Study Design I

Study design I
Nadeem Ikram
MBBS, DCP, FCPS (IMMUNOLOGY)
Objectives
After the end of the lecture the student would be able to;
• Describe the importance and aims of research studies
• Differentiate between observational and experimental study
design
• Describe case report and case series
• Describe cross sectional study with examples, its advantages
and limitations
Why we conduct studies?
• To estimate prevalence, incidence, proportion or
mean value
• To find out association between cause and effect
• To see effect of any medicine, treatment or vaccine
• To compare two diagnostic tests
What are study designs?
Structured approaches to address specific
research questions
Selection of research design is the single most
important decision the investigator has to
make
Type of Study Alternate name Unit of study
A. Observational Studies (Non
Experimental )
Descriptive Studies
Case Report -- Individuals
Case Series -- Individuals
Ecological Co relational Population
Cross sectional Prevalence Individuals
Analytical Studies
Case Control Case reference Individuals
Cohort Follow-up/ Longitudinal/ Incidence Individuals
B. Experimental/ Intervention Studies
.
RCT Clinical Trial Patients
Field Trial --- Healthy
individual
Community Community intervention Studies Communities
Trial
Aims of the study
Descriptive Studies: to generate or formulate
hypothesis
Analytical Studies: to test hypothesis
Experimental Studies: to prove hypothesis
Study Design Sequence
Hypothesis formation
Descriptive
Case reports Case series
epidemiology
Analytic Animal Lab

epidemiology study study
Clinical
Hypothesis testing
trials
Cohort Case- Cross-

control sectional
Descriptive Epidemiology
It describes
• When-time distribution
• Where-place distribution
• Who-person distribution
Procedures
Defining the population
Defining the disease under study
Describe the disease –time, place, person
Measurement of disease
Comparing with known indices
Formulation of hypothesis
Descriptive Studies
Descriptive studies
• Do not proceed to test a pre-formed
hypothesis
• Study is done only in one group of subjects;
there is no comparison group
• Can be community or hospital based
• Study proceeds to describe:
– Mean value
– Proportion
– Distribution in person, place and time
Descriptive Epidemiology
• What …………………….. Clinical information
• Who …………………….. Person
• Where …………………... Place
• When ……………………. Time
Case report
• Brief, objective report of clinical characteristic
or outcome from a single clinical subject or
event
• It is the first evidence of an unexpected or
unusual event
• Results are rarely generalizable
Case series
Objective and brief report of a clinical
characteristic or outcome from a group of clinical
subjects
• where there is atypical or abnormal behaviour or
development
• an unexplained outcome to treatment
• an emerging disease or condition
Cross sectional study f
fravelahue
• Investigator measures the outcome and the

exposures in the study participants at the same
time
• Data collected from cross section of the
population
• It is like taking a still photograph
• These provide:
– Prevalence of a factor
– Mean of a factor
– Description of a pattern
– A proxy for longitudinal study in some cases
Cross sectional study
• Participants in a cross-sectional study are just
selected based on the inclusion and exclusion criteria
set for the study
• Once the participants have been selected for the
study, the investigator follows the study to assess the
exposure and the outcomes
Cross sectional study
After the entry into the study, the participants
are measured for outcome and exposure at the
same time. The investigator can study the
association between these variables
Strengths
• Faster
• Inexpensive
• Gives information about the prevalence of outcomes
or exposures
• The information will be useful for designing the
cohort study
• Useful for public health planning, monitoring, and
evaluation
Measure trends
• Multiple cross-sectional surveys are used to assess
the changes in exposures and outcomes in a
particular population
Measure trends
• The National AIDS Control Organisation's Sentinel Surveillance
of HIV is an example of “serial cross-sectional study” or “serial
survey.”
• Sentinel Surveillance in Antenatal Clinic: The surveillance
provided data on the prevalence of HIV infection in antenatal
women, and thus, the trends of HIV infection in this
population
• It can be seen that the prevalence has, in general, reduced
over the past decade in these groups. Thus, repeated cross-
sectional surveys are also useful to monitor the trends over a
period
Measure trends
Data from National HIV Sentinel Surveillance (2003–2011)*. *Graph

generated from data in the National HIV Sentinel Surveillance
Limitations
• Since this is a 1-time measurement of exposure and outcome, it is
difficult to derive causal relationships from cross-sectional analysis
• These studies are also prone to certain biases. For example, we
wish to study the relation between diet and exercise and being
overweight/obese. We conduct a cross-sectional study and recruit
250 individuals. We assess their dietary habits, exercise habits, and
body mass index at one point of time in a cross-sectional survey.
However, individuals who are overweight/obese have started to
exercise more or altered their feeding habits (eat more salads).
Hence, in a cross-sectional survey, we may find that
overweight/obese individuals are also more likely to eat salads and
exercise more. Thus, we have to be careful about interpreting the
associations and direction of associations from a cross-sectional
survey
Limitations
The prevalence of an outcome depends on the incidence of the
disease as well as the length of survival following the outcome.
For example, even if the incidence of HIV (number of new cases)
goes down in one particular community, the prevalence (total
number of cases – old as well as new) may increase. This may be
due to cumulative HIV positive cases over a period. Thus, just
performing cross-sectional surveys may not be sufficient to
understand disease trends in this situation
Cross sectional study I
• Antibiotic resistance in Propionibacterium acnes strains
(Sardana et al., 2016)
• A study by Sardana et al. evaluated the antibiotic resistance in
isolates of Propionibacterium acnes in a tertiary care hospital in
India. They recruited 80 patients of acne vulgaris, collected
specimen for isolation from open or closed comedones. These
specimens were then cultured, the growth identified, and antibiotic
susceptibility and resistance were assessed
• They isolated P. acnes 52% of the cases. In these isolates, resistance
for erythromycin, clindamycin, and azithromycin was observed in
98%, 90%, and 100% of the isolates, respectively. However,
sensitivity for tetracycline, doxycycline, minocycline, and
levofloxacin was observed in 69%, 56%, 98%, and 90% of the
isolates, respectively
Comedones
Cross sectional study I
Cross-sectional study designs may be used for
population-based surveys
• Example: We are interested to know the prevalence of
vitiligo in a village. We design a population-based
survey to assess the prevalence of this condition. We
go to all the houses that were supposed to be included
in the study and examine the population. The total
sample surveyed is 5686. Of these, we found that 98
individuals have vitiligo. Thus, the prevalence of vitiligo
in this community is: Prevalence = 98/5686 or
17.23/1000 population
Cross sectional study II
• Cross-sectional studies may also be used for estimating the
prevalence in clinic-based studies. Example: Research
question – What is the prevalence of HIV in patients
presenting with an STI?
• We evaluate 300 patients with an STI clinic. We record this
history, clinical examination, and test them for HIV antibodies
(using ELISA) during their first visit to the clinic. We find that
60 of these individuals are HIV infected. Thus, we have
detected a prevalence of 20% HIV infection among our STI
patients
• The prevalence from these data may have limited
generalizability

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Study design I

Analytic Animal Lab

Cohort Case- Cross-

• Investigator measures the outcome and the

Data from National HIV Sentinel Surveillance (2003–2011). Graph

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