Biostatistics

DEFINITION

Biostatistics is the collection, arrangement, analysis and interpretation of mathematical facts or

data with special reference to studies of Health and Social Problems

IMPORTANCE

Used in Research

1. Assess results of Clinical Trials

2. Assess new treatment strategies; new drugs

3. To find the cause of a certain disease or condition

CLINICAL TRIALS IN PHARMACOLOGY

Set of procedures carried out in medical research to test the efficacy and
safety of different health interventions e.g. drugs.

These are used to test the effectiveness or other characteristics of a drug

for a particular condition

Also a new treatment (drug) may be compared with an old treatment

(drug)
IMPORTANT TERMINOLOGY IN CLINICAL TRIALS

SAMPLES (TEST AND CONTROL)

SAMPLE SIZE

The larger the sample size the more statistically significant the study

CONSENT written consent

PLACEBO

PROSPECTIVE STUDY-looking ahead to the future

RETROSPECTIVE STUDY-looking in the past

BIAS-undue favor
 SINGLE BLINDED STUDY

DOUBLE BLINDED STUDY

PRESENTATION OF DATA
PICTORIAL DESCRIPTION

BAR GRAPHS

HISTOGRAMS

FREQUENCY TABLES

PIE CHARTS

PICTOGRAMS

QUANTITATIVE DESCRIPTION
MEASURES OF CENTRAL TENDENCY

1. MEAN (AVERAGE)

SUM OF ALL THE READINGS DIVIDED BY THE NUMBER OF READINGS

MEAN = SUM OF ALL INDIVIDUAL OBSERVATIONS

NUMBER OF OBSERVATIONS

X = X\n

2. Median:

When all the observations of a variable are arranged in ascending/descending order,

the middle value is taken as a median in a series of odd number of observations.

While in case of even number of observations the mean of the two centre values is
taken as the median.

2 6 9 12 17 21 25 31 35

Median = 17

4 9 11 19 23 29 33 37 41 43 49 51

Median = 29 + 33/2 = 31
3. Mode:

The most frequently occurring number in a set of observations.

2 4 4 4 8 8 12 16 16

Mode = 4

MEASURES OF SPREAD (indices of variation)

1. Range:

It is the difference between largest and smallest value.

5 12 27 41 49 105 278

Range=278-5 = 273

2. Variance

1. Find the deviation of each reading from the mean

2. Square all these deviations

3. Add all these squares up

4. Divide the answer by sample size minus 1

Example

S No Syst BP Mean Difference D2 Sum of All D2

from Mean
1 110 +5 25
2 100 -5 25
3 105 105 0 0 100
4 100 -5 25
5 110 +5 25
Variance = 100/n-1
Variance = 100/4 =25

3. STANDARD DEVIATION

Standard deviation is a measure of the average distance of the observations from their
mean.

Or Measure of the dispersion of a set of values from the mean

It is the under root of variance

4. STANDARD ERROR OF THE MEAN

This is the possible deviation of the mean from its true value

Indicates the reliability of sample size representing the mean of the population from
which the sample size was drawn

SEM = SD/ n

Probability & P-Value

Everyday concepts of likelihood, chance etc are formalized by a branch of mathematics

called PROBABILITY

P-value

Probability in biostatistics is taken as the P-Value which is taken out of 100

A P Value less than 0.05 means probability of less than 5%

This is taken as statistically significant i.e.

There is a real difference between the two groups and it is not due to chance

A P value of more than 0.05 is taken as statistically insignificant i.e. just by chance

HOW TO GET P VALUE

Students t Test
 ONE OF THE TESTS USED TO FIND THE P VALUE HENCE TO DETERMINE THE STATISTICAL
SIGNIFICANCE OF CLINICAL DATA

t = M1 M2

SEM1 + SEM2

t-TABLES

THE VALUE OF t OBTAINED IS THEN USED TO OBTAIN THE P VALUE FROM t TABLES

IT IS SEEN THAT GREATER THE VALUE OF t, THE SMALLER THE VALUE OF P

IT IS WRITTEN AS tP(n-1) , FOR EXAMPLE, FOR 8 SUBJECTS, t0.5 (7) = 2.04

IF THE CALCULATED VALUE OF t IS MORE THAN THE TABLE VALUE OF t (FOR P VALUE OF
0.05), IT MEANS THAT THE MEANS OF THE TWO GROUPS (A AND B) IS STATISTICALLY
SIGNIFICANT AND VICE VERSA

INTERPRETATION OF STATISTICAL INFERENCE

This is the last step in biostatistical analysis.

To test statistical hypothesis two presumptions are made.

Null Hypothesis:

(Ho) also called hypothesis of no differences. It nullifies the claim that experiments
results differ from the one observed already.

Alternate hypothesis:

(HA) also called hypothesis of significant difference. It states that the sample result is
different (greater or smaller) from the hypothetical value of population.

Various tests are performed to accept or reject the null hypothesis (like t test above)

EXAMPLE

1. MAKE A NULL HYPOTHESIS E.G. THERE IS NO DIFFERENCE BETWEEN THE SYSTOLIC

BP OF BOYS AND GIRLS
 2. FIND OUT IF THIS NULL HYPOTHESIS IS TRUE OR FALSE BY OBTAINING P VALUE
FROM t TEST

3. IF P VALUE IS LESS THAN 0.05 NULL HYPOTHESIS IS REJECTED AND ALTERNATE

HYPOTHESIS IS ACCEPTED

4. IF P VALUE IS MORE THAN 0.05, NULL HYPOTHESIS IS ACCEPTED and ALTERNATE

HYPOTHESIS IS REJECTED