Cohort Profile: Swiss BioRef: The building blocks of a nationwide IT infrastructure in Switzerland for generating precise reference intervals

Abstract

Purpose: Swiss BioRef is a nation-wide multicenter infrastructure project, the aim of which is to become a sustainable framework for the estimation and assessment of patient-group-specific reference intervals in laboratory medicine and beyond. In this unprecedented effort, nation-wide multidimensional data from multiple clinical laboratory databases has been combined under the common interoperable semantic framework of the Swiss Personalized Health Network (SPHN) initiative. The consolidated effort enables creating extremely detailed patient group-specific queries via intuitive web applications, allowing the generation of individualised, covariate adjusted reference intervals on-the-fly. Participants: The project is a collaborative effort of four major hospitals in Switzerland, the University Hospital Bern (Inselspital, Insel), University Hospital Lausanne (CHUV), Swiss Spinal Cord Injury Cohort (SwiSCI) and the University Children's Hospital Zurich (KiSpi), and two academic groups in Bern and in Lausanne. Findings to date: Within the infrastructure we deployed, the laboratory data from four major hospitals (approximately 9 million measurements from 250'000 patients) is made available to two conceptually different web applications (one centralised and statistically detailed, one decentralised using distributed computing). They enable the inference of reference intervals for more than 40 blood test variables from clinical chemistry, hematology, point-of-care-testing and coagulation testing, with various patient factors (such as age, sex and a combination of ICD-10 defined diagnoses) and analytical factors (such as type or unique identifiers) that can be used to generate precise reference intervals for the respective groups. Future plans: Now that all required basic infrastructure elements for Swiss BioRef are deployed, we are evaluating inter-cohort transferability of semantic standards, change tracking in merged databases and biological variation of the blood test variables, in order to generate precise reference intervals. While adjusting the developed web-interfaces to suit the needs of the various end-users, we additionally plan to onboard new national and international partners.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

The Swiss BioRef project is funded by the Swiss Personalized Health Network (SPHN) with grant number 2018DEV22. Matching funds have been contributed by the University Hospital Bern and Swiss Paraplegic Research.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Cantonal Ethics Commission of the Canton of Bern gave ethical approval for this work. BASEC-Nr: Req-2020-00630

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

Data is not available.

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