What (maybe home-based) useful new research could be done using the DecodeME cohort?

[Sasha]

We've been talking today on another thread about the possibility of doing a home-based wearable-actometer study of PwME to see if overactivity causes crashes, using PwME from the well-defined DecodeME cohort instead of having to go through the BACME/NHS clinics, and:

Since 95% of participants consented to being recontacted for new research projects it might be sensible to discuss possible projects for which possibly additional data might have to be collected

26,000 people did the DecodeME questionnaire, so that's about one in 2,000 of the UK population who have consented for recontact. So there'd be dozens of DecodeME PwME in every city (hundreds in the big cities), available even if researchers wanted to be able to visit them rather than do home-based studies.

There's a thread on what else could be done with DecodeME's data, but what useful research could be done with its cohort, whether in terms of studies where the PwME wouldn't have to leave home or encounter anyone, or a home-visit study, or one where the PwME might need to go to a local lab or hospital department?

Recruitment of patients is supposed to be a major hurdle for researchers but maybe not any more, for us. This could make for cheaper, faster studies.

But what studies do we want? (Wouldn't it be great if we could propose a really good one!)

I wonder what a study involving wearables of all sorts might tell us but I don't have any specific ideas...

 

[EndME]

One pretty easy and useful project would be to recontact people in say 3 years, 5 years and then 10 years (or similar) to understand more about recovery rates. There might be some bias w.r.t. certain groups being more likely to respond etc but that'd be something that would require close to no work.

 

[Sasha]

One pretty easy and useful project would be to recontact people in say 3 years, 5 years and then 10 years (or similar) to understand more about recovery rates. There might be some bias w.r.t. certain groups being more likely to respond etc but that'd be something that would require close to no work.

Wow, that would be really, really interesting. We have no real clue about recovery rates, though some indication that they're higher in children and young people, and DecodeME might include a decent number of younger people, given that you had to be 16+ to take part.

It could be designed to have some really searching questions to determine whether someone has recovered or has just forgotten what normal health is (which has been a concern in other studies, IIRC).

That's a great idea.

 

[Utsikt]

It could be designed to have some really searching questions to determine whether someone has recovered or has just forgotten what normal health is (which has been a concern in other studies, IIRC).

I think FUNCAP, hours worked, etc. could capture some of that.

It would be very interesting if we got long term data from people that say they have recovered to see if they stay recovered.

 

[wigglethemouse]

Here is an example of a project. It's been running a number of years - people wear a smart watch for 3 months. This is a research team very experienced in using smartwatch data so lets see if they come up with anything and how useful the smart watch data is. I have not seen any updates for a long time but I guess someone could contact Jamie Seltzer at ME Action to see if she has any updates.

Crash Course

Visit the post for more.

snyderlabs.stanford.edu

The good thing about a smart watch study is we still don't know how data varies over time, and we need that knowledge on how that variation would affect clinical trial reporting if a smart watch is used there. I think Dr Bateman mentioned that the data they got was not very helpful and so they prefer adding a measure of upright time as well, as they think that would correlate better.

 

[Sasha]

I t

they prefer adding a measure of upright time as well, as they think that would correlate better.

OI is such a major and unrecognised part of ME/CFS I'd love to see something looking usefully at time spent non-upright. It's so incredibly disabling not to be able to survive vertically for long.

 

[BrightCandle]

One pretty easy and useful project would be to recontact people in say 3 years, 5 years and then 10 years (or similar) to understand more about recovery rates. There might be some bias w.r.t. certain groups being more likely to respond etc but that'd be something that would require close to no work.

A long term funcap tracking of patients for recovery and also death. We really need to have some good data on prognosis. My idea has been to have an annual funcap survey plus some basics like whether the patient has died alongside which criteria they match (CCC,IOM,International,NICE etc). Its a simple study doesn't require much from the patient but over time accumulates a lot of useful information on prognosis and course of the disease.

 

[MrMagoo]

A long term funcap tracking of patients for recovery and also death. We really need to have some good data on prognosis. My idea has been to have an annual funcap survey plus some basics like whether the patient has died alongside which criteria they match (CCC,IOM,International,NICE etc). Its a simple study doesn't require much from the patient but over time accumulates a lot of useful information on prognosis and course of the disease.

Ido a monthly FUNCAP through Visible, have a year’s worth of data already

 

[Kitty]

I'd say the single most useful thing we could do is advocate for being involved in trial design at the very earliest stage. Preferably before the funding application goes in.

Someone is eventually going to come up with a rationale for trialling a drug therapy that looks sound enough to attract funding, but we need to help them work out how to measure improvement. How to get around the problem of participants increasing some activities but dropping or reducing others to maximise more capacity. How long they need to be followed for, and how to deal with that given that projects are unlikely to be funded for five years plus. (My suggestion would be that it's set up so a hospital clinic, GP or practice nurse could collect the late data—if it can be got onto the person's medical record, it can be fed through into the trial data.)

 

[Sasha]

I'd say the single most useful thing we could do is advocate for being involved in trial design at the very earliest stage. Preferably before the funding application goes in.

Maybe we should just plain old design a trial!

Someone is eventually going to come up with a rationale for trialling a drug therapy that looks sound enough to attract funding, but we need to help them work out how to measure improvement. How to get around the problem of participants increasing some activities but dropping or reducing others to maximise more capacity.

Sounds like we should set up a thread on that. I'm hearing a lot about FUNCAP and just had a look at it and didn't think it looked very useful.

How long they need to be followed for, and how to deal with that given that projects are unlikely to be funded for five years plus. (My suggestion would be that it's set up so a hospital clinic, GP or practice nurse could collect the late data—if it can be got onto the person's medical record, it can be fed through into the trial data.)

Maybe a project could get funding for 5 years or longer - less funding would be needed for the later years.

 

[Kitty]

I'm hearing a lot about FUNCAP and just had a look at it and didn't think it looked very useful.

In terms of what it does, it's the best thing we've got.

But there are other ways to look at function and improvement that might be a better fit people who're right at the ends of the mild—moderate—severe spectrum, and also those with other impairments.

For instance, walking distance isn't going to be ideal for people with weakened muscles, or those whose mobility difficulties aren't even due to ME/CFS. It's also not ideal for people who, if they gained additional capacity, wouldn't choose to use it by walking about a lot.

We need to think about what level of detail is required, but also what's the minimum that would be useful. What has the least impact on participants, so they'll be motivated to keep doing it whether they improve, see no change, or feel worse from side effects? What collection and submission methods will be accessible to most people? Etc.

 

[Trish]

I think a combination of FUNCAP and a cognitive test filled in every couple of months and a wearable, perhaps worn around the ankle that does both steps and time upright. Have thousands of people of all severity levels do this for several years and there would be such a rich set of data. Possibly add a blood and urine test once or twice a year if there are useful things to measure and combine it with the GWAS data. People with very severe ME/CFS to have a modified version, for example if they are completly bedridden, no need for the ankle wearble, and their carer could fill in FUNCAP, where they would probably score zero or close to it.

 

[Kitty]

Maybe a project could get funding for 5 years or longer - less funding would be needed for the later years.

Thing is, most of the money will be salaries. You can't keep a whole team together just to pick up and process monthly inputs for several years. You'd need to think about how else to manage that follow-up.

You could build it into a doctoral programme or an academic post that's already funded; or keep a team together by getting funding for several different projects over the five-year period; or run the project with a couple of hospital trusts, and they collect the data and do the monitoring. There are probably other, better solutions, but I don't have enough knowledge of the sector.

 

[MrMagoo]

But in four years, Visible will have lots of 5 years worth of data…

 

[Utsikt]

Possibly add a blood and urine test once or twice a year if there are useful things to measure and combine it with the GWAS data.

Blood requires home visits for many, but would be nice to have. We could add feces and saliva as well.

 

[Sasha]

Blood requires home visits for many, but would be nice to have. We could add feces and saliva as well.

Some home-testing kits just require you to stab yourself horribly in the finger and bleed inadequately onto a bit of blotting paper. Not suitable for measuring everything, but maybe some things.

 

[bobbler]

One pretty easy and useful project would be to recontact people in say 3 years, 5 years and then 10 years (or similar) to understand more about recovery rates. There might be some bias w.r.t. certain groups being more likely to respond etc but that'd be something that would require close to no work.

that was the one that struck me.

there is a balance between making something too long or complicated vs what to add in alongside this in relation to also asking what situation said people have also been in during that time.

So for example to get a sense of whether those who recovered were indeed more likely to have a situation where they weren't over-exerted as much.

Of course what certain courses call 'recovered' isn't the same as 'back to 100%', or some people just change their lives to no longer doing the full-time hectic office or manual job they did before but something substantially less exertive and 'don't have the issue of symptoms etc' so it then gets complex. BUt as others have mentioned FUNCAP has been quite a useful development.

Or something along the lines to finally knock the brain retraining/mindfulness (in general ie the 'what if' claimers) stuff on its head by using the size of the dataset to see how many tried vs how many are 'fully recovered' or even what severity they are now.

So that people at least stop being coerced into things based on claims 'some recovered, so you can't claim you won't recover until you've completed this list' if it turns out when using a representative sample whether you did or didn't do these things made little difference?

 

[bobbler]

Wow, that would be really, really interesting. We have no real clue about recovery rates, though some indication that they're higher in children and young people, and DecodeME might include a decent number of younger people, given that you had to be 16+ to take part.

It could be designed to have some really searching questions to determine whether someone has recovered or has just forgotten what normal health is (which has been a concern in other studies, IIRC).

That's a great idea.

and if that is the case that eg children or young people do actually fully recover then it would be interesting to think about whether there is any genetic or biological check to see what that actually means. eg is it 'dormant', 'managed', 'gone' or .. about being 'discharged/released' so combines with something else for people in the most vulnerable age-group (given the past regime 'getting out of the system' must be really important, as is getting rid of the label providing as much 'pro' in many circumstances as any adjustments from keeping it might provide) ?

 

[bobbler]

One pretty easy and useful project would be to recontact people in say 3 years, 5 years and then 10 years (or similar) to understand more about recovery rates. There might be some bias w.r.t. certain groups being more likely to respond etc but that'd be something that would require close to no work.

I'm wondering too about data on other comorbidities, particularly new diagnoses.

I'd hope that we didn't have misdiagnoses but I know a lot of people who have had ME/CFS and then ended up with other significant conditions such as RA. And whether there is something that makes people who are ill with ME/CFS for long enough more vulnerable to other conditions coming through or vice versa (early stage of other conditions makes ME/CFS more likely).

I have collected another 'finding' or potential diagnosis in the last few years.

Some of these things could just be from having to live pushing through on an ME/CFS body causing other things to go awry.

Some might just be pointing out the obvious, which is that we are people in human bodies too, so pwme can also get other illnesses on top and shouldn't be dismissed when they talk about x symptom because even if we have the same stats for certain additional things as other people it is surely an important reminder that we deserve for that to be diagnosed and treated just like anyone else?

Anyway it is useful to know if there are things to watch for (that aren't just about 'check for vit D or anemia at the point of diagnosis, then leave em to it because it's just ME/CFS')

 

[bobbler]

Thing is, most of the money will be salaries. You can't keep a whole team together just to pick up and process monthly inputs for several years. You'd need to think about how else to manage that follow-up.

You could build it into a doctoral programme or an academic post that's already funded; or keep a team together by getting funding for several different projects over the five-year period; or run the project with a couple of hospital trusts, and they collect the data and do the monitoring. There are probably other, better solutions, but I don't have enough knowledge of the sector.

Good point. The oversight and trust has been vital in this project,

so I think that any continuation would need to think of how to keep those flagship aspects/that control and transparency/privacy etc in place even if the specific projects mightn't need the doer to be the whole team, I'd want to know that there is longevity in the 'who chooses if that doer gets to do and how' still being as solid.