Transcript Gastroesophageal Reflux and Chronic Pediatric Sinusitis

Making Guidelines
Actionable
Richard M. Rosenfeld, MD, MPH
Professor and Chairman of Otolaryngology, SUNY Downstate
Chair, Guideline Development Task Force, AAO-HNS
Chair, G-I-N North America Steering Group
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
Begin with the End in Mind
Habit #2, Stephen Covey
Covey S. The 7 Habits of Highly Effective People. Fireside Press, 1989
AAO-HNS
Clinical
Practice
Guideline
Development
Process
www.entnet.org
American Academy of Otolaryngology
Head and Neck Surgery (AAO-HNS)
Guidelines as Springboards for Quality Improvement
Best
Methods
+
Best
Evidence
+
Best
Consensus
Best (Actionable) Practice
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 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
Diagnosis & Management of Sinusitis:
A 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.
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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
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
Procedure
Educate
Monitor
Dispose
Consult
Advocate
Document
Prepare
Statement of Fact vs. Action
Statement of Fact
Statement of Action
Pneumatic otoscopy is the
most accurate test for otitis
media with effusion.
Clinicians should use pneumatic otoscopy as
the primary diagnostic method for otitis media
with effusion.
Randomized controlled trials
show that many episodes of
uncomplicated acute bacterial
sinusitis are self-limited.
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 <38.3OC or 101OF)
and assurance of follow-up.
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.
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
Quality-Driven Guideline Development
1. Define topic and scope
2. Create a list of quality improvement topics and
opportunities, independent of presumed evidence level
Ranked Topic List for Sudden Hearing Loss Guideline
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
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
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
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
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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.
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The clinician may offer vestibular rehabilitation, either self-administered or
with a clinician, for the initial treatment of BPPV.
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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.
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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
Forbes Magazine – November 30, 2009
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!
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
Key action statement with
recommendation strength
and justification
Evidence Profiles and
Guideline Development
Supporting text for key
action statement
1. Encourage an explicit and transparent
approach to guideline writing
Evidence profile:
 Aggregate evidence quality:
 Benefit:
 Harm:
 Cost:
 Benefit-harm assessment:
 Value judgments:
 Intentional vagueness:
 Role of patient preferences:
 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. Qual Saf Health Care 2010;19:509-513
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
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 >38.3C (101F), or
 cervical adenopathy (tender or >2cm), 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
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:
T>38.3C, 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, with
a 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
Fowler RH. Tonsil Surgery. Philadelphia: F.A. Davis Company 1931
Classifying Recommendations for Practice Guidelines
AAP Steering Committee on Quality Improvement and Management
Pediatrics 2004; 114:874-877
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
Consumer Involvement in Guidelines
What are the Possibilities?
Antoine Boivin, MD, PhD(c), G-I-N 6th Conference, Lisbon, 11-09
Is the Guideline Actionable?
Guideline Implementability Appraisal (GLIA)
Yale Center for Medical Informatics
Decidability
Precisely under what circumstances to do something
Executability
Exactly what to do under the circumstances defined
Effect on process Degree to which the recommendation impacts workflow in a
of care
typical case setting
Presentation and
formatting
Degree to which the recommendation is recognizable and
succinct
Measurable
outcomes
Degree to which the guideline identifies markers or
endpoints to track the effects of implementation
Apparent validity
Degree to which the recommendation reflects the intent of
the developer and the strength of evidence
Novelty /
innovation
Degree to which the recommendation proposes behaviors
considered unconventional
Flexibility
Degree to which a recommendation permits interpretation
and allows for alternatives in execution
BMC Med Informatics Decis Making 2005; 5:23-31
Guideline Statements Must
Be Actionable!
Crafting an actionable guideline
requires insight and planning:
1. Involve all stakeholders
2. Narrow the focus
3. Think quality improvement
4. Use key action statements
5. Develop evidence profiles
6. Get internal and external review
7. ACTION, ACTION, ACTION
Thank you for your attention!
[email protected]