How to establish and sustain a disease register: Insights from a qualitative study of six registers in the UK

Abstract Background: The advent of new chronic conditions such as long COVID-19 raises the question of whether and, if so, how best to establish new disease registers for such conditions. Prompted by the potential need for a long COVID-19 register, we examined experiences of existing UK disease registers to understand barriers and enablers to establishing and sustaining a register, and how these have changed over time. Methods: We undertook semi-structured interviews between November 2022 and April 2023 with individuals representing six disease registers that collect individual-level longitudinal data on people diagnosed with a chronic condition. Results: Registers examined were developed by a few individuals, usually clinicians, to gain a greater understanding of the disease. Patient voices were largely absent from initial agenda setting processes, but, over time, all registers sought to increase patient involvement. Securing long-term funding was cited as the biggest challenge; due to limited funds, one of the registers examined no longer actively recruits patients. Charities devoted to the diseases in question were key funders, though most registers also sought commercial opportunities. Inclusion on the NIHR Clinical Research Network Portfolio was also considered a vital resource to support recruitment and follow-up of participants. All registers have sought to minimise the primary data collected to reduce the burden on clinicians and patients, increasingly relying on linkage to other data sources. Several registers have developed consent procedures that enable participants to be contacted for additional data collection. In some cases, the initial patient consent and data sharing permissions obtained had limited the flexibility to adapt the register to changing data needs. Finally, there was a need to foster buy-in from the community of patients and clinicians who provide and/or use the data. Conclusion: We identified six key considerations when establishing a disease register: (1) include a diverse set of stakeholders; (2) involve patients at every stage; (3) collect a core data set for all participants; (4) ensure the data system is flexible and interoperable with the wider data landscape; (5) anticipate changing data needs over time; and (6) identify financial opportunities to sustain the register’s activities for the long term.