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

Expansion of technologies, changing infrastructure and dwindling resources have caused the need for healthcare reform and changes in the clinical laboratory. The healthcare model will have to shift more and more from a fee-for-service model to a value-based model. Laboratories will have to focus more on evidence-based outcome studies evaluating the effect of their pre- and post-analytic practices on real patient outcomes. Although well designed clinical trials and multicenter studies are needed to determine the effect 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 aid 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 to transparent reporting in studies, thereby allowing the creation of a robust data base for clinical practice guidelines. Three methods are also available describing the assessment of quality of data on which to base recommendations for such guidelines. Close attention must be given to the design of a study so that parameters assuring study quality are met, thereby allowing its inclusion in formulation of evidence-based laboratory best practices guidelines.