Systematic Reviews & Meta-analysis - Duke University€¦ · PubMed Clinical Queries: Systematic...
Transcript of Systematic Reviews & Meta-analysis - Duke University€¦ · PubMed Clinical Queries: Systematic...
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Systematic Reviews &Meta-analysis
Clay BordleyDepartment of Pediatrics
Division of Hospital & Emergency Medicine
Jane P. GagliardiDepartment of Psychiatry and Behavioral Sciences
Department of Medicine
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First a Case….
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3 mo w/ sneezin’, wheezin’ and fever
• Congested for 4 days, fast breathing for past 24 hours– Breast and bottle fed, but having trouble sucking and breathing– Decreased wet diapers
• 3yr cousin with URI sx’s• PMHx: 39 wk, unremarkable P/L/D• SHx: 16yr mother (sucking her thumb), lives with MGM, mo and cousins• PE
– 38.0 186 64, 93% sat– Alert, obvious congestion and increased WOB’ing, nl TM’s, (+) retractions, defuse
wheezing, no murmur, nl CR and pulses, abd soft, no HSM
• Your impression: – Bronchiolitis, fever, borderline sats
What Clinical Questions Do You Have?
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Disclosures
W. Clayton Bordley, MD, MPH
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Today’s Clinical Question
Is hypertonic saline effective in infants with bronchiolitis?
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Exercise #1
Search in groups of 2
Time: 3-5 minutes
Be prepared to report to group
1. How did you do your search2. What source did you choose?
3. Did you get an answer?
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What Did You Find?
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Is This a Systematic Review?
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eMedicne
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Did You Use PICOTT?
• Patient• Intervention• Control• Outcome• Type of question• Type of study
• Infants w/ bronchiolitis• Hypertonic saline• None• Effectiveness (?)• ?• ?
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Exercise #2
• Connie searched and came up with 7 candidate studies
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Exercise #2• In the next FIVE MINUTES:
– Critically appraise your article• Follow-up• Randomization• Intention to treat• Similar at baseline• Blinding• Equal treatment outside the intervention
• Summarize the methods and results• Be ready to share your answers out loud
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• 5 minutes to CAT the articles• Follow-up• Randomization• Intention to treat• Similar at baseline• Blinding• Equal treatment outside the intervention
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What overall grade would you assign your study?
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1. A (excellent, few sources of bias)2. B (not bad, despite some bias)3. C (mediocre, some obvious bias)4. D (barely makes the cut, lots of
bias)5. F (may not even be worth
reading)
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Please remember the grade you assigned(will return to this a bit later)
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Learning Objectives
• Understand the distinction between reviews, systematic reviews and meta-analysis
• Understand the basic methods & outcomes reported in meta-analysis
• Interpret a forest plot• Understand the critical appraisal elements that
apply to systematic reviews• Understand role systematic of reviews in
guidelines and other publication types• Use a systematic review to help guide clinical
decision-making
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Components of SystematicReviews
• Specific objective(s)• Clearly described, reproducible methods
– Databases and search terms• A priori inclusion / exclusion criteria• Data extracted by more than one reviewer• Consideration of quality• Evidence table(s)• Results
– Qualitative and/or quantitative
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Specific Objective(s)
• A focused clinical question• (May look suspiciously like a PICOTT)
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Clearly Described Methods
• LITERATURE SEARCH:
– Search Terms– Database(s)– Time Frame
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Inclusion/Exclusion Criteria
• This needs to be specified A PRIORI:– What types of studies will be included?– What characteristics of studies will be
accepted?– Is there any consideration of QUALITY of the
studies to be included?
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Consideration of quality - Assessments of study quality should resemble:
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1. PICOTT2. Validity Criteria3. Cochrane review4. Performance
Improvement5. Systematic review
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Data Abstraction
• How many reviewers?• Should the reviewer(s) be aware of the
study hypothesis?• What sort of information should the
reviewer(s) abstract?• How are conflicts resolved?
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Results
• Flow Diagram for Study Selection• Evidence Tables• Forest Plots
Impact of Diet Soda on Impulsivity
Favors regular Favors diet
*adapted from article addressing different question
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Summarizing the Evidence
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BREAK!
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Which of the following is NOT a necessary part of a systematic review?
a) b) c) d) e)
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a) Focused clinical questionb) Reproducible search
methodsc) Inclusion/exclusion criteriad) Statistical analysise) Consideration of study
quality
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Meta-analysis
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Meta-analysis
(definition): mathematical synthesis of the results of two or more primary studies that addressed the same hypothesis in the same way
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The Basic Principles• Each study reports a measure of effect
– Rate, RR, OR, risk difference, others• Summary (pooled) effect measure is calculated
– weighted average of the individual studies• Weighting may be based on sample size (usually) and/or study quality
• Confidence intervals – Communicates the precision of the summary estimate, – Allows calculation of a P value
• Measure of variability among results (aka heterogeneity)– Is the variation compatible with random variation?– Is the variation sufficiently large to suggest the studies assessed
different “truths” in their results? – Note: estimate of whether or not methods are similar enough to
combine should have been done while compiling evidence table
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Review, Systematic Review and Meta-analysis
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Exercise #3
• Who is familiar with Forest Plots?• Create a Forest Plot
– Based on the 7 RCT’s you reviewed– Each group come down and add their results
to the Forest plot
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Favors treatment Favors control
What is the outcome measure?
What is the unit of measure?
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Let’s Look at Some Prettier Examples
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Forest Plots• The label explains comparison and outcome
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Forest Plots• The data for each trial are represented, divided into
experimental and control groups• The calculated effect measure is presented numerically• The % weight given to each study is reported
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Forest Plots• The result of each study is plotted graphically with a block• The size of the block for each study is proportional to the % weight. • The horizontal line represents the confidence interval.
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• The label above the graph provides information about statistics• The horizontal line at the bottom depicts the scale for the treatment
effect
Forest Plots
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Forest Plots• The vertical line in the middle is where treatment and control have
the same effect – THE LINE OF NO DIFFERENCE
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Forest Plots• The pooled estimate is given as a diamond shape
– The horizontal width of the diamond is the confidence interval of the pooled estimate
• The pooled estimate is also given numerically
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Forest Plots• Heterogeneity: The forest plot displays the results of the Chi square
test and the p value
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Heterogeneity
• Inevitably, studies brought together in a systematic review will differ.
• The amount of variability in the results from studies in a systematic review is termed heterogeneity.
• What are some possible sources of heterogeneity?
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Measures of Heterogeneity
• Eyeball test• Chi Square• I2 Inconsistency
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“eyeball test”
Bordley 2013
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Measures of HeterogeneityEyeball test
• Chi Square– Assesses whether observed differences in results
are compatible with chance alone. – A low P value (or a large chi-squared statistic
relative to its degree of freedom) provides evidence of heterogeneity (variation in effect estimates beyond chance).
• I2 Inconsistency– Moves the focus away from testing whether
heterogeneity is present to assessing its impact on the meta-analysis.
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Back to Our Case
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Validity Criteria for a Systematic Review
• Focused clinical question?• Appropriate study inclusion criteria?• Thorough search?
– unlikely to miss relevant studies?• Quality of included studies assessed? • Heterogeneity?• Sufficient follow-up (duration, subjects
accounted for)? • Generalizable to your clinical scenario?
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It All Comes Back to the Search
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Assessing Quality of Included Studies
• Why– Garbage in leads to garbage out– Individual study bias affects meta-analysis
result• How: Quality Scores
– 25 scales & 9 checklists (e.g., Jadad)– Cochrane method:
• 7 domains and risk of bias for each– Sensitivity analysis
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Exercise #4
APPRAISE THE SYSTEMATIC REVIEW• Focused clinical question?• Appropriate study inclusion criteria?• Thorough search?
– unlikely to miss relevant studies?• Quality of included studies assessed? • Heterogeneity?• Sufficient follow-up (duration, subjects
accounted for)? • Generalizable to your clinical scenario?
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What grade would you assign this systematic review?
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1. A- nearly perfect minimal bias
2. B-not too bad; some bias3. C-mediocre; may have
biased results4. D-garbage in…5. F-garbage out…
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3% saline versus 0.9% saline: Length of hospital stay (days)
Figure 1. 3% saline versus 0.9% saline: Length of hospital stay (days)
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3% saline versus 0.9% saline: Rate of Hospitalization
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Given the information you have, would you give the baby nebulized saline?
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1. No, just use humidified air (tell the kid's parents to keep the hot shower running in a closed bathroom)
2. No, just use the nebulized Xopenex
3. Yes, use 0.9% nebulized saline4. Yes, use 3% nebulized saline5. I prefer to conduct my own
clinical trial
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Summary Points• All reviews are not Systematic Reviews• Systematic review use explicit and reproducible
methods to answer a focused question• A meta-analysis is a mathematical synthesis of
the results of two or more primary studies that addressed the same hypothesis in the same way
• Meta-analysis increases the precision of a result– Decision to perform involves judgment and
quantitative assessment
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Hierarchy of Evidence
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Extra stuff
• Systematic reviews are the foundation of other evidence based tools
• Finding systematic reviews
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Other Applications of Systematic Reviews
• Practice Guidelines– Combine quality of evidence with strength of
recommendation• Cost-benefit analyses (to derive ranges
used in models• Decision analysis (to derive probabilities
used in models)
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Practice Guidelines
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Other Studies Built Upon Systematic Reviews
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Other Systematic Reviews“The Rational Clinical Examination”
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Locate systematic reviews using• Cochrane Database of Systematic Reviews (CDSR)
The CDSR is a full-text database containing systematic reviews and protocols (reviews still in progress) of the effects of health care interventions; mainly randomized controlled trials. "Gold Standard" for high quality, systematic reviews.
• Database of Abstracts of Reviews of Effects (DARE)Structured abstracts of good quality systematic reviews from around the world. Complements CDSR by offering a selection of quality assessed reviews in subjects with no Cochrane review. Also part of the Cochrane Library.
• PubMed Systematic ReviewsPubMed Clinical Queries: Systematic Reviews combines your search term(s) with citations identified as systematic reviews, meta-analyses, reviews of clinical trials, evidence-based medicine, consensus development conferences, and guidelines. No evaluation of comparative quality of different reviews on a topic.
• PubMed | Search TipsHint: you can limit to Publication Type: Meta-Analysis
• CINAHL Plus | Search TipsHint: you can limit with Publication Types: Systematic Review
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Effective Ways to Keep Up
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Increasing Utility of Systematic Reviews
• Cochrane—standardizing methodology• The PRISMA statement
– reporting systematic reviews and meta-analyses of healthcare interventions
• Critical appraisal criteria – JAMA Users Guide to the Medical Literature
• DARE and PubMed filters – Finding systematic reviews can be easy!
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Publishing Systematic Reviews
The CONSORT equivalent
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