Today, value is one of the most discussed and aspirational goals for those involved in the delivery of healthcare (1). However, value is not an easy concept to define and therefore lacks precision in its delivery. The simplest definition of value in healthcare is that given by Porter as the “health outcomes achieved per dollar spent” (2). The patient is the customer, and the goal is maximizing benefit while minimizing risk; however, this is a shared goal, since the benefit accrues from the actions of a wide range of individuals and organizations (the stakeholders in healthcare) (3). Different stakeholders have tended to embrace the concept of value in a range of outcome measures that reflect their own contribution to the patient outcome (4). Thus, we see value often expressed in terms of quality, clinical efficacy and effectiveness, patient centeredness, patient satisfaction, timeliness, clinical efficiency, cost-effectiveness, productivity, affordability, and cost. In laboratory medicine, the commonly used metrics have been accuracy, precision, turnaround time, and cost-per-test. However, in a complex system such as healthcare, the value can only be maximized if the stakeholders work together. Indeed, Lee (5) suggested that the concept of value might be the only concept “that all stakeholders in healthcare embrace.” However, the measure of value remains elusive (6). The challenge lies in optimizing the benefits to all stakeholders across a health economy.
Laboratory medicine is one of the key stakeholders in delivering outcomes for patients. A recent interview-based study involving oncologists and cardiologists in the US and Germany concluded that approximately 66% of clinical decisions were guided by the results from in vitro diagnostic tests (7). If the real value of laboratory medicine is to be realized, it has to embrace the concept of value. In so doing, laboratory medicine has to move away from the stakeholder-centric approaches to quality and adopt an approach focused on clinical effectiveness and cost-effectiveness (8, 9). Furthermore, this process has to be applied across care pathways, rather than within the so-called silos, as at present. This step requires that the impact on all stakeholders be demonstrated and translated to meet the needs of these stakeholders, within the context of their individual roles in the clinical team, and across the care pathway continuum (1, 10).
Applying the concept of value to the delivery of laboratory medicine services is predicated on some important assumptions: (a) an “appropriate” test is one that helps to solve a problem (address an unmet clinical need); (b) test results are an integral part of a “test and act” intervention; (c) results from appropriate tests should provide a benefit; (d) several stakeholders contribute to delivery of healthcare; (e) the problem is likely to affect (positively or negatively) all stakeholders; (f) benefits are likely to affect (positively or negatively) all stakeholders; (g) all stakeholders have a responsibility to deliver the benefit. An important implication of these assumptions is that a test result alone is of no value to any of the stakeholders, with the exception of the laboratory medicine service provider, who (in economic terms) may be making a profit from provision of the test.
Adopting a value-based approach to laboratory medicine service provision, for example, in relation to quality improvement, or the adoption of a new test, carries with it the following requirements: (a) definition of the problem in the relevant part of the care pathway that the test result should address; (b) detailed information on the process, resource utilization, and outcomes from the care pathway of which the test result is a part; (c) evidence that the test result (linked with decision-making and action taken) is clinically effective and cost-effective; and (d) a plan for implementation that covers process change and resource investment and disinvestment, metrics to cover process and resource, and clinical outcomes, both before and after quality improvement or adoption. These requirements are the basis of the value proposition for the test, which informs the development of a business plan, and underpins the innovation associated with the introduction of a test (9, 10).
The shift toward a value-based approach to the provision of laboratory medicine services will undoubtedly bring challenges, as has already been recognized in relation to organizational and behavioral barriers to adoption of new technology in healthcare (11). These include (i) lack of understanding of the unmet need and detailed knowledge of the current pathway of delivery; (ii) limited formal evidence of clinical effectiveness and cost-effectiveness, and thus the benefits to stakeholders; (iii) resistance to investment and disinvestment across silos; and (iv) accountability among stakeholders to change practice.
If laboratory medicine is to respond effectively to the call for a value-based approach to healthcare delivery, with greater efficiency and productivity, in addition to better patient outcomes, it has to adapt a cross-silo approach, with outcome measures tailored for all stakeholders and founded on utilities across a care pathway (at both an individual patient as well as at a population level). To do this, the formal evidence of clinical effectiveness and cost-effectiveness has to be translated into the local setting, which can then form the basis of adoption and quality management strategies (10). Indeed, it has been suggested that more effective adoption of new technologies is best achieved at the local level rather than from a top-down approach. This result is likely due to a better understanding of problems at a local level, as well as a better understanding of the barriers to change and the means of overcoming those barriers (12).
Adopting the concept of value in laboratory medicine is an exciting opportunity to demonstrate how the service can improve the quality and productivity of healthcare for the benefit of all stakeholders involved in the provision of healthcare.
Disclaimer: The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health.
Authors' Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form.
Employment or Leadership: None declared.
Consultant or Advisory Role: None declared.
Stock Ownership: None declared.
Honoraria: None declared.
Research Funding: C.P. Price, National Institute for Health Research (NIHR) Diagnostic Evidence Co-operative Oxford.
Expert Testimony: None declared.
Patents: None declared.
- Received April 22, 2016.
- Accepted April 25, 2016.
- © 2016 by American Association for Clinical Chemistry