New Research Studies Posted at CFS/ME Registry

Thank you Hutan and all the members comments.
I will be responding shortly.

 

I see that I am late to the discussion.

I'd like to say that I agree with many of the comments made. As a preliminary comment before going further I'd like to also say that there is a great need in our community for a place to assemble a list of upcoming/ongoing research in ME but not for the purposes of simply listing opportunities to participate but to use our collective community and their various scientific knowledge to critique (good and bad) any proposal for all of our benefit.

Our discussion/input is to me a necessary ingredient in helping anyone with ME thinking about joining a particular trial. This is especially true for those of us who are either new to ME and therefore may hold a naive belief in research integrity or who simply lack the skill to assess something on our own. This is where I see this community being an advantage over some external site.

There continue to be many dubious trials out there. Having a community of ME people aware of and watching, critiquing and assessing would benefit us and would tend to give a push to researchers to do better and up their game or risk not having enough people to populate their trial. This requires some good amount of care and checks on assessment.

It also requires more/better ability to reach out to the newly diagnosed which I tend to think is where many of the dubious researchers can flourish unchecked.

*And just as an aside I think we need to educate vigorously the idea that it is likely that ME can be relapse and remitting and this is why some people newly diagnosed can seem to 'recover' and then go on to spread the word that they have and can't understand why we're all still ill.

I agree that not only a thread to discuss trials would be useful but an organised system/framework for understanding what and how to discuss the issues would be very helpful. As a group we need expertise and help with regard to knowing before offering ourselves up for study given that we all have limited functioning.

ETA: I think with regard to sharing personal information the relationship should be the other way around. Researchers can state plainly what it is they are studying and who they are looking for and each individual who knows their own medical situation can decide if this is a fit for them or not and after assessing/discussing the trial consider their involvement.

 

Firstly, thank you for the enormous amount of invaluable feedback. If it were possible, I wish we could all sit in a room for a couple of hours (or more), where I could introduce myself, along with the initiative, you could ask any question and we could collectively debate the answers. Unfortunately, we can’t do that. In its place, I will try to respond to as many comments as possible now, with likely more responses in the future. And I avoided directing responses to specific people since several themes crossed multiple members.

• Evaluating Studies – I am not a doctor nor feel qualified to judge the safety of research studies. I am concerned about studies that request exercise. I like several ideas that were proposed around having a checklist. For example, if three important criteria were checked on each study and prominently displayed, such as Requires Exercise: Yes/No (and then a link that describes the risks related to exercise)
• Evaluating Studies – I am less keen on promoting an evaluation of the study itself. I do like the idea of adding a link to a new topic on s4me.info where members can discuss the safety/efficacy/etc. of such a study.
• Evaluating Studies – I am willing to consider delisting or avoid listing studies that use practices that are universally considered harmful – can we use this forum to devise such practices?
• Personal Data Collected – Marital Status is clearly irrelevant and I will remove it – fair comment
• Personal Data Collected – I think it is a great idea to list the items that are collected so that a prospective member can decide ahead of time whether they want to provide such information
• Describing ME – The site does have a few links in the footer describing ME/CFS – the website specifically does not disseminate info on the condition – there are numerous website that do that very well. I am open to adding more links.
• Sharing of Information – Member information is never shared. The Privacy Policy is explicit and extensive. If there is any hint on the website, please bring to my attention. The FAQs are consistent with the Privacy Policy.
• 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.
• ClinicalTrials.gov – it’s a great resource, one which I respect. I have found roughly 50% stale information (“status of ‘Recruiting’ was correct at one point in time). Not all global research studies are listed on ClinicalTrials.gov. I suspect that sometimes studies are listed there towards the end, post recruitment. I am trying to determine whether this is solely a timing problem.
• ME/CFS vs CFS/ME – I am not too concerned about the distinction, although I understand the point – I am not opposed to changing it across the site
• Moderator Note – I agree on all points
• FITNET – sorry I am not aware of it but will read up on it – if someone provides a link I will educate myself on it

Final Comments (just for this post):

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. I hope this post begins to address your comments. I fully understand that not everyone will want to participate. But I do take your comments seriously and look forward to more discussions.

 

You haven't denied that you're collecting data and will try to sell it in the future.

The privacy policy says

Which to me says that you're considering selling this information in the future. The wording suggests users may not have a choice. In practice such a transition will probably be oscure so that most users do not even realize that they're agreeing to the sale of their medical information.

If you do not intent to sell this information, a clear statement ("we will never sell your private medical information to anyone") would make that clear.

 

@mlapenna, a very constructive response to the points raised. My brain is not functioning so well this morning, but hopefully will come back to you later.

[added - though first thoughts are that you definitely need to include aspects to worry about, including information of the dangers of exercise and also a list and tentative evaluation of the different research definitions of ME/CFS with clear indication that any project using the Oxford criteria is completely uninterpretable in relation to ME and should be avoided like the plague]

 

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.

 

BTW, I do think that patients volunteering for good-quality research is absolutely key to moving things forward for all of us as fast as possible. Trials and studies do have big problems recruiting and this slows research down considerably. The NIH intramural study is going slower than it needs to because of problems with recruiting enough patients.

If we had an effective system for broadcasting calls for recruitment for worthwhile studies - including repeat calls periodically, if necessary, for studies that were struggling to recruit - it would have benefits for all of us.

It seems to me that @mlapenna has identified an important area - the recruitment of patients to studies - where patients can contribute. With the right model, I think this is potentially very worthwhile.

 

This already is or was some form of international register of people with ME. I am struggling at present to remember details other than a vague image of a global map with tabs with numbers of people registered in each country. I think it just had numbers and home country and have a feeling it was intended as a campaign or publicity feature. I remember trying to sign up to it but got confused and don't know if I succeeded or not. Can any one with a better memory than me provide any details?

@mlapenna, your idea of some sort of meeting to discuss your project may not be totally impractical, either video conferencing with some S4ME members or alternatively a face to face meeting with interested delegates at a conference in your home country, might be achievable.

I do like the idea suggested above of you possibly working with an existing patient organisation to produce a resource that might gain more immediate trust/recognition.

 

Thank you again for your collective feedback.
I have never, nor will ever, share or sell members' information.
Based on your comments, I have made the following adjustments:

• Added a notice for European GDPR (I read the GDPR conditions and it now complies)
• Adjusted Privacy Policy to address @Adrian's and @strategist's comments
• Thank you Nellie for the providing links on FITNET
• Peter, I have discussed collaboration with patient organizations but no arrangement so far
• Sasha and others, I have removed Marital Status and Street Address from the Forms
• Added a FAQ regarding de-registration
• Added a FAQ regarding information fields collected
• Adjusted a few FAQs for consistent wording
• I have replaced the word 'community' with 'registry' (s4me is a community!)
• Regarding my background, there is a LinkedIn link and you can find me on facebook (you can also email me with questions if you like! michael.lapenna@cfsme-registry.info)
• Trish, I have offered my IT skills to Dr. Montoya but since I am not in the union staff at Stanford I could not be accommodated
• I am open to switching from CFS/ME to ME/CFS in each page's content but this will take some time

Thank you all and have a restful Sunday. I sincerely hope my initiative can help ME/CFS researchers and sufferers.
Mike

 

Yes Trish, I am aware of SolveCFS's effort. I had a long conversation with Allison @ SolveCFS where we compared notes.
There are a few differences between our approaches.

 

I'm logged in, but nothing appears on the Studies page, there is an introduction, and all the info is gone!

 

The website link from post 1 does not seem to work. Anybody has access to the correct link to the registry? thanks!