Result card

  • ETH16: Are the accuracy measures decided and balanced on a transparent and acceptable way?
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Are the accuracy measures decided and balanced on a transparent and acceptable way?

Authors: Dario Sacchini, Roberta Minacori, Pietro Refolo

Internal reviewers: Petra Schnell-Inderst, Mirella Marlow, Narine Sahakyan

There is limited evidence about the laboratory procedures used for these tests, including information about their reproducibility {54, 55}. Concerns have been expressed about the potential influence of several factors on the performance of these tests, such as intra-tumour molecular heterogeneity, warm/cold ischaemia time, fixation and processing using formalin fixed tumour tissue, and influence of biopsy cavity {2, 3, 4}.

More studies are available that assess the analytic performance of the Oncotype DX and MammaPrint tests, though additional data on some points (e.g. impact of variability on risk classification) are needed. Since all three of the prognostic tests are proprietary (single clinical source), and external proficiency testing is not available at this time, reporting by the laboratories of quality control/ quality assessment protocols and analytic performance data would provide additional information for clinicians and patients {18}.

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Sacchini D et al. Result Card ETH16 In: Sacchini D et al. Ethical analysis In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 3 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=113

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