JMIR Publications

ABSTRACT

Background:

Medical real-world data (RWD) are often siloed across organizations, making them inaccessible for research. Unlocking this data could advance clinical research and patient care. The Data Nexus platform links RWD for researchers. Regulations in Europe and national regulations in Germany mandate informed consent for data use.

Objective:

Evaluate the informed broad consent (BC) for the IT platform predicated on the principles of the Medical Informatics Initiative in Germany.

Methods:

The BC was developed for Data Nexus and cross-sectionally distributed to Rheumatology outpatients during routine follow-ups at a tertiary centre. A zero inflated model was used to predict response rates.

Results:

From 07/2023 to 05/2024, 292/390 (74.9%) patients signed the BC and consented to data donation. Median age was 56 years; 72.5% were female, with a median disease duration of 12 years. Diagnoses included rheumatoid arthritis (33.3%), psoriatic arthritis (10.3%), spondyloarthritis (5.2%), systemic lupus erythematosus (30.9%), systemic sclerosis (4.8%), and others (5.5%). Apart from the signature, patients could answer eight BC options with 'yes' or 'no'. The average 'yes' responses were 7.5±1.5, 'no' responses were 0.2±0.5, and missing responses averaged 0.4±1.4. Of all participants, n=228 (78.4%, of all: 58.5%) consented to all BC options. Approval rates for individual BC items exceeded 86%. The zero-inflated model showed female gender improved consent rates, while education level did not show any relevant changes.

Conclusions:

The BC for secondary use of data (here, for Data Nexus) was well received, with high patient approval. This support allows significant flexibility for conducting clinical, scientific, and pharmaceutical research, including AI applications, predicated on a robust legal basis pursuant to the European General Data Protection Regulation (GDPR) and national laws in Germany. Clinical Trial: German Clinical Trials Register (DRKS00032801).