Quantitative

research design
A/Professor Paul M Middleton
Director, South Western Emergency Research Institute
“Science is a way of
thinking much more
than it is a body of
knowledge”

Carl
Sagan
Quantitative research design
Research Methodology,
Research Designs, and Methods

Quantitative
Approaches

Exploratory Designs Descriptive designs Causal designs

Mathematical
In-depth interviews
models Single factor Multifactor
experiments experiments

Focus group
interviews Field surveys Quasi-experimental Non-experimental
designs designs
Quantitative research
The way of thinking…
Quantitative researchers study the relationships
between two variables, which are things expected
to change or vary among the group being studied
Variables are defined concepts which can be
observed or measured
Researchers study how a change in one variable
influences a change in another variable
Empirical
Quantitative research
Empirical
“…treatment should be based on observation and
experience rather than on deduction from
theoretical principles.”
“…pursues knowledge by means of direct
observation, investigation, or experiment”
Quantitative research design
Quantitative research design
Categories
Most empirical research belongs clearly to one of
two general categories.
Observational / correlational research - we try not to
influence any variables but only measure them and
look for relations (correlations) between them
Quantitative research design
Categories
Most empirical research belongs clearly to one of
two general categories…
Observational / correlational research - we try not to
influence any variables but only measure them and
look for relations (correlations) between them
Experimental research - we manipulate some
variables and then measure the effects of this
manipulation on other variables…
 Quantitative research design
Study design
Did investigator assign exposure?
Y N

Experimental study Observational study

Random allocation? Comparison group?

Y N
Y N
Analytical Descriptive
RCT Non-RCT
Direction?

Exposure > Outcome

Exposure < Outcome
Case-
Cohort
control
study
study
Quantitative research design
Variables
Two main types of variables in quantitative
studies…
Independent variable (X)
Dependent variable (Y)
Error
Quantitative research design
Variables
Quantitative research design
Independent variable
The independent variable (X) is the one that the
researchers think will have an effect on the
dependent variable (Y) being studied
If the research design is experimental, the
researchers manipulate X and observe the changes
in Y
If the study is observational, the researchers
assume variability occurs in X and observe the
changes in Y
Quantitative research design
Dependent variable
The dependent variable is assumed to be the result
of, or change based on, the presence, absence or
magnitude of the independent variable being
studied
The outcome of the dependent variable depends on
the independent variable
Research questions are worded in a way that a
reader should be able to identify the independent
and dependent variables
Quantitative research design
Research questions
Research questions / hypotheses are the
foundation of good research
Quantitative research design
Research questions
opulation
Quantitative research design
Research questions
Quantitative research design
Research questions
Quantitative research design
Research questions
Quantitative research design
Research questions
Quantitative research design
Research questions
“A concise, focused and debatable question that
provides a clear path for research”
What is the effect of tutoring on a student’s grades?
What is the relationship between the number of
tutoring sessions a student receives and their
grades?
Quantitative research design
Research questions
“A concise, focused and debatable question
Independent Dependent
that
provides a clear path for research”
variable variable
What is the effect of tutoring on a student’s grades?
What is the relationship between the number of
tutoring sessions a student receives and their
grades?
Quantitative research design
Hypothesis
“A formal statement which predicts the relationship
between two or more variables”
The researcher’s ‘best guess’ as to the
relationship…
Time spent studying is positively correlated with
student grades
The more time spent studying, the better the grades
will be
Quantitative research design
Hypothesis
“A formal statement which predicts the relationship
between two or more variables”
Independent
The researcher’s ‘best guess’ as to the
relationship…
variable
Time spent studying is positively correlated with
student grades
The more time spent studying, the better the grades
Dependent
will be variable
Quantitative research design
Which to use…?
It depends on whether a reasonable amount of
evidence exists around the topic…
Research question Exploratory research, little
research exists, or there is an ambiguous
relationship between the variables
Hypothesis Use when you are confident that a
relationship may exist between the variables
Quantitative research design
But...
Although the amount of time studying may affect
student grades, we cannot say that the studying
causes the increased grades, because there are
other factors which may have had an impact
These are known as confounders or biases
Researchers need to be careful not to state that
there is a cause – effect relationship without
controlling for confounders and biases
Quantitative research design
Confounders and biases
Both confounders and biases are forms of error
Henri-Frederic
Amiel
“An error is the more
dangerous in
proportion to the
degree of truth which it
contains”

Henri-Frederic
Amiel
Quantitative research design
Types of error
Random
Type 1
Type 2
Systematic
Bias
Confounding
Quantitative research design
Random error less precision
Quantitative research design
Systematic error less validity
Quantitative research design
Types of error
Random
Type 1
Type 2
Systematic
Bias
Confounding
Quantitative research design
Random error
Quantitative research design
Random error
Errors from random error will cancel each other out
in the long run (large sample size)
Random error leads to imprecise results
Type 1 error – false negatives
Type 2 error – false positives
Quantitative research design
Types of error
Random
Type 1
Type 2
Systematic
Bias
Confounding
Quantitative research design
Systematic error
Quantitative research design
Systematic error
Quantitative research design
Biases
Biases are systematic errors that can affect
scientific investigations and distort the
measurement process
While some study designs are more prone to bias,
its presence is universal, and it is difficult or even
impossible to completely eliminate it
The goals are to minimise bias and to understand
its residual effects, limiting misinterpretation and
misuse of data
Quantitative research design
Biases
A biased study loses validity in relation to the
degree of the bias
Researchers also need to be careful not to state
that there is a cause – effect relationship without
controlling for confounders and biases
Quantitative research design
Confounders
Confounders are variables that interfere with, or
influence, the relationship between the variables
under study
Confounding variables may compete with X to
explain Y
This is why non-experimental design cannot prove
causation
Quantitative research design
Confounders
Confounders are variables that interfere with, or
influence, the relationship between the variables
under study
Quantitative research design
Confounders
Confounders are variables that interfere with, or
influence, the relationship between the variables
under study
Quantitative research design
So back to design…
Quantitative research design
So back to design…
Quantitative research design
So back to design…
This is the time to consult a statistician!
Quantitative research design
So back to design…
Quantitative research design
Planning
Research ideas may originate from…
Practical clinical problems
Reading the literature and thinking of ways to
extend or refine previous research
Translation of basic science discoveries
Quantitative research design
Planning
Literature review always required to…
Identify related research
Define the knowledge gap
Avoid redundancy when the answer is already clear
Set the research within a proper conceptual and
theoretical context
> Generate research questions and hypotheses
Quantitative research design
Design…
 Quantitative research design
Design…
Can you assign exposure?
Y N

Experimental study Observational study

Random allocation? Comparison group?

Y N
Y N
Analytical Descriptive
RCT Non-RCT
Direction?

Exposure > Outcome

Exposure < Outcome
Case-
Cohort
control
study
study
Quantitative research design
So back to design…
Can you assign exposure?
N

Observational study
Quantitative research design
So back to design…
Can you assign exposure?
N

Observational study

Comparison group?
Quantitative research design
So back to design…
Can you assign exposure?
N

Observational study

Comparison group?
N
Descriptive
Quantitative research design
Descriptive study
Generate hypotheses
Answer what, who, where, and when
Case report
Case series
Incidence
Cross-sectional
Quantitative research design
Descriptive study
Generate hypotheses
Answer what, who, where, and when
Case report
Case series
Incidence
Cross-sectional
Quantitative research design
Cross sectional study
Purpose - To learn about the characteristics of a
population at one point in time - “snap shot”
Design - No comparison group
Population - All members of a small, defined group
or a sample from a large group
Results - Produces estimates of the prevalence of
the population characteristic of interest
Quantitative research design
Cross sectional study
Quantitative research design
Cross sectional study
Purpose - To learn about the characteristics of
patients with chest pain
Design - No comparison group
Population – All patients presenting to the ED
complaining of non-traumatic chest pain in a one-
month period
Results - Produces estimates of the prevalence of
chest pain, and describes patient outcomes
Quantitative research design
So back to design…
Can you assign exposure?
N

Observational study

Comparison group?
Y
Analytical
Quantitative research design
So back to design…
Can you assign exposure?
N

Observational study

Comparison group?
Y
Analytical

Direction?

Exposure < Outcome

Case-
control
study
Quantitative research design
Case control study
Case-control studies are observational studies that
begin by targeting a disease or condition of interest
and then work backward to determine associations
with previous exposures
Quantitative research design
Case control study
Purpose
To study uncommon diseases
To study multiple exposures > single outcome
Study Subjects
Participants selected based on outcome…
Case-subjects have outcome of interest
Control-subjects do not have outcome of
interest
Quantitative research design
Case control study
Identify case precisely
Identify control subjects who were exposed to the
same exposure but who do not have the problem
Compare the two groups using Odds Ratios
Quantitative research design
Case control study
Exposure Cases Controls
Yes a b
No c d

Odds of being exposed among the cases = a/c

Odds of being exposed among the controls = b/d
Exposure odds ratio = (a/c)/(b/d)
Quantitative research design
Case control study example
Cases - patients with pulmonary embolus following
long flight
Controls - patients without pulmonary embolus
following long flight
Exposure - consumption of alcohol
Quantitative research design
Case control study example
Alcohol PE No PE
Yes a b
No c d

Odds of alcohol among the cases = a/c

Odds of alcohol among the controls = b/d
Exposure odds ratio = (a/c)/(b/d)
Quantitative research design
So back to design…
Can you assign exposure?
N

Observational study

Comparison group?
Y
Analytical
 Quantitative research design
So back to design…
Can you assign exposure?
N

Observational study

Comparison group?
Y
Analytical

Direction?

Exposure > Outcome

Cohort
study
Quantitative research design
Cohort study
What is a cohort?
A well-defined group of individuals who share
common characteristic or experience; for example -
individuals born in the same year
Quantitative research design
Cohort study types
Prospective cohort studies
Group participants according to past or current
exposure; follow-up to determine if outcome occurs
Retrospective cohort studies
At the time of study, potential exposure and
outcomes have already occurred in the past, so a
retrospective study is conceived after the data have
been collected
Quantitative research design
Cohort study prospective
Disease
Exposed
No disease
Study
population
Disease
Unexposed
No disease

Start of study Future

Quantitative research design
Cohort study retrospective
Disease
Exposed
No disease
Study
population
Disease
Unexposed
No disease

Start of study
Quantitative research design
Cohort study
Exposure Disease No disease
Yes a b
No c d

Incidence (I) (exposed) = a/a+b

Incidence (I) (not exposed) = c/c+d
Relative risk = I (exposed) / I (not exposed)
Quantitative research design
Cohort study example
Exposed - patients given “weirdomycin” for cough
Not exposed – patients not given “weirdomycin” for
cough
Outcome - rash
Quantitative research design
Cohort study
Weirdomycin Rash No rash
Yes a b
No c d

I rash (exposed) = a/a+b

I rash (not exposed) = c/c+d
Relative risk = I rash (exposed) / I rash (not
exposed)
Quantitative research design
So back to design…
 Quantitative research design
So back to design…
Can you assign exposure?
Y N

Experimental study Observational study

Random allocation? Comparison group?

Y N
Y N
Analytical Descriptive
RCT Non-RCT
Direction?

Exposure > Outcome

Exposure < Outcome
Case-
Cohort
control
study
study
Quantitative research design
So back to design…
Can you assign exposure?
Y

Experimental study
Quantitative research design
So back to design…
Can you assign exposure?
Y

Experimental study

Random allocation?
Quantitative research design
So back to design…
In contrast to observational study designs,
interventional studies may manipulate clinical care
to evaluate treatment effects on outcomes
Prospective controlled interventional trials will
provide a higher level of evidence for a true cause-
and-effect relationship
Quantitative research design
So back to design…
Can you assign exposure?
Y

Experimental study

Random allocation?
N

Non-RCT
Quantitative research design
Non-randomised trials
Unfortunately, many interventions often do not
readily lend themselves to randomised blinded
trials, because of…
Consent
Intervention
Blinding
Therapeutic diversity
Learning effects
Quantitative research design
Non-randomised trials
Non-randomly assigned control group studies – at
least two separate groups are evaluated - one of
which receives the intervention of interest and
another that serves as a control or comparison
group
The nonrandom control group is thus similar in
design to a RCT, except that patients are assigned
to treatment groups in a nonrandom fashion
Quantitative research design
Non-randomised trials problems
Selection bias – unrepresentative group
Misclassification bias – error in classifying disease
Sampling bias
Observer bias
Detection bias
Disease progression
Consent
Quantitative research design
Non-randomised trials analysis
Various statistical techniques used to eliminate bias
due to non-randomisation
Stratification
Regression
Propensity scoring
Quantitative research design
So back to design…
Can you assign exposure?
Y

Experimental study

Random allocation?
Y

RCT
Quantitative research design
Randomised Controlled Trials (RCT)
The gold standard for assessing the effectiveness
of therapeutic interventions, providing the strongest
evidence of association between a specific factor
and an outcome
Designed to isolate the causal effects of one or
more specific interventions by assigning people to
different treatments or control procedures
Quantitative research design
Randomised Controlled Trials (RCT)
Removes systematic bias if performed correctly, but
needs potential equivalence of intervention; when
there is ongoing uncertainty regarding the impact of
the treatment.
Need equipoise - defined as the point in which a
rational and informed person has no preference
among two or more available treatments
Quantitative research design
Randomisation
Quantitative research design
Randomisation
Randomisation is used to balance the
characteristics of trial participants – both measured
and unmeasured – across the treatment groups
Quantitative research design
Randomisation
RCTs are similar to cohort studies in that they
evaluate outcomes over time, but…
Patients randomly assigned to treatment or control
group; cohort study patients allocated according to
‘natural’ exposure
Randomising large numbers of people >
confounding factors such as the presence and
severity of comorbid conditions will be
similar between the treatment and control groups
Quantitative research design
Blinding
Quantitative research design
Blinding
Blinding describes study procedures used to
prevent participants and investigators from knowing
the identity of the interventions received throughout
the duration of a trial
A single blind study describes blinding of only the
participants
A double-blind study describes blinding of both the
participants and the investigators
Quantitative research design
Concealment
Quantitative research design
Concealment
Concealment of treatment allocation is used to
prevent investigators being aware of whether the
subject is being allocated to either an intervention or
comparator / placebo group
Often use third party to perform the randomisation
and allocate the study treatments, but withhold such
information from study personnel, investigators, and
participants until the end of the study
Thank you
Well known trials

paul.middleton@health.nsw.gov.au