RESEARCH APPROACH

& DESIGN

Faculty of Health Professions

Department of Nursing
Al Quds University
 Lecture 4
Research Design
Learning Objectives:

At the end of the discussion you should be able to do

the following:
1-Define and explain the
*concept of a research design
*Purposes of research design
*Characteristics of good design
2-Identify and explain the different categories and
sub-categories of research design
 Research approach &
research design

➢ Research approach & research design are two terms

that are frequently used interchangeably; however
research design is a broader plan to conduct a study, &
research approach is an important element of the research
design, which governs it.
➢ Research design can be defined as a blue print (road
map) to conduct a research study, which involves the
description of research approach, study setting,
sampling size, sampling technique, tool & methods of
data collection & analysis to answer specific research
questions or for testing research hypothesis.
 3-4

ELEMENTS OF RESEARCH DESIGN

Research design can be defined as a set of instructions for
the researcher; to gather and analyze data in certain ways
that will control who and what are to be studied (Brink).
Thus, the choice of design is made when the question is
finalized.
The researcher’s plan:
▪ How the study will be conducted,
▪ Type of data that will be collected, and
▪ The means to be used to obtain these data (which are determined
after variables are identified & quantified).
 3-5

ELEMENTS OF RESEARCH DESIGN

Quantitative
With or without
APPROACH Conceptual
Qualitative
framework
Methods of Both
Analysis
ELEMENTS Population, Sample &
Sampling Technique

Tool & Methods Time & Method of

Data Collection
 3-6

The Approach …….

◼ It involves the description of the plan to investigate the
phenomenon under study in a structured (quantitative),
unstructured (qualitative) or a combination of the two
methods (quantitative- qualitative integrated approach).
◼ Therefore, the approach helps to decide about the presence
or absence as well as manipulation & control over
variables.
◼ It also helps to identify the presence or absence of &
comparison between groups.
◼ The approach of research study depends on several factors,
but primarily on the nature of phenomenon under study.
 3-7

Population, Sample & Sampling Technique…

◼ Research design also provides the researcher with

directions about population, sample & sampling
technique, which will be used for the research study.

◼ For example, in an ethnographic qualitative

research design, a researcher gets the directive that
the population will be a specific cultural group &
the study will include a small sample selected
through a nonprobability sampling technique.
 3-8

Time & Method of Data Collection …

◼ Time (specifying days, months, & years of study),

location (study setting) & the sources of the
requisite data are the other important constituents
essential to ensure effective planning to conduct a
research study
 3-9

Tool & Methods…

◼ This element of research design involves the

description of different tools & methods of data
collection,
◼ For example, questionnaires, interview, direct
observation or any other methods that suit the
particular approach of the research as well as nature
of the phenomenon under study
 3-10

Methods of Analysis …

◼ A research design must also include the description

of the methods of data analysis either quantitative or
qualitative data analysis techniques – that helps the
researcher to collect the relevant data, which later
can be analyzed as per the research design plan.

◼ Without a formal plan of data analysis a researcher

may collect irrelevant data, which can later become
difficult to analyze.
 3-11
Selection of Research Design
Factors affecting research design
1. Nature of the research problem.
2. Purpose of the study.
3. Researcher’s knowledge & experience.
4. Researcher’s interest & motivation.
5. Research ethics & principles.
6. Subjects & participants.
7. Resources.
8. Time.
9. Possible control on extraneous variables.
10. Users of the study findings
 Factors affecting research design ,,, 3-12

Cont’d

• Nature of the research problem: This is the most

important factor, which helps the researcher to decide about
the selection of a research design. Based on the nature of
research problem or phenomenon, researchers decide
whether it should be investigated through an experimental,
quasi experimental, or non-experimental approach.
• Purpose of the study: Study may be conducted for the
purpose of prediction, description, exploration, or
correlation of the research variable. Therefore, the purpose
of the research study helps the researcher to choose a
suitable research design.
 Factors affecting research design ,,, 3-13

Cont’d

• Researcher’s knowledge & experience: Selection of

research design is largely influenced by the researcher’s
knowledge & experience, because they avoid using those
designs wherein they lack confidence, relevant knowledge,
or experience.
• Researcher’s interest & motivation: Interest &
motivation levels help researchers decide about the
particular research design(s). Motivated researchers always
analyze most aspects of research design before selecting
one or a combination, while casual & callous researchers
‫ باحثون عاديون وقاسيون‬may choose research design(s) that may lead to

failure.
 Factors affecting research design ,,, 3-14

Cont’d

• Research ethics & principle: The incorporation &

application of ethical & legal principles in the research
design are essential. This includes moral obligations such
as respect for participants & their rights, informed consent,
& protection from harm, including any adverse effects to
educational progress, health & well-being. Selection of a
research design is significantly influenced by the ethics of
the research study.
• For example, a researcher may be willing to conduct a
research study through a certain experimental approach, but
problems of ethical approval may stop the researcher to do
so & he or she may have to settle for another available
possible research design.
 Factors affecting research design ,,, 3-15

Cont’d

• Subjects/participants: The number & availability of study

subjects may influence the selection of research design. If
only few subjects are involved, an in-depth qualitative
researcher may opt ‫ يقرر‬،‫ يختار‬for qualitative research design.
• Resources: None of the researcher can conduct without
resources such as money, equipment, facilities, & support
from colleagues. However, some of the studies require
more amounts of resources as compared to others.
• Therefore, the selection of a research design may be
affected by the availability of resources for the research
study.
 Factors affecting research design ,,, 3-16

Cont’d

• Time: Time is also a major deciding factors for the

selection of research design. For example, a researcher
needs more time to conduct longitudinal studies, while
cross-sectional studies may be conducted in shorter time.
Therefore, time is also a significant contributing factor in
selection of a research design.
• Users of the study findings: A research design also various
methods of data collection & data analysis. Therefore,
while choosing a research design, researcher must ensure
that research design is as appropriate for the users of the
study findings as possible, so that maximum advantage of
the results can be obtained.
 Factors affecting research design ,,, 3-17

Cont’d

• Possible control on extraneous variables: An efficient

design can maximize result, decrease errors, & control pre-
existing or impaired conditions that may affect the outcome
of the study. The maximized efforts of the researcher
should maximize control. Therefore, possible control over
the extraneous variables may affect the selection of a
research design.
• For example, a researcher wants to conduct a study
through true-experimental design but because of inability to
control selected extraneous variables, other similar design
has to be opted for, such as quasi-experimental or pre-
experimental research design.
 3-18

Purposes of Research Design

◼ It provides a plan for answering research question.

◼ It maintains control to avoid bias that may affect
the outcomes.
◼ Each design has its own applicability depending
on the problems and objectives of the study.
◼ Important consideration – to minimize possible
errors and maximize the reliability and validity of
data.
 3-19

Characteristics of good design

1- Appropriateness to the research question.

2- Lack of bias.
3- Precision.
4- Power.
◼ Research design can be either quantitative or
qualitative. Both designs complement each other
because they generate different kinds of
knowledge that are useful in nursing practice.
 3-20

RELIABILITY AND VALIDITY

Reliability
▪ refers to the consistency, stability, or dependability of the data.
▪ A research method should yield the same results, even if conducted
twice or more
Internal Validity
• refers to data that are not only reliable but also true and accurate.
• It refers to which extent an instrument is able to actually measure
what it is supposed to measure.
 3-21

Types of Research From the view point of

Application Objectives Type of Information

Sought
Exploratory
Research
Pure Quantitative
Research Descriptive Research
Research

Applied Correlation Qualitative

Research Research Research

Explanatory
Research
 3-22

Direction of Study

Backward Forward

Cross -sectional

Retrospective Prospective
3

4. Ambidirectional
 3-23

Decision Tree
Intervention Done
No Yes
Observational Study Experimental Study

Comparison Group Randomization

No Yes
No Yes
Descriptive Study Analytic Study
NRCT Study RCT Study

Direction of Study

E O E = O E O
Cohort Study Cross-Sectional Study Case-Control Study
 3-24

Classification according to RESEARCH DESIGN

QUANTITATIVE QUALITATIVE
QUANTITATI
RESEARCH RESEARCH
VE DESIGN DESIGN
RESEARCH
‫أالبحاث الكمية‬ ‫أالبحاث النوعية‬
DESIGN
 3-25

Types of Research Methods … Cont.

Qualitative Quantitative
▪ Grounded theory ▪ Non-Experimental or Descriptive
▪ Ethnography ▪ Experimental or Randomized
▪ Critical feminist theory Controlled Trials (RCTs)
▪ Phenomenology ▪ Other Additional Design

Models of analysis: Models of analysis:

fidelity )‫ محكوم‬،‫ (مقيد‬to Parametric vs. non-parametric
text or words of
interviewees
 3-26

QUANTITATIVE RESEARCH

▪ Quantitative research is a formal, objective and

systematic process in which the numerical data are
used to obtain information. It is used to describe
variables, examine relationships among variables.

▪ Quantitative research requires the use of: structured

interviews, questionnaires , or observations; scales; and
physiological instruments that generate numerical data.
 3-27

Qualitative research
▪ Qualitative research is a systematic, interactive and
subjective approach used to describe life experiences
and give them meaning (Marshall & Rossman, 2006;
Munhall, 2001).

▪ It is conducted to describe and promote understanding

of human experience such as pain, caring and comfort.
It is an interpretative methodological approach to
produce more of a subjective science than quantitative
research.
 3-28

Types of Research Methods … Cont.

Qualitative Quantitative
▪ Phenomenological ▪ Descriptive
research ▪ Correlational
▪ Grounded theory ▪ Quasi-experimental
▪ Ethnographic ▪ Experimental
research
▪ Historical case
study
 3-29

Difference between Qualitative &Quantitative

Theory
QUANTITATI Theory
VE Building Testing
RESEARCH
DESIGN
 3-30

Types of Studies

There are three different types of studies used in

scientific investigations:
▪ Descriptive study: Used when we have little knowledge of a
phenomena and we want to describe it accurately and truthfully
▪ Correlational study: Used when we want to understand the
relationships among variables and make predictions from present
circumstances to future ones. Correlation coefficient describes the
strength of the relationship-Range is from -1 to +1
▪ Experimental study: Used when we have a fairly good
understanding of predictive relationships and we want to
demonstrate cause/effect relationships
 3-31

QUANTITATIVE
RESEARCH
DESIGNS
 3-32

Types of Study Designs

Design Study Type

Case report Observational - Descriptive

Case series Observational - Descriptive

Cross sectional Observational - Descriptive/Analytic

Case control Observational - Analytic

Cohort (‫)جماعة‬ Observational - Analytic

Clinical trial Experimental - Analytic

 3-33

TYPES OF QUANTITATIVE RESEARCH DESIGN

1. DESCRIPTIVE 3. OTHER ADDITIONAL

DESIGN DESIGNS

2. ANALYTICAL DESIGN Others

Descriptive • Qualitative
• Exploratory • Methodological
• Case report • Meta-analysis
• Case series •Etc……
• Survey
Observational Experimental
• Cross sectional •RCTs
• Case-control (Randomized
Controlled trials)
• Cohort studies
•NRCTs
 3-34

DESCRIPTIVE STUDIES
 3-35

Descriptive Studies/ a. Exploratory

Exploratory study
▪ It is a small - scale study of relatively short duration,
which is carried out when little is known about a
situation or a problem
▪ Exploratory studies problem is not as may be descriptive
and/ analytical. If the problem is not well defined , it is
always advisable to do an exploratory study.

Example:

➢ One community with high and another with low

participation in health activities, to identify the factors
that contribute to community participation.
 3-36

Descriptive Studies/ b. Case study

▪ Case Study: in-depth study of one or handful (‫)عدد قليل‬

of people, traditionally with no manipulation of
variables. A case may be a patient, a health center, a
village etc…
▪ Case studies are descriptive in nature and generally do
not lead to valid causal conclusions.
▪ Case studies can be useful for preliminary research of
rare cases e.g. a new disease.
▪ When AIDS first appeared, there were few cases, so
researchers relied on case studies.

Case Report One case of unusual findings

 3-37

Descriptive Studies/ C. Case-series

Case-series
▪ Experience of a group of patients with a similar diagnosis
▪ Assesses prevalent disease
▪ Cases may be identified from either the practice of one or
more health care professionals or a defined health care
setting, e.g. a hospital or family practice.
▪ Generally report on new/unique condition
▪ May be only realistic design for rare disorders
▪ Analyze cases together to learn about the disease.
▪ Case-series are of value in epidemiology for:
- Studying symptoms and signs
- Creating case definitions
- Clinical education, audit and research
 3-38

Cont.
Case-series
Advantages
• Easy to do
• Excellent at identifying unusual situation
• Good for generating hypotheses
Disadvantages
• Cannot study cause and effect relationships
• Cannot assess disease frequency
• Generally short-term
• Investigators self-select (bias!)
• no controls

Case Series Multiple cases of findings

 3-39

Descriptive Studies/ D. SURVEYS

SURVEYS

“Survey research comprises a cross-sectional design in

relation to which data are collected predominantly by
questionnaire or by structured interview on more than one
case (usually quite a lot more than one) and at a single
point in time in order to collect a body of quantitative or
quantifiable data in connection with two or more
variables (usually many more than two), which are then
examined to To study characteristics on health related
variables. E.g. maternal mortality rate, incidence rate,
etc…; to study attitudes, opinions and beliefs.”
 3-40

SURVEYS Cont.

Surveys answer the following questions:

✓ When is the disease occurring?

(Time distribution)
✓ Where is the disease occurring?
(Place distribution)
✓ Who is affected? (Person distribution)
 3-41

SURVEYS Cont.

PROCEDURE
1- Define the problem under study
2- Define the population under the study.
3- Describe the disease by time, person and place.
4- Measurement of the disease.
5- Comparing with known indices ‫نتائج‬،‫مؤشرات‬.
6- Formulation of an etiological hypothesis.
 3-42

OBSERVATIONAL DESIGN/Analytic

▪ Analytic studies, etiologic studies, are

performed to test specific hypothesis about
a specific health problem.

▪ In general, associations observed in

descriptive studies are often the basis for
gathering more specific data and testing
hypothesis in additional studies.
 3-43

Analytic Studies

▪ Analytic studies involve the selection and

comparison of two or more groups of
persons, based on either their exposure or
disease status…. WHY?
▪ To evaluate an association between
exposure and disease.
▪ Analytic studies focuses on the magnitude
of the association between the exposure and
the health problem under the study.
 3-44

OBSERVATIONAL/ CROSS-SECTIONAL

Is also known as “Prevalence Study”

Data collected at a single point in time
Unit of Study Individual
Study Question What is happening?
Objectives associations

A “Snapshot”
 3-45

CROSS-SECTIONAL Continued

Cross-Sectional Research:
▪ A design in which an investigator studies groups of
different people who vary on some characteristic (e.g.,
age) at one point in time.
▪ Explanation occurs by examining differences across the
units of analysis.
▪ Example: Self-esteem and marital satisfaction are
measured for 100 individuals at one point in time. The
hypothesis: The greater the self-esteem, the greater the
marital satisfaction is tested by the correlation between
self-esteem and marital satisfaction for the 100
individuals.
 3-46

CROSS-SECTIONAL Continued

Strengths:
▪ Quick.
▪ Cheap (relatively economical).
▪ allows study of several diseases / exposures; useful
for estimation of the population burden, health
planning and priority setting of health problems
Weaknesses:
▪ Cannot establish cause-effect.
▪ Not suitable for studying rare or highly fatal diseases
or a disease with short duration of expression.
 3-47

CROSS-SECTIONAL Continued
CROSS SECTIONAL STUDY OF HYPERTENSION
1. Measure the B.p. among the study population
(prevalence).
2. Collect data on age, sex, social class, occupation etc...
3. Determine how hypertension is related to these variables
4. Compare with findings of others
5. Draw hypothesis
Example of a cross-sectional study:
Mindell and Jacobson (2000) assessed sleep patterns and the
prevalence of sleep disorders during pregnancy. With a
cross-sectional design, they compared women who were at
four points in pregnancy: 8 to 12 weeks, 18 to 22 weeks; 25
to 28 weeks; and 35 to 38 weeks.
 3-48

OBSERVATIONAL/ LONGITUDINAL DESIGNS

➢ Longitudinal Research: A design in which an

investigator studies the same people or the same
population (but different individuals) over time,
sometimes across decades
➢ Observations are taken more than once.
➢ Explanation occurs by examining differences across
time.
➢ Example: Self-esteem and marital satisfaction are
measured for 100 individuals at two points in time. The
hypothesis: The greater the self-esteem, the greater the
marital satisfaction is tested by examining changes in self-
esteem and changes in marital satisfaction across time for
the 100 individuals.
 3-49

Types of Longitudinal Studies

Special problems:
✓ Attrition, because people die, or move home, or
withdraw from the study.
✓ Knowing when is the right time for the next wave of
data collection.
✓ The first round may have been badly thought out,
which leaves the later rounds in a bit of a mess.
✓ A panel conditioning effect may creep ‫ يتسلل‬in to the
research
 3-50

Types of Longitudinal Studies

1. Cohort studies
▪ A longitudinal study that examines changes in a cohort over
time. The samples are usually drawn from specific age-
related subgroups, for example men born between 1960 and
1965 may be studied over time with respect to health care
utilization.
▪ Each study collects data from different individuals within the
same cohort.
▪ Example: In 2003, 1,000 people, ages 18-37, are asked for
their support of same-sex marriage. In 2013, a different set
of 1,000 people, ages 28-47, are asked for their support of
same-sex marriage. The difference in opinions is the cohort
support for same-sex marriage within this cohort of
individuals.
 3-51

Types of Longitudinal Studies

2. Panel Studies
• A longitudinal study that examines changes in individuals
across time.
• Each study collects data from the same individuals.
• Example: In 2003, 1,000 people are asked for their support of same-sex
marriage. In 2013, the same 1,000 people are asked for their support of
same-sex marriage. The difference in opinions is the change in support for
same-sex marriage.
•Panel studies provide the opportunity for more in-depth
analysis.
•For example, one can examine the key determinants of changes
in opinions because one is collecting data from the same
individuals.
•Longitudinal panel studies are very expensive, but very
informative forms of research.
 3-52

Types of Longitudinal Studies

3. Trend study
◼ Investigations in which samples from a population are
studied over time with respect to some phenomenon.

◼ Different samples are selected at repeated intervals, but

the sample always drawn from the same population.

◼ Research can to examine patterns and rates of change

over time and to predict future developments.
 3-53

Issues in Longitudinal Research

Attrition
▪ The loss of participants in longitudinal
research due to death, disappearance, loss of
interest, etc.
✓ Attrition is one of the most serious methodological
problems associated with longitudinal research.
✓ Those who drop out might differ in important ways
from those who remain, so conclusions based on
studies with significant attrition can be suspect.
 3-54

CASE CONTROL
How they differ from Cohort Studies?
 3-55
Case-Control Study
SOME KEY POINTS

▪Frequently used study design

▪Participants selected on the basis of whether or
not they are DISEASED (remember in a cohort
study participants are selected based on
exposure status)
▪Those who are diseased are called CASES.
▪Those who are not diseased are called
CONTROLS.
 3-56

Case-Control Study

▪ Start with people who have disease (Cases)

▪ Match them with controls that do not have
disease (Match Confounding)
▪ Look back and assess exposures

Objective of a Case-Control
➢To find out association
➢To assess Risk Ratio
 3-57

Case-Control Study

Because participants are selected on the basis of

disease, exposures for ALL PARTICIPANTS
are obtained RETROSPECTIVELY…………..
PAST PRESENT
RECALL
CASE & CONTROLS
EXPOSURE
SELECTED

Example: lung cancer cases and non-cancerous

controls recall past exposure to cigarette smoke
 3-58

SELECTION OF CASES

• Decide on a specific case definition based on a

medically diagnosed condition.
- When diagnosis relies on subjective assessment ‫التقييم الشخصي‬
case definition will be less precise.
• Must consider what criteria will confirm the case
definition:
- Lung cancer confirmed by biopsy
- Osteoporosis confirmed by bone density measurements
- Studying mild forms of a disease results in largest possible
case group but may include non-cases (misclassification)
- Studying severe forms of a disease decrease the probability
of misclassification
 3-59

SELECTION OF CONTROLS

Controls should be representative of the referent

population from which cases are selected (i.e.
comparable)

✓ Controls should have the potential to become cases;

Controls should also be candidates for having the
disease of interest
 3-60

SELECTION OF CONTROLS

Population controls
▪ Randomly selected individuals from the population like RDD
(random digit dialing).

Neighborhood controls
▪ Individuals that live in the same neighborhoods as cases.

Friends controls
▪ best friends of cases
▪ spouses or siblings of cases

Hospital controls
▪ Individuals at the same hospital with cases
 3-61

SELECTION OF CONTROLS

❑ The investigator can elect to use more than one TYPE

of control for each case……. When there is no ONE
group similar enough to cases.

EXAMPLE: A particular leukemia case may have both a

neighborhood control (similar to case in terms of
environment) and a sibling control (similar to case in
terms of genetic background)
 3-62

Cases & Controls

• For each CASE in the study, a control is selected

• How many controls should be selected per case?
–1:1 is usual
–Increasing the ratio of controls to cases
increases the precision and efficiency of the
analysis
–It also increases the cost to undertake the study
 3-63

MATCHING

CHARACTERISTICS OFTEN USED

• age
• gender
• body mass index (weight / height2)
• smoking status
• marital status
 3-64

MATCHING

1- GROUP MATCHING
• Based on proportions
• Idea is to select a control group with a certain
characteristic identical to cases in the same
proportion as it appeared in cases.

Example: If 25% of cases in your study smoke you

would select a control population that included
25% smokers.
 3-65

MATCHING

2- INDIVIDUAL MATCHING (matched pairs)

• For every individual case a control is selected

who is identical to the case on certain
characteristics.

Example: If your first case is a 25 year-old women

who smokes then you would find a control who is
25, female and a smoker. So you are matching on
age, gender, and smoking status.
 3-66

POTENTIAL PROBLEMS WITH MATCHING

• It will be difficult to find controls if too many

variables are selected for matching.

• Variables used for matching can not be studied

as exposures or confounders.

• OVERMATCHING – when variables related to

disease are inadvertently ‫ دون قصد‬matched upon.
.‫عندما يتم مطابقة المتغيرات المتعلقة بالمرض عن غير قصد‬
 3-67
Case-Control Study
How they differ from Cohort Studies?
▪ In case-control, one starts from the outcomes i.e. cases
and controls/referents ‫( مرجعيات‬matched or not), and tries
to study what the exposure was. Using the 'rare disease
assumption', both odds ratio and relative risk can be used
to study association between exposure and outcome.
However, odds ratio is preferred because the prevalence
of the disease outcome is already identified.
▪ Whereas, Retrospective cohort is when one already has
determined the exposure in the study cohort and tries to
study the association of exposure to disease outcome
within that cohort in a retrospective manner. Both OR
and RR are safe to use here, as in prospective cohort.
 3-68

COHORT STUDY
 3-69
Design of Cohort Studies
What is a cohort ?

▪ Cohort: group of individual with a common

characteristic who are followed over a period of
time e.g. A smoker’s cohort means all are
smokers in that group

▪ Selection of cohorts based on exposed and

unexposed individuals to follow in specified time
or until development of outcome (disease/death)
 3-70

Cohort Study
May be used to study…
▪ Etiology/ Risk Factors/Prognosis
▪ Effect of Treatments
Hypothesis generating!
▪ May be either Prospective or Retrospective

Features
▪ The cohort is identified before the appearance of the
investigated disease
▪ The study groups are observed over a period of time
▪ The study proceeds from cause to effect
Note: The incidence rate can be measured
 3-71

Types of Cohort Study

 3-72

1. Retrospective Cohort Study

▪ A retrospective cohort study is one in which the

outcome have all occurred before the start of
investigation.
▪ Investigator goes back to the past to select study group
from existing records of the past employment, medical
and other records and traces them forward through
time from the past date fixed on the records usually to
the present.
▪ Known with the name of Historical Cohort and
noncurrent cohort
 3-73
Data Sources for Retrospective
Cohort Studies

Retrospective cohort studies are useful for unusual

exposures and they are efficient for diseases with long
latent periods (time between exposure & disease).

However, accurate information on the main exposure and

confounding factors is often missing because the data source was not
designed for the purpose of conducting the study.
 3-74
Data Sources for Retrospective
Cohort Studies

Retrospective cohort studies are useful for unusual

exposures and they are efficient for diseases with long
latent periods (time between exposure & disease).

However, accurate information on the main exposure and

confounding factors is often missing because the data source was not
designed for the purpose of conducting the study.
 3-75

2. The Prospective Cohort Study

1. It starts with a group of people (a cohort) all considered

to be free of a given disease.
Information is obtained to determine persons having a
particular characteristic (certain exposure) that is
suspected of being related to the development of disease
being investigated.

2. These individuals are then followed for a period of time

to observe who develops/or dies from that disease

3. Incidence or death rates for the disease are then

calculated.
 3-76

The Prospective Cohort Study

4. Rates are compared for those with the characteristic and

those without it.
5. If the rates (of development of disease) are different, an
association can be said to exist between the characteristic
(exposure) and the disease.
6. It is important to obtain information on other
characteristic of the study groups: age, sex, … to account
for an influence of any factors related to the disease.
 3-77
Potential Sources of Data in
a Prospective Cohort Study

Data collected specifically for a prospective

cohort study will be of higher quality than that
obtained from pre-existing records, but it is more
expensive to do a large, prospective cohort study.
 3-78

Analysis

Relative risk:
This is the ratio that measures the strength of
association between suspected cause and effect.

Attributable risk:
▪ This is the difference in incidence of disease or
death between exposed & non-exposed group. It is
expressed as a percentage.
▪ It measures the impact that removal of a certain
factor will have on the incidence of the disease.
 3-79

Relative risk (RR) ‫ا لخطر النسبي‬

Diseased Not diseased

Exposed a b
Unexposed c d

RR = Incidence in exposed = a/a+b

Incidence in unexposed c/c+d

If causal association what is expected ?

What does RR=1 means ?

 3-80

Relative Risk Calculations

The basic analysis involves:

 Calculation of incidence rates among the exposed
 Calculation of incidence rates among the non-exposed
 Ascertain whether there is a significant statistical association
between exposure and disease.
 3-81

Relative Risk Calculations (cont.)

Interpretation: Incidence of bladder cancer is 1.61 times as great in smokers as in non-smokers

 3-82

Interpretation of Relative Risk (RR)

RR=1: No association between exposure and disease

incidence rates are identical between groups

RR> 1: Positive association (increased risk)

exposed group has higher incidence than
unexposed group

RR< 1: Negative association (protective effect)

unexposed group has higher incidence than
exposed group
 3-83

Relative Risk in Case-Control Studies

▪ Can’t derive incidence from case-control studies

✓ Begin with diseased people (cases) and non-
diseased people (controls)
▪ Therefore, can’t calculate relative risk directly
▪ But, we can use another method called an odds ratio
 3-84
Odds Ratio in
Prospective (Cohort) Studies
 3-85
Odds Ratio in
Case-Control Studies
 3-86
Odds Ratio in
Case-Control Studies (cont.)

Odds that a person with CHD smoked is 1.62 times the odds that
a person without CHD smoked

The odds that those with the outcome had the exposure is 1.62 times
greater than those who do not have the outcome
 3-87

Summary of Observational Studies

Characteristic Cross - Case Control Cohort

Sectional

Sampling Random sample: Purposive sample: Purposive sample:

population diseased/non- Exposed/non-
diseased exposed
Time One point Retrospective Prospective
Causality Statistical Screening for Testing one (or
association many risk factors few) risk factors
Frequency Prevalence None Incidence
measure
Risk Prevalence (risk) Odds ratio Relative risk, odds
parameter ratio, odds ratio ratio
 3-88

ANALYTICAL STUDY DESIGNS

B. EXPERIMENTAL DESIGN
 3-89

B. EXPERIMENTAL STUDY DESIGNS

Experimental method is an empirical research
method used to examine a hypothesized causal
relationship between independent and dependent
variables.
In experimental studies the researcher manipulates
a situation and measures its effect after that

Type:
1- RANDOMIZED CONTROLLED TRIALS (RCTs)

2- NON- RANDOMIZED CONTROLLED TRIALS (NRCTs)

 3-90

1- RANDOMIZED CONTROLLED TRIALS (RCTs)

RCTs are also called True experiments because, at their
best, they can demonstrate causality.
 3-91

Features of RCTs

▪ Randomized Controlled Trials (RCTs)

✓ the “gold standard” of research designs
✓ provides most convincing evidence of
relationship between exposure and effect

• E.g. trials of hormone replacement therapy in

menopausal women found no protection for
heart disease, contradicting findings of prior
observational studies
 3-92

Features of RCTs
RCTs design is characterized by:
1- Manipulation:
The researcher do some intervention (Example health education
program) to one of the study groups.
2- Control:
• The researcher introduces one or more control groups to compare
with the experimental (intervention) group.
• systematic research inquiries conducted under controlled
conditions, in which the researcher manipulates a variable (or a
number of variables) in order to record observed changes in an
outcome
3- Randomization:
Each subject have an equal chance of being allocated to either of the
two groups ( intervention and control groups).
 3-93

Steps of RCTs:

1. Drawing a protocol.
2. Randomization (Selecting comparison & experimental groups).
3. Control.
4. Manipulation (intervention).
5. Follow up.
6. Assessment of the outcome.
 3-94

1. Drawing a protocol

One of the essential features of the randomized trials.

The protocol specifies:
1. The objectives.
2. The questions to be answered.
3. The selection criteria.
4. The sample size.
5. The procedures of allocation of the subjects into
experimental and control groups.
6. The treatment applied: How, what dose etc...
7. The details of the scientific techniques and
investigations.
Note:
Once the protocol has been evolved, it should be strictly
adhered to through out the study.
 3-95

2. Randomization (random allocation)

▪ Randomization is the statistical procedure by which

the participants are allocated into groups usually
called study & control groups to receive or not to
receive intervention or therapeutic procedure .
▪ Randomization aims at making the groups
comparable and eliminate bias.
▪ Randomization ensures that the investigator has no
control over the allocation of the participants to
either the study or control group, thus eliminating
the selection bias.
▪ Every individual has an equal chance of being
allocated into either group.
 3-96

Cont.

EXAMPLE:

The effectiveness of a contraceptive health education

program for multiparous women.
Two groups of subjects were included.
One group was given intervention and other was not.
The women in the sample are likely to differ in age,
education, and attitude.
This would affect the woman's diligence in practicing
contraception
 3-97

3. Control.

▪ The experiment must be organized so that the

extraneous factors are prevented from operating and
confusing the outcome which is to be appraised.

▪ Control is acquired by manipulating, by randomizing,

by careful preparation of the experimental protocols,
and by the use of a comparison group or groups.
 3-98

Cont.

EXAMPLE:

If a researcher wanted to supplement diet of the low birth

baby with a particular nutrient for 2 weeks, the weight
gain at the end of 2 weeks would tell us nothing about
the treatment effectiveness
Suppose an average 1 kg. weight gain is noted does this
gain support the conclusion that nutrition supplement
(IV) caused the weight gain (DV)
 3-99

Cont.

The answer will be NO? because babies normally gain

weight as they mature
Without a control group- a group that does not receive
the nutritional supplements it is impossible to separate
the effects of maturation from those treatment

Therefore the term CONTROL GROUP refers to a

group of subjects whose performance on a dependent
variable is used to evaluate the performance of the
experimental group on the same dependent variable
 3-100

Cont.

Although randomization is a preferred scientific

method for equalizing the groups, there is no
guarantee that the group will in fact be equal.
Therefore we need a procedure to consciously
control of those characteristics of subjects that are
likely to affect the outcome is called MATCHING
(e.g. if matching were used in contraceptive
education, then the researcher might ensure that if
there was a married 38 year old woman with six
children in exp. Group, then there will also be 38
year old woman with six children in control group
 3-101

4. Manipulation (intervention).

▪ Manipulation refers to the process by which the

researcher manages the independent variable in
order to study the effect on the dependent variable.
▪ Manipulation or intervention is usually done by
application or withdrawal of the suspected factor
e.g. education intervention programs, drugs, vaccine
or dietary factor.
▪ This manipulation creates an independent variable
(education intervention programs, drug, vaccine or
new procedure) which effect is then determined by
the measurement of the final outcome which
constitutes the dependent variable e.g. mean
knowledge scores, incidence of disease, recovery.
 3-102

Cont.

EXAMPLE:
▪ Gentle massage is effective as a pain relief measure
for elderly nursing home residents
▪ The Independent variable is gentle massage which
could be manipulated by giving some patients the
massage intervention and withholding it for others
▪ Then it is possible to compare the pain level
(dependent variable) in the two group to see if
differences in receipt of the intervention resulted in
degree of pain levels
 3-103

5. Follow up.

▪ This includes examination of the study & control

groups subjects at defined intervals of time in
standard manner under the same conditions in
the same time frame till the final assessment.
▪ The main difficulties encountered in the follow
up process include:
➢ Attrition from:- death, migration,
displacement and loss of interest etc.
 3-104

6. Assessment of the outcome

The final assessment of the trial is carried in terms of:

• Positive results:
These include the benefits of the experimental study
such as reduced incidence of the disease or severity of the
disease, cost of health services or other appropriate
outcome.
• Negative results:
These include the severity & frequency of side-effects
and complications.
The incidence of positive/negative results is compared in
both groups and the differences are tested statistically.
 3-105

2- Non-randomized trials (NRCTs)

NRCTs are also called QUASI EXPERIMENTS.
 3-106

2. Non-randomized trials (NRCTs)

Is also known as: -“non equivalent control group design”.

- Quasi experiments.
Definition
• It is a research design in which the researcher initiates an experimental
treatment but some characteristics of a true experiment is lacking of either
Randomization or Control).
• An experiment in which it is impossible for the researcher to exert control over
all the active variables so as to eliminate the risk of outcomes being determined
(in part or wholly) by extraneous factors
Purposes
◼ Quasi experimental designs are generally used to establish the causality (effect
of independent variable on dependent variable) in situations where researchers
are not able to randomly assign the subjects to groups for various reasons.
◼ Quasi experimental research design involves the manipulation of independent
variable to observe the effect on dependent variable
 3-107

TYPES OF QUASI EXPERIMENTAL DESIGN

There are several types. The two important types

are as follows:

QUASI
EXPERIMENTAL
DESIGN

Non equivalent
Time series
control group
design
design
 3-108

Benefits of Doing Literature Review