RESEARCH DESIGN

DR. ADYANI MD REDZUAN

FACULTY OF PHARMACY, UKM
 Outline
• Learning outcomes
• Introduction
• Classification
• Observational studies
• Experimental studies
 Learning outcomes
• Describe different types of study designs

• Describe the advantages & disadvantages of different

study designs
 Introduction
• It is vital to design any kind of research study before
initiation of a research

• Poorly design study give misleading results

• The study design is important as it will oversee how data

are collected & analyzed
 Classification
• Observational study
I.Case-control studies
II.Cross-sectional studies, surveys
III.Cohort studies

• Experimental studies
I. Clinical trials
 Observational studies

• Specific characteristics are observed & measured

without any attempt to modify the subjects

• ‘Nature’ determines who is exposed to the factor of

interest and who is not
i. Case-control/Retrospective
• 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)

• History/previous events of both cases & controls are

analyzed by looking back in time (retrospectively)
through examination of medical records, interviews to
identify a characteristic/risk factor to determine the
relationship between the risk factor and the disease
 Advantages/Disadvantages
• Appropriate for examining condition that develop over a
long time

• Also for investigation of a preliminary hypothesis

• Fast & least espensive

• BUT have the greatest number of possible biases/errors

• Depend on high-quality existing records

• Challenge in the selection of appropriate control group

 EXAMPLE
There is a suspicion that zinc oxide, the white non-absorbent sunscreen
traditionally worn by lifeguards is more effective at preventing sunburns that
lead to skin cancer than absorbent sunscreen lotions. A case-control study
was conducted to investigate if exposure to zinc oxide is a more effective skin
cancer prevention measure. The study involved comparing a group of former
lifeguards that had developed cancer on their cheeks and noses (cases) to a
group of lifeguards without this type of cancer (controls) and assess their prior
exposure to zinc oxide or absorbent sunscreen lotions.

This study would be retrospective in that the former lifeguards would be

asked to recall which type of sunscreen they used on their face and
approximately how often. This could be either a matched or unmatched study,
but efforts would need to be made to ensure that the former lifeguards are of
the same average age, and lifeguarded for a similar number of seasons and
amount of time per season
 ii. Cross-sectional
• Data are observed, measured & collected at one point of
time

• Also labelled as survey, epidemiological or prevalence

studies

• Determine “What is happening?” at that moment

 EXAMPLE
• A medical study investigates the prevalence of breast
cancer in a population. The researcher can look at a
wide range of ages, ethnicities and social backgrounds.
If a significant number of women from a certain social
background are found to have the disease, then the
researcher can investigate further
 Advantages/Disadvantages
• Best for determining the status quo of a disease/condition

• Quick & relatively inexpensive

• BUT only provide a snapshot in time which may result

to misleading information

• Difficult to get large sample & sample may not be

representative of the entire population
 iii. Cohort/Prospective
studies
• A cohort refers to a group of people who shares
something in common and remains part of a group over
an extended time

• In cohort study, a particular group with a certain

characteristic is observed over a certain period of time

• Address “What will happen?”

 Advantages/Disadvantages
• Appropriate for study that investigates the causes of a
condition, the course of a disease or risk factors

• Possess correct time sequence to provide strong

evidence for possible causes/effects

• BUT extended study period results in large cost

• Other events occurring during study period may

have affected outcomes

• Susceptible to problems in patient follow up, drop-

out
 Experimental studies
• Experimental studies that involve humans are known as
clinical trials

• Controlled clinical trials are studies whereby

experimental drug or procedure is compared with
another drug/procedure

• In randomized clinical trials, subjects are randomized to

treatment options providing the best insurance that the
result was due to intervention or most rigorous evidence
of causality
 Advantages/Disadvantages
• Gold standard against which other studies are judged

• Provides the greatest justification for concluding

causality & subject to least biases

• BUT costly and time consuming

• Evidence from a clinical trial may not 100% applicable to

current practice as certain factors may have been
excluded
 Research Study Designs
Name Class Type Protocol Examples and uses
Experiment Experimental Longitudinal Select a sample; Measure Before and after
baseline for parameter, apply measurements such as in a
intervention, measure outcome. clinical trial for a new therapy,
Or divide sample into laboratory experiments, field
intervention and control groups. trials e.g. of pesticides or
Apply intervention to one fertilisers.
group, measure outcome for
both and compare.
Cohort Observational Longitudinal Define a cohort and assess How a disease progresses,
current status and influential Whether family income affects
factors. Observe outcomes. educational achievement.
Case-control Observational Longitudinal Define a cohort and divide into Whether most lung cancer
those exhibiting and those not patients have previously
exhibiting parameter of interest. smoked.
Investigate history to assess Whether parental divorce
risk factors. affects future employment
choice.
Cross- Observational Cross- Define a sample and collect Prevalence estimates, such as
sectional sectional information about parameter of how many people have a given
interest. disease, or how many people
watch a particular television
programme.
Repeated Observational Cross- Define a sample and collect Trends, such as how many
cross- sectional information about parameter of people are giving up smoking,
sectional interest. Repeat at defined the effect of publicity on the
intervals, but not necessarily number of people who cycle
with the same sample. regularly, or the popularity of a
political party over time