ARIC hemostasis study--III. Quality control. Atherosclerosis Risk in Communities

Area of Science:

• Cardiovascular Research
• Hematology
• Epidemiology

Background:

• The Atherosclerosis Risk in Communities (ARIC) Study previously detailed standardized blood collection and processing procedures.
• Ensuring data integrity in large multicenter studies requires rigorous quality control for hemostasis variables.

Purpose of the Study:

• To present methods and results from the ARIC Study's quality assurance program for hemostasis variables.
• To assess and control variability in hemostasis testing from sample collection to laboratory analysis.

Main Methods:

• Focused on monitoring operational aspects: fasting, phlebotomy, processing, and shipping times.
• Implemented hemostatic laboratory internal quality control measures.
• Utilized a replicate blood sample program to assess measurement variability.

Main Results:

• Estimated measures of variation (standard deviations, coefficients of variation) for key hemostatic variables.
• Included activated partial thromboplastin time, fibrinogen, factor VII and VIII activity, von Willebrand factor, antithrombin-III, and protein C.
• Demonstrated the reliability of measuring these hemostatic variables within a large multicenter study.

Conclusions:

• The ARIC Study's quality assurance program effectively minimizes variability in hemostasis testing.
• Reliable measurement of hemostatic variables is achievable in large, multicenter epidemiological studies.
• This quality control framework supports the validity of ARIC Study findings on atherosclerosis risk.