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.
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.
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.
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.
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 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
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? 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 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 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? 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? 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 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/
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?
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
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.
@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…
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 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 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?
