The objectives of this health technology assessment were to evaluate the accuracy, and clinical and cost-effectiveness of point-of-care (POC) international normalized ratio (INR) devices compared with standard lab testing, and between POC INR devices. A systematic review was performed to evaluate the accuracy and clinical effectiveness of POC INR. We also performed a primary economic analysis of the cost-effectiveness of POC INR from a Canadian perspective, as well as a review of the health services impact in Canada.

Contents

• EXECUTIVE SUMMARY
• ACRONYMS AND ABBREVIATIONS
• 1. INTRODUCTION
  • 1.1 Background
  • 1.2 Overview of Technology
• 2. ISSUES
• 3. OBJECTIVES
  • 3.1 POC Tests for INR Compared With Laboratory Methods for Testing INR
  • 3.2 POC Tests for INR Compared With Other POC Tests for INR
  • 3.3 Additional Considerations
• 4. CLINICAL REVIEW
  • 4.1 Methods
  • 4.2 Results
• 5. PRIMARY ECONOMIC EVALUATION
  • 5.1 Methods
  • 5.2 Results
• 6. DISCUSSION
  • 6.1 Findings From the Clinical Review
  • 6.2 Findings From the Economic Analysis
• 7. CONCLUSIONS
• REFERENCES
• APPENDIX 1 LITERATURE SEARCH STRATEGY
• APPENDIX 2 SELECTION OF INCLUDED STUDIES
• APPENDIX 3 INCLUDED AND EXCLUDED STUDIES
• APPENDIX 4 DATA EXTRACTION FORM FOR ACCURACY AND CLINICAL EFFECTIVENESS REVIEW
• APPENDIX 5 STUDY CHARACTERISTICS
• APPENDIX 6 PATIENT CHARACTERISTICS
• APPENDIX 7 SUMMARY OF CRITICAL APPRAISAL OF INCLUDED STUDIES
• APPENDIX 8 ACCURACY AND CLINICAL AGREEMENT OF POC DEVICES VERSUS LABORATORY
• APPENDIX 9 RESULTS OF ONE-WAY SENSITIVITY ANALYSES FOR DEVICE COST AND FREQUENCY OF TESTING
• APPENDIX 10 ONE-WAY SENSITIVITY ANALYSES FOR HEALTH CARE PROVIDER COSTS
• APPENDIX 11 RESULTS OF ONE-WAY SENSITIVITY ANALYSES FOR PATIENT COSTS
• APPENDIX 12 RESULTS OF ONE-WAY SENSITIVITY ANALYSES FOR RISK OF ADVERSE EVENTS
• APPENDIX 13 RESULTS OF ONE-WAY SENSITIVITY ANALYSES FOR UTILITY ESTIMATES
• APPENDIX 14 QUALITY ASSURANCE FOR POINT-OF-CARE TESTING ACROSS CANADA

Suggested citation:

Canadian Agency for Drugs and Technologies in Health. Point-of-Care Testing of International Normalized Ratio for Patients on Oral Anticoagulant Therapy: Systematic Review and Economic Analysis [Internet]. Ottawa: The Agency; 2014 Jul. (CADTH Optimal Use Report; vol.3 no.1b). [cited yyyy mmm dd]. Available from: http://www.cadth.ca/media/pdf/OP0515_POC%20INR_Science_Report.pdf

This report is prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). This report contains a review of existing public literature, studies, materials, and other information and documentation available to CADTH at the time it was prepared, and it was guided by expert input and advice throughout its preparation.

The information in this report is intended to help health care decision-makers, patients, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment in respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this report to ensure that its contents are accurate, complete, and up-to-date, CADTH does not make any guarantee to that effect. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or as a result of the use (or misuse) of any information contained in or implied by the information in this report.

CADTH takes sole responsibility for the final form and content of this report. The statements, conclusions, and views expressed herein do not necessarily represent the view of Health Canada or any provincial or territorial government.

Production of this document is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan, and Yukon.