UNIVERSITY OF HEALTH SCIENCE

PUBLIC HEALTH
PCEM2

VARIATION IN CLINICAL DATA

AND NORMAL DISTRIBUTION

YEAR 2013-14

PROFESSEUR AGREGE KRY

 I-VARIATION IN CLINICAL DATA
Variation in clinical measurement including bias, accuracy, and precision .
A-Bias :
1- Definition : Bias is the systematic component of both biologic variation
and measurement variation. Bias results in measurement s that are systematically
higher or lower than the true underlying value of a diagnostic variable.
2- Bias due to sampling error :
a). Incomplete information obtained from a sample
b). Example : A biopsy of the right side of the liver will give biased results or
result that are not representative of the truth , if a tumor is located on the
left side of the liver.
3- Bias due to a flaw in the measurement process :
a). A faulty measuring instrument may yield values that are consistently
higher or lower than the true diastolic pressure.
4- The relationship between bias and chance : ( fig 1-2 )
Using a series of diastolic blood pressure measurements obtained
by 2 methods an intra- arterial cannula ( assumed to be an exact and unbiased method) and a
sphygmomanometer .
 a) The sphygmomanometer values are systematically shifted to
improper cuff size or a hearing deficit of the person making the observation .
b) The sphygmomanometer values also varies according to
chance . The random variations are distributed equally to the left and to the
right of the prevailing value .
B- Accuracy :
1- Definition : When the measurement process yields values that are
equal on the average to the true underlying value for the diagnostic variable
being measured , the measurement of instrument or process is accurate or
unbiased.
2- Example : The blood pressure measurement made using the intra-
arterial cannula in fig. 1-2 are accurate because they center around the
patient’s true blood pressure .
3- Evaluating accuracy : The accuracy of a set of clinical
measurements is determined by comparing the average ( mean ) with the true
underlying value of the variable.
 C- Precision
1-Definition: The degree to which a series of measurements fluctuates
around a central measurement is a precision or reproducibility, of the measurement
( or measurement instrument or process )

Fig.1-2 : Relationship between bias and change, as illustrated by difference in diastolic

blood pressure measurements obtained by intra- arterial cannula and by a
sphygmomanometer.
 2-Precision is independent of accuracy : Measurements may vary
from inaccurate and imprecise to inaccurate but precise to accurate but imprecise
to accurate and precise .
3- Examples :
a) The sphygmomanometer in figure 1-2 not only is inaccurate
since it systematically reads to be the right of the true value of 80mm.hg but it also
is imprecise because it yields reading that very greatly from those obtained by the
intra-arterial cannula .
b) The intra-arterial cannula in figure 1-2 yields both accurate
and precise readings.
4- Evaluating and achieving precision :
a) The precision of a set of clinical values is evaluated by
observing the frequency distribution of the measurement and by calculating the
standard deviation of the measurements.
b) Perfect precision rarely, if ever, is achieved when measuring
biologic phenomena. However the degree of imprecision may be reduced by
making and recording measurements with great care and by following carefully
designed protocols.
 II- NORMAL DISTRIBUTION
Fig.1-3: The normal distribution curve

68%

95%

- 1.96SD - 1SD Mean 1SD 1.96SD

Normal Distributions :
The normal distribution has extremely useful characteristics . A large
number of statistical tests and calculations can be used if the observations
follow a normal distribution . Its is useful to know that about two-thirds of the
values under a normal distribution curve fall within one standard deviation of
the mean and approximately 95% fall within 2 standards deviations of the
mean .