RESEARCH METHODS

FINAL YEAR LECTURE

 What is research
• Research is the systematic collection, analysis
and interpretation of data to answer a certain
question or solve a problem.
• Types of research
 Basic research- generates new knowledge and
technologies to deal with major unresolved
problems.
 Applied research-identifies priority problems,
designs and evaluates policies and programmes.
 Characteristics of research
• Demands a clear statement of the problem and a
purpose
• It requires a plan [study design] so that
researchers are not just aimlessly looking for
something hoping to find a solution
• It builds on existing data using both positive and
negative findings
• New data is collected as required and organized
so that they answer the original research question
 Epidemiological studies
• Study of the distribution, determinants and
deterrents of health related events in a human
population.
• It is the foundation for health science research
It can be
 Observational descriptive
analytical
 Experimental randomized
non-randomized
Epidemiological studies
 Uses of epidemiological studies
• Diagnostic purposes (community diagnosis)
• Provides information on aetiology (causative
factors) of a disease
• Is used to determine the course of disease
over time.(knowledge of natural history of a
disease enables prediction of prognosis)
• Contributes to the evaluation of health care
 Descriptive:
• Measures distribution of time, place and
person(population) in relation to disease occurrence.
 Analytical
• This usually tests hypothesis. I.e. Test of association
between a disease and a suspected factor.
 Experimental
• This is carried out under direct control of investigator.
• Involves some action, intervention or manipulation in
one group and comparing the outcome in another
similar control group
 Descriptive studies
• Study the frequency and distribution of diseases or
events within a population
• The characteristics of the disease are studied with
reference to who (person), where (place), when
(time), what and why.
• Person: socio-demographic characteristics are studied
• Place: associated environmental factors e.g
urban/rural setting
• Time: cyclical, seasonal or periodic variations
 Examples of descriptive studies
These include
• Case reports and case series report
• Cross sectional
• Longitudinal surveys
• Surveillance
• Screening
• Ecological surveys
 Uses of Descriptive Studies
• 1. Health care planning
Descriptive studies provide knowledge about which populations or subgroups are most
or least affected by disease. This enables public health administrators to target
particular segments of the population for education or prevention programmes and
can help allocate resources more efficiently.

• 2. Hypothesis generation
Descriptive studies identify descriptive characteristics which frequently constitutes an
important first step in the search for determinants or risk factors that can be altered or
eliminated to reduce or prevent disease.

• 3. Trend Analysis
Time-trend analysis is a longitudinal descriptive study that can provide a dynamic view
of a population's health status. Data is collected over time, place and person to look
for trends and changes.
 Case report:
• Reports of unusual disease.[e.g. unusual mode of
presentation] This will generate information for further
research.
• They show:
• Any unexpected association between diseases or symptoms.
• An unexpected event in the course of observing or treating a
patient.
• Findings that shed new light on the possible pathogenesis of
a disease or an adverse effect.
• Case studies often lead to testable hypotheses 
• Unique or rare features of a disease.
• Unique therapeutic approaches.
 Case series report :
• A case series is a report on a series of patients with an
outcome of interest
• This is an aggregate or collection of individual case
reports which may occur within a fairly short period of
time .
• This study design has historical importance in
epidemiology. It was often used as an early means to
identify the beginning or presence of an epidemic.
• Consecutive reports of specific unusual diseases could
mean an imminent epidemic e.g. HIV where a case series
report of a similar clinical syndrome amongst a cluster of
homosexual males alerted the medical community.
 Uses
• Studying predictive symptoms, signs and tests
• They can provide a case group for a case-control study
• Clinical education, audit and research
• Health services research
• Establishing safety profiles
Advantage
• Can help formulate a new and useful hypothesis
rather than merely documenting an interesting
medical oddity. 
Disadvantage
• Cannot be used to test for the presence of a valid
statistical association.
 Cross-sectional(Prevalence) studies
• This is the observation of a defined population at a
single point in time or time interval.
• Exposure and outcome are determined
simultaneously.
• It is the type of observational study that involves
data collection from a population, or a representative
subset, at one specific point in time.
• They aim to provide data on the entire population
under study
• - Data collection is done in a snapshot. i.e. both
exposure and outcome data are collected at once .
 USES

 Useful for detecting prevalence of chronic diseases

 they can be used to describe, the Odds ratio, absolute
risks and relative risks from prevalence (sometimes
called prevalence risk ratio
 They may be used to describe some feature of the population,
such as prevalence of an illness, or they may support
inferences of cause and effect. 
 Knowledge Attitude and Practice studies,
 Comparative studies e.g. rural vs urban)
 Longitudinal
• Is a cross-sectional study done serially over a time period e.g.
children of different ages can be measured repeatedly every
month for some months to appraise their growth
• Provides data about events or changes during a period of time.
• Observations are repeated in same population over a
prolonged period of time.

Uses
- Used to study natural history of disease
- Identifies risk factor of disease
- Determines incidence rate of disease.(occurrence of new cases)
• Surveillance: ongoing systematic collection, analysis
and interpretation of health data essential to the planning
implementation and evaluation of public health practices.
• Should be associated with timely dissemination of the
information
• Major sources of data for disease surveillance in
Nigeria are:
- Notification-emergency and routine
- Special surveys and studies
- Screening programmes
- Laboratory reports
- Special registers
 Types of surveillance
• Full scale national surveillance
• Sentinel surveillance: application of epidemiological
surveillance to limited pockets of population
• Used to detect trends in health events

 Sentinel Surveillance

• Advantage: it is limited in scope so cheaper and easier to

conduct than full scale surveillance
• Disadvantage of sentinel survey: it is not representative of
the whole population
 screening
• This is a two stage morbidity study.
• 1st stage
- Detection of people who probably have the
condition from among a healthy population
through a screening test
• 2nd stage
- Confirmation through a confirmatory test
 Ecological surveys
• This is a population study
• This looks for association between exposure
and outcome of a disease in the whole
population rather than in individuals. E.g.
death rate from oral cancer has been
associated with increase consumption of
bethel nut.
• Advantages: inexpensive, efficient and little
ethical considerations
• Advantages of an ecological study
• An ecological study is quick and cheap to conduct.
• It can generate new hypotheses.
• It can identify new risk factors.

• Disadvantages of an ecological study

• It is unable to control for confounding factors. This is often referred to
as 'ecological fallacy', where two variables seem to be correlated but
their relationship is in fact affected by cofounding factor(s).
• It cannot link exposure with disease in individuals as those with disease
may not be expose.
• Its use of average exposure levels masks more complicated
relationships with disease.
• Its units of study are populations not individuals. Therefore, the disease
rates linked with population characteristics and the association
observed at group level does not reflect association at individual level.
 Analytical study
• This takes into consideration the comparison of groups.
• Analytical studies are used to test hypothesis i.e. you want to
determine if there is an association between a disease condition and a
particular factor which could be
• These studies investigate causal factors
• host related factors
• environmental factors
• social or behavioral factors.

• TYPES OF ANALYTICAL STUDIES

- Case control study
- Cohort study.
 Case control
• This is a retrospective study (A study that compares patients who have a
disease or outcome of interest (cases) with patients who do not have the
disease or outcome (controls), and looks back retrospectively to compare
how frequently the exposure to a risk factor is present in each group to
determine the relationship between the risk factor and the causative
factor ))
• Tests association between suspected aetiological factors and occurrence
of the disease
• Comparison of frequency of exposure to suspected aetiological factor
between persons with the disease(case) and those without
disease(control)

 Basic steps for conducting a case control study

• Selection of cases and controls [inclusion and exclusion criteria]
• Matching of cases with controls
• Measurement of exposure
• Analysis and interpretation
 Choosing cases
• Who is a case?
- Clinical signs and symptoms of disease
- Laboratory or radiological confirmation of disease age
range
• Where do you get the case
- Community
- Hospital
- Special registers e.g. cancer register
• How will the cases be selected (sampling technique)
• How many cases do you require (sample size)
 Choosing controls
• Who is a control?
- A healthy person of the same age group, sex and socio-
economic class as the case, who has an equal risk of
contacting the disease but does not have it yet.

• Where do you get the control

- Community
- Hospital (beware of confounding)
• Match a case to a control (individual matching) or match
two cases to a control (group matching)
• Define and differentiate study groups by outcome.
• Measuring exposure
o This can be done by interviews, questionnaires,
studying past records e.g. hospital records.
o Obtain information on history of exposure e.g to
similar aetiologic or environmental factors

• Analysis
o Exposure rate among cases and controls
o Estimation of disease risk associated with exposure
 Advantages of case control

• Inexpensive to perform
• Short study time(good for drug induced illness)
• For investigating rare diseases and those that take a long
time to develop e.g. cancer
• Useful for initial testing of hypothesis regarding possible
disease determinants
• Requires smaller number of patients
• No dropout problem
• Minimal ethical considerations
• Subject does not need to volunteer
• No risk to subjects
• Identifiable risk factors
 Disadvantages

• Bias in control group selection

• Recall bias
• Missing information from case note
• Missing case note
• Cannot determine incidence of disease
 Cohort study
• Group of individuals who share a common experience
within a given period of time e.g. occupation, age, etc
• It is a prospective study design
• Compare the occurrence of disease between a group of
people exposed to a certain risk factor and another group
not exposed. E.g. smokers and non smokers.
• Information obtained on incidence or outcome of disease
in each study group is analysed to obtain a relative risk.
• If incidence is higher in one group then there is evidence
of association.
• Proceeds from cause to effect
 Types of cohort study
• Prospective cohort
- Exposure and non exposure are ascertained before study begins
- Study groups are followed for several years and outcome is
measured

• Retrospective cohort
- exposure is ascertained from objective records of the past
- Outcome is ascertained in the present

• Combination of prospective and retrospective

- Exposure is ascertained from past objective records
- Outcome is followed and determined in the future
Prospective cohort
 Prospective cohort
• Key Concept: The distinguishing feature of a
prospective cohort study is that at the time
that the investigators begin enrolling subjects
and collecting baseline exposure information,
none of the subjects has developed any of the
outcomes of interest.
 Retrospective cohort
• Key Concept: The distinguishing feature of a
retrospective cohort study is that the
investigators conceive the study and begin
identifying and enrolling subjects after
outcomes have already occurred.
 Advantages of cohort study
• No bias
• Determines incidence of disease
• Absolute risk can be calculated
• Can determine relative risk
• Permits observation of many outcomes
• Association between suspected aetiology and
disease outcome is clear
• Allows study of natural history of a disease
• Minimal ethical considerations
 Disadvantages

• Very expensive
• Takes too long to complete
• High dropout rate
• Not suitable for investigation of rare diseases
• Need large number of subjects
• Changes in status of subjects (cease smokoing)
• Researcher bias
 Experimental studies
• A controlled project to determine/establish a
hypothesis
• The aim is to study the effects of exposure to or
deprivation of a defined factor
• Two groups of subjects are studied
• One group is exposed to a certain factor e.g drugs
• The other group is deprived of the factor e,g
placebo
• A decision is taken on which subjects will be
exposed and which will be deprived.
 advantages
• Provides strongest evidence of association of a
certain risk factor and disease outcome.
• It introduces or removes the suspected causal
factor.
 Types of experimental studies
 Randomized control trials
 Non randomized control trial
Randomized control trials used in :
• Preventive trials (vaccine trials)- no disease
• Community intervention trials e.g. water fluoridation
• Clinical trials (drug trials)-have disease
• Cessation experiments (smoking & lung cancer)
• Trial of aetiologic factors
• Evaluation of health services
 Randomized control trials
• Subjects are allocated into control groups and
treatment (study)groups by chance
Randomization is not a haphazard assignment
• Randomization is done in an attempt to eliminate
selection bias and allow for comparability
• HOW DO YOU RANDOMIZE
• A predetermined plan is usually instituted using a
table of random numbers
• Stratified randomization (sex, age, SES, et
BENEFITS OF RANDOMIZATION
• Eliminates bias
DISADVANTAGE
• Expensive
How bias is eliminated
• By blinding
• Types of blinding
• Single blind: the subject does not know which group he
is being assigned to
• Double blind: both the physician and the subject do
not know which group the subject is being assigned to
• Triple blind: participant, investigator and Analyzer.
 Non-randomized trials
• Quasi-experimental study is an example of a
non randomized trial
• Observations are made before and after
intervention not under the investigators control
• This involves allocation of subjects into groups
without randomization
• They can be put in groups by geographic
location, age, gender, SES etc
Non randomized trials
• Uncontrolled trials (no comparison group)
• Natural experiments (e.g. smoking, people
have naturally separated themselves into
smoking and non smoking groups)
 Classification of types of study designs
Was there an active intervention?

yes No

Experimental study Observational study

Random allocation? Any control group?

Yes No yes No

Non randomized
Randomized
control trial
control trial Descriptive
Analytical
study
study
direction

Exposure to outcome Outcome to exposure

-Case report
-cross-sectional
-Ecological study
Cohort Case -longitudinal
study control
study
 Research methods
• Research methods is the systematic procedure
for carrying out research.
• There are two basic types of research
methods
• Quantitative methods
• Qualitative methods
 Quantitative Research method
• Quantitative research method focuses on gathering
numerical data and generalizing it across groups of
people or to explain a particular phenomenon.
• It emphasize objective measurements and
the statistical, mathematical, or numerical analysis
of data collected through polls, questionnaires, and
surveys, or by using pre-existing statistical data
using computational techniques.
 Quantitative Research
• It is about asking people for their opinions in a
structured way so that you can produce hard
facts and statistics to guide you.
• To get reliable statistical results, it’s important
to survey people in fairly large numbers and to
make sure they are a representative sample of
your target population.
 Characteristics of quantitative research
• The data is usually gathered using structured research instruments.
• The results are based on larger sample sizes that are representative of the
population.
• The research study can usually be replicated or repeated, given its high
reliability.
• Researcher has a clearly defined research question to which objective answers
are sought.
• All aspects of the study are carefully designed before data is collected.
• Data are in the form of numbers and statistics, often arranged in tables, charts,
figures, or other non-textual forms.
• Project can be used to generalize concepts more widely, predict future results, or
investigate causal relationships.
• Researcher uses tools, such as questionnaires or computer software, to collect
numerical data.
 Common Approaches to Quantitative Research

• 1. Surveys
• 2. Custom surveys
• 3. Mail/e-mail/Internet surveys
• 4. Telephone surveys
• 5. Self-administered questionnaire surveys
• 6. Omnibus surveys
• 7. Correlational research
• 8. Trend analysis
• 9. Exploratory research
• 10.Descriptive research
• 11.Experimental research
 Assignment

What are the differences between case control

study and cohort study. (Tabulate)
Next lecture qualitative study & sample size
estimation