Defining Research Design/Practice Competencies for Entry-Level CLS

Clinical Laboratory Science, Spring 2004 by Greenup, Pat

NAACLS standards include the preparation of graduates to evaluate published studies based on basic knowledge, skills, and relevant experiences. A standardized approach for assessing the quality of published diagnostic assay evaluations is not currently available. The aim of this project was to review current resources to improve an instructional tool for the evaluation of published comparison study reports. Resources describing diagnostic assay accuracy studies, minimum standards and guidelines related to clinical laboratory operations, certification agency materials, basic research designs, performance assessment methods, evidence-based laboratory medicine materials, the Standards for Reporting of Diagnostic Accuracy (STARD) initiative, and the Consolidated Standards of Reporting Trials (CONSORT) statement were reviewed. Key domains for rating the quality of individual articles and criteria for determining the validity of diagnostic assay accuracy studies were identified. Instructional tools must include knowledge and skill competencies such as elements of appropriate study designs, identification of bias sources, design flaws, clinical utility characteristics, statistical methods, and standards for the reporting of assay accuracy studies. Instructional tools must be structured to analyze the elements of empirical research reports and address evidence-based laboratory medicine and patient safety guidelines. This project identified research design and analysis competencies that were used to revise an instructional tool. The revised tool addresses cognitive, psychomotor, and affective objectives at the awareness and performance levels for student development. This critical analysis tool is the basis of written summaries and recommendations summarizing the clinical usefulness of published information about the assessment of new technologies for laboratory medicine services.

Pat Greenup PhD, University of Alabama at Birmingham, Birmingham AL