Background Terminologies facilitate data exchange and enable laboratories to assist in patient care even if complex treatment pathways involve multiple stakeholders. This paper examines the three common terminologies Nomenclature for Properties and Units (NPU), Logical Observation Identifiers Names and Codes (LOINC), and SNOMED Clinical Terms (SNOMED CT). Methods The potential of each terminology to encode five exemplary laboratory results is assessed. The terminologies are evaluated according to scope, correctness, formal representations, and ease of use. Results NPU is based on metrological concepts with strict rules regarding the coding of the measurand and the result value. Clinically equivalent results are regularly mapped to the same code but there is little support to differentiate results from non-standardized measurements.
Introduction Health systems worldwide struggle to provide optimal care. Increasingly, evidence generation in medicine falls behind the rapid pace of scientific progress and structural changes. Clinical decision-making is therefore often underinformed resulting in suboptimal outcomes. As a remedy, the Institute of Medicine has proposed the development of Learning Health Systems (LHS). These systems are defined as entities in which progress in science, informatics, and care culture align to generate new knowledge as an ongoing, natural by-product of the care experience, and seamlessly refine and deliver best practices for continuous improvement in health and health care . LHS are often associated with large entities such as integrated managed care organization .
I have received the “Ivar Trautschold award for the promotion of young scientists” from the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) for my work on quality control. As I pointed out in my award speech, quality control in laboratory medicine should be patient-oriented. Instead of determining laboratory artifacts, it should reduce real risk for patients. Furthermore, quality control methods should be able to distinguish precisely between normal and out-of-control situations. A specific method should attribute errors to root causes to facilitate their quick correction. Lastly, quality control methods need to be easily integrable into laboratory daily routine.
Background Androgen receptor splice variant 7 (AR-V7) expression in circulating tumor cells (CTCs) was demonstrated to predict poor treatment response in metastatic castrationresistant prostate cancer (mCRPC) patients treated with abiraterone or enzalutamide. Objective To develop a practical and robust liquid profiling approach for direct quantification of AR-V7 in peripheral whole blood without the need of CTC capturing and to determine its potential to predict treatment response in mCRPC patients. Design, setting, and participants Whole blood samples from a prospective biorepository of 85 mCRPC patients before treatment initiation with abiraterone (n=56) or enzalutamide (n=29) were analyzed with droplet digital PCR. Outcome measurement and statistical analyses The association of AR-V7 status with prostate-specific antigen (PSA) response defined by PSA decline ≥50% as well as PSA-progression-free survival (PSA-PFS), clinical PFS, and overall survival (OS) was assessed.
The book “POCT - Patientennahe Labordiagnostik” (Point-of-Care Testing) has finally been released by Springer Heidelberg. (Disclaimer: I contributed to some chapters.) It is already the third edition of this book in Germany but it will be the first to be translated and released worldwide. The book is divided into chapters covering analytical methods, clinical applications, legal and organizational framework conditions, areas of applications, quality control and further development trends. This wide range of topics certainly distinguishes this work. POCT is now beeing employed in diverse fields such as development assistance or sports medicine. It might be surprising that this laboratory medicine book dedicates so much space to quality and organizational issues.