Using clinical guidelines to assess the potential value of laboratory medicine in clinical decision-making.

INTRODUCTION: It is often quoted that 70% of clinical decisions are based on laboratory results, but the evidence to substantiate this claim is lacking. Since clinical guidelines aim to document best-practice decision making for specific disease conditions, inclusion of any laboratory test means that the best available evidence is recommending clinicians use it. Cardiovascular disease (CVD) is the world's most common cause of mortality, so this study reviewed all CVD guidelines published by five national/international authorities to determine what proportion of them recommended laboratory testing. MATERIALS AND METHODS: Five leading CVD guidelines were examined, namely the European Society of Cardiology (ESC), the UK National Institute for Health and Clinical Excellence (NICE), the American College of Cardiology (ACC), the Australian Heart Foundation (AHF) and the Cardiac Society of Australia and New Zealand (CSANZ). RESULTS: A total of 101 guidelines were reviewed. Of the 33 individual ESC guidelines relating to CVD, 24/33 made a direct reference to the use of clinical laboratory tests in either diagnosis or follow-up treatment. The same applied to 15/20 of NICE guidelines, 24/32 from the ACC and 15/16 from the AHF/CSANZ. Renal function and blood count testing were the most recommended (39 and 26 times), with lipid, troponin and natriuretic peptide measurement advocated 25, 19 and 19 times respectively. CONCLUSIONS: This study has shown that laboratory testing is advocated by between 73% and 94% of individual CVD guideline recommendations from five national/international authorities. This provides an index to assess the potential value of laboratory medicine to healthcare.

Improving clinical outcomes - towards patient-centred laboratory medicine.

Hard evidence of the specific contribution made by laboratory testing to patient outcomes and the delivery of health care is not easy to obtain. An understanding of the value of laboratory medicine, how that value can be measured and the various factors that influence it is vital to ensuring that laboratory services are provided and used optimally to improve patient care. To maximise the value of laboratory medicine, work is required to improve the utilisation of existing and new biomarkers, develop standard protocols for prospective patient-centred studies of biomarker clinical effectiveness or extra-analytical process effectiveness, benchmark existing and new tests in specified clinical situations with commonly accepted effectiveness measures, and define new roles for laboratory professionals that are focussed on optimising patient outcomes by adding value throughout the total testing process. This requires effective collaboration with clinical staff and a determination to accept patient outcome and patient experience as the primary measure of laboratory performance.

Current evidence and future perspectives on the effective practice of patient-centered laboratory medicine.

BACKGROUND: Systematic evidence of the contribution made by laboratory medicine to patient outcomes and the overall process of healthcare is difficult to find. An understanding of the value of laboratory medicine, how it can be determined, and the various factors that influence it is vital to ensuring that the service is provided and used optimally. CONTENT: This review summarizes existing evidence supporting the impact of laboratory medicine in healthcare and indicates the gaps in our understanding. It also identifies deficiencies in current utilization, suggests potential solutions, and offers a vision of a future in which laboratory medicine is used optimally to support patient care. SUMMARY: To maximize the value of laboratory medicine, work is required in 5 areas: (a) improved utilization of existing and new tests; (b) definition of new roles for laboratory professionals that are focused on optimizing patient outcomes by adding value at all points of the diagnostic brain-to-brain cycle; (c) development of standardized protocols for prospective patient-centered studies of biomarker clinical effectiveness or extraanalytical process effectiveness; (d) benchmarking of existing and new tests in specified situations with commonly accepted measures of effectiveness; (e) agreed definition and validation of effectiveness measures and use of checklists for articles submitted for publication. Progress in these areas is essential if we are to demonstrate and enhance the value of laboratory medicine and prevent valuable information being lost in meaningless data. This requires effective collaboration with clinicians, and a determination to accept patient outcome and patient experience as the primary measure of laboratory effectiveness.

The European Federation of Clinical Chemistry and Laboratory Medicine.

Laboratory medicine is at the heart of modern health care and diagnosis and effective treatment of patients is impossible without high-quality bioanalytical services. The European Federation of Clinical Chemistry and Laboratory Medicine is a professional federation working to ensure high standards across the discipline in all European countries. This article describes our work in science, education and professional development.