Patient registries

[Hutan]

I need to write something to support the development of an ME/CFS patient registry in my country.

I'm interested to know what ME/CFS patient registries exist in the world - I think there's;
Solve M.E.'s ones - Australia and the US
OMF - US (and beyond?)
Germany - I think there's one?

And I think some researchers have relatively small registries e.g. NCNED
And biobanks of course will have patient data e.g. the UK ME/CFS biobank; the Emerge Australia biobank (which I think makes use of the Solve M.E. registry).

I guess there is a patient registry associated with DecodeME too.


As far as I know, the existing registries probably consist mainly of people with West European ancestry, so there's an argument for more registries that add to the genetic and cultural diversity of patient data.

In my country, we have no ME/CFS specialist doctors, so a patient registry can be a storehouse of knowledge that would otherwise get lost when patients are only being cared for by their local GPs.

If anyone has resources/ideas that might help with making the case for a national ME/CFS patient registry, please do post them here.

In New Zealand, we already have a Long covid registry, so the idea is that an ME/CFS registry would piggyback off that, making use of much of the work that has already been done to set that up.

 

[EndME]

Some details on the german biobank/registry: https://classic.clinicaltrials.gov/ct2/show/NCT05778006?term=Scheibenbogen&draw=2&rank=1, https://www.bundesgesundheitsminist...g/handlungsfelder/gesundheitsversorgung/mecfs, https://mecfs-research.org/wp-conte...nielaSchindler_MECFS-Register-und-Biobank.pdf. Here are some details on funding: https://www.gesundheitsforschung-bm...men-des-postinfektiosen-chronischen-15511.php.

Of course there are also now the two dutch ones (Lifelines and NMCB) but those are the worst examples and can only serve as an example on how not to do it.

 

[Andy]

I guess there is a patient registry associated with DecodeME too.

We obviously have all the responses from our participants to our primary questionnaire, and there will be a secondary questionnaire that will explore additional areas of interest, but we have never called our cohort a registry.

There is also The Netherlands ME/CFS Cohort and Biobank (NMCB) consortium which is in it's early days.

I'm sure you have thought of this but it's probably worth looking at what benefit registries have delivered for other disease areas, given that insufficient time has passed for any ME/CFS one to prove it's worth.

 

[EndME]

Apparently there is now also an Austrian Biobank setup by the WE&ME Foundation (formerly TEMPI Stiftung) https://www.weandmecfs.org/research...t-austrian-biobank-for-me-cfs-patient-samples.

 

[Ravn]

I need to write something to support the development of an ME/CFS patient registry in my country.

Looks like there's some movement on a possible NZ registry. ANZMES just put out a press release which briefly mentions the possibility of setting one up

Also, have you seen this guide?
"So You Want to Build Your Disease’s First Online Patient Registry: An Educational Guide for Patient Organizations Based on US and European Experience, 2023, Wicks et al" https://doi.org/10.1007/s40271-023-00619-w
It provides a good overview of types of registries and of the process of setting them up, as well as this piece of advice

The point of a registry is not merely to collect data [13]. The point of a registry is to answer questions. The types of questions we can answer with a registry might include scientific, clinical, and policy concerns.
[...]
If the data you gather have no path of becoming information needed to guide decisions, it is just being conducted for curiosity’s sake.

I think it's worth discussing how to get the best out of a registry. Setting one up is not a trivial exercise and it's not cheap. So you want to get significant extra value out of any new registry, on top of what you can get from the existing ones or from other sources

 

[Ravn]

I need to write something to support the development of an ME/CFS patient registry in my country.

I know this was a while ago but can you still recall or dig up, without going to too much trouble, what you wrote about establishing a patient registry?

In New Zealand, we already have a Long covid registry, so the idea is that an ME/CFS registry would piggyback off that, making use of much of the work that has already been done to set that up.

Like you said, the most likely scenario is that it would be tacked onto the Long Covid registry though I'm not sure how they stand regarding long-term funding.

But, to get a hang of the thinking behind the LC registry, this is from their enrolment page

We hope this will help us to understand

• the burden of long COVID on patients, including learning more about symptoms,
• the impact of long COVID on quality of life,
• the different pathways and possible complications to receiving diagnosis and treatment,
• the impact of long COVID on work and caregiving,
• the cost of long COVID on individuals and our wider society,
• the distribution of this burden, and
• whether the impacts improve or worsen over time.

So the immediate aims are primarily about assessing the impact or burden of LC, plus some symptom monitoring. Or maybe I should say that was the immediate aim. I'm pretty sure I read somewhere they've already written a report for the Ministry of Health about their findings but it hasn't been officially released. Though it must be floating around somewhere as some media seem to have access to it. I haven't tried to track it down

We are using a registry-based cohort study design. We will be collecting data using online surveys completed by people with self-reported long COVID symptoms

Recruitment bias would look to be an issue here. Diagnosis, too, since getting one seems to be just as hit and miss as it is for ME.

A non-representative cohort can still tell us a lot about gaps in support in a qualitative way and that would be worth documenting in NZ as some of those gaps will be specific to NZ

But is there a realistic way of getting a more representative cohort?

The types of questions in these surveys are related to your COVID-19 infection(s), use of health services, experience with long COVID and how long COVID has impacted your personal, social and work life.

We will send you a reminder to complete a monthly survey about your quality of life. Each month you will be asked to complete six short questions that will not take more than five minutes. Six months after you registered with the registry you will be asked to complete another survey so we can understand how your symptoms, diagnosis, work etc might have changed.

Monthly questionnaires make sense in the context of early illness, to track how it's developing. Probably doesn't make sense for established ME, at least for the types of questionnaires mentioned. The one exception would be symptom tracking but for that you might want to go daily with an app like Solve. Could they partner with Solve? How is Solve going these days anyway, is the data they're generating being used in useful ways?

Studies seeking to understand or treat long COVID may wish to recruit participants through the long COVID registry. Researchers would need to submit a request to the research team for the characteristics/background/demographics of individuals they want, along with the details of their study. Te Rōpū Kaitiaki (our advisory group) will review these requests to ensure they align with the aims of the registry and are mana enhancing. Professor Paula Lorgelly and the research team will identify those individuals who meet the criteria of interest, confirm the individuals have consented to being contacted for other studies (that are not related to this registry study of burden) and the registry research team will contact those participants to tell them about the study. No registry data will be released without participants’ consent.

Your data could help researchers to understand who is impacted but long COVID and why. It could also help researchers to understand if there are different types of long COVID and allow them to investigate which treatments might work and for whom.

I wonder how many other researchers have used this opportunity?

The recruitment bias and self-report diagnosis issues would be a stumbling block for some types of study

But for ME a registry might help attract some new researchers. ANZMES appears to be having trouble finding people to give grants to. Conceivably one reason for this could be that potential researchers don't know how to get hold of a cohort to study on a tiny budget

In this research we would like to link your study information with other data sets which include information about you. This is called ‘data-linking’. Data-linking in this study is optional, you can consent to data-linking on the consent form. In this study we will link the registry data to Stats NZ’s Integrated Data Infrastructure (IDI) – a large research database containing de-identified microdata about people and households, including data on health, education and training, housing, income and work, benefits and social services, and census information. We will link this using your NHI number (if you provide it) or your name, date of birth and gender.

Data-linking can produce a detailed picture of individuals. It will allow for analyses to be undertaken beyond the follow-up period of the study. Researchers will be able to investigate the burden of long COVID without having to request any more information from you. Data-linking with the Stats NZ’s IDI also means researchers (including iwi) can undertake comparisons of individuals with long COVID to those without, thereby understanding the additional impact of long COVID on healthcare use, employment, social support.

Theoretically a good idea. Practically double trouble. Trouble 1 is that a lot of people's health records (NHI linking) are such a mess they're somewhere between useless and totally misleading. Trouble 2 is that a lot of people are extremely wary of sharing sensitive statistical information (IDI linking) with anyone, de-identified or not, and that reluctance very likely is not evenly distributed across population groups

All quotes above are from https://www.lcregistry.auckland.ac.nz/about/

 

[Ravn]

So what would be the purpose of an ME patient registry in NZ, if it was similar to the Long Covid one?

Identification of gaps in support in the NZ system would be one though you'd still not get any reliable quantitative data. Also not sure if a registry would be the most efficient way of generating this sort of more qualitative data, going through the patient support orgs may be enough. Although a registry might reach people who don't engage with the patient support orgs

Playing the long game, a credible and well publicised registry could have valuable indirect effects such as

More accurate diagnostic coding of ME if the existence of a registry they know they can refer to encourages more doctors to consider an ME diagnosis in the first place and then to get it right. In this case ideally the registry would be linked to quality patient support resources as well as medical education resources, for synergistic effect. The registry itself may still not provide good prevalence data but health record research may become more accurate

Growing the research ecosystem by enabling new researchers on tight budgets easier access to a cohort to study​

Playing the long game requires stable, long-term funding. I'm not sure indirect effects such as the above would be convincing arguments in potential funders' eyes?

What would be convincing? An international partnership with Solve? Other suggestions?

 

[Hutan]

I need to write something to support the development of an ME/CFS patient registry in my country.

I know this was a while ago but can you still recall or dig up, without going to too much trouble, what you wrote about establishing a patient registry?

Yes. The Science for ME forum committee agreed to provide a letter of support. This is an example of the sort of thing the forum can potentially do to assist researchers whose aims align with the forum. We didn't post it on the forum at the time, as it was included in an application for funding.

Here it is:


International ME/CFS community support for the establishment of an Aotearoa New Zealand Patient Registry and associated analyses

HRC Ref ID#: 24/735 Component 1
12 October 2023

Science for ME is an international forum focused on ME/CFS and similar diseases, established and run by both people with ME/CFS and carers for people with ME/CFS. People with ME/CFS, staff of ME/CFS organisations, researchers and clinicians meet to discuss advocacy, research needs and opportunities, and to analyse completed research. We are very pleased to support this proposal for the development of an ME/CFS patient registry for Aotearoa New Zealand.

The need: better knowledge of a significant disease
Despite the debilitating impact of what is a relatively common disease, information about the course of the disease is still very poor. We can’t advise people with any certainty about the chances of recovery, improvement and deterioration. We don’t know what percentage of people are able to work with this illness. We don’t know how factors of age of onset, or sex, or levels of severity, or pregnancy, or menopause affect the disease course. We don’t know whether having ME/CFS affects the likelihood of other diseases. We don’t know how many people are misdiagnosed with ME/CFS and are later found to have other reasons for their symptoms. We think that the disease runs in families, but we don’t understand the patterns of inheritance. There is almost no reliable ME/CFS prevalence data world-wide, and, to our knowledge, none at all in Polynesian populations. We don’t know what causes the disease or what can treat it.

This lack of knowledge is very difficult at a personal level, but, given the large numbers of people affected by the disease (including an increasing number of people meeting ME/CFS criteria after Covid-19), it has major implications for societies and economies.



Patient registries as part of the research infrastructure to meet that need
We are seeing an increase in the number of ME/CFS patient registries around the world in response to the recognised lack of knowledge. People with ME/CFS have welcomed these registries enthusiastically and participation levels have been good. Patient registries have made the disease more visible.

It is relatively early days for ME/CFS patient registries, but we are seeing them (often with associated biobanks) facilitating research, as they have done in other similar diseases such as multiple sclerosis. Registries are improving the quality of research too. Good quality registry governance, including representation of people with ME/CFS in decision-making roles, is helping to ensure that research using registry data or cohorts is answering important questions, is well-conceived, protects the participants, and effectively communicates results to stakeholders. Digital technology (including the incorporation of data from wearable monitoring technology) is making patient registries more cost effective and more powerful.

It is clear that a proportion of the people who develop Long Covid meet ME/CFS diagnostic criteria. ME/CFS registries can provide ME/CFS cohorts in Long Covid studies, to help determine if much of Long Covid is, as seems likely, a type of ME/CFS. If it is, then the long term health outcomes of people with ME/CFS will provide indications of what can be expected with Long Covid.



Reasons for an Aotearoa New Zealand ME/CFS patient registry
An ME/CFS patient registry in Aotearoa New Zealand is particularly important because the existing ME/CFS patient registries are largely of composed of people of northern European ancestry. A registry could help tell us about the Aotearoa New Zealand experience of ME/CFS and societal costs in a way that these other registries cannot. It could help produce research cohorts with unique genetic backgrounds; this is important in genetic hypothesis testing and in treatment evaluation.

Another important reason for a national ME/CFS patient registry in Aotearoa New Zealand is that there is no ME/CFS specialist doctor in the country. Care of individuals with ME/CFS is entirely managed by GPs, many of whom have little knowledge of the disease. No specialist doctor is seeing large numbers of people with ME/CFS and so, as a result, there is no production of consolidated reliable patient records that can help identify patterns and that can contribute to national policies relevant to people with ME/CFS. The screening questions that have been carefully developed for other ME/CFS registries could help confirm diagnostic processes.

Potential for collaborations and research of international significance
The growing understanding of the significance of ME/CFS and Long Covid is resulting in governments and private foundations offering funding for research programmes. Frequently this funding allows for, or even favours, international collaborations of research teams. Aotearoa New Zealand has some researchers who have already undertaken ME/CFS and Long Covid studies of international significance, for example biochemist Emeritus Professor Warren Tate (a recipient of the Rutherford Medal) and his team, and exercise physiologist Dr Lyn Hodges. With an ME/CFS patient registry in place, alongside the established Long Covid patient registry, it will be much easier for Aotearoa New Zealand researchers to participate in international collaborations.


Team
We are familiar with Associate Professor Mona Jeffreys and Professor Paula Lorgelly who are part of the team associated with HRC 24/735 Component #1., and are confident in their ability to deliver the planned outcomes. They have strong networks within the ME/CFS and Long Covid communities. The establishment of the Long Covid Registry was an important achievement. Associate Professor Mona Jeffreys has been a source of accurate information as the Long Covid crisis unfolded. We believe that her lived experience of ME/CFS helps her to work with sensitivity and insight on these post-infection diseases projects.

xxxxxx xxxxxx
On behalf of Science for ME
https://www.s4me.info

 

[Hutan]

Like you said, the most likely scenario is that it would be tacked onto the Long Covid registry though I'm not sure how they stand regarding long-term funding.

I'm not sure what ANZMES have in mind for a patient registry, but they really do need to be collaborating with Paula Lorgelly. I have been talking with her this year about strengthening the coverage of ME/CFS in the Long Covid registry, so that the registry could work for both Long Covid and ME/CFS.

 

[Daisybell]

@Hutan - I don’t know if it would be worth speaking with Miriam Rodrigues….
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5611797/
She works out of Auckland Hospital. She may have some good ideas. I wonder if she knows Paula Lorgelly…

 

[Ravn]

Yes. The Science for ME forum committee agreed to provide a letter of support. This is an example of the sort of thing the forum can potentially do to assist researchers whose aims align with the forum. We didn't post it on the forum at the time, as it was included in an application for funding.

Thanks @Hutan. Excellent letter, too.

Do you know what if anything came of the application? If you're not bound by any confidentiality considerations

I'm not sure what ANZMES have in mind for a patient registry, but they really do need to be collaborating with Paula Lorgelly.

I expect Mona and Paula will be talking to each other about this?

The ANZMES link is unclear to me, too. The registry was mentioned as part of the grant they awarded to Mona Jeffreys and Kahurangi Dey

Project: Exploring the Prevalence and Determinants of Food Insecurity in People with ME/CFS and/or Long COVID
This study, conducted in partnership with research candidate Kahurangi Dey, investigates food insecurity among individuals with ME/CFS and long COVID. The project will not only quantify the prevalence of food insecurity but will also contribute to the creation of an ME/CFS Registry in New Zealand, a vital resource for future research.

At first glance it's an odd sounding mix of food insecurity and a registry. Of course you could ask questions about the food insecurity of registry participants. But that would mean establishing the registry first and a $25,000 grant isn't going to do that I wouldn't have thought. Unless Mona got some other funding and the grant is more for Kahurangi? Or they didn't get other funding but are doing some groundwork with the help of the grant in the hope that this will open up more funding later? Guesses guesses guesses

Talking about guesses, anyone have any idea what it would cost to establish and then maintain a registry? Just a ball park figure?

 

[Ravn]

Looks like there's some movement on a possible NZ registry. ANZMES just put out a press release which briefly mentions the possibility of setting one up

Also, have you seen this guide?
"So You Want to Build Your Disease’s First Online Patient Registry: An Educational Guide for Patient Organizations Based on US and European Experience, 2023, Wicks et al" https://doi.org/10.1007/s40271-023-00619-w
It provides a good overview of types of registries and of the process of setting them up, as well as this piece of advice

Has anyone found out more about the potential NZ patient registry? Like, what's actually being proposed and what stage it's at?

Taking another look at the bolded bits in the quote below, what are the most important questions we would want a national patient registry, in NZ or elsewhere, to answer? In an ideal world, everything. But in a highly funding-constrained world, what would be the priorities?

Throughout this Education article, we repeat the importance of starting with the end in mind. The point of a registry is not merely to collect data [13]. The point of a registry is to answer questions. The types of questions we can answer with a registry might include scientific, clinical, and policy concerns. Scientific questions might include: What sort of people have this disease? Where can we find people who might be eligible to enroll in clinical trials? Could we stratify patients into different forms of the disease, for example, moderate/severe? Clinical questions might include: How are the outcomes of people with this disease changing over time? What are the most important symptoms to manage? How well do drugs and other interventions work in this disease? Finally, policy questions might include: What sort of services and support are people seeking and getting? Is there enough funding being provided to support people with this condition nationally as well as locally? Are people with this disease still able to work, study, and be productive? If not, what is getting in their way? There are several different types of project associated with the word “registry” and Table 2 attempts to differentiate between the most common examples of terms used in the field, but these are not always applied consistently.
[...]
Too often we see registries set up that will only describe the state of a given population, with the intent of generating hypotheses that can be tested later. However, it is worth going through this exercise up front because in many cases the decisions you make at an early stage will become hard to change later on. If the data you gather have no path of becoming information needed to guide decisions, it is just being conducted for curiosity’s sake.

 

[Ravn]

Some thoughts about the example questions in the previous post's quote, and their relevance to ME (I'll break it into several posts)

What sort of people have this disease?

Would be important information to have, we seem to be 'missing' whole chunks of the population e.g. non-Caucasians, but given the diagnostic mess - including suspected high numbers of undiagnosed pwME - is this a question for a registry or does it need a good epidemiological study?

Other patient registries often have fewer issues with recruitment bias because the condition they're monitoring falls under a medical specialty, has more diagnostic certainty and every patient diagnosed gets automatically referred to the registry. They may choose to not participate and there may be some bias in who does and doesn't but nowhere near the level of bias there'd be in an ME registry

Where can we find people who might be eligible to enroll in clinical trials?

People volunteering to be contacted for trials would be a simple and useful addition to a registry but not by itself sufficient reason to build one as there are other ways to find potential trial participants

/continues.../

 

[Ravn]

/...continued/

Could we stratify patients into different forms of the disease, for example, moderate/severe?

This could be a useful question. Not so much for the mod/severe issue, we already stratify by severity, and the bit we don't know - how many in each category - would be another question for that elusive good epidemiological study

But a large enough registry could help make sense of the many diagnostic criteria. With the right questionnaires people diagnosed with ME or CFS could be matched against several key criteria. This would facilitate studies looking at people with and without PEM, or with and without any other symptom of interest.

Longitudinal follow-up could look at if people stay in the same set of criteria over time, or if people fitting certain criteria are more likely to recover. Lots of opportunities here but it would take a large cohort and very carefully constructed questionnaires (though DecodeMe and CureME probably have good ones to get started with)

Then there's the whole issue of some pwME accumulating a long list of comorbidities whereas for others the same symptoms are attributed to ME. Does one group get better support, medical or financial, than the other?

How are the outcomes of people with this disease changing over time?

See previous question

/continues.../

 

[Ravn]

/...continued/

What are the most important symptoms to manage?

Not by itself a question to build a registry on but could be interesting in conjunction with the stratifying question above and it would be an easy question to add to a registry. The symptom/s bothering people the most could be markers of important subgroups, e.g. the always extremely fatigued group vs the group that's only extremely fatigued during PEM could just be different because they're pacing differently or they may have different pathology

How well do drugs and other interventions work in this disease?

Not by itself a question to build a registry on (at this stage) though it could be worth replicating some of the international surveys to get some local figures for advocacy purposes. Different story once new treatments become available, a registry would help give a faster idea of how or even if they work in the real world

/continues.../

 

[Ravn]

/...continued/

What sort of services and support are people seeking and getting?

We have a general idea already, there's much more seeking (and needing) than getting going on. Selection bias would likely skew figures obtained from a registry but they could still be useful for advocacy

Is there enough funding being provided to support people with this condition nationally as well as locally?

See previous question

Are people with this disease still able to work, study, and be productive? If not, what is getting in their way?

See previous question

/continues.../

 

[Ravn]

/...continued/

An finally:

• What other important questions could a (low-budget) registry answer?
• And which question should be the main priority?
• Or, given there's not been much engagement with this thread, do people think a registry would not be a good idea?
• If so, why do you think it's a bad idea? Apart from the obvious that spending money on a bad idea is usually a bad idea

/end/

 

[hibiscuswahine]

I think a patient registry is a good idea, the Australian one is run out of La Trobe University, Melbourne. I was on their registry but this is now only really useful for Australians as NZers are now not able to take part in their research. I think selection bias is still an issue for any registry, some people are happy to contribute, some are not. But the more people who join, the more useful it becomes statistically and for advocacy.

It would need to have strict confidentiality and secure IT systems for people with ME to want to submit their data. Though I suppose a low budget anonymised registry could be done but one would have to trust this organisation to keep the data safe and confidential forever. People would have to consent for the different uses of their health information and to who it can be shared.

The Long Covid Registry is based in Auckland. I wonder what funding was required to start and maintain it? It would need continuous funding - something perhaps ANZMES might consider doing. It would be an important tool for that organisation to document all the different things mentioned in Ravn and Hutan's post.

I read on another forum Mona wanted to do a patient registry for ME but didn't have the resource to do it. She is well placed being at Victoria University and is involved in Long Covid research.

Another possible institution that might be suitable is the University of Otago - Wellington Clinical School (or another clinical school, perhaps Christchurch but not Dunedin....) - that has post-graduate research units embedded in their different departments eg General Practice. But one would need a suitable person willing and able to set up such a registry and secure funding.

 

[Ravn]

A discussion in a private group raised the question of how to deal with comorbidities in a registry.
Summarising:

• Reasons for capturing common comorbidities: to look for possible commonalities in underlying pathology, to see if symptom subsets correspond with pathology subsets
• The obvious way is to ask people what clinical diagnoses they have
• The obvious problem is that this depends largely on the doctor you happened to see and what diagnoses that doctor 'likes' when it comes to the more contested conditions
• An alternative way would be to not ask about diagnoses at all but instead ask about symptoms (easier said than done as people have such different understandings of what is meant by a particular symptom) and see if grouping people based on those provides any leads

Additional thoughts:

• Asking specifically if people have a clinical diagnosis of MCAS, hEDS etc could mislead people into thinking these are well established diagnoses (and be in for a nasty surprise if they take the idea to their doctor and get short shrift)
• However, recording comorbidities - all types, not just the contested ones - is important. E.g. if a later study wants to use registry data or recruit from the registry for looking at things like HRV or activity levels or employment status then they'd need to know if participants also have for example heart disease, to make sense of the data
• So maybe the best way is a combination approach:
  • ask people to list all of their clinical diagnoses in a free form text box (rather than a list to tick)
  • possibly also ask if they think the diagnoses are accurate rather than lazy misdiagnoses (ok, not in those precise words)
  • tick symptoms on a comprehensive list - free text here would be too unwieldy - with the list covering symptoms from the various diagnostic criteria as well as common comorbidities and misdiagnoses

 

[Ravn]

A comprehensive plain language resource covering the very many things that need to be thought through when considering establishing a registry

https://registrybootcamp.org/short-menu

ETA
Also contains links to more in-depth resources like this book & addendum (haven't read either)

Registries for Evaluating Patient Outcomes: A User’s Guide, 4th edition
https://www.ncbi.nlm.nih.gov/books/NBK562575/

Patient- or Participant-Generated Registries - Addendum to Registries for Evaluating Patient Outcomes: A User’s Guide, Third Edition
https://www.ncbi.nlm.nih.gov/books/NBK493594/

Plus links to at least one webinar (I haven't worked my way through the whole resource yet, haven't watched the video yet either)

Presented by Michelle Leavy (Editor, Registries for Evaluating Patient Outcomes: A User's Guide), this webinar draws on the “Planning a Registry” chapter of the Agency for Health Care Research and Quality’s “Registries for Evaluating Patient Outcomes: A User’s Guide: 4th Edition" and will review key steps in planning a registry, including articulating the purpose, determining if a registry is appropriate, gathering stakeholders, assessing feasibility and sustainability, building the registry team, establishing governance plans, defining the scope and rigor, defining the data set, outcomes, and population of interest, developing the study plan or protocol, and developing the project plan. The webinar discusses planning for registries generally, as well as planning for specific types of registries such as rare disease registries.

https://registrybootcamp.org/technical-planning