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Intro Study Designs-AB

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24 views28 pages

Intro Study Designs-AB

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mr2944
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© © All Rights Reserved
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Epidemiology for

Global Health

Introduction to study designs


The design of a study is defined by the research
question

¿What is the prevalence of low birth weight babies in


this community?

¿What is the relationship between smoking and


cardiovascular events?

Is there an association between


the use of cell phones and cerebral tumors ?

¿What is the effect of an intensive DBT educational


program on DBT complications?
¿What is the prevalence of HIV+
Among adults in my health district?

Do they have a higher risk of TB than


HIV- individuals?

¿Does that risk change if I give them ATB


compared to no treatment?
HIERARCHY OF STUDY DESIGNS

Analytic
Descriptive
(association)

•Case report/series
•Cross sectional/Survey Observational
Experimental
•Cross sectional/Survey
•Randomized
•Ecological
controlled trials
•Case-control
•Cohort studies
Quasi-Experimental
•Before-after
•Time-series analysis

Strength of evidence for causality between a risk factor and outcome


TIMEFRAME OF STUDIES

• Prospective Study - looks forward,


looks to the future, examines future
events, follows a condition, concern or
disease into the future

(looking forward)

time
Study begins here
TIMEFRAME OF STUDIES

• Retrospective Study - “to look back”,


looks back in time to study events that
have already occurred

(looking back)
time

Study begins here

e.g. Case-Control Study


Descriptive Studies
CASE REPORTS

• Detailed presentation of a single case or


handful of cases
• Generally report a new or unique finding
• previous undescribed disease
• unexpected link between diseases
• unexpected new therapeutic effect
• adverse events
CASE SERIES

• Experience of a group of patients with a


similar diagnosis
• Assesses prevalent disease
• Cases may be identified from a single or
multiple sources
• Generally report on new/unique condition
• May be only realistic design for rare
disorders
CASE SERIES

STRENGHTS LIMITATIONS
• Useful for hypothesis • Cannot study cause and
generation effect relationships
• Informative for very • Cannot assess disease
rare disease with few frequency
established risk factors
• Characterizes averages
for disorder
¿What is the prevalence of HIV+
among adults in my health district?
CROSS-SECTIONAL STUDIES

• An observational design that surveys


exposures and disease status at a single point
in time (a cross-section of the population)

time

Study only exists at this point in time


CROSS-SECTIONAL STUDIES

• Often used to study conditions that are relatively


frequent with long duration of expression
(nonfatal, chronic conditions)
• It measures prevalence, not incidence of disease
• Example: community surveys
• Not suitable for studying
– rare or highly fatal diseases
– diseases with short duration of expression
• Temporal ambiguity: Cannot determine
temporality of exposure and disease
Large cross-sectional studies
• New York City Community Health Survey (NYC CHS)
• National Health and Nutrition Examination Survey
(NHANES)
• World Health Organization World Mental Health
Survey Initiative
• Argentina National survey of risk factors
Prevalence of diabetes among adults
in NYC, CHS 2013
100
89.2
90
80
70
Percent

60
50
40
30
20
10.8
10
0
Yes No
Ever been diagnosed with diabetes?
source of potential bias:
non-response

Sample
Population
ECOLOGIC STUDIES

• Unit of analysis is the group, not the individual; both


exposure and outcome measured for group
– e.g., countries, states, neighborhoods
• Can be used for generating hypotheses
• Level of exposure for each individual in the unit being
studied is unknown
• Generally makes use of secondary data
ECOLOGIC STUDIES

STRENGHTS LIMITATIONS
• Quick, simple, inexpensive
• Ecologic Fallacy
• Good for generating hypotheses
when disease is of unknown
etiology
• Some exposures may not vary
within a given group, and some
variables are only
defined/measured for groups
• Sometimes question is about
group differences, not individual
differences
• Brings back Context to
epidemiologic discussion
Do HIV+ individuals have a higher risk of TB
than HIV- individuals?
COHORT DESIGN

• Selection of subjects according to exposure, and


outcome-free at the time of inclusion

Cummings, Newman, Hulley. Designing Clinical Research. 2007


COHORT: PROSPECTIVE and RETROSPECTIVE

PROSPECTIVE RETROSPECTIVE

Cummings, Newman, Hulley. Designing Clinical Research. 2007


COHORT STUDIES

STRENGHTS LIMITATIONS
• Exposure status • Expensive and time-
determined before disease consuming
detection • Inefficient for rare diseases
• Subjects selected before or diseases with long
disease detection latency
• Can study several • Loss to follow-up
outcomes for each
exposure
CASE-CONTROL DESIGN

• Selection of subjects according to outcome

Cummings, Newman, Hulley. Designing Clinical Research. 2007


CASE-CONTROL STUDIES

STRENGHTS LIMITATIONS
• Less expensive and time • Exposure measurements
consuming than prospective taken after disease
cohorts occurrence
• Efficient for studying rare • Disease status can influence
diseases selection of subjects
¿Does that risk change if I give them ATB
compared to no treatment?
EXPERIMENTAL STUDIES: RANDOMIZED CONTROL TRIAL

Randomization

Cummings, Newman, Hulley. Designing Clinical Research. 2007


RANDOMIZED CONTROLLED TRIALS

STRENGHTS LIMITATIONS
• Confounding control • Duration of trials
• Prospective measurement – Expense

• "Gold-standard" for causal – Latency period

inference – Losses to follow-up


• Unethical in certains
circumstances

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