Making Guidelines Actionable - PowerPoint Presentation

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Making GuidelinesActionable

Richard Rosenfeld & Richard Shiffman

E-GAPPS Breakout SessionNY Academy of Medicine 12/12

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Standards for DevelopingTrustworthy Clinical Practice Guidelines

Updated IOM Definition ofClinical Practice Guidelines

Guidelines are statements that include recommendations intended to optimizepatient 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

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AAO-HNS Clinical Practice Guideline Development Processwww.entnet.org

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Clinical Practice Guideline Development: A Quality-Driven Approach for Translating Evidence into ActionPragmatic, transparent approach to creating guidelines for performance assessment

Evidence-based, multidisciplinary process leading to publication in 12-18 monthsEmphasizes a focused set of key action statements to promote quality improvement

Uses evidence profiles to summarize decisions and value judgments in recommendations

Rosenfeld & Shiffman, Otolaryngol HNS 2009

Otolaryngol Head Neck Surg 2009; 140(Suppl):S1-43

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Two Approaches to Evidence and Guidelines

Evidence as Protagonist Model

Development is driven by the literature search,which takes center stage with exhaustive evidence tablesor 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

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Generating Topics for Action StatementsAsk “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 allimportant topics to be included, even if evidence isweak or limited. Action statements may still bepossible based on the balance of benefit and harm.

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

Otolaryngol Head Neck Surg 2009; 140(Suppl):S1-43

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Ranked Topic List for Hoarseness Guideline

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Promote appropriate careReduce inappropriate or harmful care

Reduce variations in delivery of careImprove access to care

Facilitate ethical careEducate & empower clinicians & patientsFacilitate coordination & continuity of careImprove knowledge base across disciplinesQuality Improvement Opportunities

Eden J, Wheatley B, McNeil B, Sox H (eds).Washington, DC: Nat’l Academies Press

a.k.a. Potential topics for guideline action statements

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Standards for DevelopingTrustworthy Clinical Practice Guidelines

Standard 6. Articulation of Recommendations6.1 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

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Statements of Fact vs. Action

Clinicians

should not routinely administer or prescribe perioperative antibiotics to children undergoing tonsillectomy.Antibiotic therapy does not improve recovery after tonsillectomy

The management of acute otitis externa

should include an assessment of pain

.

The clinician

should recommend analgesic treatment

based on the severity of pain.

Acute otitis externa (swimmer’s ear) is associated with moderate to severe pain.

Clinicians

should advocate for voice therapy

for patients diagnosed with hoarseness (dysphonia) that reduces voice-related quality of life.

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.

Pneumatic otoscopy is the most accurate test for otitis media with effusion.

Statement of Action

Statement of Fact

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Guidelines ARE NOT Review Articles!

Guidelines contain key statements that are

action-oriented prescriptions of specific behavior from a clinician

Monitor

Test

Gather

Interpret

Perform

Dispose

Action

Conclude

Prescribe

Educate

Document

Procedure

Consult

Advocate

Prepare

Beware of the dreaded “Consider…”

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Key Action Statements

An ideal action statement describes:When (under what conditions)

Who (specifically)Must, Should, or May(e.g., the level of obligation)do What (precisely)to Whom

Anatomy of a Guideline Recommendation

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Action Statement Profiles andGuideline Development

Encourage an explicit and transparent approach to guideline writingForce guideline developers to discuss and document the decision making process

Create “organizational memory” to avoidre-discussing already agreed upon issuesAllow guideline users to rapidly understand how and why statements were developedFacilitate identifying aspects of guideline best suited to performance assessment

Key action statement with

recommendation strength

and justification

Supporting text for key

action statement

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:

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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.

AAO-HNS Adult Sinusitis Clinical Practice Guideline

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

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Classifying Recommendations for Practice Guidelines

AAP Steering Committee on Quality Improvement and Management

Pediatrics 2004; 114:874-877

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Action Statements as Behavior Constraints

MAY

SHOULD

MUST or SHOULD

Obligation level

Be flexible in decision making regarding appropriate practice, although bounds may be set on alternatives

Generally follow a recommendation, but remain alert to new information

Follow unless a clear and compelling rationale for alternative approach exists

Implication for clinicians

Option

Recommendation

Strong recommendation

Policy strength

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

Lomotan

E, et al. How “should” we write guideline recommendations? Interpretation of deontic terminology. Quality Safety Health Care

2009

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Standards for DevelopingTrustworthy Clinical Practice Guidelines

Standard 5. Recommendations

For each recommendation provide:An explanation of the reasoning including: benefits, harms, evidence summary (quality, quantity, consistency), and the role of values, opinion and experienceA rating of the level of confidence in (certainty regarding) the evidenceA rating of recommendation strengthA 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

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Building Better Guidelines with BRIDGE-Wiz

Description of a software assistant for structured action statement

creation to promote clarity, transparency and implementability

Shiffman

…Rosenfeld

et al, JAMIA 2012

J Am Med Inform Assoc

2012

; 19:94-101.

Choose an action type

Choose a verb

Define the object for the verb

Add actions

Check

executability

Define conditions for the action

Check decidability

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

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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.AAO-HNS Adult Sinusitis Clinical Practice Guideline

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

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Classifying Recommendations for Practice Guidelines

AAP Steering Committee on Quality Improvement and Management

Pediatrics 2004; 114:874-877

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Clinicians and OptionsEvidence quality is suspect or well-designed studies have demonstrated little clear advantage to one approach vs. another

Options offer flexibility in decision making about appropriate practice, although they may set boundaries on alternativesHard to hold clinicians accountable (performance measures)Patient preference should have a substantial role in influencing clinical decision making

What Do They Mean?

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…And Now It’s Your Turn…

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Treatment & Prevention of the Common Cold

Cochrane Systematic Reviews

The Cochrane Library, 2010; John Wiley & Sons, LtdIntervention (update)

Evidence

Conclusion

Antibiotics (2009)

6 trials

No benefits; more adverse events

Non-steroidal anti-inflammatory 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