Biomarkers of diseases: An evidence-based approach

Abstract

Evidence-based medicine (EBM) combines individual clinical expertise with the best available clinical evidence from systematic research in making decisions about the care of individual patients. Clinical expertise is the proficiency and judgment that individual clinicians acquire through knowledge, clinical experience, and practice. Clinical evidence comes from patient-centered clinical research which investigates the accuracy and precision of diagnostic tests and biomarkers, the efficacy and safety of therapeutic regimes, and the reliability of prognostic indicators. The powerful combination of clinical expertise and documented evidence results in safer, more efficacious and accurate care of the patient. Evidence-based guidelines are commonly used tools for supporting medical decisions. Formulating evidence-based recommendations has become a leading principle in guideline development. In laboratory medicine, guidelines provide recommendations on the use of a wide range of tests in detecting or predicting a target condition, for staging and monitoring a disease, and for decisions to initiate, modify, or terminate treatments. Systematic, standardized, and explicit methodology, adapted to laboratory medicine, should be followed when developing recommendations involving the use of laboratory tests and biomarkers. There are many opportunities for the application and evaluation of laboratory tests in good clinical trials. There are even greater opportunities for correlating various laboratory procedures with the clinical findings, outcomes and diagnoses, and using the stored samples collected for those studies. In this era of evidence-based medicine, clinicians and other decision-makers turn to the scientific literature for high-quality evidence about the usefulness, precision, and accuracy of diagnostic tests. Such evidence is needed more than ever because the list of diagnostic tests is growing exponentially, and even more biomarkers, proteomics, and applications of gene expression profiling will be added in the years to come.

Medicina zasnovana na dokazima (EBM) pri donošenju odluka o nezi pacijenata kombinuje individualnu kliničku veštinu sa najboljim raspoloživim kliničkim dokazima iz sistematičnih istraživanja. Klinička veština odlikuje se tačnošću u proceni i stiče se učenjem, kliničkim iskustvom i praksom. Klinički dokazi dobijaju se iz kliničkih istraživanja koja su usmerena na pacijenta, a koja ispituju tačnost i preciznost dijagnostičkih testova i biomarkera, efikasnost i sigurnost terapeutskih postupaka i pouzdanost prognostičkih indikatora. Kombinacija kliničke veštine i dokumentovanih dokaza omogućava sigurniju, efikasniju i pouzdaniju negu pacijenta. Vodiči zasnovani na dokazima najčešće se koriste kao dodatne alatke pri donošenju medicinskih odluka. Formulisanje preporuka zasnovanih na dokazima predstavlja vodeći princip u pripremi vodiči. U razvoju preporuka koje uključuju laboratorijske testove i biomarkere treba primeniti sistematsku i standardizovanu metodologiju koja je prilagođena laboratorijskoj medicini. Postoji veliki broj mogućnosti za primenu i evaluaciju laboratorijskih testova u dobrim kliničkim ispitivanjima. Još su veće mogućnosti za uspostavljanje korelacija između različitih laboratorijskih postupaka i kliničkih nalaza, ishoda i dijagnoza, kao i za korišćenje uzoraka koji su skladišteni za ova ispitivanja. Era medicine zasnovane na dokazima zahteva od eksperata koji donose medicinske odluke proučavanje naučne literature kako bi se obezbedio visok kvalitet dokaza o korisnosti i tačnosti dijagnostičkih testova. Ovakva vrsta dokaza potrebnija je više nego ikad zato što lista dijagnostičkih testova raste eksponencijalno i u godinama koje dolaze na nju će biti dodato još više biomarkera, proteomike aplikacija profiliranja ekspresije gena.