Determining value – Do laboratory professionals need to learn more about the ‘dismal science’?

Laboratory professionals live with the ongoing dilemma of knowing that their contribution to clinical medicine is significant but too often lack the hard evidence to prove their value. With a growing focus on value in healthcare, various professional groups have been working on initiatives to address this dilemma, albeit in different ways. In 2015, an International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force indicated that to maximize the value of laboratory testing, work was required in a number of different areas including processes to improve clinical effectiveness and ensure better test utilization. ¹ Other national and international groups which continue to work in the value area, include the European Federation of Laboratory Medicine’s Test Evaluation Working Group ² and the Lab 2.0 group in the United States. ³

The IFCC’s contribution has continued through the joint IFCC-WASPalM (World Association of Societies of Pathology and Laboratory Medicine) Committee for the Value Proposition in Laboratory Medicine which was established by the late IFCC President, Howard Morris, in 2017 and is currently chaired by the author. Using a concept originally developed in the business world, the Committee seeks to use the value proposition as a means to improve the process of test implementation and ensure that global evidence of effectiveness is actually translated into similar and measurable benefits when the test is implemented in a local setting. ⁴

The value proposition for any test will describe explicitly how a test will be used including aspects such as the unmet need, the care pathway in which the test will be applied and the expected benefits based on the evidence. In addition, and most critically, it identifies all those so-called stakeholders who will be involved in the care pathway, the benefits they receive from testing (and sometimes disbenefits) and lastly an implementation plan which lists the different measures that will need be to be monitored on an ongoing basis. Since some of these measures will be economic in nature, the Committee also seeks to broaden the use of economic analysis tools by laboratory professionals.

The reality for many tests is that they are often implemented into routine practice on the basis of clinical effectiveness but with little if any data of economic effectiveness. In such cases, there is an even greater need for the application of economic analysis to support local implementation. This might take the form of a simple business case, but the complexity of testing usually demands more sophisticated techniques in order to justify investment in the test when there are always likely to be other healthcare entities competing for the same pot of funds. Economics after all, is about the allocation of scarce resources.

The origins of the term ‘dismal science’ for economics are disputed but may have come from the use of economics in the 19th century to highlight population constraints or its application to the economics of slavery. Both such uses might justify the negative connotation but dismal or not, there is no escaping economics in all walks of life including healthcare. Indeed, with the ever increasing focus on value and accepting that it has many different perspectives including those that are not monetary, the application of economics to testing is necessary if we are to go beyond the superficial and all too common measurement of just considering cost alone.

The highest level of economic evidence for tests usually comes from studies which report their outcomes in term of quality adjusted life years (QALYs), but Fang et al. showed that such studies are relatively few. ⁵ Furthermore, the audience for these types of study are primarily policymakers and concern decisions about whether a test should be adopted, a process which precedes implementation. While such evidence is undoubtedly useful, it is not so helpful at a local level when it comes to implementing a test within an individual healthcare system.

Laboratory scientists and health economists are not natural bedfellows. While economic effectiveness is part of evidence-based laboratory medicine, it is fair to say that there is much more emphasis on, and indeed data for, clinical effectiveness. Considerations of economic effectiveness are usually considered as part of the portfolio of health technology analysis through organizations such as the National Institute for Health and Care Excellence in the UK and the Medical Services Advisory Committee in Australia and are somewhat remote from laboratory professionals. Julicher et al. reviewed 140 health economic evaluations of tests and showed that only 17% involved laboratory professionals. ⁶ Thus, there is a substantial and unsurprising gulf between laboratory science and economic analysis, but this cannot be ignored if we are to make headway in determining the value of what the profession does and also to attract the necessary investment in testing for the future.

One of the tasks of the Value Proposition Committee is to try and bridge this gulf through education and possibly future workshops which will illustrate how economic analysis tools such as pathway mapping and modelling can be used to support business cases for implementing a new test as well as show the value that tests bring to clinical care. ⁷ One of the tests for which the Committee has described the value proposition is high-sensitive troponin (hsTrop). ⁸ The evidence cited to support the value proposition includes an example of economic modelling using data from several separate trials comparing the outcomes of hsTrop to those of conventional, lower sensitivity troponin; the modelling data showed significant cost savings from use of the high-sensitive assay. ⁹

The value proposition for hsTrop also identifies the outcome measures, including economic ones, which could be used to monitor the implementation of this test on an ongoing basis. Importantly, while a few of these are laboratory based, most are outside of the laboratory. This emphasizes that better test implementation also requires collaboration with clinical and other non-laboratory colleagues. A recent audit of hsTrop use in the UK perhaps highlights the challenges associated with improved test implementation. The audit showed through a survey that there had been widespread implementation of hsTrop, but there were no data on how the test was being used or whether it was delivering the expected benefits. ¹⁰ Therefore, on the basis of this audit, we have no indication of the value of this new test.

It is appreciated that the value proposition approach and its use of economic analysis is not applicable to a large proportion of existing testing. However, that should not stop its application to the introduction of most if not all new tests. Nor should it for existing tests where there are measurable benefits or outcomes but it is clear from either published evidence or local data, that the test is not delivering the potential value.

All of the above is not to suggest clinical scientists or pathologists must become economic modellers or practitioners of the ‘dismal science’ itself. Instead what is required is an appreciation of how economic analysis can help make the case for value and become a useful tool in what is the ongoing task of changing the perception of the laboratory and medical testing as something other than a cost centre which produces test results.