Thanks,
@mlapenna, for taking seriously the concerns expressed on this thread and for taking time to address them.
I think it's a great idea to try to boost recruitment to good ME/CFS studies - it's win/win for both patients and researchers and can help get us all better faster.
But I think there are some fairly big problems in the way that the site is set up, and the way that the process has been conceived. I'd like to make some comments in the spirit of constructive criticism, because I'd like to see this initiative succeed, although in a different format to the one that you have now.
(1) First, having scanned the site, I don't know who you are. You refer to yourselves as 'we', which implies that there's more than one of you, but I couldn't find your names or credentials. Have I missed this information? Are there indeed several of you?
Even if you did name yourselves and give your backgrounds (which is an absolute minimum when you're asking people for their data), I wouldn't be able to verify the information or know whether to trust you. This is nothing personal, of course, but you're strangers on the internet and not part of an existing and well known organisation. I might give my information to an established and trusted organisation such as Solve ME/CFS Initiative or the ME Association, but not to an unknown and new organisation. I think a lot of people will feel the same way and that this will be an enormous barrier to recruitment. I think it will be a large enough barrier to make this project fail.
You mentioned:
I totally agree that we should be critical and discerning of any website that collects our information.
cfsme-registry.info is no different. It takes a long time to build trust. And that trust can evaporate with one mistake. I don’t have a medical degree. But, I have been thinking about adding a page that describes the folks I have been working with. I have been communicating with Dr. Montoya’s team, Carol Heard’s (
solvecfs.org) team, Lucinda Bateman (Bateman Horner Institute), Lydia Neilsen (National ME/FM Action Network) and researchers at hospitals/research centers in other counties.
The fact that you've been communicating with these established researchers and organisations doesn't establish you as trustworthy (I hope that doesn't sound rude or personal - it's not meant to be, only to help you see how your organisation looks from the outside). Only your own track record can establish your trustworthiness, and that record would have to be publicly verifiable. It does indeed take a long time to build trust, as you say, but you are asking for instant trust, with all the risk being carried by patients who subscribe to your site.
To be honest, I think you need to completely rethink this 'subscription' idea and go to a 'broadcast' model if you want to boost recruitment to trials. That is, instead of getting patients to subscribe, I think you should create information and disseminate it as widely as you can, via other organisations and groups.
(2) I don't understand why you need any demographic or health information from patients at all. On the site, you say:
At some point in the future, aggregated data may be provided to a researcher who asks to know the number having a specific criteria. For example, a researcher may be interested in how many members have headaches, or how many members live in eastern Europe or are females over age of 50.
And in your post above you said:
Why Member Signup – As one members determined, it is for the future when researchers ask how many members have tried a certain remedy or have a certain symptom. They could determine their recruitment strategy. Just because x members match, it does not mean I would send their contact information. It means I might email those members and say that a researcher is considering a study for which they match the criteria – take a look at study X on the site.
But I don't think that this information would be helpful for researchers at all. If I'm a researcher and want patients from Eastern Europe, I can simply broadcast my request through all available channels. I don't have to filter it. It doesn't matter to me whether you've got three people from Eastern Europe in your database or 3,000.
Have you actually asked any researchers whether they'd find any of this information useful? I very much doubt that they would. Perhaps
@Jonathan Edwards (who has conducted clinical trials) would comment.
There aren't so many clinical trials in ME/CFS that patients are likely to be overwhelmed by requests to take part in them, and the very fact that you're requiring patients to (a) sign up to your service and (b) give you a lot of personal information are very large barriers to your getting many sign-ups.
(3) I think an ideal method of recruiting patients to trials - and one that served both patients and researchers would:
(a) provide an up to date and comprehensive list of trials (and this is where your research could add value over what clinicaltrials.gov does) and
(b) provide an assessment of the quality of the research and
(c) provide warnings about any risky studies.
After PACE, it's important that patients are warned about studies that are doomed to produce useless results and/or might be a risk to their health.
I don't think that linking to a discussion on S4ME is necessarily the best way for brainfogged patients to get that information. I think some kind of expert summary would be best. You said that you didn't feel qualified to do that, so I think you need to team up with someone who can. But I think it's absolutely crucial that you do this. It wouldn't be good to tell patients about a new trial and let them walk into one that's a risk to their health or that will be later used in a way that will damage the health of other patients.
You mentioned perhaps delisting or avoiding listing certain studies - but it might be better to actively warn patients about them. Or at least have a blanket warning about certain kinds of studies (such as those with open-label designs and subjective measures, and/or ones that involve graded exercise).
(4) I agree that 'CFS/ME' needs to be ditched and replaced throughout with 'ME/CFS'. 'CFS' is a much-hated name imposed on this disease and the 'CFS/ME' form is associated with UK psychiatrists who push the biopsychosocial model of ME/CFS in which patients perpetuate their symptoms because they falsely believe themselves to be sick.
I hope this list isn't overwhelming! I very much admire your willingness to listen and engage. It can be hard to roll back an idea once you've launched it but it's not too late to rethink things even quite fundamentally. As things stand, I would neither sign up to your site nor feel able to recommend others to do so. But although this might be hard to hear, I think that recognising these problems could help you to move on to a far better and more effective way of helping with research recruitment. You've picked a very worthy goal and with the right structure and the right collaborations, I think you could do a lot of good.
