“Registry-based research is not a plaything for academics but a bridge between science and practice”

In order to advance research into heart failure and atrial fibrillation, the Dutch Heart Foundation and the DCVA have been working for years on preparations for registry-based research. Planners Dennis van Veghel and Folkert Asselbergs are now going to work with other researchers to establish the requisite infrastructure in a new call from the Dutch Heart Foundation and ZonMw. They tell us what will change for researchers and the planned benefits.

Young and old, women and men, patients with just one condition or with multiple conditions: really helping them depends on looking very closely at how therapies over a longer period of time, in normal circumstances, work for people who have not been selected in advance. But it is difficult and expensive to arrange research of this kind and, in practice, it rarely gets off the ground.
Registry-based research tackles this difficulty by using a single system to provide access to the data that doctors and nurses in hospitals collect anyway during everyday treatment and check-ups. That makes randomised studies possible of large groups of people receiving day-to-day care.
Even so, a lot has to be done before that stage can be reached. So don't congratulate Dennis van Veghel (NHR) and Folkert Asselbergs (UMCU and DCVA) just yet because they still have a lot of homework to do first. The standardisation of, and access to, the data have to be sorted out. That's a job that nobody looks forward to. The exciting part starts once that work has been done and you can start studying the data. “That's what we believe in: there's a treasure trove of information out there and we can use it to make major improvements to patients' lives.”

Congratulations on your role as arrangers. Why is this call good news for the rest of the world?
Dennis: “I would say that it's particularly good news for researchers, cardiologists and patients. Our assignment is to get various organisations around the table and to establish an infrastructure for meaningful research. That's going to be quite a challenge. But if we succeed, the field really will have the tools it needs. And obviously, it's fantastic that we can now move down this road after years of preparation. The best part is that we will be able to use the infrastructure in the future for all sorts of diseases and treatments.”
Folkert: “The initiative for research will be returned to the experts: the doctors and, in the future, even the patients. At the moment, that initiative often resides with pharmaceutical companies. They have to test their medicines and that is of course a good thing. Even so, there are very few opportunities to address day-to-day questions in research of that kind. In practice, we would like to have answers to apparently banal questions like: does it matter if I take my pills at night or in the morning? Or, to take a more complicated example, does a combination of weight, age and gender affect the dosage of the medication? Should a patient with a leaky heart valve be referred for a follow-up echocardiogram after three years, or after five years? At the moment it takes four or five years before we can take a treatment a step further; this infrastructure will allow us to shorten the cycle more and more. And to make treatment more accessible and affordable.”

If registry-based research has so many benefits, why aren't we doing it already?
Folkert: “That's down to us. The national electronic patient file was rejected by the country as a whole ten years ago. But the reality is that we have the opportunity to do what is needed and take good records to improve the quality of care. So every hospital has started doing its own thing. We've now reached the point where we actually do want to integrate those systems but everyone's talking a different language. Basically, our plan is to deliver a sort of Google Translate that will allow all those systems to talk to each other again.”
Dennis: “This would have been impossible six years ago because there were no electronic patient files back then. And because everyone has now acquired extensive experience with registration, we have a clear picture of how we want to do this in practice. In very concrete terms: which information do we want to record in coded form and what do we want in text fields? That may sound very detailed but if you don't have an idea about how to go about this, registration becomes fairly pointless. We have the resources now and we know what we want.”

How do you explain this to non-academics?
Dennis: “When my wife and children ask me what I'm actually doing, I tell them that we don't want to work with pre-selected, ideal patients who fit a particular pattern and that we want to create an environment where we can study real, everyday patients. And that we've found a way to do that inexpensively with very large groups so that the results are genuinely meaningful.”
Folkert: “I tell patients that too many groups in society are under-represented in scientific research. This approach solves that problem. A concrete example is that we have to ask for consent beforehand in a lot of research. We give patients a long form to read and so, almost inevitably, many of them think: ‘I don't understand any of that. Forget it.’ We would like to keep it short and simple but that gets us into difficulties with the ethics committees. If we can work with data that hospitals collect anyway, we can include every group in society. I think that's very important.”

But what about the privacy concerns?
Dennis: “Depending on the type of research, patient consent will be required. The general research rules apply. Because this type of research mainly looks at accepted treatment methods, there will also be openings for research without informed consent. We still have to work on the frameworks that will be needed in that area.”
Folkert: “There was a reason for saying that we are working on a sort of Google Translate for medical research. It really is that technical. We extract data from the data. In the future, I expect teams to have a colleague with a technical background to whom doctors can turn with questions like: can you extract this information from that database so that I can make a decision in this particular case?”

But before that can be done, a lot of standardisation and automation will be needed. How can you make that enjoyable?
Folkert: “To be honest: the initial phases aren't particularly inspiring. The enjoyable part is when we can harvest the information. It's quite a complicated and tough job. And it's not something that makes our heart beat faster either: we prefer to do our own research just like everyone else. Obviously, the hospitals have a job to do as well: Utrecht has to register data in the same way as Amsterdam. That will make things much easier for our colleagues down the line. No one will have to transfer data from one system to another; we promise you that. It really will be an enormous step ahead.”
Dennis: “It's true that you have to standardise the basic records. The good news is: we've actually made a lot of progress there already. Since the Netherlands Heart Registration (NHR) was established, we have seen a significant improvement in the quality of data from intervention clinics. Well formulated, neatly integrated in electronic patient files, proper links to other sources. So we know that, once we get started, things quickly improve a lot. And we also have a lot of experience with supervising the process. There will be a desk you can turn to with good questions, where you can get more help with the methodology and statistics, and where we can show you where to find the data.”
Folkert: “We're doing this together, with the DCVA, the cardiologists, the researchers and, of course, the patients. If we start to get the idea down the line that we are recording data pointlessly, then we will have done something wrong; it's up to all of us to make sure that doesn't happen.”
Dennis: “Above all, let's not pretend this is something new. There are already a lot of projects in hospitals: there's just no overall orchestration yet. Almost by definition, those projects are still too small to allow conclusions to be drawn. There are a lot of questions to which we still don't have answers because the data are stored in fragments in all the different hospitals. So scaling up is more of a challenge. Setting up a study in your own hospital with a few friends is a bit quicker at present. We'll soon move beyond that stage: you will suddenly find that you have friends you can call everywhere in the country.”

What misconceptions do you run into when you advocate registry-based research?
Dennis: “Some cardiologists and researchers say they are concerned that they will no longer have control over their research data. This way of doing research is seemingly at odds with how we have always worked: recruiting patients, managing data ourselves, analysis, publication. Are the data I have fought so hard for as a researcher still mine? And we understand that concern. The fact that other people will eventually be able to work with your research data is of course the advantage of this approach. But it won't come at the expense of recognition for working hard on a good idea. We are going to make very good agreements about this area before we get started. For example, that researchers will retain control over the research data until their own research questions have been answered.”
Folkert: “Until now, you could build a career on a high-quality population of 10,000 patients. You work eighty hours a week on that and so you want recognition. But who does the data really belong to? The patient, of course. If you make the data public, we can do a lot more with them.”
Dennis: “If everyone shares, everyone has more data, and data can be used again and again. But appreciation is also important. We still have to work out exactly how to go about that. We will devise a solution with the parties involved. The approach to management could be different but it won't mean losing control.”

Anyone who knows anything about registry-based research immediately starts talking about Sweden. Are they really that good? And what are we good at?
Dennis: “What I really like about Sweden is that they were clear from the outset: we're going to get everyone involved. I hope that approach will take root here too given the importance for society as a whole. We are going to do things differently. They have established a separate system in which the data have to be transferred manually. We are going to work primarily with the electronic patient files that we already have.”
Folkert: “The Swedes are much further ahead in their thinking than we are. But we're catching up now, particularly because we'll be collecting data directly at the source. They collect only what they have decided on beforehand; in our system, you will be able to ask questions about basically everything that is on record. That's a much broader scope. So we're better off than the rest of Europe.”

You are also looking for ambassadors for registry-based research. What type of people are you looking for and what will be their role?
Folkert: “We actually have enough ambassadors but they are mainly from the teaching hospitals. I would very much like to see more applications from other hospitals. Medical teams. Clinics. Get on board! We aren't building a plaything for academics; this is more of a bridge between science and practice.”
Dennis: “We are starting now with heart failure and atrial fibrillation but the underlying, linking infrastructure of the research will be widely available once we complete it. For example for angioplasty, implants and cardiac surgery. So that's something that we can already start thinking about. Above all, please get in touch. It will be possible to apply this approach to all medical research; even outside the field of cardiology, people will learn from it.”

You were both there at the launch of CAPACITY last year. What are the implications of that success for registry-based research?
Folkert: “CAPACITY shows how strong we can be if we work together. In this case, the need for registry-based research was fully and immediately apparent. We couldn't wait, we had to make the link to day-to-day practice. The process went into a pressure cooker: there were results within a year, which was a little slower than we wanted, but still fast. If the infrastructure we plan to build had already been in place, we could have got the job done better and, above all, much faster.”
Dennis: “The fundamental difference between CAPACITY and the call relating to heart failure and atrial fibrillation is that, in registry-based research, we can build on the basis of systems for structural registration. On top of that, we can prospectively collect additional data to answer research questions.”

Is this turning out to be what you dreamed of?
Dennis: “This approach narrows the gap between high-quality registration and data research. I'm convinced these areas are drivers of improvements in care. Basically, that's why I do this work. So yes, this could turn out to be the fulfilment of a dream.”
Folkert: “I sometimes joke about how this is some sort of punishment for bad behaviour. But in all honesty: we have been working towards this for a decade. This is where all the challenges meet up. It's going to be a bit of a grind now for a while but I really do expect a lot from registry-based research in the future. It's great to actually get started.”

Registry-based research: a question of perseverance
Years of preparation preceded the call for registry-based research of the Dutch Heart Foundation and ZonMw. Back in 2014, when the Research Agenda was drafted, it became clear that registry-based research was needed to develop better treatments for heart failure and atrial fibrillation. To make this possible, the three registry organisations in place needed to merge. In addition, new registries for heart failure and atrial fibrillation needed to be developed and harmonised in the new Netherlands Heart Registation. That was done in the three successive phases of the RITS project. All these steps towards registry-based research received financial report from the Dutch National Heart Foundation. Patients were explicitly involved in this process, for example by participating in discussions to identify the most relevant research. Patients were also involved in the drafting of the Research Agenda. In addition, patients are consulted about every new study funded by the Heart Foundation and there is, for example, direct patient representation on the Supervisory Board of the NHR.

Would you like to join the new consortium?
Are you involved in registry-based research or clinical research looking at the treatment of heart failure? And would you like to join this new consortium? Check out the conditions in the brochure and contact the planners. The deadline is 18 May 2021.


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