The biomarker paradigm: between diagnostic efficiency and clinical efficacy

Polskie Archiwum Medycyny Wewnętrznej
Giuseppe Lippi, Camilla Mattiuzzi

Abstract

The interest in biomarker research has been growing exponentially, and this trend is not expected to reverse soon. Although the clinical usefulness of laboratory tests is conventionally defined in terms of diagnostic efficiency or clinical efficacy (or effectiveness), these notions are complementary but not interchangeable. The former concept is an expression of diagnostic accuracy but does not entail outcome assessment. Conversely, clinical efficacy investigates whether or not a certain test can produce significant changes in managed care and an improvement of clinical outcomes. The vast majority of published studies were mainly focused on diagnostic efficacy rather than on clinical efficacy, and this seems no longer sustainable in a world with limited resources. Although bridging the gap between efficiency and efficacy is not a trivial endeavour, a paradigm shift is necessary, wherein the laboratory community should focus on what clinicians need rather than pursuing an endless search for analytically perfect tests. In the foreseeable future, efficacy should be improved by translating this concept into a simple "six R" paradigm, namely, performing the Right test, with the Right method, at the Right time, to the Right patient, ...Continue Reading

Citations

Dec 15, 2020·Expert Review of Molecular Diagnostics·Thomas B G PoulsenAllan Stensballe
Oct 18, 2019·Diagnosis·Giuseppe LippiFabian Sanchis-Gomar
Nov 24, 2019·Clinical Chemistry and Laboratory Medicine : CCLM·Giuseppe LippiUNKNOWN European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Psychiatric Services : a Journal of the American Psychiatric Association
C Edward Coffey
Annals of Emergency Medicine
Marten C Howes
© 2021 Meta ULC. All rights reserved