Definitions of the levels of evidence (I—III) and grades of the recommendation (A, B, C, I) are presented at the end of the "Major Recommendations" field.
Note from the National Academy of Clinical Biochemistry (NACB) and the National Guideline Clearinghouse (NGC): The Laboratory Medicine Practice Guidelines (LMPG) evidence-based practice for point-of-care testing sponsored by the NACB have been divided into individual summaries covering disease- and test-specific areas. In addition to the current summary, the following are available:
Activated Partial Thromboplastin Time (aPTT)
Is there evidence of improved clinical outcome using point-of-care aPTT testing? (Literature Search 10 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 23. The guideline developers recommend that the use of point-of-care aPTT be considered a safe and effective alternative to laboratory aPTT testing for anticoagulation and hemostasis monitoring.
Strength/consensus of recommendation: B
Level of evidence: I and II (at least 1 randomized controlled trial, small randomized controlled trials, nonrandomized controlled trials, and multiple time series without intervention)
Guideline 24. The guideline developers strongly recommend that therapeutic ranges, workflow patterns, and cost analysis be evaluated, and where necessary altered, during the implementation of point-of-care aPTT testing to ensure optimization of patient treatment protocols.
Strength/consensus of recommendation: A
Level of evidence: II (small randomized controlled trials and nonrandomized controlled trials)
Prothrombin Time/International Normalized Ratio (PT/INR)
Is there evidence of improved clinical outcome using point-of-care PT testing? In the hospital? (Literature Search 11 – Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 25. The guideline developers recommend that the use of point-of-care PT be considered a safe and effective alternative to laboratory PT testing for hemostasis monitoring.
Strength/consensus of recommendation: B
Level of evidence: I and II (at least 1 randomized controlled trial, small randomized controlled trials, nonrandomized controlled trials, and multiple time series without intervention)
Guideline 26. The guideline developers strongly recommend that critical ranges, workflow patterns, and cost analysis be evaluated, and where necessary altered, during the implementation of point-of-care PT testing to ensure optimization of patient treatment protocols.
Strength/consensus of recommendation: A
Level of evidence: II (small randomized controlled trials, nonrandomized controlled trials)
Is there evidence of improved clinical outcome using point-of-care PT testing? In the anticoagulation clinic?
Guideline 27. The guideline developers recommend that the use of point-of-care PT be considered a safe and effective alternative to laboratory PT testing for oral anticoagulation monitoring and management.
Strength/consensus of recommendation: B
Level of evidence: II and III (controlled trials without randomization, cohort or case-control analytic studies, and opinions of respected authorities)
Is there evidence of improved clinical outcome using point-of-care PT testing? For patient self-testing (PST)/patient self-management (PSM)?
Guideline 28. The guideline developers recommend the use of point-of-care PT as a safe and effective method for oral anticoagulation monitoring for appropriately trained and capable individuals.
Strength/consensus of recommendation: B
Level of evidence: I, II, and III (at least 1 randomized controlled trial, small randomized controlled trials, nonrandomized controlled trials, and opinions of respected authorities)
Activated Clotting Time (ACT)
Is there evidence of improved clinical outcome with ACT testing? Is there evidence for optimal target times to be used with ACT monitoring? In cardiovascular surgery? (Literature Search 12 - Refer to Appendix B - see the "Availability of Companion Documents" field)
Guideline 29. The guideline developers strongly recommend ACT monitoring of heparin anticoagulation and neutralization in the cardiac surgery arena.
Strength/consensus of recommendation: A
Level of evidence: I and II (at least 1 randomized controlled trial, small randomized controlled trials, nonrandomized controlled trials)
Guideline 30. There is insufficient evidence to recommend specific target times for use in ACT-managed heparin dosing during cardiovascular surgery.
Strength/consensus of recommendation: I (conflicting evidence across clinical trials)
Is there evidence of improved clinical outcome with ACT testing? Is there evidence for optimal target times to be used with ACT monitoring? In interventional cardiology?
Guideline 31. The guideline developers strongly recommend ACT monitoring of heparin anticoagulation and neutralization during interventional cardiology procedures.
Strength/consensus of recommendation: A
Level of evidence: II (small randomized controlled trials, nonrandomized controlled trials, and case-controlled analytic studies from more than 1 center or research group)
Guideline 32. The guideline developers recommend the use of target times specific to ACT system used that differ if specific platelet inhibitors are used concurrently with heparin. Without intravenous platelet inhibitors, the evidence suggests that targets of >250 seconds with the Medtronic ACTII or >300 seconds with the Hemochron FTCA510 tube assay are appropriate.
Strength/consensus of recommendation: B
Level of evidence: II (small randomized controlled trials, nonrandomized controlled trials, case-controlled analytic studies from more than 1 center or research group)
Guideline 33. With the intravenous platelet inhibitors abciximab or eptifibatide, a target of 200 to 300 seconds is recommended; with tirofiban, a somewhat tighter range of 250 to 300 seconds is recommended.
Strength/consensus of recommendation: B
Level of evidence: I (at least 1 randomized controlled trial)
Is there evidence of improved clinical outcome using ACT testing? Is there evidence for optimal target times to be used with ACT monitoring? In extracorporeal membrane oxygenation (ECMO)?
Guideline 34. The guideline developers strongly recommend ACT monitoring to control heparin anticoagulation during ECMO.
Strength/consensus of recommendation: A
Level of evidence: III (opinions of respected authorities based on clinical experience, descriptive studies or reports of expert committees)
Guideline 35. The guideline developers recommend that ACT target times for ECMO be determined according to the ACT system in use.
Strength/consensus of recommendation: B
Level of evidence: III (opinions of respected authorities according to clinical experience, descriptive studies, or reports of expert committees)
Is there evidence of improved clinical outcome using ACT testing? Is there evidence for optimal target times to be used with ACT monitoring? In other applications (e.g., vascular surgery, intravenous heparin therapy, dialysis, neuroradiology, etc)?
Guideline 36. There is insufficient evidence to recommend for or against ACT monitoring in applications other than cardiovascular surgery, interventional cardiology, or extracorporeal oxygenation.
Strength/consensus of recommendation: I
Definitions:
Levels of Evidence
- Evidence includes consistent results from well-designed, well-conducted studies in representative populations.
- Evidence is sufficient to determine effects, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies; generalizability to routine practice; or indirect nature of the evidence.
- Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information.
Strength of Recommendations
A - The National Academy of Clinical Biochemistry (NACB) strongly recommends adoption; there is good evidence that it improves important health outcomes and concludes that benefits substantially outweigh harms.
B - The NACB recommends adoption; there is at least fair evidence that it improves important health outcomes and concludes that benefits outweigh harms.
C - The NACB recommends against adoption; there is evidence that it is ineffective or that harms outweigh benefits.
I - The NACB concludes that the evidence is insufficient to make recommendations; evidence that it is effective is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.
