A Procedure for the Simplification and Assessment of Lab Parameters in Clinical Trials

The article introduces two concepts which simplify the display and interpretation of lab data monitoring. The two concepts are: (1) a normalization (or standardization) of each lab value so that it can be interpreted without reference to its normal range and (2) a multivariate scoring system that combines lab parameters into functionally related groups. The technique is demonstrated with real clinical data. Several functional group scores are evaluated and a Global Score produced for individual patients at each time point. The Global Score, viewed over the course of therapy, presents a concise review of drug safety (or toxicity) for each patient and for the study as a whole. Examples will illustrate that the global score can be used as “a safety measure.”

[1]  E. K. Harris,et al.  Some theory of reference values. I. Stratified (categorized) normal ranges and a method for following an individual's clinical laboratory values. , 1975, Clinical chemistry.

[2]  D L DeMets,et al.  Estimation of normal ranges and cumulative proportions by transforming observed distributions to gaussian form. , 1972, Clinical chemistry.

[4]  A. H. Reed,et al.  Influence of statistical method used on the resulting estimate of normal range. , 1971, Clinical chemistry.

[5]  J.W. Lewis.  Commentary: Clinical laboratory information systems , 1979, Proceedings of the IEEE.

[6]  F W Sunderman,et al.  Current concepts of "normal values," "reference values," and "discrimination values," in clinical chemistry. , 1975, Clinical chemistry.

[7]  L. Elveback,et al.  Health, normality, and the ghost of Gauss. , 1970, JAMA.

[8]  E. A. Johnson.  Some basic considerations of the needs for improved clinical laboratory data analyses. , 1973, Human pathology.

[9]  W. Marsh,et al.  Normal values: theoretical and practical aspects. , 1975, CRC critical reviews in clinical laboratory sciences.

[10]  S. Ciccolunghi,et al.  Interpretation of Hematological and Biochemical Laboratory Data in Large‐Scale, Multicenter Clinical Trials , 1979, Journal of clinical pharmacology.

[11]  Reed M. Gardner,et al.  Integrated Computer Systems for Monitoring of the Critically Ill , 1977 .

[12]  P D Bezemer,et al.  Determining reference ('normal') limits in medicine: an application. , 1983, Statistics in medicine.

[13]  K. McPherson,et al.  The effect of age, sex and other factors on blood chemistry in health. , 1978, Clinica chimica acta; international journal of clinical chemistry.

[14]  E. S. Benson.  Strategies For Improving The Use Of The Clinical Laboratory: Computer Applications , 1978 .