A5015023423- Diabetes Management and Research
- Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Clinical Laboratory Practices and Quality Control
- Statistical Methods in Clinical Trials
- Diabetes and associated disorders
- Diabetes, Cardiovascular Risks, and Lipoproteins
- Meta-analysis and systematic reviews
- Metabolism, Diabetes, and Cancer
- Patient Safety and Medication Errors
- Intravenous Infusion Technology and Safety
- Pharmaceutical studies and practices
- Quality and Safety in Healthcare
- ECG Monitoring and Analysis
- Pesticide Residue Analysis and Safety
- Artificial Intelligence in Healthcare
- Advanced Statistical Process Monitoring
- Medical Malpractice and Liability Issues
- Sensor Technology and Measurement Systems
- Analytical Chemistry and Chromatography
- Electrochemical sensors and biosensors
- Biosimilars and Bioanalytical Methods
- Optimal Experimental Design Methods
- Diabetes Treatment and Management
- Analytical Chemistry and Sensors
- Reliability and Agreement in Measurement
Bayer (Germany)
2000
Corning (United States)
1987-1995
Authors sometimes report total imprecision as being less than within-run imprecision. This leads one to question how well the underlying statistical concepts are understood. article explains relevant studies and reviews proper use of terms. Calculation its components is illustrated by a numerical example. Two most common calculation mistakes pointed out. Finally, we recommend improvements in experimental design that will result more precise estimates.
An error grid compares measured versus reference glucose concentrations to assign clinical risk values observed errors. Widely used grids for blood monitors (BGMs) have limited value because they do not also reflect accuracy of continuous (CGMs).
Total analytical error has been a useful metric both to assess laboratory assay quality and set goals. It is often estimated by combining imprecision (SD) average bias in the equation: total = + 1.65 x imprecision. This indirect estimation model (referred as simple combination model) leads different estimates of than that direct method distribution-of-differences method) or simulation.A review literature was undertaken reconcile approaches.The can underestimate neglecting random interference...
Abstract Background: The Guide to the Expression of Uncertainty in Measurement (GUM) provides instructions for constructing uncertainty intervals a measurement. This method is usually reserved reference materials, but GUM has been recently proposed as way express commercial diagnostic assays. Methods: Using official standard and published applications assays, I undertook an analysis evaluate whether applying assays warranted. Results: Certain important such troponin I, would not be...
Abstract Objective.—To review the Failure Mode Effects Analysis (FMEA) process recommended by Joint Commission on Accreditation of Health Organizations and to alternatives. This reliability engineering tool may be unfamiliar hospital personnel. Data Sources.—Joint recommendations, Mil-Std-1629A, other articles about FMEA were used. Study Selection.—The selected a literature search that included Web site–accessible material. Extraction.—All found Synthesis.—The results are based cited...
We examine limitations of common analytical performance specifications for quantitative assays. Specifications can be either clinical or regulatory. Problems with current include specifying limits only 95% the results, having one set that demarcate no harm from minor harm, using incomplete models total error, not accounting potential user and supplying sufficient protocol requirements. Error grids are recommended to address these problems as error account 100% data stratify errors into...
Journal Article Cumulative distribution analysis graphs--an alternative to ROC curves. Get access J S Krouwer Ciba Corning Diagnostics Corp., Medfield, MA 02052 Search for other works by this author on: Oxford Academic Google Scholar Clinical Chemistry, Volume 33, Issue 12, 1 December 1987, Pages 2305–2306, https://doi.org/10.1093/clinchem/33.12.2305a Published: 01 1987
Background: Adverse events for continuous glucose monitors (CGMs) represent a significant issue people with diabetes 281 963 CGM adverse occurring in 2022. The process to obtain and the US Food Drug Administration (FDA) database that contains them are reviewed. Methods: Tables were created SQL Server four products (Dexcom G6, all versions of Abbott Libre, Medtronic Guardian 3, Senseonics Eversense) containing either malfunction or injury sorted by manufacturer’s chosen product code. As code...
This is a summary report of the most important aspects discussed during YSI 2300 Analyzer Replacement Meeting. The aim to provide interested reader with an overview complex topic and propose solutions for current issue. solution should not only be adequate United States or Europe markets but also all other countries. meeting addendum presents three outcomes meeting.
US Food and Drug Administration adverse event data for 2019 were analyzed two insulin pumps continuous glucose monitors (CGMs). The analyses selective-they guided by the text described in events. They included (1) percent using auto mode Medtronic 670G pump, (2) distributions of hyper hypo values Tandem pumps, (3) a Parkes error grid Dexcom CGM vs meter when complaint was inaccuracy, (4) most frequent events Abbott Freestyle. We found that there more on than off. With CGMs, users complained...
We present a statistical method to quantify deviations from linearity for assays that veer linear assay responses. Our procedure handles the common case of unequally spaced analyte levels and nonconstant variance provides least-squares estimate with confidence interval amount deviation at specified concentration. This bias due nonlinearity goes beyond NCCLS EP6 lack-of-fit test, which tests only presence nonlinearity. Knowing is insufficient; users need know magnitude caused by can also be...
Abstract A recent issue in this journal revisited performance specifications since the Stockholm conference. Of three recommended methods, two use total error models to establish specifications. It is shown that most commonly used model – Westgard deficient, yet even more complete fail capture all errors comprise error. Moreover, are often set at 95% of results, which leave 5% results as unspecified. Glucose meter standards illustrate these problems. The useful asses assay but not Total can...
A multi-factor experimental design for evaluating random-access analyzers has been developed and tested the Ciba Corning "550 Express" analyzer. The 12-sample estimates imprecision, slope, nonlinearity, linear drift, reagent carryover to next assay. was constructed so that of factors' effects are almost entirely uninfluenced by each other. Use is illustrated an example in which reagent-to-assay pinpointed as apparent cause high imprecision. This led a modification analyzer such...
Glucose meter evaluations are common and provide important information about glucose performance versus standards. Although some meters meet guidelines others fall short in these evaluations, most results within the A B zones of a error grid. Another data source that is seldom used FDA adverse event database (MAUDE). This describes malfunctions injury as reported by actual users returned 10 837 events across all for first 7 months 2018. Reliability growth management an established tool to...