Andy
Retired committee member
I think it's a great idea and I would like to see it if it's feasible.
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New Forum Software Installed (Still a few issues but reopening the forum) More details.
UK Genome Wide Association Study (GWAS) project - draft website goes live, feedback sought on recruitment plan, and updates
Invisible Woman
Senior Member (Voting Rights)
Re the questionnaires business (again).
I agree with @Ravn and wouldn't have an issue with suitable questionnaires.
Regarding the providing a sample and then you can fill in currently unknown questionnaires later as an option - I'm afraid that would put me off completely unless the questionnaires were specifically related to the data thrown up and were factual. As opposed to the ambiguously worded stuff, however well intended.
The reason I am opposed to this is that, presumably, this data will be shared in the future. I can't imagine the BPSers won't want to see it at some stage. We know from past experience they will "backfill", for want of the correct stats term, for any missing data. Therefore, even if I don't fill in a form assumptions will be made about what my answer might have been and papers written as though I had filled in the optional questionnaires.
Again, assuming this data will be shared, I do not want to provide an overlay of ambiguous or subjective data (that might change with time or the course of the illness anyway). This could easily be used/twisted against us later. Having already been through all the arguments and AfME reassurance about PACE, I really don't want to be sitting here in 5 or 6 years time having the data collection from this research used against me.
I don't share my genetic data lightly. Looking for answers to a treatment or cure for this disease is about the only thing that would induce me to provide a sample voluntarily. To have that twisted against me later would feel like a violation.
I agree with @Ravn and wouldn't have an issue with suitable questionnaires.
Regarding the providing a sample and then you can fill in currently unknown questionnaires later as an option - I'm afraid that would put me off completely unless the questionnaires were specifically related to the data thrown up and were factual. As opposed to the ambiguously worded stuff, however well intended.
The reason I am opposed to this is that, presumably, this data will be shared in the future. I can't imagine the BPSers won't want to see it at some stage. We know from past experience they will "backfill", for want of the correct stats term, for any missing data. Therefore, even if I don't fill in a form assumptions will be made about what my answer might have been and papers written as though I had filled in the optional questionnaires.
Again, assuming this data will be shared, I do not want to provide an overlay of ambiguous or subjective data (that might change with time or the course of the illness anyway). This could easily be used/twisted against us later. Having already been through all the arguments and AfME reassurance about PACE, I really don't want to be sitting here in 5 or 6 years time having the data collection from this research used against me.
I don't share my genetic data lightly. Looking for answers to a treatment or cure for this disease is about the only thing that would induce me to provide a sample voluntarily. To have that twisted against me later would feel like a violation.
Example of a current GWAS study & recruitment strategy
Apologies if people have seen this already. It is a study on anxiety and depression but bear with me...
I told my doctor about the potential ME GWAS today and he told me about the GLAD study.
It's a GWAS study funded (I believe) by NIHR.
My GP surgery is helping to recruit participants.
On each doctor's desk they have an A5 leaflet attached to a letter from the practice inviting people to take part.
The leaflet gives a brief overview of the study, and a link to the website: www.gladstudy.org.uk
I had a quick look at the website and it looks very similar to the methodology that has been proposed/discussed for the ME GWAS study.
Anyway, just sharing in case this is useful as a current, live example of a study with a very similar methodology, in terms of how they are recruiting participants and managing sign-ups, questionnaires, saliva samples, publicity, social media etc.
I am NOT attempting to start a debate about the merits of GWAS for a study on anxiety and depression. I am just sharing this in case it contains any useful ideas for thing to do (or not to do!) for patient recruitment, web design, online platform, etc.
P.s. sorry for the poor quality photos. I am too tired to get the scanner out today.
Edited: I accidentally uploaded the letter showing the name of my surgery. I deleted and re-posted with the surgery name obscured.
Apologies if people have seen this already. It is a study on anxiety and depression but bear with me...
I told my doctor about the potential ME GWAS today and he told me about the GLAD study.
It's a GWAS study funded (I believe) by NIHR.
My GP surgery is helping to recruit participants.
On each doctor's desk they have an A5 leaflet attached to a letter from the practice inviting people to take part.
The leaflet gives a brief overview of the study, and a link to the website: www.gladstudy.org.uk
I had a quick look at the website and it looks very similar to the methodology that has been proposed/discussed for the ME GWAS study.
Anyway, just sharing in case this is useful as a current, live example of a study with a very similar methodology, in terms of how they are recruiting participants and managing sign-ups, questionnaires, saliva samples, publicity, social media etc.
I am NOT attempting to start a debate about the merits of GWAS for a study on anxiety and depression. I am just sharing this in case it contains any useful ideas for thing to do (or not to do!) for patient recruitment, web design, online platform, etc.
P.s. sorry for the poor quality photos. I am too tired to get the scanner out today.
Edited: I accidentally uploaded the letter showing the name of my surgery. I deleted and re-posted with the surgery name obscured.
Attachments
Kitty
Senior Member (Voting Rights)
The study title, though...you just know King's College is involved without even looking!
They just love a catchy title
Andy
Retired committee member
Thanks, useful extra info.
I've noted earlier in this thread that we will be trying to learn all the useful lessons that there are from the GLAD study regarding reaching out to potential participants.
GLAD study thread here, https://www.s4me.info/threads/genet...f-depression-anxiety-2019-davies-et-al.12086/,
Oh thanks Andy - sorry I didn't see your earlier comment or the GLAD study thread!
Andy
Retired committee member
So I think there are a lot of potential aspects to this discussion area that could do with being clarified.
1. What questionnaires will the GWAS use? At this moment in time, the intention is to use the CureME developed ones to find out if the potential participant meets CCC or IOM/NAM, and RAND-36 (the open access version of the SF-36) which, while it definitely has its issues, will allow comparison with the existing biobank cohort (who have completed it already).
2. Any participant in the GWAS will be asked if they would be happy to receive contact from researchers in the future. It is possible to say no at this stage and so only take part in the GWAS, never to be contacted again.
3. If you have indicated that you are happy to be contacted in the future, then any researcher, either the same researchers or others, will have had to get ethical approval for their research. As we know from examples that we have looked at on the forum, that is not a guarantee that the research has value to us as patients, but it at least forces some minimum standards. And even if you are contacted, you can turn the approach down if you weren't comfortable with the study.
4. Will the BPSers want/try to make use of this re-contactable cohort? Yes, almost certainly, and there is almost nothing that we can practically do to stop that, but the patient will always be able to choose whether they take part, and, more importantly for me, biomedical researchers will also be able make use of it. Given that recruitment is such an issue for biomedical researchers, a bank of patients who have already indicated their potential willingness to be involved; who have, to a certain degree, been pre-assessed; and who can be contacted on the basis of where they are, could prove to be invaluable for future research.
5. "papers written as though I had filled in the optional questionnaires". Sorry, but being blunt, we can't legislate for that kind of thing. We cannot, in good faith, give a guarantee that the data shared with us will always be used in ways that every participant will be completely happy with. My personal belief though is that my, and everybody else's, data will enable research that will bring positive, potentially massive, change to the lives of many people, and I will put up with the garbage that will be bound to come from the BPSers on that basis. However, I can understand that if people don't feel the same way then that might mean that they won't want to take part.
Invisible Woman
Senior Member (Voting Rights)
Good clarification, thanks @Andy!
The concerns I raised were about what questionnaires would be included in the GWAS study itself and your clarification puts my concern to rest.
Studies by other researchers that crop up at a later date, requiring additional questionnaires and patient can be judged on their own merits as and when. That seems fair enough to me.
The concerns I raised were about what questionnaires would be included in the GWAS study itself and your clarification puts my concern to rest.
Studies by other researchers that crop up at a later date, requiring additional questionnaires and patient can be judged on their own merits as and when. That seems fair enough to me.
Snow Leopard
Senior Member (Voting Rights)
Yes, most questionnaires should be burned in a large fire for all the good they do...
Jonathan Edwards
Senior Member (Voting Rights)
I am puzzled by this. Other researchers should be able to make use of the anonymised genetic data but I am not sure what is meant by making use of this re-contactable cohort. I don't see any reason why anyone except the grant holders should be permitted to contact patients. If the impression is given that other researchers can contact patients then I think this would be a isasterfor recruitment. The word would rapidly get around. If I was a PWME no way would I allow re-contacting by other researchers.
Jonathan Edwards
Senior Member (Voting Rights)
I am not at all sure about that. I think people volunteering have a right to want to be sure they are not going to be contacted on behalf of anyone except the grant holders.
I think it would be a serious mistake to treat this cohort as a 'general research resource' in the way that Google and Facebook sell general market population resources. This is not going to be a standard recruitment situation. It will need a lot of care to get the goodwill of very large numbers I think. From what I gather, outside the central core of people on forums a large proportion of PWME may be very wary about anything that reminds them of 'being someone with CFS/ME'. In our family it is cancer that individuals do not want to be reminded of. Any communication relating to cancer goes straight in the bin.
Andy
Retired committee member
Jonathan Edwards
Senior Member (Voting Rights)
I would actually recommend that the issue of re-contacting people is not raised and that it is made clear that if further contact for future projects might be helpful then people will be alert through press releases to log on again if they wish.
Andy
Retired committee member
Jonathan Edwards
Senior Member (Voting Rights)
When people sign up to this study, we will ask them if they are willing to be contacted about taking part (directly, or by agreeing to share samples and data from this study) in new studies, either related to this one or unrelated. This will make it much easier for researchers to recruit participants for studies, speeding up the pace of research.
That worries me. People will have to make a decision. They may well be wary of saying yes. They may also feel negative at saying no. My instinct is that this sort of decision is exactly the sort of thing that leads to clicking on 'close window'.
It also raises the question of what is the point of having a partial cohort of those people who clicked yes. For the great majority of studies a cohort the size of the CureME one is adequate.
That worries me. People will have to make a decision. They may well be wary of saying yes. They may also feel negative at saying no. My instinct is that this sort of decision is exactly the sort of thing that leads to clicking on 'close window'.
It also raises the question of what is the point of having a partial cohort of those people who clicked yes. For the great majority of studies a cohort the size of the CureME one is adequate.
Jonathan Edwards
Senior Member (Voting Rights)
The GLAD study would not have had the make or break issue of getting enough cases because anxiety/depression is much more common. Moreover, there would not be the sensitivity about the 'wrong people' having the ability to contact.
Invisible Woman
Senior Member (Voting Rights)
Speaking entirely for myself I wouldn't opt-in to be recontactable by anyone other the original researchers should they need more information. I don't want to be on anyone's list for anything where it's at all avoidable.
I don't know what's normal for this kind of thing though.
I don't know what's normal for this kind of thing though.
Jonathan Edwards
Senior Member (Voting Rights)
It is hard to say what is normal, since the business of mass contacting people and privacy protection is relatively new. Historically it was not considered ethical for anyone to contact patients other than their own medical carers. If I had a list of patients I had studied there was no way I was going to give their details for contacting to another researcher. If there was another project I thought of value I would ask the patient myself if they were interested.
I think the default position is that you do not even think of suggesting other researchers contact patients who have volunteered for your study.
Hoopoe
Senior Member (Voting Rights)
It seems sensible to prioritize maximization of recruitment rates above all else because that is the main obstacle to overcome.
I would have second thoughts participating if there was any indication that the usual CBT/GET careerists could get their hands on the data and as usual, offer bizarre interpretations that aren't really supported by the data but create the superficial appearance that what they're doing is sensible. The NICE review stakeholder consultation showed that there is widespread and unanimous opposition to CBT/GET by patient organizations in a way that is unheard of for any NICe recommended treatment. The circumstances are unusual. Patients feel like they are severely misunderstood and that the establishment has failed them.
To maximize recruitment rates, the recruitment material must leave no doubts that this study will not be used to further promote harmful misconceptions and ineffective therapies.
Truth and reconcilition requires that there be some sort of admission that the dominant line of research into ME/CFS done in he UK was rubbish and has harmed patients. Genrtics research hasn't been rubbish as far as I can tell but there is the issue of questionnaires. For example a common way these are abused by CBT/GET proponents is that patients agreeing to questionnaire items such as "exertion can cause relapses" are labelled as engaging in a maladaptive behaviour called catastrophizing, and that this is evidence of irrational beliefs that require CBT (rather than an accurate description of the symptoms of the illness).
Despite my concerns I would still participate if I could because I'm highly motivated to help advance research, but less motivated patients might weigh the pros and cons and not come away with the feeling that this is worth their time and effort.
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