DESCRIBING CLINICAL DATA TYPES OF VARIABLES AS TO RELATIONSHIPS

Dependent Variable
GENERAL CLASSIFICATION OF DATA
 A variable which is affected by another variable
Qualitative Data
 Also known as the OUTCOME VARIABLE
 Measured at the Nominal level
 e.g. Test scores
 e.g. A diagnostic test for pregnancy gives a result of
either “positive” or “negative”
Independent Variables
Quantitative Data
 A variable which affects the dependent variable
 Can be continuous or discrete
 Also known as the CAUSE VARIABLE
 Measured on an ordinal or interval or ratio scale
 e.g. Number of hours spent in studying prior to a test
 e.g. Serum Na concentration (140 mEq/L) expresses
the exact amount of sodium, Serum cholesterol level,
Confounding Variables or Extraneous Variables
SBP, blood urea nitrogen (BUN)
 Affect both Dependent and Independent Variables
SCALES OF MEASUREMENT
BASIS FOR VARIATION
Nominal Scale  Fluctuation among clinical measurements reflects the
 Uses names numbers or other symbols to assign each combined effects of several phenomena
measurement to one of a limited number of categories  The interpretation of the clinical observations depends
that cannot be ordered one above the other on the physician’s ability to recognize the sources of
 The categories must be exhaustive and mutually variation and to account for them in the diagnostic and
exclusive; each measurement must fall into only 1 therapeutic processes
category
TRUE BIOLOGIC VARIATION
 Within any category, the members are assumed to be
equivalent with respect to the characteristic being scaled  In clinical measurements is the sum of many unknown
factors each of which contributes a small RANDOM effect.
 Blood type
Type A, Type B, Type AB or Type O  Random effects are as likely to be positive (causing the
measurement to exceed the true value) as they are to be
 Psychiatric Diagnosis
negative (causing the measurement to be less than the
The DSM IV Number 295 refers to Schizophrenia
true value)
 Others
 e.g. Measurement of consecutive BP on the same patient
Sex, race, eye color
under theoretically identical conditions will NOT be
exactly equal because of true biologic variation inherent
Ordinal Scale
in these measurements within a given patient
 Assigns each measurement to one of a limited number of
categories that are ranked in terms of a graded order
Variation Associated with Making Observations under
 Differences among categories are not necessarily equal
Different Conditions
and often are not even measurable
 Variation occurs when the conditions under which the
 The amount of variable represented by a change from
measurements are made are known to affect the values
category 1 to category 2 is not necessarily the same as
obtained.
the amount represented by a change from category 3 to
 This type of variation is SYSTEMATIC rather than
category 4
random because its effect is predictable and NOT based
 The symbols assigned to represent the categories are not
on the laws of chance
important as long as the ranking system is preserved
 e.g. A patient’s systolic BP varies according to the time of
the day (temporal variation) and the position of the
Nominal Ordinal
person (postural variation) when the measurement is
 Nutritional Status
taken. The pattern associated is somewhat regular and
Unimproved, stable or improved
predictable within a given person
 Cancer Staging
Hodgkins stage 1- limited to a single lymph node MEASUREMENT VARIATION
Hodgkins stage 4 - diffuse or disseminated
 Sometimes called “measurement error”
involvement of tissues.
 Variation among clinical observations that is attributed
to the measurement process
Numerical Ordinal
 May have a random component and a systematic
 Status Based on Monthly Income (Pesos)
component
Class 1 < 5,000
Class 2 5,001 – 10,000
Random Measurement Error
Class 3 10,001 -15,000
 Governed by the laws of chance
Class 4 > 15,000
 Results in a measurement that is above or below the true
Interval Scale value with EQUAL probability
 Assigns each measurement to one of an unlimited  A series of measurements affected only by random
number of categories that are equally spaced variation will center on the true value of the variable
being measured
 The scale has NO TRUE ZERO POINT (i.e. the zero point
on the scale does not represent the true or theoretical
Systematic Measurement Error
absent of the variable)
 Occurs when, as a result of a flaw in the measurement
 With the interval scale, one can determine exactly how
process
much more (or how much less) of the variable being
measured is represented by each category  The measurements NO longer center around the true
value but around a value that is systematically higher or
 0ºC is the point at which water freezes, it does not
lower than the true value
represent absence of temperature
Example:
Ratio Scale
For a given sample of urine, a series of measurements of urine
 The measurement begins at a TRUE ZERO POINT and
pH made with the same meter by the same analyst under
the scale has EQUAL INTERVALS
theoretically identical conditions will not be exactly equal
 length time, mass, volume and temperature in Kelvin
 Random variation in these measurements is the sum of
Hence if the weight is 0 grams, then there is absence of
many components, including instrumental precision.
weight
 Systematic variation results if the instrument is out of
calibration.
WITHIN PATIENT VARIATION
 Variation in the value of a clinical variable within a given
patient may result from true biologic variation, varying
conditions under which the measurement is made, or
measurement error, or it may be due to a pathologic
change in the biologic state of the patient
 The doctor is concerned with identifying sources of
variation within a given patient, because intervention
should occur only if there is a true pathologic change
VARIATION AMONG PATIENTS
 Attributable to inherent biologic differences among
patients, systematic differences in conditions of
measurement and measurement error
 The doctor is concerned with variation among patients
because most answers to clinical questions for an
individual patient are derived from information obtained
from groups of patients with similar conditions.
 For example, a doctor would study variation among
patients to answer questions such as:
1. How unusual is Mr Smith’s creatine kinase (CK)
value relative to a group of persons known to be free
of myocardial infarction?
2. Do groups of patients who receive antihypertensive
agent have drug A lower diastolic blood pressure
measurements, on the average, than those who
received drug B?
Precision Is Independent of Accuracy
 Measurements may vary from:
 inaccurate and imprecise (biased)
 inaccurate but precise (systematically shifted
from the true value but varying little from a
central value)
 accurate but imprecise, (averaging around the
true value but varying widely from it)
 ACCURATE AND PRECISE! (ideal)
 Precision is evaluated by observing the frequency
distribution of the measurements and by calculating the
standard deviation of the measurements
Enhancing Precision
 Perfect precision is rare
 Degree of imprecision may be reduced by making and
recording instruments with great care
 Following carefully designed protocols

DESCRIBING VARIATION IN CLINICAL DATA

BIAS
 Is the systematic component of both biologic variation
and measurement variation
 Bias results in measurements that are systematically
higher or lower than the true underlying value (unlike
random variation)
 Bias may result from a flaw in the measurement process
or from sampling error
 Bias occurs in multiple measurements in a single patient
or comparisons among group of patients

DUE TO SAMPLING ERROR

 Arises when statements about reality (for an
individual or group) are made on the basis of
INCOMPLETE information obtained from a sample
 e.g. A biopsy of the right side of the liver will give
biased results or results that are not representative
of the truth (i.e., the presence of a tumor) if a tumor
is located on the left side of the liver

DUE TO A FLAW IN THE MEASUREMENT PROCESS

 A faulty measuring instrument may yield values that
are consistently higher or lower than the true value
of the variable being measured
 e.g. A doctor with hearing impairment may obtain
diastolic BP measurements that are consistently
above the true diastolic BP

ACCURACY
 When the measurement process yields values that are
equal, on the average to the true underlying value, the
measurement (measurement process or instrument) is
accurate or unbiased
 Measurements made with the Intra-arterial cannula are
accurate because they center around the patients true
blood pressure Accuracy of a set of measurements is
determined by comparing the average (mean) of a set of
readings of a given variable with the true underlying
value of the variable (if that value is known)

PRECISION
 The degree to which a series of measurements fluctuates
around a central measurement
 Also known as reproducibility or repeatability of the
measurement process (instrument)
 The central value may or may not be the true value of the
variable