Building a PSSD, PFS, PAS patient registy: Discussion

This is a place to post research you have done on the topic along with your conclusions.
Firstprinciples
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Building a PSSD, PFS, PAS patient registy: Discussion

Unread post by Firstprinciples »

Dear PSSD-Community,

as some of You know we founded an organisation whose primary function should be to accelerate the speed of PFS, PSSD and PAS research.

One of our friends in the US got in touch with NORD (National organisation of rare disorders) to discuss the opportunity to start a patients registry.

What is a patient registry?
A registry is a platform where patient data can be stored.
Here is more information from NORD on what a patient registry is. There is a good video: https://rarediseases.org/iamrare-registry-program/

What can be stored in a patient registry?
Nearly everything: Results of blood tests, cerebrospinal biomarkers, MRI pictures, surveys, even results of previous studies could be combines with new studies and allow instantaneous to draw relationships between markers tested in the same patient (for example previous lab data with data from a post-mortem tissue sample that was stored in a biobank)....

Why is a patient registry a necessary step for the PSSD/PFS/PAS community?
Here is a short video of NORD explaining the significance of patient registries for rare diseases: https://rarediseases.org/wp-content/upl ... eo.mp4?_=1
Longitudinal data acquisition: Currently we don't know much about how the disease develops over time. With a patient registry, we could make studies on possible secondary diseases like Alzheimer's, Parkinson's, autoimmune diseases, cardiovascular diseases, changes in risk of infection, what impact the disease has on fertility etc. These insights would help to provide affected individuals with training to reduce additional risk factors for these diseases and would provide insights into the affected pathways which directly could lead to better studies.
Who has PSSD and who has something else: Although we are pretty sure that we have PSSD or PFS, there will be patients among us who are affected by a different disease that is not PSSD or PFS. The problem with studies is that these patients cause a bias in the study data and can lead to study results that are not representative of PSSD. This would not only lead to a lot of money being burned but could also lead to wrong future study directions. A validated survey/online test or seeing an expert doctor before signing up in the registry could reduce the wrong data and lead to better studies.
Patient recruitment: One of the most important things when doing a study is to get a pretty homogenous group of patients. Otherwise, you need patient cohorts of very big numbers. The problem with PSSD and PFS is that we all vary a lot in symptoms and symptom severity. We don't even know whether there might be PSSD subgroups that are a different disease. This makes making a good study with trustworthy results nearly impossible. A patient registry would allow recruiting patients according to a specific set of symptoms. Therefore it would allow to build and test pretty homogenous patient groups. The registry would allow pretty quick and cost-efficient recruitment. Otherwise, recruitment would take months and oftentimes costs money or time of volunteers.
Control group: Part of every serious study is a control group. Oftentimes healthy people are used, but in our case, it would also make sense to use patients that use SSRI or finasteride but don't develop symptoms. Registration of these control groups would even allow following patients who get PSSD over time. We would have valuable pre-/post data and could tell that person exactly what biomarkers to test during the crash (probably there are values that go off the chart during the crash).
Symptom and supplement tracking: Theoretically this registry would even allow tracking people who take certain supplements and see their biomarkers. It would allow shedding light on who is really a recovery and who not, what may work and whatnot.

Now the important part:

The organisation NORD got 250K from the FDA to build 20 patient registries and they have a great experience. It looks even like it's combined with a study they would do.
The tricky thing is that a registry probably costs money and needs volunteers to make sure the data is inserted correctly by the patients.
I can't say yet how much money that is. But I hope if the PFS and PSSD community decides together to do this, it will be affordable.
Last but not least, we would need a team that maintains the database. As I think that this project is one of the most important milestones in fighting the disease, I will offer myself as a volunteer, but we need at least 5-6 volunteers I guess.

As there is sometimes financial governmental support or support from Orphanet and similar organisations to build a patient registry. I will see if there is a way that we don't have to pay for it as a community.

My questions:
- Is the PSSD community interested in a joint patient registry?
- Would there be possible volunteers from your side that would help taking care of the registry?
- Would the community be willing to financially participate in the project (I don't have numbers yet)?
Frog
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Re: Building a PSSD, PFS, PAS patient registy: Discussion

Unread post by Frog »

It would be great to get something like this going! Are you suggesting that it’s the same registry for all 3? This worries me as it’s likely that all of the conditions are different and in my opinion, need to be investigated individually before being linked
Firstprinciples
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Re: Building a PSSD, PFS, PAS patient registy: Discussion

Unread post by Firstprinciples »

This wouldn't be a problem. Each disease could maintain its identity. It would allow cross-validation of aberrant biomarkers. Ideally, the registry would also be used for a certain amount of disease-relevant control groups, such as SSRI users, finasteride users, isotretinoin users. The ME/CFS community has a similar registry where control groups can sign up as well.
Frog
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Re: Building a PSSD, PFS, PAS patient registy: Discussion

Unread post by Frog »

That sounds great! Have you considered emailing Dr Healy about this? If he can send an email out or do a blog post people would be much more likely to get involved. It could also help to reach people who don’t use the forums. Great work!👍🏻
JP1985
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Re: Building a PSSD, PFS, PAS patient registy: Discussion

Unread post by JP1985 »

Firstprinciples wrote: Tue Dec 01, 2020 11:50 am Dear PSSD-Community,

as some of You know we founded an organisation whose primary function should be to accelerate the speed of PFS, PSSD and PAS research.

One of our friends in the US got in touch with NORD (National organisation of rare disorders) to discuss the opportunity to start a patients registry.

What is a patient registry?
A registry is a platform where patient data can be stored.
Here is more information from NORD on what a patient registry is. There is a good video: https://rarediseases.org/iamrare-registry-program/

What can be stored in a patient registry?
Nearly everything: Results of blood tests, cerebrospinal biomarkers, MRI pictures, surveys, even results of previous studies could be combines with new studies and allow instantaneous to draw relationships between markers tested in the same patient (for example previous lab data with data from a post-mortem tissue sample that was stored in a biobank)....

Why is a patient registry a necessary step for the PSSD/PFS/PAS community?
Here is a short video of NORD explaining the significance of patient registries for rare diseases: https://rarediseases.org/wp-content/upl ... eo.mp4?_=1
Longitudinal data acquisition: Currently we don't know much about how the disease develops over time. With a patient registry, we could make studies on possible secondary diseases like Alzheimer's, Parkinson's, autoimmune diseases, cardiovascular diseases, changes in risk of infection, what impact the disease has on fertility etc. These insights would help to provide affected individuals with training to reduce additional risk factors for these diseases and would provide insights into the affected pathways which directly could lead to better studies.
Who has PSSD and who has something else: Although we are pretty sure that we have PSSD or PFS, there will be patients among us who are affected by a different disease that is not PSSD or PFS. The problem with studies is that these patients cause a bias in the study data and can lead to study results that are not representative of PSSD. This would not only lead to a lot of money being burned but could also lead to wrong future study directions. A validated survey/online test or seeing an expert doctor before signing up in the registry could reduce the wrong data and lead to better studies.
Patient recruitment: One of the most important things when doing a study is to get a pretty homogenous group of patients. Otherwise, you need patient cohorts of very big numbers. The problem with PSSD and PFS is that we all vary a lot in symptoms and symptom severity. We don't even know whether there might be PSSD subgroups that are a different disease. This makes making a good study with trustworthy results nearly impossible. A patient registry would allow recruiting patients according to a specific set of symptoms. Therefore it would allow to build and test pretty homogenous patient groups. The registry would allow pretty quick and cost-efficient recruitment. Otherwise, recruitment would take months and oftentimes costs money or time of volunteers.
Control group: Part of every serious study is a control group. Oftentimes healthy people are used, but in our case, it would also make sense to use patients that use SSRI or finasteride but don't develop symptoms. Registration of these control groups would even allow following patients who get PSSD over time. We would have valuable pre-/post data and could tell that person exactly what biomarkers to test during the crash (probably there are values that go off the chart during the crash).
Symptom and supplement tracking: Theoretically this registry would even allow tracking people who take certain supplements and see their biomarkers. It would allow shedding light on who is really a recovery and who not, what may work and whatnot.

Now the important part:

The organisation NORD got 250K from the FDA to build 20 patient registries and they have a great experience. It looks even like it's combined with a study they would do.
The tricky thing is that a registry probably costs money and needs volunteers to make sure the data is inserted correctly by the patients.
I can't say yet how much money that is. But I hope if the PFS and PSSD community decides together to do this, it will be affordable.
Last but not least, we would need a team that maintains the database. As I think that this project is one of the most important milestones in fighting the disease, I will offer myself as a volunteer, but we need at least 5-6 volunteers I guess.

As there is sometimes financial governmental support or support from Orphanet and similar organisations to build a patient registry. I will see if there is a way that we don't have to pay for it as a community.

My questions:
- Is the PSSD community interested in a joint patient registry?
- Would there be possible volunteers from your side that would help taking care of the registry?
- Would the community be willing to financially participate in the project (I don't have numbers yet)?
Hello.. Yep will donate to this 👍
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climb
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Re: Building a PSSD, PFS, PAS patient registy: Discussion

Unread post by climb »

It's a good idea. It seems like it has the potential to contain a variety of data, so would add additional value compared to existing databases for PSSD and PFS.

I'd be willing to contribute financially. In theory, I'm happy to spend some time helping out, but within reasonable limits as my day job has me stuck in front of a computer 😃.
Firstprinciples
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Re: Building a PSSD, PFS, PAS patient registy: Discussion

Unread post by Firstprinciples »

Thanks.
I also thought if we make a small public fundraisung campaign. This could be something good for a public crowdfunding project. It would be a good thing to raise public awareness.

I think some public grants for example from the EJP program or NIH could finance the project, but I think we need recognition as a rare disease first. Still don't understand why we are excluded from rare disease funding. There are 100M currently funded by the EU to rare disease projects. I have difficulties finding out why we are but elegible and what we can do to become elegible
Kiliantkt
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Re: Building a PSSD, PFS, PAS patient registy: Discussion

Unread post by Kiliantkt »

That's a very good idea. Def interested to participate.
Money wise, I would contribute, like I did for Rxisk and currently the Go Fund for Dr Melcangi .
English isn't my native language so not sure about managing the database, and I'm located in Switzerland.
Look forward to hearing more details.
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