megan von isenburg may 5, 2017 - ohsla - home · ebp the basics: study design and randomized...
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Megan von Isenburg
May 5, 2017
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EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 2
EBM Basics:
- What?
- Why?
Study Design
- Hierarchy
- Searching
Randomized
Controlled Trials
- Randomization
- Critical appraisal
- Math
Image from Pexels
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Study Designs
3
EBP the Basics: Study Design and
Randomized Controlled Trials. 2017
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EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 4
Shared Decision
Making
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EBP the Basics: Study Design and Randomized Controlled Trials. 2017 5
Study
Design
1. Describe the studies used in
clinical
medicine
2. Identify the strengths /
weaknesses
3. Identify search
strategies in
PubMed
4. Identify study designs
from article
abstracts
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Cookie-cutter medicine?
Following guidelines?
A bunch of algorithms in an EHR?
EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 6
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7
Assess
Ask
AcquireAppraise
Apply
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Randomized Controlled Trials. 2017
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Randomized Controlled Trials. 2017 8
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P
I
C
O
Patient Problem, Population
Intervention, prognostic factor
Comparison
Outcome
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Randomized Controlled Trials. 2017 9
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Randomized Controlled Trials. 2017 10
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Background◦ General knowledge
◦ What are the clinical manifestations of…?
Foreground◦ Seek specific knowledge to inform clinical
decisions
◦ In pediatric patients with rhinitis, are intranasal steroids more effective than antihistamines?
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Randomized Controlled Trials. 2017 11
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EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 12
The better the
evidence the
more confidence
in the decision
Patient
values and
preferences
matter
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Randomized Controlled
Trials
Cohort Study
Case Control Study
Meta -analysis
Systematic reviews
Cross Sectional
Case Reports/Case Series
EBP the Basics: Study Design and Randomized Controlled Trials. 201713
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EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 14
OBSERVATIONAL
RCT COHORT
CASE CONTROL
EXPERIMENTAL
ANALYTICALDescriptive
CROSS
SECTIONAL
QUALITATIVE
CASE
REPORTS
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OBSERVATIONAL
RCT COHORT
CASE CONTROL
EXPERIMENTAL
ANALYTICAL
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Is this EXPOSURE
(Intervention, prognostic factor, test, or study
factor)
Associated with this Disease or
OUTCOME
16EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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17EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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18EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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Randomized Controlled
Trials
Cohort Study
Case Control Study
Meta -analysis
Systematic reviews
Cross Sectional
Case Reports/Case Series
EBP the Basics: Study Design and Randomized Controlled Trials. 201719
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Starts with patients with an
OUTCOME
and looks back to an
EXPOSURE
20EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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EXPOSURENo
Cell phone usage
EXPOSURECell phone usage
OUTCOMENo Brain Tumors
21
OUTCOMEBrain
Tumors
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Randomized Controlled Trials. 2017
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22EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Cheap
Quick
Rare outcomes
Ethical
Recall Bias
Confounders
Difficult to choose
control groups
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a variable that is associated with both the
exposure and disease and could provide an
alternative explanation for why an exposure is
associated with a disease in a study.
http://theebmproject.wordpress.com/fundamentals/study_design/study-validity/
23EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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24EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Confounder: obesity
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Cases
Controls
TIME
Case-Control Study
Exposure
Absent
Exposure
Present
Measure HERE
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Randomized Controlled
Trials
Cohort Study
Case Control Study
Meta -analysis
Systematic reviews
Cross Sectional
Case Reports/Case Series
EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 26
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Starts with patients with an
EXPOSURE and
follows them forward to
an OUTCOME
27EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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28
EXPOSURE
NO HRT
EXPOSURE
HRTOUTCOMENo Heart Disease
OUTCOMEHeart
Disease
EBP the Basics: Study Design and
Randomized Controlled Trials. 2017
Self Select
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29EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Ethical
Establish timing
Prospective
Show association
Time Consuming
Confounders
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30EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Confounder?
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Outcome
Yes
Outcome
No
Exposure
Absent
TIME
Cohort Study
Exposure
Present
Measure HERE
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Framingham Heart Study
NHANES Studies
Black Women’s Health Study
Nurses Health Study
Physician’s Health Study
Avon Longitudinal Study of Parents and Children (ALSPAC)
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Cohort - Starts with patients
with an EXPOSURE and
follows them forward to
an OUTCOME;
Retrospective - All the data has
already been collected
33EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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EXPOSUREMI Admitted
weekday
EXPOSUREMI Admitted
weekend
2010-2013
Database
34
OUTCOMEIn-HospitalMortality
OUTCOMENo
In-HospitalMortality
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35EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Ethical
Establish timing
Data already
collected
Confounders
Data collected
before research
question
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Retrospective Cohort Study
Outcome
Yes
Outcome
No
TIME
Exposure
Absent
Exposure
Present
Measure HERE
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Randomized Controlled
Trials
Cohort Study
Case Control Study
Meta -analysis
Systematic reviews
Cross Sectional
Case Reports/Case Series
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Randomized Controlled Trials. 2017 37
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Start with patients who are
randomized to an EXPOSURE
and follows them forward to
an OUTCOME
38EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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39EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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40
EXPOSURE
NO HRT
EXPOSURE
HRTOUTCOMENo Heart Disease
OUTCOMEHeart
Disease
EBP the Basics: Study Design and
Randomized Controlled Trials. 2017
Randomized
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41EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Confounder?
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42EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Controls for bias
Balanced groups
Proves efficacy
Expensive
Ethical issues
Time consuming
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TIME
Cure
No
Cure
Drug
Placebo
Randomized Controlled Trial
Measure HERE
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Randomized Controlled
Trials
Cohort Study
Case Control Study
Meta -analysis
Systematic reviews
Cross Sectional
Case Reports/Case Series
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Randomized Controlled Trials. 2017 44
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Focuses on a clinical question
Conducts a thorough literature search
Validates credibility of the studies
Summarizes the data
45EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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AUTHOR'S CONCLUSIONS:
This systematic review,
incorporating the latest available
trial data, shows that hormone
therapy does not significantly
change the risk of all-cause
morality, CHD death or non-fatal
AMI but increases the risk of
stroke in postmenopausal
women.
46
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47
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48EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Summarizes
studies
Validates smaller
studies
Generalizability
Saves time
Time Consuming
Publication bias
Heterogeneity
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Case Control
Retrospective Cohort
Cohort
Randomized Controlled Trial
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Randomized Controlled Trials. 2017 49
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50EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Descriptive
CROSS
SECTIONAL
QUALITATIVE
CASE
REPORTS
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Randomized Controlled
Trials
Cohort Study
Case Control Study
Meta -analysis
Systematic reviews
Cross Sectional
Case Reports/Case Series
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Randomized Controlled Trials. 2017 51
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A report of a single unique or
unusual case or a number of
similar cases
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53
ExposureLavender
OUTCOMEEnlarged Breasts
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EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 54
20172010 2019
EXPOSURE
OUTCOME
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55EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Brings to attention
unusual case
Start of research
Observation
No control
No association
No comparison
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Randomized Controlled
Trials
Cohort Study
Case Control Study
Meta -analysis
Systematic reviews
Cross Sectional
Case Reports/Case Series
EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 56
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Both EXPOSURE and
OUTCOME are measured
simultaneously in a given
population
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58
EXPOSURENew Test
AndGold Standard
Test
OUTCOMESensitivity/
Specificity of New Test
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Randomized Controlled Trials. 2017
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59EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Shows accuracy
of new test
Calculate
likelihood ratios
Expensive
Ethical issues
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60
OUTCOMEDoctor’s visit
EXPOSUREApple a day
EBP the Basics: Study Design and
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EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 61
20172010 2019
EXPOSURE
OUTCOME
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62EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Cheap
Easy
Ethical
Recall Bias
Confounders
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Addresses questions related to the
human response to health issues.
Describes, explores and explains
human behavior.
63EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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Qualitative study
64
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Qualitative study
Based mainly on their
family history and
lifestyle, women do
not generally
consider themselves
to be at personal risk of heart disease.
Ballard K. Understanding risk: women's perceived risk of menopause-
related disease and the value they place on preventive hormone
replacement therapy. Fam Pract. 2002 Dec;19(6):591-5. PubMed
PMID: 12429660.
65
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66EBP the Basics: Study Design and Randomized Controlled Trials. 2017
Documents the
human experience
Motivations
Explains behavior
Poorly understood
Lack of objectivity
Lack of
Generalizability
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EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 67
Why is this important?
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EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 68
The better the
evidence the
more confidence
in the decision
Patient
values and
preferences
matter
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P
I
C
O
T
T
Patient Problem, Population
Intervention, prognostic factor
Comparison
Outcome
Type of Question
Type of Study
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Randomized Controlled Trials. 2017 69
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Type of
Question
Type of
Study
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Type of questions:
Therapy determine the effect of an
assigned intervention
Does this treatment work?
Study
Design:
Systematic Review/Meta-Analysis
Randomized Controlled Trial
Cohort Study
71EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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Type of questions:
Diagnosis Determine the ability of a test
to differentiate between those
with and without a target
condition
Is one test as good or better
than another test?
Study
Design:
Cross Sectional
Prospective comparison
Sensitivity and Specificity
72EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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Type of questions:
Prognosis Determine a patient’s likely
clinical course over time due to
factors other than interventions
What will happen to these
patients over time?
Study
Design:
Cohort Study
73EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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Type of questions:
Harm Determine the effects of
potentially harmful agents
Is this agent harmful?
Study
Design:
Cohort Study
Case-Control Study
*Randomized Controlled Trial
74EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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La
nce
t 2
00
2; 3
59
:57
-61
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nce
t 2
00
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La
nce
t 2
00
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Know your chances. Steven
Woloshin et al. University of
California Press, 2008
79
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ExerciseBuild-a-Study
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EBP the Basics: Study Design and
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Who is your population and how would you
select them?
Who is your comparison
group and how would you
select them?
What would you assess? What is the direction of
inquiry?
What are the Benefits and Problems?
83EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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EBP the Basics: Study Design and Randomized Controlled Trials. 2017 84
Study
Design
1. Describe the studies used in
clinical
medicine
2. Identify the strengths /
weaknesses
3. Identify search
strategies in
PubMed
4. Identify study designs
from article
abstracts
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Publication Type
MeSH
◦ Case-Control Studies
◦ Cohort Studies
◦ Sensitivity and Specificity
◦ Qualitative Research
Clinical Queries
86EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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87
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88EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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89EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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90
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91EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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Cross sectional
Prospective blind comparison
Sensitivity and Specificity[MeSH]
Best way to search:
Specificity[tiab] OR Sensitivity and Specificity[MeSH]
92EBP the Basics: Study Design and Randomized Controlled Trials. 2017
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Therapy
Diagnosis
Harm/Etiology
Prognosis
EBP the Basics: Study Design and
Randomized Controlled Trials. 2017 93
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Can a Mediterranean-style diet reduce CV risk?
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Your pediatric patient has abdominal pain. Should you use US or CT to rule out appendicitis?
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Your new house is near power lines. Are you going to get leukemia?
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Your patient suffered a TBI during a motorcycle crash and is in in a coma. When will he make a full recovery?
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You know much has been written about ICDs for Afib and want to find something that synthesizes the evidence for you.
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EBP the Basics: Study Design and Randomized Controlled Trials. 2017 99
Study
Design
1. Describe the studies used in
clinical
medicine
2. Identify the strengths/
weaknesses
3. Identify search
strategies in
PubMed
4. Identify study designs
from article
abstracts
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NAME THAT STUDY
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1. Randomized Controlled Trial
2. Cohort Study
3. Case Control Study
4. Case Series
5. Systematic Review
6. Cross-Sectional Study
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1. Randomized Controlled Trial
2. Cohort Study
3. Case Control Study
4. Case Series
5. Systematic Review
6. Cross-Sectional Study
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1. Randomized Controlled Trial
2. Cohort Study
3. Case Control Study
4. Case Series
5. Systematic Review
6. Cross-Sectional Study
Persistent hiccups have been reported to occur occasionally during
rehabilitation hospitalizations. Hiccups can interfere with patient
participation and progress, and this can lengthen and complicate the
rehabilitation hospitalization. Chlorpromazine, the only Food and Drug
Administration-approved agent specifically indicated for hiccups, is often
chosen as a first-line treatment. However, chlorpromazine does not always
provide favorable results. The intent of this paper is to (1) review hiccups
and implications of persistent hiccups in the rehabilitation setting, (2)
provide additional evidence that chlorpromazine is often not the best
treatment choice for hiccups in rehabilitative patients, (3) report the
effectiveness and favorable tolerability of modest doses of gabapentin in a
small ________ of three patients, and (4) review potentially effective
treatment approaches for hiccups.
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1. Randomized Controlled Trial
2. Cohort Study
3. Case Control Study
4. Case Series
5. Systematic Review
6. Cross-Sectional Study
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1. Randomized Controlled Trial
2. Cohort Study
3. Case Control Study
4. Case Series
5. Systematic Review
6. Cross-Sectional Study
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1. Randomized Controlled Trial
2. Cohort Study
3. Case Control Study
4. Case Series
5. Systematic Review
6. Cross-Sectional Study
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EBP the Basics: Study Design and
Randomized Controlled Trials. 2017
10
7
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Study Design
should be part of
EBM search
strategy
Level of
evidence
matters
Study design
should
match
question
108
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EBP the Basics: Study Design and Randomized Controlled Trials. 201710
9
Study
Design
1. Describe the studies used in
clinical
medicine
2. Identify the strengths /
weaknesses
3. Identify search
strategies in
PubMed
4. Identify study designs
from article
abstracts