Clinical laboratories: production industry or medical services?

Plebani, Mario

doi:10.1515/cclm-2014-1007

Cited by 37 publications

(24 citation statements)

References 55 publications

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“…With these clarifications, it can be argued that the convergence of custom-designed technology, of digital technology and communication technology sets the conditions to develop laboratory diagnostics that are more and more tailored to the patient, thus meeting the principles of "innovative innovation" [24,25].…”

Section: Innovation and Translational Research In Laboratory Medicinementioning

confidence: 99%

The principles of Health Technology Assessment in laboratory medicine

Liguori

Belfiore

D’Amora³

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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The Health Technology Assessment (HTA) is a multi-professional and multidisciplinary evaluation approach designed to assess health technology in the broadest sense of the term, from its instruments to the rearranging of its organizational structures. It is by now an established methodology at national and international levels that involves several medical disciplines thanks to its versatility. Laboratory medicine is one of these disciplines. Such specialization was subjected, in recent years, to deep changes even from an organizational standpoint, in order to meet the health needs of the population, making them as effective and cost-effective as possible. In this regard, HTA was the tool used to assess implications in different areas.

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Section: Innovation and Translational Research In Laboratory Medicinementioning

confidence: 99%

The principles of Health Technology Assessment in laboratory medicine

Liguori

Belfiore

D’Amora³

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Laboratory tests are currently not perceived as playing a primary role in providing added value to medical treatments, as diagnostic tests are often considered a "commodity" in health resource [14,15]. A great challenge in laboratory medicine is communicating to users about the best biomarker that contributes to the best downstream clinical pathway, including management based on test results.…”

Section: The Challengesmentioning

confidence: 99%

Developing GRADE outcome-based recommendations about diagnostic tests: a key role in laboratory medicine policies

Trenti

Plebani

2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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Harmonisation and risk management policies represent key-issues in modern laboratory medicine as they focus on a more patient-centred delivery of laboratory information based on the recognition of the importance of all steps of the total testing process (TTP) for assuring quality and patient safety. However, a further essential step in project aiming to improve the value of laboratory medicine becomes the assessment of the impact of testing on patient-important outcomes. The grading of recommendations assessment, development and evaluation (GRADE) evidence to decision (EtD) frameworks may provide a systematic and transparent approach for translating the best clinical evidence available into healthcare decisions and recommendations. GRADE is a tool appropriate not only for evaluating test accuracy but also for clinical impact, such as mortality, morbidity, symptoms, and quality of life and therefore it should be applied to the outcome research in laboratory medicine. The application of GRADE requires the recognition that a recommendation about the use of test results should result from a balance between the desirable and the undesirable consequences, including non-health related consequences such as resource utilisation, feasibility, acceptability, equity and other factors. GRADE EtDs, represents a fundamental step in projects designed to improve care quality. Patient-physician-laboratory feedback can be assured through the GRADE process, where the team developing the recommendations should include the "three-parties" representatives; clinicians, laboratorians and patient/ consumers. This ensures that the laboratory-patient interaction should not be a one-way process only (information from laboratory to patient) but a two-way process, incorporating patient expectations and feedback.

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“…New diagnostic tests must be evaluated for their accuracy, precision, specificity and long-term robustness. Trueness and precision (accuracy) need to be maintained over months or years, and monitored by external quality assurance programs, so that patient's data can be directly compared over long periods of time [6]. Without independent validation, Theranos technology's quality and robustness will remain in question.…”

Section: Theranos Technologymentioning

confidence: 99%

Theranos phenomenon: promises and fallacies

Diamandis¹

2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:Recently, spectacular advances in diagnostic technologies, genomics, etc. offer unprecedented opportunities for widespread testing of asymptomatic individuals, in the hope that this testing will unravel early disease signs which could lead to preventative or more effective therapeutic measures. In particular, one commercial organization, Theranos, promises to revolutionize diagnostics by offering multi-analyte testing at low prices in commercial outlets, thus challenging the current paradigm of targeted and centralized diagnostic testing. In this paper, I analyze the Theranos technology and their promises, and contrast this information with the currently used technologies, to show that most of the company's claims are exaggerated. While it remains to be seen if this technology will revolutionize diagnostics, in this Opinion Paper, I also draw attention of associated issues, such as self-testing and self-interpretation of results, over-testing, over-diagnosis and over-treatment, along with their associated harms. As the public is bombarded daily with new and revolutionary health-related advances, it is time to balance the enthusiasm of the seemingly obvious huge gains, by also explaining the associated possible harms.

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Clinical laboratories: production industry or medical services?

Cited by 37 publications

References 55 publications

The principles of Health Technology Assessment in laboratory medicine

The principles of Health Technology Assessment in laboratory medicine

Developing GRADE outcome-based recommendations about diagnostic tests: a key role in laboratory medicine policies

Theranos phenomenon: promises and fallacies

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