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Reliability of molecular imaging diagnostics

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Abstract

Advanced medical imaging, such as CT, fMRI and PET, has undergone enormous progress in recent years, both in accuracy and utilization. Such techniques often bring with them an illusion of immediacy, the idea that the body and its diseases can be directly inspected. In this paper we target this illusion and address the issue of the reliability of advanced imaging tests as knowledge procedures, taking positron emission tomography (PET) in oncology as paradigmatic case study. After individuating a suitable notion of reliability, we argue that (1) PET is a highly theory-laden and non-immediate knowledge procedure, in spite of the photographic-like quality of the images it delivers; (2) the diagnostic conclusions based on the interpretation of PET images are population-dependent; (3) PET images require interpretation, which is inherently observer-dependent and therefore variable. We conclude with a three-step methodological proposal for enhancing the reliability of advanced medical imaging.

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Notes

  1. “Precision medicine” and “personalised medicine” are often used as synonyms; though with “precision medicine”, the stress is on targeting a specific disease or malfunction with treatments and tests, rather than a larger category of similar diseases (i.e. triple negative breast cancer versus breast cancer, see Wu et al. 2018), whereas “personalised medicine” refers to the consideration of patient-specific factors in diagnosis and treatment (Desmond-Hellmann et al. 2011; National Institute of Health 2018). We acknowledge this distinction though it is not essential to the argument of this paper, (see https://ghr.nlm.nih.gov/ Precision Medicine; see also https://www.nih.gov/research-training/allofus-research-program).

  2. A notable exception is Megan Delehanty’s PhD’s dissertation on the epistemic credentials, and especially on the reliability, of PET images in clinical oncology. Delehanty focuses on the question of whether and how PET as a data-generating process produces reliable knowledge, while we enlarge the picture and consider the reliability of the technology together with the way it is usually employed within the medical community. In broadening our scope with such socio-epistemological question, we think our work completes Delehanty’s excellent analysis.

  3. As we will see in a while, FDG stands for fludeoxyglucose, that is, the usual radiotracer used for PET neuroimaging and cancer patient management.

  4. The non-immediacy of medical imaging in the philosophy of neuroscience has been studied extensively, see Bogen (2001).

  5. For an introduction to the differences between PET and CT, see for example RSNA 2019. For a philosophical illustration of CT and “seeing styles”, see Friedrich (2010). We thank one of the reviewers for pressing us on this point.

  6. See the position and the terminology suggested by the National Institute of Standards and Technology (https://www.nist.gov/pml/nist-technical-note-1297).

  7. We believe that the distinction between reliability of process (first sense, epistemology), reliability of data (second sense, philosophy of science) and reliability as repeatability (third sense, scientific methodology) can be useful in the paper because different readers can be more familiar with one or the other of the three senses. We thank one of the reviewers for pressing us on this point.

  8. Here we use personalised medicine since we are in the situation indicated as such by National Research Council in footnote 2.

  9. Alongside campaigns promoted by scientific societies and institutional and private healthcare providers, there is a philosophical debate on overutilisation and medical futility, addressing both the definition of the phenomenon and ethical consequences. See Hofmann (2010).

  10. The psychological allure of images is of course not unique to molecular imaging tests, of course, but is common to all medical imaging diagnostic tests (such as CT for example, see footnote 4 above). What is specific to molecular imaging, we believe, is that immediacy of images is additionally difficult to defend.

  11. Nonetheless, medical images as numbers can be more easily read by software, and this is the basis of Radiomics. See Gillies et al. (2015).

  12. As known, under this tradition in the philosophy of science, there was the hidden figure of Kant and of a form of neo- or post-Kantism, see Boniolo (2007).

  13. The competence and expertise of an expert reader of medical images are a research field in itself, and it is especially debated now that artificial readers become increasingly available. See Krupinski (2010), Samei and Krupinski (2010) and Shiraishi et al. (2011).

  14. To put it very simply, the interquartile range of a data set is where is a measure of where the bulk of the values lie.

  15. The use of consensus conferences and Delphi procedures is widespread in the social and life sciences, whenever evidence underdetermines the answer to a given scientific or policy question, and experts disagree. For example, they are often employed in psychiatry, in order to decide whether a certain condition is to be considered a disease or not, and they were used in astronomy to assess the status of Pluto as a planet. In philosophy, their epistemic pedigree has been analysed by philosophers like Miriam Solomon and Jakob Stegenga. In advanced diagnostic imaging, they are often utilized in order to write and publish guidelines for the appropriate use of tests (see e.g. In philosophy of science, Miriam Solomon has studied the role of consensus conferences and Delphi studies in the making of medical knowledge (Solomon 2007, 2015).

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Lalumera, E., Fanti, S. & Boniolo, G. Reliability of molecular imaging diagnostics. Synthese 198 (Suppl 23), 5701–5717 (2021). https://doi.org/10.1007/s11229-019-02419-y

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