Illustrating the GRADE Methodology: The Cather Associated-UTI Case Study TEACH Level II Workshop 5...

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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CDC Guideline on Preventing CAUTI

Full guideline at http://www.cdc.gov/hicpac/index.html

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Grades of Recommendation Assessment,

Development and Evaluation

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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


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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Comparison Outcome

Quantity and Type

of Evidence


for Outcome


Overall Evidence

Base


Symptomatic UTI*

1 RCTDecreased

riskModerate



Patient Satisfaction*

1 RCT

1 OBSIncreased

satisfactionHigh

* = CRITICAL OUTCOMES

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Comparison Outcome

Quantity and Type

of Evidence


for Outcome


Overall Evidence

Base


Symptomatic UTI*

1 RCTDecreased

riskModerate

Moderate




1 RCT

1 OBSIncreased

satisfactionHigh


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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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Comparison Outcome

Quantity and Type

of Evidence


for Outcome


Overall Evidence

Base


Symptomatic UTI*

1 RCTDecreased

riskModerate

Moderate




1 RCT

1 OBSIncreased

satisfactionHigh


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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

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Questions?

Illustrating the GRADE Methodology: The Cather Associated-UTI Case Study TEACH Level II Workshop 5...

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