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ARIC hemostasis study--III. Quality control. Atherosclerosis Risk in Communities
L E Chambless1, R McMahon, A Finch
1Department of Biostatistics, University of North Carolina, Chapel Hill 27514.
Insights
The Atherosclerosis Risk in Communities (ARIC) Study established a robust quality assurance program for hemostasis variables. This program ensures reliable measurement of key blood clotting factors in large-scale research.
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.
Abstract:
Methods and results from the quality assurance program of the Atherosclerosis Risk in Communities (ARIC) Study regarding hemostasis variables are presented, following up previous reports in this journal on standardized procedures for blood collection and processing (7) and an organized plan for the performance of those procedures (8). Efforts were made to control for and assess all sources of variability, from venipuncture to laboratory analysis, including also local field center processing and sample shipping. The quality control program included (a) a standardized protocol for blood collection and processing; (b) training, certification, and annual recertification of field center personnel for blood collection and processing; (c) monitoring of fasting times, phlebotomy times, processing times, and shipping problems; (d) hemostatic laboratory internal quality control; (e) a replicate blood sample program; (f) an intraindividual variability study; and (g) continual monitoring of quality control and study participants' data. This paper focused on items (c), (d), and (e). Measures of variation, generally standard deviations and coefficients of variation, are estimated for replicate blood sampling and internal quality control data, for activated partial thromboplastin time, fibrinogen, factor VII and VIII activity, von Willebrand factor, antithrombin-III, and protein C. The results demonstrate that it is possible to reliably measure these hemostatic variables in a large multicenter study.