Transcript Gastroesophageal Reflux and Chronic Pediatric Sinusitis

Making Guidelines
Actionable
E-GAPPS Breakout Session
NY Academy of Medicine 12/12
Richard Rosenfeld & Richard Shiffman
Standards for Developing
Trustworthy Clinical Practice Guidelines
Updated IOM Definition of
Clinical Practice Guidelines
Guidelines are statements that include
recommendations intended to optimize
patient care that are informed by a
systematic review of evidence and an
assessment of the benefits and harms of
alternative care options
http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx
AAO-HNS
Clinical
Practice
Guideline
Development
Process
www.entnet.org
Clinical Practice Guideline Development: A QualityDriven Approach for Translating Evidence into Action
Rosenfeld & Shiffman, Otolaryngol HNS 2009
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Pragmatic, transparent approach to creating
guidelines for performance assessment
Evidence-based, multidisciplinary process
leading to publication in 12-18 months
Emphasizes a focused set of key action
statements to promote quality improvement
Uses evidence profiles to summarize decisions
and value judgments in recommendations
Otolaryngol Head Neck Surg 2009; 140(Suppl):S1-43
Two Approaches to Evidence and Guidelines
Evidence as Protagonist Model
Development is driven by the literature search,
which takes center stage with exhaustive evidence tables
or textual discussions that rank and summarize citations.
Product is a Practice Parameter, Evidence
Report, or Evidence-Based Review
Evidence as Supporting Cast Model
Development is driven by a priori considerations of
quality improvement, using the literature search as one of many
factors that are used to translate evidence into action.
Product is a Guideline with Actionable Statements
Generating Topics for Action Statements
Rosenfeld & Shiffman, Otolaryngol HNS 2009
Developing key action statements begins with asking the group to suggest
topics that are opportunities for quality improvement within the scope
 Ask “If we could only discuss a few aspects of this condition,
what topics would we focus on most to improve quality of care?”
 Ask “What should we focus on to minimize harm?”
 Consider high level evidence from systematic review and the
concept list generating when discussion scope.
 Remember: A quality-driven approach allows all
important topics to be included, even if evidence is
weak or limited. Action statements may still be
possible based on the balance of benefit and harm.
Otolaryngol Head Neck Surg 2009; 140(Suppl):S1-43
Ranked Topic List for Hoarseness Guideline
Quality Improvement Opportunities
1. Promote appropriate care
2. Reduce inappropriate or harmful care
3. Reduce variations in delivery of care
4. Improve access to care
5. Facilitate ethical care
6. Educate & empower clinicians & patients
7. Facilitate coordination & continuity of care
8. Improve knowledge base across disciplines
a.k.a. Potential topics for guideline action statements
Eden J, Wheatley B, McNeil B, Sox H (eds).Washington, DC: Nat’l Academies Press
Standards for Developing
Trustworthy Clinical Practice Guidelines
Standard 6. Articulation of
Recommendations
6.1 Recommendations should be articulated
in a standardized form detailing precisely:
what the recommended action is, and under
what circumstances it should be performed.
6.2 Strong recommendations should be
worded so that compliance with the
recommendation(s) can be evaluated.
http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx
Statements of Fact vs. Action
Statement of Fact
Statement of Action
Pneumatic otoscopy is the
most accurate test for otitis
media with effusion.
Voice therapy has been
shown to improve quality of
life for patients with
hoarseness (dysphonia).
Clinicians should use pneumatic otoscopy
as the primary diagnostic method for otitis
media with effusion.
Clinicians should advocate for voice therapy
for patients diagnosed with hoarseness
(dysphonia) that reduces voice-related quality
of life.
Acute otitis externa
(swimmer’s ear) is associated
with moderate to severe pain.
The management of acute otitis externa
should include an assessment of pain.
The clinician should recommend analgesic
treatment based on the severity of pain.
Antibiotic therapy does not
improve recovery after
tonsillectomy
Clinicians should not routinely administer or
prescribe perioperative antibiotics to
children undergoing tonsillectomy.
Guidelines ARE NOT Review Articles!
Guidelines contain key statements that are action-oriented
prescriptions of specific behavior from a clinician
Action
Gather
Interpret
Test
Conclude
Perform
Prescribe
Educate
Monitor
Procedure
Consult
Advocate
Document
Beware of the dreaded “Consider…”
Dispose
Prepare
Key Action Statements
Anatomy of a Guideline Recommendation
An ideal action statement describes:
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When (under what conditions)
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Who (specifically)
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Must, Should, or May
(e.g., the level of obligation)
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do What (precisely)
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to Whom
Key action statement with
recommendation strength
and justification
Action Statement Profiles and
Guideline Development
Supporting text for key
action statement
1. Encourage an explicit and transparent
approach to guideline writing
Action statement profile:
 Aggregate evidence quality:
 Confidence in evidence:
 Benefit:
 Risk, harm, cost:
 Benefit-harm assessment:
 Value judgments:
 Intentional vagueness:
 Role of patient preferences:
 Differences of opinion:
 Exclusions:
2. Force guideline developers to discuss and
document the decision making process
3. Create “organizational memory” to avoid
re-discussing already agreed upon issues
4. Allow guideline users to rapidly understand
how and why statements were developed
5. Facilitate identifying aspects of guideline
best suited to performance assessment
AAO-HNS Adult Sinusitis Clinical Practice Guideline
1. Diagnosis of acute rhinosinusitis: Clinicians should distinguish presumed acute
bacterial rhinosinusitis (ABRS) from acute rhinosinusitis caused by viral upper
respiratory infections and non-infectious conditions.
A clinician should diagnose ABRS when (a) symptoms or signs of acute
rhinosinusitis are present 10 days or more beyond the onset of upper respiratory
symptoms, or (b) symptoms or signs of acute rhinosinusitis worsen within 10 days
after an initial improvement (double worsening).
Strong recommendation based on diagnostic studies with minor limitations and a
preponderance of benefit over harm.
Evidence profile (abbreviated):
 Aggregate evidence quality: Grade B, diagnostic studies with minor limitations
regarding signs and symptoms associated with ABRS
 Benefits: decrease inappropriate use of antibiotics for non-bacterial illness;
distinguish non-infectious conditions from rhinosinusitis
 Harms: risk of misclassifying bacterial rhinosinusitis as viral, or vice-versa
 Benefits-harm assessment: preponderance of benefit over harms
 Value judgments: importance of avoiding inappropriate antibiotics for treatment of
viral or non-bacterial illness; emphasis on clinical signs and symptoms for initial
diagnosis; importance of avoiding unnecessary diagnostic tests
Otolaryngol Head Neck Surg 2007; 137(Suppl):S1-S31
Classifying Recommendations for Practice Guidelines
AAP Steering Committee on Quality Improvement and Management
Pediatrics 2004; 114:874-877
Action Statements as Behavior Constraints
Policy strength
Implication for clinicians
Obligation level
Strong
recommendation
Follow unless a clear and compelling
rationale for alternative approach exists
MUST or
SHOULD
Recommendation
Generally follow a recommendation, but
remain alert to new information
SHOULD
Option
Be flexible in decision making regarding
MAY
appropriate practice, although bounds may
be set on alternatives
Lomotan E, et al. How “should” we write guideline recommendations?
Interpretation of deontic terminology. Quality Safety Health Care 2009
Cross-sectional survey of 1,332 registrants of the 2008 annual AHRQ
conference given a clinical scenario with recommendations and asked
to rate the level of obligation they believe the authors intended
Standards for Developing
Trustworthy Clinical Practice Guidelines
Standard 5. Recommendations
For each recommendation provide:
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An explanation of the reasoning including:
benefits, harms, evidence summary (quality,
quantity, consistency), and the role of values,
opinion and experience
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A rating of the level of confidence in (certainty
regarding) the evidence
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A rating of recommendation strength
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A description and explanation of any differences
of opinion regarding the recommendation
http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx
Building Better Guidelines with BRIDGE-Wiz
Shiffman…Rosenfeld et al, JAMIA 2012
Description of a software assistant for structured action statement
creation to promote clarity, transparency and implementability
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2.
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6.
7.
Choose an action type
Choose a verb
Define the object for the verb
Add actions
Check executability
Define conditions for the
action
Check decidability
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10.
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12.
13.
14.
J Am Med Inform Assoc 2012; 19:94-101.
Describe benefits, risks, harms & costs
Judge the benefit-harms balance
Select aggregate evidence quality
Review proposed strength of
recommendation and level of obligation
Define the actor
Choose recommendation style
Edit the final statement
AAO-HNS Adult Sinusitis Clinical Practice Guideline
8. Testing for allergy and immune function: Clinicians may obtain testing for allergy
and immune function in evaluation a patient with chronic rhinosinusitis (CRS) or
recurrent acute rhinosinusitis.
Option based on observational studies with an unclear balance of benefit vs. harm.
Evidence profile:
 Aggregate evidence quality: Grade C, observational studies
 Benefits: identify allergies or immunodeficient states that are potential modifying
factors for CRS or recurrent acute rhinosinusitis
 Harms: procedural discomfort; instituting therapy based on test results with limited
evidence of efficacy for CRS or recurrent acute rhinosinusitis; very rare chance of
anaphylactic reactions during allergy testing
 Cost: procedural and laboratory cost
 Benefits-harm assessment: unclear balance of benefit vs. harm
 Value judgments: need to balance detecting allergy in a population with high
prevalence vs. limited evidence showing benefits of allergy management outcomes
 Role of patient preferences: role for shared decision making
Otolaryngol Head Neck Surg 2007; 137(Suppl):S1-S31
Classifying Recommendations for Practice Guidelines
AAP Steering Committee on Quality Improvement and Management
Pediatrics 2004; 114:874-877
Clinicians and Options
What Do They Mean?
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Evidence quality is suspect or well-designed studies have
demonstrated little clear advantage to one approach vs. another
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Options offer flexibility in decision making about appropriate
practice, although they may set boundaries on alternatives
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Hard to hold clinicians accountable (performance measures)
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Patient preference should have a substantial role in influencing
clinical decision making
…And Now It’s Your Turn…
Treatment & Prevention of the Common Cold
Cochrane Systematic Reviews
Intervention (update)
Evidence
Conclusion
Antibiotics (2009)
6 trials
No benefits; more adverse events
Non-steroidal antiinflammatory drugs (2009)
9 trials
Reduced headache, ear pain, muscle & joint pain; no
effect on duration or adverse events
Echinacea (2007)
16 trials
Some early treatment benefit; no effect on prevention
Heated, humidified air
(2006)
6 trials
Benefit for symptom relief in 3 studies; overall effects
equivocal; minor discomfort, irritation, congestion
Chinese medicinal herbs
(2008)
17 trials
Faster recovery 7 trials; no benefits in 10; problem
with heterogeneity
Vitamin C (2010)
29 trials
Reduced duration and severity in prophylaxis trials
(but not treatment trials); no benefit for prevention
Garlic (2009)
1 trial
Benefit for prevention in a single trial
The Cochrane Library, 2010; John Wiley & Sons, Ltd