A Roadmap for Patient and Disease Registries: Linking Health Data to Enhance Rare Disease Decision-Making

Canada’s Drug Agency, with support from our health system partners including ICES and Health Data Research Network Canada (HDRN), has published a new roadmap that will help those who manage patient and disease registries in Canada navigate the process of linking data records to help answer relevant research and policy questions and support decision-making about care for rare diseases.

The new tool consists of 2 separate documents:

1. A guide that outlines an 8-step process to help patient and disease registry teams as they prepare to link data in registry records with administrative health services data. The guide also highlights key considerations and best practices that registry teams should keep in mind when preparing to link data.
2. An outline of what to consider when developing or revising informed consent forms.

What Is Data Linkage and Why Is It Important?

In simple terms, data linkage is the process of connecting information about the same person from different datasets — such as data from patient and disease registries and administrative health services data, which serve distinct purposes and are both essential for a comprehensive understanding of patient care and outcomes.

Patient and disease registries collect standardized information about patients who share a specific disease or condition, aiding research and evaluation. Registry data can describe disease progression, assess clinical effectiveness, cost-effectiveness, and safety of health care interventions, evaluate appropriateness of care, and/or measure care quality. Administrative health services data on the other hand is information generated from patient encounters within health care systems (e.g., hospital admissions, physician billings, drugs dispensed at a pharmacy) and is collected by public or private health system organizations for administrative purposes.

By linking patient and disease registry data with administrative health services data, policy-makers and researchers can get a more fulsome understanding of the impact of a disease on patients, outcomes, and the health system, which could add to the evidence needed to support decision-making.

Potential Benefits of Linking Health Data for Registry Teams

For registry teams, linking patient and disease registry data with administrative health services data can:

• improve insights into the disease burden and outcomes by combining the use of patient and system information
• reduce duplication and minimize the need to collect information that is already available in administrative datasets
• allow the assessment of the vital status of patients included in the registry and outcomes related to their use of health care resources
• allow for the assessment of medication adherence by monitoring what prescriptions patients filled and how often they filled them.

While linking data can provide a more complete picture, registry teams can encounter challenges in linking their data with the administrative data sources available in Canada. Challenges may include privacy legislation and ethical considerations that may vary across jurisdictions, funding agreements that impact how registry data can be disclosed, and fees and costs related to linking and cleaning the data. There may also be challenges with ensuring appropriate patient consent has been obtained. The roadmap is designed to help registry teams effectively navigate these challenges and optimize the advantages of data linkage.

Supporting the National Strategy and Our Expanded Mandate

This work is part of a broader group of initiatives that Canada’s Drug Agency has undertaken to support the federal government’s National Strategy for Drugs for Rare Disease. As part of the strategy, we are leading activities that help improve evidence generation and enhance the value of real-world data from rare disease registries.

This work also supports the expanded mandate of our organization, which includes increasing pan-Canadian data collection and expanding access to drug and treatment data, including real-world evidence data, to better support patients and inform decisions.