Beyond accuracy: Evidence gaps and unintended consequences. Factors influencing utility of point-of-care diagnostic tests

Point-of-care or near-patient-tests, are as these descriptors suggest, medical diagnostic tests which can be performed by a clinician, patient, or carer of a patient, without the need for samples to be transported to laboratories. These tests usually yield results rapidly, with clear convenience benefits for patients but with the potential to variably impact on clinicians. Our research suggests that evaluations of point-of-care tests usually focus on the accuracy of these tests when compared to the ‘reference standard’ laboratory tests, with manufacturers aiming to achieve equivalence or non-inferiority. This is admirable and essential, however the broader impact of tests on the relevant clinical pathways and patient health are often neglected. This talk will outline the areas of evidence which are frequently underrepresented in point-of-care test evaluations and will explore some of the more nuanced and unusual barriers and impacts of test introduction using some true and hypothetical examples to illustrate the inherent complexity of the test-pathway nexus. Phil Turner is a diagnostics researcher and Manager of the Community Healthcare MIC. His role incorporates responsibility for liaising with members of the in vitro diagnostics industry and for facilitating interactions with the MIC research team. His research has focussed on the diagnostic needs of clinicians, barriers to implementation, and the identification of evidence gaps which commonly exist in the evidence base for point-of-care diagnostic tests. He has a personal interest in IVDs which could be deployed in resource-limited settings. His background is in cell physiology, membrane transport processes and signalling and he has a particular interest in the control of ventilation and in particular how humans respond to changes in the partial pressure of inspired oxygen. He has an associated interest in the physiology and medicine of life in remote regions and at high altitude. This talk was held as part of the Evidence-Based Diagnosis and Screening course which is part of the Evidence-Based Health Care Programme.

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