Designing Studies Acceptable for Abstraction and Inclusion in Evidence-Based Laboratory Practice Guidelines

• Type of Material: Article
• Authors: Micheal A. Saubolle, Banner -University Medical Center; Alice S. Weissfeld, Microbiol Specialists Inc.; Colleen Kraft, Emory University
• Language: English
• Date: 2019-03-01
• Publisher: American Society for Microbiology
• Publication Version: Final Published Version
• Copyright Statement: © 2019 Saubolle et al.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1128/JCM.00842-18
• Title of Journal or Parent Work: Journal of Clinical Microbiology
• ISSN: 0095-1137
• Volume: 57
• Issue: 3
• Grant/Funding Information: The work was funded in part by Grant OE13-1304 from the HHS; Centers for Disease Control and Prevention (CDC).
• Keywords: evidence-based; clinical outcomes; Science & Technology; Life Sciences & Biomedicine; guidelines; abstraction; study design; Microbiology; laboratory medicine best practices; MEDICINE
• Research Categories: Biology, Microbiology

Abstract

Expansion of technologies, changing infrastructure, and dwindling resources have produced the need for health care reform and changes in clinical laboratories. The health care model will have to shift increasingly from a fee-for-service model to a value-based model. Laboratories will have to focus more on evidence-based outcome studies evaluating the effects of their preanalytical and postanalytical practices on real patient outcomes. Although well-designed clinical trials and multicenter studies are needed to determine the effects of laboratory processes on outcomes, there has been concern that too few well-designed studies have been published. To help improve the quality of study design and to facilitate reporting transparency, several method statements have been developed. The Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative was recently updated, listing 30 items deemed crucial for transparent reporting of studies, thereby allowing the creation of a robust database for clinical practice guidelines. Three methods describing the assessment of the quality of data on which to base recommendations for such guidelines are also available. Close attention must be given to study design so that parameters ensuring study quality are met, thereby allowing inclusion of the study data in the formulation of evidence-based laboratory best practices guidelines.