Introduction

Study Designs
Observational
Case Report
Case Control
Cross-sectional
Cohort
Robbie A. Beyl, PhD
Experimental
Randomized Trail
Pennington Biomedical Research Center
Systematic
Review

Questions

Supported by 1 U54 GM104940 from the National Institute of

General Medical Sciences of the National Institutes of Health which
funds the Louisiana Clinical and Translational Science Center

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 Outline

Introduction 1 Introduction
Observational
Case Report
Case Control
2 Observational
Cross-sectional
Cohort
Case Report
Experimental
Case Control
Randomized Trail Cross-sectional
Systematic
Review
Cohort
Questions

3 Experimental
Randomized Trail

4 Systematic Review

5 Questions

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 Study designs

Key terms
Introduction

Observational
Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Study designs

Key terms
Introduction

Observational Exposure-predictor event

Case Report
Case Control -smoking status, amount of fats ingested, new surgery tool
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Study designs

Key terms
Introduction

Observational Exposure-predictor event

Case Report
Case Control -smoking status, amount of fats ingested, new surgery tool
Cross-sectional
Cohort
Outcome-response event
Experimental
Randomized Trail -weight, presence of cancer, recovery time
Systematic
Review

Questions

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 Study designs

Key terms
Introduction

Observational Exposure-predictor event

Case Report
Case Control -smoking status, amount of fats ingested, new surgery tool
Cross-sectional
Cohort
Outcome-response event
Experimental
Randomized Trail -weight, presence of cancer, recovery time
Systematic
Review
Confounder -variable that may influence the outcome
Questions
-age, gender, education level

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 Study designs

Key terms
Introduction

Observational Exposure-predictor event

Case Report
Case Control -smoking status, amount of fats ingested, new surgery tool
Cross-sectional
Cohort
Outcome-response event
Experimental
Randomized Trail -weight, presence of cancer, recovery time
Systematic
Review
Confounder -variable that may influence the outcome
Questions
-age, gender, education level

Bias-a systematic difference between results of a study and true

measure
-recall, psychological, selection

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 Study designs

Key terms
Introduction

Observational Exposure-predictor event

Case Report
Case Control -smoking status, amount of fats ingested, new surgery tool
Cross-sectional
Cohort
Outcome-response event
Experimental
Randomized Trail -weight, presence of cancer, recovery time
Systematic
Review
Confounder -variable that may influence the outcome
Questions
-age, gender, education level

Bias-a systematic difference between results of a study and true

measure
-recall, psychological, selection
Relative Risk -ratio of the probability of the event occurring in the
exposed group versus a control group

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 Study designs

Introduction

Observational
Case Report
Case Control
Key terms
Cross-sectional
Cohort
Prevalence-the proportion of a population found to have a
Experimental
Randomized Trail
condition
Systematic
Review

Questions

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 Study designs

Introduction

Observational
Case Report
Case Control
Key terms
Cross-sectional
Cohort
Prevalence-the proportion of a population found to have a
Experimental
Randomized Trail
condition
Systematic
Review Populations-group of individuals who share a common set of
Questions characteristic

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 Study designs

Introduction

Observational
Case Report
Case Control
Key terms
Cross-sectional
Cohort
Prevalence-the proportion of a population found to have a
Experimental
Randomized Trail
condition
Systematic
Review Populations-group of individuals who share a common set of
Questions characteristic
-location: neighborhood, country, desert

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 Study designs

Introduction

Observational
Case Report
Case Control
Key terms
Cross-sectional
Cohort
Prevalence-the proportion of a population found to have a
Experimental
Randomized Trail
condition
Systematic
Review Populations-group of individuals who share a common set of
Questions characteristic
-location: neighborhood, country, desert
-biological factors: age, race, genetic condition

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 Study designs

Introduction

Observational
Case Report
Case Control
Key terms
Cross-sectional
Cohort
Prevalence-the proportion of a population found to have a
Experimental
Randomized Trail
condition
Systematic
Review Populations-group of individuals who share a common set of
Questions characteristic
-location: neighborhood, country, desert
-biological factors: age, race, genetic condition
-social factors: income level, education, religion

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 Study designs

Three main types of study designs

Introduction

Observational
Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Study designs

Three main types of study designs

Introduction

Observational
Case Report Observational- researcher does not intervene
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Study designs

Three main types of study designs

Introduction

Observational
Case Report Observational- researcher does not intervene
Case Control
Cross-sectional
Cohort
Case Report
Experimental Case Control
Randomized Trail

Systematic
Cross-sectional
Review

Questions
Cohort

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 Study designs

Three main types of study designs

Introduction

Observational
Case Report Observational- researcher does not intervene
Case Control
Cross-sectional
Cohort
Case Report
Experimental Case Control
Randomized Trail

Systematic
Cross-sectional
Review

Questions
Cohort

Experimental- participants are randomization to specific treatment

groups

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 Study designs

Three main types of study designs

Introduction

Observational
Case Report Observational- researcher does not intervene
Case Control
Cross-sectional
Cohort
Case Report
Experimental Case Control
Randomized Trail

Systematic
Cross-sectional
Review

Questions
Cohort

Experimental- participants are randomization to specific treatment

groups
Randomized Trial

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 Study designs

Three main types of study designs

Introduction

Observational
Case Report Observational- researcher does not intervene
Case Control
Cross-sectional
Cohort
Case Report
Experimental Case Control
Randomized Trail

Systematic
Cross-sectional
Review

Questions
Cohort

Experimental- participants are randomization to specific treatment

groups
Randomized Trial

Systematic review- uses past studies

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 Case Report

Introduction

Observational
Goal: detail the aspects of the patient’s medical situation
Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Case Report

Introduction

Observational
Goal: detail the aspects of the patient’s medical situation
Case Report
Case Control
Cross-sectional
Lowest level of study design
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Case Report

Introduction

Observational
Goal: detail the aspects of the patient’s medical situation
Case Report
Case Control
Cross-sectional
Lowest level of study design
Cohort

Experimental Consists of a single case

Randomized Trail

Systematic
Review

Questions

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 Case Report

Introduction

Observational
Goal: detail the aspects of the patient’s medical situation
Case Report
Case Control
Cross-sectional
Lowest level of study design
Cohort

Experimental Consists of a single case

Randomized Trail

Systematic Common topic of case reports:

Review

Questions An unexpected association between diseases or symptoms

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 Case Report

Introduction

Observational
Goal: detail the aspects of the patient’s medical situation
Case Report
Case Control
Cross-sectional
Lowest level of study design
Cohort

Experimental Consists of a single case

Randomized Trail

Systematic Common topic of case reports:

Review

Questions An unexpected association between diseases or symptoms

An unexpected event in the course of observing or treating a
patient

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 Case Report

Introduction

Observational
Goal: detail the aspects of the patient’s medical situation
Case Report
Case Control
Cross-sectional
Lowest level of study design
Cohort

Experimental Consists of a single case

Randomized Trail

Systematic Common topic of case reports:

Review

Questions An unexpected association between diseases or symptoms

An unexpected event in the course of observing or treating a
patient
Unique or rare features of a disease

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 Case Report

Introduction

Observational
Goal: detail the aspects of the patient’s medical situation
Case Report
Case Control
Cross-sectional
Lowest level of study design
Cohort

Experimental Consists of a single case

Randomized Trail

Systematic Common topic of case reports:

Review

Questions An unexpected association between diseases or symptoms

An unexpected event in the course of observing or treating a
patient
Unique or rare features of a disease
A variation of anatomical structures

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 Case Report

Introduction

Observational
Case Report Example
Case Control
Cross-sectional
Cohort Dr. Rivers treats a young and otherwise healthy patient suffering
Experimental
Randomized Trail
from numbness over the patient’s body.
Systematic
Review

Questions

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 Case Report

Introduction

Observational
Case Report Example
Case Control
Cross-sectional
Cohort Dr. Rivers treats a young and otherwise healthy patient suffering
Experimental
Randomized Trail
from numbness over the patient’s body.
Systematic
Review After an exhaustive history, Dr. Rivers believes that the numbness
Questions occurred because of a new type of sunscreen the patient used

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 Case Report

Introduction

Observational
Case Report Example
Case Control
Cross-sectional
Cohort Dr. Rivers treats a young and otherwise healthy patient suffering
Experimental
Randomized Trail
from numbness over the patient’s body.
Systematic
Review After an exhaustive history, Dr. Rivers believes that the numbness
Questions occurred because of a new type of sunscreen the patient used
Dr. Rivers writes up a case report describing how the numbness
presented, how and why she concluded it was the sunscreen, and
how she treated the patient.

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 Case Report

Introduction

Observational
Case Report
Advantages
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Case Report

Introduction

Observational
Case Report
Advantages
Case Control
Cross-sectional Requires only one patient
Cohort

Experimental
Details many different aspects of the patient’s medical
Randomized Trail situation
Systematic
Review Quickly inform the medical community of new trends
Questions

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 Case Report

Introduction

Observational
Case Report
Advantages
Case Control
Cross-sectional Requires only one patient
Cohort

Experimental
Details many different aspects of the patient’s medical
Randomized Trail situation
Systematic
Review Quickly inform the medical community of new trends
Questions

Disadvantages
Case may not be generalizable
May emphasize the bizarre or focus on misleading elements

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 Case Series

Introduction
Goal: detail a medical condition in a collection of people that is
Observational
Case Report
rare or otherwise unknown
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Case Series

Introduction
Goal: detail a medical condition in a collection of people that is
Observational
Case Report
rare or otherwise unknown
Case Control
Cross-sectional
Cohort
Expands on case report by investigating several cases
Experimental
Randomized Trail

Systematic
Review

Questions

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 Case Series

Introduction
Goal: detail a medical condition in a collection of people that is
Observational
Case Report
rare or otherwise unknown
Case Control
Cross-sectional
Cohort
Expands on case report by investigating several cases
Experimental
Randomized Trail

Systematic
Example
Review

Questions Dr. Rivers examines the original patient’s friends that also used
the same sunscreen.

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 Case Series

Introduction
Goal: detail a medical condition in a collection of people that is
Observational
Case Report
rare or otherwise unknown
Case Control
Cross-sectional
Cohort
Expands on case report by investigating several cases
Experimental
Randomized Trail

Systematic
Example
Review

Questions Dr. Rivers examines the original patient’s friends that also used
the same sunscreen.

Two of the six patients also present with similar symptoms.

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 Case Series

Introduction
Goal: detail a medical condition in a collection of people that is
Observational
Case Report
rare or otherwise unknown
Case Control
Cross-sectional
Cohort
Expands on case report by investigating several cases
Experimental
Randomized Trail

Systematic
Example
Review

Questions Dr. Rivers examines the original patient’s friends that also used
the same sunscreen.

Two of the six patients also present with similar symptoms.

Dr. Rivers writes a case series for the three patients that
presented with the numbness.

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 Case Series

Introduction

Observational Advantages
Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Case Series

Introduction

Observational Advantages
Case Report
Case Control Requires a small number of patients
Cross-sectional
Cohort
Details many different aspects of the patient’s medical
Experimental
Randomized Trail
situation
Systematic
Review
Informs the medical community of new trends quickly
Questions

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 Case Series

Introduction

Observational Advantages
Case Report
Case Control Requires a small number of patients
Cross-sectional
Cohort
Details many different aspects of the patient’s medical
Experimental
Randomized Trail
situation
Systematic
Review
Informs the medical community of new trends quickly
Questions
Disadvantages
Selection bias
Unknown causality

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 Case Control Study

Introduction

Observational
Case Report
Case Control Goal: determine if exposure and outcome are associated.
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Case Control Study

Introduction

Observational
Case Report
Case Control Goal: determine if exposure and outcome are associated.
Cross-sectional
Cohort
Compares patients who have the outcome of interest (cases) with
Experimental
Randomized Trail patients who do not have the outcome (controls)
Systematic
Review

Questions

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 Case Control Study

Introduction

Observational
Case Report
Case Control Goal: determine if exposure and outcome are associated.
Cross-sectional
Cohort
Compares patients who have the outcome of interest (cases) with
Experimental
Randomized Trail patients who do not have the outcome (controls)
Systematic
Review
Subject are selected by outcome status and afterward exposure
Questions
status is assessed

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 Case Control Study

Introduction

Observational
Case Report
Case Control Goal: determine if exposure and outcome are associated.
Cross-sectional
Cohort
Compares patients who have the outcome of interest (cases) with
Experimental
Randomized Trail patients who do not have the outcome (controls)
Systematic
Review
Subject are selected by outcome status and afterward exposure
Questions
status is assessed
Controls must be carefully chosen to match the population the
cases are from

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 Case Control Study

Introduction

Observational Example
Case Report
Case Control
Cross-sectional
Cohort
Dr. Washburne has read about Dr. Rivers’ studies and wants to
Experimental find out if the numbness and the sunscreen are associated.
Randomized Trail

Systematic
Review

Questions

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 Case Control Study

Introduction

Observational Example
Case Report
Case Control
Cross-sectional
Cohort
Dr. Washburne has read about Dr. Rivers’ studies and wants to
Experimental find out if the numbness and the sunscreen are associated.
Randomized Trail

Systematic
Review
He finds 20 people that have experienced numbness (cases) and
Questions
20 people that have not (controls).

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 Case Control Study

Introduction

Observational Example
Case Report
Case Control
Cross-sectional
Cohort
Dr. Washburne has read about Dr. Rivers’ studies and wants to
Experimental find out if the numbness and the sunscreen are associated.
Randomized Trail

Systematic
Review
He finds 20 people that have experienced numbness (cases) and
Questions
20 people that have not (controls).
Dr. Washburne interviewed all the people to find if they used the
sunscreen and finds that 16 of the people with numbness used
the sunscreen while only 2 people who did not experience
numbness used it.

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 Case Control Study

Introduction

Observational Advantages
Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Case Control Study

Introduction

Observational Advantages
Case Report
Case Control Require only a moderate amount of time to complete
Cross-sectional
Cohort Relatively inexpensive to carry out
Experimental
Randomized Trail Useful when outcomes are rare
Systematic
Review

Questions

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 Case Control Study

Introduction

Observational Advantages
Case Report
Case Control Require only a moderate amount of time to complete
Cross-sectional
Cohort Relatively inexpensive to carry out
Experimental
Randomized Trail Useful when outcomes are rare
Systematic
Review
Disadvantages
Questions

Subject to several biases

May be difficult to find an appropriate control group
Unknown causality

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 Cross-sectional Study

Introduction

Observational
Case Report
Case Control
Cross-sectional Goal: determine prevalence of outcome for entire population
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Cross-sectional Study

Introduction

Observational
Case Report
Case Control
Cross-sectional Goal: determine prevalence of outcome for entire population
Cohort

Experimental
Randomized Trail
Sample is based on the entire population, not just cases and
Systematic
controls
Review

Questions

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 Cross-sectional Study

Introduction

Observational
Case Report
Case Control
Cross-sectional Goal: determine prevalence of outcome for entire population
Cohort

Experimental
Randomized Trail
Sample is based on the entire population, not just cases and
Systematic
controls
Review

Questions Sample taken at one specific point in time

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 Cross-sectional Study

Introduction

Observational
Case Report
Case Control
Cross-sectional Goal: determine prevalence of outcome for entire population
Cohort

Experimental
Randomized Trail
Sample is based on the entire population, not just cases and
Systematic
controls
Review

Questions Sample taken at one specific point in time

Surveys are example of cross-sectional studies

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 Cross-sectional Study

Introduction

Observational
Case Report
Case Control
Example
Cross-sectional
Cohort

Experimental
Dr. Jayne has heard that the new sunscreen and numbness are
Randomized Trail associated and wants to know if this condition is wide spread
Systematic
Review

Questions

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 Cross-sectional Study

Introduction

Observational
Case Report
Case Control
Example
Cross-sectional
Cohort

Experimental
Dr. Jayne has heard that the new sunscreen and numbness are
Randomized Trail associated and wants to know if this condition is wide spread
Systematic
Review
Dr. Jayne collects information on a random sample of people
Questions
across the state

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 Cross-sectional Study

Introduction

Observational
Case Report
Case Control
Example
Cross-sectional
Cohort

Experimental
Dr. Jayne has heard that the new sunscreen and numbness are
Randomized Trail associated and wants to know if this condition is wide spread
Systematic
Review
Dr. Jayne collects information on a random sample of people
Questions
across the state

He finds that the risk of numbness is low for the general state
population, but high for people between the ages of 13 and 18

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 Cross-sectional Study

Introduction

Observational
Case Report Advantages
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Cross-sectional Study

Introduction

Observational
Case Report Advantages
Case Control
Cross-sectional Results can be applied to the population
Cohort

Experimental
Relatively low cost
Randomized Trail

Systematic
Review

Questions

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 Cross-sectional Study

Introduction

Observational
Case Report Advantages
Case Control
Cross-sectional Results can be applied to the population
Cohort

Experimental
Relatively low cost
Randomized Trail

Systematic
Review
Disadvantages
Questions
Does not work well for rare outcomes
Unknown causality
Recall bias

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 Cohort Study

Introduction

Observational
Case Report
Case Control
Cross-sectional Goal: determine if the exposure precedes the outcome
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Cohort Study

Introduction

Observational
Case Report
Case Control
Cross-sectional Goal: determine if the exposure precedes the outcome
Cohort

Experimental
Randomized Trail
Also call longitudinal studies or prospective studies
Systematic
Review

Questions

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 Cohort Study

Introduction

Observational
Case Report
Case Control
Cross-sectional Goal: determine if the exposure precedes the outcome
Cohort

Experimental
Randomized Trail
Also call longitudinal studies or prospective studies
Systematic
Review Cohort is identified before the appearance of the outcome
Questions

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 Cohort Study

Introduction

Observational
Case Report
Case Control
Cross-sectional Goal: determine if the exposure precedes the outcome
Cohort

Experimental
Randomized Trail
Also call longitudinal studies or prospective studies
Systematic
Review Cohort is identified before the appearance of the outcome
Questions
Exposure is assessed and then participants are followed for a set
amount of time

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 Cohort Study

Introduction

Observational
Case Report
Case Control
Example
Cross-sectional
Cohort

Experimental
After seeing the findings from Dr. Jayne, Drs. Kay and Lee want
Randomized Trail to know if the sunscreen precedes the numbness
Systematic
Review

Questions

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 Cohort Study

Introduction

Observational
Case Report
Case Control
Example
Cross-sectional
Cohort

Experimental
After seeing the findings from Dr. Jayne, Drs. Kay and Lee want
Randomized Trail to know if the sunscreen precedes the numbness
Systematic
Review
Focusing on people between the ages 13 and 18, the doctors
Questions
finds 500 participants and follow them for two years

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 Cohort Study

Introduction

Observational
Case Report
Case Control
Example
Cross-sectional
Cohort

Experimental
After seeing the findings from Dr. Jayne, Drs. Kay and Lee want
Randomized Trail to know if the sunscreen precedes the numbness
Systematic
Review
Focusing on people between the ages 13 and 18, the doctors
Questions
finds 500 participants and follow them for two years
Over the course of the two years, 60% of the participants who use
the sunscreen experienced numbness

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 Cohort Study

Introduction

Observational Advantages
Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Cohort Study

Introduction

Observational Advantages
Case Report
Case Control Risk can be assessed
Cross-sectional
Cohort Accurate collection of information
Experimental
Randomized Trail
Less expensive than randomized trials
Systematic
Review

Questions

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 Cohort Study

Introduction

Observational Advantages
Case Report
Case Control Risk can be assessed
Cross-sectional
Cohort Accurate collection of information
Experimental
Randomized Trail
Less expensive than randomized trials
Systematic
Review
Disadvantages
Questions

More expensive than previous studies

Confounding caused by no randomization
Outcome may require a long time until it occurs

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 Randomized Trail

Introduction

Observational
Case Report
Case Control Goal: determine the efficacy or effectiveness of a exposure or
Cross-sectional
Cohort
treatment
Experimental
Randomized Trail

Systematic
Review

Questions

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 Randomized Trail

Introduction

Observational
Case Report
Case Control Goal: determine the efficacy or effectiveness of a exposure or
Cross-sectional
Cohort
treatment
Experimental
Randomized Trail Also called Randomized Control Trail or Randomized Clinical Trail
Systematic
Review

Questions

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 Randomized Trail

Introduction

Observational
Case Report
Case Control Goal: determine the efficacy or effectiveness of a exposure or
Cross-sectional
Cohort
treatment
Experimental
Randomized Trail Also called Randomized Control Trail or Randomized Clinical Trail
Systematic
Review
Subjects are randomly assigned to a treatment group
Questions

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 Randomized Trail

Introduction

Observational
Case Report
Case Control Goal: determine the efficacy or effectiveness of a exposure or
Cross-sectional
Cohort
treatment
Experimental
Randomized Trail Also called Randomized Control Trail or Randomized Clinical Trail
Systematic
Review
Subjects are randomly assigned to a treatment group
Questions

Subjects are followed for a set amount of time

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 Randomized Trail

Introduction

Observational
Case Report
Case Control Goal: determine the efficacy or effectiveness of a exposure or
Cross-sectional
Cohort
treatment
Experimental
Randomized Trail Also called Randomized Control Trail or Randomized Clinical Trail
Systematic
Review
Subjects are randomly assigned to a treatment group
Questions

Subjects are followed for a set amount of time

Various outcomes can be investigated

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 Randomized Trial

Introduction

Observational 5 phases of clinical trials

Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Randomized Trial

Introduction

Observational 5 phases of clinical trials

Case Report
Case Control Phase 0-Pharmacodynamics and Pharmacokinetics (10-15
Cross-sectional
Cohort subjects)
Experimental
Randomized Trail

Systematic
Review

Questions

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 Randomized Trial

Introduction

Observational 5 phases of clinical trials

Case Report
Case Control Phase 0-Pharmacodynamics and Pharmacokinetics (10-15
Cross-sectional
Cohort subjects)
Experimental
Randomized Trail
Phase 1-Screening for safety (20-100 subjects)
Systematic
Review

Questions

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 Randomized Trial

Introduction

Observational 5 phases of clinical trials

Case Report
Case Control Phase 0-Pharmacodynamics and Pharmacokinetics (10-15
Cross-sectional
Cohort subjects)
Experimental
Randomized Trail
Phase 1-Screening for safety (20-100 subjects)
Systematic Phase 2-Establishing the efficacy of the drug (100-300
Review

Questions
subjects)

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 Randomized Trial

Introduction

Observational 5 phases of clinical trials

Case Report
Case Control Phase 0-Pharmacodynamics and Pharmacokinetics (10-15
Cross-sectional
Cohort subjects)
Experimental
Randomized Trail
Phase 1-Screening for safety (20-100 subjects)
Systematic Phase 2-Establishing the efficacy of the drug (100-300
Review

Questions
subjects)
Phase 3-Final confirmation of safety and efficacy (300+
subjects)

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 Randomized Trial

Introduction

Observational 5 phases of clinical trials

Case Report
Case Control Phase 0-Pharmacodynamics and Pharmacokinetics (10-15
Cross-sectional
Cohort subjects)
Experimental
Randomized Trail
Phase 1-Screening for safety (20-100 subjects)
Systematic Phase 2-Establishing the efficacy of the drug (100-300
Review

Questions
subjects)
Phase 3-Final confirmation of safety and efficacy (300+
subjects)
Phase 4-Postmarketing surveillance (number of subjects
varies)

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 Randomized Trial

Introduction Example
Observational
Case Report
Case Control Dr. Simon is part of a Phase 4 trial to determine how much the
Cross-sectional
Cohort
sunscreen is effecting the risk of numbness
Experimental
Randomized Trail

Systematic
Review

Questions

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 Randomized Trial

Introduction Example
Observational
Case Report
Case Control Dr. Simon is part of a Phase 4 trial to determine how much the
Cross-sectional
Cohort
sunscreen is effecting the risk of numbness
Experimental
Randomized Trail Focusing on subjects between the ages of 13-18, Dr. Simon
Systematic follows 200 subjects who are using the sunscreen over the course
Review

Questions
of a year

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 Randomized Trial

Introduction Example
Observational
Case Report
Case Control Dr. Simon is part of a Phase 4 trial to determine how much the
Cross-sectional
Cohort
sunscreen is effecting the risk of numbness
Experimental
Randomized Trail Focusing on subjects between the ages of 13-18, Dr. Simon
Systematic follows 200 subjects who are using the sunscreen over the course
Review

Questions
of a year
Initial results appear inconclusive with only 50% of the subjects
experiencing numbness

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 Randomized Trial

Introduction Example
Observational
Case Report
Case Control Dr. Simon is part of a Phase 4 trial to determine how much the
Cross-sectional
Cohort
sunscreen is effecting the risk of numbness
Experimental
Randomized Trail Focusing on subjects between the ages of 13-18, Dr. Simon
Systematic follows 200 subjects who are using the sunscreen over the course
Review

Questions
of a year
Initial results appear inconclusive with only 50% of the subjects
experiencing numbness

After adjusting for confounding variables, it appears that 90% of

the subjects on a particular acne medication experience
numbness

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 Randomized Trial

Introduction

Observational
Case Report Advantages
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Randomized Trial

Introduction

Observational
Case Report Advantages
Case Control
Cross-sectional
Cohort
Strong cause and effect association
Experimental Can adjust for confounding
Randomized Trail

Systematic Easier to removes biases than observational studies

Review

Questions

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 Randomized Trial

Introduction

Observational
Case Report Advantages
Case Control
Cross-sectional
Cohort
Strong cause and effect association
Experimental Can adjust for confounding
Randomized Trail

Systematic Easier to removes biases than observational studies

Review

Questions
Disadvantages
Usually the most expensive study design
Volunteer bias

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 Systematic Review

Introduction

Observational
Case Report
Case Control Goal: comprehensive review of all relevant studies on a particular
Cross-sectional
Cohort topic
Experimental
Randomized Trail

Systematic
Review

Questions

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 Systematic Review

Introduction

Observational
Case Report
Case Control Goal: comprehensive review of all relevant studies on a particular
Cross-sectional
Cohort topic
Experimental
Randomized Trail Highest level of analysis
Systematic
Review

Questions

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 Systematic Review

Introduction

Observational
Case Report
Case Control Goal: comprehensive review of all relevant studies on a particular
Cross-sectional
Cohort topic
Experimental
Randomized Trail Highest level of analysis
Systematic
Review
Can employ meta-analysis
Questions
contrasting and combining results from different studies

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 Systematic Review

Introduction

Observational
Case Report
Case Control Goal: comprehensive review of all relevant studies on a particular
Cross-sectional
Cohort topic
Experimental
Randomized Trail Highest level of analysis
Systematic
Review
Can employ meta-analysis
Questions
contrasting and combining results from different studies

Based on both published and unpublished results

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 Systematic Review

Introduction

Observational Example
Case Report
Case Control
Cross-sectional Dr. Reynolds reviews all the literature on the connection between
Cohort

Experimental
sunscreen and numbness
Randomized Trail

Systematic
Review

Questions

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 Systematic Review

Introduction

Observational Example
Case Report
Case Control
Cross-sectional Dr. Reynolds reviews all the literature on the connection between
Cohort

Experimental
sunscreen and numbness
Randomized Trail

Systematic Based on the finding from the RCT, he goes back to get data from
Review
previous studies
Questions

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 Systematic Review

Introduction

Observational Example
Case Report
Case Control
Cross-sectional Dr. Reynolds reviews all the literature on the connection between
Cohort

Experimental
sunscreen and numbness
Randomized Trail

Systematic Based on the finding from the RCT, he goes back to get data from
Review
previous studies
Questions

He finds that 87% of the patients that experienced numbness

were on the same acne medication

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 Systematic Review

Introduction

Observational Example
Case Report
Case Control
Cross-sectional Dr. Reynolds reviews all the literature on the connection between
Cohort

Experimental
sunscreen and numbness
Randomized Trail

Systematic Based on the finding from the RCT, he goes back to get data from
Review
previous studies
Questions

He finds that 87% of the patients that experienced numbness

were on the same acne medication

Dr. Reynolds makes a recommendation to the FDA to inform

them about the interaction between the two items

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 Systematic Review

Introduction

Observational
Case Report
Advantages
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Systematic Review

Introduction

Observational
Case Report
Advantages
Case Control
Cross-sectional
Strongest form of medical evidence
Cohort
Less time and cost than conducting a new RCT or cohort
Experimental
Randomized Trail study
Systematic
Review More reliable and accurate than individual studies
Questions

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 Systematic Review

Introduction

Observational
Case Report
Advantages
Case Control
Cross-sectional
Strongest form of medical evidence
Cohort
Less time and cost than conducting a new RCT or cohort
Experimental
Randomized Trail study
Systematic
Review More reliable and accurate than individual studies
Questions

Disadvantages
Difficult to determine if studies could be combined
Requires using results from other researchers

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 Questions

The lowest level of study design is what type of study?

Introduction

Observational
Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Questions

The lowest level of study design is what type of study?

Introduction case study
Observational
Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Questions

The lowest level of study design is what type of study?

Introduction case study
Observational
Case Report
Case Control
Cross-sectional
Which type of study assess outcome first?
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Questions

The lowest level of study design is what type of study?

Introduction case study
Observational
Case Report
Case Control
Cross-sectional
Which type of study assess outcome first?
Cohort

Experimental
case-control study
Randomized Trail

Systematic
Review

Questions

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 Questions

The lowest level of study design is what type of study?

Introduction case study
Observational
Case Report
Case Control
Cross-sectional
Which type of study assess outcome first?
Cohort

Experimental
case-control study
Randomized Trail

Systematic
Review What type of study follows subjects for a set amount of time?
Questions

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 Questions

The lowest level of study design is what type of study?

Introduction case study
Observational
Case Report
Case Control
Cross-sectional
Which type of study assess outcome first?
Cohort

Experimental
case-control study
Randomized Trail

Systematic
Review What type of study follows subjects for a set amount of time?
Questions
cohort and randomized trial

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 Questions

The lowest level of study design is what type of study?

Introduction case study
Observational
Case Report
Case Control
Cross-sectional
Which type of study assess outcome first?
Cohort

Experimental
case-control study
Randomized Trail

Systematic
Review What type of study follows subjects for a set amount of time?
Questions
cohort and randomized trial

What type involves no new subject?

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 Questions

The lowest level of study design is what type of study?

Introduction case study
Observational
Case Report
Case Control
Cross-sectional
Which type of study assess outcome first?
Cohort

Experimental
case-control study
Randomized Trail

Systematic
Review What type of study follows subjects for a set amount of time?
Questions
cohort and randomized trial

What type involves no new subject?

systematic review

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 Questions

The lowest level of study design is what type of study?

Introduction case study
Observational
Case Report
Case Control
Cross-sectional
Which type of study assess outcome first?
Cohort

Experimental
case-control study
Randomized Trail

Systematic
Review What type of study follows subjects for a set amount of time?
Questions
cohort and randomized trial

What type involves no new subject?

systematic review

Which studies are not affected by recall bias?

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 Questions

The lowest level of study design is what type of study?

Introduction case study
Observational
Case Report
Case Control
Cross-sectional
Which type of study assess outcome first?
Cohort

Experimental
case-control study
Randomized Trail

Systematic
Review What type of study follows subjects for a set amount of time?
Questions
cohort and randomized trial

What type involves no new subject?

systematic review

Which studies are not affected by recall bias?

cohort and randomized trial

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 Questions

Introduction What phase of a clinical trial focuses on determining safe levels?

Observational
Case Report
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Questions

Introduction What phase of a clinical trial focuses on determining safe levels?

Observational
Case Report
Phase 1 and Phase 3
Case Control
Cross-sectional
Cohort

Experimental
Randomized Trail

Systematic
Review

Questions

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 Questions

Introduction What phase of a clinical trial focuses on determining safe levels?

Observational
Case Report
Phase 1 and Phase 3
Case Control
Cross-sectional
Cohort T/F: Subjects are randomized into treatment groups for a cohort
Experimental
Randomized Trail
study.
Systematic
Review

Questions

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 Questions

Introduction What phase of a clinical trial focuses on determining safe levels?

Observational
Case Report
Phase 1 and Phase 3
Case Control
Cross-sectional
Cohort T/F: Subjects are randomized into treatment groups for a cohort
Experimental
Randomized Trail
study.
Systematic False
Review

Questions

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 Questions

Introduction What phase of a clinical trial focuses on determining safe levels?

Observational
Case Report
Phase 1 and Phase 3
Case Control
Cross-sectional
Cohort T/F: Subjects are randomized into treatment groups for a cohort
Experimental
Randomized Trail
study.
Systematic False
Review

Questions

What study design is used to measure prevalence?

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 Questions

Introduction What phase of a clinical trial focuses on determining safe levels?

Observational
Case Report
Phase 1 and Phase 3
Case Control
Cross-sectional
Cohort T/F: Subjects are randomized into treatment groups for a cohort
Experimental
Randomized Trail
study.
Systematic False
Review

Questions

What study design is used to measure prevalence?

Cross-sectional

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 Questions

Introduction What phase of a clinical trial focuses on determining safe levels?

Observational
Case Report
Phase 1 and Phase 3
Case Control
Cross-sectional
Cohort T/F: Subjects are randomized into treatment groups for a cohort
Experimental
Randomized Trail
study.
Systematic False
Review

Questions

What study design is used to measure prevalence?

Cross-sectional

What study requires the fewest number of subjects?

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 Questions

Introduction What phase of a clinical trial focuses on determining safe levels?

Observational
Case Report
Phase 1 and Phase 3
Case Control
Cross-sectional
Cohort T/F: Subjects are randomized into treatment groups for a cohort
Experimental
Randomized Trail
study.
Systematic False
Review

Questions

What study design is used to measure prevalence?

Cross-sectional

What study requires the fewest number of subjects?

Case study

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 Questions

Introduction

Observational
Case Report A research team wants to know if there is an association between
Case Control
Cross-sectional artificial sweeteners and urinary tract cancers. The prevalence of
Cohort
urinary tract cancers is low.
Experimental
Randomized Trail

Systematic
Review

Questions

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 Questions

Introduction

Observational
Case Report A research team wants to know if there is an association between
Case Control
Cross-sectional artificial sweeteners and urinary tract cancers. The prevalence of
Cohort
urinary tract cancers is low.
Experimental
Randomized Trail case control study
Systematic
Review

Questions

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 Questions

Introduction

Observational
Case Report A research team wants to know if there is an association between
Case Control
Cross-sectional artificial sweeteners and urinary tract cancers. The prevalence of
Cohort
urinary tract cancers is low.
Experimental
Randomized Trail case control study
Systematic
Review

Questions A doctor examines an extended family of 20 people who all have

Heterochromia. 5 otherwise healthy family members also suffer
from vision loss in one eye.

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 Questions

Introduction

Observational
Case Report A research team wants to know if there is an association between
Case Control
Cross-sectional artificial sweeteners and urinary tract cancers. The prevalence of
Cohort
urinary tract cancers is low.
Experimental
Randomized Trail case control study
Systematic
Review

Questions A doctor examines an extended family of 20 people who all have

Heterochromia. 5 otherwise healthy family members also suffer
from vision loss in one eye.
case series

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 Questions

Introduction

Observational
A research team is interested in whether a new medication
Case Report
Case Control
reduces the risk of strokes. They ask the drug manufacturer for
Cross-sectional the number of annual prescriptions in the US and obtain data from
Cohort
death certificates to assess the number of death due to strokes.
Experimental
Randomized Trail

Systematic
Review

Questions

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 Questions

Introduction

Observational
A research team is interested in whether a new medication
Case Report
Case Control
reduces the risk of strokes. They ask the drug manufacturer for
Cross-sectional the number of annual prescriptions in the US and obtain data from
Cohort
death certificates to assess the number of death due to strokes.
Experimental
Randomized Trail
cross-sectional study
Systematic
Review

Questions

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 Questions

Introduction

Observational
A research team is interested in whether a new medication
Case Report
Case Control
reduces the risk of strokes. They ask the drug manufacturer for
Cross-sectional the number of annual prescriptions in the US and obtain data from
Cohort
death certificates to assess the number of death due to strokes.
Experimental
Randomized Trail
cross-sectional study
Systematic
Review

Questions
A research group is interested in determining the relationship
between the Atkins diet and heart disease. They sample 150
people that have heart disease and 200 people without heart
disease.

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 Questions

Introduction

Observational
A research team is interested in whether a new medication
Case Report
Case Control
reduces the risk of strokes. They ask the drug manufacturer for
Cross-sectional the number of annual prescriptions in the US and obtain data from
Cohort
death certificates to assess the number of death due to strokes.
Experimental
Randomized Trail
cross-sectional study
Systematic
Review

Questions
A research group is interested in determining the relationship
between the Atkins diet and heart disease. They sample 150
people that have heart disease and 200 people without heart
disease.
case control study

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 Questions

Introduction
Researchers want to know if the number of plants in a patient’s
Observational
Case Report room impacts recovery time. The researchers randomly select
Case Control
Cross-sectional
300 patients entering the ICU. Measurements are taken on the
Cohort number of plants in the room and the number of days until they
Experimental
Randomized Trail
leave the ICU.
Systematic
Review

Questions

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 Questions

Introduction
Researchers want to know if the number of plants in a patient’s
Observational
Case Report room impacts recovery time. The researchers randomly select
Case Control
Cross-sectional
300 patients entering the ICU. Measurements are taken on the
Cohort number of plants in the room and the number of days until they
Experimental
Randomized Trail
leave the ICU.
Systematic cohort study
Review

Questions

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 Questions

Introduction
Researchers want to know if the number of plants in a patient’s
Observational
Case Report room impacts recovery time. The researchers randomly select
Case Control
Cross-sectional
300 patients entering the ICU. Measurements are taken on the
Cohort number of plants in the room and the number of days until they
Experimental
Randomized Trail
leave the ICU.
Systematic cohort study
Review

Questions

Researchers want to know if the number of plants in a patient’s

room impacts recovery time. The researcher select 500 patients
entering the ICU and place either 0, 1, 4, or 8 plants in their
rooms and measure the number of days until they leave the ICU.

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 Questions

Introduction
Researchers want to know if the number of plants in a patient’s
Observational
Case Report room impacts recovery time. The researchers randomly select
Case Control
Cross-sectional
300 patients entering the ICU. Measurements are taken on the
Cohort number of plants in the room and the number of days until they
Experimental
Randomized Trail
leave the ICU.
Systematic cohort study
Review

Questions

Researchers want to know if the number of plants in a patient’s

room impacts recovery time. The researcher select 500 patients
entering the ICU and place either 0, 1, 4, or 8 plants in their
rooms and measure the number of days until they leave the ICU.
randomized trial

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 References

Introduction

Observational
Case Report
Case Control
Cross-sectional Andresen, Elena and Erin DeFrises Bouldin eds. (2010) Public
Cohort
Health Foundations: Concepts and Practices. John Wiley &
Experimental
Randomized Trail
Sons.
Systematic
Review
DeMets, D., Friedman, L., and Furberg, C., (2010). Fundamentals
Questions
of Clinical Trials. Springer 4th Edition
Himmelfarb Health Sciences Library Study Design 101. (2011)
http://www.gwumc.edu/library/tutorials/studydesign101/index.html

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