MCB: Setting up MS Registries with MS Societies in the Western European region

19.12.2025

The Workshop on Setting up MS Registries with Multiple Sclerosis Societies in the Western European region, part of EMSP’s Membership Capacity Building (MCB) Programme, was held in 2023. It brought together representatives from various EMSP member organisations to share experiences and best practices. In this article, you can explore the main outcomes of the workshop.

Objectives

1. Empowerment through Education: Provide participants with comprehensive knowledge and tools to confidently navigate the complexities of setting up an MS Registry.
2. Facilitate Collaborative Learning: Foster a collaborative environment where MS Societies can co-create solutions and share experiences, enabling them to learn from one another.
3. Practical Application of Registry Data: Equip participants with the skills to transform research questions into actionable plans, leveraging registry data for meaningful insights and improved MS care and advocacy efforts.

Important concepts

Infinite vs. Finite Games

• “Finite: Known and Bounded”: In the world of finite games, everything from the players to the funding, outcomes, and time frame is predefined. Examples abound in structured endeavors like clinical trials, specific project roadmaps such as the UK Registry roadmap 2022-2026, the EURIMS project, and even sports like basketball. The language here is definitive, with terms like ‘better,’ ‘not good enough,’ ‘win,’ ‘lose,’ and ‘failure’ dominating the discourse.
• “Infinite: The Boundless Journey”: Contrastingly, infinite games defy traditional boundaries. They commence without a set start date and continue indefinitely. The players may be a mix of known and unknown entities, and even the rules are not set in stone, exemplified by policy shifts like the GDPR. The terminology shifts to ‘different,’ ‘grow,’ and ‘improve,’ highlighting the ongoing nature of these endeavors.

The Power of Language and Trust

“Trust is overrated” Rethinking Values
This provocative statement urges a reconsideration of conventional values. It emphasizes the need for multi-stakeholder interest and engagement, where trust is less about a feeling and more about being trustworthy.

This includes:

• Engaging positively with stakeholders like the MS Society.
• Ensuring that actions align with words.
• Maintaining transparency and honesty, including admitting mistakes.
• Building a reputation without hidden agendas.

Strategies for Growth and Adaptation

• “Act like water“: Embracing Flexibility
  This philosophy advises a pragmatic approach that aligns with one’s values, avoiding the trap of immediate perfectionism.
• “Do one thing”: The Power of Small Steps
  Echoing the sentiment that small actions can have a profound impact, this approach advocates tackling priorities one at a time, where even a single workshop can catalyze significant change.

Research Methodologies: Quantitative vs. Qualitative

Quantitative research, defined by its reliance on data and hypothesis testing, contrasts sharply with the open-ended nature of qualitative research. The ideal scenario combines both, leveraging their strengths in parallel, despite their inherent communication challenges.

Exploring vs. Finding: Search vs. Research

While searching implies finding existing answers, research delves into the unknown. Various forms of research, from clinical to industry-focused, embody this exploratory spirit.

Initiating Change: The Example of a Movement

Referencing the “Leadership Lessons from Dancing Guy” video, this segment illustrates how movements start with individual actions that gradually gain momentum. The initial discomfort of the first few participants eventually gives way to a tipping point, where not participating becomes the outlier.

Four key phases to set-up a registry and related challenges and solutions

There is not one ideal registry. Building, maintaining and improving a registry is an infinite game, which comes together with challenges, such as resource constraints, data registration complexity, lack of collaboration, disjointed efforts, etc. Although there is not one ultimate way to get there, regardless of the type of a registry, there are in general four hidden phases that all registries pull through before data collection really starts. In general, people don’t talk about these phases and therefore, it could feel like a beginning registry did not start yet, whereas it actually did.

Important to note is that the time per phase can be diverse and one can stop or pause during every phase, so there are no fixed timelines and the context of a registry is important to keep in mind.

The four identified phases are:

1. Registry ideation (idea generation)
2. Towards a concept note
3. Build first minimal viable product
4. Pilot – first data collection efforts

As already mentioned above, it’s an infinite game. Therefore, after phase 4, there will be an additional continuous assessment phase and/or you start again from phase 1 for the next defined project. For every phase it is important to stay open, flexible and adaptable. There should  be a balance between doing something (imperfectly) and reflecting, reiterating. If something didn’t work out, try something else. Try to be self-aware. It’s always about learning.

1) Registry ideation

Reflection and Action

Phase 1 of developing a registry is characterized by a reflective and active process. Reflection is not merely a passive endeavor; it is a verb that denotes action and engagement. In this phase, the most crucial task is to articulate the ‘Why’ and ‘Who’ of the registry. This foundational step is imperative as it sets the stage for all subsequent phases.

Defining the “Why” and “Who”

Understanding the purpose behind the registry is essential. The ‘Why’ can be diverse and multi-faceted, making it a challenging yet vital aspect to agree upon. This clarification is necessary before progressing to Phase 2. The ‘Why’ of the registry directly influences the ‘How’ and ‘What’ of its creation and operation. Each ‘Why’ leads to different approaches and outcomes.Clusters of “Why”

Several key motivations or ‘clusters’ drive the creation of a registry:

1. Regulatory: This includes assessing the safety of a Drug or Medical Technology (DMT), and determining whether it should be government-subsidized.
2. Research Context: This encompasses various research angles, such as:
   ○ Clinical research
   ○ Patient-focused research
   ○ Industry-focused research, which involves pharmaceuticals, medical technologies,
   and companies of varying sizes.
3. Advocacy: Advocacy efforts aim to improve care, though they can be broad and include aspects like:
   ○ Drug market access
   ○ Rehabilitation services
   ○ Enhancing the quality of life for affected individuals.

Significance and Redundancy Checks

A critical assessment in Phase 1 involves determining whether starting a new registry is significant or necessary. There is a possibility that a similar registry might already exist, making the creation of a new one redundant. Such an assessment prevents unnecessary duplication of efforts and resources.

Key Profiles

Two primary profiles are pivotal in this phase:

1. The Initiator (Influencer): This individual or entity is the driving force behind the
   registry, playing a critical role in defining its purpose and scope.
2. People with MS: Their needs and experiences are central to the creation of the registry,
   especially if the focus is on conditions like MS.

In conclusion, Phase 1 serves as the bedrock of the registry creation process. It involves deep reflection and active engagement in defining the core reasons and target audience for the registry. This phase sets the direction for all subsequent activities, ensuring that the registry is purposeful, relevant, and non-redundant.

2) Towards a concept note 

Transitioning to Concretization

In Phase 2, the journey progresses from the established ‘Why’ of Phase 1 towards developing a concrete concept. This phase is about taking the theoretical underpinnings and transforming them into a tangible project. The ‘We’ (Who) and ‘How’ aspects of the registry become more defined and focused.

Leadership and Clarity

A crucial figure in this phase is ‘the leader’, who brings clarity to the purpose and direction of the registry. This individual is responsible for crystallizing the strategy and values that will guide the project.

Document Creation

The creation of foundational documents is key in this phase. These may vary in form, from one-pagers to detailed slide decks. By the end of Phase 2, there should be a concept note encapsulating:

1. A Concrete Idea: Clearly outlining the project’s core concept.
2. Strategy for Implementation: Including funding mechanisms and operational methodologies.
3. Initial Plan: A flexible blueprint that outlines the project’s initial direction and can be adapted as needed.

Core Questions

The concept note should address several critical questions:

• What to Collect: Determining the data types and categories to be included in the registry.
• How to Collect: Establishing methodologies for data collection.
• Privacy, Ethics, and Trust: Ensuring the protection of personal information, ethical data handling, and building trust among participants.
• Accessibility: Guidelines on who can access what data and under what conditions.
• Sustainability: Strategies for maintaining the registry over time, ensuring its continued relevance and effectiveness.

Expansion of Roles

In this phase, the team expands to include diverse expertise such as IT professionals, legal advisors, health informatics specialists, analysts, and a board of directors. Understanding and defining each individual’s role in the setup of the registry is crucial for success.

Governance and Legal Framework

Defining the governance and legal structure of the registry is imperative. This involves deciding the nature of the legal entity (e.g., a new entity or a consortium agreement) and outlining decision-making processes. It’s important to note that the legal structure is intrinsically linked to financial flows, which can significantly shape the project’s scope and capabilities.

Funding Strategies

Exploring various fundraising strategies and sources of funding is essential. Potential sources include:

• Industry partnerships
• Regulatory bodies
• Gifts from sponsors or donors
• Societies
• Research grants (e.g., from the European Commission, Horizon Europe, Innovative Health Initiative)

Adaptive Strategy

The recommended approach is to be adaptable and opportunistic, aligning actions with the registry’s values while exercising caution. Understanding the implications of different funding sources is crucial. Gaining regulatory endorsement often serves as a pivotal point for the success of registries.

In summary, Phase 2 is about transforming the foundational ‘Why’ into a structured and detailed concept note, outlining the practical aspects of the registry. This phase involves expanding the team, defining roles, establishing a legal and governance framework, and securing funding. The concept note crystallizes the registry into a viable project, ready for implementation.

3) Build first minimal viable product

Transition to Execution

Phase 3 marks the shift from strategic planning to hands-on execution. It’s a phase where the theoretical aspects developed in the previous stages are put into practice. This phase involves delving into the details and complexities of the project, often underrated in its challenges.

Iterative Process

This phase often necessitates revisiting and refining elements from Phase 2. The iterative process of moving back and forth between planning and execution is essential to address evolving challenges and insights.

Defining the Details

Key elements to be defined in this phase include:

1. Detailed List of Variables/Dictionary: This should align with the ‘Why’ established in Phase 1, outlining the specific data points to be collected.
2. Data Collection Methodology: Developing a detailed approach for data acquisition and managing data flow.
3. IT Architecture: Defining the technological framework and infrastructure that will support the registry.
4. Privacy Measures: Establishing privacy notices and terms and conditions to protect participant data.
5. Security Protocols: Ensuring the integrity and security of the data collected.
6. User-Friendliness: Creating an interface that is accessible and easy to use for all stakeholders.
7. Alignment with Funding: Ensuring that the project’s development is in line with the financial resources and constraints.

Learning and Aligning with Pioneers

A crucial aspect of this phase is to learn from and align with pioneers and existing models. Collaboration with existing registries, data collection agencies, and support initiatives like the MS Data Alliance can provide both technical and sociological support. This phase emphasizes the importance of partnerships and the realization that not everything has to be built from scratch.

Collaboration and Common Ground

The success of this phase relies heavily on collaboration, guided by the principle of mutual benefit and support – “How can I help?” as opposed to “What’s in it for me?”. Finding common ground is essential, which can be achieved by:

1. Agreeing on a Minimal Dataset: Establishing a core set of data points that all stakeholders agree upon.
2. Engaging in Discussions and Reflections: Building relationships and understanding through continuous dialogue.
3. Starting with a Coalition of the Willing: Initially collaborating with those who are open and willing to contribute, and then allowing the movement to grow organically.

Settling for Imperfect

An important lesson in this phase is the acceptance of imperfection. It’s about finding the right people and solutions that may not be perfect but are effective and functional. This approach facilitates progress and helps overcome the challenges of building a complex system like a registry.

In summary, Phase 3 is about bringing the conceptualized strategy into a tangible form. It’s a phase of execution, detailing, and building the first minimal viable product of the registry. This phase is characterized by an iterative process of development, learning from others, collaboration, and finding practical, albeit imperfect, solutions to complex problems.

4) Pilot – first data collection efforts

Going Live: A Milestone Moment

Phase 4 marks a significant milestone in the registry’s journey: going live. This phase is both exhilarating and daunting, as it transitions the registry from planning and development to active operation.

Core Activities in Phase

1. Data Collection: The primary activity in this phase is the collection of data. This process should be executed with precision and adherence to the established methodologies and goals of the registry.
2. Data Analysis Preparation: The collected data is not just to be accumulated; it must be analyzed meaningfully. This requires a clear understanding of the research questions the registry aims to answer.

Steps for Effective Research and Analysis

1. Formulating a Hypothesis: Each research question should begin with a well-defined hypothesis. This hypothesis guides the data collection and analysis process, providing a clear objective for what the registry seeks to investigate or prove.
2. Creating a Data Dictionary: A data dictionary is essential for ensuring that everyone involved in the registry understands what each piece of data represents. It defines each variable collected and is instrumental in maintaining consistency and clarity in data analysis.
3. Data Visualization and Insights: Developing visualizations is a key step in making the collected data understandable and accessible. Effective visualizations can reveal patterns, trends, and insights that might not be apparent in raw data.
4. Selecting Methodologies and Tools: Choosing the right methodologies and tools for data analysis is crucial. The analysis must be robust and trustworthy, employing statistical and data analysis techniques that are appropriate for the data and the research questions.

Embracing the Challenge

While Phase 4 can be intimidating, it is a pivotal moment where the registry starts to fulfill its purpose. The focus is on ensuring that data collection and analysis are executed with rigor and precision, guided by clear research objectives and methodologies. This phase is about turning data into meaningful insights, contributing to the broader understanding and management of the subject at hand.

List of research questions and associated reflections

Introduction to the Research Question Selection Process

In our workshop, participants were presented with a curated set of research questions, sourced from authoritative references such as MSIF’s Atlas of MS and the EMSP MS Barometer. This selection process was not merely academic; it was an engaging and interactive exercise, where participants actively partook in the ranking of these questions.

The Ranking Exercise and Its Significance

This exercise was designed to immerse participants in the strategic and efficient selection of research questions. Such a process is crucial for aligning research objectives with the available resources. To facilitate this, a color-coded system was employed:

• Green (A): Straightforward questions answerable with the MSDA CDS v2022.
• Yellow (B): Complex questions, yet still answerable with the MSDA CDS v2022.
• Red (C): Questions that are impossible to answer with the MSDA CDS v2022.

Each color represents a level of feasibility and resource alignment, guiding participants in making informed decisions.

Critical Parameters for Evaluating Research Questions

Our approach to evaluating research questions rests on three critical parameters:

1. Feasibility: Assessing whether the question can be realistically answered.
2. Number of Variables: Determining the number and type of variables required.
3. Power Analysis: Estimating the patient numbers needed for statistically significant
   results.

These parameters are instrumental in filtering out questions that are either too ambitious or not well-defined.

Refining and Reformulating Research Questions

It’s essential to recognize that not all research questions are immediately viable. Some demand reformulation, and others, although not answerable with the CDS, could be addressed with alternative designs. This phase is a crucial step, as every answer leads to further questions, enriching the research process.

The End-to-End Pipeline for Research Questions

As highlighted in phase 4 of our workshop, the comprehensive pipeline for handling a research question includes:

1. Formulating a Hypothesis: The starting point of any research.
2. Creating a Data Dictionary: Defining the data requirements.
3. Creating Visualizations and Drawing Insights: Turning data into understandable and actionable information.
4. Identifying Methodologies and Tools: Ensuring robust and trustworthy analysis.

Each project should consider these steps to define its scope and direction effectively.

Beyond the CDS: Expanding Data Collection

After assessing the adequacy of the CDS for a project’s data dictionary, it’s vital to critically evaluate what other data variables are necessary. This step is about aligning with the initial “why” of setting up a registry, considering additional data sources such as PROMs, claims data, and pharmacists’ data to benchmark treatment accessibility, among others.

Links to YouTube videos and slides

• Act like water (Be humble): link
• How to start a movement? Leadership Lessons from Dancing Guy: link

Other resources

Tool that can be used to define the list of variables: core dataset (CDS):

The primary goal of a core dataset (CDS) is to minimize heterogeneity among various real-world data sources related to MS. By standardizing and sharing real-world data globally, we can swiftly address global MS challenges. This involves early alignment on the data variables to be collected, their format, and preparation for analysis.

In 2022, the MS Data Alliance established the Core Dataset (v2022). This dataset represents a foundational set of variables, serving as a common denominator across diverse areas of interest in MS research and their respective minimal datasets. The CDS is designed with a holistic and research question-agnostic approach, meaning it does not prioritize any specific MS research area, such as pharmacovigilance.

The development and approval of this CDS were led by a multi-stakeholder global task force, comprising 20 experts and key opinion leaders in the field of Real-World Data (RWD) in MS.

This diverse group included clinicians, data custodians, leads of MS registries and cohortspatient organization, representatives from the pharmaceutical industry, and regulatory agencies. The task force’s geographical diversity, with members from North and South America, North-Eastern Africa, Europe, and Oceania, enriched the discussions and decisions regarding the core variables. This process was expertly orchestrated and coordinated by the MSDA, ensuring efficiency and feasibility for the task force members. A systematic workflow was established prior to the task force’s initiation, streamlining the process of landscaping, discussing, reviewing, and agreeing upon the core dataset.

The CDS v2022 aims to support emerging registries and initiatives in defining their datasets and facilitates integration into larger initiatives within or outside the MS community. By adopting a common data model based on the MS Data Alliance Core Dataset, registries at any stage can enhance collaboration and data sharing.

In practice, the CDS should be the starting point for most registries, addressing basic research questions. However, depending on the specific ‘Why’ of a registry, it may be necessary to expand beyond the CDS. This expansion should align with the registry’s goals and the unique aspects of the MS data it seeks to collect and analyse.

Link to paper CDS:

Parciak T, Geys L, et al. Introducing a core dataset for real-world data in multiple sclerosis – recommendations from a global task force. Mult Scler. Dec 2023; doi.org/10.1177/13524585231216004 (link)

MSBase (msbase.org)

The MSBase Foundation Ltd is a non-profit charitable organization incorporated in Australia.

The foundation is governed by a board of directors responsible for overseeing the charity. In collaboration with participating neurologists, the MSBase Foundation has established a unique, Web-based platform, The MSBase Registry, dedicated to sharing, tracking and evaluating outcomes of MS and other demyelinating diseases of the central nervous system.

In particular, the MSBase Foundation aims to foster collaboration in epidemiological and outcomes research by providing a freely accessible resource for combining, comparing and analyzing large data sets, for the benefit of people with MS. Neurologists from around the world can participate in MSBase by contributing data. In that case, the neurologist can access the resulting MSBase Global dataset, as only contributing PIs can submit requests for the global dataset.

The SLG (Scientific Leadership Group of the MSBase Registry) is the custodian of the data in the MSBase Registry, but the data remain the property of the individual contributing centers under the control of their principal investigator (PI). All identifying information is removed from patient records before they reach the MSBase Registry. The main focus is on clinical pathway information.

MSBase Registry advantages:

• If you share data, you can ask for data
• Clinicians can get it for free if they contribute
• Very collaborative
• Good secretariat

MSBase Registry pitfalls:

• Not nation-wide
• Only clinician-focused
• Only research-focused

Contact details: info@msbase.org

Relevant publications

• Peeters LM, Parciak T, Kalra D, et al. Multiple Sclerosis Data Alliance – A globalcmulti-stakeholder collaboration to scale-up real world data research. Mult Scler Relat Disord. Jan 2021;47:102634. doi:10.1016/j.msard.2020.102634 (link)
• Peeters LM, Parciak T, Walton C, et al. COVID-19 in people with multiple sclerosis: A global data sharing initiative. Mult Scler. 09 2020;26(10):1157-1162. doi:10.1177/1352458520941485 (link)
• Geys L, Parciak T, Pirmani A, et al. The Multiple Sclerosis Data Alliance Catalogue: Enabling Web-Based Discovery of Metadata from Real-World Multiple Sclerosis Data Sources. Dec 29 2021; doi:10.7224/1537-2073.2021-006 (link)
• Parciak T, Geys L, et al. Introducing a core dataset for real-world data in multiple sclerosis – recommendations from a global task force. Mult Scler. Dec 2023;doi.org/10.1177/13524585231216004 (link)

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