Significance of consecutive international normalized ratio (INR) outcomes using statistical control rules in long-term anticoaguated patients. Optimitization of laboratory monitoring and interpretation of borderline measurements

Giovanni Introcaso, Goampietro Gesu

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Analysis of serial measurements is needed to elaborate observations in all fields of medical research. In the present study, retrospective data of anticoagulated patients were used to calculate a mean of observations and control limits, X±1σ and X±2σ (mean±standard deviation). During 18 months of coagulation monitoring, 45 patients without major oral anticoagulant therapy complications, with more international normalized ratio (INR) determinations in the therapeutic range and with a normal distribution of INR values according to the Kurtosis coefficient, were selected. The cumulative distribution functions allowed us to obtain critical limits of INR with a cumulative probability (p). Control limits, calculated for a therapeutic control chart, indicated through different control rules, 1S2 or 2S1 an alarm signal to analyze the cause of INR outside the therapeutic range. Our investigation suggested that for results at the level of the therapeutic control limits, we needed at least two consecutive INR results to detect a significant over- or under-anticoagulation. The therapeutic control chart method should be a useful means in clinical practice for evaluating the statistical significance of consecutive and borderline INR outcomes. Analytical improvements and control rules applied to laboratory monitoring may help optimize drug dose administration.

Original languageEnglish
Pages (from-to)294-299
Number of pages6
JournalClinical Chemistry and Laboratory Medicine
Volume42
Issue number3
DOIs
Publication statusPublished - 2004

Fingerprint

International Normalized Ratio
Monitoring
Therapeutics
Patient monitoring
Normal distribution
Coagulation
Normal Distribution
Anticoagulants
Physiologic Monitoring
Distribution functions
Biomedical Research
Pharmaceutical Preparations

Keywords

  • Borderline measurements
  • International normalized ratio (INR) variability
  • Oral anticoagulant therapy
  • Statistics
  • Therapeutic control chart

ASJC Scopus subject areas

  • Clinical Biochemistry

Cite this

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