Objective: To develop methods for systematically reviewing evidence for identifying effective laboratory medicine (LM) practices associated with improved healthcare quality outcomes.
Relevance: Although many evidence-evaluation systems have been developed, none are designed to include and rate healthcare quality improvement studies to identify evidence-based practices that improve patient safety and LM quality.
Methods: Validated evidence-based medicine methods established by governmental agencies, the Guide to Community Preventive Services, and others were adapted for the LM field. Key methods modifications included (a) inclusion of quality improvement study designs; (b) mechanisms for inclusion of unpublished evidence, (c) combining of individual ratings of study quality, effect size, and relevance of outcome measures to evaluate consistency of practice evidence; and (d) deriving an overall strength rating to support evidence-based best practice recommendations. The methods follow the process steps of: ask; acquire; appraise; analyze; apply; and assess. Expert panels used the systematic evidence review results on practice effectiveness for improving healthcare quality outcomes consistent with the Institute of Medicine's healthcare quality aims (safe, timely, effective, equitable, efficient, and patient-centered).
Conclusions: Adapting and developing methods from validated systems and applying them to systematically review and evaluate practices in LM by using published and unpublished studies is feasible. With these methods, evidence from quality improvement studies can be systematically synthesized and summarized to identify effective LM practices. Practical and scientifically validated demonstration of a positive impact on outcomes ensures that practitioners, policy makers, and decision makers at all levels have the evidence needed for improving healthcare quality and public health.