Unit-V

Quantitative Research Designs

Mr Zafar Iqbal
MSN,MPH,BSN
Assistant Professor-KMU
 Objectives
• Define Research Design.
• Describe the types of quantitative research designs.
• Discuss the characteristics of quantitative researches.
• Write down methods of data collection in quantitative researches
• Discuss the main characteristics of experimental studies.
• Understand quasi experimental studies.
• Differentiate between experimental and quasi experimental studies.
• Discuss non experimental or non-interventional research.
• Enlist the types of non-experimental researches.
• Explain descriptive design as one of the non-experimental design.
• Discuss descriptive cross sectional research design.
• Discuss correlational study design.
• Discuss the advantages of correlational studies.
 Research/Study Design

• A research design is a systematic plan to study a scientific

problem.

OR

• Research design is the framework that has been created to

seek answers to research questions.
 Research/Study Design

Different aspects of the research/study design include;

[Link],
[Link],
[Link], and
[Link]
 Research/Study Design

[Link] Design includes;

[Link] justifications and protocols,

[Link] the appropriate study type,
[Link] sample sizes,
[Link] on criteria for subject selection (e.g., choosing
controls),
[Link] questionnaires, and numerous other tasks that
are part of the study plan.
 Research/Study Design

2. To conduct a study requires;

[Link] appropriate clearances and approvals, abstracting

records,
[Link] down and interviewing subjects,
[Link] and handling specimens, and
[Link] the data.
 Research/Study Design

3. Analysis begins with;

[Link] the characteristics of the subjects and
[Link] to calculating rates, creating comparative tables
(e.g., two-by-two tables), and
[Link] measures of association (e.g., risk ratios and
odds ratios), tests of statistical significance (e.g., chi-
square), confidence intervals, and the like.

4. Finally, interpretation involves putting the findings of the

study into perspective and making appropriate
recommendations.
 Research/Study Designs

1. Quantitative
2. Qualitative
3. Mixed Methods
 Quantitative Research Designs

• Quantitative research design, with their deductive approach

are well suited for "when", "how much" and "how many"
questions and are therefore suitable for problem
quantification and testing of theories, interventions and
new treatments.

• The general purpose of Quantitative research is to

generalize about or control phenomena.
 Quantitative Research Designs

• An important assumption that underlines the quantitative

approach is that the world that we live in and carry out our
research in is relatively stable, uniform, and coherent;
therefore, it can be measured, understood, and classified
(positivist paradigm).

• Positivist paradigm – reality is fixed objective and exist

independent of knower
 Quantitative Research Designs

• Quantitative methods involve the collection and analysis of

numerical data that is obtained from tests, questionnaires,
checklist, and surveys.
 Quantitative Research Designs

Important features of quantitative research are:

[Link] the problem or questions to be studied and

developing a hypotheses that predicts the results of the
research before the study begins;
[Link] contextual factors that might influence the
results of the study;
[Link] data from samples of participants; and
[Link] numerical, statistical approaches to analyze the
collected data.
 Qualitative Research Designs

• Qualitative research is a type of scientific research. It is an

empirical method of investigation aiming to describe the
informant's perception and experience of the world and its
phenomena.

• Qualitative research is well suited for "why", "how" and

"what" questions about human behaviour, motives, views
and barriers.
 Qualitative Research Designs

• The underlining belief of qualitative research is that the

world is neither stable, coherent, nor uniform, and
therefore, "truth" as sought by quantitative researchers
cannot be obtained because perspectives and
understandings differ from group to group.

• Thus, qualitative research is suitable for problem

identification, hypothesis generation, theory formation and
concept development.
 Qualitative Research Designs

• Qualitative research methods involve the collection and

analysis of primarily non numerical data obtained from
observation, interviews, taped information, documents etc.
 Qualitative Research Designs

The important points of qualitative research are the

following:

[Link] the problem or question to be studied

[Link] researcher takes into account contextual factors of the
research participants;
[Link] is collected from a small number of purposely
selected research participants; and
[Link] non-numerical, interpretive approaches to provide
narrative descriptions of the participants and their contexts.
 Mixed Method

• When used along with quantitative methods, qualitative

research can help us to interpret and better understand the
complex reality of a given situation and the implications of
quantitative data.

• In mixed methods studies, investigators intentionally

integrate or combine quantitative and qualitative data
rather than keeping them separate.
Quantitative Study Designs
 Types of Study Designs

• In observational studies, the researcher observes and

systematically collects information, but does not try to
change the people (or animals, or reagents) being
observed.

• In experimental studies, by contrast, the researcher

intervenes to change something (e.g., gives some patients a
drug) and then observes what happens. In an observational
study there is no intervention.
 Types of Study Designs

• The distinction arises in the method by which study subjects

are exposed.

• Experimental (interventional) study assigns exposure to

study subjects, usually at random, while an observational
study observes the exposure, which occurs “naturally.”

• The essence of an Experimental (interventional) study is

that we intervene.

• In Observational study, the researcher don’t intervene or

manipulate the situation in any way, he simply observe.
Types of Study Designs
 Objectives at various levels

Study Types Objectives

1. Knowing the frequency of disease
DESCRIPTIVE STUDIES 2. Knowing the distribution
3. Developing the hypothesis

OBSERVATIONAL 1. Testing the hypothesis

ANALYTICAL 2. Establishing association

EXPERIMENTAL OR
INTERVENTIONAL 1. Strength of association
STUDIES 2. Establishing the cause
23
 Descriptive Studies

• Describe only; do NOT examine associations between

Exposure (E) and health Outcome (O).

• Generally the purpose is to describe the variability in a

health outcome and/or formulate hypotheses.

• A descriptive study involves describing the

characteristics of a particular situation event or case.

• Descriptive studies can be carried out on a small or

larger scale.
24 24
Types of Descriptive Studies(Individual Based)

Case Study
A study of one diseased individual, providing a
detailed description of an uncommon disease;
provides timely or rare information.
OR
A single patient’s clinical history is described in
detail, and then discussed in relation to the
literature. Almost always a rare unusual, or atypical
case.
Types of Descriptive Studies(Individual Based)

Case Series :
A study of multiple occurrences of unusual cases that
have similar characteristics.
Investigators can calculate the frequency of symptoms
or characteristics of people with the disease.
Results may generate causal hypotheses. Neither a
case study nor a case series includes a comparison
group.
Types of Descriptive Studies(Individual Based)

Cross sectional Surveys

• Subjects or institutions are surveyed in order to
describe the prevalence of health outcomes and
/or characteristics of a population

27 27
Types of Descriptive Studies(Population Based)

• Ecological
• An ecological study focuses on groups of people
(rather than individuals) as the units of analysis.
• The variables include measurements taken at the
group level e.g. infant mortality rates of different
countries.

28
Types of Observational Analytical Studies

29 29
 Analytical (Non-
Intervention) Studies

Cross-
sectional Cohort
studies studies

Case-
control
studies
 Cross-sectional study
• A cross sectional study measures the prevalence of
health outcomes or determinants of health, or both, in a
population at a point in time or over a short period.
• Information is collected from each subject at one point of
time
• Used to provide a snapshot of a population at a point in
time
• The main out-come measure is prevalence
• Limited to the measurement of risk factor and out-comes
at one simultaneous point in time
• Examples: screening surveys
• knowledge attitude and practice (K.A.P.) surveys
 Begin with: Target Population
I

Determine presence or
Sample absence of exposure &
presence or absence of
disease

Gather Data on Exposure and Disease

Exposed; Exposed; Not Not Exposed;

Have Do not Exposed; Do not have
Disease have Have Disease
Disease Disease

4 groups are possible

 Disease No disease II
Exposed a b
Not
Exposed c d

Disease No disease Disease No disease

Exposed a b Exposed a b
Not
Exposed
c d Not c d
Exposed
 III
Disease No disease Disease No disease

Exposed
a b Exposed a b
Not
c d Not c d
Exposed Exposed

Prevalence of exposure Prevalence of disease

compared in diseased and compared in exposed and
non diseased non exposed
a
vs.
b OR a c
a+c vs.
b+d a+b c+d
 Advantages of cross-sectional

• Outcomes and exposures measured at the same time

• Uncovers associations for further study
• Useful for hypothesis generation
• Quick & cheap (no follow up)
• Best way to determine prevalence
• Questionnaire/interview based
• Useful for assessing practice, attitudes, knowledge,
beliefs , utilisation of services etc
 Advantages of cross-sectional
• Can be conducted to assess the health care needs of the
population
• Helpful in measuring access and utilization of health
services
• Provides information between disease and various
variables
• Provides information regarding distribution of a disease
• Determines burden of the diseases in a population. So
helpful for planning purposes
 Limitations of Cross-Sectional study

• No temporal or time sequence:

so gives no information whether which comes first i.e.
Cause or Disease

• Gives no idea about natural history of the disease or

etiology

• Gives no measure of new cases occurrence

• Not useful for rare exposures or rare outcomes
 COHORT STUDY

• Cohort studies are also called “Follow-up or Incidence

Studies”.

• Because the data on exposure and disease refer to

different points in time, cohort studies are also
longitudinal.

• Cohort studies have also been called “Prospective

Studies”.
 Cohort studies

Birth cohort: all individuals in a defined geographical

area born in the same period (usually a year)
Inception cohort: all individuals assembled at a given
point based on some factor e.g. Workplace
 Cohort studies

Exposure cohort: a group of individuals that

potentially share a common exposure e.g. Radiation

Disease cohort: a group of individuals with a

specific disease.
 STEPS IN COHORT STUDY

Cohort studies are conducted in three fundamental

steps:

[Link] cohorts of exposed and unexposed

individuals who are free of the disease/outcome of
interest at the beginning of the study.
[Link] each cohort over time for the development
of the outcome(s) of interest.
[Link] the risks of outcomes between the cohorts.
COHORT STUDY DESIGN
Cohort studies
Recruitment

Prospective
Exposure Outcome

Retrospective
Exposure Outcome

Exposure Outcome
Ambidirectional
Exposure Outcome

Time
 COHORT STUDY DESIGN

• Cohort study measure:

[Link] rate
[Link] Risk
[Link] Risk
 DESIGN OF A COHORT STUDY

Then Follow to see whether

Disease Disease Total Incidence

Develop Does not Rate of
Develop Disease

First Exposed a b a+b a/a+ b

Select
Not
Exposed c d c+d c/c + d
 INCIDENCE RATE

• Incidence in exposed group = a/ a + b

• Incidence in unexposed group = c/ c + d

• Incidence in total (exposed + unexposed)

•= a+c
a+b+c+d
 RELATIVE RISK

• Cohort study determine whether there is an

association between exposure to a factor and
development of a disease.

• Relative Risk = Incidence in exposed

Incidence in unexposed

= a/ a + b
c/ c + d
 ATTRIBUTABLE RISK

• This is determined by the “Attributable Risk”, which is

defined as “the amount or proportion of diseases
incidence (or disease risk) that can be attributed to a
specific exposure”.

• Attributable Risk is calculated as follow:

• Risk Difference = (Incidence in exposed group ) –

(Incidence in non-exposed group [Background risk]
 Advantages of cohort studies

• Useful for rare exposures

• Useful for more than one outcome
• Incidence of the outcome (and incidence rates)
• Temporal relationship between exposure and outcome
is clear as exposure status defined at start of study
• If prospective, minimises bias in measurement of
exposure
• Sometimes the only ethical or legal way to do study
• Stratification, nested case-controls, and multivariate
analyses (adjustment) can be applied
 Disadvantages of cohort studies

• Not good for study of rare outcomes

• If retrospective they rely on the adequacy of records
• Exposed may be followed more closely than
unexposed
• If prospective they can be very expensive and slow
• As they are follow up studies, the validity of results
is highly sensitive to losses to follow up (migration,
withdrawal, lack of participation, death)
CASE-CONTROL STUDY DESIGN
 Case-control studies

•An analytical epidemiologic study design in which

individuals who have the disease under study, also called
cases, are compared to individuals free of disease (controls)
regarding past exposures.
•Exposure differences between cases and controls are
helpful to find potential risk or protective factors.
•The purpose is to determine if there are one or more
factors associated with the disease under study.
 CASE-CONTROL STUDY

• To examine the possible relation of an exposure to a

certain disease, we identify;

1.A group of individuals with the disease (called cases)

and for purpose of comparison,

2.A group of people without the disease or outcome

variable (called controls ).

[Link] study compares the occurrence of the possible

cause in cases and in controls.
DESIGN OF A CASE-CONTROL STUDY
 Advantages of case-control Studies

• Can be carried out quickly and quite cheaply

• Useful for rare diseases and outcomes
• Can study multiple exposures for a single outcome
• Case control studies can be ideal for the study of rare
diseases or those with a long latency
• Compares odds of exposure between cases and
controls
 Disadvantages of case-control studies

• Selection of control population, overmatching

• Information bias as exposures – similar status
determined after outcome has occurred e.g. Recall
• Selection bias especially regarding controls
• Cannot establish sequence of events (temporal
relationship)
• Not good for rare exposures
• Cannot usually be used to estimate incidence rates,
relative risks or attributable risks
EXPERIMENTAL STUDY
DESIGN
 Types of Experimental Research Design

There are two types of experimental research design

[Link] Controlled Trials (RCTs)

[Link]-experimental research design (With out Controlled Trials)

 RANDOMIZED CONTROLLED TRIAL

• The true experimental study design (RCT) has three

characteristics:

[Link] - the researcher takes care to

randomly assign subjects to the control and
experimental groups.

• (Each subject is given an equal chance of being

assigned to either group.)
 RANDOMIZED CONTROLLED TRIAL

[Link] - the researcher introduces one or more

control group(s) to compare with the experimental
group.

[Link] - the researcher does something to

one group of subjects in the study.

• Note: The strength of experimental studies is that by

randomization of confounding variables.
 BLINDING IN RCT

• Blinding represents an important, distinct aspect of

randomized controlled trials.

• The term blinding (masking) refers to keeping trial

participants, investigators (usually healthcare
providers), or assessors (those collecting outcome
data) unaware of an assigned intervention, so that
they are not influenced by that knowledge.

• Blinding prevents bias at several stages of a trial.

 TYPES OF BLINDING

• Single Blind
• The subjects are not knowing the group to which they are
belonging .

• Double blind trials

• Neither the subject nor care giver is aware about the groups

• Triple blind trials

• The subject, the care giver (nurse or doctor) and the person
doing the analysis are not aware about the groups in.

78
78
 Types of RCTs Design

• Posttest-Only Design
• Pretest post-test Design
• Solomon 4 Groups
• Factorial
 Randomized Posttest-Only Design

• This type of design has two randomly assigned

groups
• An experimental group and a control group.
• Neither group is pretested before the
implementation of the treatment.
• The treatment is applied to the experimental group
and the post-test is carried out on both groups to
assess the effect of the treatment or manipulation.
• This type of design is common when it is not
possible to pretest the subjects.
 Randomized Pretest-Posttest Design

• In this designs, subjects are randomly assigned to

either the experimental or the control group.
• The effect of the dependent variable on both the
groups is seen before the treatment (pretest).
• Later, the treatment is carried out on experimental
group only, & after-treatment observation of
dependent variable is made on both the groups
(post-test)
 Factorial design
• In factorial design, researcher manipulates two or
more independent variables simultaneously to
observe their effects on the dependent variable.
• This design allows for the testing of two or more
hypotheses in a single project.
• For example, a researcher wants to observe the
effect of two different protocols of mouth care on
prevention of VAP(Ventilator-associated Pneumonia)
when performed at different frequencies in a day.
 Solomon 4 Groups

The Solomon four-group design is a true experimental research design

that involves four groups of participants:
•A pretest-treatment group,
•A pretest-control group,
•A treatment-posttest group,
•A control-posttest group.
This design allows researchers to assess the impact of a treatment while
also controlling for potential pretesting effects.
 Advantages of RCT

• Exposure in under control.

• Due to randomization both intervention and
control groups have similar characteristics.
• By blinding the study, the observer and selection
bias can be eliminated.
• If properly designed & conducted, it can reduce
the confounding.
• Can confirm or refute etiological hypothesis.
• Can evaluate the efficacy / effectiveness /
efficiency of health services.
• Best method for studying causal relationship.
88
 Disadvantages of RCT

• Ethical problems:
Due to adverse effects
Due to benefits of intervention in the treated group
Provision of Placebo

• Relatively expensive

89
 QUASI EXPERIMENTAL STUDY

• In a Quasi Experimental Study, at least one

characteristic of a true experiment is missing, either
randomization or the use of a separate control group.

• A quasi experimental study, however, always includes

manipulation of an independent variable that serves
as the intervention.
Types of Quasi-experimental Design

• Nonrandomized control group design

• Time-series design
 Non-randomized control group design

• This type of design includes at least one

experimental group and one control group used for
comparison.
• This design is identical to the pretest-posttest
control group design, except there is no random
assignment of subjects in experimental & control
groups.
• Once the experimental and control groups have
been identified, the groups may be tested and
compared in a pre-test/post-test manner or in a
longitudinal manner (time series).
 Time-series Design
• A time series design is one in which the researcher
observes a group of subjects repeatedly both before
and after the administration of treatment.
• This design is chosen when attempting to
demonstrate long term effects.
• The experimenter would continue to administer the
treatment & measure the effects a number of times
during the course of the experiment.
• The time series design can be improved by adding
comparison with a control group that does not
receive the treatment.
 Time-series Design Example

• A researcher might want to assess pain levels of a

group of patients. After 3 weeks of pain
assessment, subjects are taught special exercises to
reduce that pain. During the next 3 weeks, pain
levels would again be measured.
 STUDY TYPES & STRENGTH OF EVIDENCE

• Analytic Study involves the systematic evaluation of suspected

relationships, for example, between an exposure and a health
outcome.

• Analytic studies typically provide stronger evidence concerning

particular relationships.

• An experimental design is the only type of study design that

can actually prove causation.
 References

Burns, N. & Grove, S. K. (2007). Understanding nursing research.

(4th ed.). Philadelphia: W.B. Saunders.

Burn, N., & Grove, S. K. (2005). The practice of nursing research:

Conduct, critique & utilization. (5th ed.). Philadelphia: W.B.
Saunders.
Principles of Epidemiology in Public Health Practice, Third
Edition An Introduction to Applied Epidemiology and
Biostatistics