WP1 – A Swedish infrastructure for longitudinal patient surveillance and biobanking for chronic inflammatory diseases

WP coordinator: Johan Askling

1. Biobanking
Swedish Rheumatology, and Swedish MS-research, have national systems
in operation for the capture of electronic data on patients in various
phases of their disease. Local biobanking efforts, as well as
biobanking within the framework of specific studies, are also in
operation. The proposed domain aims at offering a concerted action
towards a unified, comprehensive data repository that, added to the
electronic information already registered, would offer important
possibilities for studies of e.g., etiology, pharmaco-safety,
prognosis, and mechanism of action. The potential for additional
external funding for the collection of biological samples is
substantial, be it targeted towards specific projects or not. For the
biobanking domain within WP1, we propose expenditures to cover:

• the creation of a surveillance system for the identification
of patients in clinical practice eligible for biological sampling
• the establishment of a logistics system by which appropriate
samples are being taken, stored, and retrieved at minimum additional
cost for the care provider, but at full insight and with retained
governance of the data owner, i.e., the same department that owns the
electronic Swedish Rheumatology (or other) register data for the
patient in question
• the establishment of a monitoring system through which quality
control and improvement related to capture of samples can be
instituted, and through which local biobanks can be integrated with a
national effort through a meta-database
• population of the biobank with appropriate samples,
• efforts to optimise patients' awareness and understanding of
the system, and willingness to cooperate
• the creation of the infrastructure in such a way that
additional CIDs can easily be added.

2. Register linkages

Internationally, one of the greatest comparative strengths of Swedish
medical research is the possibility to perform population based
register-linkages using data from clinical care. For biologics in RA,
a system for repeated register-linkages is now in place, with the
primary aim of assessing the medium- to long-term safety profile of
new drugs like biologics. In this WP1 domain, the main aim is to
further exploit these possibilities, and to extend them to other
diagnosis than RA.

With respect to RA, the added value derives from increased
understanding of the quality of the registers (ARTIS) already in
operation, of means to improve its quality, and through a better
understanding of qualitative differences in terms of signal generation
gained by various methods of adverse event capture. With respect to
non-RA conditions, the proposed work would offer a jump-start for
efforts to establish biologics registers (i.e., identification of all
patients who should be in the register). The proposed linkages to
identify control cohorts and adverse events would capitalise on our
experience with similar work in RA and would represent a world unique
contribution to our understanding of the safety-, co-morbidity, and
total costs of biologics. For the assessment of safety profiles of
biologics using register-linkages for non-rheumatological diagnoses,
the potential for external, project-oriented, funding, is presumed to
be substantial.

3. Capture of routine data

The potential for profession-based registers to survive and to employ
a high capture are both dependent on the degree of additional work
imposed on the care providers. Similarly, the registered information
may serves as a basis for efficient monitoring of patients and visits
in the underlying care. Currently, very little such process-oriented
feed-back has come out of quality registers. Efforts over the last few
years have led to the establishment of an integration platform for
data from Take Care (a medical filing system) and Swedish Rheumatology
Register, such that a semi-automatised export / import of data items
between these two databases is possible. The aims of this domain

• increasing the degree of automation
• implementing this functionality also to other medical filing
• implementing a similar system for other diagnoses that RA
• using this platform and its combination with administrative
databases to monitor capture of eligible patients, capture of relevant
data items and samples, and planning and prioritisation of eligible