This health technology assessment (HTA) will inform decisions regarding the accuracy, and clinical and cost-effectiveness of point-of-care (POC) International Normalized Ratio (INR) compared with standard laboratory testing, and compared with other POC INR devices. A systematic review to evaluate the clinical effectiveness of POC INR compared with laboratory methods, and other POC INR devices, followed by a review of economic evaluation studies will be conducted. CADTH will also conduct a primary economic analysis of the cost-effectiveness of POC INR from a Canadian perspective.

Contents

• 1. CONTEXT AND POLICY ISSUES
  • 1.1 Overview of Technology
• 2. ISSUES
• 3. OBJECTIVES
• 4. RESEARCH QUESTIONS
  • 4.1 POC Tests for INR Compared With Laboratory Methods for Testing INR
  • 4.2 POC Tests for INR Compared With Other POC Tests for INR
  • 4.3 Supplemental Issues
• 5. METHODS
  • 5.1 Clinical Effectiveness
  • 5.2 Supplemental Issues
• REFERENCES
• APPENDIX 1 LITERATURE SEARCH STRATEGY
• APPENDIX 2 DATA EXTRACTION FORM FOR ACCURACY AND CLINICAL EFFECTIVENESS REVIEW
• APPENDIX 3 DOWNS AND BLACK CHECKLIST FOR CLINICAL TRIAL QUALITY ASSESSMENT

Suggested citation:

Canadian Agency for Drugs and Technologies in Health. Point-of-Care Testing of International Normalized Ratio for Patients on Oral Anticoagulant Therapy – Project Protocol [Internet]. Ottawa: The Agency; 2013 Jul. (CADTH Optimal Use Report; vol.3 no.1a). [cited yyyy mmm dd]. Available from: http://www.cadth.ca/media/pdf/Point-of-care_INR_Protocol_e.pdf

This report is prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). This report contains a comprehensive review of existing public literature, studies, materials, and other information and documentation (collectively the “source 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 report is made possible through a financial contribution from Health Canada.