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Mapping point-of-care performance using locally-smoothed median and maximum absolute difference curves

Abstract Background: The goal is to introduce visual performance mapping efficient for establishing acceptance criteria and facilitating decisions regarding the utility of hospital point-of-care devices. This approach uniquely reveals the quality of performance locally, as opposed to globally. Methods: After presenting theoretical foundations, this study illustrates the approach by applying it to six hospital glucose meter systems (GMSs) using clinical multi-center (n=2767) and multi-system (n=613, n=100) observations. Results: LS MAD curves identified breakouts, that is, points where the locally-smoothed median absolute difference (LS MAD) curve exceeds the recommended error tolerance limit of 5 mg/dL (0.28 mmol/L). LS maximum absolute difference (MaxAD) breakthroughs, which occur where the LS MaxAD curve exceeds the 99th percentile of MaxADs from x=30–200 mg/dL (1.67–11.10 mmol/L), showed extreme error locations. A multi-sensor interference- and hematocrirt-correcting GMS displayed a flat LS MAD curve u...

Authors:   Gerald J. Kost; Nam K. Tran; Harpreet Singh
Journal:   Clinical Chemistry
Year:   2011
DOI:   10.1515/CCLM.2011.655
Publication date:   19-Oct-2011
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