Improving clinical outcomes – towards patient-centred laboratory medicine

Abstract

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.

Laboratory medicine is the single highest volume medical activity and is fundamental to fast, accurate diagnosis of a wide range of clinical conditions. It is recognised as essential for the cost-effective delivery of clinical care, as it is often the principal basis for determining the need for costly downstream procedures such as admission to hospital or high-cost investigative procedures (complex imaging or invasive biopsy). Laboratory testing also has an enormous impact upstream of primary diagnosis, playing a key role in screening and risk assessment, both of which are areas of increasing importance with the growing recognition that early diagnosis and intervention reduce overall health care costs for a wide range of common diseases.

However, systematic evidence of the specific contribution of laboratory medicine to clinical outcomes has been difficult to obtain – with good reason, in view of the many factors that come together to reach a diagnosis or plan a course of treatment in individual cases. The oft-quoted statement that ‘70% of medical decisions depend on laboratory data’ is not supported by published evidence, ¹ and the need for more specific evidence-based measures of the added value of laboratory medicine has been recognised for many years. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on the Impact of Laboratory Medicine on Clinical Management and Outcomes was established in 2012 to evaluate the available evidence supporting the impact of laboratory medicine in health care, and to develop the study design for new and prospective studies to demonstrate the contribution made by laboratory medicine to improving outcomes. The Task Force report was published earlier this year. ²

The primary barrier to producing good evidence supporting the impact of laboratory testing on clinical outcomes is that ‘in order to improve outcomes, a laboratory test must be appropriately ordered, conducted, returned with results on a timely basis, correctly interpreted and affect a decision for further diagnosis and treatment’. ³ In practice, this means that links between testing strategies and outcomes can only be demonstrated if the study design is rigorously defined (in terms of expected outcome) and properly implemented, and the test is used appropriately during the evaluation: requested on the right patients, with the results properly communicated to the right people at the right time, interpreted correctly and acted upon to determine a clinical management strategy.

Outcome studies must also be designed to capture all the relevant effects of testing, including the potential negative consequences for patients of false-positive results, missed results, requesting inappropriate tests (over-utilisation) and not requesting appropriate tests (under-utilisation). Space does not permit a full discussion of these issues, and the reader is referred to a Special Issue of the eJIFCC which discusses them fully in the context of improving patient outcome. ⁴

The need for better, more clinically-focused biomarker evaluations is now receiving considerable attention. The Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) classify the components of test evaluation as: (1) analytical performance; (2) clinical performance (diagnostic sensitivity and specificity, etc); (3) clinical effectiveness (impact on decision-making); (4) cost-effectiveness; and (5) the impact of testing on the patient, the organisation and society. ⁵

The recommendations of the IFCC Task Force are firstly, the development of agreed definition and validation of effectiveness measures – a “common currency” for outcome studies across the discipline; secondly, the absolute need to benchmark new biomarkers (and existing biomarkers wherever possible) in specific clinical situations using commonly accepted effectiveness measures; and thirdly, a concerted effort to improve the utilisation of new and existing biomarkers. Improving utilisation requires the development (in close collaboration with clinical staff) of optimal testing strategies based on presenting complaint, support for effective requesting practices via order communications systems, timely and appropriate result transmission, availability of consultation and interpretation (in person and online) and audit of biomarker effectiveness in practice, to ensure that the potential benefits of testing strategies identified in evaluation studies are realised in routine use. The latter aspect is exactly analogous to post-marketing surveillance for new drugs.

The traditional focus of laboratory medicine has been on the improvement of analytical quality, and this has succeeded to the extent that analytical error has been shown to be the least common source of error in the total testing process. ⁶ Significant progress in improving patient outcomes will now only occur if laboratory medicine professionals direct their attention to making improvements right across the total testing process, from producing guidelines for investigation and devising testing strategies for specific clinical presentations or to confirm a diagnosis, through reducing preanalytical error, to producing meaningful reports with context-specific interpretation which get to the right person at the right time and are acted upon.

Laboratory workers who choose to work in these areas will play a leading role in improving patient care and developing laboratory medicine as a clinical specialty rather than a number-generating system, leading to improved job satisfaction and enhanced ability to recruit and retain good scientists and pathologists. The time is now right for specialists in laboratory medicine in all countries to take up the challenge to look outside the laboratory and forge effective links with multi-disciplinary teams that seek to use laboratory testing to optimise clinical outcomes and patient experiences in an efficient and cost-effective way.