Professional Documents
Culture Documents
&
BIOSTATISTICS
“Research is a
systematized effort
to gain new knowledge”.
Data Collection
5
Steps in Research
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
12/08/2012 Dr. Kusum Gaur 13
Association of Garlic consumption with
coronary Artery Diseases
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
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
09/03/2010 Dr. Kusum Gaur 30
Analytical Observational Studies
• 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
DefinedofPopulation
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
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
• Cannot study rare outcomes
• Confounding variables
Cases control
Exposed a b
a x 100
Exposure Rates = in Cases (P2) Non- c d
exposed
a+c
b x 100
Exposure Rates = in Controls (P1) P2 – P1
b+d Z Score =
SEDP
P1Q 1 P2Q2
09/03/2010 Dr. Kusum Gaur
SEDP = ------------- + -------- 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
09/03/2010 Dr. Kusum Gaur 59
Experimental Studies
As per Randomization:
• Randomized Control Trials (RCT)
As per Design:
• Simple
• Clinical Trials
• 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 Outcomes
z Control Group
e
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
Positive Positive
Negative Negative
Outcome Outcome Outcome Outcome
Positive Negative
Outcome Outcome
Reference Population
Sample Population
Exclusions
Randomization
Experimental Group Control Group
Manipulation/Intervention
Follow - up
12/08/2012 Assessment
Dr. Kusum Gaur of Outcome 74
Strength
Ideal Study Design for established causality
Weakness
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
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
Strata 3
Sample
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
• Questionnaire
• Not need of questionnaire
• Purpose served
• Purpose served ?
• Analysis as per
purpose • Descriptive
• Require more time and
• Less expensive
money
12/08/2012 Dr. Kusum Gaur 141
Type of Data Collection Methods
Interview
Personnel
Telephonic
Observation
Experimental
Interview and Observation
Observation and Experimental
Interview ,Observation and Experimental
(Questionnaire/Interview schedule)
Pre testing
12/08/2012
Steps of Questionnaire Design Dr. Kusum Gaur 146
Organization and Compilation of Data
• Master Chart
• Tabulation
• Diagrammatic Presentation
As per purpose
General tables –about Socio-demographic profile
Specific tables –about Aims and objectives
As per originality
Original tables-from original Data
Derived tables –from original tables
As per Construction
Simple tables- showing one variable at one time
Complex tables – showing > one variable at one time
12%
4th Qtr
3rd Qtr
14%
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 (X-X)
it is the most commonly used measure of spread SD=√ N
of
significance tests
TEST OF SIGNIFICANCE OF QUALITATIVE DATA
One Sample Two Sample >Two Sample
Sample proportion
to Independent Dependent Dependent Independent
Population Proportion
Mc Numer Cochron’s
TEST OF SIGNIFICANCE OF QUANTITATIVE DATA
One Sample Two Sample >Two Sample
Sample Mean
to Independent Dependent Dependent Independent
Population Mean
Paired ‘T’ Test ANOVA Friedman
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)
ANCOVA
2+ Categorical 1 factorial ANOVA
1+ factorial ANCOVA
2+ Continuous 1 Categorical 1 one-way MANOVA Create linear
1+ one-way MANCOVA combo of Dependent variable
2+ Categorical 1 factorial (Dvs)
MANOVA to maximize
1+ factorial MANCOVA mean group
differences
Degree of Continuous 1 Continuous Bivariate Determine
relationship Correlation relationship/prediction
Inferences
If Chi Square(x2 ) Test Value is –
Higher than Table value = Difference in proportions is
Significant at that desired level of significance.
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
Regression Equation of Y on X
SD of series Y
(Y – Y)= r (X –X) ------- (4)
SD of series X
b(xy)= r =
SD of series Y ∑(X – X)2
Regression Coefficient of Y on X
SD of series Y ∑(X-X)(Y –Y)
b(yx)= r =
SD of series X ∑(Y – Y)2
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
Independent Independent-
Mann-Whitney test
measures, 2 groups measures t-test
One-way,
Independent
independent- Kruskal-Wallis test
measures, >2 groups
measures ANOVA
Repeated measures,
Matched-pair t-test Wilcoxon test
2 conditions
• 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/
• ………………………………………………………
……
12/08/2012 Dr. Kusum Gaur 257
Computer Softwares in Statistics
• Microsoft Excel
• SPSS
• Epi info
• Epi tab
• Mini tab
• Graph Pad
• Primer
• Medcal
• ……………..
12/08/2012 Dr. Kusum Gaur 258
Always there is room for improvement