„Patient-reported outcomes“ in medizinischen Registern

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2024年3月1日

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Susanne Singer,
Oliver Bayer,
Melanie Schranz,
Anke Ohler,
Stephanie Herold,
Julia Popow,
Nadine Warnke,
Hanna Malm,
Oliver Deuster,
Kai Kronfeld,
Georg Heß

摘要

Background

Patient-reported outcomes (PROs) are important for assessing drug benefits. The Federal Joint Committee (G-BA) in Germany has introduced a new instrument, the so-called application-related data collection (in German: Anwendungsbegleitende Datenerhebung, AbD), which requires availability of data from registries for PRO comparisons.

Research question

How can PROs be successfully implemented in a European registry?

Methods

As part of the AbD for a CAR T‑cell product, the European Mantle Cell Lymphoma Network (EMCL) introduced recording of PROs in its registry in fall 2023. Solutions had to be found for issues such as contract design, data protection, data collection logistics, workload for the centers, and data transfer. This article reports on initial experiences with implementation.

Results and conclusion

Collection of PROs in medical registries is possible, but involves a great deal of effort. Public funding of PRO ascertainment in registries is advised, for example within AbD.