Qualitative and Quantitative
Research Methods: Statistical
Software Based Training
Prof. (Dr.) Asir John Samuel, BSc (Psych), BPT, MPT, PhD (Physiotherapy)
Professor
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Maharishi Markandeshwar (Deemed-to-be University)
Accredited by NAAC with Grade A++
Mullana-Ambala, Haryana, India
NORMALIZING LIFE POST COVID 19
27th & 28th March 2022
Prof. Asir John Samuel, Professor, MMIPR 1
Prof. Asir John Samuel, Professor, MMIPR 2
Good Morning
Why do research?
• One might want to get degree
• One might want to become famous
• One might want to get rich
• One might want to get a free trip
• One might want to help patients
• One might want to discover something new
Asir John Samuel, Assoc. Prof, MMIPR
http://orcid.org/0000-0003-1747-0415
First research?
• Adam and eve
Asir John Samuel, Assoc. Prof, MMIPR
http://orcid.org/0000-0003-1747-0415
Asir John Samuel, Assoc. Prof, MMIPR
http://orcid.org/0000-0003-1747-0415
Prof. Asir John Samuel, Professor, MMIPR 6
Research Design
Prof. Asir John Samuel, Professor, MMIPR 7
Different research designs
Study designs
Observational
Descriptive
Case report Case series
Analytical
Cross-
sectional
study
Case control
study
Cohort
Experimental
RCT Non-RCT
Prof. Asir John Samuel, Professor, MMIPR 8
Research Designs by
Portney & Watkins
Describe
population
Descriptive
Research Find
Relationship
Exploratory
Research
Cause
and
Effect
Experimental
Research
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015
Prof. Asir John Samuel, Professor, MMIPR 9
10
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015. p.21
Prof. Asir John Samuel, Professor, MMIPR
Prof. Asir John Samuel, Professor, MMIPR 11
Descriptive research designs
• Developmental research
• Normative research
• Qualitative research
• Descriptive survey
• Case study
• Case series
Prof. Asir John Samuel, Professor, MMIPR 12
Descriptive research
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015. p.301
Prof. Asir John Samuel, Professor, MMIPR 13
Case report
• Studies describing the characteristics of a
single patient
• Collection of cases may be up to 4
Prof. Asir John Samuel, Professor, MMIPR 14
Purpose of case studies
• Understanding unusual patient conditions
• Providing examples of innovative or creative
therapies
• Generating and testing theory
• Providing future research directives
Prof. Asir John Samuel, Professor, MMIPR 15
Case report-merits
• Record unusual medical occurrences and can
give the first clues in identification of a new
disease or adverse effects of an exposure
• Only means of surveillance for rare clinical
events
• Serve to elucidate the mechanism of disease
and treatmentProf. Asir John Samuel, Professor, MMIPR 16
Case report-Demerits
• Cannot be used to test for the presence of
valid statistical association because it is based
on the experience of one person
Prof. Asir John Samuel, Professor, MMIPR 17
Case series
• Studies describing the characteristics of a
group of patients with similar diagnosis
• Collection of 5 & more cases
Prof. Asir John Samuel, Professor, MMIPR 18
Case series-merits
• Helps in formulating a useful hypothesis
regarding risk factors of disease or identifying
a new disease or outcome of new treatment
• Informative for very rare disease with few
established risk factors
• May suggest the emergence of a new disease
or epidemic
Prof. Asir John Samuel, Professor, MMIPR 19
Case series-Demerits
Cannot be used to test for the presence of valid
statistical association due to absence of a
comparison group
Prof. Asir John Samuel, Professor, MMIPR 20
Exploratory research designs
• Case-Control studies
• Cohort studies
• Cross-sectional studies
• Correlational research
• Methodological research reliability and validity
• Historical research
Prof. Asir John Samuel, Professor, MMIPR 21
Exploratory research
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015
Prof. Asir John Samuel, Professor, MMIPR 22
Exploratory research
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015
Prof. Asir John Samuel, Professor, MMIPR 23
Cross-sectional studies
• Single examination of a cross section of
population at one point of time
• Prevalence study
• Used to investigate non fatal diseases
• Both exposure and outcome (disease) are
determined simultaneously for each subject
• Provide information about the frequency or
characteristic of disease
Prof. Asir John Samuel, Professor, MMIPR 24
Cross-sectional studies-Merits
• Provide information about the frequency of an
attribute and potential risk factors
• Helps to generate a hypothesis
• Can give a good picture about the health care
needs of the population at the point of time
• Can be used to investigate multiple exposure and
multiple outcome
• Suitable for chronic cases
Prof. Asir John Samuel, Professor, MMIPR 25
Cross-sectional studies-Demerits
• Difficult to establish the time of sequence of
events
• They are not suitable to investigate rare diseases,
rare exposure or disease of short duration
• Being based on prevalent rather than incident
cases
• Limited value to investigate etiological
relationship Prof. Asir John Samuel, Professor, MMIPR 26
Case control study
• Type of analytical study
• By observation and analysis
• Retrospective evaluation to determine who
was exposed and who was not exposed –
retrospective study
Prof. Asir John Samuel, Professor, MMIPR 27
Case control study
• To examine the possible relation of an
exposure to certain disease
- Identify the individual having the disease –
case
- Individual don’t have the disease –
comparison purpose
Prof. Asir John Samuel, Professor, MMIPR 28
Case control study
Factor (s)
Present individuals with disease
TIME
Direction of enquiry
Absent individuals w/o disease
Prof. Asir John Samuel, Professor, MMIPR 29
Case control study
4 basic steps in conducting a case control study,
1. Selection of cases and controls
2. Matching
3. Measurement of exposure
4. Analysis and interpretation
Prof. Asir John Samuel, Professor, MMIPR 30
Case control study – Merits
• Quick, less expensive
• Well suited for disease with long latent period
• Optimal for evaluation of rare diseases
• Can study etiological factors for a single
disease
• Requires small sample than a cohort study
• No attrition (drop outs) problem
• Ethical problems are minimal, no risk to
subjects
Prof. Asir John Samuel, Professor, MMIPR 31
Case control study- Demerits
• More prone to bias
• Selection of appropriate control group may be
difficult
• Inefficient for evaluation of rare exposure
• Cannot directly measure incidence, can only
estimate relative risk
Prof. Asir John Samuel, Professor, MMIPR 32
Cohort study
• Forward looking study
• Prospective study
• Incidence study
• Longitudinal study
• There is regular follow up over a period of
time
Prof. Asir John Samuel, Professor, MMIPR 33
Cohort study
Factor (s)
Individuals exposed Present
TIME
Direction of enquiry
individuals unexposed Absent
Prof. Asir John Samuel, Professor, MMIPR 34
Cohort study
• Proceeds from cause to effect
• Exposure has occurred when the study is
initiated, but the disease has not occurred
Prof. Asir John Samuel, Professor, MMIPR 35
Cohort
• A group of people who share a common
characteristic or experience within a defined
time period
• Cohort must be free from disease under study
• Both groups (study cohort & control cohort)
should be equally susceptible for the disease
under study
• Should be comparable in all possible variables
Prof. Asir John Samuel, Professor, MMIPR 36
Cohort study
• Elements of a cohort study,
1. Selection of study subjects
2. Obtaining data on exposure
3. Selection of comparison group
4. Follow-up
5. Analysis
Prof. Asir John Samuel, Professor, MMIPR 37
Cohort study - Merits
• Incidence can be calculated
• Examines multiple effects of a single exposure
• Provides direct estimate of relative risk
• Minimizes bias
• Dose-response ratios can be calculated
• Elucidates temporal relationship b/w exposure
& disease Prof. Asir John Samuel, Professor, MMIPR 38
Cohort study - Demerits
• Inefficient for rare diseases
• Expensive and time consuming
• Involves large sample size
• Alters people behaviour
• Changes in standard methods or diagnostic
criteria of disease over prolonged follow-up
Prof. Asir John Samuel, Professor, MMIPR 39
Exploratory research
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015
Prof. Asir John Samuel, Professor, MMIPR 40
RCT
• Basic steps in conducting a RCT,
1. Drawing up a protocol
2. Selecting reference & exp. Group
3. Randomization
4. Manipulation or intervention
5. Follow-up
6. Assessment of outcome
Prof. Asir John Samuel, Professor, MMIPR 41
Select
suitable
population
Select
suitable
sample
Exclusions
Randomize
Experimental
group
Control group
Intervention
& follow-up
Prof. Asir John Samuel, Professor, MMIPR 42
Experimental (RCT) research designs
• Pretest-posttest control group design
• Two-group pretest-posttest design
• Posttest-only control group design
• One-way repeated measures design
• Crossover design
• Two-way design with two repeated measures
• Mixed design Prof. Asir John Samuel, Professor, MMIPR 43
Pretest-Posttest Control Group Design
Experimental
Group
Control
Group
Study
Sample
Pretest
Pretest
No
Intervention
or Placebo
Experimental
Intervention
Posttest
Posttest
Random
Assignment
Prof. Asir John Samuel, Professor, MMIPR 44
Two-Group Pretest-Posttest Design
Experimental
Group
Control
Group
Study
Sample
Pretest
Pretest
Experimental
Intervention
2 or
Standard care
Experimental
Intervention
1
Posttest
Posttest
Random
Assignment
Prof. Asir John Samuel, Professor, MMIPR 45
MultiGroup Pretest-Posttest Design
Experimental
Group 2
Control
Group
Study
Sample
Pretest
Pretest
No
Intervention or
Placebo
Experimental
Intervention
2
Posttest
Posttest
Experimental
Group 1
Pretest
Experimental
Intervention
1
Posttest
Random
Assignment
Random
Assignment
Prof. Asir John Samuel, Professor, MMIPR 46
Posttest-only Control Group Design
Experimental
Group
Control
Group
Study
Sample
No
Intervention
or Placebo
Experimental
Intervention
Posttest
Posttest
Random
Assignment
Prof. Asir John Samuel, Professor, MMIPR 47
Crossover design
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015
Prof. Asir John Samuel, Professor, MMIPR 48
Quasi-Experimental Design
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015
Prof. Asir John Samuel, Professor, MMIPR 49
Quasi-experimental study design
• An empirical study used to estimate the causal
impact of an intervention on its target
population
• Type of evaluation which aims to determine
whether a program or intervention has the
intended effect or not
Prof. Asir John Samuel, Professor, MMIPR 50
Founder
• Donald Thomas Campbell
• November 20, 1916 to May 5, 1996
• American social scientist
Prof. Asir John Samuel, Professor, MMIPR 51
Lacking key components
• Pre-post test design
• Treatment and control group
• Random assignment of participants
- Lack one or more of the above
Prof. Asir John Samuel, Professor, MMIPR 52
Concern about
• Internal validity
• Confounding variables
• Ethical issues
Prof. Asir John Samuel, Professor, MMIPR 53
Advantages
• Randomization is impractical
• Not Unethical
• Minimizes threats to external validity
• Natural experiments
• Continue as longitudinal study
Prof. Asir John Samuel, Professor, MMIPR 54
Disadvantages
• Impact of confounding variables
• Threat to internal validity
• Provide weaker evidence because of the lack
of randomness
• Extraneous variable
Prof. Asir John Samuel, Professor, MMIPR 55
Forms of quasi-exp. study
• Pre-post test design without a control group
• Pre-post test design with a control group
Prof. Asir John Samuel, Professor, MMIPR 56
One-group pretest-posttest design
Prof. Asir John Samuel, Professor, MMIPR 57
One-way repeated measures design
Prof. Asir John Samuel, Professor, MMIPR 58
Interrupted time-series design
Prof. Asir John Samuel, Professor, MMIPR 59
Nonequivalent pretest-posttest
control group design
Prof. Asir John Samuel, Professor, MMIPR 60
Nonequivalent posttest-only
control group design
Prof. Asir John Samuel, Professor, MMIPR 61
Single-subject designs
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015
Prof. Asir John Samuel, Professor, MMIPR 62
Reporting of health research studies
• CARE
- CAse Report (13)
• STROBE
- Strengthening the Reporting of Observational
Studies in Epidemiology (22)
63
www.equator-network.org
Prof. Asir John Samuel, Professor, MMIPR
Reporting of health research studies
• SPIRIT
- Standard Protocol Items Recommendations
for Interventional Trials (33)
• PRISMA (http://www.prisma-statement.org/)
- Preferred Reporting Items for Systematic
Reviews and Meta-Analyses (27)
www.equator-network.org
Prof. Asir John Samuel, Professor, MMIPR 64
Reporting of statistical analysis
• SAMPL
- Statistical Analyses and Methods in the
Published Literature
www.equator-network.org
Prof. Asir John Samuel, Professor, MMIPR 65
Reporting of health research studies
• CONSORT
- Consolidated Standards of Reporting Trials
(25)
• TREND
- Transparent Reporting of Evaluations with
Nonrandomized Designs (22)
www.equator-network.org
Prof. Asir John Samuel, Professor, MMIPR 66
Prof. Asir John Samuel, Professor, MMIPR 67
Choice of Design
–Research Questions
–Research Goals
–Researcher Beliefs and Values
–Researcher Skills
–Time and Funds
–Status of existent knowledge
–Nature and availability of information
–Available resources
Prof. Asir John Samuel, Professor, MMIPR 68
SACKETT LEVEL OF EVIDENCE
Prof. Asir John Samuel, Professor, MMIPR 69
PEDro scale
Prof. Asir John Samuel, Professor, MMIPR 70
Randomization
• Simple randomization
• Block randomization
• Stratified randomization
• Unequal randomization
• http://www.graphpad.com/quickcalcs/index.cfm
• http://www.randomization.com
Prof. Asir John Samuel, Professor, MMIPR 71
Simple Randomization
• Single sequence of random assignments
• Maintains complete randomness of the
assignment of a subject to a particular group
• Flipping a coin
• Heads - control, tails – treatment
• Unequal number of participants among groups
• Simple and easy to implement
Prof. Asir John Samuel, Professor, MMIPR 72
Block randomization
• Randomize subjects into groups in equal
sample sizes
• Blocks are small and balanced with
predetermined group assignments
• Numbers of subjects in each group similar at
all times
• Subjects are randomly assigned into blocks
Prof. Asir John Samuel, Professor, MMIPR 73
Block randomization
Prof. Asir John Samuel, Professor, MMIPR 74
Stratified randomization
• Control and balance the influence of covariates
• Generate a separate block for each combination
of covariates
• Subjects are assigned to the appropriate block
of covariates
• Simple randomization is performed within each
block Prof. Asir John Samuel, Professor, MMIPR 75
Allocation concealment
• Generation of an unpredictable randomised
allocation sequence
• concealing it at least until patients have been
assigned to their groups
• Sequentially numbered, opaque, sealed
envelopes (SNOSE)
Prof. Asir John Samuel, Professor, MMIPR 76
Allocation concealment
Prof. Asir John Samuel, Professor, MMIPR 77
Systematic Reviews
and
Meta-analysis
Prof. Asir John Samuel, Professor, MMIPR 78
Systematic Reviews and
Meta-Analyses
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015
Prof. Asir John Samuel, Professor, MMIPR 79
Reasons to synthesize the literature
• To identify experts in a given topic
• More deeper understanding of a given topic
• Identify research methods
• Single conclusion
Prof. Asir John Samuel, Professor, MMIPR 80
Ways to synthesize literature
• Narrative reviews
• Systematic reviews without meta-analysis
• Systematic reviews with meta-analysis
Prof. Asir John Samuel, Professor, MMIPR 81
Systematic reviews without meta-analysis
• Compiling studies on a focused topic based on
predefined inclusion and exclusion criteria
• Reduces bias in interpreting results
• Consider negative studies
• Come with single unique conclusion
Prof. Asir John Samuel, Professor, MMIPR 82
Systematic reviews with meta-analysis
• Meta-analysis is the analysis of analyses
• The size of differences b/w treatment groups
(effect size) is mathematically standardized so
that it can be pooled across studies with
different, conceptually related, dependent
variables
• Include statistical pooling of results
Prof. Asir John Samuel, Professor, MMIPR 83
1. Framing questions for a review
2. Identifying relevant work
3. Assessing the quality of studies
4. Summarizing the evidence
5. Interpreting the findings
Prof. Asir John Samuel, Professor, MMIPR 84
Steps in conducting Meta-analysis
1. Framing questions for a review
2. Identifying relevant work
3. Assessing the quality of studies
4. Statistical pooling of results
5. Interpreting the findings
Prof. Asir John Samuel, Professor, MMIPR 85
Framing questions for a review
• Specified in a clear form before beginning
• Once protocol is set difficult to change
1. Free-form questions
2. Structured question
• Based on population, intervention, outcome
and study designs
Prof. Asir John Samuel, Professor, MMIPR 86
Identifying relevant work
• Extensive search without language restrictions
• Begin with bibliographic databases
• Most researchers will “play around”
• Printed, online, published and unpublished
• Based on selection criteria set in advance
• Follows strict inclusion and exclusion criteria
Prof. Asir John Samuel, Professor, MMIPR 87
Assessing the quality of studies
• Based on LoE
• Use critical appraisal guidelines & design-
based quality checklists
• Explore heterogeneity
• PEDro for RCT’s
Prof. Asir John Samuel, Professor, MMIPR 88
Summarizing the evidence
• Summarize from various study quality
• Difference b/w study results
• Compare negative
and positive studies
Prof. Asir John Samuel, Professor, MMIPR 89
Statistical pooling of results
• Use of confidence intervals
• Pooling of effects across studies
• Mathematical complexities are often elegantly
summarized in a “forest plot”/blobbogram
• Pat Forrest dates back to 1970s
Prof. Asir John Samuel, Professor, MMIPR 90
Forrest Plot
Prof. Asir John Samuel, Professor, MMIPR 91
Prof. Asir John Samuel, Professor, MMIPR 92
Interpreting the findings
• Care is taken in interpreting the results of low
quality studies
Prof. Asir John Samuel, Professor, MMIPR 93
Prof. Asir John Samuel, Professor, MMIPR 94
Prof. Asir John Samuel, Professor, MMIPR 95
Surveys and
Questionnaires
Prof. Asir John Samuel, Professor, MMIPR 96
Surveys and Questionnaires
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice.
3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015
Prof. Asir John Samuel, Professor, MMIPR 97
Survey
• System for collecting information from or
about people to describe, compare, or explain
their knowledge, attitudes, and behaviour
- Fink A (2003)
Prof. Asir John Samuel, Professor, MMIPR 98
Survey
• Non-experimental research
• Prospective collection of self-reported
information
• 2 methods
- Questionnaires (mailed, internet)
- Interview (in-person or telephone)
Prof. Asir John Samuel, Professor, MMIPR 99
Steps in Implementation
• Sampling and sample size
• Interview or questionnaire design
• Implementation
• Follow-up
• Analysis
• Interpretation/inference
Prof. Asir John Samuel, Professor, MMIPR 100
Sampling and sample size
N = Z2 (p)(1-p) / error2
Prof. Asir John Samuel, Professor, MMIPR 101
Questionnaire development
• Drafting
- Needs based on literature
- Reexamine the purpose of study
- Format and comprehensibility
- More easily digestible parts
- readability
Prof. Asir John Samuel, Professor, MMIPR 102
Questionnaires
• Consists of no. of questions printed or typed
in definite order on a form or set of forms
• Respondents have to answer the questions on
their own
• Data is collected through mailing or
distributing the questionnaires
• Used in survey
Prof. Asir John Samuel, Professor, MMIPR 103
3 main aspects
• General form
• Question sequence
• Question formulation and wording
Prof. Asir John Samuel, Professor, MMIPR 104
General form
• Structured/unstructured
• Closed (Y/N) or open (inviting free response)
• In pilot study unstructured then standardized
Prof. Asir John Samuel, Professor, MMIPR 105
Question sequence
• Clear and smoothly-moving
• Easiest question being put in beginning
• Avoid question that put too great strain on
memory, personal character, wealth, etc
• General to more specific
Prof. Asir John Samuel, Professor, MMIPR 106
Question formulation and wording
• Short and Easily understood
• Simple and convey only one thought at a time
• Concrete
• Can be dichotomous, multiple choice or open-
ended
Prof. Asir John Samuel, Professor, MMIPR 107
Questionnaires - Merits
• Low cost even when sample size is large
• Free from bias of interviewer
• Respondent who are not easily approachable
can be reached conveniently
• More reliable
• Respondents have adequate time to answer
Prof. Asir John Samuel, Professor, MMIPR 108
Questionnaires - Demerits
• Low rate of return of duly filled in
questionnaires
• Can be used only when respondents are
educated and cooperating
• There is inbuilt inflexibility
• Slowest of all
Prof. Asir John Samuel, Professor, MMIPR 109
Questionnaires - Demerits
• Interpretation of omissions is difficult
• Control over the questionnaire may be lost
once it is sent
• Difficult to know whether willing respondents
are true representative
Prof. Asir John Samuel, Professor, MMIPR 110
Questionnaire development
• Expert review
- Review by a colleague or colleagues
knowledgeable about the topic under study
- All important elements of constructs under
were addressed ?
- Were Q understandable?
Prof. Asir John Samuel, Professor, MMIPR 111
Questionnaire development
• First revision
- Accept or reject recommendations for change
- After critical or peer review
• Pilot test
- Return rate/response rate
- Difficulty in reaching
Prof. Asir John Samuel, Professor, MMIPR 112
Survey method
• Final revision
• Motivating prospects to respond
• Implementation
• Data analysis
• Reporting
Prof. Asir John Samuel, Professor, MMIPR 113
Sampling
Prof. Asir John Samuel, Professor, MMIPR 114
Basic definitions
• Population
- Collection of all the units that are of interest
to the investigator
• Sample
- Representative part of population
• Sampling
- Technique of selecting a representative group
from a population
Prof. Asir John Samuel, Professor, MMIPR 115
Basic definitions
• Sampling error
- The difference that occurs purely by chance
between the values of sample statistic and
that of the corresponding population
parameter
Prof. Asir John Samuel, Professor, MMIPR 116
Why ?
• Only feasible method for collecting information
• Reduces demands on resources (time, finance,.)
• Results obtained more quickly
• Better accuracy of collected data
• Ethically acceptable
Prof. Asir John Samuel, Professor, MMIPR 117
Steps in sampling design
Target
population
Study
population
Sample
Study
participation
Prof. Asir John Samuel, Professor, MMIPR 118
Characteristic of good sample design
• True representation of population
• May result in small sampling error
• Each member in population should get an
opportunity of being selected
• Systematic bias can be controlled in a better way
• Results should be capable of being extrapolated
Prof. Asir John Samuel, Professor, MMIPR 119
Types of sample design
• Probability/Random sampling
- Selection of subjects are according to any
predicted chance of probability
• Non-probability/non-random sampling
- Does not depend on any chance of predecided
probability
Prof. Asir John Samuel, Professor, MMIPR 120
Types of sample design
Sample
design
Random
sampling
Simple Stratified Systematic Cluster Multistage
Non-random
sampling
convenience Quota Judgment
Prof. Asir John Samuel, Professor, MMIPR 121
Simple random sampling
• Equal and independent chance or probability
of drawing each unit
• Take sampling population
• Need listing of all sampling units (sampling
frame)
• Number all units
• Randomly draw units
Prof. Asir John Samuel, Professor, MMIPR 122
How to ensure randomness?
• Lottery method
• Table of random numbers
- e.g. Tippett’s series
- Fisher and Yates series
- Kendall and Smith series
- Rand corporation series
Prof. Asir John Samuel, Professor, MMIPR 123
Table of Random Numbers
Prof. Asir John Samuel, Professor, MMIPR 124
SRS - Merits
• No personal bias
• Easy to assess the accuracy
Prof. Asir John Samuel, Professor, MMIPR 125
SRS - Demerits
• Need a complete catalogue of universe
• Difficult if size sample is large
• Widely dispersed
Prof. Asir John Samuel, Professor, MMIPR 126
Stratified Random Sampling
• Used for heterogeneous population
• Population is divided into homogeneous
groups (strata), according to a characteristic of
interest (e.g. sex, religion, location)
• Then a simple random sample is selected from
each stratum
Prof. Asir John Samuel, Professor, MMIPR 127
SRs - Merits
• More representative
• Greater accuracy
• Can acquire information about whole
population and individual strata
Prof. Asir John Samuel, Professor, MMIPR 128
SRs - Demerits
• Careful stratification
• Random selection in each stratum
• Time consuming
Prof. Asir John Samuel, Professor, MMIPR 129
Systematic Sampling
• Sampling units are selected in a systematic
way, that is, every Kth unit in the population is
selected
• First divide the population size by the,
required sample size (sampling fraction). Let
the sampling fraction be K
Prof. Asir John Samuel, Professor, MMIPR 130
Systematic Sampling
• Select a unit at random from the first K units
and thereafter every Kth unit is selected
• If, N=1200
• And n=60
• Then, SF=20
Prof. Asir John Samuel, Professor, MMIPR 131
SS - Merits
• Simple and convenient
• Less time and work
Prof. Asir John Samuel, Professor, MMIPR 132
SS - Demerits
• Need complete list of units
• Periodicity
• Less representation
Prof. Asir John Samuel, Professor, MMIPR 133
Cluster Sampling
• The sampling units are groups or clusters
• The population is divided into clusters, and a
sample of clusters are selected randomly
• All the units in the selected clusters are then
examined or studied
Prof. Asir John Samuel, Professor, MMIPR 134
Types of cluster sampling
• Single-stage cluster sampling
- All the elements from each of the selected
clusters are used
• Two-stage cluster sampling
- A random sampling technique is applied to the
elements from each of the selected clusters
Prof. Asir John Samuel, Professor, MMIPR 135
Cluster Sampling
• It is always assumed that the individual items
within each cluster are representation of
population
• E.g. District, wards, schools, industries
Prof. Asir John Samuel, Professor, MMIPR 136
CS - Merits
• Saving of travelling time and consequent
reduction in cost
• Cuts down on the cost of preparing the
sampling frame
Prof. Asir John Samuel, Professor, MMIPR 137
CS - Demerits
• Units close to each other may be very similar
and so, less likely to represent the whole
population
• Larger sampling error than simple random
sampling
Prof. Asir John Samuel, Professor, MMIPR 138
Multistage Sampling
• Selection is done in stages until final sampling
units are arrived
• At first stage, Random sampling of large sized
sampling units are selected, from the selected
1st stage sampling units another sampling
units of smaller sampling units are selected,
randomly Prof. Asir John Samuel, Professor, MMIPR 139
Multistage Sampling
• Continue until the final sampling units are
selected
• E.g. Few states – District – Taulk
Prof. Asir John Samuel, Professor, MMIPR 140
MS - Merits
• Cut down the cost of preparing the sampling
frame
Prof. Asir John Samuel, Professor, MMIPR 141
MS - Demerits
• Sampling error is increased compared to
simple random sampling
Prof. Asir John Samuel, Professor, MMIPR 142
Quota Sampling
• Interviewers are requested to find cases with
particular types of people to interview
Prof. Asir John Samuel, Professor, MMIPR 143
Judgment (Purposive Sampling)
• Researcher attempts to obtain sample that
appear to be representative of the population
selected by the researcher subjectively
Prof. Asir John Samuel, Professor, MMIPR 144
Convenience Sampling
• Sampling comprises subject who are simply
avail in a convenient way to the researcher
• No randomness and likelihood of bias is high
• Consecutive sampling
Prof. Asir John Samuel, Professor, MMIPR 145
Snowball Sampling
• Investigators start with a few subjects and
then recruit more via word of mouth from the
original participants
Prof. Asir John Samuel, Professor, MMIPR 146
Merits
• Easy
• Low cost
• Limited time
• Total list population
Prof. Asir John Samuel, Professor, MMIPR 147
Demerits
• Selection bias
• Sample is not representation of population
• doesn’t allow generalization
Prof. Asir John Samuel, Professor, MMIPR 148
Validity and
Reliability
Prof. Asir John Samuel, Professor, MMIPR 149
Validity
• Validity of an assessment is the degree to
which it measures what it is supposed to
measure
Prof. Asir John Samuel, Professor, MMIPR 150
Reliability
• Reliability is the extent to which a
measurement gives results that are consistent
• Reliability is used to describe the overall
consistency of a measure
• A measure is said to have a high reliability if it
produces similar results under consistent
conditions
Prof. Asir John Samuel, Professor, MMIPR 151
Prof. Asir John Samuel, Professor, MMIPR 152
Prof. Asir John Samuel, Professor, MMIPR 153
Prof. Asir John Samuel, Professor, MMIPR 154
Prof. Asir John Samuel, Professor, MMIPR 155
Prof. Asir John Samuel, Professor, MMIPR 156
Validity
• Construct validity
• Content validity
• Face validity
• Criterion-related validity
- Concurrent validity
- Predictive validity
Prof. Asir John Samuel, Professor, MMIPR 157
Construct validity
• Construct validity refers to the extent to which
operations of a construct do actually measure
what the theory says they do
• Measure an abstract concept, or construct
Prof. Asir John Samuel, Professor, MMIPR 158
Content validity
• Content validity is a non-statistical type of
validity that involves "the systematic
examination of the test content to determine
whether it covers a representative sample of
the behavior domain to be measured“
• E.g. VAS vs McGill Pain Questionnaire
Prof. Asir John Samuel, Professor, MMIPR 159
Representation validity
• Representation validity also known as
translation validity, is about the extent to
which an abstract theoretical construct can be
turned into a specific practical test
Prof. Asir John Samuel, Professor, MMIPR 160
Face validity
• Face validity is an estimate of whether a test
appears to measure what it is supposed to
• Measures may have high validity, but when
the test does not appear to be measuring
what it is, it has low face validity
Prof. Asir John Samuel, Professor, MMIPR 161
Criterion-related validity
• Criterion validity is the correlation between
the test and a criterion variable (or variables)
taken as representative of the construct
• Compares the test with other measures (gold
standard) or outcomes (the criteria) already
held to be valid
Prof. Asir John Samuel, Professor, MMIPR 162
Concurrent validity
• Concurrent validity refers to the degree to
which the operations correlates with other
measures of the same construct that are
measured at the same time
Prof. Asir John Samuel, Professor, MMIPR 163
Predictive validity
• Predictive validity refers to the degree to
which the operation can predict (or correlate
with) other measures of the same construct
that are measured at some time in the future
• E.g. BBS or TUG predicts risk of fall
Prof. Asir John Samuel, Professor, MMIPR 164
Reliability
• Inter-rater reliability
• Test-retest reliability
• Inter-method reliability
Prof. Asir John Samuel, Professor, MMIPR 165
Inter-rater reliability
• Degree to which test scores are consistent
when measurements are taken by different
people using the same methods
Prof. Asir John Samuel, Professor, MMIPR 166
Test-retest/Intra-rater reliability
• Degree to which test scores are consistent
from one test administration to the next
• Measurements are gathered from a single
rater who uses the same methods or
instruments and the same testing conditions
• Intra-rater reliability
Prof. Asir John Samuel, Professor, MMIPR 167
Inter-method reliability
• Degree to which test scores are consistent
when there is a variation in the methods or
instruments used
Prof. Asir John Samuel, Professor, MMIPR 168
Bio-statistics for
physiotherapists
Asir John Samuel, BSc (Psy), MPT (Neuro Paed), MAc, DYScEd, FAGE
Assistant Professor, MMIPR
Mullana-Ambala,
Haryana
Prof. Asir John Samuel, Professor, MMIPR 169
Statistics in Medical Research
• Documentation of medical history of disease,
their progression, variability b/w patient,
association with age, gender, etc.
• Efficacy of various types of therapy
• Definition of normal range
• Used in Epidemiological studies
Prof. Asir John Samuel, Professor, MMIPR 170
Statistics in Medical Research
• Study the effect of environment, socio-
economic and seasonal factors
• Provide assessment of state health in
common, met and unmet needs
• Success/failure of specific treatment
• Promote health legislation
• Evaluate total health programme of action
Prof. Asir John Samuel, Professor, MMIPR 171
Statistics in Medical Research - Limitation
• Does not deal with individual fact
• Conclusion are not exact
• Can be misused
• Common men cannot handle properly
Prof. Asir John Samuel, Professor, MMIPR 172
Normal distribution
• Represented by a family of infinite curves
defined uniquely by 2 parameter the mean
and the SD of the population
• The curve are always symmetrically bell
shaped. The width of the curve is defined by
population, SD
Prof. Asir John Samuel, Professor, MMIPR 173
Normal distribution
• Mean, median and mode coincide
• It extends from - ∞ to + ∞
• Symmetrically about the mean
• Approx 68% of distribution is within 1SD of
mean (68.27%)
- 95% - 2SD (1.96 SD)
- 99% - 3SD (2.58 SD)
Prof. Asir John Samuel, Professor, MMIPR 174
Normal distribution
• The total area under the curve is 1
• The value of measure of skewness is zero. It is
not skewed
• The curve is asymptotic. It approaches but
never touches baseline at extremes
• The curve extends on the both sides -3σ
distance on left to +3σ distance on the right
Prof. Asir John Samuel, Professor, MMIPR 175
Normal distribution - Uses
• Construct confidence interval
• Many statistical techniques makes an
underlying assumption of normality
• Distribution of sample means is normal
• Normality is important in statistical inference
Prof. Asir John Samuel, Professor, MMIPR 176
Normality test
• Shapiro-Wilk test
• Kolmogorov-Smirnov test
Prof. Asir John Samuel, Professor, MMIPR 177
Prof. Asir John Samuel, Professor, MMIPR 178
Prof. Asir John Samuel, Professor, MMIPR 179
Shapiro-Wilk test
• More appropriate for small sample sizes (< 50
samples)
• But can also handle sample sizes as large as
2000
• If the Sig. value of the Shapiro-Wilk Test is
greater the 0.05, the data is normal
• If it is below 0.05, the data significantly
deviate from a normal distribution
Prof. Asir John Samuel, Professor, MMIPR 180
Prof. Asir John Samuel, Professor, MMIPR 181
Kolmogorov-Smirnov test
• Appropriate for larger samples
• ≥ 50 samples
• If the Sig. value of the Kolmogorov-Smirnov test
is greater the 0.05, the data is normal
Prof. Asir John Samuel, Professor, MMIPR 182
Descriptive statistics
• Measures of location
- Central tendency
- Mean, median and mode
• Measures of variation
- Dispersion
- Range, quartile, IQR, variance and SD
Prof. Asir John Samuel, Professor, MMIPR 183
Prof. Asir John Samuel, Professor, MMIPR 184
Prof. Asir John Samuel, Professor, MMIPR 185
Sample Size
Determination
Prof. Asir John Samuel, Professor, MMIPR 186
MCID
• ‘the smallest difference in score in the domain
of interest which patients perceive as
beneficial…’, - Jaeschke
• MDC = SEM × √2 × 1.9
• SEM = SD pooled X √(1-r)
• MCID = 1 X MDC
Prof. Asir John Samuel, Professor, MMIPR 187
MDC - MCID
Prof. Asir John Samuel, Professor, MMIPR 188
Effect size
• Effect size index (ESI)
ESI = Mean Post – Mean Pre / S Pre
• Standard response mean (SRM)
SRM = Mean Post – Mean Pre / S Change
Prof. Asir John Samuel, Professor, MMIPR 189
Effect size grading
Prof. Asir John Samuel, Professor, MMIPR 190
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed.
Upper Saddle River, NJ: Prentice Hall; 2015. p.649
p-value
• Probability of getting a minimal difference of
what has observed is due to chance
• Probability that the difference of at least as
large as those found in the data would have
occurred by chance
Prof. Asir John Samuel, Professor, MMIPR 191
Hypothesis
• Alternate hypothesis (HA)
- Statement predict that a difference or
relationship b/w groups will be demonstrated
• Null hypothesis (H0)
- Researcher anticipate “no difference” or “no
relationship”
Prof. Asir John Samuel, Professor, MMIPR 192
Decision for 5% LOS
• If p-value <0.05, then data is against null
hypothesis
• If p-value ≥0.05, then data favours null
hypothesis
Prof. Asir John Samuel, Professor, MMIPR 193
Type I & II errors
Possible states of Null Hypothesis
Possible
actions on
Null
Hypothesis
True False
Accept Correct
Action
Type II
error
Reject Type I
error
Correct
Action
Prob (Type I error) – α (LoS) – False positive
Prob (Type II error) – β – False negative
1-β – power of test
Dr. Asir John Samuel (PT), Ast Prof, MMIPR
Type I Error and Type II Error
Z values
Z 0.05 – 1.96 – 95%
Z 0.10 – 1.282 – 90%
Z 0.20 – 0.84 – 80%
Prof. Asir John Samuel, Professor, MMIPR 197
Comparison of 2 means
n= 2 [(Zα+Zβ)s/d]²
Zα – LoS
Zβ – power of study
s – pooled SD of the two sample
d – clinically significant difference
Prof. Asir John Samuel, Professor, MMIPR 198
Eg. for Comparison of 2 means
• A RCT to study the effect of BP reduction. One
group received a no intervention and other-
aerobic exercise. What would be the sample
size in order to provide the study with power
of 90% to detect a difference in sys. BP of 2
mm Hg b/w two groups at 5% LoS? The SD of
sys. BP is observed to be 6 mmHg.
Prof. Asir John Samuel, Professor, MMIPR 199
Estimating proportion
n = Z α² P (1-P) / d²
P – proportion of event in population
d – acceptable margin of error in estimating the
true population proportion
Prof. Asir John Samuel, Professor, MMIPR 200
Eg. Estimating proportion
• To determine the prevalence of navicular drop
in ACL injured population by anticipating of
15% with acceptable margin of error is 3%
= (1.96)²(0.15)(0.85) / (0.03)²
= 544.2
Prof. Asir John Samuel, Professor, MMIPR 201
Estimating mean
n = (Zα σ / d)²
σ – anticipated SD of population
d – acceptable margin of error in estimating true
population mean
Prof. Asir John Samuel, Professor, MMIPR 202
Eg. Estimating mean
• To determine the mean no. of days to
ambulate pt undergoing stroke rehabilation
among stroke pts. Where anticipated SD of
days are 60 and acceptable margin of error is
20 days
n = (1.96 x 60/20)²
n = (5.88)² = 34.6
Prof. Asir John Samuel, Professor, MMIPR 203
Comparison of 2 proportions
n = (Zα√2PQ + Zβ√P1Q1+P2Q2)²/(P1-P2)²
P = P1+P2/2 Q = 1-P
Prof. Asir John Samuel, Professor, MMIPR 204
Eg. Comparison of 2 proportions
• To see whether there is any sig. difference in
percentage of strength increase after 4 wks of
intervention b/w a new technique and
standard one
• Standard one – 70% (P1)
• New technique – 75% (P2)
Prof. Asir John Samuel, Professor, MMIPR 205
Multiple regression
N > 50 + 8p
Where,
p - number of predictors
Prof. Asir John Samuel, Professor, MMIPR 206
Testing of hypothesis
1. Evaluate data
2. Review assumption
3. State hypothesis
4. Presume null hypothesis
5. Select test statistics
6. Determine distribution of test statistics
7. State decision rule
Prof. Asir John Samuel, Professor, MMIPR 207
Testing of hypothesis
8. Calculate test statistics
9. What is the probability that the data conform
10. Make statistical decision
11. If p>0.05, then reject(HA)
12. If p<0.05, then accept (HA)
Prof. Asir John Samuel, Professor, MMIPR 208
Testing of Hypothesis
Presume null hypothesis
What is the probability
that data conform to
null hypothesis
Retain H0 reject H0
p>0.05 P<0.05
Prof. Asir John Samuel, Professor, MMIPR 209
Test of Hypothesis
• Parametric test
• Non-parametric test
Prof. Asir John Samuel, Professor, MMIPR 210
Parametric & non-parametric test
• Paired t-test
• Repeated measure
ANOVA
• Independent t-test
• ANOVA
• Pearson correlation
coefficient
• Wilcoxon Signed Rank T
• Friedman test
• Mann-Whitney U test
• Kruskal Wallis test
• Spearman Rank
correlation coefficient
Prof. Asir John Samuel, Professor, MMIPR 211
Paired t-test
• Two measures taken on the same subject or
naturally occurring pairs of observation or two
individually matched samples
• Variable of interest is quantitative
Prof. Asir John Samuel, Professor, MMIPR 212
Assumption
• The difference b/w pairs in the population is
independent and normally or approximately
normally distributed
Prof. Asir John Samuel, Professor, MMIPR 213
Wilcoxon Signed Rank test
• Used for paired data
• The sample is random
• The variable of interest is continuous
• The measurement scale is at least ordinal
• Based on the rank of difference of each paired
values
Prof. Asir John Samuel, Professor, MMIPR 214
Repeated measures ANOVA
• Measurements of the same variable are made
on each subject on more than two different
occasion
• The different occasions may be different point
of time or different conditions or different
treatments
Prof. Asir John Samuel, Professor, MMIPR 215
Assumptions
• Observations are independent
• Differences should follow normal distribution
• Sphericity-differences have approximately
same variances
Prof. Asir John Samuel, Professor, MMIPR 216
Fried Man test
• Data is measured in ordinal scale
• The subjects are repeatedly observed under 3
or more conditions
• The measurement scale is at least ordinal
(qualitative)
• The variable of interest is continuous
Prof. Asir John Samuel, Professor, MMIPR 217
Independent t-test
• Compare the means of two independent
random samples from two population
• Variable of interest is quantitative
Prof. Asir John Samuel, Professor, MMIPR 218
Assumptions
• The population from which the sample were
obtained must be normally or approximately
normally distributed
• The variances of the population must be equal
Prof. Asir John Samuel, Professor, MMIPR 219
Mann Whitney-U test
• Two independent samples have been drawn
from population with equal medians
• Samples are selected independently and at
random
• Population differ only with respect to their
median
• Variable of interval is continuous
Prof. Asir John Samuel, Professor, MMIPR 220
Mann Whitney-U test
• Measurement scale is at least ordinal
(qualitative)
• Based on ranks of the observations
Prof. Asir John Samuel, Professor, MMIPR 221
ANOVA
• Extension of independent t-test to compare
the means of more than two groups
• F = b/w group variation/within group variation
• F ratio
• Post hoc test (which mean is different)
Prof. Asir John Samuel, Professor, MMIPR 222
Assumptions
• Observations are independent and randomly
selected
• Each group data follows normal distribution
• All groups are equally variable (homogeneity
of variance)
Prof. Asir John Samuel, Professor, MMIPR 223
Why not t-test?
• Tedious
• Time consuming
• Confusing
• Potentially misleading – Type I error is more
Prof. Asir John Samuel, Professor, MMIPR 224
Kruskal Wallis H test
• Used for comparison of more than 2 groups
• Extension of Mann-Whitney U test
• Used for comparing medians of more than 2
groups
Prof. Asir John Samuel, Professor, MMIPR 225
Assumptions
• Samples are independent and randomly
selected
• Measurement scale is at least ordinal
• Variable of interest is continuous
• Population differ only with respect to their
medians
Prof. Asir John Samuel, Professor, MMIPR 226
Chi-square Test (x2)
• Variables of interest are categorical
(quantitative)
• To determine whether observed difference in
proportion b/w the study groups are
statistically significant
• To test association of 2 variables
Prof. Asir John Samuel, Professor, MMIPR 227
Chi-square Test-Assumption
• Randomly drawn sample
• Data must be reported in number
• Observed frequency should not be too small
• When observed frequency is too small and
corresponding expected frequency is less than
5 (<5) – Fischer Exact test
Prof. Asir John Samuel, Professor, MMIPR 228
Relationship
• Correlation (relative reliability)
• Regression (absolute reliability)
Prof. Asir John Samuel, Professor, MMIPR 229
Correlation
• Method of analysis to use when studying the
possible association b/w two continuous
variables
• E.g.
- Birth wt and gestational period
- Anatomical dead space and ht
- Plasma volume and body weight
Prof. Asir John Samuel, Professor, MMIPR 230
Correlation
• Scatter diagram
• Linear correlation
• Non-linear correlation
Prof. Asir John Samuel, Professor, MMIPR 231
Properties
• Scatter diagrams are used to demonstrate the
linear relationship b/w two quantitative
variables
• Pearson’s correlation coefficient is denoted by r
• r measures the strength of linear relationship
b/w two continuous variable (say x and y)
Prof. Asir John Samuel, Professor, MMIPR 232
Properties
• The sign of the correlation coefficient tells us
the direction of linear relationship
• The size (magnitude) of the correlation
coefficient r tells us the strength of a linear
relationship
Prof. Asir John Samuel, Professor, MMIPR 233
Properties
• Better the points on the scatter diagram
approximate a straight line, the greater is the
magnitude r
• Coefficient ranges from -1 ≤ r ≤ 1
Prof. Asir John Samuel, Professor, MMIPR 234
Interpretation
• r = 1, two variables have a perfect +ve linear
relationship
• r = -1, two variables have a perfect -ve linear
relationship
• r = 0, there is no linear relationship b/w two
variables
Prof. Asir John Samuel, Professor, MMIPR 235
Assumption
• Observations are independent
• Relationship b/w two variables are linear
• Both variables should be normal distributed
Prof. Asir John Samuel, Professor, MMIPR 236
Caution
• Correlation coefficient only gives us an
indication about the strength of a linear
relationship
• Two variables may have a strong curvilinear
relationship but they could have a weak value
for r
Prof. Asir John Samuel, Professor, MMIPR 237
Judging the strength – Portney &
Watkins criteria
• 0.00-0.25 – little or no relationship
• 0.26-0.50 – fair degree of relationship
• 0.51-0.75 – moderate to good degree of
relationship
• 0.76-1.00 – good to excellent relationship
Prof. Asir John Samuel, Professor, MMIPR
Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed.
Upper Saddle River, NJ: Prentice Hall; 2015
238
Spearman’s Rank correlation
• Non-parametric measure of correlation
between the two variables (at least ordinal)
• Ranges from -1 to +1
Eg:
- Pain score of age
- IQ and TV watched /wk
- Age and EEG output values
Prof. Asir John Samuel, Professor, MMIPR 239
Situation
• Relationship b/w two variables is non-linear
• Variables measured are at least ordinal
• One of the variables not following normal
distribution
• Based on the difference in rank between each
variable
Prof. Asir John Samuel, Professor, MMIPR 240
Assumption
• Observation are independent
• Samples are randomly selected
• The measurement scale is at least ordinal
Prof. Asir John Samuel, Professor, MMIPR 241
Shrout and Fleiss criteria for ICC
• < 0.4 = poor
• < 0.4 to 0.75 = moderate
• 0.75 to < 0.9 = good
• ≥ 0.9 = excellent
Prof. Asir John Samuel, Professor, MMIPR
Shrout PE, Fleiss JL. Intra-class correlations: uses in assessing rater reliability. Psychol Bull.
1979;86:420–428. 242
Regression
• Expresses the linear relationship in the form of
an equation
• In other words a prediction equation for
estimating the values of one variable given the
valve of the other,
y = a + bx
Prof. Asir John Samuel, Professor, MMIPR 243
Regression - eg
• Wt (y) and ht (x)
• Birth wt (y) and gestation period (x)
• Dead space (y) and height (x)
x and y are continuous
y-dependent variable
x-independent variable
Prof. Asir John Samuel, Professor, MMIPR 244
Regression line
• Shows how are variable changes on average
with another
• It can be used to find out what one variable is
likely to be (predict) when we know the other
provided the prediction is within the limits of
data range
Prof. Asir John Samuel, Professor, MMIPR 245
Regression analysis
• Derives a prediction equation for estimating
the value of one variable (dependent) given the
value of the second variable (independent)
y = a + bx
Prof. Asir John Samuel, Professor, MMIPR 246
Assumption
• Randomly selection
• Linear relationship between variables
• The response variable should have a normal
distribution
• The variability of y should be the same for
each value of the predictor value
Prof. Asir John Samuel, Professor, MMIPR 247
Prof. Asir John Samuel, Professor, MMIPR 248
Multiple regression
• One dependent variable and multiple
independent variable
• Derives a prediction equation for estimating
the value of one variable (dependent) given
the value of the other variables (independent)
Prof. Asir John Samuel, Professor, MMIPR 249
Multiple regression
• The dependent variable is continuous and
follows normal distribution
• Independent variable can be quantitative as
well as qualitative
Prof. Asir John Samuel, Professor, MMIPR 250
Prof. Asir John Samuel, Professor, MMIPR 251
252
Quantative Research Methods

Quantative Research Methods

  • 1.
    Qualitative and Quantitative ResearchMethods: Statistical Software Based Training Prof. (Dr.) Asir John Samuel, BSc (Psych), BPT, MPT, PhD (Physiotherapy) Professor Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar (Deemed-to-be University) Accredited by NAAC with Grade A++ Mullana-Ambala, Haryana, India NORMALIZING LIFE POST COVID 19 27th & 28th March 2022 Prof. Asir John Samuel, Professor, MMIPR 1
  • 2.
    Prof. Asir JohnSamuel, Professor, MMIPR 2 Good Morning
  • 3.
    Why do research? •One might want to get degree • One might want to become famous • One might want to get rich • One might want to get a free trip • One might want to help patients • One might want to discover something new Asir John Samuel, Assoc. Prof, MMIPR http://orcid.org/0000-0003-1747-0415
  • 4.
    First research? • Adamand eve Asir John Samuel, Assoc. Prof, MMIPR http://orcid.org/0000-0003-1747-0415
  • 5.
    Asir John Samuel,Assoc. Prof, MMIPR http://orcid.org/0000-0003-1747-0415
  • 6.
    Prof. Asir JohnSamuel, Professor, MMIPR 6
  • 7.
    Research Design Prof. AsirJohn Samuel, Professor, MMIPR 7
  • 8.
    Different research designs Studydesigns Observational Descriptive Case report Case series Analytical Cross- sectional study Case control study Cohort Experimental RCT Non-RCT Prof. Asir John Samuel, Professor, MMIPR 8
  • 9.
    Research Designs by Portney& Watkins Describe population Descriptive Research Find Relationship Exploratory Research Cause and Effect Experimental Research Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 Prof. Asir John Samuel, Professor, MMIPR 9
  • 10.
    10 Portney LG, WatkinsMP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015. p.21 Prof. Asir John Samuel, Professor, MMIPR
  • 11.
    Prof. Asir JohnSamuel, Professor, MMIPR 11
  • 12.
    Descriptive research designs •Developmental research • Normative research • Qualitative research • Descriptive survey • Case study • Case series Prof. Asir John Samuel, Professor, MMIPR 12
  • 13.
    Descriptive research Portney LG,Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015. p.301 Prof. Asir John Samuel, Professor, MMIPR 13
  • 14.
    Case report • Studiesdescribing the characteristics of a single patient • Collection of cases may be up to 4 Prof. Asir John Samuel, Professor, MMIPR 14
  • 15.
    Purpose of casestudies • Understanding unusual patient conditions • Providing examples of innovative or creative therapies • Generating and testing theory • Providing future research directives Prof. Asir John Samuel, Professor, MMIPR 15
  • 16.
    Case report-merits • Recordunusual medical occurrences and can give the first clues in identification of a new disease or adverse effects of an exposure • Only means of surveillance for rare clinical events • Serve to elucidate the mechanism of disease and treatmentProf. Asir John Samuel, Professor, MMIPR 16
  • 17.
    Case report-Demerits • Cannotbe used to test for the presence of valid statistical association because it is based on the experience of one person Prof. Asir John Samuel, Professor, MMIPR 17
  • 18.
    Case series • Studiesdescribing the characteristics of a group of patients with similar diagnosis • Collection of 5 & more cases Prof. Asir John Samuel, Professor, MMIPR 18
  • 19.
    Case series-merits • Helpsin formulating a useful hypothesis regarding risk factors of disease or identifying a new disease or outcome of new treatment • Informative for very rare disease with few established risk factors • May suggest the emergence of a new disease or epidemic Prof. Asir John Samuel, Professor, MMIPR 19
  • 20.
    Case series-Demerits Cannot beused to test for the presence of valid statistical association due to absence of a comparison group Prof. Asir John Samuel, Professor, MMIPR 20
  • 21.
    Exploratory research designs •Case-Control studies • Cohort studies • Cross-sectional studies • Correlational research • Methodological research reliability and validity • Historical research Prof. Asir John Samuel, Professor, MMIPR 21
  • 22.
    Exploratory research Portney LG,Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 Prof. Asir John Samuel, Professor, MMIPR 22
  • 23.
    Exploratory research Portney LG,Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 Prof. Asir John Samuel, Professor, MMIPR 23
  • 24.
    Cross-sectional studies • Singleexamination of a cross section of population at one point of time • Prevalence study • Used to investigate non fatal diseases • Both exposure and outcome (disease) are determined simultaneously for each subject • Provide information about the frequency or characteristic of disease Prof. Asir John Samuel, Professor, MMIPR 24
  • 25.
    Cross-sectional studies-Merits • Provideinformation about the frequency of an attribute and potential risk factors • Helps to generate a hypothesis • Can give a good picture about the health care needs of the population at the point of time • Can be used to investigate multiple exposure and multiple outcome • Suitable for chronic cases Prof. Asir John Samuel, Professor, MMIPR 25
  • 26.
    Cross-sectional studies-Demerits • Difficultto establish the time of sequence of events • They are not suitable to investigate rare diseases, rare exposure or disease of short duration • Being based on prevalent rather than incident cases • Limited value to investigate etiological relationship Prof. Asir John Samuel, Professor, MMIPR 26
  • 27.
    Case control study •Type of analytical study • By observation and analysis • Retrospective evaluation to determine who was exposed and who was not exposed – retrospective study Prof. Asir John Samuel, Professor, MMIPR 27
  • 28.
    Case control study •To examine the possible relation of an exposure to certain disease - Identify the individual having the disease – case - Individual don’t have the disease – comparison purpose Prof. Asir John Samuel, Professor, MMIPR 28
  • 29.
    Case control study Factor(s) Present individuals with disease TIME Direction of enquiry Absent individuals w/o disease Prof. Asir John Samuel, Professor, MMIPR 29
  • 30.
    Case control study 4basic steps in conducting a case control study, 1. Selection of cases and controls 2. Matching 3. Measurement of exposure 4. Analysis and interpretation Prof. Asir John Samuel, Professor, MMIPR 30
  • 31.
    Case control study– Merits • Quick, less expensive • Well suited for disease with long latent period • Optimal for evaluation of rare diseases • Can study etiological factors for a single disease • Requires small sample than a cohort study • No attrition (drop outs) problem • Ethical problems are minimal, no risk to subjects Prof. Asir John Samuel, Professor, MMIPR 31
  • 32.
    Case control study-Demerits • More prone to bias • Selection of appropriate control group may be difficult • Inefficient for evaluation of rare exposure • Cannot directly measure incidence, can only estimate relative risk Prof. Asir John Samuel, Professor, MMIPR 32
  • 33.
    Cohort study • Forwardlooking study • Prospective study • Incidence study • Longitudinal study • There is regular follow up over a period of time Prof. Asir John Samuel, Professor, MMIPR 33
  • 34.
    Cohort study Factor (s) Individualsexposed Present TIME Direction of enquiry individuals unexposed Absent Prof. Asir John Samuel, Professor, MMIPR 34
  • 35.
    Cohort study • Proceedsfrom cause to effect • Exposure has occurred when the study is initiated, but the disease has not occurred Prof. Asir John Samuel, Professor, MMIPR 35
  • 36.
    Cohort • A groupof people who share a common characteristic or experience within a defined time period • Cohort must be free from disease under study • Both groups (study cohort & control cohort) should be equally susceptible for the disease under study • Should be comparable in all possible variables Prof. Asir John Samuel, Professor, MMIPR 36
  • 37.
    Cohort study • Elementsof a cohort study, 1. Selection of study subjects 2. Obtaining data on exposure 3. Selection of comparison group 4. Follow-up 5. Analysis Prof. Asir John Samuel, Professor, MMIPR 37
  • 38.
    Cohort study -Merits • Incidence can be calculated • Examines multiple effects of a single exposure • Provides direct estimate of relative risk • Minimizes bias • Dose-response ratios can be calculated • Elucidates temporal relationship b/w exposure & disease Prof. Asir John Samuel, Professor, MMIPR 38
  • 39.
    Cohort study -Demerits • Inefficient for rare diseases • Expensive and time consuming • Involves large sample size • Alters people behaviour • Changes in standard methods or diagnostic criteria of disease over prolonged follow-up Prof. Asir John Samuel, Professor, MMIPR 39
  • 40.
    Exploratory research Portney LG,Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 Prof. Asir John Samuel, Professor, MMIPR 40
  • 41.
    RCT • Basic stepsin conducting a RCT, 1. Drawing up a protocol 2. Selecting reference & exp. Group 3. Randomization 4. Manipulation or intervention 5. Follow-up 6. Assessment of outcome Prof. Asir John Samuel, Professor, MMIPR 41
  • 42.
  • 43.
    Experimental (RCT) researchdesigns • Pretest-posttest control group design • Two-group pretest-posttest design • Posttest-only control group design • One-way repeated measures design • Crossover design • Two-way design with two repeated measures • Mixed design Prof. Asir John Samuel, Professor, MMIPR 43
  • 44.
    Pretest-Posttest Control GroupDesign Experimental Group Control Group Study Sample Pretest Pretest No Intervention or Placebo Experimental Intervention Posttest Posttest Random Assignment Prof. Asir John Samuel, Professor, MMIPR 44
  • 45.
    Two-Group Pretest-Posttest Design Experimental Group Control Group Study Sample Pretest Pretest Experimental Intervention 2or Standard care Experimental Intervention 1 Posttest Posttest Random Assignment Prof. Asir John Samuel, Professor, MMIPR 45
  • 46.
    MultiGroup Pretest-Posttest Design Experimental Group2 Control Group Study Sample Pretest Pretest No Intervention or Placebo Experimental Intervention 2 Posttest Posttest Experimental Group 1 Pretest Experimental Intervention 1 Posttest Random Assignment Random Assignment Prof. Asir John Samuel, Professor, MMIPR 46
  • 47.
    Posttest-only Control GroupDesign Experimental Group Control Group Study Sample No Intervention or Placebo Experimental Intervention Posttest Posttest Random Assignment Prof. Asir John Samuel, Professor, MMIPR 47
  • 48.
    Crossover design Portney LG,Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 Prof. Asir John Samuel, Professor, MMIPR 48
  • 49.
    Quasi-Experimental Design Portney LG,Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 Prof. Asir John Samuel, Professor, MMIPR 49
  • 50.
    Quasi-experimental study design •An empirical study used to estimate the causal impact of an intervention on its target population • Type of evaluation which aims to determine whether a program or intervention has the intended effect or not Prof. Asir John Samuel, Professor, MMIPR 50
  • 51.
    Founder • Donald ThomasCampbell • November 20, 1916 to May 5, 1996 • American social scientist Prof. Asir John Samuel, Professor, MMIPR 51
  • 52.
    Lacking key components •Pre-post test design • Treatment and control group • Random assignment of participants - Lack one or more of the above Prof. Asir John Samuel, Professor, MMIPR 52
  • 53.
    Concern about • Internalvalidity • Confounding variables • Ethical issues Prof. Asir John Samuel, Professor, MMIPR 53
  • 54.
    Advantages • Randomization isimpractical • Not Unethical • Minimizes threats to external validity • Natural experiments • Continue as longitudinal study Prof. Asir John Samuel, Professor, MMIPR 54
  • 55.
    Disadvantages • Impact ofconfounding variables • Threat to internal validity • Provide weaker evidence because of the lack of randomness • Extraneous variable Prof. Asir John Samuel, Professor, MMIPR 55
  • 56.
    Forms of quasi-exp.study • Pre-post test design without a control group • Pre-post test design with a control group Prof. Asir John Samuel, Professor, MMIPR 56
  • 57.
    One-group pretest-posttest design Prof.Asir John Samuel, Professor, MMIPR 57
  • 58.
    One-way repeated measuresdesign Prof. Asir John Samuel, Professor, MMIPR 58
  • 59.
    Interrupted time-series design Prof.Asir John Samuel, Professor, MMIPR 59
  • 60.
    Nonequivalent pretest-posttest control groupdesign Prof. Asir John Samuel, Professor, MMIPR 60
  • 61.
    Nonequivalent posttest-only control groupdesign Prof. Asir John Samuel, Professor, MMIPR 61
  • 62.
    Single-subject designs Portney LG,Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 Prof. Asir John Samuel, Professor, MMIPR 62
  • 63.
    Reporting of healthresearch studies • CARE - CAse Report (13) • STROBE - Strengthening the Reporting of Observational Studies in Epidemiology (22) 63 www.equator-network.org Prof. Asir John Samuel, Professor, MMIPR
  • 64.
    Reporting of healthresearch studies • SPIRIT - Standard Protocol Items Recommendations for Interventional Trials (33) • PRISMA (http://www.prisma-statement.org/) - Preferred Reporting Items for Systematic Reviews and Meta-Analyses (27) www.equator-network.org Prof. Asir John Samuel, Professor, MMIPR 64
  • 65.
    Reporting of statisticalanalysis • SAMPL - Statistical Analyses and Methods in the Published Literature www.equator-network.org Prof. Asir John Samuel, Professor, MMIPR 65
  • 66.
    Reporting of healthresearch studies • CONSORT - Consolidated Standards of Reporting Trials (25) • TREND - Transparent Reporting of Evaluations with Nonrandomized Designs (22) www.equator-network.org Prof. Asir John Samuel, Professor, MMIPR 66
  • 67.
    Prof. Asir JohnSamuel, Professor, MMIPR 67
  • 68.
    Choice of Design –ResearchQuestions –Research Goals –Researcher Beliefs and Values –Researcher Skills –Time and Funds –Status of existent knowledge –Nature and availability of information –Available resources Prof. Asir John Samuel, Professor, MMIPR 68
  • 69.
    SACKETT LEVEL OFEVIDENCE Prof. Asir John Samuel, Professor, MMIPR 69
  • 70.
    PEDro scale Prof. AsirJohn Samuel, Professor, MMIPR 70
  • 71.
    Randomization • Simple randomization •Block randomization • Stratified randomization • Unequal randomization • http://www.graphpad.com/quickcalcs/index.cfm • http://www.randomization.com Prof. Asir John Samuel, Professor, MMIPR 71
  • 72.
    Simple Randomization • Singlesequence of random assignments • Maintains complete randomness of the assignment of a subject to a particular group • Flipping a coin • Heads - control, tails – treatment • Unequal number of participants among groups • Simple and easy to implement Prof. Asir John Samuel, Professor, MMIPR 72
  • 73.
    Block randomization • Randomizesubjects into groups in equal sample sizes • Blocks are small and balanced with predetermined group assignments • Numbers of subjects in each group similar at all times • Subjects are randomly assigned into blocks Prof. Asir John Samuel, Professor, MMIPR 73
  • 74.
    Block randomization Prof. AsirJohn Samuel, Professor, MMIPR 74
  • 75.
    Stratified randomization • Controland balance the influence of covariates • Generate a separate block for each combination of covariates • Subjects are assigned to the appropriate block of covariates • Simple randomization is performed within each block Prof. Asir John Samuel, Professor, MMIPR 75
  • 76.
    Allocation concealment • Generationof an unpredictable randomised allocation sequence • concealing it at least until patients have been assigned to their groups • Sequentially numbered, opaque, sealed envelopes (SNOSE) Prof. Asir John Samuel, Professor, MMIPR 76
  • 77.
    Allocation concealment Prof. AsirJohn Samuel, Professor, MMIPR 77
  • 78.
    Systematic Reviews and Meta-analysis Prof. AsirJohn Samuel, Professor, MMIPR 78
  • 79.
    Systematic Reviews and Meta-Analyses PortneyLG, Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 Prof. Asir John Samuel, Professor, MMIPR 79
  • 80.
    Reasons to synthesizethe literature • To identify experts in a given topic • More deeper understanding of a given topic • Identify research methods • Single conclusion Prof. Asir John Samuel, Professor, MMIPR 80
  • 81.
    Ways to synthesizeliterature • Narrative reviews • Systematic reviews without meta-analysis • Systematic reviews with meta-analysis Prof. Asir John Samuel, Professor, MMIPR 81
  • 82.
    Systematic reviews withoutmeta-analysis • Compiling studies on a focused topic based on predefined inclusion and exclusion criteria • Reduces bias in interpreting results • Consider negative studies • Come with single unique conclusion Prof. Asir John Samuel, Professor, MMIPR 82
  • 83.
    Systematic reviews withmeta-analysis • Meta-analysis is the analysis of analyses • The size of differences b/w treatment groups (effect size) is mathematically standardized so that it can be pooled across studies with different, conceptually related, dependent variables • Include statistical pooling of results Prof. Asir John Samuel, Professor, MMIPR 83
  • 84.
    1. Framing questionsfor a review 2. Identifying relevant work 3. Assessing the quality of studies 4. Summarizing the evidence 5. Interpreting the findings Prof. Asir John Samuel, Professor, MMIPR 84
  • 85.
    Steps in conductingMeta-analysis 1. Framing questions for a review 2. Identifying relevant work 3. Assessing the quality of studies 4. Statistical pooling of results 5. Interpreting the findings Prof. Asir John Samuel, Professor, MMIPR 85
  • 86.
    Framing questions fora review • Specified in a clear form before beginning • Once protocol is set difficult to change 1. Free-form questions 2. Structured question • Based on population, intervention, outcome and study designs Prof. Asir John Samuel, Professor, MMIPR 86
  • 87.
    Identifying relevant work •Extensive search without language restrictions • Begin with bibliographic databases • Most researchers will “play around” • Printed, online, published and unpublished • Based on selection criteria set in advance • Follows strict inclusion and exclusion criteria Prof. Asir John Samuel, Professor, MMIPR 87
  • 88.
    Assessing the qualityof studies • Based on LoE • Use critical appraisal guidelines & design- based quality checklists • Explore heterogeneity • PEDro for RCT’s Prof. Asir John Samuel, Professor, MMIPR 88
  • 89.
    Summarizing the evidence •Summarize from various study quality • Difference b/w study results • Compare negative and positive studies Prof. Asir John Samuel, Professor, MMIPR 89
  • 90.
    Statistical pooling ofresults • Use of confidence intervals • Pooling of effects across studies • Mathematical complexities are often elegantly summarized in a “forest plot”/blobbogram • Pat Forrest dates back to 1970s Prof. Asir John Samuel, Professor, MMIPR 90
  • 91.
    Forrest Plot Prof. AsirJohn Samuel, Professor, MMIPR 91
  • 92.
    Prof. Asir JohnSamuel, Professor, MMIPR 92
  • 93.
    Interpreting the findings •Care is taken in interpreting the results of low quality studies Prof. Asir John Samuel, Professor, MMIPR 93
  • 94.
    Prof. Asir JohnSamuel, Professor, MMIPR 94
  • 95.
    Prof. Asir JohnSamuel, Professor, MMIPR 95
  • 96.
    Surveys and Questionnaires Prof. AsirJohn Samuel, Professor, MMIPR 96
  • 97.
    Surveys and Questionnaires PortneyLG, Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 Prof. Asir John Samuel, Professor, MMIPR 97
  • 98.
    Survey • System forcollecting information from or about people to describe, compare, or explain their knowledge, attitudes, and behaviour - Fink A (2003) Prof. Asir John Samuel, Professor, MMIPR 98
  • 99.
    Survey • Non-experimental research •Prospective collection of self-reported information • 2 methods - Questionnaires (mailed, internet) - Interview (in-person or telephone) Prof. Asir John Samuel, Professor, MMIPR 99
  • 100.
    Steps in Implementation •Sampling and sample size • Interview or questionnaire design • Implementation • Follow-up • Analysis • Interpretation/inference Prof. Asir John Samuel, Professor, MMIPR 100
  • 101.
    Sampling and samplesize N = Z2 (p)(1-p) / error2 Prof. Asir John Samuel, Professor, MMIPR 101
  • 102.
    Questionnaire development • Drafting -Needs based on literature - Reexamine the purpose of study - Format and comprehensibility - More easily digestible parts - readability Prof. Asir John Samuel, Professor, MMIPR 102
  • 103.
    Questionnaires • Consists ofno. of questions printed or typed in definite order on a form or set of forms • Respondents have to answer the questions on their own • Data is collected through mailing or distributing the questionnaires • Used in survey Prof. Asir John Samuel, Professor, MMIPR 103
  • 104.
    3 main aspects •General form • Question sequence • Question formulation and wording Prof. Asir John Samuel, Professor, MMIPR 104
  • 105.
    General form • Structured/unstructured •Closed (Y/N) or open (inviting free response) • In pilot study unstructured then standardized Prof. Asir John Samuel, Professor, MMIPR 105
  • 106.
    Question sequence • Clearand smoothly-moving • Easiest question being put in beginning • Avoid question that put too great strain on memory, personal character, wealth, etc • General to more specific Prof. Asir John Samuel, Professor, MMIPR 106
  • 107.
    Question formulation andwording • Short and Easily understood • Simple and convey only one thought at a time • Concrete • Can be dichotomous, multiple choice or open- ended Prof. Asir John Samuel, Professor, MMIPR 107
  • 108.
    Questionnaires - Merits •Low cost even when sample size is large • Free from bias of interviewer • Respondent who are not easily approachable can be reached conveniently • More reliable • Respondents have adequate time to answer Prof. Asir John Samuel, Professor, MMIPR 108
  • 109.
    Questionnaires - Demerits •Low rate of return of duly filled in questionnaires • Can be used only when respondents are educated and cooperating • There is inbuilt inflexibility • Slowest of all Prof. Asir John Samuel, Professor, MMIPR 109
  • 110.
    Questionnaires - Demerits •Interpretation of omissions is difficult • Control over the questionnaire may be lost once it is sent • Difficult to know whether willing respondents are true representative Prof. Asir John Samuel, Professor, MMIPR 110
  • 111.
    Questionnaire development • Expertreview - Review by a colleague or colleagues knowledgeable about the topic under study - All important elements of constructs under were addressed ? - Were Q understandable? Prof. Asir John Samuel, Professor, MMIPR 111
  • 112.
    Questionnaire development • Firstrevision - Accept or reject recommendations for change - After critical or peer review • Pilot test - Return rate/response rate - Difficulty in reaching Prof. Asir John Samuel, Professor, MMIPR 112
  • 113.
    Survey method • Finalrevision • Motivating prospects to respond • Implementation • Data analysis • Reporting Prof. Asir John Samuel, Professor, MMIPR 113
  • 114.
    Sampling Prof. Asir JohnSamuel, Professor, MMIPR 114
  • 115.
    Basic definitions • Population -Collection of all the units that are of interest to the investigator • Sample - Representative part of population • Sampling - Technique of selecting a representative group from a population Prof. Asir John Samuel, Professor, MMIPR 115
  • 116.
    Basic definitions • Samplingerror - The difference that occurs purely by chance between the values of sample statistic and that of the corresponding population parameter Prof. Asir John Samuel, Professor, MMIPR 116
  • 117.
    Why ? • Onlyfeasible method for collecting information • Reduces demands on resources (time, finance,.) • Results obtained more quickly • Better accuracy of collected data • Ethically acceptable Prof. Asir John Samuel, Professor, MMIPR 117
  • 118.
    Steps in samplingdesign Target population Study population Sample Study participation Prof. Asir John Samuel, Professor, MMIPR 118
  • 119.
    Characteristic of goodsample design • True representation of population • May result in small sampling error • Each member in population should get an opportunity of being selected • Systematic bias can be controlled in a better way • Results should be capable of being extrapolated Prof. Asir John Samuel, Professor, MMIPR 119
  • 120.
    Types of sampledesign • Probability/Random sampling - Selection of subjects are according to any predicted chance of probability • Non-probability/non-random sampling - Does not depend on any chance of predecided probability Prof. Asir John Samuel, Professor, MMIPR 120
  • 121.
    Types of sampledesign Sample design Random sampling Simple Stratified Systematic Cluster Multistage Non-random sampling convenience Quota Judgment Prof. Asir John Samuel, Professor, MMIPR 121
  • 122.
    Simple random sampling •Equal and independent chance or probability of drawing each unit • Take sampling population • Need listing of all sampling units (sampling frame) • Number all units • Randomly draw units Prof. Asir John Samuel, Professor, MMIPR 122
  • 123.
    How to ensurerandomness? • Lottery method • Table of random numbers - e.g. Tippett’s series - Fisher and Yates series - Kendall and Smith series - Rand corporation series Prof. Asir John Samuel, Professor, MMIPR 123
  • 124.
    Table of RandomNumbers Prof. Asir John Samuel, Professor, MMIPR 124
  • 125.
    SRS - Merits •No personal bias • Easy to assess the accuracy Prof. Asir John Samuel, Professor, MMIPR 125
  • 126.
    SRS - Demerits •Need a complete catalogue of universe • Difficult if size sample is large • Widely dispersed Prof. Asir John Samuel, Professor, MMIPR 126
  • 127.
    Stratified Random Sampling •Used for heterogeneous population • Population is divided into homogeneous groups (strata), according to a characteristic of interest (e.g. sex, religion, location) • Then a simple random sample is selected from each stratum Prof. Asir John Samuel, Professor, MMIPR 127
  • 128.
    SRs - Merits •More representative • Greater accuracy • Can acquire information about whole population and individual strata Prof. Asir John Samuel, Professor, MMIPR 128
  • 129.
    SRs - Demerits •Careful stratification • Random selection in each stratum • Time consuming Prof. Asir John Samuel, Professor, MMIPR 129
  • 130.
    Systematic Sampling • Samplingunits are selected in a systematic way, that is, every Kth unit in the population is selected • First divide the population size by the, required sample size (sampling fraction). Let the sampling fraction be K Prof. Asir John Samuel, Professor, MMIPR 130
  • 131.
    Systematic Sampling • Selecta unit at random from the first K units and thereafter every Kth unit is selected • If, N=1200 • And n=60 • Then, SF=20 Prof. Asir John Samuel, Professor, MMIPR 131
  • 132.
    SS - Merits •Simple and convenient • Less time and work Prof. Asir John Samuel, Professor, MMIPR 132
  • 133.
    SS - Demerits •Need complete list of units • Periodicity • Less representation Prof. Asir John Samuel, Professor, MMIPR 133
  • 134.
    Cluster Sampling • Thesampling units are groups or clusters • The population is divided into clusters, and a sample of clusters are selected randomly • All the units in the selected clusters are then examined or studied Prof. Asir John Samuel, Professor, MMIPR 134
  • 135.
    Types of clustersampling • Single-stage cluster sampling - All the elements from each of the selected clusters are used • Two-stage cluster sampling - A random sampling technique is applied to the elements from each of the selected clusters Prof. Asir John Samuel, Professor, MMIPR 135
  • 136.
    Cluster Sampling • Itis always assumed that the individual items within each cluster are representation of population • E.g. District, wards, schools, industries Prof. Asir John Samuel, Professor, MMIPR 136
  • 137.
    CS - Merits •Saving of travelling time and consequent reduction in cost • Cuts down on the cost of preparing the sampling frame Prof. Asir John Samuel, Professor, MMIPR 137
  • 138.
    CS - Demerits •Units close to each other may be very similar and so, less likely to represent the whole population • Larger sampling error than simple random sampling Prof. Asir John Samuel, Professor, MMIPR 138
  • 139.
    Multistage Sampling • Selectionis done in stages until final sampling units are arrived • At first stage, Random sampling of large sized sampling units are selected, from the selected 1st stage sampling units another sampling units of smaller sampling units are selected, randomly Prof. Asir John Samuel, Professor, MMIPR 139
  • 140.
    Multistage Sampling • Continueuntil the final sampling units are selected • E.g. Few states – District – Taulk Prof. Asir John Samuel, Professor, MMIPR 140
  • 141.
    MS - Merits •Cut down the cost of preparing the sampling frame Prof. Asir John Samuel, Professor, MMIPR 141
  • 142.
    MS - Demerits •Sampling error is increased compared to simple random sampling Prof. Asir John Samuel, Professor, MMIPR 142
  • 143.
    Quota Sampling • Interviewersare requested to find cases with particular types of people to interview Prof. Asir John Samuel, Professor, MMIPR 143
  • 144.
    Judgment (Purposive Sampling) •Researcher attempts to obtain sample that appear to be representative of the population selected by the researcher subjectively Prof. Asir John Samuel, Professor, MMIPR 144
  • 145.
    Convenience Sampling • Samplingcomprises subject who are simply avail in a convenient way to the researcher • No randomness and likelihood of bias is high • Consecutive sampling Prof. Asir John Samuel, Professor, MMIPR 145
  • 146.
    Snowball Sampling • Investigatorsstart with a few subjects and then recruit more via word of mouth from the original participants Prof. Asir John Samuel, Professor, MMIPR 146
  • 147.
    Merits • Easy • Lowcost • Limited time • Total list population Prof. Asir John Samuel, Professor, MMIPR 147
  • 148.
    Demerits • Selection bias •Sample is not representation of population • doesn’t allow generalization Prof. Asir John Samuel, Professor, MMIPR 148
  • 149.
    Validity and Reliability Prof. AsirJohn Samuel, Professor, MMIPR 149
  • 150.
    Validity • Validity ofan assessment is the degree to which it measures what it is supposed to measure Prof. Asir John Samuel, Professor, MMIPR 150
  • 151.
    Reliability • Reliability isthe extent to which a measurement gives results that are consistent • Reliability is used to describe the overall consistency of a measure • A measure is said to have a high reliability if it produces similar results under consistent conditions Prof. Asir John Samuel, Professor, MMIPR 151
  • 152.
    Prof. Asir JohnSamuel, Professor, MMIPR 152
  • 153.
    Prof. Asir JohnSamuel, Professor, MMIPR 153
  • 154.
    Prof. Asir JohnSamuel, Professor, MMIPR 154
  • 155.
    Prof. Asir JohnSamuel, Professor, MMIPR 155
  • 156.
    Prof. Asir JohnSamuel, Professor, MMIPR 156
  • 157.
    Validity • Construct validity •Content validity • Face validity • Criterion-related validity - Concurrent validity - Predictive validity Prof. Asir John Samuel, Professor, MMIPR 157
  • 158.
    Construct validity • Constructvalidity refers to the extent to which operations of a construct do actually measure what the theory says they do • Measure an abstract concept, or construct Prof. Asir John Samuel, Professor, MMIPR 158
  • 159.
    Content validity • Contentvalidity is a non-statistical type of validity that involves "the systematic examination of the test content to determine whether it covers a representative sample of the behavior domain to be measured“ • E.g. VAS vs McGill Pain Questionnaire Prof. Asir John Samuel, Professor, MMIPR 159
  • 160.
    Representation validity • Representationvalidity also known as translation validity, is about the extent to which an abstract theoretical construct can be turned into a specific practical test Prof. Asir John Samuel, Professor, MMIPR 160
  • 161.
    Face validity • Facevalidity is an estimate of whether a test appears to measure what it is supposed to • Measures may have high validity, but when the test does not appear to be measuring what it is, it has low face validity Prof. Asir John Samuel, Professor, MMIPR 161
  • 162.
    Criterion-related validity • Criterionvalidity is the correlation between the test and a criterion variable (or variables) taken as representative of the construct • Compares the test with other measures (gold standard) or outcomes (the criteria) already held to be valid Prof. Asir John Samuel, Professor, MMIPR 162
  • 163.
    Concurrent validity • Concurrentvalidity refers to the degree to which the operations correlates with other measures of the same construct that are measured at the same time Prof. Asir John Samuel, Professor, MMIPR 163
  • 164.
    Predictive validity • Predictivevalidity refers to the degree to which the operation can predict (or correlate with) other measures of the same construct that are measured at some time in the future • E.g. BBS or TUG predicts risk of fall Prof. Asir John Samuel, Professor, MMIPR 164
  • 165.
    Reliability • Inter-rater reliability •Test-retest reliability • Inter-method reliability Prof. Asir John Samuel, Professor, MMIPR 165
  • 166.
    Inter-rater reliability • Degreeto which test scores are consistent when measurements are taken by different people using the same methods Prof. Asir John Samuel, Professor, MMIPR 166
  • 167.
    Test-retest/Intra-rater reliability • Degreeto which test scores are consistent from one test administration to the next • Measurements are gathered from a single rater who uses the same methods or instruments and the same testing conditions • Intra-rater reliability Prof. Asir John Samuel, Professor, MMIPR 167
  • 168.
    Inter-method reliability • Degreeto which test scores are consistent when there is a variation in the methods or instruments used Prof. Asir John Samuel, Professor, MMIPR 168
  • 169.
    Bio-statistics for physiotherapists Asir JohnSamuel, BSc (Psy), MPT (Neuro Paed), MAc, DYScEd, FAGE Assistant Professor, MMIPR Mullana-Ambala, Haryana Prof. Asir John Samuel, Professor, MMIPR 169
  • 170.
    Statistics in MedicalResearch • Documentation of medical history of disease, their progression, variability b/w patient, association with age, gender, etc. • Efficacy of various types of therapy • Definition of normal range • Used in Epidemiological studies Prof. Asir John Samuel, Professor, MMIPR 170
  • 171.
    Statistics in MedicalResearch • Study the effect of environment, socio- economic and seasonal factors • Provide assessment of state health in common, met and unmet needs • Success/failure of specific treatment • Promote health legislation • Evaluate total health programme of action Prof. Asir John Samuel, Professor, MMIPR 171
  • 172.
    Statistics in MedicalResearch - Limitation • Does not deal with individual fact • Conclusion are not exact • Can be misused • Common men cannot handle properly Prof. Asir John Samuel, Professor, MMIPR 172
  • 173.
    Normal distribution • Representedby a family of infinite curves defined uniquely by 2 parameter the mean and the SD of the population • The curve are always symmetrically bell shaped. The width of the curve is defined by population, SD Prof. Asir John Samuel, Professor, MMIPR 173
  • 174.
    Normal distribution • Mean,median and mode coincide • It extends from - ∞ to + ∞ • Symmetrically about the mean • Approx 68% of distribution is within 1SD of mean (68.27%) - 95% - 2SD (1.96 SD) - 99% - 3SD (2.58 SD) Prof. Asir John Samuel, Professor, MMIPR 174
  • 175.
    Normal distribution • Thetotal area under the curve is 1 • The value of measure of skewness is zero. It is not skewed • The curve is asymptotic. It approaches but never touches baseline at extremes • The curve extends on the both sides -3σ distance on left to +3σ distance on the right Prof. Asir John Samuel, Professor, MMIPR 175
  • 176.
    Normal distribution -Uses • Construct confidence interval • Many statistical techniques makes an underlying assumption of normality • Distribution of sample means is normal • Normality is important in statistical inference Prof. Asir John Samuel, Professor, MMIPR 176
  • 177.
    Normality test • Shapiro-Wilktest • Kolmogorov-Smirnov test Prof. Asir John Samuel, Professor, MMIPR 177
  • 178.
    Prof. Asir JohnSamuel, Professor, MMIPR 178
  • 179.
    Prof. Asir JohnSamuel, Professor, MMIPR 179
  • 180.
    Shapiro-Wilk test • Moreappropriate for small sample sizes (< 50 samples) • But can also handle sample sizes as large as 2000 • If the Sig. value of the Shapiro-Wilk Test is greater the 0.05, the data is normal • If it is below 0.05, the data significantly deviate from a normal distribution Prof. Asir John Samuel, Professor, MMIPR 180
  • 181.
    Prof. Asir JohnSamuel, Professor, MMIPR 181
  • 182.
    Kolmogorov-Smirnov test • Appropriatefor larger samples • ≥ 50 samples • If the Sig. value of the Kolmogorov-Smirnov test is greater the 0.05, the data is normal Prof. Asir John Samuel, Professor, MMIPR 182
  • 183.
    Descriptive statistics • Measuresof location - Central tendency - Mean, median and mode • Measures of variation - Dispersion - Range, quartile, IQR, variance and SD Prof. Asir John Samuel, Professor, MMIPR 183
  • 184.
    Prof. Asir JohnSamuel, Professor, MMIPR 184
  • 185.
    Prof. Asir JohnSamuel, Professor, MMIPR 185
  • 186.
    Sample Size Determination Prof. AsirJohn Samuel, Professor, MMIPR 186
  • 187.
    MCID • ‘the smallestdifference in score in the domain of interest which patients perceive as beneficial…’, - Jaeschke • MDC = SEM × √2 × 1.9 • SEM = SD pooled X √(1-r) • MCID = 1 X MDC Prof. Asir John Samuel, Professor, MMIPR 187
  • 188.
    MDC - MCID Prof.Asir John Samuel, Professor, MMIPR 188
  • 189.
    Effect size • Effectsize index (ESI) ESI = Mean Post – Mean Pre / S Pre • Standard response mean (SRM) SRM = Mean Post – Mean Pre / S Change Prof. Asir John Samuel, Professor, MMIPR 189
  • 190.
    Effect size grading Prof.Asir John Samuel, Professor, MMIPR 190 Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015. p.649
  • 191.
    p-value • Probability ofgetting a minimal difference of what has observed is due to chance • Probability that the difference of at least as large as those found in the data would have occurred by chance Prof. Asir John Samuel, Professor, MMIPR 191
  • 192.
    Hypothesis • Alternate hypothesis(HA) - Statement predict that a difference or relationship b/w groups will be demonstrated • Null hypothesis (H0) - Researcher anticipate “no difference” or “no relationship” Prof. Asir John Samuel, Professor, MMIPR 192
  • 193.
    Decision for 5%LOS • If p-value <0.05, then data is against null hypothesis • If p-value ≥0.05, then data favours null hypothesis Prof. Asir John Samuel, Professor, MMIPR 193
  • 194.
    Type I &II errors Possible states of Null Hypothesis Possible actions on Null Hypothesis True False Accept Correct Action Type II error Reject Type I error Correct Action Prob (Type I error) – α (LoS) – False positive Prob (Type II error) – β – False negative 1-β – power of test Dr. Asir John Samuel (PT), Ast Prof, MMIPR
  • 195.
    Type I Errorand Type II Error
  • 197.
    Z values Z 0.05– 1.96 – 95% Z 0.10 – 1.282 – 90% Z 0.20 – 0.84 – 80% Prof. Asir John Samuel, Professor, MMIPR 197
  • 198.
    Comparison of 2means n= 2 [(Zα+Zβ)s/d]² Zα – LoS Zβ – power of study s – pooled SD of the two sample d – clinically significant difference Prof. Asir John Samuel, Professor, MMIPR 198
  • 199.
    Eg. for Comparisonof 2 means • A RCT to study the effect of BP reduction. One group received a no intervention and other- aerobic exercise. What would be the sample size in order to provide the study with power of 90% to detect a difference in sys. BP of 2 mm Hg b/w two groups at 5% LoS? The SD of sys. BP is observed to be 6 mmHg. Prof. Asir John Samuel, Professor, MMIPR 199
  • 200.
    Estimating proportion n =Z α² P (1-P) / d² P – proportion of event in population d – acceptable margin of error in estimating the true population proportion Prof. Asir John Samuel, Professor, MMIPR 200
  • 201.
    Eg. Estimating proportion •To determine the prevalence of navicular drop in ACL injured population by anticipating of 15% with acceptable margin of error is 3% = (1.96)²(0.15)(0.85) / (0.03)² = 544.2 Prof. Asir John Samuel, Professor, MMIPR 201
  • 202.
    Estimating mean n =(Zα σ / d)² σ – anticipated SD of population d – acceptable margin of error in estimating true population mean Prof. Asir John Samuel, Professor, MMIPR 202
  • 203.
    Eg. Estimating mean •To determine the mean no. of days to ambulate pt undergoing stroke rehabilation among stroke pts. Where anticipated SD of days are 60 and acceptable margin of error is 20 days n = (1.96 x 60/20)² n = (5.88)² = 34.6 Prof. Asir John Samuel, Professor, MMIPR 203
  • 204.
    Comparison of 2proportions n = (Zα√2PQ + Zβ√P1Q1+P2Q2)²/(P1-P2)² P = P1+P2/2 Q = 1-P Prof. Asir John Samuel, Professor, MMIPR 204
  • 205.
    Eg. Comparison of2 proportions • To see whether there is any sig. difference in percentage of strength increase after 4 wks of intervention b/w a new technique and standard one • Standard one – 70% (P1) • New technique – 75% (P2) Prof. Asir John Samuel, Professor, MMIPR 205
  • 206.
    Multiple regression N >50 + 8p Where, p - number of predictors Prof. Asir John Samuel, Professor, MMIPR 206
  • 207.
    Testing of hypothesis 1.Evaluate data 2. Review assumption 3. State hypothesis 4. Presume null hypothesis 5. Select test statistics 6. Determine distribution of test statistics 7. State decision rule Prof. Asir John Samuel, Professor, MMIPR 207
  • 208.
    Testing of hypothesis 8.Calculate test statistics 9. What is the probability that the data conform 10. Make statistical decision 11. If p>0.05, then reject(HA) 12. If p<0.05, then accept (HA) Prof. Asir John Samuel, Professor, MMIPR 208
  • 209.
    Testing of Hypothesis Presumenull hypothesis What is the probability that data conform to null hypothesis Retain H0 reject H0 p>0.05 P<0.05 Prof. Asir John Samuel, Professor, MMIPR 209
  • 210.
    Test of Hypothesis •Parametric test • Non-parametric test Prof. Asir John Samuel, Professor, MMIPR 210
  • 211.
    Parametric & non-parametrictest • Paired t-test • Repeated measure ANOVA • Independent t-test • ANOVA • Pearson correlation coefficient • Wilcoxon Signed Rank T • Friedman test • Mann-Whitney U test • Kruskal Wallis test • Spearman Rank correlation coefficient Prof. Asir John Samuel, Professor, MMIPR 211
  • 212.
    Paired t-test • Twomeasures taken on the same subject or naturally occurring pairs of observation or two individually matched samples • Variable of interest is quantitative Prof. Asir John Samuel, Professor, MMIPR 212
  • 213.
    Assumption • The differenceb/w pairs in the population is independent and normally or approximately normally distributed Prof. Asir John Samuel, Professor, MMIPR 213
  • 214.
    Wilcoxon Signed Ranktest • Used for paired data • The sample is random • The variable of interest is continuous • The measurement scale is at least ordinal • Based on the rank of difference of each paired values Prof. Asir John Samuel, Professor, MMIPR 214
  • 215.
    Repeated measures ANOVA •Measurements of the same variable are made on each subject on more than two different occasion • The different occasions may be different point of time or different conditions or different treatments Prof. Asir John Samuel, Professor, MMIPR 215
  • 216.
    Assumptions • Observations areindependent • Differences should follow normal distribution • Sphericity-differences have approximately same variances Prof. Asir John Samuel, Professor, MMIPR 216
  • 217.
    Fried Man test •Data is measured in ordinal scale • The subjects are repeatedly observed under 3 or more conditions • The measurement scale is at least ordinal (qualitative) • The variable of interest is continuous Prof. Asir John Samuel, Professor, MMIPR 217
  • 218.
    Independent t-test • Comparethe means of two independent random samples from two population • Variable of interest is quantitative Prof. Asir John Samuel, Professor, MMIPR 218
  • 219.
    Assumptions • The populationfrom which the sample were obtained must be normally or approximately normally distributed • The variances of the population must be equal Prof. Asir John Samuel, Professor, MMIPR 219
  • 220.
    Mann Whitney-U test •Two independent samples have been drawn from population with equal medians • Samples are selected independently and at random • Population differ only with respect to their median • Variable of interval is continuous Prof. Asir John Samuel, Professor, MMIPR 220
  • 221.
    Mann Whitney-U test •Measurement scale is at least ordinal (qualitative) • Based on ranks of the observations Prof. Asir John Samuel, Professor, MMIPR 221
  • 222.
    ANOVA • Extension ofindependent t-test to compare the means of more than two groups • F = b/w group variation/within group variation • F ratio • Post hoc test (which mean is different) Prof. Asir John Samuel, Professor, MMIPR 222
  • 223.
    Assumptions • Observations areindependent and randomly selected • Each group data follows normal distribution • All groups are equally variable (homogeneity of variance) Prof. Asir John Samuel, Professor, MMIPR 223
  • 224.
    Why not t-test? •Tedious • Time consuming • Confusing • Potentially misleading – Type I error is more Prof. Asir John Samuel, Professor, MMIPR 224
  • 225.
    Kruskal Wallis Htest • Used for comparison of more than 2 groups • Extension of Mann-Whitney U test • Used for comparing medians of more than 2 groups Prof. Asir John Samuel, Professor, MMIPR 225
  • 226.
    Assumptions • Samples areindependent and randomly selected • Measurement scale is at least ordinal • Variable of interest is continuous • Population differ only with respect to their medians Prof. Asir John Samuel, Professor, MMIPR 226
  • 227.
    Chi-square Test (x2) •Variables of interest are categorical (quantitative) • To determine whether observed difference in proportion b/w the study groups are statistically significant • To test association of 2 variables Prof. Asir John Samuel, Professor, MMIPR 227
  • 228.
    Chi-square Test-Assumption • Randomlydrawn sample • Data must be reported in number • Observed frequency should not be too small • When observed frequency is too small and corresponding expected frequency is less than 5 (<5) – Fischer Exact test Prof. Asir John Samuel, Professor, MMIPR 228
  • 229.
    Relationship • Correlation (relativereliability) • Regression (absolute reliability) Prof. Asir John Samuel, Professor, MMIPR 229
  • 230.
    Correlation • Method ofanalysis to use when studying the possible association b/w two continuous variables • E.g. - Birth wt and gestational period - Anatomical dead space and ht - Plasma volume and body weight Prof. Asir John Samuel, Professor, MMIPR 230
  • 231.
    Correlation • Scatter diagram •Linear correlation • Non-linear correlation Prof. Asir John Samuel, Professor, MMIPR 231
  • 232.
    Properties • Scatter diagramsare used to demonstrate the linear relationship b/w two quantitative variables • Pearson’s correlation coefficient is denoted by r • r measures the strength of linear relationship b/w two continuous variable (say x and y) Prof. Asir John Samuel, Professor, MMIPR 232
  • 233.
    Properties • The signof the correlation coefficient tells us the direction of linear relationship • The size (magnitude) of the correlation coefficient r tells us the strength of a linear relationship Prof. Asir John Samuel, Professor, MMIPR 233
  • 234.
    Properties • Better thepoints on the scatter diagram approximate a straight line, the greater is the magnitude r • Coefficient ranges from -1 ≤ r ≤ 1 Prof. Asir John Samuel, Professor, MMIPR 234
  • 235.
    Interpretation • r =1, two variables have a perfect +ve linear relationship • r = -1, two variables have a perfect -ve linear relationship • r = 0, there is no linear relationship b/w two variables Prof. Asir John Samuel, Professor, MMIPR 235
  • 236.
    Assumption • Observations areindependent • Relationship b/w two variables are linear • Both variables should be normal distributed Prof. Asir John Samuel, Professor, MMIPR 236
  • 237.
    Caution • Correlation coefficientonly gives us an indication about the strength of a linear relationship • Two variables may have a strong curvilinear relationship but they could have a weak value for r Prof. Asir John Samuel, Professor, MMIPR 237
  • 238.
    Judging the strength– Portney & Watkins criteria • 0.00-0.25 – little or no relationship • 0.26-0.50 – fair degree of relationship • 0.51-0.75 – moderate to good degree of relationship • 0.76-1.00 – good to excellent relationship Prof. Asir John Samuel, Professor, MMIPR Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall; 2015 238
  • 239.
    Spearman’s Rank correlation •Non-parametric measure of correlation between the two variables (at least ordinal) • Ranges from -1 to +1 Eg: - Pain score of age - IQ and TV watched /wk - Age and EEG output values Prof. Asir John Samuel, Professor, MMIPR 239
  • 240.
    Situation • Relationship b/wtwo variables is non-linear • Variables measured are at least ordinal • One of the variables not following normal distribution • Based on the difference in rank between each variable Prof. Asir John Samuel, Professor, MMIPR 240
  • 241.
    Assumption • Observation areindependent • Samples are randomly selected • The measurement scale is at least ordinal Prof. Asir John Samuel, Professor, MMIPR 241
  • 242.
    Shrout and Fleisscriteria for ICC • < 0.4 = poor • < 0.4 to 0.75 = moderate • 0.75 to < 0.9 = good • ≥ 0.9 = excellent Prof. Asir John Samuel, Professor, MMIPR Shrout PE, Fleiss JL. Intra-class correlations: uses in assessing rater reliability. Psychol Bull. 1979;86:420–428. 242
  • 243.
    Regression • Expresses thelinear relationship in the form of an equation • In other words a prediction equation for estimating the values of one variable given the valve of the other, y = a + bx Prof. Asir John Samuel, Professor, MMIPR 243
  • 244.
    Regression - eg •Wt (y) and ht (x) • Birth wt (y) and gestation period (x) • Dead space (y) and height (x) x and y are continuous y-dependent variable x-independent variable Prof. Asir John Samuel, Professor, MMIPR 244
  • 245.
    Regression line • Showshow are variable changes on average with another • It can be used to find out what one variable is likely to be (predict) when we know the other provided the prediction is within the limits of data range Prof. Asir John Samuel, Professor, MMIPR 245
  • 246.
    Regression analysis • Derivesa prediction equation for estimating the value of one variable (dependent) given the value of the second variable (independent) y = a + bx Prof. Asir John Samuel, Professor, MMIPR 246
  • 247.
    Assumption • Randomly selection •Linear relationship between variables • The response variable should have a normal distribution • The variability of y should be the same for each value of the predictor value Prof. Asir John Samuel, Professor, MMIPR 247
  • 248.
    Prof. Asir JohnSamuel, Professor, MMIPR 248
  • 249.
    Multiple regression • Onedependent variable and multiple independent variable • Derives a prediction equation for estimating the value of one variable (dependent) given the value of the other variables (independent) Prof. Asir John Samuel, Professor, MMIPR 249
  • 250.
    Multiple regression • Thedependent variable is continuous and follows normal distribution • Independent variable can be quantitative as well as qualitative Prof. Asir John Samuel, Professor, MMIPR 250
  • 251.
    Prof. Asir JohnSamuel, Professor, MMIPR 251
  • 252.