Considerations for the use of biochemical laboratory registry data in clinical and public health research

Abstract

Objectives: To inform researchers of central considerations and limitations when applying biochemical laboratory-generated registry data in clinical and public health research.

Study design and setting: After review of literature on registry-based studies and the utilization of clinical laboratory registry data, relevant paragraphs and their applicability toward the creation of considerations for the use of biochemical registry data in research were evaluated. This led to the creation of an initial ten considerations. These were elaborated, edited, and merged after several read-throughs by all authors and discussed thoroughly under influence by the authors' personal experiences with laboratory databases and research registries in Denmark, leading to the formulation of five central considerations with corresponding items and illustrative examples.

Results: We recommend that the following considerations should be addressed in studies relying on biochemical laboratory-generated registry data: why are biochemical laboratory data relevant to examine the hypothesis, and how were the variable(s) utilized in the study? What were the primary indications for specimen collection in the study population of interest? Were there any pre-analytical circumstances that could influence the test results? Are data comparable between producing laboratories and within the single laboratory over time? Is the database representative in terms of completeness of study populations and key variables?

Conclusion: It is crucial to address key errors in laboratory registry data and acknowledge potential limitations.

Keywords: Biochemical data; Considerations; Guideline; Laboratory data; Laboratory registry; Methodology; Pitfalls; Registry-based.