3.

22 BIOSTATISTICS AND RESEARCH

2.
Intellectual Property
This type of IPRs includes,
To draw a false base line, the
is broken into two parts and the
METHODOLOGY
vertical scale
values of
dependent variable from zero to the
(a) Protection of distinctive designs (trade
omitted by drawing
the lowest
marks and geographical indications).
value are
two
horizontal lines above the base line i Zig-zag
(b) Industrial property that are
ie., X-axis.
protected
mainly for the stimulation of design,
7. Line Designs
innovation and creation of technology. In case of representing several variable.
3. GRAPHS on the same graph for comparison, we
differentiate between them by using may
Graphical Presentation lines. dash-dotted lines, broken lines, dotted
thicl,
Graphical presentation refers to the way of lines and thin lines. An index must also be
presenting the data with the help of graphs. Graphs provided to clarify the meanings of the lines
play a significant role in presentation of data related Functions of Graphs
to time series. Frequency
distributions can also be The functions of graphs are as follows.
efficiently presented using graphs.
Rules for Graphing 1. They facilitate the presentation and inter.
pretation of data in graphical form.
The rules of
as follows, graphing/constructing graphs are 2. They provide an idea regarding variations in
distribution trends.
1. Title
3 They serve as effective tools in comparing two
Aheading depicting the matter and or more frequency distributions.
of the data must be provided as titlecontents
for all 4 They serve as tool for further analysis.
the graphical representations. The title must
be clear, simple and precise. The graphical curve provides answer to various
2 questions. These answers are more accurate
Organization of the Graph when compared to tabular presentation
Each graph must be structurally drawn in an answers.
attractive manner. The portion of axis must be
chosen and drawn neatly. We must represent Advantages of Graphs
independent and dependent parameters on X The advantages of graphs are as follows,
and Yaxis respectively. 1 Graphs represent the data in a simple manner
3. Scale which is easy to understand by the users.
The scale selected must satisfy all the values 2 The curves drawn on graphs are helpful in
to be plotted on the graph. determining the values which are not available.
4 Index 3. Easy comparisons can be made, if the data is
The index must be provided to show the scale presented in a graphical manner.
4.
ofX and Yaxis. The various lines drawn in the Graphs are highly attractive.
graph must be defined clearly in the index. Graphs can be used for further data analysis.
5. Source of Data 6
Graphs are useful in extrapolation and
The source of data gives the information intrapolation methods.
about the data retrieval and is mentioned at Limitations of Graphs
the bottom of the graph.
The limitations of graphs are as
6. False Base Line 1.
follows,
One should possess skills to
The vertical scale must start with zero for graphs. understand the
representing the given variable effectively. 2.
When the fluctuations are maximum and the Graphs are not precise when compared to tables.
3
starting values are very far from zero, a false Constructing a graph is a time consuming process.
base line is used to break the vertical scale 4 At times,
and to plot the values.
graphs create problems.
S.
Graphs provide restricted information.
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 3.23
NON, APAMETRIC TESTS, INTRODUCION TO RESEARCH, GRAPHS AND DESIGNING THE METHODOLOGY
unlt-3:
31 Histogram
representation
Histogramisone ofthe most commonly used and easily understood methods for graphical
distribution data. is also known as 'column depicting the class frequencies in a
frequency
fiequencydistribution by vertical adjacent rectangles. diagram',
of
frequencies on the Y-axis.
Duringtheconstruction of histogram, variable is taken on the X-axis and the X-axis should
ifference i between the classintervals are same then distance betweenthe rectangles onthe
the shown on Y-axis.
f Thefrequencies of each class which is equivalent to its height of rectangle can be
same. frequency
be histograms by series of rectangles each with a class-interval distance as its breadth andthe
histogram.
Weget length. The total frequency that is distributed among the classes
its isthe area of the
intervalsas
ELample
Draw the histogram for the following,
Marks No. of Students
050 15

50-100 10

100-150 25
150-200 38
200-250 45
250-300 30

300-350 49
3S0-400

Solution:
Scale
X-aXis Icm = 50 marks
y-axis l cm =Z students

HIsTOGRAM

25

X-ais

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 3.24 BIOSTATISTICS AND RESEARCH METHODOLOGy
3.2 Pie Chart
It is also known as circle diagram and ranks very high with respect to its
popular1ty. lt partitions the
Whoie commodity into its various component parts. This diagram represents the distribution of things related
to a particular element and facilitate comparison between
various components of it.
Steps for Constructing Pie Diagram
The steps involved in constructing pie diagram are.
1 Plot acircle of appropriate radius with a total of 360°.
Convert different commodities into degrees by multiplying the given percentages with 360 i.c.,
360 xPercentage value of the commodity.
3 Arange sectors according to their size with the largest at the top and others in sequence running
clockwise.
4 Points on a circle representing the size of each sector are finally measured with the help of a protractor.
Example
Draw a pie diagram to represent the following data relating to the production cost of manufacture.
Cost of material =38,400
Cost of labour = 30,720
Direct expenses =11,520
Overhead expenses= 15,360
Solution:
Total Production Cost = Cost of Material + Cost of Labour + Direct Expenses
+Overhead Expenses
=38,400+30,720+ 11,520 +15,360 =96,000.
Computations for construction of pie diagram for the given data are as follows,
Item of Expenditure Expenditure in ) Expenditure in Percentage (%) Expenditure in Degree (°)
Cost of material 38,400 38400 x 100 40x360
40% = 144°
96000 100
Cost of labour 30,720 30720 × I00 32x 360
96000
=32% = ||3.2
100
Direct expenses 11,520 11520 x100
12% 12x360
96000 = 43.2°
100
Overhead expenses 15,360 15360 ×100 16x360
16% = $7.6°
96000 100
Total 96,000 100% 360°

Cost of material
l440

57.0 |1S.2°
Overhead expenscs Cost of labour
43.2
Direct
expenses

Figure: Ple Diagram

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 Unit-3: NON PARAMETRIC TESTS, INTRODUCTION TO RESEARCH, GRAPHS AND DESIGNING THE METHODOLOGY 3.25
3.3 Cubic Graph
In mathematical terms, the graphs whose functions carries a third degree polynomial i.e., x' are referred
as cubic graphs. Asimple example of this graph is y x'. The table values of this graph is shown below,
X -2 1 0 2

The graph can be plotted as follows,

8+
6+

4+

2+

t-4
+-6

In other words, if all the vertices are of samne degreek and if kvalue is 3
then the graph is said to be
cubic graph.
Example

e h
g

d C

3.4 Response Surface Plot, Contour Plot Graph

Response surface methodology refers to aset of techniques that are based on mathematics and statistics
and are used for managing problems associated with response of interest. This methodology is adopted for
response optimization. For instance, if temperature (a,) and pressure (a,) are to be determined for increasing
the yield, then this yield can be given by the function,
y=fla,, a,)te
In this function, e refers to the noise in response yield. If the expected response is given by E(y) =fa.
)=n, then the response surface is given by,
n= fa,, a,)
The common graphical way of representing response surface is response surface plot which can be
urther turned intocontour plot. The response surtace plotror n with respect to temperature (a,) and pressure
(a) can be plotted as follows,

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3.26 BIOSTATISTICS AND RESEARCH METHODOLOGY

70 -
=n
E(y)
60

50

100 40

120 30

Temperature (a,) 140

160
1

Figure: Response Surface Plot

Pressure
20
(a,)

The response surface plot can be translated into contour plot for better understanding. In contour plot
constant response lines are considered representing the height of response surface. The corresponding contour
plot for the above response surface plot is shown below,

70

80

50
Current
operating
Contour
conditions /plot
40
Co Maximum
70 60 50 40
100
120 3

Temperatue (a,) 180 10

Flgure: Contour Plot Corresponding to Response Surface Plot

Pressure
(a,)

4. DESIGNING THE METHODOLOGY

4.1 Sample Size Determination and Power of a Study
Sample Size
Sample size has a major significance in the field of agriculture, medicine and biology. The term sample
size is defined as the number of sampling items which are selected from a
population for investigation.
The decision regarding size of the sample drawn from the population is difficult to take. The smal
samples may not represent the population and may not determine correctness in
results.
The large samples represent the population more clearly and thus managing them is a bit
Therefore, it is preferred to have an 'optimum' sized sample such that the size of the sample is not toodifnuit.
or too big pattern defines the optimum sample as The one which fulfills the Sa
requirements of eficieny
representativeness, reliability and flexibility".
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 PARAMETRIC TESTS,
ünlt-3: NON INTRODUCTION TO RESEARCH, GRAPHS AND DESIGNING THE METHODOLOGY
3.27
Sample Size Considerations

The sample
size is decided based on the following
considerations,
If the size of the population is large, it is preferred to have alarge sample Size as well.
1.
When the population consists of homogenous units, asmall sanple can be used in giving conclusion
2. aboutthe whole population. When the population consists of heterogenous units, alarge sample should
be used toobtain valid results
If the data is to be classified into several classes, then sample size should be large in order to obtain valid
3 results.
When an intensive study or continuous study is considered, asmall sample size can be used. In addition
tothat, studies that are not considered repeatedly can also have small sample size.
Ifarandom sampling technique is used, large samples should be taken in order to obtain more accurate
results. If astratified sampling is used, small samples can be taken as they give better results.
6 Sample size also depends on the available finance and time, trained personnel and other practical
considerations.

7. Mostly, large samples gives accurate results. But, when the sample is obtained using scientific method,
only a small part of it can also give better results.
Sample Size Determination
Based on the information available, several formulae have been devised which can be used to determine
the sample size. Few of them are listed below.

Where,
s=Size of the sample
V= Value when a specified confidence level or a desired degree of precision is reached.
d = Difference of population mean and sample mean.
S =Population's standard deviation.
The steps involved in computing a sample using the formula defined above are,
1. Selection of a specified level of confidence which is named as V'.
2. Multiplication of the valueV' from step 1by 'S' i.e., standard deviation of the population.
standard error of mean
3 Divide the product obtained fron step 2 with the standard error of mean. The
can be obtained by subtracting sample mean from the population mean.
desired size of the sample.
4. The quotient obtained in step 3 is then squared and the resultant will be the
Statistical Power of a Study
difference exist between
Statistical power of a study refers to the capability of study to capture whether
and difference between two
two samples or not. Its value depends on the number of elements in a sample results to be valid. This means
Samples. The higher value of statistical power indicates higher ch¡nces of
that the chances of errors decrease with increase of statistical power) However, computation of power can be
software for calculating power of
skipped while berforming hypothesis testing. Two of the commonly used results.
Study are SAS and PASS. Experiments whqse,stati_jcal power is low, will likely generate incorrect
of Data
Report Writing and Presentation
Report
The word renort' is originated from the Latin word "repot" which implies to 'carry back. A report is a
required for reviewing
Ogical presentation offacts andinformation. The intormation generated by reports is decisions. Renorts acts
and evaluating nrogress for nlanning future course of action and for taking effective
aspects of the organization
Sa tool for providing feedback to the managers related to various
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 BIOSTATISTICS AND RESEARCH
3.28

Report Writing
METHODOLOGY
Report writing is a conscious, , rational and systematic effort. It is both an art as well as science. Report-
writingrequires conceptual and communication skills and ascientific approach to investigation, analysis and
creating effective reports.
Presentation. Managers should possess rioht abilities and attitudes for
Research Report
findings to the readers of the report A..
Kesearch report is achannel to communicate the research
research report is that which does its task efficiently and effectively.
Importance/Significance of Report Writing
The following points helps us to know the significance ofa report writing,
helps in transterring the information
1 A research report is a true, accurate and historical message which information to the clients
relating to the research results, recommendations conclusions and other vital
2 The clients makes his or her decisions on the basis of the contents of the report, so It is very important
for the researchers to provide value to the client in the research report.
3. The researchers should properly and effectively make their research report as poorly written research
report will not be able to communicate effectively and the time and efforts spend in the research proces8
willbe wasted.
4. Agood research report helps in making effective communication with the readers of the report and also
helps in building credibility.
5 The quality of research report and presentation helps in evaluating the quality of marketing research
project or work.
6 The usefulness of research report affects the management's decision to carry out research in the future
or whether to deal with the particular supplier again or not.
Types of Report
Reports may be classified into routine or special reports,

Types of Reports

Routine Special
Reports Reports

Progress Report 1. FIR

2. Inspection Report 2. Investigation Report
3. Performance Appraisal Report 3. Feasibility or Sur vey Report
4. Periodical Report 4. Project Report
Figure: Types of Reports
1. Routine Reports
Routine reports are periodical and these reports are prepared by filling in
provide information related to the status of the work. Routine reports consists ofprinted/cyclostyled forms,
forms in which blanks neeu
to be filled in or multiple choice statements are to be
ticked. Report forms are prepared carefully becaus
gives complete information to management.
The different types of routine reports are,
(a) Progress Report
Progress report provides information regarding progress of a project during completion ofthe project
like manufacture of products or
implementation of a scheme, construction of a building.
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 P
NON ADAMETRIC TESTS, INTRODUCON TO RESEARCH, GRAPHS AND DESIGNING THE METHODOLOGY 3.29
Unit-3:
InspectionReport
(c) Feasibilit or Survey Report
Afierrthe completionof inspection, inspection
reportissubmitted.Inspection is necessary for Feas1bility report is prepared when an organization
launches a newproduct in the market, introduce
determining irregularities or deviation fromn a new serviceor anvmaior changes
which have
standardI practiceinthe daily activities of the The factors to
IS Impact oncompany's cUstomer.
company. be examincd totally depends on the purp0se of
Example: Internal audit reports. the survey.
PerformanceAppraisal (dy Project Report
Performance appraisal report is prepared by Project report is written after the completion
filling aform periodically. It helps in assessing of the preliminary survey and shaping up of a
flow and
the peerformance off an employee. Supervisor new proposal. It indicates the cash
expected results for the proposal undertaken.
jobisto fill an assessment report regarding Preparation and Presentation of Report
the working of the subordinates. Performance report may
appraisal reports helps in taking decisions Ineffective presentation or poor final
related to promotions and other employee have a bad impact
on research study. Aresearch report
which is not presented in an effective way is ignored
benefits.
by the research technicians but the quality presentation
d) PeriodicalReport influence several readers. This fact encourage a
Periodical reports are made at regular intervals researcher to make special efforts to communicate
and provides information about the day-to-day skillfully and clearly. To communicate skillfully and
work. These reports are usually prepared by clearly, researcher need to follow a proper procedure/
research
flling in a form. process for preparation and presentation of
report.
Special Reports
Process ofPreparation and Presentation of Report
Special reports are prepared depending upon The process of preparation and presentation of
asDecial situation or when a problem emerges. For report is as follows,
making special reports individuals or a committee 1. Title Page
of persons having knowledge in the field/subject are The title page should indicate the subject,
appointed. The appointed individuals investigate date on which the report is prepared, for whom it is
and study a specific problem by collecting relevant prepared and by whom. Some times it is not necessary
information. The suggestions provided by the tospecify for whom the report is prepared, while at
appointed individuals helps in taking effective some other time, it is wise to indicate this precisely
decisions.
and show who actually receives copies.
The following are the different types of special 2. Table of Contents
reports, If the report is lengthy or if it is divided into
(a) First Information Report (FIR) numerous parts, it is usually desirable to have a table
FIR is always written by an individual. This of contents.
report is needed for reasons including disaster3 Foreword (Introduction)
like fire, building collapse, robbery or accident This section serves to introduce the reader to
nan organization. It is prepared soon after the the research project. It should give the background
incident and is submitted to a higher authority of the problem, the importance of the problem, the
o take necessary action. The report should give various dimensions of the problem and whether any
information like what happened, at what time, previous research was done which is pertinent to the
Who first noticed and what steps were taken to specific project being reported.
that incident etc. 4. Statement of Objectives
(b)
Investigation Report The specific objectives of the report need to
Investigation report is usually prepared after be set forth clearly. The reader must know exactly
making thorough enquiry. Investigation iS what the report covers. If the particular project is part
done when a problem rises and management of a large problem, it is desirable to state the overall
Tind alternatives to solve those problems. problem and the problem solution process, sometimes
Investigation is usually done for the cases it may even be wise to provide some background
Ike falling sales, declining deposits in a bank, information as to how the problem arose and what
Customer complaints. losses in a branch etc. previous research work, if any has been carried out.

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3.30 BIOSTATISTICS AND RESEARCH
5.
Methodologv METHODOLOGY
The purpose of methodology section is to describe the research procedure. This includes the
research design, the sampling : procedures,the data collection method, thefield methods andl analysis overall
This section is dificult to write because it is hard to discuss methodology without using technical procedure.
ter
most of the audience for the report willnot understand technical language.
6. Limitations
A good report "sells" the results of the study, but it should not "oversell". Every project ke.
Iimitations. The conmpetent rescarcher does not attempt to gross over these points but instead calls ther
tothe attention of the readers. This helps readers form a more accurate interpretation of the results the
they would otherwise do.
7. Findings
Findings are the results of the study. This section makes up the bulk of the report. It is not just an
assortment of statistical tables and charts but an organized narration of the results. Summary tables and
graphical method of pYesentation should be used liberally. Highly detailed tables should be relegated to the
appendix. The specific objectives of the study should be kept in mind while presenting the findings.
8. Conclusions and Recommendations
Conclusion should be drawn with direct reference to the objectives of the study. The reader should be
able to read the objectives, turn to conclusion section and find specific conclusion relative to each objective.
If, as sometimes happens, the study does not obtain satisfactory data from which to draw a conclusion relative
to an objective, this should be acknowledged rather than disguised.
9 Appendix
The purpose of the appendix is to provide a place for those report items which do not fit in the research
report properly because they are either too detailed or are too specific. For example, the appendix may contain
adetailed statement of the sample design, the formulas used to determine the sampling error, detailed statistical
tables, and various research forms used, such as the questionnaire and the written interviewer instructjons.
Computer Graphics in Report Writing
Computer graphics will have an impact on the research report writing format. Graphics or visual aids
helps in explaining complicated points or focus on amessage, if they are utilized in aproper way. If they are
used in an improper way then they will mislead or distract the information.
The following are some of the types of computer graphic used in research reports writing,
1 Tables

Tables helps in exhibiting numerical data, specifically when such data can be organized into rows and
columns. It enables the writer to highlight the important characteristics rather than going in detail. Every table
must consists of title, table number, Head note and subheads, source and footnotes.
Format ofa Statistical Table
Title
[Head Note] :
HEADING

Subheading I Subheading 2
CoumnCohumnColumn Cohumn Coumn Row
Heading Heading Heading Heading Heading Total
Row Heading
Row Heading
Row Heading Body
Row Heading
Row Heading
Row Heading
[Foot Note]: Row total CoumnCohumn CoumnCohumnCoumn Grand
[Source Note]: Total Total Total Total Total Total

Pigure: Format of a Statistical Table

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ualt-3:NONPARAMETRIC TESTS, INTRODUCTION TO RESEARCH, GRAPHS AND DESIGNING THE METHODOLOGY 3.33

Seale

at

Aereral Thdek

30+

Pigure: Multiple Line Graph

4.3/Protocol of aresearch plan fora clinical trial. t

Protocol is a research document that specifies the structure
methodology and organization of a trial ec. It serves
describes the background, objectives, design, rationales, investigator's attention Generally, staff the consists
deserves
as the keystone of the planning process and hence
Associate Investigators (AI), a Research Contact (RC) a Medical
of aPrincipal Investigator (PI), one or more like scientific consuBtant, statistical consultant ete
Advisory Investigator (MA) and consultants
Awell documented protocol,
meaningful and is relevant to the research questions
Can ensure that the data obtained is
proposal submitted for funding
2 Is anessential component of a research
to think about all the aspects of the study
3 Enables the investigators toclarify their thoughts and also
acceptable for publication
4. Ensures that the data obtained is
on the research
Serves as a gujde for working
the study
6.
Is feasible in a particular set-up for
objectives
Issufficient to achieve the study
study and arrve at comparable conchSions)
8 Provjdes sufñcient information for a new investigator lo
have been considered.
9 Highlights the ethical issues that
g i B E to face LEGAL procdng
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 BIOSTATISTICS AND RESEARCH
3.34
5.
Effective/Amended Date
METHODOLOGY Q

Structure of Protocol
It is imnportant to mention the
Main headings in the structure of protocol are
listed below.
effective date
on the title page. Effective date is the date
me

finalization of the original protocol. Subsequent

1. First Page Title Page
changes (if any), made to the original
Table of Contents are known as protocol amendments, The protocol
a
3 Study Protocol Summary of protocol amendment (if any) should also he
4 Contents of Protocol mentioned.

Signature 6. Version
First Page/Title Page The tracks of the original protocol versin
It isan essential part of all research protocols. and the protocol amendmnent(s) version if ans.
It should include, should be maintained for the sake of regulatory
1. Tide of Protocol compliance.
Ii should be in bold and all capitals. Whenever 7. Names of the approval personnel, statistician
applicable, it should be accompanied with Medical Director, Vice President etc.
a short title. The title is descriptive of the
8. Details of all the responsible perSonnel.
protocol. It should be concise and state the
name of the investigational drug product, 9. Confidentiality Statement
phase and design of the trial, population to be Every protocol should carry a confidentiality
studied and the target disease(s). In order to statement on its first page in italics.
more closely reflect the sense of the study,
may be revised after completion of its writing. Examples
Examples ofStudy Title This document contains information
proprietary to the Company. The
APhase II, Randomized, Double blind, unauthorized use, disclosure, distribution
Placebo-controlled, Multi-centre Study
or copying of these information is strictly
of the Effects of X drug on Infarct Size in
prohibited.
Subjects with Diabetes Mellitus presenting
with Acute Myocardial Infarction. This document is confidential and the
A Phase II, Randomized, Controlled, property of the Company. No part of
Multi-centre, Prospective Comparison of it may be transmitted, reproduced,
Panacea Acetate with Standard Therapy published or used by other persons
in Subjects with Progressive Alopecia. without prior written authorization from
A Phase I, Single-centre, Single arm, the study sponsor.
Study of Panaceaacetate in Subjects with 4.4 Cohorts Studies, Observational
Progressive Alopecia. Studies
2. Protocol Identification Number Cohort Studies
These are the codes issued by the respective
companies and often includethe codes for the Cohort study involves the comparison of
name of the investigational products. outcomes in two groups which are segregated on
the basis of drug use i.e., one group uses the drug
3. Names and Addresses of Regulatory Sponsor, whereas the other does not. The study is known as
Funding Sponsor (if any), and CRO (f any) historic cohort stucty, if the data is collected from
These names and addresses help the study existing databases or patient charts and prospective
subjects, investigators, regulatory agencies and cohort study, if the data is collected directly from
institutional review committees to know about
the individuals responsible for the conduct of
the patients at the time of therapy. Cohort study
allows measurement of outcome incidence and
the study. also examination of several outcomes to a singie
4. Name of the Investigational Medicinal drug exposure. These studies are not suitable if
Product (IMP) the outcomes are of rare type. The demerits of the
Its generic name should be mentioned and in study are that it requires large number of people, 1S
case the IMP has nogeneric name, itschemical time consuming, expensive and requires effectiVe
name should be mentioned. management team

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 3.35
THE METHODOLOGY
Unt-3: NON PARAMETRIC TESTS, INTRODUCTION TO RESEARCH, GRAPHS AND DESIGNING
Qbservational Studies
supplements other
Observation is a major primary source of information. While observation often unique source of
methods of collection of data, it is very much a scientific inquiry that alone serves as a reasons. In such
information. Most of the times, respondents fail to give accurate information for different mobiles,
cases, researchers rely on observation source of information. For instance, not
all users of products like
researcher observes the products
laptops, etc, are aware of the technical details of the products. Therefore, the
dcollects the information needed rather than asking the respondent.
Uses of Observation
phase of a researcn
Generally marketing managers make use of observation as part of exploratory
roiect This collection of data is referred to as simple observation.
authentiC, renab
Observation is used as a primary method to answer research questions. It provides
and executed in a systematic manne.
and accurate information about the research, only when it is planned
Figure below shows the use of observation in research process,
Investigative Questions
Observation
Measurement Questions

Research
Design

Select the type of

observation

Design Human Prepare error

observer Observation reduction plan
training
Prepare observation
checklist
Train Non-availability of
observers
Select sample and observation subject Reschedule
schedule observation observation
Availability of
observation subject
Verify Collect and/
observation process,
protocol data

Figure: Observation and Research Process

The systematic observation makes use of standardized procedures, schedules for recording, trained
observers and other different devices which helps in reflecting the scientific procedures of other primary data
methods.
Observation not only collects the data visually, it also includes reading, smelling, touching, listening
ete. According to behavioral scientist, observation can be defined in terms of human or animal behavior.
Asobservation method is quite versatile, it is considered to be an essential primary method. It also
forms a basis for other methods.
Apart from this, observation method also uses the complete range of monitoring behavioral and non
behavioral conditions and activities.

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3.36 BIOSTATISTICS AND RESEARCH METHODOLoGy
Categories of Observational Study
Observation studies are divided into four categories namely.
1 Unstructured / Natural
2. Unstructured/Laboratory
3 Structured/Natural and
4 Structured /Laboratory.
These classifications can be used for various research purpose. To generate a hypothesis first three
categories are used and to test a hypothesis the fourth category is used.
Instructured observation, particular behaviour and effect of participants are monitored and recorded for
all respondents. Ameasuring instument like an observation checklist which may be similar to a questionnaie
isneeded for structured obsevation.
In unstructured observation, researchers record all behaviour andeffects that take place in a specifc
event with aspecific participant.
When the behaviour or effecttakesplace naturally. the natural study is said to be occurred. The laboratory
study permitsthe rescarcher to operate and control the studied variables as actions may not be possible in a
natural environment. The researcher also makes use of the facilities of a laboratory i.e., mirrored windows.
props, videotape recording to control the environment and to reduce the time requirement for the observation.
Table: Classification of Observation Studies

Reserch class Environment Objective /purpose Research Tool

1. Wholly unstructured Natural setting To generate hypothesis Recorded Notes.
2 Unstructured Laboratory settingTo generate hypothesis Recorded electronically or
pen-paper Notes.
3. Structured Natural setting Togenerate hypothesis Observation checklist.
4. Wholly structured Laboratory setting To test hypothesis Observation checklist and
electronic record of events.

Checklist Design process

Measurement
Questions
|Administrative|Data for observation Target
Notations Classification Observations
Revise

Observation Observation
Participant Timing Group 'A' Pretest
Observation Observation Observation
Observer Protocol
ID Location Group *B'
Observation Observation
Conditions Group 'C

Observation Checklist Designed

Revise

Pretest Checklist and Observer Training

Flgure: Flowchart for Observation Checklist Design

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 3.37
NONIPARAMETRIC TESTS, INTRODUCTION TO RESEARCH, GRAPHS AND DESIGNING THE METHODOLOGY
Unit-3:
uninvited interference
Content Specification 4 Ohservation reduces the
nto aparlicipant's life. setting
Observation reporting system can be detenincd naturalness of research
hased on speciic events, conditions or activities In It optmizesthe
influencing behaviour.
orderto define, the observation content, both najor Inorder topreve1t
ariables and other variables of interest which alfect Limitatins of Observational Study
of observation as
them must be
included Following are the limitations
a data collection method.
The items which are planned to be observed andcostly procesS.
ohould bc sclected from this cataloging. In case of It is a time-consuming
records compared to others.
any questionof conecept of ambiguity, an operational 2 It maintans large
Aefinition must be provided for cach selectedvariable. 3. Itquantifies the data
Itis essential to ensure that all observers agree on the reliabilityof inferences from
measurement terms if there is a coMmon Concept. It is
4 It may have lesser
the surface indicators.
to be noted that the observationdate can be inferential exactly happening at
or factual.
5 It cannoteasily find what
different places.
which
Observer Training and a slow process
6 It is an expensive
surveillance equipment or
Following are some common guidelines for the needs either costly
qualification and selection of observers, human observers.
not easy to gather
7 Using observation, it is
1. Concentration
information on topics like attitudes, views,
The capability to work in a specific setting intentions or preferences.
which is full of distractions.
4.5 Experimental Studies
Detail-Oriented studies in
2 Experimental studies are the
details to an investigator/
The capability to keep in mind all the which the control is handed over differences
the
of an experience. experimenter. It is used for analyzingother words, it is
prevention. In
3. Unobtrusive in disease/measure of relationship. These
used for obtaining the cause-effect
not to
The ability to mix with the setting and studies usually consume more
time and cost.
be a unique one. Experimental studies are usually perfomed
they can also be
4. Experience Level on individual subjects. However, individuals
The ability to take out lot of
information from performed on population samples. In
interventions is
an observation study. based study, random allocation of
sample
as per possible. However, it willbe ineffective if the
The observers must be experiencedmust be size is smaller. In such cases, a planned
allocation on
study. They
the requirements of the specific exact content elements various intervention groups.
informed about the results and
that are required to be studied. 4.6 Designing Clinical Trial, Various
Phases
Research Design
outs the Clinical Trials (Human Studies)
Generally data collection plan list method of
all the questions A clinical trial is defined as the
details ofaparticular task. It answerswhere. for
how and comparison of a medicine or a medical device
such as what, when, who, (inert
treatment with a standard drug and placebo
Strengths ofObservational Study substance), by performing trials on human beings. It
the
1. Observation study helps in obtaining which can be undertaken only when the concerned authorities
informtion of people or activities
experiments or
have approved the drug to be used in humans.
cannot be secured through Clinical trials are performed by clinical
surveys. investigators who have sufficient knowledge in
It can successfully
obtain the environmental interpreting animal studies and who have the
2.
information. capability tostudy and analyze the effect of drugs
clinical
filtering information and on humans. They are more often referred as
3. It prevents participant pharmacologists.
forgetting.
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