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July 1, 1999Annals of Pharmacotherapy

Accuracy, Clinical Correlation, and Patient Acceptance of Two Handheld Prothrombin Time Monitoring Devices in the Ambulatory Setting

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Key result

The Coaguchek monitor was superior to the ProTime system in clinical correlation, with fewer INRs resulting in a different therapeutic decision compared to standard lab testing (8.3% vs 50%, p<0.005).

Why the study?

Do handheld prothrombin time monitoring devices (Coaguchek and ProTime) provide accurate and clinically correlated INR values compared to standard laboratory methods in ambulatory patients?

Population

Patients requiring prothrombin time monitoring in an ambulatory setting

Comparison

Coaguchek and ProTime Microcoagulation System… vs Standard laboratory methods for prothrombin time…

Design

Cross-sectional

Authors

DCDerek C ChapmanUniversity Medical CenterMSMark A. StephensJohn Innes CentreGHGale L. HamannUniversity of Tennessee Health Science Center

Discussion

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Implication

May inform point-of-care INR device selection in ambulatory care; hypothesis-generating and requires prospective validation before practice change.

Study Design

Type

Observational

Structured PICO

Do handheld prothrombin time monitoring devices (Coaguchek and ProTime) provide accurate and clinically correlated INR values compared to standard laboratory methods in ambulatory patients?

P
Population
Ambulatory patients undergoing prothrombin time monitoring to compare handheld devices with standard laboratory methods.
E
Exposure
Coaguchek and ProTime Microcoagulation System handheld devices for INR determination via finger stick
C
Comparator
Standard laboratory methods for prothrombin time determination via venipuncture
O
Outcome
Accuracy (absolute difference for each pair of INR values) and clinical correlation (whether the handheld monitor would have resulted in the same therapeutic decision as the laboratory method)surrogate

Main Result

Absolute Event Rate: 8.3% vs 50%

p-value: p=<0.005

The Coaguchek handheld monitor provides superior accuracy and clinical correlation compared to the ProTime system for INR monitoring, and patients strongly prefer the finger stick method over venipuncture.

Cite This Study

Chapman et al. (1999) conducted an observational in Patients requiring prothrombin time monitoring. Coaguchek monitor vs. ProTime Microcoagulation System was evaluated on INRs resulting in a different therapeutic decision compared to standard laboratory method (p=<0.005). The Coaguchek monitor was superior to the ProTime system in clinical correlation, with fewer INRs resulting in a different therapeutic decision compared to standard lab testing (8.3% vs 50%, p<0.005).

synapsesocial.com/papers/6a93e9a8bc28082652fc100ehttps://doi.org/10.1345/aph.18317
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A Statistical and Clinical Evaluation of Fingerstick and Routine Laboratory Prothrombin Time Measurements1997 · 42 citations
  2. 2Accuracy of Laboratory and Portable Monitor International Normalized Ratio Determinations1995 · 94 citations
  3. 3Outpatient Use of a Portable International Normalized Ratio/Prothrombin Time Monitor1994 · 17 citations
  4. 4Home Prothrombin Time Monitoring after the Initiation of Warfarin Therapy1989 · 191 citations
  5. 5Evaluation of a Portable Prothrombin Time Monitor for Home Use by Patients Who Require Long-term Oral Anticoagulant Therapy1993 · 152 citations