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Chapter 47 : Clinical and Evidence-Based Research in the Clinical Laboratory
Laboratory interventions are becoming more data driven, outcome oriented, and evidence based. As such, laboratory professionals need more background in experimental study design and biostatistical methods, so that laboratory data can be used to generate outcomes data from quality. Several types of patient-oriented research (POR) are found in academic and non-university-based healthcare systems such as (i) mechanistic (physiological) studies of human disease, therapeutic studies, and clinical trials. An important translational step is the translation of research findings from POR and clinical trials into daily clinical practice. Thus, POR plays an important role in the translation of basic research findings and clinical trial data to improve medical practice and patient care. This chapter aims to acquaint the clinical laboratory with the basic types of experimental approaches used by clinical (patient-oriented) researchers, and defines the basic terms typically used in clinical research. It describes the concept of systematic review of literature, and describes initiatives occurring for evidence-based laboratory medicine. The laboratory medicine best practices (LMBP) initiative at the Centers for Disease Control and Prevention (CDC) adapts evidence-based medicine (EBM) concepts to clinical laboratory practice and quality improvement (QI) studies. Within LMBP, systematic reviews can provide information to support decision making for health outcomes achieved from use of a diagnostic test and for additional outcomes that influence cost and quality of patient care.