Making Guidelines Actionable

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Making GuidelinesActionable

• Richard M. Rosenfeld, MD, MPH

Professor and Chairman of Otolaryngology, SUNY
DownstateChair, Guideline Development Task
Force, AAO-HNSChair, G-I-N North America
Steering Group
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Standards for DevelopingTrustworthy 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
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Begin with the End in Mind
Habit 2, Stephen Covey
Covey S. The 7 Habits of Highly Effective People.
Fireside Press, 1989
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AAO-HNS Clinical Practice Guideline Development
Processwww.entnet.org
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American Academy of OtolaryngologyHead and Neck
Surgery (AAO-HNS)
Guidelines as Springboards for Quality Improvement
BestEvidence
BestMethods
BestConsensus


Best (Actionable) Practice
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Clinical Practice Guideline Development A
Quality-Driven Approach for Translating Evidence
into Action
Rosenfeld Shiffman, Otolaryngol HNS 2009

• Pragmatic, transparent approach to creating
  guidelines for performance assessment
• Evidence-based, multidisciplinary process leading
  to publication in 12 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
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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,
EvidenceReport, or Evidence-Based Review
Evidence as Supporting Cast Model Development is
driven by a priori considerations ofquality
improvement, using the literature search as one
of manyfactors that are used to translate
evidence into action. Product is a Guideline with
Actionable Statements
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Diagnosis Management of SinusitisA Practice
Parameter Update
Slavin et al, J All Clin Immunol 2005
Initial draft prepared by experts in the field
who carefully reviewed the current medical
literature, then peer-reviewed by a national
panel of allergists-immunologists, then reviewed
by co-sponsoring organizations.

• Contains 82 summary statements with strength of
  recommendation graded as A, B, C, or D based on
  level of evidence (288 references graded I to IV)
  
• Discusses anatomy, allergy, immunology,
  physiology, clinical diagnosis, testing, and
  treatment algorithms
• The parameter represents an evidence-based,
  broadly accepted consensus opinion

J All Clin Immunol 2005 116(Suppl) S13-S47
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Guidelines ARE NOT Review Articles!
Guidelines contain key statements that are
action-oriented prescriptions of specific
behavior from a clinician
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Statement of Fact vs. Action
Statement of Action
Statement of Fact
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.
Observation without the use of antibiotics is an
option for selected adults with uncomplicated
acute bacterial sinusitis who have mild illness
(mild pain and temperature lt38.3OC or 101OF) and
assurance of follow-up.
Randomized controlled trials show that many
episodes of uncomplicated acute bacterial
sinusitis are self-limited.
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 (swimmers ear) is
associated with moderate to severe pain.
Clinicians should not routinely administer or
prescribe perioperative antibiotics to children
undergoing tonsillectomy.
Antibiotic therapy does not improve recovery
after tonsillectomy
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Key Action Statements
Anatomy of a Guideline Recommendation

• 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

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Quality-Driven Guideline Development

1. Define topic and scope
2. Create a list of quality improvement topics and
   opportunities, independent of presumed evidence
   level

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Ranked Topic List for Sudden Hearing Loss
Guideline
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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,
EvidenceReport, or Evidence-Based Review
Evidence as Supporting Cast Model Development is
driven by a priori considerations ofquality
improvement, using the literature search as one
of manyfactors that are used to translate
evidence into action. Product is a Guideline with
Actionable Statements
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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 Natl Academies Press
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Quality-Driven Guideline Development

1. Define topic and scope
2. Create a list of quality improvement topics and
   opportunities, independent of presumed evidence
   level
3. Refine list based on existing guidelines,
   systematic reviews, and randomized trials
4. Prioritize topics and draft key action statements

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Key Action Statements on Benign Paroxysmal
Positional Vertigo (BPPV)
BPPV is a disorder of the inner ear characterized
by repeated episodes of a spinning sensation
(vertigo) from changes in head position relative
to gravity

• Clinicians should assess patients with BPPV for
  factors that modify management, including
  impaired mobility or balance, CNS disorders, a
  lack of home support, and increased risk for
  falling.
• The clinician may offer vestibular
  rehabilitation, either self-administered or with
  a clinician, for the initial treatment of BPPV.
• Clinicians should not obtain radiographic imaging
  or vestibular testing in a patient diagnosed with
  BPPV, unless the diagnosis is uncertain or there
  are additional symptoms or signs unrelated to
  BPPV that warrant testing.
• Clinicians should not routinely treat BPPV with
  vestibular suppressant medications, such as
  antihistamines or benzodiazepines.

Bhattacharyya et al, Otolaryngol Head Neck Surg
2008 139(Suppl)S47-81
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Forbes Magazine November 30, 2009
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Action Palate for Guideline Recommendations
Essaihi et al, AMIA Ann Symp Proc 2003 220-4
Test Obtain or collect additional data
Prescribe Order a treatment requiring medication or durable equipment
Perform Perform therapeutic procedure order therapeutic activities
Educate/counsel Inform patient about means to improve/maintain health
Dispose Initiate an activity to direct patient flow (admit, transfer, etc.)
Monitor Make serial observations according to specific criteria, schedule
Refer/consult Direct a patient to another clinician for evaluation or treatment
Prepare Make ready for a guideline-related activity by training, etc.
Document Record one or more facts in the patient record
Advocate Argue in support of a policy
Diagnose Determine a diagnose or clinical status
Never use the word CONSIDER to describe an action!
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Quality-Driven Guideline Development

1. Define topic and scope
2. Create a list of quality improvement topics and
   opportunities, independent of presumed evidence
   level
3. Refine list based on existing guidelines,
   systematic reviews, and randomized trials
4. Prioritize topics and draft key action statements
5. Use evidence profiles to refine statements and
   determine corresponding strength of action

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Evidence Profiles andGuideline Development

• Key action statement withrecommendation
  strengthand justification
• Supporting text for keyaction statement
• Evidence profile
• Aggregate evidence quality
• Benefit
• Harm
• Cost
• Benefit-harm assessment
• Value judgments
• Intentional vagueness
• Role of patient preferences
• Exclusions

1. Encourage an explicit and transparent approach to
   guideline writing
2. Force guideline developers to discuss and
   document the decision making process
3. Create organizational memory to
   avoidre-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

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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
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Classifying Recommendations for Practice
Guidelines
AAP Steering Committee on Quality Improvement and
Management
Pediatrics 2004 114874-877
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Action Statements as Behavior Constraints
Implication for clinicians
Policy strength
Follow unless a clear and compelling rationale
for alternative approach exists
Strong recommendation
Generally follow a recommendation, but remain
alert to new information
Recommendation
Be flexible in decision making regarding
appropriate practice, although bounds may be set
on alternatives
Option
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Tonsillectomy in Children
AAO-HNS Clinical Practice Guideline

• Clinicians may recommend tonsillectomy for
  recurrent throat infection with a frequency of at
  least
• 7 episodes in the past year, or
• 5 episodes per year in the preceding 2 years,
  or
• 3 episodes per year in the preceding 3 years,
• With documentation in the medical record for each
  episode of sore throat and one or more of the
  following
• temperature gt38.3C (101F), or
• cervical adenopathy (tender or gt2cm), or
• tonsillar exudate, or
• positive test for group A beta-hemolytic
  streptococcus.
• Option based on systematic reviews and randomized
  controlled trials with minor limitations, with
  relative balance of benefit and harm.

Otolaryngol Head Neck Surg 2011 14(Suppl)S1-S30
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AAO-HNS Tonsillectomy Clinical Practice Guideline

• Clinicians may recommend tonsillectomy for
  recurrent throat infection with a frequency of at
  least 7 episodes the past year or 5 episodes per
  year for 2 years or 3 episodes per year for 3
  years with documentation in the medical record
  for each episode of sore throat and one or more
  of the following Tgt38.3C, cervical adenopathy,
  tonsillar exudate, or positive test for group A
  beta-hemolytic streptococcus. Option based on
  systematic reviews and randomized controlled
  trials with minor limitations, witha relative
  balance of benefit and harm.

• Evidence profile
• Aggregate evidence quality Grade B, randomized
  controlled trials with minor limitations
• Benefits Modest reduction in the frequency and
  severity of recurrent throat infection for up to
  2 years after surgery modest reduction in
  frequency of group A streptococcal infection for
  up to 2 years
• Harms Risk and morbidity of tonsillectomy
  including, but not limited to, pain and missed
  activity after surgery, hemorrhage, dehydration,
  injury, and anesthetic complications
• Cost Cost of tonsillectomy direct non-surgical
  costs (antibiotics, clinician visit) and indirect
  costs (caregiver time, time missed from school)
  associated with recurrent infection.
• Benefits-harm assessment Uncertain relationship
  of benefit to harm
• Value judgments Importance of balancing the
  modest, short-term benefits of tonsillectomy in
  carefully selected children against the favorable
  natural history seen in control groups and the
  potential for harm or adverse events, which
  although infrequent, may be severe or
  life-threatening
• Intentional vagueness None
• Patient preference Large role for shared
  decision-making in severely affected patients,
  given the favorable natural history of recurrent
  throat infections and modest improvement
  associated with surgery limited role in patients
  who do not meet strict indications for surgery
• Exclusions None

Otolaryngol Head Neck Surg 2011 In press
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Fowler RH. Tonsil Surgery. Philadelphia F.A.
Davis Company 1931
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Classifying Recommendations for Practice
Guidelines
AAP Steering Committee on Quality Improvement and
Management
Pediatrics 2004 114874-877
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AAO-HNS Hoarseness Clinical Practice Guideline

• Anti-reflux Medication and Hoarseness Clinicians
  should not prescribe anti-reflux medications for
  patients with hoarseness without signs or
  symptoms of gastroesophageal reflux disease
  (GERD) Recommendation against prescribing based
  on randomized trials with limitations and
  observational studies with a preponderance of
  harm over benefit.

• Evidence profile
• Aggregate evidence quality Grade B, randomized
  trials with limitations showing lack of benefits
  for anti-reflux therapy in patients with
  laryngeal symptoms, including hoarseness
  observational studies with inconsistent or
  inconclusive results inconclusive evidence
  regarding the prevalence of hoarseness as the
  only manifestation of reflux disease
• Benefits avoid unnecessary drugs and adverse
  events from unproven therapy
• Harms potential withholding of therapy from
  patients who may benefit
• Cost none
• Benefits-harm assessment preponderance of
  benefit over harm
• Value judgments acknowledgment by the working
  group of the controversy surrounding
  laryngopharyngeal reflux, and the need for
  further research before definitive conclusions
  can be drawn desire to avoid known adverse
  events from therapy
• Intentional vagueness none
• Patient preference limited
• Exclusions patients immediately before or after
  laryngeal surgery and patients with other
  diagnosed pathology of the larynx

Otolaryngol Head Neck Surg 2009 141(Suppl)S1-31
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Consumer Involvement in Guidelines
What are the Possibilities?
Antoine Boivin, MD, PhD(c), G-I-N 6th Conference,
Lisbon, 11-09
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Is the Guideline Actionable?
Guideline Implementability Appraisal (GLIA)Yale
Center for Medical Informatics
BMC Med Informatics Decis Making 2005 523-31
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Guideline Statements Must Be Actionable!

• Crafting an actionable guidelinerequires insight
  and planning
• Involve all stakeholders
• Narrow the focus
• Think quality improvement
• Use key action statements
• Develop evidence profiles
• Get internal and external review
• ACTION, ACTION, ACTION

Thank you for your attention!richrosenfeld_at_msn.co
m