Illustrating the GRADE Methodology: The Cather Associated-UTI Case Study
TEACH Level II Workshop 5
NYAM
August 9th, 2013
Craig A Umscheid, MD, MSCE, FACP
Assistant Professor of Medicine and Epidemiology
Director, Center for Evidence-based Practice
University of Pennsylvania
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The GRADE Working Group
Since 2000
Researchers/guideline developers with interest in methodology
Goal to develop one worldwide system of rating quality of evidence and strength of recommendations
Clear separation of 2 elements:
Quality of evidence: very low, low, moderate, or high quality
Strength of recommendation: weak or strong
www.GradeWorking-Group.org
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GRADE Uptake
World Health Organization National Institute Clinical Excellence (NICE) British Medical Journal Infectious Disease Society of America Centers for Disease Control and Prevention (HICPAC and ACIP) American College of Chest Physicians UpToDate American College of Physicians Cochrane Collaboration Agency for Healthcare Research and Quality (AHRQ)
Over 20 other major organizations
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Example key question in guideline:
VS.
Do Texas catheters impact UTI outcomes differently than Foley catheters?
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Comparison Outcome Quantity and Type of Evidence
Findings
Texas vs. Foley catheter
Symptomatic UTI 1 RCT Decreased risk
Bacteriuria 1 RCT No difference
Bacteremia 1 OBS No difference
Patient Satisfaction 1 RCT
1 OBS
Increased satisfaction
Risks and benefits associated with Texas vs. Foley catheters?
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Determinants of quality
RCTs start high Observational studies start low
5 factors lower the quality of evidence 3 factors can increase the quality of evidence
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Grading the Evidence
Type of evidence
Initial grade
Criteria to decrease grade Criteria to increase grade Overall quality grade
RCT High Study quality limitations
Serious (-1) or very serious
(-2) study quality limitations
Inconsistency
Important inconsistency (-1)
Indirectness
Some (-1) or major
(-2) uncertainty about directness
Imprecision
Imprecise or sparse data (-1)
Publication bias
High risk of bias (-1)
Strength of Association
Strong (+1) or very strong evidence of association (+2)
Dose-Response
Evidence of a dose-response gradient (+1)
Confounding
Inclusion of unmeasured confounders increases the magnitude of effect
(+1)
High
Moderate
Observational study
Low Low
Any other evidence
(e.g. expert opinion)
Very low
Very Low
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Overall Quality Grades
High• further research is very unlikely to change confidence in the estimate of
effect
Moderate• further research is likely to impact confidence in the estimate and may
change the estimate
Low• further research is very likely to impact confidence in the estimate and is
likely to change the estimate
Very low• any estimate is very uncertain
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Grading the Evidence for Each Outcome
Comparison Outcome
Quantity and Type
of Evidence
FindingsGRADE of Evidence
for Outcome
GRADE of Evidence for
Overall Evidence
Base
Texas vs. Foley catheter
Symptomatic UTI
1 RCTDecreased
riskModerate
Bacteriuria 1 RCT No difference Moderate
Bacteremia 1 OBS No difference Very Low
Patient Satisfaction
1 RCT
1 OBSIncreased
satisfactionHigh
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Grading the Evidence for Each Outcome
Comparison Outcome
Quantity and Type
of Evidence
FindingsGRADE of Evidence
for Outcome
GRADE of Evidence for
Overall Evidence
Base
Texas vs. Foley catheter
Symptomatic UTI*
1 RCTDecreased
riskModerate
Bacteriuria 1 RCT No difference Moderate
Bacteremia 1 OBS No difference Very Low
Patient Satisfaction*
1 RCT
1 OBSIncreased
satisfactionHigh
* = CRITICAL OUTCOMES
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Grading the Evidence for Each Outcome
Comparison Outcome
Quantity and Type
of Evidence
FindingsGRADE of Evidence
for Outcome
GRADE of Evidence for
Overall Evidence
Base
Texas vs. Foley catheter
Symptomatic UTI*
1 RCTDecreased
riskModerate
Moderate
Bacteriuria 1 RCT No difference Moderate
Bacteremia 1 OBS No difference Very Low
Patient Satisfaction*
1 RCT
1 OBSIncreased
satisfactionHigh
* = CRITICAL OUTCOMES
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Q2A1. Condom versus indwelling urethral
There was moderate quality evidence to support the use of condom catheters over indwelling urethral catheters in male patients. This was based on decreased risk of symptomatic UTI as well as increased patient satisfaction with condom catheters.
Narrative Evidence Summary
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Three key inputs:• Values and preferences used to determine the “critical”
outcomes• Overall GRADE of the evidence for the “critical” outcomes• Net benefits, net harms, or trade-offs that result from
weighing the "critical" outcomes
Formulating Recommendations
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Grading the Evidence for Each Outcome
Comparison Outcome
Quantity and Type
of Evidence
FindingsGRADE of Evidence
for Outcome
GRADE of Evidence for
Overall Evidence
Base
Texas vs. Foley catheter
Symptomatic UTI*
1 RCTDecreased
riskModerate
Moderate
Bacteriuria 1 RCT No difference Moderate
Bacteremia 1 OBS No difference Very Low
Patient Satisfaction*
1 RCT
1 OBSIncreased
satisfactionHigh
* = CRITICAL OUTCOMES
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GRADE Recommendation
Weighing Risks and Benefits
Quality of Evidence
STRONG (I) Net Benefits
Net Harms
IA – High-Moderate
IB – Low-Very Low
IC – High-Very Low
WEAK (II) Trade-offs II – High to Very Low
Recommendation for further research
Uncertain Trade-offs Low to Very Low
CDC Recommendation Scheme
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Example:Condom catheter drainage should be used in cooperative male patients without urinary retention or bladder outlet obstruction. (Category IA)
Recommendation