Medical Research: Unit II

Research Methodology & Biostatistics

MRM-301T
Dr. Uttam Kumar Mandal
Associate Professor
MRSPTU
Bathinda
 Topics to be covered
• Biostatistics: Definition, application, sample size,
importance of sample size, factors influencing sample
size, dropouts, statistical tests of significance, type of
significance tests, parametric tests (students “t” test,
ANOVA, Correlation coefficient, regression), non-
parametric tests (wilcoxan rank tests, analysis of
variance, correlation, chi square test), null hypothesis,
P values, degree of freedom, interpretation of P
values.
“Bio-Statistics – Concept, Definition”
What is Statistics? (Definition)

The Statistics is defined differently by

different authors from time to time.
The reasons being:
Its scope and utility has widened
considerably over time.
It is defined in two ways:
as “statistical data” and
“statistical methods”
DEFINITION OF STATISTICS IN DATA SENSE

Statistics is defined as the aggregate of facts

effected to a marked extent by multiplicity of
causes, numerically expressed, enumerated or
estimated according to a reasonable standard
of accuracy, collected in a systematic manner
for a predetermined purpose and placed in
relation to each other.
Prof. Horace Secrist
DEFINITION OF STATISTICS AS A BODY OF SCIENCE

American Heritage Dictionary® defines statistics as:

"The mathematics of the collection, organization, and
interpretation of numerical data, especially the
analysis of population characteristics by inference from
sampling.“

The Merriam-Webster’s Collegiate Dictionary®

definition is: "A branch of mathematics dealing with
the collection, analysis, interpretation, and
presentation of masses of numerical data."
 A Simple but Concise definition by
Croxton and Cowden:
“Statistics is defined as the
collection, presentation, analysis
and interpretation of numerical
data.”
 A statistics is "a type of information
obtained through mathematical
operations on numerical data".
 What is Biostatistics ?
Development and application of statistical techniques
to scientific research relating to life:
Human, Plant and Animal
Here the focus is on Human life and Health. Thus the
areas of application relates to:
Pharmacology,
medicine,
epidemiology,
public health,
Physiology and anatomy,
Genetics
Essence of Bio-Statistics?
 DATA, INFORMATION AND STATISTICS
DATA

“Facts or figures from which conclusions can be drawn".

• Data can take various forms, but are often

numerical.
 COLLECTION OF DATA

This is the first and most important stage of statistical investigation.

Since the data are the raw material to any statistical investigation,
utmost care is necessary to be taken for collection of reliable and
accurate data.

The first hand collection of data is very difficult. Therefore the

investigator should see if the data intended for the purpose is
already collected by some other agencies. This would help save
time, money and duplication of effort.
 ORGANISATION OF DATA
The data collected from a published secondary source is in organised
form. The large mass of data collected from a survey need to be
organised.
The first stage in organizing data is editing.
Editing for completeness,
Editing for inconsistencies,
Editing for homogeneity,
Editing for accuracy,
Editing for reliability,
The 2nd stage in organizing data is classification of data.
That means arranging data according to certain common characteristics of
the units on which data are collected.
The final step is the tabulation.
The purpose is to present data in rows and columns so that there is
absolute clarity in data to be presented
 PRESENTATION OF DATA:
The presentation of data is an art and science. It facilitate
statistical analysis,
comparison and
appreciation.
The data can be presented through:
Diagrams, Graphs, Pictures etc.
ANALYSIS OF DATA:
Analysis of data are done through;
Simple observation,
Application of simple and highly sophisticated statistical
techniques like; Measures of central tendency, variation,
correlation, regression, seasonality, trend, computation of
indices etc.
 INTERPRETATION:
This refers to drawing conclusion from the data collected and
analysed.

This requires high degree of skill and experience.

Wrong interpretations lead to fallacious conclusion and

decisions.

According to Prof. Ya Lun Chaou “ Statistics is a method of

decision making in the face of uncertainty on the basis of
numerical data and calculated risk”.
 TYPES OF DATA
• Qualitative Data: They are Nonnumeric.
In form of words such as
– Description of events: Verbal Autopsy
– Transcripts of interview: Opinion of CDMOs
on efficacy of ASHA
– Written documents: Guidelines on roles and
responsibility of ASHA
– Characteristic not capable of quantitative
measurement: Organoleptic properties of an
API
• Quantitative Data: They are numeric.
The characteristic capable of quantitative
measurement: Height, Weight, Blood pressure etc.
 MEASUREMENT AND MEASUREMENT SCALES
 Measurement: Assignment of numbers to
object/observation or event according to a set of
rules.
 Measurement Scale: Measurements carried out under
different sets of rules results in different categories of
measurement scale.
 4 categories of measurement scale
Nominal scale
Ordinal scale
Interval scale
Ratio scale
 NOMINAL SCALE
 The lowest measurement scale.

 It consist of naming observations or classifying them

into mutually exclusive and collectively exhaustive
categories.

 The practice of using numbers to distinguish among

the various medical diagnosis constitutes
measurement on a nominal scale.

 It includes such dichotomies as male - female, well -

sick, under 65 years of age - 65 and over, child -
adult, and married-not married.
 ORDINAL SCALE
 This is an improved scale than nominal

 Whenever observations are not only different from

category to category but can be ranked according to
some criterion, they are said to be measured on an
ordinal scale.

 In this scale data can be compared as less than or

greater than.

 But the difference between two ordinal values can’t be

'quantified'.
 ORDINAL SCALE
Examples:
 The Nutritional Status of a group of Children
Classified as Normal, Gr. 1, Gr. 2, Gr. 3, Gr. 4 level of
malnutrition.

 Convalescing patients classified as Unimproved,

Improved, Much improved.

 Socio-economic Status: Low, Medium and High

 Appropriate Statistics:
 Non-parametric statistics are uses for analysis of
ordinal scale data.
 INTERVAL SCALE
 This is more sophisticated than the previous two

 In this scale it is possible to order measurements and also the

distance between any two measurements can be quantified.

 There is a use of unit distance and zero point, both of which are
arbitrary.

 The selected Zero is not necessarily a true Zero in that it does

not have to indicate a total absence of the quantity being
measured.

 It is truly quantitative scale

Example:

 The way in which temperature is usually measured

(degrees Fahrenheit or Celsius). The unit of
measurement is the degree and the point of
comparison is the arbitrarily chosen “Zero degrees,”
which doesn’t indicate a lack of heat. The interval
scale unlike the nominal and ordinal scales is a truly
quantitative scale.
 Statistics used: Parametric statistical technique is
used.
 RATIO SCALE
• It is the highest level of measurement scale

• You are also allowed to take ratios among ratio

scaled variables.
– Physical measurements of height, weight, length
are typically ratio variables.
It is now meaningful to say that 10 m is twice as long
as 5 m. This ratio hold true regardless of which scale
the object is being measured in (e.g. meters or
yards). This is because there is a natural zero.
Statistics used: Parametric statistical technique is
used.
 Functions of Statistics

 It presents facts in a definite form

 It simplifies mass of figures
 It facilitate comparison
 It helps in formulating and testing hypothesis.
 It helps in prediction
 It helps in formulation of suitable policies.
 Importance of Statistics
 The Statistics is viewed not as a mere method of data
collection, but as a means of developing sound techniques
for their handling and analysis and interpretation and
helping to take decision in the face of uncertainty.
 It provides crucial guidance in determining what
information is reliable and which predictions can be
trusted. They often help search for clues to the solution of
a scientific mystery, and sometimes keep investigators
from being misled by false impressions.
 Importance Statistics
Contd. ….

 Therefore the importance of bio-statistics is increasing

day by day and its scope is widening day by day.
There is hardly any sphere of human life where
Statistics is not being used.
 Limitations of statistics?
 However wonderful statistics are, they are not
flawless and have some very important limitations.

 How representative is your sample?

Samples used in statistical tests that do not
represent the population adequately can give
reliable results but with little relevance to the
population that it came from.
 Limitations of Statistics
How well does your data fit the requirements of
the tests?
 All statistical tests are limited to particular types of
data they can be applied to. For instance, some
tests are based on the data having a normal
distribution. By using this "normal" pattern in the
data they provide us with the results.
 Results based on data with strong departures from
the requirements of the test used will be less
reliable than results from data that meet the
requirements of the test.
 Limitations of Statistics
 How well the statistics is suited to the study of qualitative
phenomena
 Statistics deals with phenomena capable of being expressed
numerically.
 The qualitative phenomena like honesty, integrity, poverty can
not be analysed directly by statistical technique. However,
they can be analysed once they are converted to some
quantitative scores on suitable scales of measurement.
 Statistics does not study individuals
Statistics deals with aggregate of facts and does not give specific
recognition to the individuals items of a series. Individual items
taken separately does not constitute statistical data and
meaningless for statistical enquiry.
 Limitations of Statistics

Statistical Laws are not exact

 Unlike physical sciences, the statistical laws
are only approximation and not exact.
Statistics gives conclusion or decision in
terms of probability not in terms of
certainty. Statistical conclusions are not
universally true. They are true on an
average.
 Limitations of Statistics
 Statistics is liable to be misused
 It must be used by experts. It is most dangerous
in the hands of inexpert.
 The use of statistical tools by inexperienced
untrained persons might lead to very fallacious
conclusion.
 Statistics do not bear the label on their face
regarding their quality and hence can be misused
with ulterior motives by people with vested
interest.
“Beauty of Statistics lies in its
capability of handling a large mass of
data, scientific analysis backed by
sound reasoning and logic skills and a
little common sense to figure out
problems”

B. B. Nanda- 28.10.2007
When you can measure what you are
speaking about and express it in
numbers, you know something about
it but when you can’t measure it, when
you can’t express it in numbers your
knowledge is a meager and
unsatisfactory one.
Lord Kelvin
 And Always Remember

THERE IS STRENGTH IN
NUMBERS