Closed UK: DecodeME updates, was recruitment thread.

Update: I have completed the questionnaire and been selected to take part, which is a strange feeling.

I was in the middle of worrying I hadn't described my case accurately enough. So I wanted to write about that.

I found it harder to do the questionnaire than I thought as I really had to think about whether I was experiencing certain symptoms because I am so used to them. I had to go back over it again and realized that maybe I had not ticked boxes I should have ticked or that I just tune out something or consider it normal after all these years. Anyway I just thought I would write that if it helps anyone prepare to fill it out. I just tried to pick stuff that best described my case in the end but was unsure about some of the answers like whether I am staying the same or getting better. It's kind of both. (I went with staying the same in the end as it's pretty much the same day to day.) I was unsure about certain symptoms too as I have forgotten what it is like to not have ME. I hope that helps someone.

I am really glad this project is taking place. Thank-you to all.

ETA: It was psychologically quite confusing because it's like, do I not have this symptom anymore or am I just telling myself that? And then I felt like I was either underdoing or overdoing it and nothing felt "accurate". I am still worried I didn't fill it out accurately enough. Gah.

 

I've noticed this on social media as well. I understand the disappointment. We all want to feel like our experience could count for something and lead to something positive. I'm sure I will have some feelings of disappointment if I am not asked to spit (if I eventually manage to get my survey completed!) But it is difficult to see people being critical of the study and potentially discouraging others from taking part.

Interestingly, I read somebody on twitter saying they felt that not being selected meant that they wouldn't benefit from any treatments that may arise from the study. That helped me to understand the intensity of the emotions some people are feeling. I can see how this could lead people to feel left behind and shut out. Perhaps it's something the team might want to address at some point. I know there are no guarantees about outcomes or what treatments they might eventually lead to. But I wonder if there's a way to reassure people that the aim of the study is to help us move towards eventual treatments that will help all people with ME, not just those selected? (And that the selection criteria are designed to do this, not to narrow down the group of people who might eventually be helped.) I can see how complicated this is to explain. I've been so impressed with the whole study so far and the way everything has been communicated.

 

Just to clarify I absolutely encourage everyone to take part, in case that wasn't clear.

 

Don't worry @V.R.T. I didn't doubt that. I was reflecting on some comments on twitter/facebook in my post above. To be honest, I'm not sure my post was particularly constructive anyway, brain very slow today!

 

Slow brain day here too!

 

Exciting that the study has started!

I hope I'm not wrong in stating this but if you are not invited to the second stage to provide a DNA sample, that doesn't necessarily mean you do not have ME/CFS. Selection criteria for scientific studies are often different from clinical diagnosis, depending on the aim they have in mind.

DecodeME is also a major study that aims to recruit thousands of patients so that's why they need to select based on the info used in questionnaires, which can be quite challenging.

Hope that further recruitment goes well. Good luck to all participants and the DecodeME team.

 

I have no insight into the process within DecodeME itself but I was aware of the complex factors that had to be weighed up in getting any possibility of a valid and big enough cohort. The fact that a significant minority of people are being excluded sounds a good thing to me, even if it is hard for individuals to understand.

I think it is important to exclude people with other diagnoses that might be responsible for symptoms. Thyroid disease would be an obvious one. Hashimoto's disease may be capable of producing symptoms indistinguishable from ME even if the thyroid hormone status is perfect. As things are we really do not know what are classifiable as 'co-morbidities' in the sense of being associated. Much of what is said about that seems unreliable.

So I am encouraged that things are progressing as they should.

 

From what I've seen, most people mentioning that they haven't been invited to submit a sample have thyroid disease. Whilst they said it felt frustrating, they generally understood the reasons. Their disappointment seemed mostly to be about the fact that they've wanted to take part in biomedical ME research for years, but have never had an opportunity.

Several also said that they knew that they'd contributed usefully just by filling in the questionnaire and making themselves available for future contact. I haven't seen posts where people felt that (for instance) not being invited to send a sample somehow raised questions over their ME diagnosis; however, it may be that I only see posts from certain types of patient because I've interacted with sensible or well-informed comments they've made in the past. It's hard to get any sense of what's going on outside your largely self-selected little echo chamber, especially when you're not a frequent user in the first place.

 

I wonder if the reason is that if you provided (free) genetic data then a lot of people (who do not have ME/CFS) may be inclined to apply to participate in the study.

 

Maybe, but to do that you might need half the amount of funding again to set up a team to resolve all the ethical complications and commission the necessary infrastructure. If they had that money, I'd rather they spent it on more ME research.

 

I've filled the questionnaire out (confused for for a little while by the trying to get a password reset from registering previously but on the advice of one of the team re-registered), and got an email saying I can spit in a tube.

TBH, I've been really taken aback by some of the comments on twitter. Feeling quite defensive of the DecodeME team as I know that you've put so much effort in to be as inclusive as possible and into the messaging. I guess it shows how difficult it is to get these things to satisfy everyone, and that it probably isn't possible.

I've been rejected for participation in studies in the past, and to me it's just a case of accepting that there are certain acceptance criteria for a reason and trusting in those in the study. Perhaps that's the root for some of the emotion, as some have suffered for a long time and seen studies come and go that weren't really run with the sufferers best interests at the heart. I have complete faith that that is not the case this time.

For what it's worth @Andy and the others involved, I really appreciate all the effort you've put into this, and the unexpected challenges that have had to be overcome.

 

Yes, those of us who see disappointed people commenting might be able to help, by mentioning that it's normal and it happens in most or all biomedical studies. Not everyone necessarily knows that, and there's no reason they should.

Doesn't even need a detailed explanation, as some of them may only have posted in a moment of frustration and may since have realised that it's standard practice.

 

The alternative is the participant demonstrates commitment to genetic counselling using their own money/insurance and is therefore eligible to see their own data.

 

I've replied to a few trying to put that across, in what is a hopefully sympathetic fashion, but am finding twitter in general a fairly miserable place at the moment, so I've not lingered too long!

 

Thanks for trying, and thanks for the positive feedback from you and others in more recent posts here. We are working on a blog post that hopefully will be out today which will seek to respond to the major concerns that have been raised.

 

Thanks everyone involved in setting up the DecodeME study. These are just some thoughts I’ve had; sharing in case helpful at all.

As another post mentioned, I couldn’t remember if I’d signed up already or not. I remembered signing up for something a while ago but couldn’t remember exactly what. I couldn’t find any password in my keychain so tried password recovery but didn’t get any reply - it would have been helpful to be notified that I didn’t have a login. Eventually I worked this out and signed up, a number of friends had the same issue. From there it was straightforward.

Qn 1, have you been given a diagnosis by a health professional. I’m sure you’ve thought about this, but ‘health professional’ is quite a broad term potentially including alternative health practitioners. Would it have been possible to specify ‘Yes, by my GP’, or hospital consultant, private doctor, etc., potentially with an ‘other’ option at the end, and then ‘No’.

Qn 15, about alcohol sensitivity in past 6 months. I took this literally and didn’t tick the box as I’ve not had any alcohol in past 6 months, but from previous experience I know that I am indeed sensitive to alcohol. So should I have ticked it?

Qn 25, did you have an infection. Yes… Options considered: ‘yes, glandular fever’ or ‘yes, another infection’. I didn’t know what to tick as, with hindsight, I suspect it was glandular fever (EBV) but this was never investigated at the time. So I ticked ‘yes, another infection’. Would it have been better to have an additional option ‘yes, unspecified infection’?

This was suggested in another thread - to take a random sample of the study participants and do a more detailed assessment as quality control? Would something like that be possible and ethical? Without wanting to make enrolees anxious.

Then, a question I have, in part 4 where an ‘other condition’ not listed is entered into the text box, is this reviewed by a clinician to determine relevance, or by a computer? I put in a condition that I don’t believe should be exclusionary, but haven’t been selected for DNA sampling. Thanks.

 

"DecodeME participation and criteria for the DNA stage

We know how important DecodeME is to people with ME/CFS and we are grateful to the patient community for such a positive reaction to our launch. We have also seen and taken on board the frustration expressed by some who haven’t been asked to donate a DNA sample, and wanted to address the various points raised.

If you have completed the DecodeME questionnaire but have not been asked to provide a DNA sample it is not because we are questioning if you have ME/CFS. You are still a DecodeME participant and your questionnaire answers are valuable to understanding more about the illness and helping the development of future treatments.

It means that for this study your answers didn’t meet all requirements for the DNA stage. These requirements are set out by the study criteria that were agreed by the team, including people with ME/CFS, and in response to peer review. This is standard practice and ensured that the study received funding. Using strict criteria is important for scientific research studies as it ensures the results can stand up to scientific scrutiny and therefore progress further research and the development of treatments.

The DNA part of the study will help us understand the biological causes of ME/CFS which will benefit the whole community whether individuals meet the criteria we are using or not.

We also understand any frustration caused by not knowing why you weren’t asked for a DNA sample or why you weren’t able to view the criteria before completing the questionnaire. We don’t take this frustration lightly, however, it is vital that we not disclose the criteria at this stage. If we had, this would inevitably introduce unwanted bias into the study. It is essential that we protect the integrity of the DecodeME study design for when we publish results. Only then will we make the criteria publicly available. We hope you understand that our reasons for this are in the best interest of the whole ME/CFS community.

As with every aspect of this study, there was strong Patient and Public Involvement (PPI) in the decisions about the criteria used. For more information on the Patient and Public Involvement in the study please read our FAQ: How have you involved the community in the design of the project?

We are so grateful for everyone who has signed and up and taken the DecodeME questionnaire and appreciate the energy and emotions that may have gone into it. We hope the above has provided more clarity on the processes in place for the DNA stage of the study and emphasised the importance of ALL DecodeME participants, not just those asked for a DNA sample.

Thank you for supporting the study, your experience matters.

Warmest wishes,

The DecodeME team."

Original here, https://www.decodeme.org.uk/participation-and-criteria-for-the-dna-stage/

 

Thanks for taking part.

Yes, unfortunately this wasn't as clear as it could have been. We have already made changes to the text on the website to try to make this clearer to participants.

Technically, yes, it would have been possible but we preferred the simplicity of "health professional" over trying to list out the potential titles of those professionals that might have made a diagnosis. I would also imagine that the number of people taking part who have been diagnosed by someone who might count as an alternative health professional would be very small and therefore not worth the additional text.

No, with questions like this, we are solely interested in your experience in the last 6 months. We plan a number of optional additional questionnaires which we will alert people to at a later date, and I believe asking about people's general experience of alcohol sensitivity is one of the questions we are considering.

No, given that question 26 asks if the infection was confirmed via test.

Certainly it would be possible to do and could be done so ethically, however given how much this would additionally cost it was decided to, in effect, put that money into getting as many DNA samples as possible.

Inclusion or exclusion is determined by your earlier answers. The only way that anything entered into the text box could affect whether we ask for a sample donation or not would be if the participant indicated that they had incorrectly answered a relevant earlier question, and gave us their correct answer.

Hope that helps.