MCB: Design and data considerations for MS registries

23.12.2025

The Workshop on Design and data considerations for MS registries, part of EMSP’s Membership Capacity Building (MCB) Programme, was held in 2020.  In this article, you can explore the main outcomes of the workshop and access the presentation slides for further learning.

Objective:

• To focus on data collection and identify the needs and opportunities to strengthen the MS community in the Balkan region.

Presentation on design and data considerations for MS registries – Prof. Dipak Kalra

Professor Dipak Kalra is the President of the European Institute for Innovation through Health Data, which is a neutral and not for profit multi-stakeholder body promoting good practices in the use of health data and collaboration in scaling up data uses.

Professor Kalra gave a presentation on the design and capacity decisions when setting up or extending a registry such as an MS registry. He started by reminding the audience that there are many different kinds of knowledge gap for which we need large quantities of health data to study. These could be related to having a better understanding of the disease, its course, which populations experience which complications and trajectory, the effectiveness of different treatments and the impact of the condition and its complications on social needs and well-being.

The Multiple Sclerosis Data Alliance (MSDA) is a not-for-profit body led by Liesbet Peeters, in which the EMSP and i~HD are founding partners. The MDSA is establishing an academy to provide education and promote the collection, sharing and use of MS data and a toolbox of ICT components to help registries and health record systems to map their data to come and model and share the data.

When it comes to setting up or scaling up an MS registry, it is important to first interact with organisations and experience who would use the data, to understand the knowledge and understanding gaps they prioritise and the kind of data that would help address those needs. Only then is it useful to look at what data resources might be available, and negotiate data access and agree on any financial arrangements in case the registry receives income from the use of data provided by others. It is important also to decide whether the registry will exist only within one country, or will share its data with other countries, which may alter the data protection and legal requirements it has to meet. Ethical committee approval may also be required.

Funding is a very important issue. Not only is it essential to secure funding to create the registry, but to rapidly identify the funding streams and the champions who would enable sustainability of funding. These champions and organisations could be the registry users, or downstream beneficiaries of knowledge derived from the registry data.

There are several data management issues that the registry operating model needs to work out at the beginning. One of these is data quality, since we know that health data is of highly variable quality in the real world. The registry owners need to decide if they will set a minimum data quality standard for imported data, how they will measure that data quality, if they will undertake any data cleaning on the imported data (which has resource implications) and if they will undertake or collaborate on any educational programmes to help healthcare organisations to improve their data quality.

Dipak’s Institute i~HD undertakes data quality assessment and helps to run improvement workshops. Interoperability standards, so that it becomes feasible to import data from multiple different sources, is another area of important decision making and skills capacity which a registry must have within its team. It is normally wise to adopt a common data model for the registry itself, which reduces the cost of the burdens of importing data, and enable users of the registry to more easily analyse the data. There is an increasing momentum favouring federated architecture, in which the data is not all put in one gigantic database but a series of connected ones to which research queries are distributed, performed locally, and then the results are aggregated. The European Health Data and Evidence Network project (EHDEN) is creating a larger European network of data sources using this architectural approach, to which registry may consider connecting. The Balkan community in this meeting could consider collaborating by connecting their registries using a federated architecture.

One of the biggest challenges for any large data repository is trust. It is important that the registry core team includes expertise in data protection and GDPR compliance. This includes knowing how to conduct data protection impact assessments, how to establish code of conduct and information security policies and practices, how to anonymise the data and how to manage the linkage of data sets in a secure way. Registration must be transparent to the public about how they safeguard the data, to whom they grant access, for what purposes, and should make a strong point of regularly publishing information about how the registry has been used and what research findings and benefits have come from this. This helps to ensure public and stakeholder support and is valuable for helping to convince future funders that the registry is a worthy initiative to sustain.

Discussion with the meeting participants

There was a rich and thought-provoking discussion stimulated by each participant introducing themselves, summarising briefly the current state of play in their country with regard to an MS registry, and what challenges were being faced. They were invited to help identify the needs and opportunities to strengthen the MS community in the Balkan region.

As the discussion went round all of the participants it became clear that there were some common themes and challenges that were being faced by multiple countries, for which collaborations would be helpful, and also where the European bodies MSDA, EMSP and i~HD could play a valuable role by being external to any individual country (and therefore perceived as neutral). The discussion contributions are grouped under the main themes below.

Financing of registries

Although some countries have a running registry, usually funded by the Ministry of Health, it has proved difficult in some of the Balkan countries to persuade Ministries and senior MS clinicians that a registry would be a valuable resource to all, that it should be funded. Building on this meeting, it may be helpful for the different MS societies to share their knowledge and experience of how to convince ministries or other bodies to fund a registry. They could also share experiences of how to overcome the resistance factors to establishing a registry, since in some countries it appears that ministries and public health authorities are reluctant to establish a registry because it would make transparent areas of poor health care quality and poor social service support for MS patients. The participants would also like to share knowledge about the costs of running a registry (so a country knows how much to budget, and an MS society knows how much funding to request.)

Registry examples as case studies

There are some excellent examples of registries across Europe, some of which have been running for decades, have achieved substantial support, accumulated a lot of data, and generated a lot of research results. Some of the meeting participants had recalled the Swedish registry, learning some valuable ideas, and others agreed that it would be useful for a future meeting to consider inviting members of the Swedish registry to come and present their history, how they got started and with what funding sources and political endorsement, what data is collected, how is it collected, how is the registry used, how is it governed, how are patients involved.

Other high profile MS registries might also be invited to subsequent meetings, so that the Balkan societies could progressively pick up good practices that they could adopt. Registries can also reuse each other’s templates for data collection, data sharing etc. They can also benefit from seeing each other’s policies, even if these would need to be adapted for a different country.

Legislative concerns

Data protection laws, or other existing national legislation, is sometimes used as a reason why a registry cannot be established, and especially as a reason why MS societies cannot have access to information in a registry. At times there may be genuine good reasons, and at other times these legislative barriers may be used as an excuse to prevent establishing a registry or to exclude representatives of MS patients from gaining knowledge from and existing registry. It may be useful to bring decision-makers from different Balkan countries together into a panel discussion about the merits of registries, what enabling legislation may be required so that they are successful and well used, and how to make patient organisation access to aggregate information from a registry a success for all rather than a threat.

Gaining data access and using registry data

As indicated above, not all of the MS societies in the meeting were able to access aggregated data from existed registry in their country. It was understood that patient level data would not normally be provided, because of data protection rules. However, some societies indicated that they were not even permitted to have aggregate information from the registry. This is another area where the European organisations could help by convening meetings and panel discussions amongst decision-makers, including patients in the panel, to help promote the value of engaging societies in using the registry.

The societies are likely to want to explore and address different issues to the clinical and academic communities, so there would be no threat to the research and publication streams of those professionals. However, there is at times the risk of safeguarding attitudes to a registry by the clinical or academic community running it, so goodwill and a collaborative spirit first need to be created before data sharing might occur. It was noted that the GDPR states that every patient should have access to the data about themselves held in the registry. However, this is a cumbersome approach to take, and not scalable to many thousands of patients.

It would be helpful if those societies which do have access could publicise more widely what access they have, how they use the knowledge they get from the registry and what benefits they bring to their communities. We need to share the benefits in order to help promote wider society access to registry information. There may also be skills in how best to publicise beneficial registrars, which societies could share with each other and the European organisations could also help with.

Promoting data that patients want to capture

Some MS societies already collect information from their members, and in some cases from family caregivers, and some of them have been doing this for many years. Societies may need support in how to modernise their methods of capturing and holding the data, including how to transfer many years of legacy paper information into an electronic form so that it can be more useful to them. Societies often know the kind of information that patients themselves most want to collect about their condition, care and life, and could contribute this information to registries so that the registries expand their dataset to include patient driven data capture.

Apps for patients to use, to collect their own data, is one way forward that is being explored. This would also make the registry more useful to patients and patient organisations, and encourage better cross stakeholder collaboration.

Growing and supporting the right skills set

Some of the Balkan registries, and a number of others across Europe, already have staff who have expertise in topics like data management, data protection, and research analysis. Others have struggled to recruit the right skills, and others are at an earlier stage not yet having the funding to recruit staff. However, in all cases there would be value in sharing.

As a starting point, it may be helpful for registries to share the kinds of skills that they need in order to run efficiently and effectively, and to share anonymised job descriptions so that any available funding for new post is used wisely. The Balkans, or even a wider geographical area, may consider forming peer networks for some of the registry staff. For example, it may be helpful for data managers in different registries across Europe to connect with each other, share knowledge, help each other to troubleshoot, signpost courses and useful conferences to each other, and in the future maybe even meet in person. The meeting concluded with a very positive spirit of collaboration, with the members looking forward to the next meeting and hoping that the European organisations MSDA, EMSP, i~HD could support them with some of the challenges summarised above.