Professional Documents
Culture Documents
Research Methodology
Research Methodology
&
BIOSTATISTICS
“Research is a
systematized effort
to gain new knowledge”.
Data Collection
5
Execution
Execution
Research Problem
Define
1
for Pretest
Collection
Data
Review of Literature Methodology
4
2 3
Planning
DEFINITION
OF THE
RESEARCH PROBLEM
Statement of
Research Objectives
Researcher‟s Interest,
Researcher‟s Competence,
What
How
When
Where
Mission:
Reduce the incidence of heart disease
Belief:
Meditation is good to reduce stress which
is an important precursor of DM
Hypothesis
H- Meditation decreases the risk of DM
Objectives:
1. To assess and compare the proportion of DM
cases in individuals doing regular meditation and
not doing meditation.
REVIEW
OF
LITERATURE
What ?
Why ?
Where ?
Methodology
Methodology
Study Area : Location of study - Hospital, community etc.
Backward Forward
Cross -sectional
Retrospective Prospective
3
4. Ambidirectional
12/08/2012 Dr. Kusum Gaur 24
Decision Tree
Intervention Done
No Yes
Observational Study Experimental Study
No Yes
No Yes
Descriptive Study Analytic Study
NRCT Study RCT Study
Direction of Study
E O E O
Cohort Study E = O Case-Control Study
Cross-Sectional Study
Analytic
Cross-Sectional
Case-Control
Cohort
• Case reports
• Case series
• Population studies
• Hypothesis generating
• Suggesting associations
Advantages
• Easy to do
• Excellent at identifying unusual situation
• Good for generating hypotheses
Disadvantages
• Generally short-term
• Investigators self-select (bias!)
• no controls
• Cross-sectional
• Case-control
• Cohort
• Describes associations
• Prevalence
A “Snapshot”
Not
Exposed
Diseased to Factor
Population Exposed to
Factor
Non-
Disease Not
Exposed to
12/08/2012 Dr. Kusum Gaur Factor 33
Objectives of a Cross-Sectional Study
Sample of Population
Defined Population
Prevalence of Prevalence of
DM DM
+ DM -
2 98
Meditation
- 220 680
• Strengths
– Quick
– Cheap
• Weaknesses
– Cannot establish cause-effect
for
• Effects
• Variability
Cases
Not
Exposed
Exposed
Control
Not
Exposed
12/08/2012 Dr. Kusum Gaur 40
Objective of a Case-Control Study
Cases
Regular Meditation
Patients with DM
No Meditation
Controls
Regular Meditation
Persons w/o DM
No Meditation
Past Present
12/08/2012 Dr. Kusum Gaur 42
The logic of Case-Control Studies
• Cannot measure
– Incidence
– Prevalence
– Relative Risk
• Can only study one outcome
• High susceptibility to bias
•
Exposed to Not Non
Factor Diseased
Cohort
Cohort Diseased
Not
Exposed to
Factor
Non-Diseased
Prospective (usually)
Controlled
Cohort
DM
Regular
Meditation No DM
Present Future
12/08/2012 Dr. Kusum Gaur 52
Cohort Study: Strengths
• Expensive
• Time consuming
• Confounding variables
Cases control
Exposed a b
a x 100
Exposure Rates = in Cases Non- c d
exposed
(P2) a+c
b x 100
Exposure Rates = in Controls P2 – P1
(P1) b+d Z Score =
SEDP
P1 Q 1 P 2 Q 2
SEDP = ------------- + --------
09/03/2010 Dr. Kusum Gaur 57
N1 N2
ad
ODD‟s Ratio = Times
bc
a/a+b a (c+d)
= =
c/c+d c (a+b)
AR = x 100
Incidence among Exposed
a
Incidence among Exposed= x 100
a+b
c
Incidence among Non-Exposed= x 100
c+d
As per Randomization:
• Randomized Control Trials (RCT)
As per Design:
• Simple
• Clinical Trials
• Lab. Trials
12/08/2012 Dr. Kusum Gaur 62
Quality of Experimental Study
• Randomization
• Blinding
• Control
• Cross-Over
Single-blind
Patient or evaluator (either of one) is blinded as
to intervention
Double-blind design
Neither patient nor outcome evaluator knows Rx
to which patient was assigned
Positive
Outcome
Group
Placebo
2/control
Negative
Outcome
R Treatment
a Outcomes
Group
n
d
Study o
Population m
i
z Outcomes
e Control Group
Cases
Meeting
Entry criteria
Group - 1 Group -2
Positive Negative
Positive Negative Outcome
Outcome Outcome
Outcome
Group -1
Group -2 Crossover
Intervention -2
Intervention -1
Positive Negative
Positive Negative
Outcome
Outcome Outcome
Outcome
Cases
Meeting
Entry criteria
Group - 1 Group -2
Cases
Meeting
Entry criteria
Group -3
Group - 1
Group -2
Intervention Intervention-3
Intervention -1 Intervention
Intervention-2
Reference Population
Sample Population
Exclusions
Randomization
Experimental Group Control Group
Manipulation/Intervention
Follow - up
12/08/2012 Assessment
Dr. Kusum Gaur of Outcome 74
Ideal Study Design for established causality
Ethical Issues
STUDY QUESTIONS AND APPROPRIATE DESIGNS
Cohort
Case Control
Cross-Sectional
Case Series
Whole Population
Sample Population
To get inferences
applicable to universe
Qualities
Adequate size
• Population Factors
– Type of information available
• Type of study
– Type of Data
– Type of study design
– Type of sampling
– Type of Statistical Analysis for outcome needed
• Determined values of research by researcher
– Power
– Significance level
Z 2 PQ 4 PQ
Sample Size= ------------------- -- = ------------------
L2 L2
P= Prevalence of disease
Q = 100-P
L = allowable error
Z= 1.96 ≈ 2 for 95% CL
for descriptive/case-series type of study design
Z 2 SD 2 4 SD 2
Sample Size= ------------------- -- =----------------------
L2 L2
n
k Here n0=No. of cases &
2n0 n n = expected no. of cases
Power 80%
• PROBABILITY/RANDOM SAMPLING
• NONPROBABILITY SAMPLING
• Lottery Method
Sample Strata 1
Sample
Strata 2
Sample Strata 3
12/08/2012 Dr. Kusum Gaur 128
Multiphase Random Technique
Specific test
Screening Test
S/S
Population
village
State 1 district
Population village
Study
Of Population
Nation village
district
village
State 2
village
district
village
Cluster 1 Cluster 27
Cluster 2 Cluster 28
Population Study
Of Population
Nation Cluster 3 Cluster 29
Cluster 30
Cluster 4
Through Simple RT
Convenience
Purposive
Quota
Snow ball study
Contact tracing
Initial respondent helps in recruiting
new population
Useful in network analysis approach
Data Collection
and
Data Management
Sources of Data
Interview
Personnel
Telephonic
Observation
Experimental
Interview and Observation
Observation and Experimental
Interview ,Observation and Experimental
(Questionnaire/Interview schedule)
Pre testing
• Master Chart
• Tabulation
• Diagrammatic Presentation
12%
4th Qtr
14%
3rd Qtr 12%
2nd Qtr
32%
1st Qtr
82%
0 1 2 3 4 5 6 7 8 9
50
40
20
10
0
(1) Very Dissatisfied (2) Dissatisfied (3) neither satisfied (4) Satisfied (5) Very Satisfied
nor dissatisfied
12%
4
Series 2
3
Series 1
2
0
2000 2001 2002 2003 2004 2005
Series 1
40
30
20
10
Series 1
0
0 to 5 yrs
5yrs to 10
10 yrs to
yrs 15 yrs to
15 yrs 20 yrs to
20 yrs
25 yrs
25
20
Duration of Diabetes
15
Duration of diabetes in yrs.
Linear (Duration of diabetes in yrs.)
10
0
0 50 100 150 200 250 300
No. of Patients
5/1/2002
40
30
20
9/1/2002 6/1/2002
10
Series 1
0
Series 2
8/1/2002 7/1/2002
60
50
40 Open
High
30 Low
20 Close
10
0
5/1/2002 6/1/2002 7/1/2002 8/1/2002 9/1/2002
Analysis of Data
Biostatistics = Biology + Statistics
Qualitative Data
Rates
Ratios
Proportions
Quantitative Data
Central Tendencies Disperson
Mean Standard Deviation
Mode Standard Error
Median Confidencial Limit
Skeweness
Standard Deviation = It tells how much scores deviate from the mean
it is the square root of the variance
it is the most commonly used measure of spread (X-X)
SD=√ N
Standard Error = Deviation from mean per observation
SD/ √N
of
significance tests
Sample proportion
to Independent Dependent Dependent Independent
Population Proportion
Mc Numer Cochron’s
Large Sample Small Sample
(>30) (<30)
Small Sample Large Sample Large Sample Small Sample
Yat’s Corrected
‘Z’ Score Corrected ‘Z’ Score Chi Squire
Chi Squire ‘Z’ Score Chi Squire
Yat’s Corrected Chi
Chi Squire
Sample Mean
to Independent Dependent Dependent Independent
Population Mean
Paired ‘T’ Test ANOVA Friedman
Large Sample Small Sample
(>30) (<30)
Small Sample Large Sample Large Sample Small Sample
Descriptive Study
Analytical
Case Control Study OR
Qualitative ‘Z’ Score Test/Chi-Square Test
Quantitative ‘Z’ Test/’t’ Test
Cohort study OR, AR, & RR
Qualitative ‘Z’ Score Test/Chi-Square Test
Quantitative ‘Z’ Test/’t’ Test
12/08/2012 Dr. Kusum Gaur 195
STUDY DESIGNS AND APPROPRIATE TEST
Type Study Design Appropriate Significance Test
Two Groups ‘Z’ Score Test ‘Z’ test (n>30) Mann Whitny
Chi-square Test T Test (n<30)
Inferences
If Chi Square(x2 ) Test Value is –
Higher than Table value = Difference in proportions is
Significant at that desired level of significance.
Indications
To see the Significance of any Observation in
reference of Mean Value of that sample
Comparing difference between
Sample Mean to Population Mean
Means of Two independent Samples
Random Sample
Quantitative data
Normally Distributed
as per design
Unpaired / Paired
for inference
One Tail /Two tail
Population -1 Population -2
S-1 S-2
Intervention
Population Sam
Observations-1 Observations 2
ple-
Inferences
If „T‟ Test Value is –
Higher than Table value = Difference in Means is
Significant at that desired level of significance.
Pre-requisites
Quantitative data
Homogenous normally distributed Random
Sample
Indications
Comparing difference between more than Two
Means
Inferences
If Test value is > Table value = Difference in Means is
Significant at that desired level of significance.
Indications
CORRELATION
. ∑ ( X – X) ∑ ( Y – Y) ∑xy
Correlation (r) = =
√∑ ( X – X)2 ∑ ( Y – Y)2 √ ∑ x2 y2
Direct Method
∑ X Y - ∑ X ∑Y / N
Correlation (r) = -----------------------------
√ {∑X2 – (∑X)2/N}{ ∑Y2 – (∑Y)2 /N}
here,
∑ X Y = Sum of multiplication of X and Y
∑ X = Sum of all observations of X Series
∑ Y = Sum of all observations of YX Series
N =Total no. of observations
∑X2 = Sum of Squares of all observations of X Series
∑Y2 = Sum of Squares of all observations of Y Series
(∑X)2 = Square of Sum of all observations of X Series
(∑Y)2 = Square of Sum of all observations of Y Series
6∑D2
• Spearman‟s Rank (rs ) = 1 -
N3 - N
Inference
• If difference >2 SE of r =Difference is
Significant at 5% level
• If difference < 2SE of r =Difference is
Not Significant at 5% level
Indication
To find out causal relationship between
variables
SD of series X
(X – X)= r (Y –Y) ---- (3)
SD of series Y
Regression Equation of Y on X
SD of series Y
(Y – Y)= r (X –X) ------- (4)
SD of series X
12/08/2012 Dr. Kusum Gaur 227
Regression – coefficients
Regression Coefficient of X on Y
b(xy)= r =
SD of series Y ∑(X – X)2
Regression Coefficient of Y on X
Diseased Normal
Disadvantages
They ignore certain amount of information
Indicated only ordinal or nominal data
Statistically Less efficient
Indicated only to test hypothesis, not for
estimates
• Simplest
• Based on direction(- /+/0)
• Signs as per the direction are counted
Inferences
Reporting
Title of Project
Abstract
Introduction
Aims & Objectives
Methodology
Observations-Compilation, Classification &
Presentation of data with analysis and inferences
Discussion
Conclusions
Recommendations
Limitations
Acknowledgment
Bibliography
Explanation of findings
Logic and reasoning for the results as it
appears
Compare and contrast with findings of other
researchers
Based on objectives of the study
Should answer the research question
Scope & limitations of the study
Protocol development
Time line/Gantt chart
Peer review
Development of tools
Training in data collection
Budget/ financial accounting
Quality control
Monitoring & Evaluation
Planning
Officials
Que. Dev
Training
Poilet Survey
Corrections
Re-training
Resource Proc
Survey
Analysis
Report Writing
Dissemination
of Report
Computer in Statistics
• http://stattrek.com
• http://vassarstat.net
• http://www.scribd.com
• http://www.statistixl.com
• http://statistics calculators.com
• http://stat.ubc.ca/~rollin/stats/ssize/
• ………………………………………………………
……
• Microsoft Excel
• SPSS
• Epi info
• Epi tab
• Mini tab
• Graph Pad
• Primer
• Medcal
• ……………..