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Introduction Observational Case Report Case Control Cross-sectional Cohort Experimental Randomized Trail Systematic Review Questions Study Designs Robbie A. Beyl, PhD Pennington Biomedical Research Center 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 1 / 130

Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

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Page 1: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study Designs

Robbie A. Beyl, PhD

Pennington Biomedical Research Center

Supported by 1 U54 GM104940 from the National Institute ofGeneral Medical Sciences of the National Institutes of Health which

funds the Louisiana Clinical and Translational Science Center

1 / 130

Page 2: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Outline

1 Introduction

2 ObservationalCase ReportCase ControlCross-sectionalCohort

3 ExperimentalRandomized Trail

4 Systematic Review

5 Questions

2 / 130

Page 3: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Exposure-predictor event-smoking status, amount of fats ingested, new surgery tool

Outcome-response event-weight, presence of cancer, recovery time

Confounder -variable that may influence the outcome-age, gender, education level

Bias-a systematic difference between results of a study and truemeasure-recall, psychological, selection

Relative Risk -ratio of the probability of the event occurring in theexposed group versus a control group

3 / 130

Page 4: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Exposure-predictor event-smoking status, amount of fats ingested, new surgery tool

Outcome-response event-weight, presence of cancer, recovery time

Confounder -variable that may influence the outcome-age, gender, education level

Bias-a systematic difference between results of a study and truemeasure-recall, psychological, selection

Relative Risk -ratio of the probability of the event occurring in theexposed group versus a control group

4 / 130

Page 5: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Exposure-predictor event-smoking status, amount of fats ingested, new surgery tool

Outcome-response event-weight, presence of cancer, recovery time

Confounder -variable that may influence the outcome-age, gender, education level

Bias-a systematic difference between results of a study and truemeasure-recall, psychological, selection

Relative Risk -ratio of the probability of the event occurring in theexposed group versus a control group

5 / 130

Page 6: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Exposure-predictor event-smoking status, amount of fats ingested, new surgery tool

Outcome-response event-weight, presence of cancer, recovery time

Confounder -variable that may influence the outcome-age, gender, education level

Bias-a systematic difference between results of a study and truemeasure-recall, psychological, selection

Relative Risk -ratio of the probability of the event occurring in theexposed group versus a control group

6 / 130

Page 7: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Exposure-predictor event-smoking status, amount of fats ingested, new surgery tool

Outcome-response event-weight, presence of cancer, recovery time

Confounder -variable that may influence the outcome-age, gender, education level

Bias-a systematic difference between results of a study and truemeasure-recall, psychological, selection

Relative Risk -ratio of the probability of the event occurring in theexposed group versus a control group

7 / 130

Page 8: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Exposure-predictor event-smoking status, amount of fats ingested, new surgery tool

Outcome-response event-weight, presence of cancer, recovery time

Confounder -variable that may influence the outcome-age, gender, education level

Bias-a systematic difference between results of a study and truemeasure-recall, psychological, selection

Relative Risk -ratio of the probability of the event occurring in theexposed group versus a control group

8 / 130

Page 9: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Prevalence-the proportion of a population found to have acondition

Populations-group of individuals who share a common set ofcharacteristic-location: neighborhood, country, desert-biological factors: age, race, genetic condition-social factors: income level, education, religion

9 / 130

Page 10: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Prevalence-the proportion of a population found to have acondition

Populations-group of individuals who share a common set ofcharacteristic

-location: neighborhood, country, desert-biological factors: age, race, genetic condition-social factors: income level, education, religion

10 / 130

Page 11: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Prevalence-the proportion of a population found to have acondition

Populations-group of individuals who share a common set ofcharacteristic-location: neighborhood, country, desert

-biological factors: age, race, genetic condition-social factors: income level, education, religion

11 / 130

Page 12: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Prevalence-the proportion of a population found to have acondition

Populations-group of individuals who share a common set ofcharacteristic-location: neighborhood, country, desert-biological factors: age, race, genetic condition

-social factors: income level, education, religion

12 / 130

Page 13: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Key terms

Prevalence-the proportion of a population found to have acondition

Populations-group of individuals who share a common set ofcharacteristic-location: neighborhood, country, desert-biological factors: age, race, genetic condition-social factors: income level, education, religion

13 / 130

Page 14: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Three main types of study designs

Observational- researcher does not interveneCase ReportCase ControlCross-sectionalCohort

Experimental- participants are randomization to specific treatmentgroups

Randomized Trial

Systematic review- uses past studies

14 / 130

Page 15: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Three main types of study designs

Observational- researcher does not intervene

Case ReportCase ControlCross-sectionalCohort

Experimental- participants are randomization to specific treatmentgroups

Randomized Trial

Systematic review- uses past studies

15 / 130

Page 16: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Three main types of study designs

Observational- researcher does not interveneCase ReportCase ControlCross-sectionalCohort

Experimental- participants are randomization to specific treatmentgroups

Randomized Trial

Systematic review- uses past studies

16 / 130

Page 17: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Three main types of study designs

Observational- researcher does not interveneCase ReportCase ControlCross-sectionalCohort

Experimental- participants are randomization to specific treatmentgroups

Randomized Trial

Systematic review- uses past studies

17 / 130

Page 18: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Three main types of study designs

Observational- researcher does not interveneCase ReportCase ControlCross-sectionalCohort

Experimental- participants are randomization to specific treatmentgroups

Randomized Trial

Systematic review- uses past studies

18 / 130

Page 19: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Study designs

Three main types of study designs

Observational- researcher does not interveneCase ReportCase ControlCross-sectionalCohort

Experimental- participants are randomization to specific treatmentgroups

Randomized Trial

Systematic review- uses past studies

19 / 130

Page 20: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Goal: detail the aspects of the patient’s medical situation

Lowest level of study design

Consists of a single case

Common topic of case reports:An unexpected association between diseases or symptomsAn unexpected event in the course of observing or treating apatientUnique or rare features of a diseaseA variation of anatomical structures

20 / 130

Page 21: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Goal: detail the aspects of the patient’s medical situation

Lowest level of study design

Consists of a single case

Common topic of case reports:An unexpected association between diseases or symptomsAn unexpected event in the course of observing or treating apatientUnique or rare features of a diseaseA variation of anatomical structures

21 / 130

Page 22: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Goal: detail the aspects of the patient’s medical situation

Lowest level of study design

Consists of a single case

Common topic of case reports:An unexpected association between diseases or symptomsAn unexpected event in the course of observing or treating apatientUnique or rare features of a diseaseA variation of anatomical structures

22 / 130

Page 23: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Goal: detail the aspects of the patient’s medical situation

Lowest level of study design

Consists of a single case

Common topic of case reports:An unexpected association between diseases or symptoms

An unexpected event in the course of observing or treating apatientUnique or rare features of a diseaseA variation of anatomical structures

23 / 130

Page 24: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Goal: detail the aspects of the patient’s medical situation

Lowest level of study design

Consists of a single case

Common topic of case reports:An unexpected association between diseases or symptomsAn unexpected event in the course of observing or treating apatient

Unique or rare features of a diseaseA variation of anatomical structures

24 / 130

Page 25: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Goal: detail the aspects of the patient’s medical situation

Lowest level of study design

Consists of a single case

Common topic of case reports:An unexpected association between diseases or symptomsAn unexpected event in the course of observing or treating apatientUnique or rare features of a disease

A variation of anatomical structures

25 / 130

Page 26: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Goal: detail the aspects of the patient’s medical situation

Lowest level of study design

Consists of a single case

Common topic of case reports:An unexpected association between diseases or symptomsAn unexpected event in the course of observing or treating apatientUnique or rare features of a diseaseA variation of anatomical structures

26 / 130

Page 27: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Example

Dr. Rivers treats a young and otherwise healthy patient sufferingfrom numbness over the patient’s body.

After an exhaustive history, Dr. Rivers believes that the numbnessoccurred because of a new type of sunscreen the patient used

Dr. Rivers writes up a case report describing how the numbnesspresented, how and why she concluded it was the sunscreen, andhow she treated the patient.

27 / 130

Page 28: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Example

Dr. Rivers treats a young and otherwise healthy patient sufferingfrom numbness over the patient’s body.

After an exhaustive history, Dr. Rivers believes that the numbnessoccurred because of a new type of sunscreen the patient used

Dr. Rivers writes up a case report describing how the numbnesspresented, how and why she concluded it was the sunscreen, andhow she treated the patient.

28 / 130

Page 29: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Example

Dr. Rivers treats a young and otherwise healthy patient sufferingfrom numbness over the patient’s body.

After an exhaustive history, Dr. Rivers believes that the numbnessoccurred because of a new type of sunscreen the patient used

Dr. Rivers writes up a case report describing how the numbnesspresented, how and why she concluded it was the sunscreen, andhow she treated the patient.

29 / 130

Page 30: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

Advantages

Requires only one patientDetails many different aspects of the patient’s medicalsituationQuickly inform the medical community of new trends

DisadvantagesCase may not be generalizableMay emphasize the bizarre or focus on misleading elements

30 / 130

Page 31: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

AdvantagesRequires only one patientDetails many different aspects of the patient’s medicalsituationQuickly inform the medical community of new trends

DisadvantagesCase may not be generalizableMay emphasize the bizarre or focus on misleading elements

31 / 130

Page 32: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Report

AdvantagesRequires only one patientDetails many different aspects of the patient’s medicalsituationQuickly inform the medical community of new trends

DisadvantagesCase may not be generalizableMay emphasize the bizarre or focus on misleading elements

32 / 130

Page 33: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Series

Goal: detail a medical condition in a collection of people that israre or otherwise unknown

Expands on case report by investigating several cases

Example

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

Two of the six patients also present with similar symptoms.

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

33 / 130

Page 34: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Series

Goal: detail a medical condition in a collection of people that israre or otherwise unknown

Expands on case report by investigating several cases

Example

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

Two of the six patients also present with similar symptoms.

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

34 / 130

Page 35: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Series

Goal: detail a medical condition in a collection of people that israre or otherwise unknown

Expands on case report by investigating several cases

Example

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

Two of the six patients also present with similar symptoms.

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

35 / 130

Page 36: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Series

Goal: detail a medical condition in a collection of people that israre or otherwise unknown

Expands on case report by investigating several cases

Example

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

Two of the six patients also present with similar symptoms.

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

36 / 130

Page 37: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Series

Goal: detail a medical condition in a collection of people that israre or otherwise unknown

Expands on case report by investigating several cases

Example

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

Two of the six patients also present with similar symptoms.

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

37 / 130

Page 38: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Series

Advantages

Requires a small number of patientsDetails many different aspects of the patient’s medicalsituationInforms the medical community of new trends quickly

Disadvantages

Selection biasUnknown causality

38 / 130

Page 39: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Series

AdvantagesRequires a small number of patientsDetails many different aspects of the patient’s medicalsituationInforms the medical community of new trends quickly

Disadvantages

Selection biasUnknown causality

39 / 130

Page 40: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Series

AdvantagesRequires a small number of patientsDetails many different aspects of the patient’s medicalsituationInforms the medical community of new trends quickly

Disadvantages

Selection biasUnknown causality

40 / 130

Page 41: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

Goal: determine if exposure and outcome are associated.

Compares patients who have the outcome of interest (cases) withpatients who do not have the outcome (controls)

Subject are selected by outcome status and afterward exposurestatus is assessed

Controls must be carefully chosen to match the population thecases are from

41 / 130

Page 42: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

Goal: determine if exposure and outcome are associated.

Compares patients who have the outcome of interest (cases) withpatients who do not have the outcome (controls)

Subject are selected by outcome status and afterward exposurestatus is assessed

Controls must be carefully chosen to match the population thecases are from

42 / 130

Page 43: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

Goal: determine if exposure and outcome are associated.

Compares patients who have the outcome of interest (cases) withpatients who do not have the outcome (controls)

Subject are selected by outcome status and afterward exposurestatus is assessed

Controls must be carefully chosen to match the population thecases are from

43 / 130

Page 44: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

Goal: determine if exposure and outcome are associated.

Compares patients who have the outcome of interest (cases) withpatients who do not have the outcome (controls)

Subject are selected by outcome status and afterward exposurestatus is assessed

Controls must be carefully chosen to match the population thecases are from

44 / 130

Page 45: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

Example

Dr. Washburne has read about Dr. Rivers’ studies and wants tofind out if the numbness and the sunscreen are associated.

He finds 20 people that have experienced numbness (cases) and20 people that have not (controls).

Dr. Washburne interviewed all the people to find if they used thesunscreen and finds that 16 of the people with numbness usedthe sunscreen while only 2 people who did not experiencenumbness used it.

45 / 130

Page 46: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

Example

Dr. Washburne has read about Dr. Rivers’ studies and wants tofind out if the numbness and the sunscreen are associated.

He finds 20 people that have experienced numbness (cases) and20 people that have not (controls).

Dr. Washburne interviewed all the people to find if they used thesunscreen and finds that 16 of the people with numbness usedthe sunscreen while only 2 people who did not experiencenumbness used it.

46 / 130

Page 47: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

Example

Dr. Washburne has read about Dr. Rivers’ studies and wants tofind out if the numbness and the sunscreen are associated.

He finds 20 people that have experienced numbness (cases) and20 people that have not (controls).

Dr. Washburne interviewed all the people to find if they used thesunscreen and finds that 16 of the people with numbness usedthe sunscreen while only 2 people who did not experiencenumbness used it.

47 / 130

Page 48: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

Advantages

Require only a moderate amount of time to completeRelatively inexpensive to carry outUseful when outcomes are rare

Disadvantages

Subject to several biasesMay be difficult to find an appropriate control groupUnknown causality

48 / 130

Page 49: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

AdvantagesRequire only a moderate amount of time to completeRelatively inexpensive to carry outUseful when outcomes are rare

Disadvantages

Subject to several biasesMay be difficult to find an appropriate control groupUnknown causality

49 / 130

Page 50: Study Designs - lacats.org design.pdf · Study designs Three main types of study designs Observational- researcher does not intervene Case Report Case Control Cross-sectional Cohort

Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Case Control Study

AdvantagesRequire only a moderate amount of time to completeRelatively inexpensive to carry outUseful when outcomes are rare

Disadvantages

Subject to several biasesMay be difficult to find an appropriate control groupUnknown causality

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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

Goal: determine prevalence of outcome for entire population

Sample is based on the entire population, not just cases andcontrols

Sample taken at one specific point in time

Surveys are example of cross-sectional studies

51 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

Goal: determine prevalence of outcome for entire population

Sample is based on the entire population, not just cases andcontrols

Sample taken at one specific point in time

Surveys are example of cross-sectional studies

52 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

Goal: determine prevalence of outcome for entire population

Sample is based on the entire population, not just cases andcontrols

Sample taken at one specific point in time

Surveys are example of cross-sectional studies

53 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

Goal: determine prevalence of outcome for entire population

Sample is based on the entire population, not just cases andcontrols

Sample taken at one specific point in time

Surveys are example of cross-sectional studies

54 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

Example

Dr. Jayne has heard that the new sunscreen and numbness areassociated and wants to know if this condition is wide spread

Dr. Jayne collects information on a random sample of peopleacross the state

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

55 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

Example

Dr. Jayne has heard that the new sunscreen and numbness areassociated and wants to know if this condition is wide spread

Dr. Jayne collects information on a random sample of peopleacross the state

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

56 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

Example

Dr. Jayne has heard that the new sunscreen and numbness areassociated and wants to know if this condition is wide spread

Dr. Jayne collects information on a random sample of peopleacross the state

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

57 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

Advantages

Results can be applied to the populationRelatively low cost

Disadvantages

Does not work well for rare outcomesUnknown causalityRecall bias

58 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

AdvantagesResults can be applied to the populationRelatively low cost

Disadvantages

Does not work well for rare outcomesUnknown causalityRecall bias

59 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cross-sectional Study

AdvantagesResults can be applied to the populationRelatively low cost

Disadvantages

Does not work well for rare outcomesUnknown causalityRecall bias

60 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

Goal: determine if the exposure precedes the outcome

Also call longitudinal studies or prospective studies

Cohort is identified before the appearance of the outcome

Exposure is assessed and then participants are followed for a setamount of time

61 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

Goal: determine if the exposure precedes the outcome

Also call longitudinal studies or prospective studies

Cohort is identified before the appearance of the outcome

Exposure is assessed and then participants are followed for a setamount of time

62 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

Goal: determine if the exposure precedes the outcome

Also call longitudinal studies or prospective studies

Cohort is identified before the appearance of the outcome

Exposure is assessed and then participants are followed for a setamount of time

63 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

Goal: determine if the exposure precedes the outcome

Also call longitudinal studies or prospective studies

Cohort is identified before the appearance of the outcome

Exposure is assessed and then participants are followed for a setamount of time

64 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

Example

After seeing the findings from Dr. Jayne, Drs. Kay and Lee wantto know if the sunscreen precedes the numbness

Focusing on people between the ages 13 and 18, the doctorsfinds 500 participants and follow them for two years

Over the course of the two years, 60% of the participants who usethe sunscreen experienced numbness

65 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

Example

After seeing the findings from Dr. Jayne, Drs. Kay and Lee wantto know if the sunscreen precedes the numbness

Focusing on people between the ages 13 and 18, the doctorsfinds 500 participants and follow them for two years

Over the course of the two years, 60% of the participants who usethe sunscreen experienced numbness

66 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

Example

After seeing the findings from Dr. Jayne, Drs. Kay and Lee wantto know if the sunscreen precedes the numbness

Focusing on people between the ages 13 and 18, the doctorsfinds 500 participants and follow them for two years

Over the course of the two years, 60% of the participants who usethe sunscreen experienced numbness

67 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

Advantages

Risk can be assessedAccurate collection of informationLess expensive than randomized trials

Disadvantages

More expensive than previous studiesConfounding caused by no randomizationOutcome may require a long time until it occurs

68 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

AdvantagesRisk can be assessedAccurate collection of informationLess expensive than randomized trials

Disadvantages

More expensive than previous studiesConfounding caused by no randomizationOutcome may require a long time until it occurs

69 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Cohort Study

AdvantagesRisk can be assessedAccurate collection of informationLess expensive than randomized trials

Disadvantages

More expensive than previous studiesConfounding caused by no randomizationOutcome may require a long time until it occurs

70 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trail

Goal: determine the efficacy or effectiveness of a exposure ortreatment

Also called Randomized Control Trail or Randomized Clinical Trail

Subjects are randomly assigned to a treatment group

Subjects are followed for a set amount of time

Various outcomes can be investigated

71 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trail

Goal: determine the efficacy or effectiveness of a exposure ortreatment

Also called Randomized Control Trail or Randomized Clinical Trail

Subjects are randomly assigned to a treatment group

Subjects are followed for a set amount of time

Various outcomes can be investigated

72 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trail

Goal: determine the efficacy or effectiveness of a exposure ortreatment

Also called Randomized Control Trail or Randomized Clinical Trail

Subjects are randomly assigned to a treatment group

Subjects are followed for a set amount of time

Various outcomes can be investigated

73 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trail

Goal: determine the efficacy or effectiveness of a exposure ortreatment

Also called Randomized Control Trail or Randomized Clinical Trail

Subjects are randomly assigned to a treatment group

Subjects are followed for a set amount of time

Various outcomes can be investigated

74 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trail

Goal: determine the efficacy or effectiveness of a exposure ortreatment

Also called Randomized Control Trail or Randomized Clinical Trail

Subjects are randomly assigned to a treatment group

Subjects are followed for a set amount of time

Various outcomes can be investigated

75 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

5 phases of clinical trials

Phase 0-Pharmacodynamics and Pharmacokinetics (10-15subjects)Phase 1-Screening for safety (20-100 subjects)Phase 2-Establishing the efficacy of the drug (100-300subjects)Phase 3-Final confirmation of safety and efficacy (300+subjects)Phase 4-Postmarketing surveillance (number of subjectsvaries)

76 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

5 phases of clinical trialsPhase 0-Pharmacodynamics and Pharmacokinetics (10-15subjects)

Phase 1-Screening for safety (20-100 subjects)Phase 2-Establishing the efficacy of the drug (100-300subjects)Phase 3-Final confirmation of safety and efficacy (300+subjects)Phase 4-Postmarketing surveillance (number of subjectsvaries)

77 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

5 phases of clinical trialsPhase 0-Pharmacodynamics and Pharmacokinetics (10-15subjects)Phase 1-Screening for safety (20-100 subjects)

Phase 2-Establishing the efficacy of the drug (100-300subjects)Phase 3-Final confirmation of safety and efficacy (300+subjects)Phase 4-Postmarketing surveillance (number of subjectsvaries)

78 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

5 phases of clinical trialsPhase 0-Pharmacodynamics and Pharmacokinetics (10-15subjects)Phase 1-Screening for safety (20-100 subjects)Phase 2-Establishing the efficacy of the drug (100-300subjects)

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

79 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

5 phases of clinical trialsPhase 0-Pharmacodynamics and Pharmacokinetics (10-15subjects)Phase 1-Screening for safety (20-100 subjects)Phase 2-Establishing the efficacy of the drug (100-300subjects)Phase 3-Final confirmation of safety and efficacy (300+subjects)

Phase 4-Postmarketing surveillance (number of subjectsvaries)

80 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

5 phases of clinical trialsPhase 0-Pharmacodynamics and Pharmacokinetics (10-15subjects)Phase 1-Screening for safety (20-100 subjects)Phase 2-Establishing the efficacy of the drug (100-300subjects)Phase 3-Final confirmation of safety and efficacy (300+subjects)Phase 4-Postmarketing surveillance (number of subjectsvaries)

81 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

Example

Dr. Simon is part of a Phase 4 trial to determine how much thesunscreen is effecting the risk of numbness

Focusing on subjects between the ages of 13-18, Dr. Simonfollows 200 subjects who are using the sunscreen over the courseof a year

Initial results appear inconclusive with only 50% of the subjectsexperiencing numbness

After adjusting for confounding variables, it appears that 90% ofthe subjects on a particular acne medication experiencenumbness

82 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

Example

Dr. Simon is part of a Phase 4 trial to determine how much thesunscreen is effecting the risk of numbness

Focusing on subjects between the ages of 13-18, Dr. Simonfollows 200 subjects who are using the sunscreen over the courseof a year

Initial results appear inconclusive with only 50% of the subjectsexperiencing numbness

After adjusting for confounding variables, it appears that 90% ofthe subjects on a particular acne medication experiencenumbness

83 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

Example

Dr. Simon is part of a Phase 4 trial to determine how much thesunscreen is effecting the risk of numbness

Focusing on subjects between the ages of 13-18, Dr. Simonfollows 200 subjects who are using the sunscreen over the courseof a year

Initial results appear inconclusive with only 50% of the subjectsexperiencing numbness

After adjusting for confounding variables, it appears that 90% ofthe subjects on a particular acne medication experiencenumbness

84 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

Example

Dr. Simon is part of a Phase 4 trial to determine how much thesunscreen is effecting the risk of numbness

Focusing on subjects between the ages of 13-18, Dr. Simonfollows 200 subjects who are using the sunscreen over the courseof a year

Initial results appear inconclusive with only 50% of the subjectsexperiencing numbness

After adjusting for confounding variables, it appears that 90% ofthe subjects on a particular acne medication experiencenumbness

85 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

Advantages

Strong cause and effect associationCan adjust for confoundingEasier to removes biases than observational studies

Disadvantages

Usually the most expensive study designVolunteer bias

86 / 130

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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

AdvantagesStrong cause and effect associationCan adjust for confoundingEasier to removes biases than observational studies

Disadvantages

Usually the most expensive study designVolunteer bias

87 / 130

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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Randomized Trial

AdvantagesStrong cause and effect associationCan adjust for confoundingEasier to removes biases than observational studies

Disadvantages

Usually the most expensive study designVolunteer bias

88 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

Goal: comprehensive review of all relevant studies on a particulartopic

Highest level of analysis

Can employ meta-analysiscontrasting and combining results from different studies

Based on both published and unpublished results

89 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

Goal: comprehensive review of all relevant studies on a particulartopic

Highest level of analysis

Can employ meta-analysiscontrasting and combining results from different studies

Based on both published and unpublished results

90 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

Goal: comprehensive review of all relevant studies on a particulartopic

Highest level of analysis

Can employ meta-analysiscontrasting and combining results from different studies

Based on both published and unpublished results

91 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

Goal: comprehensive review of all relevant studies on a particulartopic

Highest level of analysis

Can employ meta-analysiscontrasting and combining results from different studies

Based on both published and unpublished results

92 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

Example

Dr. Reynolds reviews all the literature on the connection betweensunscreen and numbness

Based on the finding from the RCT, he goes back to get data fromprevious studies

He finds that 87% of the patients that experienced numbnesswere on the same acne medication

Dr. Reynolds makes a recommendation to the FDA to informthem about the interaction between the two items

93 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

Example

Dr. Reynolds reviews all the literature on the connection betweensunscreen and numbness

Based on the finding from the RCT, he goes back to get data fromprevious studies

He finds that 87% of the patients that experienced numbnesswere on the same acne medication

Dr. Reynolds makes a recommendation to the FDA to informthem about the interaction between the two items

94 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

Example

Dr. Reynolds reviews all the literature on the connection betweensunscreen and numbness

Based on the finding from the RCT, he goes back to get data fromprevious studies

He finds that 87% of the patients that experienced numbnesswere on the same acne medication

Dr. Reynolds makes a recommendation to the FDA to informthem about the interaction between the two items

95 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

Example

Dr. Reynolds reviews all the literature on the connection betweensunscreen and numbness

Based on the finding from the RCT, he goes back to get data fromprevious studies

He finds that 87% of the patients that experienced numbnesswere on the same acne medication

Dr. Reynolds makes a recommendation to the FDA to informthem about the interaction between the two items

96 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

Advantages

Strongest form of medical evidenceLess time and cost than conducting a new RCT or cohortstudyMore reliable and accurate than individual studies

Disadvantages

Difficult to determine if studies could be combinedRequires using results from other researchers

97 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

AdvantagesStrongest form of medical evidenceLess time and cost than conducting a new RCT or cohortstudyMore reliable and accurate than individual studies

Disadvantages

Difficult to determine if studies could be combinedRequires using results from other researchers

98 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Systematic Review

AdvantagesStrongest form of medical evidenceLess time and cost than conducting a new RCT or cohortstudyMore reliable and accurate than individual studies

Disadvantages

Difficult to determine if studies could be combinedRequires using results from other researchers

99 / 130

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Introduction

ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

case study

Which type of study assess outcome first?case-control study

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

What type involves no new subject?systematic review

Which studies are not affected by recall bias?cohort and randomized trial

100 / 130

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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Which type of study assess outcome first?case-control study

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

What type involves no new subject?systematic review

Which studies are not affected by recall bias?cohort and randomized trial

101 / 130

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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Which type of study assess outcome first?

case-control study

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

What type involves no new subject?systematic review

Which studies are not affected by recall bias?cohort and randomized trial

102 / 130

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ObservationalCase Report

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Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Which type of study assess outcome first?case-control study

What type of study follows subjects for a set amount of time?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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ObservationalCase Report

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Cross-sectional

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ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Which type of study assess outcome first?case-control study

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

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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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Which type of study assess outcome first?case-control study

What type of study follows subjects for a set amount of time?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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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Which type of study assess outcome first?case-control study

What type of study follows subjects for a set amount of time?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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Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Which type of study assess outcome first?case-control study

What type of study follows subjects for a set amount of time?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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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Which type of study assess outcome first?case-control study

What type of study follows subjects for a set amount of time?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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Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Which type of study assess outcome first?case-control study

What type of study follows subjects for a set amount of time?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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ExperimentalRandomized Trail

SystematicReview

Questions

Questions

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

Phase 1 and Phase 3

T/F: Subjects are randomized into treatment groups for a cohortstudy.

False

What study design is used to measure prevalence?Cross-sectional

What study requires the fewest number of subjects?Case study

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ExperimentalRandomized Trail

SystematicReview

Questions

Questions

What phase of a clinical trial focuses on determining safe levels?Phase 1 and Phase 3

T/F: Subjects are randomized into treatment groups for a cohortstudy.

False

What study design is used to measure prevalence?Cross-sectional

What study requires the fewest number of subjects?Case study

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ExperimentalRandomized Trail

SystematicReview

Questions

Questions

What phase of a clinical trial focuses on determining safe levels?Phase 1 and Phase 3

T/F: Subjects are randomized into treatment groups for a cohortstudy.

False

What study design is used to measure prevalence?Cross-sectional

What study requires the fewest number of subjects?Case study

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ExperimentalRandomized Trail

SystematicReview

Questions

Questions

What phase of a clinical trial focuses on determining safe levels?Phase 1 and Phase 3

T/F: Subjects are randomized into treatment groups for a cohortstudy.

False

What study design is used to measure prevalence?Cross-sectional

What study requires the fewest number of subjects?Case study

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ExperimentalRandomized Trail

SystematicReview

Questions

Questions

What phase of a clinical trial focuses on determining safe levels?Phase 1 and Phase 3

T/F: Subjects are randomized into treatment groups for a cohortstudy.

False

What study design is used to measure prevalence?

Cross-sectional

What study requires the fewest number of subjects?Case study

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SystematicReview

Questions

Questions

What phase of a clinical trial focuses on determining safe levels?Phase 1 and Phase 3

T/F: Subjects are randomized into treatment groups for a cohortstudy.

False

What study design is used to measure prevalence?Cross-sectional

What study requires the fewest number of subjects?Case study

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SystematicReview

Questions

Questions

What phase of a clinical trial focuses on determining safe levels?Phase 1 and Phase 3

T/F: Subjects are randomized into treatment groups for a cohortstudy.

False

What study design is used to measure prevalence?Cross-sectional

What study requires the fewest number of subjects?

Case study

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ExperimentalRandomized Trail

SystematicReview

Questions

Questions

What phase of a clinical trial focuses on determining safe levels?Phase 1 and Phase 3

T/F: Subjects are randomized into treatment groups for a cohortstudy.

False

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

A research team wants to know if there is an association betweenartificial sweeteners and urinary tract cancers. The prevalence ofurinary tract cancers is low.

case control study

A doctor examines an extended family of 20 people who all haveHeterochromia. 5 otherwise healthy family members also sufferfrom vision loss in one eye.

case series

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Questions

A research team wants to know if there is an association betweenartificial sweeteners and urinary tract cancers. The prevalence ofurinary tract cancers is low.

case control study

A doctor examines an extended family of 20 people who all haveHeterochromia. 5 otherwise healthy family members also sufferfrom vision loss in one eye.

case series

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Case Control

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ExperimentalRandomized Trail

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Questions

A research team wants to know if there is an association betweenartificial sweeteners and urinary tract cancers. The prevalence ofurinary tract cancers is low.

case control study

A doctor examines an extended family of 20 people who all haveHeterochromia. 5 otherwise healthy family members also sufferfrom vision loss in one eye.

case series

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Questions

A research team wants to know if there is an association betweenartificial sweeteners and urinary tract cancers. The prevalence ofurinary tract cancers is low.

case control study

A doctor examines an extended family of 20 people who all haveHeterochromia. 5 otherwise healthy family members also sufferfrom vision loss in one eye.

case series

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Questions

Questions

A research team is interested in whether a new medicationreduces the risk of strokes. They ask the drug manufacturer forthe number of annual prescriptions in the US and obtain data fromdeath certificates to assess the number of death due to strokes.

cross-sectional study

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

case control study

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SystematicReview

Questions

Questions

A research team is interested in whether a new medicationreduces the risk of strokes. They ask the drug manufacturer forthe number of annual prescriptions in the US and obtain data fromdeath certificates to assess the number of death due to strokes.

cross-sectional study

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

case control study

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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

A research team is interested in whether a new medicationreduces the risk of strokes. They ask the drug manufacturer forthe number of annual prescriptions in the US and obtain data fromdeath certificates to assess the number of death due to strokes.

cross-sectional study

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

case control study

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ObservationalCase Report

Case Control

Cross-sectional

Cohort

ExperimentalRandomized Trail

SystematicReview

Questions

Questions

A research team is interested in whether a new medicationreduces the risk of strokes. They ask the drug manufacturer forthe number of annual prescriptions in the US and obtain data fromdeath certificates to assess the number of death due to strokes.

cross-sectional study

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

case control study

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Questions

Questions

Researchers want to know if the number of plants in a patient’sroom impacts recovery time. The researchers randomly select300 patients entering the ICU. Measurements are taken on thenumber of plants in the room and the number of days until theyleave the ICU.

cohort study

Researchers want to know if the number of plants in a patient’sroom impacts recovery time. The researcher select 500 patientsentering the ICU and place either 0, 1, 4, or 8 plants in theirrooms and measure the number of days until they leave the ICU.

randomized trial

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Questions

Researchers want to know if the number of plants in a patient’sroom impacts recovery time. The researchers randomly select300 patients entering the ICU. Measurements are taken on thenumber of plants in the room and the number of days until theyleave the ICU.

cohort study

Researchers want to know if the number of plants in a patient’sroom impacts recovery time. The researcher select 500 patientsentering the ICU and place either 0, 1, 4, or 8 plants in theirrooms and measure the number of days until they leave the ICU.

randomized trial

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Questions

Questions

Researchers want to know if the number of plants in a patient’sroom impacts recovery time. The researchers randomly select300 patients entering the ICU. Measurements are taken on thenumber of plants in the room and the number of days until theyleave the ICU.

cohort study

Researchers want to know if the number of plants in a patient’sroom impacts recovery time. The researcher select 500 patientsentering the ICU and place either 0, 1, 4, or 8 plants in theirrooms and measure the number of days until they leave the ICU.

randomized trial

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ExperimentalRandomized Trail

SystematicReview

Questions

Questions

Researchers want to know if the number of plants in a patient’sroom impacts recovery time. The researchers randomly select300 patients entering the ICU. Measurements are taken on thenumber of plants in the room and the number of days until theyleave the ICU.

cohort study

Researchers want to know if the number of plants in a patient’sroom impacts recovery time. The researcher select 500 patientsentering the ICU and place either 0, 1, 4, or 8 plants in theirrooms and measure the number of days until they leave the ICU.

randomized trial

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References

Andresen, Elena and Erin DeFrises Bouldin eds. (2010) PublicHealth Foundations: Concepts and Practices. John Wiley &Sons.

DeMets, D., Friedman, L., and Furberg, C., (2010). Fundamentalsof 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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