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. 2025 Jan;34(1):e70076.
doi: 10.1002/pds.70076.

Success of the German Cystic Fibrosis Registry

Lutz Naehrlich  1 , Manuel Burkhart  2 ; Registry Working Group of the German CF Registry
Collaborators, Affiliations

Success of the German Cystic Fibrosis Registry

Lutz Naehrlich et al. Pharmacoepidemiol Drug Saf. 2025 Jan.

Abstract

The German Cystic Fibrosis (CF) Registry (GCFR) is a national General Data Protection Regulation-compliant centralised database sponsored by the German Cystic Fibrosis Association (Mukoviszidose e.V.) and based on informed consent for each participating patient, ethical approval, and data protection votes. The aims of the GCFR are to optimise quality of care for CF at the centres, generate epidemiologic overviews, address research questions related to improved CF care, and inform caregivers, patients (aimed at patient empowerment), and health authorities and industry (aimed at care planning and pharmacovigilance). Established in 1995, the Registry has captured data on > 9600 individuals with a combined total of more than 140 000 annual assessments with an estimated coverage rate of > 90%. Patient data are collected after informed consent and confirmed diagnosis of CF, or a CFTR-related disorder, or a screening-positive inconclusive diagnosis of CF (i.e., CFSPID). The registry collects core, encounter, and annual health data. Data include demographics, anthropometrics, lung function, microbiology, CF-specific complications and chronic medications, hospitalisations, demand-oriented antibiotic therapies, and outcomes (death and transplants). Real world and pharmacovigilance studies have been published and additional research underway; there is a formal process for requesting access to the GCFR.

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Conflict of interest statement

L.N. is the medical lead of the German CF Registry, the pharmacovigilance study manager of the European CF Society Patient Registry and the principal investigator for GCFR and ECFSPR based pharmacovigilance studies for Chiesi Farmaceuti S. p. A. and Vertex Pharmaceuticals. M.B. is employee of the Mukoviszidose Institut gGmbH, Bonn, Germany, a non‐profit limited company of the Mukoviszidose e.V.

Figures

FIGURE 1
FIGURE 1
Annual count of people with cystic fibrosis (CF) in the German CF Registry divided by registry report population (encounter‐based documentation, or Level 2; annual report, or Level 0) and living CF population in the registry from 1995 to 2022.
See this image and copyright information in PMC

References

    1. Sommerburg O., Hammermann J., Lindner M., et al., “Five Years of Experience With Biochemical Cystic Fibrosis Newborn Screening Based on IRT/PAP in Germany,” Pediatric Pulmonology 50, no. 7 (2015): 655–664, 10.1002/ppul.23190. - DOI - PubMed
    1. Nährlich L., Burkhart M., and Wosniok J., “German Cystic Fibrosis Registry—Annual Report,” 2021, https://www.muko.info/fileadmin/user_upload/was_wir_tun/register/bericht.... - PubMed
    1. Stern M., Wiedemann B., and Wenzlaff P., “From Registry to Quality Management: The German Cystic Fibrosis Quality Assessment Project 1995 2006,” European Respiratory Journal 31, no. 1 (2008): 29–35, 10.1183/09031936.00056507. - DOI - PubMed
    1. Mukoviszidose e.V , “German Cystic Fibrosis Registry,” accessed October 22, 2024, https://www.muko.info/englisch‐version/registry.
    1. Nährlich L., Burkhart M., and Wosniok J., “German Cystic Fibrosis Registry—Annual Report 2019,” accessed October 22, 2024, https://www.muko.info/fileadmin/user_upload/was_wir_tun/register/bericht....