2.7. Methods and approaches to determine “optimal” quality for clinical chemical data

Abstract

“There is no simple over-all answer, and any answer that we find will be temporary, depending on the progress of medical knowledge and technology”. R.N. Barnett 1968 [4]

Although clinical reasoning and decision-making may be very complex, there are methods to perform both piecemeal and more complete optimizations with regard to the use of clinical chemical data and for assessing quality specifications. Some methods and approaches are described and illustrated with examples: (i) rules for propagation of errors in simple algebraic/statistical transformations; (ii) systems and sensitivity analysis using biochemical/ pathophysiological simulation models; (iii) systems and sensitivity analysis of simulated clinical classification and decision processes. It is concluded that the possible gain of useful information by improving analytical and pre-analytical quality should be related to the often more important aspects of test selection and test combination, period and frequency of observation, and the use of correct conceptual models for transformation of data.

Key Words:

• analytical goals
• analytical quality
• clinical chemical data
• medical decision-making
• modeling
• optimization
• quality specifications
• quality requirements
• simulation