to take into account a whole section of the research literature from view points differing to theirs, such studies ignore thousands of other peer reviewed reports making them deliberately negligent. Historically these studies have failed to adequately record adverse effects and one such study, FITNET as pointed out above, is currently recruiting significant numbers of children and adolescents. Further specifically with FITNET the recent promotion of this study by Red Whale has served to prejudice potential subjects, undermining any potential value of their results indicating a worrying ignorance of experimental design and making participation a waste of scarce energy as well as potentially injurious to health.

    How does the CFS/ME registry plan to police studies it supports/facilitates?

    A further more trivial point, the name for our condition that the CFS/ME registry uses is contentious. Though it could be argued that any potential name would for some be contentious, using CFS/ME, rather than ME or ME/CFS preferred by the majority of patient organisations, will only serve to alienate potential participants as it indicates an affiliation to the discredited (at least within the patient community, but increasingly more widely) sections of British academia that have given grossly uncritical support for the harmful BPS school of researchers.

    [Corrected for grammar.]
     
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  4. Sasha

    Sasha Senior Member (Voting Rights)

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    Hi, @mlapenna. This is a good idea. I just looked at the site, though, and can't see a list of studies. I'm always reluctant to register for things online - is it possible to see the list without signing up? That might be a barrier for quite a few people.
     
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  5. adambeyoncelowe

    adambeyoncelowe Senior Member (Voting Rights)

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    From the site:
    I can't see FITNET.
     
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  6. Sasha

    Sasha Senior Member (Voting Rights)

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    Thanks!

    What did you click on to access that list?
     
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  7. Trish

    Trish Moderator Staff Member

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    But I can see the so called pacing study using video games which specifically talks about helping people increase activity.
    Not one I would recommend anyone participating in.
     
  8. Hutan

    Hutan Moderator Staff Member

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    I was just making the same point as @Trish:
    There is the South Australian one that has an interesting definition of pacing:

     
  9. Sasha

    Sasha Senior Member (Voting Rights)

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    I wonder if it would be good to have something telling patients how to tell whether a study is a good one and therefore worth risking their health in.

    Although that might be beyond a lot of patients. I wonder if a short review of each study in design terms from someone with expertise in trial methodology might be good. Even a basic checklist of the big issues (such as the PACE-killer of an open label design relying on subjective measures) might help.

    Really, that ought to be done for all RCTs that are recruiting patients, regardless of whether it's in ME/CFS or not. Loads of badly designed and unnecessary trials are conducted, and funding bodies and ethics committees and steering committees seem collectively poor at preventing them.

    Any suggestions for how patients can avoid being recruited into bad trials, @Jonathan Edwards?

    I'd also like to know what information patients can expect to have before they go in, such as whether it's reasonable to ask to see the protocol.
     
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  10. Hutan

    Hutan Moderator Staff Member

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    And there's this one:
    To study the therapeutic effect and mechanism of Chinese Traditional Gongfa on chronic fatigue syndrome

    with Gong Fa being Tai chi? There are three treatment arms: exercise, CBT and control. There's not enough detail to know if the control treatment means sitting at home with no care.

    Perhaps the registry could give a link to a new thread on S4ME created for each trial? So then patients considering the trial could read the views of a range of people about how likely it is to be safe or to produce useful results.

    Edit: now that I understand more about the information required for registration, I'm not comfortable with the amount of personal data required to be provided. While my suggestion was to provide people with ME access to independent information by links to S4ME threads, such links could make it appear that we are endorsing the site.
     
    Last edited: Sep 7, 2018
  11. adambeyoncelowe

    adambeyoncelowe Senior Member (Voting Rights)

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    I'm a member. I clicked on the menu, then went down to studies.
     
  12. Trish

    Trish Moderator Staff Member

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    Hi @mlapenna. While I can see that there is some value in collecting together in one place a regularly updated list of studies that people with ME may be able to participate in, I can't understand the point of asking people to give you the details of their illness and symptoms.

    Surely it would be better to make it an open site that everyone can look at and find the studies, whether they are members or not, and to simply have a list of people who want e-mail alerts when new studies are added. I cannot understand the purpose of asking people for private medical information. What use do you make of it? To put it bluntly, my marital status and whether I get headaches is none of your business...

    As I understand it, members details are, quite rightly, not sent to the researchers by your organisation, they are simply used to e-mail the members when new studies are added to the list, and it is up to members to read the details of the study and apply if they want to take part.

    Also, if you are going to promote studies in this way, it would, I think, be worth adding to your site some basic information about what ME is, the different definitions used in research and the pitfalls to look out for when deciding to participate, such as exercise therapies which may cause harm, trials based on inadequate criteria such as Oxford which will not provide useful information about ME, and open label trials with subjective outcome criteria which are scientifically unsound.
     
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  13. Peter Trewhitt

    Peter Trewhitt Senior Member (Voting Rights)

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    @mlapenna, again I want to stress that I think this is a very valuable undertaking, but I have been looking through the CFS/ME registry site and just had a couple of points:

    - I have learned not to be confident of my judgement on quick decisions, as I am quite capable of making silly errors by acting too quickly, be it transferring £22,000 instead of £2,000 when paying an invoice on line or ordering 1000 square metres too much turf for a new lawn I was having laid. Brain fog strikes again. Increasingly I try to read everything through several times before acting. So when looking at the site I was trying to find out what information would be required when registering, however it seems the only way to find this out is to register

    - As with the point above, I feel it would be helpful to have some examples of participating research projects. Is there a reason that the recruiting research projects are only visible to people who have already signed up? Examples of participating projects, if the full list was not appropriate, would enable prospective members to know what sort of information would be provided.

    NB Relating to this last point and my point in the above post I can see there are justifications for providing an exhaustive list of recruiting projects even FITNET, as much as I would prefer this study did not take place. If some one was fully informed of the risks and the flaws in the study, but still wanted to participate, it would not necessarily be the place of such as the CFS/ME registry or anyone to seek to block them. However if the registry is making the introduction as it were it must ensure that potential subjects have the opportunity to be fully informed. At present in ME/CFS research in the UK, I would argue that not all researchers can be relied or are capable of providing all the information required for participants to make a fully informed choice.

    With such as the FITNET study ideally I would want potential subjects to be made aware of the criticisms of the original Dutch study and of some of the patient forum discussion around it. However this would require the registry to find independent 'reviewers' and complicate its relationship with participating organisations.

    [added I had missed on the site that there is in fact open access to the list of research projects participating and description of each project see https://cfsme-registry.info/rs#ac_977_collapse1 . Appologies for misrepresenting the site. ]
     
    Last edited: Sep 7, 2018
  14. Peter Trewhitt

    Peter Trewhitt Senior Member (Voting Rights)

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    On the site @mlapenna makes the point that it may be useful for researchers when planning studies to have a profile of the potential pool of subjects they may be able to draw on. No matter how well designed research is, it is of no use if it can not recruit sufficient subjects. I would agree with this though it may be debated what is required and I feel potential recruits should be able to review the information to be collected before start the registration process.

    Though like you @Trish I do wonder if having the list of participating research projects only available to registered patients is the way to go.


    [added I had missed on the site that there is in fact open access to the list of research projects participating and description of each project see https://cfsme-registry.info/rs#ac_977_collapse1 . Appologies for misrepresenting the site. ]
     
    Last edited: Sep 7, 2018
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  15. Trish

    Trish Moderator Staff Member

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    Sorry to harp on, but to be honest, the more I look at the site, the more uncomfortable I feel about it.

    You say this:
    I see no information about how the site can in any way be described as creating 'a community'. What you are actually doing, as far as I can see, is collecting private medical information from people who you are asking to trust you with that information and that you will not share it with anyone, without giving any rationale for you holding that information. One person holding a database of private medical information is not a community.

    And you are going to the trouble of searching out studies from around the world that people with ME might be able to participate in, but only making that information available to people who have given you their personal information. Surely if your purpose is to increase participation in ME studies, an open site is the only way to ensure this.
     
  16. Peter Trewhitt

    Peter Trewhitt Senior Member (Voting Rights)

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    Sorry @mlapenna I had not found the list of participating research projects on the site, so obviously withdraw my point relating to this. Though it may be with noting that several of us missed this when exploring the your site.

    [added - I am getting confused, it seems that the list of research projects is on a page of the site that is not password protected, so effectively has open access, but the link to it requires membership and is password protected so in practise the information is very difficult for non members to find, but please correct me if I am wrong]
     
    Last edited: Sep 7, 2018
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  17. strategist

    strategist Senior Member (Voting Rights)

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    Same thought here. There is clinicaltrials.gov which offers more and doesn't require an email address.
     
  18. Sasha

    Sasha Senior Member (Voting Rights)

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    @mlapenna, is there some reason why the list of studies isn't visible to those who aren't members? I seem to be seeing a different menu to @adambeyoncelowe.
     
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  19. Sasha

    Sasha Senior Member (Voting Rights)

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    Not having registered, I didn't realise you were asking for this kind of information, @mlapenna, and I share Trish's concerns. I think it would be better to openly maintain a list of studies and broadcast that list.

    Clinicaltrials.gov is worldwide (I'd thought it was US-only, but it's not) and if you aren't offering more than they do, then the information to broadcast is a link to that list, or to a search that's openly based on it.
     
  20. Peter Trewhitt

    Peter Trewhitt Senior Member (Voting Rights)

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    Having now read through the list of recruiting trials and the associated summaries it is apparant that there is enormous variation in standards and quality.

    I have concerns about a couple of those included, particularly where the Oxford Criteria seem to be still being used. With these I feel unless potential participants have opportunity to fully understand the potential failings they should be strongly discouraged from doing so [participating that is].

    I have undergraduate and post graduate experience in relation to experimental design and professional experience of managing clinical research albeit some twenty years ago, so can claim to have experience in this area, but on the basis of the information provided I did not feel able to comment on the value of all the studies listed, so question if a lay member not following research issues could make a fully informed decision on participation with many.

    It seems to me at present this exercise is falling between two stools: it is seeking to be more than just a list of research projects but it falls short of being a community that shares information and understanding. If it is to be more than just a neutral list of projects and contacts, which to be most effective should be total open access, there needs to be some mechanism for sharing evaluations of the research or rating its clinical value. Obviously with the latter there is a risk that this biases or restricts what research happens, but given the historic restrictions and biases of ME/CFS research this is not necessarily totally bad. It could even result in an improvement in research. For example, if the BPS crew were to find they could not recruit to open label trials with subjective outcomes, they might actually seriously explore using objective outcomes.

    I think this is a potentially valuable exercise and I hope it continues to grow and develop, but so far I personally have reservations about registering in its current format.

    [edited to correct grammar and to clarify]
     
    Last edited: Sep 7, 2018

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