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RESEARCH METHODOLOGY
              &
        BIOSTATISTICS




*   Few jewels from ocean
                            Dr. Kusum Gaur
                            Professor, PSM
                            WHO Fellow IEC
Definition of Research

“Research is a
       systematized effort
                to gain new knowledge”.




12/08/2012      Dr. Kusum Gaur        2
Steps in Research (Holy 11)
 1.  Collect review of literature/Situation Analysis
 2.  Identify and prioritize health problems
 3.  Decide aims & objectives
 4.  Planning Methodology
 5.  Execution
 6.  Compilation, Classification & Presentation of
     data
 7. Analysis
 8. Test of Significance/Test of Hypothesis
 9. Inferences
 10. Report Writing
 11. Dissemination of Report

12/08/2012              Dr. Kusum Gaur                 3
Process of Concluding
             8                              7                                      6


             Reporting                      Inferences                  Analysis




                                                                                       Data Collection
                                                                                                              5




                                                                                       Execution


                                                                                                             Execution
                     Research Problem
                     Define
                 1




                                                                                       for Pretest
                                                                                       Collection
                                                                                       Data
                            Review of Literature              Methodology
                                                                                                              4

                                        2                                3
                                                      Planning



12/08/2012                                   Dr. Kusum Gaur                                              4
STEP-1




                 DEFINITION
                   OF THE
             RESEARCH PROBLEM


12/08/2012         Dr. Kusum Gaur   5
RESEARCH PROBLEM ?


   Research Problem refers to some difficulty
    which a researcher experiences and
   wants to obtain a solution for the same.

             i.e. a question or issue to be examined.



12/08/2012                 Dr. Kusum Gaur               6
Process of Defining Problem

               Analysis of the Situation


             Identify & Prioritize Problems


               Select & Define Problem


                    Statement of
                 Research Objectives



12/08/2012                Dr. Kusum Gaur      7
CRITERIA OF SELECTION
      The selection of one appropriate researchable
      problem out of the identified problems requires
      evaluation of certain criteria.

 * Internal / Personal criteria – Researcher‟s side

 * External Criteria – Problem side factors




12/08/2012                Dr. Kusum Gaur                8
INTERNAL CRITERIA OF SELECTION


      Researcher‟s Interest,

     Researcher‟s Competence,

     Researcher‟s own Resource:
       Human Resource
       Money
       Material
       Time



12/08/2012                Dr. Kusum Gaur   9
EXTERNAL CRITERIA OF SELECTION


            Researchability of the problem,
            Importance and Urgency,
            Novelty of the Problem,
            Feasibility,
            Facilities,
            Social Relevance
            Public health Importance




12/08/2012                    Dr. Kusum Gaur   10
DEFINE RESEARCH PROBLEM
             (Title of the Research Topic)

   Transforming the selected research problem into a
    scientifically researchable statement.

   Problem definition or Problem statement should be
    clear, precise, self-explanatory and include:-

                         What
                         How
                         When
                         Where

12/08/2012                Dr. Kusum Gaur                11
RESEARCH OBJECTIVES
                    (Objectives)
   Research Objectives are the statement of the
    questions that is to be investigated with the goal of
    answering the overall research problem.

   Research Objectives should be clear and achievable.

   Generally, they are written as statements, using the
    word “to”
    (For example, „to discover …‟, „to determine …‟, „to
    establish …‟, „to find out -----‟, „to assess -----‟etc. )
        Objectives should infer in the end of the study

12/08/2012                   Dr. Kusum Gaur                 12
Hypothetical Research Question
   Problem:
    PCR of Diabetes Mellitus is increasing very
    fast during last five year

   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

Aim: To Study the association of Meditation with
  Diabetes Mellitus in patients attending at Medical
  OPD of SMS Hospital, Jaipur (Raj) India.

Objectives:
1. To assess and compare the proportion of DM
   cases in individuals doing regular meditation and
   not doing meditation.

2. To find out the risk ratio of DM in individuals not
   doing meditation on doing regular meditation.
STEP-2




               REVIEW
                 OF
             LITERATURE

12/08/2012      Dr. Kusum Gaur   15
Review of literature


             What ?

             Why ?

             Where ?




12/08/2012              Dr. Kusum Gaur   16
What ?
                 REVIEW OF LITERATURE


          Literature Review is the documentation

              of a published and unpublished work

                 from secondary sources of data

in the areas of specific interest to the researcher.


 12/08/2012                  Dr. Kusum Gaur         17
Why ? - PURPOSE OF REVIEW
 Tofind out already investigated problems and
 those that need further investigation.

 To    formulate researchable hypothesis.

 To    gain a background knowledge

 To    identify data sources

 To    learn how others structured their reports.
 12/08/2012              Dr. Kusum Gaur              18
Where ?
             SOURCES OF LITERATURE
       Books and Journals
       Databases
           Bibliographic Databases
           Abstract Databases
           Full-Text Databases
       Govt. and NGO Records & Reports
       Internet
         On line journals: ww.articalbase.com …….
         E. Databases – Popline, Medline …….
       Research Dissertations / Thesis


12/08/2012               Dr. Kusum Gaur              19
Step-3




Methodology
Methodology
    Study Area : Location of study - Hospital, community etc.

    Study Period: Start to end of Study (maximum period
     available for study should be defined)

    *Selection of Study Design

    * Selection of Study Population

    Pre-requisits of study: Study Tools, Terminologies,
     Orientation trainings etc.


        *will be taken separately


12/08/2012                          Dr. Kusum Gaur          21
Methodology……

• Study Tools for data collection: subjects, proforma,
  examination, measurements, lab investigations
• Planning
    Data collection, compilation, data entry
    Data cleaning
    Analysis plan:
• Confidentiality
• Ethical clearance: Consent from
    Institutional Review Board
    Observational units

12/08/2012              Dr. Kusum Gaur                   22
Study Design


  A study design is a specific plan or protocol
  for conducting the study,
  which allows the investigator
  to translate the conceptual hypothesis
  into an operational one.




12/08/2012            Dr. Kusum Gaur              23
Direction of Study

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

               Comparison Group                                Randomization

       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


  12/08/2012                         Dr. Kusum Gaur                               25
Epidemiological Study Design
 Observational Studies
   Descriptive Studies

    Analytic
        Cross-Sectional
        Case-Control
        Cohort

 Experimental / Interventional studies
  As per Control: RCT/NRCT
  As per Blinding: Single /Double Blind
  As per Design: Simple/Cross-over
  As per Area: Field/Clinical/Lab
12/08/2012             Dr. Kusum Gaur      26
Descriptive Studies



             • Case reports
             • Case series
             • Population studies



12/08/2012               Dr. Kusum Gaur   27
Descriptive Studies: Uses



      • Hypothesis generating


      • Suggesting associations




12/08/2012             Dr. Kusum Gaur    28
Descriptive Type of Observational Study


•   Other Name          Case-Series/Population
•   Unit of Study       Case/Individuals
•   Study Question      What is happening 
•   Direction Of Inquiry
•   Study Design
                                       desired information
                       about cases/individuals is
    collected


12/08/2012            Dr. Kusum Gaur                         29
Case-Series …….

 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



12/08/2012         Dr. Kusum Gaur   31
Cross-sectional Study
   • Data collected at a single point in time



   • Describes associations



   • Prevalence
                         A “Snapshot”

12/08/2012               Dr. Kusum Gaur         32
Cross-Sectional Study

•   Other Name           Prevalence Study
•   Unit of Study        Individual
•   Study Question             What is happening 
•   Direction of Inquiry
•   Study Design                     Exposed
                                     to Factor

                                                     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



             To find out association




12/08/2012            Dr. Kusum Gaur   34
Cross-sectional Study

                      Sample of Population
                      Defined Population

              Regular                  Not doing meditation
              Meditation


              Prevalence of                    Prevalence of
                   DM                               DM



                       Time Frame = Present
12/08/2012                    Dr. Kusum Gaur                   35
Cross-sectional Study
E.G. Out of 1000 population if 100 were doing meditation regularly &
out of that only 2 were having DM. Remaining 900 were not doing
meditation at all, out of that 220 were having DM.

                         +     DM                -

                       2                         98
      Meditation




                   +



                   -   220                       680


12/08/2012                      Dr. Kusum Gaur                         36
Cross-Sectional Study

   • Strengths
         – Quick
         – Cheap

   • Weaknesses
         – Cannot establish cause-effect


09/03/2010             Dr. Kusum Gaur      37
Case-Control Studies
  Start with people who have disease(Cases)


  Match them with controls that do not have
     disease (Match Confounding)


  Look back and assess exposures

12/08/2012           Dr. Kusum Gaur            38
Controls

  A control is a standard of comparison
   (confounded with variability but without effect)

             for

                   • Effects

                         • Variability


12/08/2012              Dr. Kusum Gaur          39
Case-Control Study
•   Other Name          Retrospective Study
•   Unit of Study       Cases/Control
•   Study Question      What has happened 
•   Direction of Inquiry= F            O
•   Study Design
                   Exposed

                                          Cases
                     Not
                   Exposed


                   Exposed

                                         Control
                  Not
                  Exposed
12/08/2012              Dr. Kusum Gaur             40
Objective of a Case-Control Study


             To find out association

             To assess Risk Ratio




12/08/2012            Dr. Kusum Gaur    41
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

Cases differ from controls only in having the
 disease

If exposure does not predispose to having
 the disease, then exposure should be equally
 distributed between the cases and controls.

 The extent of greater previous exposure
 among the cases reflects the increased risk
 that exposure confers
12/08/2012          Dr. Kusum Gaur             43
Case-Control Studies: Strengths

• Good for rare outcomes: cancer
• Can examine relation of exposures to disease
• Useful to generate hypothesis
• Fast
• Cheap
• Provides Odds Ratio



 09/03/2010          Dr. Kusum Gaur              44
Case-Control Studies: Weaknesses


     • Cannot measure
             – Incidence
             – Prevalence
             – Relative Risk
     • Can only study one outcome
     • High susceptibility to bias

09/03/2010                 Dr. Kusum Gaur   45
Cohort Study


   • Begin with disease-free individuals

   • Classify patients as exposed/unexposed

   • Record outcomes in both groups

   • Compare outcomes using relative risk



12/08/2012            Dr. Kusum Gaur          46
Cohort Study
•   Other Name Prospective Study / Follow-up Study/Incidence Study
•   Unit of Study        Individual
•   Study Question       What is happening 
•   Direction of Inquiry F              O
•   Study Design                             Diseased

•
                         Exposed to                 Not Non
                         Factor                     Diseased


        Cohort
          Cohort                                  Diseased
                             Not
                          Exposed to
                            Factor
                                                  Non-Diseased

12/08/2012                       Dr. Kusum Gaur                      47
Logic of Cohort Study

Cohort is a group of persons sharing a
 common characteristics

Differences in the rate at which exposed and
 control subjects contract a disease is due to
 the differences in exposure, since others are
 known and similar.



12/08/2012           Dr. Kusum Gaur          48
Cohort Study

 Prospective (usually)

 Controlled

 Can determine causes and incidence of
 diseases as well as identify risk factors

 Generally expensive, time consuming and
 difficult to carry out
12/08/2012          Dr. Kusum Gaur           49
Steps for Cohort Study

 Identify geographically defined group
 Identify exposed subjects and not exposed
  subjects
 Follow over a specific time
 Record the fraction in each group who
  develop the condition of interest
 Compare these fractions using RR, AR or OR



12/08/2012            Dr. Kusum Gaur       50
Objectives of a Cohort Study

              To find out association

              To assess Risk Ratio

              To find out Relative Risk

              To find out Attributed Risk




12/08/2012                  Dr. Kusum Gaur   51
Prospective Cohort Study
                                   DM
No Meditation
                                 No DM

     Cohort
                                   DM
Regular
Meditation                       No DM

    Present                      Future
12/08/2012      Dr. Kusum Gaur            52
Cohort Study: Strengths


   • Can measure multiple outcomes

   • Can adjust for confounding variables

   • Can calculate Attributed Risk




09/03/2010            Dr. Kusum Gaur        53
Cohort Study: Weaknesses

    • Expensive

    • Time consuming

    • Cannot study rare outcomes

    • Confounding variables




09/03/2010             Dr. Kusum Gaur   54
Measurements of association


    Cohort Study                    Case Control Study


  •Significance Test                    •Significance Test
  •Relative Risk                        •OR
  •Attributable Risk
  •OR


12/08/2012             Dr. Kusum Gaur                        55
Measures of Association
 Significance Test – to test significance of
  difference in exposure between control and
  Cases
 Odds ratio - ratio of the odds of contracting
  disease in given exposure
 Relative Risk – Ratio between incidence
  among exposed and incidence among non-
  exposed
 Attributed Risk – percentage of difference
  between incidence among exposed and non-
  exposed with incidence among exposed
             RR or OR of 1 indicate no effect of exposure (equal odds)
12/08/2012                        Dr. Kusum Gaur                         56
‘Z’ Score of Exposure Rates

                                                               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

             Incidence among Exposed
    RR =                              Times
             Incidence among Non-Exposed

                      a/a+b                   a (c+d)
                  =                       =
                   c/c+d                      c (a+b)


09/03/2010               Dr. Kusum Gaur                 58
Attributed Risk


    (Incidence among Exposed - Incidence among Non-Exposed)

 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


    Clinical trials provide the “gold standard” of

    determining the relationship between factor

    and the event




12/08/2012             Dr. Kusum Gaur                60
Types of Experimental Study

As per Randomization:
      • Randomized Control Trials (RCT)

             • Concurrent Parallel Design (RCT)

             • Sequential RCT Design

             • RCT with External Control


      • Non – Randomized Trials (NRCT)

12/08/2012               Dr. Kusum Gaur           61
Types of Experimental Study….

As per Design:
                • Simple

                • Cross-Over Study Design


As per Study Area:
              • Field Trials

              • Clinical Trials

              • Lab. Trials
 12/08/2012                    Dr. Kusum Gaur   62
Quality of Experimental Study


       • Randomization

       • Blinding

       • Control

       • Cross-Over



12/08/2012               Dr. Kusum Gaur   63
Controls in Clinical Trials

    A clinical trial is a comparative, prospective
    experiment conducted in human subjects

• Historical controls are better than no
  controls

• Patients can serve as own controls - This is
  usually beneficial as the comparison
  removes patient differences

12/08/2012              Dr. Kusum Gaur               64
Blinding
  Good practice: factors that can affect the
   evaluation of outcome should not be permitted
   to influence the evaluation process

 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


12/08/2012             Dr. Kusum Gaur              65
Randomized Control Trials (RCT)


• Before and After Comparison

• Comparison with Placebo

• Comparison Of two medicine/procedure/tests

• Comparison Of > two medicine/procedure/tests


12/08/2012         Dr. Kusum Gaur          66
Experimental Study
• Other Name           Intervention Study
• Objective            To know the effect of intervention
• Unit of Study                Individual meeting entry criteria
• Study Question       What is happening after intervention in
  both                         groups 
• Direction of Inquiry I               E
• Study Design            1(Intervention with Placebo)   Positive
                                                         Outcome

       Group 1/cases        Intervention
                                                         Negative
                                                         Outcome


                                                         Positive
                                                         Outcome
        Group
                             Placebo
        2/control
                                                          Negative
                                                          Outcome

12/08/2012                        Dr. Kusum Gaur                     67
Clinical Trial


               R          Treatment
               a                       Outcomes
                            Group
               n
               d
    Study      o
  Population   m

               i
               z                       Outcomes
               e       Control Group




12/08/2012          Dr. Kusum Gaur                68
Intervention Study - Design 2
    (Comparison of Effect of Two Interventions)

                                           Cases
                                          Meeting
                                       Entry criteria


                Group - 1                                             Group -2




              Intervention -1               Intervention               Intervention - 2




   Positive                 Negative                       Positive
                            Outcome                                                  Negative
   Outcome                                                 Outcome                   Outcome




12/08/2012                                   Dr. Kusum Gaur                                     69
Cross Over Design
               Group -1                        Cases                   Group-2
                                              Meeting
                                            Entry
                                            criteria                  Intervention - 2
               Intervention - 1

                                                                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

  12/08/2012                                   Dr. Kusum Gaur                                        70
Other Types of Experimental Study


       • Quincy Experimental Study


       • Block Experimental Study




12/08/2012             Dr. Kusum Gaur   71
Quincy Experimental Study

                                     Cases
                                     Meeting
                                     Entry criteria

              Group - 1                                             Group -2




              Intervention                Intervention               No Intervention




   Positive               Negative                       Positive
                          Outcome                                                Negative
   Outcome                                               Outcome                 Outcome




12/08/2012                                 Dr. Kusum Gaur                                   72
Block Experimental Study

                                    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


  12/08/2012                                   Dr. Kusum Gaur                                           73
Steps of Experimental Study
                       Drawing up a Protocol


                       Reference Population


                         Sample Population


                             Exclusions


                           Randomization
             Experimental Group      Control Group


                       Manipulation/Intervention

                              Follow - up


12/08/2012              Assessment of Outcome
                         Dr. Kusum Gaur              74
Ideal Study Design for established causality




 Ethical Issues
STUDY QUESTIONS AND APPROPRIATE DESIGNS

   Type of Question                       Appropriate Study Design
   Burden of illness                              Field Surveys
               - Prevalence               Cross Sectional Survey
             - Incidence                  Longitudinal survey

   Causation, Risk & Prognosis           Case Control Study,
                                         Cohort study, RCT

   Treatment Efficacy                      Randomized Controlled study

   Diagnostic Test Evaluation              Randomized Controlled study

   Cost Effectiveness                     Randomized Controlled study

12/08/2012                       Dr. Kusum Gaur                          76
Hierarchy of Epidemiological Study Design

  Establish Causality                         RCT

                                              Cohort

                                              Case Control


                                              Cross-Sectional

                                              Case Series


Generate Hypothesis                           Case Report

12/08/2012                   Dr. Kusum Gaur                     77
Methodology

       Study Area : Location of study - Hospital, community
        etc.

       Study Period: Start to end of Study (maximum period
        available for study should be defined)

       *Selection of Study Design

       * Selection of Study Population
             Sample Size
             Sampling Technique

       Pre-requisits of study: Study Tools, Terminologies,
        Orientation trainings etc.

12/08/2012                   Dr. Kusum Gaur                    78
Selection of study population



             Whole Population

             Sample Population




12/08/2012          Dr. Kusum Gaur   79
What is Sample ?


• A sample is a small representative
  segment of a population

• Inferences drawn from a sample are
  expected to be applicable for the source
  population



12/08/2012          Dr. Kusum Gaur           80
Why do we need a sample?



 To get inferences

             applicable to universe

                 with minimum resources

12/08/2012           Dr. Kusum Gaur   81
Sample – Qualities

 Sample is a part of population but it is true
  representative of whole.

 Qualities

 Adequate size

 Appropriate sampling technique


12/08/2012            Dr. Kusum Gaur             82
Factors on which SAMPLE SIZE depend:

• 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


 12/08/2012              Dr. Kusum Gaur                83
Power: Ability to detect right answer



Alpha Error: Chance to miss right answer
Type of Data & level of Measurements


 Qualitative – Counted Facts – Nominal Data
  Measured as Numbers expressed as proportions

 Quantitative- Measured Facts - Numerical Data
  Measured as quantity & expressed as Mean SD

 *Ordinal Data – Rank Order Data
   Measured as rank & expressed as Median   Percentile




12/08/2012            Dr. Kusum Gaur               91
Sample size for Qualitative data


                      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

09/03/2010                      Dr. Kusum Gaur                   92
Sample size for Quantitative data

                      Z 2 SD 2                   4 SD 2
      Sample Size= ------------------- -- =----------------------
                      L2                         L2

                                   SD= Standard Deviation
                                        L = allowable error
                          Z= 1.96 ≈ 2 for 95% CL
      For Descriptive Studies only



09/03/2010                      Dr. Kusum Gaur                      94
Finite Correction

Sample Size – Finite Population (where the
  population is less than 50,000)
                 SS
New SS = _________________
          ( 1 + ( SS – 1 ))Pop
How many controls?

                       n
                  k                    Here n0=No. of cases &
                     2n0  n            n = expected no. of cases




• k = 13 / (2*11 – 13) = 13 / 9 = 1.44
• kn0 = 1.44*11 ≈ 16 controls (and 11 cases)
   – Same precision as 13 controls and 13 cases
Sampling Design factors of sample size




                  Variance of Specified Sampling
Design Effect =
                  Variance of Simple Random Sampling




12/08/2012             Dr. Kusum Gaur                  97
Sampling Technique effect on Sample Size

    Sampling Technique    Design Effect Size Multiplier

    Simple Random Sampling                1

    Systemic Random Sampling              1.2

     Stratified Random Sampling           0.8

    Cluster Random Sampling               2


 12/08/2012              Dr. Kusum Gaur                   98
Conventionally accepted
             Researcher’s Estimations


   Alpha Error                          0.05

   Power                                80%

    Confidence Limit                    95%




12/08/2012             Dr. Kusum Gaur          99
Key Concepts: Sample size
• Sampling Design - larger sample for Custer

• Desired Power – more power for larger sample

• Allowable error – smaller error for larger sample

• Heterogeneity leads to have larger sample to
  cover diversities

• Nature of Analysis – Complex multivariate
  needs larger sample
 12/08/2012           Dr. Kusum Gaur             100
Steps -Sample Size Estimation
    • Stage 1- * Base Sample Size Calculation (n)

    • Stage 2 – Sample Size with Design Effect (d)
               =n*d

    • Stage 3- Contingency Addition (e.g. 5%)
               SS Estimation for study population
                    =(n*d)+5%of n

    *Use appropriate equation for sample size
      calculation
      http://stat.ubc.ca/~rollin/stats/ssize/
12/08/2012            Dr. Kusum Gaur            101
E.G. Mean 1= 5, Mean 2 = 15 & SD = 14   inputting values
12/08/2012   Dr. Kusum Gaur   107
12/08/2012   Dr. Kusum Gaur   108
12/08/2012   Dr. Kusum Gaur   109
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12/08/2012   Dr. Kusum Gaur   111
12/08/2012   Dr. Kusum Gaur   112
SAMPLING
TECHNIQUES
SAMPLING TECHNIQUES

• PROBABILITY/RANDOM SAMPLING



• NONPROBABILITY SAMPLING




12/08/2012      Dr. Kusum Gaur   119
Random sampling Techniques

  Aim is to give equal chance to
    every observation unit to be
          selected for study in sample.

(Any Observation unit
          should not have Zero Probability )




 12/08/2012            Dr. Kusum Gaur          120
* Random Sampling Techniques

Simple Random Technique

       Systemic Random Technique

              Stratified Random Technique

                   Multiphase Random Technique

                           Multistage Random Technique

                                      Cluster Random Technique

 12/08/2012                Dr. Kusum Gaur                  121
Simple Random Technique

 • Lottery Method




 • Random Table Method


12/08/2012            Dr. Kusum Gaur   122
12/08/2012   Dr. Kusum Gaur   123
Steps –Use of Random Table
• Stage 1- Give number to each member of population
• Stage 2 – Determine total population size (N)
• Stage 3- Determine Sample size (S)

• Stage 4 – Drop one finger on Random Table with eyes
  closed
• Stage 5 – Drop one finger with eyes closed on direction
  to be chosen – Up/Down/Rt/Lt

• Stage 6- Determine first number within 0 to N
• Stage 7- * Determine other numbers till Sample size (S)

* Once a number is chosen do not repeat it again
  12/08/2012              Dr. Kusum Gaur               124
Steps –Use of Random Table..
e.g. N=300, M=50

Random no. Selected no. (3 digits from 0-300)
49468
49699
14043       043
15013       013
12600
33122       122
94169       169
89916
74169       169
32007       007
www.evaluation
  wikiog/index/how_to_use_a_random_number_Table
  12/08/2012           Dr. Kusum Gaur             125
Systemic Random Technique

The selection of sample follows a systematic
  interval of selection
• Find serial interval
               (K) = total population/sample size
• 1st observation through simple random sampling
  among 1to K.                    th
• Next observation = (1st +K) Observation
• Next observation = (2     nd +K)th Observation

• -------------so on till No. of observations
                      = Sample Size


12/08/2012             Dr. Kusum Gaur          126
Systemic Random Technique               Population
N=100 (Given)                              1     21   41   61   81
                                            2     22   42   62   82
S=20 (Estimated)                           3     23   43   63   83
K=N/S =100/20 =5                           4     24   44   64   84
                                            5     25   45   65   85
1st observation between 1 to 5             6     26   46   66   86
                                            7     27   47   67   87
      though SRS e.g. 3                     8     28   48   68   88
Every 5th observation from 3rd             9     29   49   69   89
                                            10    30   50   70   90
      observation will be included in       11    31   51   71   91
      sample population                     12    32   52   72   92
                                            13    33   53   73   93
So, sample population will be – 3rd        14    34   54   74   94
      8th 13th 18th 23rd 28th 33rd 38th     15    35   55   75   95
                                            16    36   56   76   96
      43rd 48th 53rd 58th 63rd 68th 73rd    17    37   57   77   97
      78th 83rd 88th 93rd and 98th          18    38   58   78   98
                                            19    39   59   79   99
      observation                           20    40   60   80   100
 12/08/2012                Dr. Kusum Gaur                        127
Stratified Random Technique
  Sample selection through Simple Random/Systemic Random Technique


              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



                                                     Probable cases              Cases
             Suspected cases                                                      For
                                                                                 study




12/08/2012                                      Dr. Kusum Gaur                           129
Multistage Random Technique

Each stage Simple RT is used                    village
                                     district
                                                village

                                                village
                State 1             district
   Population                                   village
                                                           Study
       Of                                                 Population
     Nation                                     village
                                    district
                                                village
                State 2
                                                village
                                    district
                                                village



12/08/2012                Dr. Kusum Gaur                       130
Cluster Random Technique
The unit of random selection is a cluster rather than individual
• CI = Total population /30 (in 30 Cluster Technique)


                Cluster 1         Cluster 27


                    Cluster 2            Cluster 28
   Population                                                  Study
       Of                                                     Population
     Nation        Cluster 3            Cluster 29


                                Cluster 30
                Cluster 4


                                     Through Simple RT

12/08/2012                      Dr. Kusum Gaur                     131
Stratified Vs Cluster Technique

    Stratified Technique         Cluster Technique
•   Homogenous groups          • Comparable groups of
    are made                     population are made
•   Randomly select              (usually 30)
    sample from each           • Randomly select
    group
                                 sample from each
•   To make it more truly        group
    representative, take
    sample population          • More chances of error
    proportion to size (PPS)     than simple random
•   Less chances of error
    than simple random
Non Probability Sampling



    •   When random samples are not possible
    •   Rare disease
    •   Small population
    •   Special population
    •   Special Condition
    •   Difficult to reach population


12/08/2012             Dr. Kusum Gaur          133
Non-probability Samples


             Convenience
              Purposive
              Quota
              Snow ball study



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12/08/2012   Dr. Kusum Gaur   137
Snow ball sampling


Contact tracing
Initial respondent helps in recruiting
 new population
Useful in network analysis approach


12/08/2012          Dr. Kusum Gaur        138
Step-4 & 5




 Data Collection
      and
Data Management
Sources of Data


• Primary –Own generated data

• Secondary –Already generated data
  Published
  Non-Published




12/08/2012         Dr. Kusum Gaur     140
Primary Vs Secondary source of Data

           Primary data                     Secondary data
• Need to be generated            • Readily available

• First hand information          • Second hand information
• Questionnaire
                                  • Not need of questionnaire
• Purpose served
                                  • Purpose served ?
• Analysis as per
  purpose
• Require more time and           • Descriptive
  money                           • Less expensive
  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


12/08/2012         Dr. Kusum Gaur          142
Forms of questions(Open Vs Closed)

             Open ended                    Close ended

• Possible responses are              • Categories are given
  not given.                             already coded
• Mean, SD, Median                    • Proportion
• For seeking opinions,               • For eliciting factual
  attitudes ,perceptions                information
                                      • Not so depth
• Provides in depth info.             • Investigator‟s bias
• Experience of                       • Ease of answering,
  investigator and                    • Easy to analyse
  analyst required

12/08/2012                Dr. Kusum Gaur                        143
Considerations in formulating questionnaire

      (Questionnaire/Interview schedule)

  Use simple and everyday language

  Do not use ambiguous questions(?/?)

  Do not ask leading questions

  The order of questions:

  Guideline for filling an instrument, pen-pencil


 Pre testing

 12/08/2012                    Dr. Kusum Gaur        144
Validity of a Research Instrument

Ability of an instrument to measure what it is
designed to measure being measured


    Establish the logical link between the
     questions and objectives

     Items/questions cover the full range of
      issue/attitude being measured


 12/08/2012            Dr. Kusum Gaur            145
1.Decide the information required.
                                                               Steps
  2. Define the target respondents.
     3. Method(s) of reaching target
          4. Decide on question content.
                5. Develop the question wording.
                  6. Put questions into a meaningful order.
                   7. Check the length of the questionnaire.
                    8. Pre-test the questionnaire.

                      9. Develop      the final survey form




   12/08/2012                          Dr. Kusum Gaur             146
Organization and Compilation of Data

  Organization and Compilation of Data in such a way
      (Master Chart ) to have reliable, relevant, adequate
      and reasonably complete data with following
      requisites –
                          Simplicity
                          Briefness
                          Utility
                          Distinctively
                          Comparability
                          Scientific Arrangement
                          Attractive
 12/08/2012               Effective
                            Dr. Kusum Gaur                 147
Observations
Steps of Observations

       • Entry of Observations Unites

       • Master Chart

       • Tabulation

       • Diagrammatic Presentation



12/08/2012              Dr. Kusum Gaur   149
Entry of Observation Unites
Master Chart
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Grouping & Classification
Master Chart for Analysis
Tabulation – Content of Table
  Table No. Sequence in the text
  Tile of Table –short, clear and self explanatory to say about for
   what the table is ?
  Body of Table –consist of rows and columns
   Rows – 1st row shows headings of columns
   1st column shows headings of rows
   rest of rows and columns are showing data as per required
   number of rows and columns should be limited to maintained
      simplicity of table
   source of data ( if it is other than the present study ) should be
      written just below the body of table
  Source of Data ?
  Foot Note - written just below the body of table, if there is any
   hidden information
  Inferences –summary value of table

12/08/2012                     Dr. Kusum Gaur                            168
Types of Tables

  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


12/08/2012                     Dr. Kusum Gaur                   169
12/08/2012   Dr. Kusum Gaur   170
Tabulation
Diagrammatic Presentations
 Bar
Qualitative Data
  Simple                     Histogram
  Multiple                   Frequency Polygon
  Component                  Cumulative Frequency
 Pie                          Polygon
 Line                        Scatter Diagram
 Pictogram                   Box and Whisker
 Spot Map                    Correlation Diagram



Qualitative Data              Quantitative Data
12/08/2012         Dr. Kusum Gaur                 172
12/08/2012   Dr. Kusum Gaur   173
Diagrammatic Presentations
Simple Bar diagram

                     12%
4th Qtr


                      14%
3rd Qtr                     12%



2nd Qtr
                                  32%


1st Qtr
                                                                    82%

             0   1     2     3          4           5   6   7   8         9



12/08/2012                         Dr. Kusum Gaur                             175
Multiple Bar diagram
 60



 50



 40


                                                                                                              (1) 1-5 Years
 30
                                                                                                              (2) 6-10 Years
                                                                                                              (3) 11 & Above Years

 20



 10



  0
      (1) Very Dissatisfied   (2) Dissatisfied   (3) neither satisfied   (4) Satisfied   (5) Very Satisfied
                                                   nor dissatisfied




12/08/2012                                                      Dr. Kusum Gaur                                                 176
12/08/2012   Dr. Kusum Gaur   177
Pie diagram

             Propotion of Pie = (Proportion of that variable )(360)Degree



                                   12%

                             14%                                            1st Qtr
                                                                            2nd Qtr
                                                 82%                        3rd Qtr
                                                                            4th Qtr
                             32%




12/08/2012                               Dr. Kusum Gaur                          178
Line diagram
   7

   6

   5

   4
                                                                 Series 2
   3
                                                                 Series 1
   2

   1

   0
             2000   2001   2002            2003    2004   2005




12/08/2012                        Dr. Kusum Gaur                   179
Histogram ( Area Diagramme)

                                                   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




12/08/2012                                   Dr. Kusum Gaur                         180
Scatter Diagram
                        30




                        25




                        20
Duration of Diabetes




                        15
                                                                                              Duration of diabetes in yrs.
                                                                                              Linear (Duration of diabetes in yrs.)


                        10




                         5




                         0
                             0      50   100        150                200        250   300
                                               No. of Patients



                       12/08/2012                                Dr. Kusum Gaur                                         181
Radar diagram

                             5/1/2002
                             40
                             30
                             20
             9/1/2002                              6/1/2002
                             10
                                                              Series 1
                              0
                                                              Series 2




                  8/1/2002                    7/1/2002




12/08/2012                        Dr. Kusum Gaur                    182
Box & Whisker
70

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

 12/08/2012                    Dr. Kusum Gaur                           183
Step-6




Analysis of Data
Biostatistics = Biology + Statistics

• Biostatistics is application of statistics in
  biology i.e. science of figure in medical science

• Data: Set of information, facts or figures
  numerically coded and from which conclusions
  may be drawn is called data (singular-datum).

• Statistics: The collection of methods used in
  planning              an           experiment
  and analyzing data in order to draw accurate
  conclusions.
Type of Biostatistics


• Descriptive statistics generally characterizes
  or describes a set of data elements

• Inferential statistics tries to infer information
  about a population by using information
  gathered by sampling
Descriptive Analysis

                          Qualitative Data
                               Rates
                               Ratios
                             Proportions


                          Quantitative Data
    Central Tendencies                        Disperson
       Mean                                      Standard Deviation
       Mode                                      Standard Error
       Median                                    Confidencial Limit
                                                  Skeweness


12/08/2012                   Dr. Kusum Gaur                         187
Descriptive Analysis of
                 Qualitative Data
                       No. of total Events in a year (A)
             Rate =                                    * 1000
                            MYP of that Region (T)

                                       No. of total (A)
             Ratio =
                                        No. of total (B)
                             No. of Specific Events (A)
    Percentage of Events =                                         * 100
                                       Total Events (T)

                                       Event of Sp. Cause (A)
             Proportional Rate =                                * 10 n
                                       Total Deaths (T)
12/08/2012                       Dr. Kusum Gaur                            188
Descriptive Analysis of
                Quantitative Data
    Mean =            Mathematical Average                           ∑X
                                                                      N
    Mode = Most commonly occurring value
    Median = Center value when arrange in increasing                  N+1
    or decreasing fashion                                              2

    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

    Skewness = Deviation of peak from median
                                                   SK= 3 (Mean –Median)/SD
12/08/2012                        Dr. Kusum Gaur                             189
SD from MS Excel
SD from MS Excel…
Appropriate choice

                        of

             significance tests



12/08/2012          Dr. Kusum Gaur   192
TEST OF SIGNIFICANCE OF QUALITATIVE DATA


                        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
  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


12/08/2012                              Dr. Kusum Gaur                                   193
TEST OF SIGNIFICANCE OF QUANTITATIVE DATA


                    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
  Large Sample Small Sample
     (>30)           (<30)
                                 Small Sample Large Sample      Large Sample Small Sample


 ‘Z’ Test             ‘T’ Test
                                            ‘Z’ Test            ANOVA         ANOVA




 12/08/2012                              Dr. Kusum Gaur                                  194
STUDY DESIGNS AND APPROPRIATE TEST


   Type Study Design                   Appropriate Significance Test

   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

  Randomized Controlled study
             Quantitative (before and after)- Paired ‘t’ Test
             Quantitative (before and after >1 followup)- Freidmen ANOVA
             Quantitative (between two Gps)- Unpaired ‘t’ Test
             Quantitative (between > two Gps)- ANOVA Test


  Randomized Controlled study
             Qualitative (before and after)- Mac Numer Test
              Qualitative (before and after >1 followup)- Cochron’s Test
              Qualitative (between two Gps)- ‘Z’ Score/Chi-square Test
12/08/2012    Qualitative (between > two Gps)- Chi-square Test
                                    Dr. Kusum Gaur                         196
STATISTICAL TEST OF SIGNIFICANCE
                 Nominal           Numerical              Ordinal

Two Groups       ‘Z’ Score Test    ‘Z’ test (n>30)        Mann Whitny
                 Chi-square Test   T Test (n<30)


> Two Groups     Chi-square Test   ANOVA                  Kruskal Wallis

Paired Two       Mec Numer         Paired ANOVA           Wilcoxon Sign

Multiple        Cohrane            Repeated               Friedman
Observation in                     Multivarient ANOVA
same individual

Association of   Contegency        Correlation(Pearson)   Spearman
Two Variable     Cofficient        Regression             Correlation
STATISTICAL TEST OF SIGNIFICANCE
Research    Number and      Number and       Covariates      Test                Goal of Analysis
Question    type of DV      type of IV




            Nominal         1 nominal                        chi square          determine if difference between
Group                                                                            croups
differences Continuous      1 dichotomous                    t-test
                                                                                 Determine significance of
                            1 Categorical    1               one-way ANOVA       mean group
                                             1+              one-way             differences
                                                             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/prediction
relationship                                                 Correlation


                            2+ Continuous                    Multiple            Linear combination to predict the
                                                             Regression          DV
            1+ Continuous   2+ Continuous                    Path Analysis       Estimate causal relations among
                                                                                 variables
     12/08/2012                                   Dr. Kusum Gaur                                        198
Comparing difference between
              Two Sample Proportions
                                 „Z‟ Score Test
                       P2 – P1     here, P1– proportion of that event in 1st Sample
    „Z‟ Score =                      P2 - proportion of that event in 2nd Sample
                      SEDP           SEDP – Standard Error of
                                                     Difference in Proportion


                                              Q1 - proportion without that event
                                                       in 1st Sample i.e. Q1 = 100 – P1
                                              Q2 - proportion without that event in
             P1 Q 1 P 2 Q 2                            2nd Sample i.e. 100 – P2
SEDP =      ------- + --------                N1 - Sample Size of 1st Sample
              N1          N2                  N2 - Sample Size of 2nd Sample



    12/08/2012                       Dr. Kusum Gaur                                   199
Inference of ‘Z’ Score Test



 If „Z‟ > 2 = Difference is Significant

 If „Z‟ < 2 = Difference is Not Significant

 If „Z‟ > 3 = Difference is Highly Significant



12/08/2012              Dr. Kusum Gaur            200
Comparing difference between
          >Two Sample Proportions
                Chi-Square Test
 Indications
 Qualitative data
 Normal distribution
 Comparing difference between
  Two Sample proportions
  Multiple Sample proportions



12/08/2012          Dr. Kusum Gaur     201
Comparing difference between
            >Two Sample Proportions
                                Chi-Square Test
 Chi Square(2) = ∑all cells(O-E)2                                            Tr x Tc
                                                                       E=
                           E                                                    T

                     (O1-E1)2            (O2-E2)2               (O3-E4)2              (On-En)2
Chi Squire =                         +                     +                + ---+
                        E1                  E2                    E3                      En
                                                                   Tr – Total of that Row
 here, O – Observed value of cell
                                                                   Tc – Total of that column
           E – Expected value of cell,
                                                           T – Grand Total i.e. a+b+c+d
           considering Null Hypothesis
                                                    Degree of Freedom (DF) = (C – 1) (R -1)

                                                    R= No. of Rows, C = No. of Column
  12/08/2012                              Dr. Kusum Gaur                                       202
Inference of Chi Square(x2)
     Chi Square(x2 ) value is seen at Degree of Freedom
      DF = (R – 1) (C – 1), from Chi Square((2) Table
         (here R=No. of Rows &C= No. of Column)
               at desired level of significance

                        Inferences
  If Chi Square(x2 ) Test Value is –
  Higher than Table value = Difference in proportions is
     Significant at that desired level of significance.

  If Chi Square(x2 ) Test Value is –
  Lower than Table value = Difference in proportions is
     Not Significant at that desired level of significance.
12/08/2012                Dr. Kusum Gaur                  203
Comparing difference between
    Two Sample Means (>30)
                  „Z‟ Test
 Pre-requisites
 Quantitative data
  Homogenous normally distributed Random Sample
 Sample Size > 30

 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

12/08/2012              Dr. Kusum Gaur            204
Comparing difference between
       Two Sample Means (>30)
                                    „Z‟ Test
                      X2 – X1       here, X1– Mean of that event in 1st Sample
    „Z‟ Test =                        X2 - Mean of that event in 2nd Sample
                     SEDM             SEDM – Standard Error of
                                                     Difference in Means


                                              SD1 – Standard Error of 1st Sample
                                              SD2 – Standard Error of 2nd Sample
                                              N1 - Sample Size of 1st Sample
            SD2 1           SD2 2             N2 - Sample Size of 2nd Sample
SEDM =     ------- + --------
             N1           N2



   12/08/2012                        Dr. Kusum Gaur                                205
Comparing difference between
          Two Sample Means (<30)
                 „T‟ Test
 Prerequisites

 Random Sample

 Quantitative data

 Normally Distributed

 Sample Size < 30

12/08/2012            Dr. Kusum Gaur   206
Type of ‘T’ Test


as per design
  Unpaired / Paired

               for inference
                     One Tail /Two tail




12/08/2012            Dr. Kusum Gaur      207
Unpaired ‘T’ Test Design


             Population -1                       Population -2




                 S-1                                   S-2



               Mean --1      Unpaired ‘T’ test    Mean --2



12/08/2012                     Dr. Kusum Gaur                    208
Paired ‘T’ Test Design

                                          Intervention




 Population      Sam
                        Observations-1                      Observations 2
                 ple-



                         Mean --1                             Mean --2
                                          Paired ‘T’ test




12/08/2012               Dr. Kusum Gaur                                  209
One Tail ‘T’ Test




     Acceptance Zone                            Rejection Zone
One Tail – Results are aspect only in one direction
Two Tail ‘T’ Test




Rejection Zone              Acceptance Zone                Rejection Zone
             Two Tail – Results are aspect in both direction
Comparing difference between
             Two Sample Means (<30)
                                          „T‟ Test
                   X2 – X1                here, X1– Mean of that event in 1st Sample
    „T‟ Test = ---------------              X2 - Mean of that event in 2nd Sample
                  SEDM                      SEDM – Standard Error of
                                                           Difference in Means


                                                     SD1 – Standard Error of 1st Sample
                                                     SD2 – Standard Error of 2nd Sample
                                                     N1 - Sample Size of 1st Sample
            SD2 1     SD2 2                          N2 - Sample Size of 2nd Sample
SEDM =     ------- + --------
             N1          N2

                            Degree of Freedom (DF) = (N1 – 1) + (N2 -1) = N1 + N2 - 2

   12/08/2012                               Dr. Kusum Gaur                                212
Inference of ‘T’ Test Value
       „T‟ Test Value is matched at Degree of Freedom
              (DF) = N1 + N2 – 2 in the Table of “T”
                at desired level of significance.



                        Inferences
  If „T‟ Test Value is –
  Higher than Table value = Difference in Means is
     Significant at that desired level of significance.

  If „T‟ Test Value is –
  Lower than Table value = Difference in Means is
     Not Significant at that desired level of significance.
12/08/2012                 Dr. Kusum Gaur                     213
Comparing difference between
            >Two Sample Means

             ANALYSIS OF VARIENCE (ANOVA) TEST

  Pre-requisites
 Quantitative data
  Homogenous normally distributed Random
  Sample

 Indications
 Comparing difference between more than Two
   Means

12/08/2012                Dr. Kusum Gaur         214
Comparing difference between
         >Two Sample Means
                                          „ANOVA‟ Test
                     MSOSI                                   MSOS2 - Mean Sum Of Squares Within Classes
     ANOVA =         ----------                              = Total SOS – MSOSI
                     MSOS2
                                                             T SOS    = X2 – (X)2/N


MSOSI – Mean Sum Of Squares Between Classes = SOSI / K-1

SOSI –Sum Of Squares Between Classes

                (Xa)2 (Xb)2 (Xc)2                           (Xk)2    (X)2
         =      ---------   + ----------- + ----------- +   ….+ ____ __ - ---------
                Na             Nb                Nc               Nk            N



                                                      At Degree of Freedom (DF) = ( K-1) Horizontal
   12/08/2012                                         Dr. Kusum Gaur
                                                                             (N – K) Vertical
                                                                                             215
Inference of ANOVA
      Find out Variance Ratio value at Degree of Freedom
           (DF) = ( K-1) Horizontal, (N – K) Vertical
                  from the Variance Ratio Table
                at desired level of significance.

                         Inferences
  If Test value is > Table value = Difference in Means is
     Significant at that desired level of significance.


   If Test value is < Table value = Difference in Means is
      Not Significant at that desired level of significance.

12/08/2012                 Dr. Kusum Gaur                   216
CORRELATION


Indications



To find out relationship between variables




12/08/2012          Dr. Kusum Gaur           217
Type & Degree of Correlation
Correlation          Inference                   Correlation (r)   Inference
+1                   Perfect +ve                 -1                Perfect +ve
                     Correlation                                   Correlation
> 0.95               About Perfect +ve           > - 0.95          About Perfect +ve
                     Correlation                                   Correlation
> 0.75               V. Good Correlation         > - 0.75          V. Good Correlation

0.75 – 0.5           Moderate Correlation - 0.75 to – 0.5          Moderate
                                                                   Correlation
0.5 – 0.25           Fair Correlation            - 0.5 to – 0.25   Fair Correlation
0.25 - 0             No Correlation              < - 0.25          No Correlation


     12/08/2012                          Dr. Kusum Gaur                          218
Correlation

                         CORRELATION

             Two Variables                     > Two Variables


    Un-Paired Data       Paired Data


    Pearson‟s Spearman‟s Rank Order Multivariate
    Correlation   Correlation       Correlation




12/08/2012                    Dr. Kusum Gaur                     219
Pearson’s 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}

12/08/2012                 Dr. Kusum Gaur                  220
Pearson’s correlation -----

 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


12/08/2012              Dr. Kusum Gaur               221
Spearman’s Rank Order Correlation




                                      6∑D2
• Spearman‟s Rank (rs ) = 1 -
                                      N3 - N




12/08/2012           Dr. Kusum Gaur            222
Significance Test for Correlation (r)


    Standard Error (SE) of rs = rs √ N-1

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


12/08/2012              Dr. Kusum Gaur      223
REGRESSION

 Indication
 To find out causal relationship between
   variables

 REGRESSION COFFICIENT- It is a measure of
  change in one dependent variable (y) with
  one unit change in the other variable (x)




12/08/2012           Dr. Kusum Gaur           224
Regression line with Regression Equation




  The regression equation of ‘Y’ on ‘X’ is expressed as follows:
  Here, ‘a’ is interceptor & ‘b’ is slope                        Yc = a + bX
Regression Lines

Régression line of Y on X is Y = a + bX   ----(1)
Régression line of X on Y is X = a + bY   ----(2)

  Here- Y = one variable
           X = other variable
           a = interceptor of X line on Y line
     b = slope of X line on Y line Regression



 12/08/2012            Dr. Kusum Gaur               226
Regression – Equations
   Regression Equation of X on Y

                 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

                   SD of series X                 ∑(X-X)(Y –Y)

 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                                 =
12/08/2012
                   SD of series Kusum Gaur
                              Dr.
                                  X              ∑(Y – Y)2       228
Relation of correlation and
                 Regression




Co-rrelation (r) = √ bxy byx




12/08/2012          Dr. Kusum Gaur     229
Between
              Tests/Procedure/Therapy
For comparison with Gold Standard:
  Sensitivity
  Specificity
  PPV
  NPV
  ROC

For agreement of association: Kappa
For appropriate cut of value for diagnostic test: ROC

 12/08/2012             Dr. Kusum Gaur             230
Sensitivity and Specificity
                                         Status based on gold standard test

                                     Diseased                    Normal

                  Test positive        True positive          False positive
Observation in                                a                     b
new test          Test negative        False negative         True negative
                                              c                     d


         Sensitivity = a /(a+c)                      PPV = a /(a+b)

          Specificity = d /(b+d)                      NPV = d /(c+d)


 12/08/2012                       Dr. Kusum Gaur                               231
‘ROC’ Curve
Kappa Statistics
     (Measurement of Agreement)
              Test Value                    Inference
0.93 – 1                      Excellent Agreement
0.81 – 0.92                   Very Good Agreement
0.61 – 0.80                   Good Agreement
0.41 – 0.60                   Fair Agreement
0.21 – 0.40                   Slight Agreement
0.01 – 0.20                   Poor Agreement
< 0.01                        No Agreement
 12/08/2012                Dr. Kusum Gaur               233
Non-Parametric Tests
 Advantages
 Distribution free
 Easier to do
 Easier to understand/infer

 Disadvantages
 They ignore certain amount of information
 Indicated only ordinal or nominal data
 Statistically Less efficient
 Indicated only to test hypothesis, not for
  estimates

12/08/2012            Dr. Kusum Gaur           234
Parametric Test Vs Non-Parametric
Test Quality              Parametric           Non-Parametric

 Assumed Distribution           Normal                   Any

    Assumed Variance        Homogenous                   Any

             Data Type    Interval-Continous    Nominal /Ordinal

 Data set Relationship      Independent                  Any

 Usual Centre Measure             Mean                 Median

                           More conclusions       Easier to calculate
             Advantages
                             More efficient    Less affected by outliers


12/08/2012                    Dr. Kusum Gaur                            235
Parametric Test Vs Non-Parametric
Test                          Parametric                   Non-Parametric
    Correlation test                  Pearson                     Spearman
   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
Repeated measures,             One-way, repeated
                                                               Friedman's test
  >2 conditions                measures ANOVA

    Sign Test (K Test)– nonparametric test for quantitative paired data
12/08/2012                            Dr. Kusum Gaur                             236
Sign test

• Simplest
• Based on direction(- /+/0)
• Signs as per the direction are counted

• Inference – if S≤K = Null hypothesis (H₀) is
  rejected
• Here „S‟ is net sum of signs as per sign
• „K‟ is constant


12/08/2012           Dr. Kusum Gaur              237
Sign test – Steps
Sign K Test for Small Sample (<30)
   – Find out net sum of signs as per sign(S)
   – S = (total + signs) – (total – signs)
   – K = (n-1)/2 - 0.98√n
• Inference – if S≤K = Null hypothesis (H₀) is rejected


Sign Z Test for Large Sample (>30)
     – Find out no of ties with less frequent sign(X)
     – Z = (X – np) / √ np (1-p) here X= no. + Sign
• Inference – if Z>2 = Null hypothesis is rejected


12/08/2012                   Dr. Kusum Gaur               238
12/08/2012   Dr. Kusum Gaur   239
12/08/2012   Dr. Kusum Gaur   240
12/08/2012   Dr. Kusum Gaur   241
12/08/2012   Dr. Kusum Gaur   242
12/08/2012   Dr. Kusum Gaur   243
Step-7




             Inferences




12/08/2012      Dr. Kusum Gaur   244
Steps in Statistical Inference

Generating NULL and ALTERNATIVE
 hypothesis
Testing the hypothesis using appropriate
 statistical tests
Obtaining „p‟ value
Concluding from the p value.
Obtaining Level of Significance
Comparing „p‟ value with CI.


 12/08/2012          Dr. Kusum Gaur         245
‘P’ Value and Inferences
                 with Normal Curve




12/08/2012            Dr. Kusum Gaur    246
Rejection Zone          Acceptance Zone            Rejection Zone
Mean 1SD =68% values - Confidence Limit 68% - P Value = >0.05 - NS
     Mean 2SD =95% values - Confidence Limit 95% - P Value = 0.05 - S
    Mean 3SD =99% values - Confidence Limit 99% - P Value = 0.001 - HS
Rejection Zone    Acceptance Zone            Rejection Zone

Mean 1SD =68% values - Confidence Limit 68% - P Value =/>0.05 - NS
 Mean 2SD =95% values - Confidence Limit 95% - P Value < 0.05 – S
Mean 3SD =99% values - Confidence Limit 99% P Value < 0.001 - HS
  12/08/2012                 Dr. Kusum Gaur                    248
Conventionally Accepted
          Significance Level


 P Value > 0.05    LS=Not Significant

 P Value < 0.05    LS=Significant

 P Value < 0.001   LS=Highly Significant
Step-8




             Reporting




12/08/2012     Dr. Kusum Gaur   250
Steps of Report Writing

      Title of Project
      Abstract
      Introduction
      Aims & Objectives
      Methodology
      Observations-Compilation, Classification &
      Presentation of data with analysis and inferences
      Discussion
      Conclusions
      Recommendations
      Limitations
      Acknowledgment
      Bibliography

12/08/2012                    Dr. Kusum Gaur              251
Discussion

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


12/08/2012         Dr. Kusum Gaur          252
Recommendations & conclusions


•   Based on our findings
•   Limited to objectives of the study
•   Policy implications
•   Relevance should be emphasized
•   Should be exclusively limited to
    observations



12/08/2012             Dr. Kusum Gaur    253
Managerial and financial aspects

Protocol development
Time line/Gantt chart
Peer review
Development of tools
Training in data collection
Budget/ financial accounting
Quality control
Monitoring & Evaluation

12/08/2012         Dr. Kusum Gaur      254
Time Line/Gant chart/log Fram
Activities       1.1.12-   16.1-   1.2.12-   1.3.12-   16.5.12-   16.6.12-   16.7.12-
                 15.1.12   31.1    15.2.12   15.5.12   15.6.12    15.7.12    31.7.12


Planning
Officials
Que. Dev
Training
Poilet Survey
Corrections
Re-training
Resource Proc

Survey
Analysis
Report Writing
Dissemination
of Report
Computer in Statistics


12/08/2012            Dr. Kusum Gaur   256
Web sites related to 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




12/08/2012       Dr. Kusum Gaur                     259

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Research methodology & Biostatistics

  • 1. RESEARCH METHODOLOGY & BIOSTATISTICS * Few jewels from ocean Dr. Kusum Gaur Professor, PSM WHO Fellow IEC
  • 2. Definition of Research “Research is a systematized effort to gain new knowledge”. 12/08/2012 Dr. Kusum Gaur 2
  • 3. Steps in Research (Holy 11) 1. Collect review of literature/Situation Analysis 2. Identify and prioritize health problems 3. Decide aims & objectives 4. Planning Methodology 5. Execution 6. Compilation, Classification & Presentation of data 7. Analysis 8. Test of Significance/Test of Hypothesis 9. Inferences 10. Report Writing 11. Dissemination of Report 12/08/2012 Dr. Kusum Gaur 3
  • 4. Process of Concluding 8 7 6 Reporting Inferences Analysis Data Collection 5 Execution Execution Research Problem Define 1 for Pretest Collection Data Review of Literature Methodology 4 2 3 Planning 12/08/2012 Dr. Kusum Gaur 4
  • 5. STEP-1 DEFINITION OF THE RESEARCH PROBLEM 12/08/2012 Dr. Kusum Gaur 5
  • 6. RESEARCH PROBLEM ? Research Problem refers to some difficulty which a researcher experiences and wants to obtain a solution for the same. i.e. a question or issue to be examined. 12/08/2012 Dr. Kusum Gaur 6
  • 7. Process of Defining Problem Analysis of the Situation Identify & Prioritize Problems Select & Define Problem Statement of Research Objectives 12/08/2012 Dr. Kusum Gaur 7
  • 8. CRITERIA OF SELECTION The selection of one appropriate researchable problem out of the identified problems requires evaluation of certain criteria. * Internal / Personal criteria – Researcher‟s side * External Criteria – Problem side factors 12/08/2012 Dr. Kusum Gaur 8
  • 9. INTERNAL CRITERIA OF SELECTION  Researcher‟s Interest,  Researcher‟s Competence,  Researcher‟s own Resource:  Human Resource  Money  Material  Time 12/08/2012 Dr. Kusum Gaur 9
  • 10. EXTERNAL CRITERIA OF SELECTION  Researchability of the problem,  Importance and Urgency,  Novelty of the Problem,  Feasibility,  Facilities,  Social Relevance  Public health Importance 12/08/2012 Dr. Kusum Gaur 10
  • 11. DEFINE RESEARCH PROBLEM (Title of the Research Topic)  Transforming the selected research problem into a scientifically researchable statement.  Problem definition or Problem statement should be clear, precise, self-explanatory and include:-  What  How  When  Where 12/08/2012 Dr. Kusum Gaur 11
  • 12. RESEARCH OBJECTIVES (Objectives)  Research Objectives are the statement of the questions that is to be investigated with the goal of answering the overall research problem.  Research Objectives should be clear and achievable.  Generally, they are written as statements, using the word “to” (For example, „to discover …‟, „to determine …‟, „to establish …‟, „to find out -----‟, „to assess -----‟etc. )  Objectives should infer in the end of the study 12/08/2012 Dr. Kusum Gaur 12
  • 13. Hypothetical Research Question  Problem: PCR of Diabetes Mellitus is increasing very fast during last five year  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
  • 14. Association of Garlic consumption with coronary Artery Diseases Aim: To Study the association of Meditation with Diabetes Mellitus in patients attending at Medical OPD of SMS Hospital, Jaipur (Raj) India. Objectives: 1. To assess and compare the proportion of DM cases in individuals doing regular meditation and not doing meditation. 2. To find out the risk ratio of DM in individuals not doing meditation on doing regular meditation.
  • 15. STEP-2 REVIEW OF LITERATURE 12/08/2012 Dr. Kusum Gaur 15
  • 16. Review of literature What ? Why ? Where ? 12/08/2012 Dr. Kusum Gaur 16
  • 17. What ? REVIEW OF LITERATURE Literature Review is the documentation of a published and unpublished work from secondary sources of data in the areas of specific interest to the researcher. 12/08/2012 Dr. Kusum Gaur 17
  • 18. Why ? - PURPOSE OF REVIEW  Tofind out already investigated problems and those that need further investigation.  To formulate researchable hypothesis.  To gain a background knowledge  To identify data sources  To learn how others structured their reports. 12/08/2012 Dr. Kusum Gaur 18
  • 19. Where ? SOURCES OF LITERATURE  Books and Journals  Databases Bibliographic Databases Abstract Databases Full-Text Databases  Govt. and NGO Records & Reports  Internet  On line journals: ww.articalbase.com …….  E. Databases – Popline, Medline …….  Research Dissertations / Thesis 12/08/2012 Dr. Kusum Gaur 19
  • 21. Methodology  Study Area : Location of study - Hospital, community etc.  Study Period: Start to end of Study (maximum period available for study should be defined)  *Selection of Study Design  * Selection of Study Population  Pre-requisits of study: Study Tools, Terminologies, Orientation trainings etc. *will be taken separately 12/08/2012 Dr. Kusum Gaur 21
  • 22. Methodology…… • Study Tools for data collection: subjects, proforma, examination, measurements, lab investigations • Planning  Data collection, compilation, data entry  Data cleaning  Analysis plan: • Confidentiality • Ethical clearance: Consent from  Institutional Review Board  Observational units 12/08/2012 Dr. Kusum Gaur 22
  • 23. Study Design A study design is a specific plan or protocol for conducting the study, which allows the investigator to translate the conceptual hypothesis into an operational one. 12/08/2012 Dr. Kusum Gaur 23
  • 24. Direction of Study Backward Forward Cross -sectional Retrospective Prospective 3 4. Ambidirectional 12/08/2012 Dr. Kusum Gaur 24
  • 25. Decision Tree Intervention Done No Yes Observational Study Experimental Study Comparison Group Randomization 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 12/08/2012 Dr. Kusum Gaur 25
  • 26. Epidemiological Study Design Observational Studies  Descriptive Studies Analytic Cross-Sectional Case-Control Cohort Experimental / Interventional studies As per Control: RCT/NRCT As per Blinding: Single /Double Blind As per Design: Simple/Cross-over As per Area: Field/Clinical/Lab 12/08/2012 Dr. Kusum Gaur 26
  • 27. Descriptive Studies • Case reports • Case series • Population studies 12/08/2012 Dr. Kusum Gaur 27
  • 28. Descriptive Studies: Uses • Hypothesis generating • Suggesting associations 12/08/2012 Dr. Kusum Gaur 28
  • 29. Descriptive Type of Observational Study • Other Name Case-Series/Population • Unit of Study Case/Individuals • Study Question What is happening  • Direction Of Inquiry • Study Design desired information about cases/individuals is collected 12/08/2012 Dr. Kusum Gaur 29
  • 30. Case-Series ……. 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
  • 31. Analytical Observational Studies • Cross-sectional • Case-control • Cohort 12/08/2012 Dr. Kusum Gaur 31
  • 32. Cross-sectional Study • Data collected at a single point in time • Describes associations • Prevalence A “Snapshot” 12/08/2012 Dr. Kusum Gaur 32
  • 33. Cross-Sectional Study • Other Name Prevalence Study • Unit of Study Individual • Study Question What is happening  • Direction of Inquiry • Study Design Exposed to Factor Not  Exposed Diseased to Factor Population Exposed to  Factor Non- Disease Not Exposed to 12/08/2012 Dr. Kusum Gaur Factor 33
  • 34. Objectives of a Cross-Sectional Study To find out association 12/08/2012 Dr. Kusum Gaur 34
  • 35. Cross-sectional Study Sample of Population Defined Population Regular Not doing meditation Meditation Prevalence of Prevalence of DM DM Time Frame = Present 12/08/2012 Dr. Kusum Gaur 35
  • 36. Cross-sectional Study E.G. Out of 1000 population if 100 were doing meditation regularly & out of that only 2 were having DM. Remaining 900 were not doing meditation at all, out of that 220 were having DM. + DM - 2 98 Meditation + - 220 680 12/08/2012 Dr. Kusum Gaur 36
  • 37. Cross-Sectional Study • Strengths – Quick – Cheap • Weaknesses – Cannot establish cause-effect 09/03/2010 Dr. Kusum Gaur 37
  • 38. Case-Control Studies  Start with people who have disease(Cases)  Match them with controls that do not have disease (Match Confounding)  Look back and assess exposures 12/08/2012 Dr. Kusum Gaur 38
  • 39. Controls A control is a standard of comparison (confounded with variability but without effect) for • Effects • Variability 12/08/2012 Dr. Kusum Gaur 39
  • 40. Case-Control Study • Other Name Retrospective Study • Unit of Study Cases/Control • Study Question What has happened  • Direction of Inquiry= F O • Study Design Exposed  Cases Not Exposed Exposed Control Not Exposed 12/08/2012 Dr. Kusum Gaur 40
  • 41. Objective of a Case-Control Study To find out association To assess Risk Ratio 12/08/2012 Dr. Kusum Gaur 41
  • 42. 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
  • 43. The logic of Case-Control Studies Cases differ from controls only in having the disease If exposure does not predispose to having the disease, then exposure should be equally distributed between the cases and controls.  The extent of greater previous exposure among the cases reflects the increased risk that exposure confers 12/08/2012 Dr. Kusum Gaur 43
  • 44. Case-Control Studies: Strengths • Good for rare outcomes: cancer • Can examine relation of exposures to disease • Useful to generate hypothesis • Fast • Cheap • Provides Odds Ratio 09/03/2010 Dr. Kusum Gaur 44
  • 45. Case-Control Studies: Weaknesses • Cannot measure – Incidence – Prevalence – Relative Risk • Can only study one outcome • High susceptibility to bias 09/03/2010 Dr. Kusum Gaur 45
  • 46. Cohort Study • Begin with disease-free individuals • Classify patients as exposed/unexposed • Record outcomes in both groups • Compare outcomes using relative risk 12/08/2012 Dr. Kusum Gaur 46
  • 47. Cohort Study • Other Name Prospective Study / Follow-up Study/Incidence Study • Unit of Study Individual • Study Question What is happening  • Direction of Inquiry F O • Study Design Diseased • Exposed to Not Non Factor Diseased Cohort Cohort Diseased Not Exposed to Factor Non-Diseased 12/08/2012 Dr. Kusum Gaur 47
  • 48. Logic of Cohort Study Cohort is a group of persons sharing a common characteristics Differences in the rate at which exposed and control subjects contract a disease is due to the differences in exposure, since others are known and similar. 12/08/2012 Dr. Kusum Gaur 48
  • 49. Cohort Study  Prospective (usually)  Controlled  Can determine causes and incidence of diseases as well as identify risk factors  Generally expensive, time consuming and difficult to carry out 12/08/2012 Dr. Kusum Gaur 49
  • 50. Steps for Cohort Study  Identify geographically defined group  Identify exposed subjects and not exposed subjects  Follow over a specific time  Record the fraction in each group who develop the condition of interest  Compare these fractions using RR, AR or OR 12/08/2012 Dr. Kusum Gaur 50
  • 51. Objectives of a Cohort Study  To find out association  To assess Risk Ratio  To find out Relative Risk  To find out Attributed Risk 12/08/2012 Dr. Kusum Gaur 51
  • 52. Prospective Cohort Study DM No Meditation No DM Cohort DM Regular Meditation No DM Present Future 12/08/2012 Dr. Kusum Gaur 52
  • 53. Cohort Study: Strengths • Can measure multiple outcomes • Can adjust for confounding variables • Can calculate Attributed Risk 09/03/2010 Dr. Kusum Gaur 53
  • 54. Cohort Study: Weaknesses • Expensive • Time consuming • Cannot study rare outcomes • Confounding variables 09/03/2010 Dr. Kusum Gaur 54
  • 55. Measurements of association Cohort Study Case Control Study •Significance Test •Significance Test •Relative Risk •OR •Attributable Risk •OR 12/08/2012 Dr. Kusum Gaur 55
  • 56. Measures of Association Significance Test – to test significance of difference in exposure between control and Cases Odds ratio - ratio of the odds of contracting disease in given exposure Relative Risk – Ratio between incidence among exposed and incidence among non- exposed Attributed Risk – percentage of difference between incidence among exposed and non- exposed with incidence among exposed RR or OR of 1 indicate no effect of exposure (equal odds) 12/08/2012 Dr. Kusum Gaur 56
  • 57. ‘Z’ Score of Exposure Rates 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
  • 58. ad ODD‟s Ratio = Times bc Incidence among Exposed RR = Times Incidence among Non-Exposed a/a+b a (c+d) = = c/c+d c (a+b) 09/03/2010 Dr. Kusum Gaur 58
  • 59. Attributed Risk (Incidence among Exposed - Incidence among Non-Exposed) 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
  • 60. Experimental Studies Clinical trials provide the “gold standard” of determining the relationship between factor and the event 12/08/2012 Dr. Kusum Gaur 60
  • 61. Types of Experimental Study As per Randomization: • Randomized Control Trials (RCT) • Concurrent Parallel Design (RCT) • Sequential RCT Design • RCT with External Control • Non – Randomized Trials (NRCT) 12/08/2012 Dr. Kusum Gaur 61
  • 62. Types of Experimental Study…. As per Design: • Simple • Cross-Over Study Design As per Study Area: • Field Trials • Clinical Trials • Lab. Trials 12/08/2012 Dr. Kusum Gaur 62
  • 63. Quality of Experimental Study • Randomization • Blinding • Control • Cross-Over 12/08/2012 Dr. Kusum Gaur 63
  • 64. Controls in Clinical Trials A clinical trial is a comparative, prospective experiment conducted in human subjects • Historical controls are better than no controls • Patients can serve as own controls - This is usually beneficial as the comparison removes patient differences 12/08/2012 Dr. Kusum Gaur 64
  • 65. Blinding Good practice: factors that can affect the evaluation of outcome should not be permitted to influence the evaluation process 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 12/08/2012 Dr. Kusum Gaur 65
  • 66. Randomized Control Trials (RCT) • Before and After Comparison • Comparison with Placebo • Comparison Of two medicine/procedure/tests • Comparison Of > two medicine/procedure/tests 12/08/2012 Dr. Kusum Gaur 66
  • 67. Experimental Study • Other Name Intervention Study • Objective To know the effect of intervention • Unit of Study Individual meeting entry criteria • Study Question What is happening after intervention in both groups  • Direction of Inquiry I E • Study Design 1(Intervention with Placebo) Positive Outcome Group 1/cases Intervention Negative Outcome Positive Outcome Group Placebo 2/control Negative Outcome 12/08/2012 Dr. Kusum Gaur 67
  • 68. Clinical Trial R Treatment a Outcomes Group n d Study o Population m i z Outcomes e Control Group 12/08/2012 Dr. Kusum Gaur 68
  • 69. Intervention Study - Design 2 (Comparison of Effect of Two Interventions) Cases Meeting Entry criteria Group - 1 Group -2 Intervention -1 Intervention Intervention - 2 Positive Negative Positive Outcome Negative Outcome Outcome Outcome 12/08/2012 Dr. Kusum Gaur 69
  • 70. Cross Over Design Group -1 Cases Group-2 Meeting Entry criteria Intervention - 2 Intervention - 1 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 12/08/2012 Dr. Kusum Gaur 70
  • 71. Other Types of Experimental Study • Quincy Experimental Study • Block Experimental Study 12/08/2012 Dr. Kusum Gaur 71
  • 72. Quincy Experimental Study Cases Meeting Entry criteria Group - 1 Group -2 Intervention Intervention No Intervention Positive Negative Positive Outcome Negative Outcome Outcome Outcome 12/08/2012 Dr. Kusum Gaur 72
  • 73. Block Experimental Study 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 12/08/2012 Dr. Kusum Gaur 73
  • 74. Steps of Experimental Study Drawing up a Protocol Reference Population Sample Population Exclusions Randomization Experimental Group Control Group Manipulation/Intervention Follow - up 12/08/2012 Assessment of Outcome Dr. Kusum Gaur 74
  • 75. Ideal Study Design for established causality Ethical Issues
  • 76. STUDY QUESTIONS AND APPROPRIATE DESIGNS Type of Question Appropriate Study Design Burden of illness Field Surveys - Prevalence Cross Sectional Survey - Incidence Longitudinal survey Causation, Risk & Prognosis Case Control Study, Cohort study, RCT Treatment Efficacy Randomized Controlled study Diagnostic Test Evaluation Randomized Controlled study Cost Effectiveness Randomized Controlled study 12/08/2012 Dr. Kusum Gaur 76
  • 77. Hierarchy of Epidemiological Study Design Establish Causality RCT Cohort Case Control Cross-Sectional Case Series Generate Hypothesis Case Report 12/08/2012 Dr. Kusum Gaur 77
  • 78. Methodology  Study Area : Location of study - Hospital, community etc.  Study Period: Start to end of Study (maximum period available for study should be defined)  *Selection of Study Design  * Selection of Study Population Sample Size Sampling Technique  Pre-requisits of study: Study Tools, Terminologies, Orientation trainings etc. 12/08/2012 Dr. Kusum Gaur 78
  • 79. Selection of study population Whole Population Sample Population 12/08/2012 Dr. Kusum Gaur 79
  • 80. What is Sample ? • A sample is a small representative segment of a population • Inferences drawn from a sample are expected to be applicable for the source population 12/08/2012 Dr. Kusum Gaur 80
  • 81. Why do we need a sample? To get inferences applicable to universe with minimum resources 12/08/2012 Dr. Kusum Gaur 81
  • 82. Sample – Qualities Sample is a part of population but it is true representative of whole. Qualities Adequate size Appropriate sampling technique 12/08/2012 Dr. Kusum Gaur 82
  • 83. Factors on which SAMPLE SIZE depend: • 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 12/08/2012 Dr. Kusum Gaur 83
  • 84. Power: Ability to detect right answer Alpha Error: Chance to miss right answer
  • 85. Type of Data & level of Measurements Qualitative – Counted Facts – Nominal Data Measured as Numbers expressed as proportions Quantitative- Measured Facts - Numerical Data Measured as quantity & expressed as Mean SD *Ordinal Data – Rank Order Data Measured as rank & expressed as Median Percentile 12/08/2012 Dr. Kusum Gaur 91
  • 86. Sample size for Qualitative data 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 09/03/2010 Dr. Kusum Gaur 92
  • 87. Sample size for Quantitative data Z 2 SD 2 4 SD 2 Sample Size= ------------------- -- =---------------------- L2 L2 SD= Standard Deviation L = allowable error Z= 1.96 ≈ 2 for 95% CL For Descriptive Studies only 09/03/2010 Dr. Kusum Gaur 94
  • 88. Finite Correction Sample Size – Finite Population (where the population is less than 50,000) SS New SS = _________________ ( 1 + ( SS – 1 ))Pop
  • 89. How many controls? n k Here n0=No. of cases & 2n0  n n = expected no. of cases • k = 13 / (2*11 – 13) = 13 / 9 = 1.44 • kn0 = 1.44*11 ≈ 16 controls (and 11 cases) – Same precision as 13 controls and 13 cases
  • 90. Sampling Design factors of sample size Variance of Specified Sampling Design Effect = Variance of Simple Random Sampling 12/08/2012 Dr. Kusum Gaur 97
  • 91. Sampling Technique effect on Sample Size Sampling Technique Design Effect Size Multiplier Simple Random Sampling 1 Systemic Random Sampling 1.2 Stratified Random Sampling 0.8 Cluster Random Sampling 2 12/08/2012 Dr. Kusum Gaur 98
  • 92. Conventionally accepted Researcher’s Estimations Alpha Error 0.05 Power 80% Confidence Limit 95% 12/08/2012 Dr. Kusum Gaur 99
  • 93. Key Concepts: Sample size • Sampling Design - larger sample for Custer • Desired Power – more power for larger sample • Allowable error – smaller error for larger sample • Heterogeneity leads to have larger sample to cover diversities • Nature of Analysis – Complex multivariate needs larger sample 12/08/2012 Dr. Kusum Gaur 100
  • 94. Steps -Sample Size Estimation • Stage 1- * Base Sample Size Calculation (n) • Stage 2 – Sample Size with Design Effect (d) =n*d • Stage 3- Contingency Addition (e.g. 5%) SS Estimation for study population =(n*d)+5%of n *Use appropriate equation for sample size calculation http://stat.ubc.ca/~rollin/stats/ssize/ 12/08/2012 Dr. Kusum Gaur 101
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  • 97. E.G. Mean 1= 5, Mean 2 = 15 & SD = 14 inputting values
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  • 112. SAMPLING TECHNIQUES • PROBABILITY/RANDOM SAMPLING • NONPROBABILITY SAMPLING 12/08/2012 Dr. Kusum Gaur 119
  • 113. Random sampling Techniques Aim is to give equal chance to every observation unit to be selected for study in sample. (Any Observation unit should not have Zero Probability ) 12/08/2012 Dr. Kusum Gaur 120
  • 114. * Random Sampling Techniques Simple Random Technique Systemic Random Technique Stratified Random Technique Multiphase Random Technique Multistage Random Technique Cluster Random Technique 12/08/2012 Dr. Kusum Gaur 121
  • 115. Simple Random Technique • Lottery Method • Random Table Method 12/08/2012 Dr. Kusum Gaur 122
  • 116. 12/08/2012 Dr. Kusum Gaur 123
  • 117. Steps –Use of Random Table • Stage 1- Give number to each member of population • Stage 2 – Determine total population size (N) • Stage 3- Determine Sample size (S) • Stage 4 – Drop one finger on Random Table with eyes closed • Stage 5 – Drop one finger with eyes closed on direction to be chosen – Up/Down/Rt/Lt • Stage 6- Determine first number within 0 to N • Stage 7- * Determine other numbers till Sample size (S) * Once a number is chosen do not repeat it again 12/08/2012 Dr. Kusum Gaur 124
  • 118. Steps –Use of Random Table.. e.g. N=300, M=50 Random no. Selected no. (3 digits from 0-300) 49468 49699 14043 043 15013 013 12600 33122 122 94169 169 89916 74169 169 32007 007 www.evaluation wikiog/index/how_to_use_a_random_number_Table 12/08/2012 Dr. Kusum Gaur 125
  • 119. Systemic Random Technique The selection of sample follows a systematic interval of selection • Find serial interval (K) = total population/sample size • 1st observation through simple random sampling among 1to K. th • Next observation = (1st +K) Observation • Next observation = (2 nd +K)th Observation • -------------so on till No. of observations = Sample Size 12/08/2012 Dr. Kusum Gaur 126
  • 120. Systemic Random Technique Population N=100 (Given) 1 21 41 61 81 2 22 42 62 82 S=20 (Estimated) 3 23 43 63 83 K=N/S =100/20 =5 4 24 44 64 84 5 25 45 65 85 1st observation between 1 to 5 6 26 46 66 86 7 27 47 67 87 though SRS e.g. 3 8 28 48 68 88 Every 5th observation from 3rd 9 29 49 69 89 10 30 50 70 90 observation will be included in 11 31 51 71 91 sample population 12 32 52 72 92 13 33 53 73 93 So, sample population will be – 3rd 14 34 54 74 94 8th 13th 18th 23rd 28th 33rd 38th 15 35 55 75 95 16 36 56 76 96 43rd 48th 53rd 58th 63rd 68th 73rd 17 37 57 77 97 78th 83rd 88th 93rd and 98th 18 38 58 78 98 19 39 59 79 99 observation 20 40 60 80 100 12/08/2012 Dr. Kusum Gaur 127
  • 121. Stratified Random Technique Sample selection through Simple Random/Systemic Random Technique Sample Strata 1 Sample Strata 2 Sample Strata 3 12/08/2012 Dr. Kusum Gaur 128
  • 122. Multiphase Random Technique Specific test Screening Test S/S Population Probable cases Cases Suspected cases For study 12/08/2012 Dr. Kusum Gaur 129
  • 123. Multistage Random Technique Each stage Simple RT is used village district village village State 1 district Population village Study Of Population Nation village district village State 2 village district village 12/08/2012 Dr. Kusum Gaur 130
  • 124. Cluster Random Technique The unit of random selection is a cluster rather than individual • CI = Total population /30 (in 30 Cluster Technique) Cluster 1 Cluster 27 Cluster 2 Cluster 28 Population Study Of Population Nation Cluster 3 Cluster 29 Cluster 30 Cluster 4 Through Simple RT 12/08/2012 Dr. Kusum Gaur 131
  • 125. Stratified Vs Cluster Technique Stratified Technique Cluster Technique • Homogenous groups • Comparable groups of are made population are made • Randomly select (usually 30) sample from each • Randomly select group sample from each • To make it more truly group representative, take sample population • More chances of error proportion to size (PPS) than simple random • Less chances of error than simple random
  • 126. Non Probability Sampling • When random samples are not possible • Rare disease • Small population • Special population • Special Condition • Difficult to reach population 12/08/2012 Dr. Kusum Gaur 133
  • 127. Non-probability Samples Convenience  Purposive  Quota  Snow ball study 12/08/2012 Dr. Kusum Gaur 134
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  • 131. Snow ball sampling Contact tracing Initial respondent helps in recruiting new population Useful in network analysis approach 12/08/2012 Dr. Kusum Gaur 138
  • 132. Step-4 & 5 Data Collection and Data Management
  • 133. Sources of Data • Primary –Own generated data • Secondary –Already generated data Published Non-Published 12/08/2012 Dr. Kusum Gaur 140
  • 134. Primary Vs Secondary source of Data Primary data Secondary data • Need to be generated • Readily available • First hand information • Second hand information • Questionnaire • Not need of questionnaire • Purpose served • Purpose served ? • Analysis as per purpose • Require more time and • Descriptive money • Less expensive 12/08/2012 Dr. Kusum Gaur 141
  • 135. Type of Data Collection Methods Interview Personnel Telephonic Observation Experimental Interview and Observation Observation and Experimental Interview ,Observation and Experimental 12/08/2012 Dr. Kusum Gaur 142
  • 136. Forms of questions(Open Vs Closed) Open ended Close ended • Possible responses are • Categories are given not given. already coded • Mean, SD, Median • Proportion • For seeking opinions, • For eliciting factual attitudes ,perceptions information • Not so depth • Provides in depth info. • Investigator‟s bias • Experience of • Ease of answering, investigator and • Easy to analyse analyst required 12/08/2012 Dr. Kusum Gaur 143
  • 137. Considerations in formulating questionnaire (Questionnaire/Interview schedule)  Use simple and everyday language  Do not use ambiguous questions(?/?)  Do not ask leading questions  The order of questions:  Guideline for filling an instrument, pen-pencil Pre testing 12/08/2012 Dr. Kusum Gaur 144
  • 138. Validity of a Research Instrument Ability of an instrument to measure what it is designed to measure being measured Establish the logical link between the questions and objectives  Items/questions cover the full range of issue/attitude being measured 12/08/2012 Dr. Kusum Gaur 145
  • 139. 1.Decide the information required. Steps 2. Define the target respondents. 3. Method(s) of reaching target 4. Decide on question content. 5. Develop the question wording. 6. Put questions into a meaningful order. 7. Check the length of the questionnaire. 8. Pre-test the questionnaire. 9. Develop the final survey form 12/08/2012 Dr. Kusum Gaur 146
  • 140. Organization and Compilation of Data Organization and Compilation of Data in such a way (Master Chart ) to have reliable, relevant, adequate and reasonably complete data with following requisites – Simplicity Briefness Utility Distinctively Comparability Scientific Arrangement Attractive 12/08/2012 Effective Dr. Kusum Gaur 147
  • 142. Steps of Observations • Entry of Observations Unites • Master Chart • Tabulation • Diagrammatic Presentation 12/08/2012 Dr. Kusum Gaur 149
  • 160. Master Chart for Analysis
  • 161. Tabulation – Content of Table  Table No. Sequence in the text  Tile of Table –short, clear and self explanatory to say about for what the table is ?  Body of Table –consist of rows and columns  Rows – 1st row shows headings of columns  1st column shows headings of rows  rest of rows and columns are showing data as per required  number of rows and columns should be limited to maintained simplicity of table  source of data ( if it is other than the present study ) should be written just below the body of table  Source of Data ?  Foot Note - written just below the body of table, if there is any hidden information  Inferences –summary value of table 12/08/2012 Dr. Kusum Gaur 168
  • 162. Types of Tables 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 12/08/2012 Dr. Kusum Gaur 169
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  • 165. Diagrammatic Presentations Bar Qualitative Data Simple Histogram Multiple Frequency Polygon Component Cumulative Frequency Pie Polygon Line Scatter Diagram Pictogram Box and Whisker Spot Map Correlation Diagram Qualitative Data Quantitative Data 12/08/2012 Dr. Kusum Gaur 172
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  • 168. Simple Bar diagram 12% 4th Qtr 14% 3rd Qtr 12% 2nd Qtr 32% 1st Qtr 82% 0 1 2 3 4 5 6 7 8 9 12/08/2012 Dr. Kusum Gaur 175
  • 169. Multiple Bar diagram 60 50 40 (1) 1-5 Years 30 (2) 6-10 Years (3) 11 & Above Years 20 10 0 (1) Very Dissatisfied (2) Dissatisfied (3) neither satisfied (4) Satisfied (5) Very Satisfied nor dissatisfied 12/08/2012 Dr. Kusum Gaur 176
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  • 171. Pie diagram Propotion of Pie = (Proportion of that variable )(360)Degree 12% 14% 1st Qtr 2nd Qtr 82% 3rd Qtr 4th Qtr 32% 12/08/2012 Dr. Kusum Gaur 178
  • 172. Line diagram 7 6 5 4 Series 2 3 Series 1 2 1 0 2000 2001 2002 2003 2004 2005 12/08/2012 Dr. Kusum Gaur 179
  • 173. Histogram ( Area Diagramme) 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 12/08/2012 Dr. Kusum Gaur 180
  • 174. Scatter Diagram 30 25 20 Duration of Diabetes 15 Duration of diabetes in yrs. Linear (Duration of diabetes in yrs.) 10 5 0 0 50 100 150 200 250 300 No. of Patients 12/08/2012 Dr. Kusum Gaur 181
  • 175. Radar diagram 5/1/2002 40 30 20 9/1/2002 6/1/2002 10 Series 1 0 Series 2 8/1/2002 7/1/2002 12/08/2012 Dr. Kusum Gaur 182
  • 176. Box & Whisker 70 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 12/08/2012 Dr. Kusum Gaur 183
  • 178. Biostatistics = Biology + Statistics • Biostatistics is application of statistics in biology i.e. science of figure in medical science • Data: Set of information, facts or figures numerically coded and from which conclusions may be drawn is called data (singular-datum). • Statistics: The collection of methods used in planning an experiment and analyzing data in order to draw accurate conclusions.
  • 179. Type of Biostatistics • Descriptive statistics generally characterizes or describes a set of data elements • Inferential statistics tries to infer information about a population by using information gathered by sampling
  • 180. Descriptive Analysis Qualitative Data Rates Ratios Proportions Quantitative Data Central Tendencies  Disperson Mean Standard Deviation Mode Standard Error Median Confidencial Limit Skeweness 12/08/2012 Dr. Kusum Gaur 187
  • 181. Descriptive Analysis of Qualitative Data No. of total Events in a year (A) Rate = * 1000 MYP of that Region (T) No. of total (A) Ratio = No. of total (B) No. of Specific Events (A) Percentage of Events = * 100 Total Events (T) Event of Sp. Cause (A) Proportional Rate = * 10 n Total Deaths (T) 12/08/2012 Dr. Kusum Gaur 188
  • 182. Descriptive Analysis of Quantitative Data Mean = Mathematical Average ∑X N Mode = Most commonly occurring value Median = Center value when arrange in increasing N+1 or decreasing fashion 2 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 Skewness = Deviation of peak from median SK= 3 (Mean –Median)/SD 12/08/2012 Dr. Kusum Gaur 189
  • 183. SD from MS Excel
  • 184. SD from MS Excel…
  • 185. Appropriate choice of significance tests 12/08/2012 Dr. Kusum Gaur 192
  • 186. TEST OF SIGNIFICANCE OF QUALITATIVE DATA 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 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 12/08/2012 Dr. Kusum Gaur 193
  • 187. TEST OF SIGNIFICANCE OF QUANTITATIVE DATA 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 Large Sample Small Sample (>30) (<30) Small Sample Large Sample Large Sample Small Sample ‘Z’ Test ‘T’ Test ‘Z’ Test ANOVA ANOVA 12/08/2012 Dr. Kusum Gaur 194
  • 188. STUDY DESIGNS AND APPROPRIATE TEST Type Study Design Appropriate Significance Test 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
  • 189. STUDY DESIGNS AND APPROPRIATE TEST Type Study Design Appropriate Significance Test Randomized Controlled study Quantitative (before and after)- Paired ‘t’ Test Quantitative (before and after >1 followup)- Freidmen ANOVA Quantitative (between two Gps)- Unpaired ‘t’ Test Quantitative (between > two Gps)- ANOVA Test Randomized Controlled study Qualitative (before and after)- Mac Numer Test Qualitative (before and after >1 followup)- Cochron’s Test Qualitative (between two Gps)- ‘Z’ Score/Chi-square Test 12/08/2012 Qualitative (between > two Gps)- Chi-square Test Dr. Kusum Gaur 196
  • 190. STATISTICAL TEST OF SIGNIFICANCE Nominal Numerical Ordinal Two Groups ‘Z’ Score Test ‘Z’ test (n>30) Mann Whitny Chi-square Test T Test (n<30) > Two Groups Chi-square Test ANOVA Kruskal Wallis Paired Two Mec Numer Paired ANOVA Wilcoxon Sign Multiple Cohrane Repeated Friedman Observation in Multivarient ANOVA same individual Association of Contegency Correlation(Pearson) Spearman Two Variable Cofficient Regression Correlation
  • 191. STATISTICAL TEST OF SIGNIFICANCE Research Number and Number and Covariates Test Goal of Analysis Question type of DV type of IV Nominal 1 nominal chi square determine if difference between Group croups differences Continuous 1 dichotomous t-test Determine significance of 1 Categorical 1 one-way ANOVA mean group 1+ one-way differences 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/prediction relationship Correlation 2+ Continuous Multiple Linear combination to predict the Regression DV 1+ Continuous 2+ Continuous Path Analysis Estimate causal relations among variables 12/08/2012 Dr. Kusum Gaur 198
  • 192. Comparing difference between Two Sample Proportions „Z‟ Score Test P2 – P1 here, P1– proportion of that event in 1st Sample „Z‟ Score = P2 - proportion of that event in 2nd Sample SEDP SEDP – Standard Error of Difference in Proportion Q1 - proportion without that event in 1st Sample i.e. Q1 = 100 – P1 Q2 - proportion without that event in P1 Q 1 P 2 Q 2 2nd Sample i.e. 100 – P2 SEDP = ------- + -------- N1 - Sample Size of 1st Sample N1 N2 N2 - Sample Size of 2nd Sample 12/08/2012 Dr. Kusum Gaur 199
  • 193. Inference of ‘Z’ Score Test If „Z‟ > 2 = Difference is Significant If „Z‟ < 2 = Difference is Not Significant If „Z‟ > 3 = Difference is Highly Significant 12/08/2012 Dr. Kusum Gaur 200
  • 194. Comparing difference between >Two Sample Proportions Chi-Square Test Indications Qualitative data Normal distribution Comparing difference between Two Sample proportions Multiple Sample proportions 12/08/2012 Dr. Kusum Gaur 201
  • 195. Comparing difference between >Two Sample Proportions Chi-Square Test Chi Square(2) = ∑all cells(O-E)2 Tr x Tc E= E T (O1-E1)2 (O2-E2)2 (O3-E4)2 (On-En)2 Chi Squire = + + + ---+ E1 E2 E3 En Tr – Total of that Row here, O – Observed value of cell Tc – Total of that column E – Expected value of cell, T – Grand Total i.e. a+b+c+d considering Null Hypothesis Degree of Freedom (DF) = (C – 1) (R -1) R= No. of Rows, C = No. of Column 12/08/2012 Dr. Kusum Gaur 202
  • 196. Inference of Chi Square(x2) Chi Square(x2 ) value is seen at Degree of Freedom DF = (R – 1) (C – 1), from Chi Square((2) Table (here R=No. of Rows &C= No. of Column) at desired level of significance Inferences If Chi Square(x2 ) Test Value is – Higher than Table value = Difference in proportions is Significant at that desired level of significance. If Chi Square(x2 ) Test Value is – Lower than Table value = Difference in proportions is Not Significant at that desired level of significance. 12/08/2012 Dr. Kusum Gaur 203
  • 197. Comparing difference between Two Sample Means (>30) „Z‟ Test Pre-requisites Quantitative data  Homogenous normally distributed Random Sample Sample Size > 30 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 12/08/2012 Dr. Kusum Gaur 204
  • 198. Comparing difference between Two Sample Means (>30) „Z‟ Test X2 – X1 here, X1– Mean of that event in 1st Sample „Z‟ Test = X2 - Mean of that event in 2nd Sample SEDM SEDM – Standard Error of Difference in Means SD1 – Standard Error of 1st Sample SD2 – Standard Error of 2nd Sample N1 - Sample Size of 1st Sample SD2 1 SD2 2 N2 - Sample Size of 2nd Sample SEDM = ------- + -------- N1 N2 12/08/2012 Dr. Kusum Gaur 205
  • 199. Comparing difference between Two Sample Means (<30) „T‟ Test Prerequisites Random Sample Quantitative data Normally Distributed Sample Size < 30 12/08/2012 Dr. Kusum Gaur 206
  • 200. Type of ‘T’ Test as per design Unpaired / Paired for inference One Tail /Two tail 12/08/2012 Dr. Kusum Gaur 207
  • 201. Unpaired ‘T’ Test Design Population -1 Population -2 S-1 S-2 Mean --1 Unpaired ‘T’ test Mean --2 12/08/2012 Dr. Kusum Gaur 208
  • 202. Paired ‘T’ Test Design Intervention Population Sam Observations-1 Observations 2 ple- Mean --1 Mean --2 Paired ‘T’ test 12/08/2012 Dr. Kusum Gaur 209
  • 203. One Tail ‘T’ Test Acceptance Zone Rejection Zone One Tail – Results are aspect only in one direction
  • 204. Two Tail ‘T’ Test Rejection Zone Acceptance Zone Rejection Zone Two Tail – Results are aspect in both direction
  • 205. Comparing difference between Two Sample Means (<30) „T‟ Test X2 – X1 here, X1– Mean of that event in 1st Sample „T‟ Test = --------------- X2 - Mean of that event in 2nd Sample SEDM SEDM – Standard Error of Difference in Means SD1 – Standard Error of 1st Sample SD2 – Standard Error of 2nd Sample N1 - Sample Size of 1st Sample SD2 1 SD2 2 N2 - Sample Size of 2nd Sample SEDM = ------- + -------- N1 N2 Degree of Freedom (DF) = (N1 – 1) + (N2 -1) = N1 + N2 - 2 12/08/2012 Dr. Kusum Gaur 212
  • 206. Inference of ‘T’ Test Value „T‟ Test Value is matched at Degree of Freedom (DF) = N1 + N2 – 2 in the Table of “T” at desired level of significance. Inferences If „T‟ Test Value is – Higher than Table value = Difference in Means is Significant at that desired level of significance. If „T‟ Test Value is – Lower than Table value = Difference in Means is Not Significant at that desired level of significance. 12/08/2012 Dr. Kusum Gaur 213
  • 207. Comparing difference between >Two Sample Means ANALYSIS OF VARIENCE (ANOVA) TEST Pre-requisites Quantitative data  Homogenous normally distributed Random Sample Indications Comparing difference between more than Two Means 12/08/2012 Dr. Kusum Gaur 214
  • 208. Comparing difference between >Two Sample Means „ANOVA‟ Test MSOSI MSOS2 - Mean Sum Of Squares Within Classes ANOVA = ---------- = Total SOS – MSOSI MSOS2 T SOS = X2 – (X)2/N MSOSI – Mean Sum Of Squares Between Classes = SOSI / K-1 SOSI –Sum Of Squares Between Classes (Xa)2 (Xb)2 (Xc)2 (Xk)2 (X)2 = --------- + ----------- + ----------- + ….+ ____ __ - --------- Na Nb Nc Nk N At Degree of Freedom (DF) = ( K-1) Horizontal 12/08/2012 Dr. Kusum Gaur (N – K) Vertical 215
  • 209. Inference of ANOVA Find out Variance Ratio value at Degree of Freedom (DF) = ( K-1) Horizontal, (N – K) Vertical from the Variance Ratio Table at desired level of significance. Inferences If Test value is > Table value = Difference in Means is Significant at that desired level of significance. If Test value is < Table value = Difference in Means is Not Significant at that desired level of significance. 12/08/2012 Dr. Kusum Gaur 216
  • 210. CORRELATION Indications To find out relationship between variables 12/08/2012 Dr. Kusum Gaur 217
  • 211. Type & Degree of Correlation Correlation Inference Correlation (r) Inference +1 Perfect +ve -1 Perfect +ve Correlation Correlation > 0.95 About Perfect +ve > - 0.95 About Perfect +ve Correlation Correlation > 0.75 V. Good Correlation > - 0.75 V. Good Correlation 0.75 – 0.5 Moderate Correlation - 0.75 to – 0.5 Moderate Correlation 0.5 – 0.25 Fair Correlation - 0.5 to – 0.25 Fair Correlation 0.25 - 0 No Correlation < - 0.25 No Correlation 12/08/2012 Dr. Kusum Gaur 218
  • 212. Correlation CORRELATION Two Variables > Two Variables Un-Paired Data Paired Data Pearson‟s Spearman‟s Rank Order Multivariate Correlation Correlation Correlation 12/08/2012 Dr. Kusum Gaur 219
  • 213. Pearson’s 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} 12/08/2012 Dr. Kusum Gaur 220
  • 214. Pearson’s correlation ----- 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 12/08/2012 Dr. Kusum Gaur 221
  • 215. Spearman’s Rank Order Correlation 6∑D2 • Spearman‟s Rank (rs ) = 1 - N3 - N 12/08/2012 Dr. Kusum Gaur 222
  • 216. Significance Test for Correlation (r) Standard Error (SE) of rs = rs √ N-1 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 12/08/2012 Dr. Kusum Gaur 223
  • 217. REGRESSION Indication To find out causal relationship between variables REGRESSION COFFICIENT- It is a measure of change in one dependent variable (y) with one unit change in the other variable (x) 12/08/2012 Dr. Kusum Gaur 224
  • 218. Regression line with Regression Equation The regression equation of ‘Y’ on ‘X’ is expressed as follows: Here, ‘a’ is interceptor & ‘b’ is slope Yc = a + bX
  • 219. Regression Lines Régression line of Y on X is Y = a + bX ----(1) Régression line of X on Y is X = a + bY ----(2) Here- Y = one variable X = other variable a = interceptor of X line on Y line b = slope of X line on Y line Regression 12/08/2012 Dr. Kusum Gaur 226
  • 220. Regression – Equations Regression Equation of X on Y 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
  • 221. Regression – coefficients Regression Coefficient of X on Y SD of series X ∑(X-X)(Y –Y) 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 = 12/08/2012 SD of series Kusum Gaur Dr. X ∑(Y – Y)2 228
  • 222. Relation of correlation and Regression Co-rrelation (r) = √ bxy byx 12/08/2012 Dr. Kusum Gaur 229
  • 223. Between Tests/Procedure/Therapy For comparison with Gold Standard: Sensitivity Specificity PPV NPV ROC For agreement of association: Kappa For appropriate cut of value for diagnostic test: ROC 12/08/2012 Dr. Kusum Gaur 230
  • 224. Sensitivity and Specificity Status based on gold standard test Diseased Normal Test positive True positive False positive Observation in a b new test Test negative False negative True negative c d Sensitivity = a /(a+c) PPV = a /(a+b) Specificity = d /(b+d) NPV = d /(c+d) 12/08/2012 Dr. Kusum Gaur 231
  • 226. Kappa Statistics (Measurement of Agreement) Test Value Inference 0.93 – 1 Excellent Agreement 0.81 – 0.92 Very Good Agreement 0.61 – 0.80 Good Agreement 0.41 – 0.60 Fair Agreement 0.21 – 0.40 Slight Agreement 0.01 – 0.20 Poor Agreement < 0.01 No Agreement 12/08/2012 Dr. Kusum Gaur 233
  • 227. Non-Parametric Tests Advantages Distribution free Easier to do Easier to understand/infer Disadvantages They ignore certain amount of information Indicated only ordinal or nominal data Statistically Less efficient Indicated only to test hypothesis, not for estimates 12/08/2012 Dr. Kusum Gaur 234
  • 228. Parametric Test Vs Non-Parametric Test Quality Parametric Non-Parametric Assumed Distribution Normal Any Assumed Variance Homogenous Any Data Type Interval-Continous Nominal /Ordinal Data set Relationship Independent Any Usual Centre Measure Mean Median More conclusions Easier to calculate Advantages More efficient Less affected by outliers 12/08/2012 Dr. Kusum Gaur 235
  • 229. Parametric Test Vs Non-Parametric Test Parametric Non-Parametric Correlation test Pearson Spearman 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 Repeated measures, One-way, repeated Friedman's test >2 conditions measures ANOVA Sign Test (K Test)– nonparametric test for quantitative paired data 12/08/2012 Dr. Kusum Gaur 236
  • 230. Sign test • Simplest • Based on direction(- /+/0) • Signs as per the direction are counted • Inference – if S≤K = Null hypothesis (H₀) is rejected • Here „S‟ is net sum of signs as per sign • „K‟ is constant 12/08/2012 Dr. Kusum Gaur 237
  • 231. Sign test – Steps Sign K Test for Small Sample (<30) – Find out net sum of signs as per sign(S) – S = (total + signs) – (total – signs) – K = (n-1)/2 - 0.98√n • Inference – if S≤K = Null hypothesis (H₀) is rejected Sign Z Test for Large Sample (>30) – Find out no of ties with less frequent sign(X) – Z = (X – np) / √ np (1-p) here X= no. + Sign • Inference – if Z>2 = Null hypothesis is rejected 12/08/2012 Dr. Kusum Gaur 238
  • 232. 12/08/2012 Dr. Kusum Gaur 239
  • 233. 12/08/2012 Dr. Kusum Gaur 240
  • 234. 12/08/2012 Dr. Kusum Gaur 241
  • 235. 12/08/2012 Dr. Kusum Gaur 242
  • 236. 12/08/2012 Dr. Kusum Gaur 243
  • 237. Step-7 Inferences 12/08/2012 Dr. Kusum Gaur 244
  • 238. Steps in Statistical Inference Generating NULL and ALTERNATIVE hypothesis Testing the hypothesis using appropriate statistical tests Obtaining „p‟ value Concluding from the p value. Obtaining Level of Significance Comparing „p‟ value with CI. 12/08/2012 Dr. Kusum Gaur 245
  • 239. ‘P’ Value and Inferences with Normal Curve 12/08/2012 Dr. Kusum Gaur 246
  • 240. Rejection Zone Acceptance Zone Rejection Zone Mean 1SD =68% values - Confidence Limit 68% - P Value = >0.05 - NS Mean 2SD =95% values - Confidence Limit 95% - P Value = 0.05 - S Mean 3SD =99% values - Confidence Limit 99% - P Value = 0.001 - HS
  • 241. Rejection Zone Acceptance Zone Rejection Zone Mean 1SD =68% values - Confidence Limit 68% - P Value =/>0.05 - NS Mean 2SD =95% values - Confidence Limit 95% - P Value < 0.05 – S Mean 3SD =99% values - Confidence Limit 99% P Value < 0.001 - HS 12/08/2012 Dr. Kusum Gaur 248
  • 242. Conventionally Accepted Significance Level  P Value > 0.05 LS=Not Significant  P Value < 0.05 LS=Significant  P Value < 0.001 LS=Highly Significant
  • 243. Step-8 Reporting 12/08/2012 Dr. Kusum Gaur 250
  • 244. Steps of Report Writing Title of Project Abstract Introduction Aims & Objectives Methodology Observations-Compilation, Classification & Presentation of data with analysis and inferences Discussion Conclusions Recommendations Limitations Acknowledgment Bibliography 12/08/2012 Dr. Kusum Gaur 251
  • 245. Discussion 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 12/08/2012 Dr. Kusum Gaur 252
  • 246. Recommendations & conclusions • Based on our findings • Limited to objectives of the study • Policy implications • Relevance should be emphasized • Should be exclusively limited to observations 12/08/2012 Dr. Kusum Gaur 253
  • 247. Managerial and financial aspects Protocol development Time line/Gantt chart Peer review Development of tools Training in data collection Budget/ financial accounting Quality control Monitoring & Evaluation 12/08/2012 Dr. Kusum Gaur 254
  • 248. Time Line/Gant chart/log Fram Activities 1.1.12- 16.1- 1.2.12- 1.3.12- 16.5.12- 16.6.12- 16.7.12- 15.1.12 31.1 15.2.12 15.5.12 15.6.12 15.7.12 31.7.12 Planning Officials Que. Dev Training Poilet Survey Corrections Re-training Resource Proc Survey Analysis Report Writing Dissemination of Report
  • 249. Computer in Statistics 12/08/2012 Dr. Kusum Gaur 256
  • 250. Web sites related to 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
  • 251. Computer Softwares in Statistics • Microsoft Excel • SPSS • Epi info • Epi tab • Mini tab • Graph Pad • Primer • Medcal • …………….. 12/08/2012 Dr. Kusum Gaur 258
  • 252. Always there is room for improvement 12/08/2012 Dr. Kusum Gaur 259

Hinweis der Redaktion

  1. Snow ball study