Making GuidelinesMaking Guidelines

ActionableActionable

Richard M. Rosenfeld, MD, MPHRichard M. Rosenfeld, MD, MPH

Professor and Chairman of Otolaryngology, SUNY DownstateProfessor and Chairman of Otolaryngology, SUNY DownstateChair, Guideline Development Task Force, AAO-HNSChair, Guideline Development Task Force, AAO-HNS

Chair, G-I-N North America Steering GroupChair, G-I-N North America Steering Group

Standards for DevelopingStandards for DevelopingTrustworthy Clinical Practice GuidelinesTrustworthy Clinical Practice Guidelines

Standard 6. Articulation of Standard 6. Articulation of RecommendationsRecommendations

6.1 Recommendations should be articulated 6.1 Recommendations should be articulated in a standardized form detailing precisely: in a standardized form detailing precisely: what the recommended action is, and under what the recommended action is, and under what circumstances it should be performed.what circumstances it should be performed.

6.2 Strong recommendations should be 6.2 Strong recommendations should be worded so that compliance with the worded so that compliance with the recommendation(s) can be evaluated.recommendation(s) can be evaluated.

http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspxhttp://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx

Begin with the End in MindBegin with the End in Mind

Covey S. The 7 Habits of Highly Effective People. Fireside Press, 1989Covey S. The 7 Habits of Highly Effective People. Fireside Press, 1989

Habit #2, Stephen CoveyHabit #2, Stephen Covey

AAO-HNS AAO-HNS Clinical Clinical Practice Practice

Guideline Guideline Development Development

ProcessProcess

www.entnet.orgwww.entnet.org

American Academy of OtolaryngologyAmerican Academy of OtolaryngologyHead and Neck Surgery (AAO-HNS)Head and Neck Surgery (AAO-HNS)

Guidelines as Springboards for Quality ImprovementGuidelines as Springboards for Quality Improvement

BestBestEvidenceEvidence

BestBestMethodsMethods

BestBestConsensusConsensus

Best (Actionable) PracticeBest (Actionable) Practice

++ ++

Clinical Practice Guideline Development: A Quality-Clinical Practice Guideline Development: A Quality-Driven Approach for Translating Evidence into ActionDriven Approach for Translating Evidence into Action

Pragmatic, transparent approach to creating Pragmatic, transparent approach to creating guidelines for performance assessmentguidelines for performance assessment

Evidence-based, multidisciplinary process Evidence-based, multidisciplinary process leading to publication in 12 monthsleading to publication in 12 months

Emphasizes a focused set of Emphasizes a focused set of key action key action statementsstatements to promote quality improvement to promote quality improvement

Uses Uses evidence profilesevidence profiles to summarize decisions to summarize decisions and value judgments in recommendationsand value judgments in recommendations

Rosenfeld & Shiffman, Otolaryngol HNS 2009Rosenfeld & Shiffman, Otolaryngol HNS 2009

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

Two Approaches to Evidence and GuidelinesTwo Approaches to Evidence and Guidelines

Evidence as Protagonist ModelEvidence as Protagonist ModelDevelopment is driven by the literature search,Development is driven by the literature search,

which takes center stage with exhaustive evidence tableswhich takes center stage with exhaustive evidence tablesor textual discussions that rank and summarize citations.or textual discussions that rank and summarize citations.

Product is a Practice Parameter, EvidenceProduct is a Practice Parameter, EvidenceReport, or Evidence-Based ReviewReport, or Evidence-Based Review

Evidence as Supporting Cast ModelEvidence as Supporting Cast ModelDevelopment is driven by a priori considerations ofDevelopment is driven by a priori considerations of

quality improvement, using the literature search as one of manyquality improvement, using the literature search as one of manyfactors that are used to translate evidence into action.factors that are used to translate evidence into action.

Product is a Guideline with Actionable StatementsProduct is a Guideline with Actionable Statements

Diagnosis & Management of Sinusitis:Diagnosis & Management of Sinusitis:A Practice Parameter UpdateA Practice Parameter Update

Contains 82 “summary statements”Contains 82 “summary statements” with strength of with strength of recommendation graded as A, B, C, or D based on level of recommendation graded as A, B, C, or D based on level of evidence (288 references graded I to IV) evidence (288 references graded I to IV)

Discusses anatomy, allergy, immunology, physiology, Discusses anatomy, allergy, immunology, physiology, clinical diagnosis, testing, and treatment algorithmsclinical diagnosis, testing, and treatment algorithms

The parameter represents “an evidence-based, broadly The parameter represents “an evidence-based, broadly accepted consensus opinion”accepted consensus opinion”

Slavin et al, J All Clin Immunol 2005Slavin et al, J All Clin Immunol 2005

Initial draft prepared by “experts in the field who carefully reviewed the Initial draft prepared by “experts in the field who carefully reviewed the current medical literature,” then peer-reviewed by a national panel of current medical literature,” then peer-reviewed by a national panel of

allergists-immunologists, then reviewed by co-sponsoring organizations.allergists-immunologists, then reviewed by co-sponsoring organizations.

J All Clin Immunol 2005; 116(Suppl): S13-S47J All Clin Immunol 2005; 116(Suppl): S13-S47

Guidelines ARE NOT Review Articles!Guidelines ARE NOT Review Articles!Guidelines contain key statements that are Guidelines contain key statements that are action-oriented action-oriented

prescriptions of specific behavior from a clinicianprescriptions of specific behavior from a clinician

Monitor

Test

Gather Interpret Perform Dispose

Action

Conclude Prescribe

Educate

Document

Procedure

Consult

Advocate

Prepare

Statement of Fact vs. Statement of Fact vs. ActionAction

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.

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.

Randomized controlled trials show that many episodes of uncomplicated acute bacterial sinusitis are self-limited.

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 ActionStatement of Fact

Key Action StatementsKey Action Statements

An ideal action statement describes:An ideal action statement describes:

WhenWhen (under what conditions)(under what conditions)

WhoWho (specifically) (specifically)

Must, Should, or MayMust, Should, or May(e.g., the level of obligation)(e.g., the level of obligation)

do do What What (precisely)(precisely)

toto Whom Whom

Anatomy of a Guideline RecommendationAnatomy of a Guideline Recommendation

Quality-DrivenQuality-Driven Guideline Development Guideline Development

1.1. Define topic and scopeDefine topic and scope

2.2. Create a list of quality improvement topics and Create a list of quality improvement topics and opportunities, opportunities, independent of presumed evidence levelindependent of presumed evidence level

Ranked Topic List for Sudden Hearing Loss GuidelineRanked Topic List for Sudden Hearing Loss Guideline

Two Approaches to Evidence and GuidelinesTwo Approaches to Evidence and Guidelines

Evidence as Protagonist ModelEvidence as Protagonist ModelDevelopment is driven by the literature search,Development is driven by the literature search,

which takes center stage with exhaustive evidence tableswhich takes center stage with exhaustive evidence tablesor textual discussions that rank and summarize citations.or textual discussions that rank and summarize citations.

Product is a Practice Parameter, EvidenceProduct is a Practice Parameter, EvidenceReport, or Evidence-Based ReviewReport, or Evidence-Based Review

Evidence as Supporting Cast ModelEvidence as Supporting Cast ModelDevelopment is driven by a priori considerations ofDevelopment is driven by a priori considerations of

quality improvement, using the literature search as one of manyquality improvement, using the literature search as one of manyfactors that are used to translate evidence into action.factors that are used to translate evidence into action.

Product is a Guideline with Actionable StatementsProduct is a Guideline with Actionable Statements

1.1. Promote appropriate carePromote appropriate care

2.2. Reduce inappropriate or harmful careReduce inappropriate or harmful care

3.3. Reduce variations in delivery of careReduce variations in delivery of care

4.4. Improve access to careImprove access to care

5.5. Facilitate ethical careFacilitate ethical care

6.6. Educate & empower clinicians & patientsEducate & empower clinicians & patients

7.7. Facilitate coordination & continuity of careFacilitate coordination & continuity of care

8.8. Improve knowledge base across disciplinesImprove knowledge base across disciplines

Quality Improvement OpportunitiesQuality Improvement Opportunities

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

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

Quality-Driven Guideline DevelopmentQuality-Driven Guideline Development

1.1. Define topic and scopeDefine topic and scope

2.2. Create a list of quality improvement topics and Create a list of quality improvement topics and opportunities, independent of presumed evidence levelopportunities, independent of presumed evidence level

3.3. Refine list based on existing guidelines, systematic Refine list based on existing guidelines, systematic reviews, and randomized trialsreviews, and randomized trials

4.4. Prioritize topics and draft key action statementsPrioritize topics and draft key action statements

Clinicians should Clinicians should assess patients with BPPV for factors that modify assess patients with BPPV for factors that modify managementmanagement, including impaired mobility or balance, CNS disorders, a lack , including impaired mobility or balance, CNS disorders, a lack of home support, and increased risk for falling.of home support, and increased risk for falling.

The clinician The clinician may offer vestibular rehabilitationmay offer vestibular rehabilitation, either self-administered , either self-administered or with a clinician, for the initial treatment of BPPV.or with a clinician, for the initial treatment of BPPV.

Clinicians should Clinicians should not obtain radiographic imaging or vestibular testingnot obtain radiographic imaging or vestibular testing in in a patient diagnosed with BPPV, unless the diagnosis is uncertain or there are a patient diagnosed with BPPV, unless the diagnosis is uncertain or there are additional symptoms or signs unrelated to BPPV that warrant testing.additional symptoms or signs unrelated to BPPV that warrant testing.

Clinicians should Clinicians should not routinely treat BPPV with vestibular suppressant not routinely treat BPPV with vestibular suppressant medicationsmedications, such as antihistamines or benzodiazepines., such as antihistamines or benzodiazepines.

Bhattacharyya et al, Otolaryngol Head Neck Surg 2008; 139(Suppl):S47-81Bhattacharyya et al, Otolaryngol Head Neck Surg 2008; 139(Suppl):S47-81

Key Action Statements on Benign Key Action Statements on Benign Paroxysmal Positional Vertigo (BPPV)Paroxysmal Positional Vertigo (BPPV)

BPPV is a disorder of the inner ear characterized by repeated episodes of a BPPV is a disorder of the inner ear characterized by repeated episodes of a spinning sensation (vertigo) from changes in head position relative to gravityspinning sensation (vertigo) from changes in head position relative to gravity

Forbes Magazine – November 30, 2009Forbes Magazine – November 30, 2009

Never use the word CONSIDER to describe an action!Never use the word CONSIDER to describe an action!

Test Obtain or collect additional dataObtain or collect additional data

Prescribe Order a treatment requiring medication or durable equipmentOrder a treatment requiring medication or durable equipment

Perform Perform therapeutic procedure; order therapeutic activitiesPerform therapeutic procedure; order therapeutic activities

Educate/counsel Inform patient about means to improve/maintain healthInform patient about means to improve/maintain health

Dispose Initiate an activity to direct patient flow (admit, transfer, etc.)Initiate an activity to direct patient flow (admit, transfer, etc.)

Monitor Make serial observations according to specific criteria, scheduleMake serial observations according to specific criteria, schedule

Refer/consult Direct a patient to another clinician for evaluation or treatmentDirect a patient to another clinician for evaluation or treatment

Prepare Make ready for a guideline-related activity by training, etc.Make ready for a guideline-related activity by training, etc.

Document Record one or more facts in the patient recordRecord one or more facts in the patient record

Advocate Argue in support of a policyArgue in support of a policy

Diagnose Determine a diagnose or clinical statusDetermine a diagnose or clinical status

Action Palate for Guideline RecommendationsAction Palate for Guideline RecommendationsEssaihi et al, AMIA Ann Symp Proc 2003; 220-4Essaihi et al, AMIA Ann Symp Proc 2003; 220-4

Quality-Driven Guideline DevelopmentQuality-Driven Guideline Development

1.1. Define topic and scopeDefine topic and scope

2.2. Create a list of quality improvement topics and Create a list of quality improvement topics and opportunities, independent of presumed evidence levelopportunities, independent of presumed evidence level

3.3. Refine list based on existing guidelines, systematic Refine list based on existing guidelines, systematic reviews, and randomized trialsreviews, and randomized trials

4.4. Prioritize topics and draft key action statementsPrioritize topics and draft key action statements

5.5. Use evidence profiles to refine statements and Use evidence profiles to refine statements and determine corresponding strength of actiondetermine corresponding strength of action

Evidence Profiles andEvidence Profiles andGuideline DevelopmentGuideline Development1.1. Encourage an explicit and transparent Encourage an explicit and transparent

approach to guideline writingapproach to guideline writing

2.2. Force guideline developers to discuss and Force guideline developers to discuss and document the decision making processdocument the decision making process

3.3. Create “Create “organizational memoryorganizational memory” to avoid” to avoidre-discussing already agreed upon issuesre-discussing already agreed upon issues

4.4. Allow guideline users to rapidly understand Allow guideline users to rapidly understand how and why statements were developedhow and why statements were developed

5.5. Facilitate identifying aspects of guideline Facilitate identifying aspects of guideline best suited to performance assessmentbest suited to performance assessment

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:

1.1. Diagnosis of acute rhinosinusitisDiagnosis of acute rhinosinusitis: Clinicians should distinguish presumed acute : Clinicians should distinguish presumed acute bacterial rhinosinusitis (ABRS) from acute rhinosinusitis caused by viral upper bacterial rhinosinusitis (ABRS) from acute rhinosinusitis caused by viral upper respiratory infections and non-infectious conditions.respiratory infections and non-infectious conditions.

A clinician should diagnose ABRS when (a) symptoms or signs of acute 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 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 symptoms, or (b) symptoms or signs of acute rhinosinusitis worsen within 10 days after an initial improvement (double worsening). after an initial improvement (double worsening). Strong recommendationStrong recommendation based on diagnostic studies with minor limitations and a based on diagnostic studies with minor limitations and a preponderance of benefit over harm.preponderance of benefit over harm.

AAO-HNS Adult Sinusitis Clinical Practice GuidelineAAO-HNS Adult Sinusitis Clinical Practice Guideline

Evidence profile (abbreviated):Evidence profile (abbreviated): Aggregate evidence quality:Aggregate evidence quality: Grade B, diagnostic studies with minor limitations Grade B, diagnostic studies with minor limitations

regarding signs and symptoms associated with ABRSregarding signs and symptoms associated with ABRS Benefits:Benefits: decrease inappropriate use of antibiotics for non-bacterial illness; decrease inappropriate use of antibiotics for non-bacterial illness;

distinguish non-infectious conditions from rhinosinusitisdistinguish non-infectious conditions from rhinosinusitis Harms:Harms: risk of misclassifying bacterial rhinosinusitis as viral, or vice-versa risk of misclassifying bacterial rhinosinusitis as viral, or vice-versa Benefits-harm assessment:Benefits-harm assessment: preponderance of benefit over harms preponderance of benefit over harms Value judgments:Value judgments: importance of avoiding inappropriate antibiotics for treatment of importance of avoiding inappropriate antibiotics for treatment of

viral or non-bacterial illness; emphasis on clinical signs and symptoms for initial viral or non-bacterial illness; emphasis on clinical signs and symptoms for initial diagnosis; importance of avoiding unnecessary diagnostic testsdiagnosis; importance of avoiding unnecessary diagnostic tests

Otolaryngol Head Neck Surg 2007; 137(Suppl):S1-S31Otolaryngol Head Neck Surg 2007; 137(Suppl):S1-S31

Classifying Recommendations for Practice GuidelinesClassifying Recommendations for Practice GuidelinesAAP Steering Committee on Quality Improvement and ManagementAAP Steering Committee on Quality Improvement and Management

Pediatrics 2004; 114:874-877Pediatrics 2004; 114:874-877

Action Statements as Behavior ConstraintsAction 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 Cross-sectional survey of 1,332 registrants of the 2008 annual AHRQ conference given a clinical scenario with recommendations and asked to conference given a clinical scenario with recommendations and asked to

rate the level of obligation they believe the authors intendedrate the level of obligation they believe the authors intended

Lomotan E, et al. How “should” we write guideline recommendations? Lomotan E, et al. How “should” we write guideline recommendations? Interpretation of deontic terminology. Qual Saf Health Care 2010;19:509-513Interpretation of deontic terminology. Qual Saf Health Care 2010;19:509-513

Clinicians may recommend tonsillectomy for recurrent throat infection with a Clinicians may recommend tonsillectomy for recurrent throat infection with a frequency of at leastfrequency of at least:: 7 episodes in the past year, or7 episodes in the past year, or 5 episodes per year in the preceding 2 years, or5 episodes per year in the preceding 2 years, or 3 episodes per year in the preceding 3 years,3 episodes per year in the preceding 3 years,

With With documentation in the medical recorddocumentation in the medical record for each episode of sore throat for each episode of sore throat and one or more of the following:and one or more of the following: temperature >38.3C (101F), ortemperature >38.3C (101F), or cervical adenopathy (tender or >2cm), orcervical adenopathy (tender or >2cm), or tonsillar exudate, ortonsillar exudate, or positive test for group A beta-hemolytic streptococcus.positive test for group A beta-hemolytic streptococcus.OptionOption based on systematic reviews and randomized controlled trials with based on systematic reviews and randomized controlled trials with minor limitations, with relative balance of benefit and harm. minor limitations, with relative balance of benefit and harm.

Otolaryngol Head Neck Surg 2011; 14(Suppl):S1-S30Otolaryngol Head Neck Surg 2011; 14(Suppl):S1-S30

Tonsillectomy in ChildrenTonsillectomy in ChildrenAAO-HNS Clinical Practice GuidelineAAO-HNS Clinical Practice Guideline

Clinicians may recommend tonsillectomy for recurrent throat infection with a frequency of at least 7 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 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: 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. T>38.3C, cervical adenopathy, tonsillar exudate, or positive test for group A beta-hemolytic streptococcus.

OptionOption based on systematic reviews and randomized controlled trials with minor limitations, with based on systematic reviews and randomized controlled trials with minor limitations, witha relative balance of benefit and harm. a relative balance of benefit and harm.

AAO-HNS Tonsillectomy Clinical Practice GuidelineAAO-HNS Tonsillectomy Clinical Practice Guideline

Evidence profile:Evidence profile: Aggregate evidence quality:Aggregate evidence quality: Grade B, randomized controlled trials with minor limitations Grade B, randomized controlled trials with minor limitations Benefits:Benefits: Modest reduction in the frequency and severity of recurrent throat infection for up to 2 years after 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 yearssurgery; modest reduction in frequency of group A streptococcal infection for up to 2 years Harms:Harms: Risk and morbidity of tonsillectomy including, but not limited to, pain and missed activity after Risk and morbidity of tonsillectomy including, but not limited to, pain and missed activity after

surgery, hemorrhage, dehydration, injury, and anesthetic complicationssurgery, hemorrhage, dehydration, injury, and anesthetic complications Cost:Cost: Cost of tonsillectomy; direct non-surgical costs (antibiotics, clinician visit) and indirect costs Cost of tonsillectomy; direct non-surgical costs (antibiotics, clinician visit) and indirect costs

(caregiver time, time missed from school) associated with recurrent infection.(caregiver time, time missed from school) associated with recurrent infection. Benefits-harm assessment:Benefits-harm assessment: Uncertain relationship of benefit to harm Uncertain relationship of benefit to harm Value judgments:Value judgments: : Importance of balancing the modest, short-term benefits of tonsillectomy in carefully : 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 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-threateningadverse events, which although infrequent, may be severe or life-threatening

Intentional vagueness:Intentional vagueness: None None Patient preference:Patient preference: Large role for shared decision-making in severely affected patients, given the favorable 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 natural history of recurrent throat infections and modest improvement associated with surgery; limited role in patients who do not meet strict indications for surgeryin patients who do not meet strict indications for surgery

Exclusions:Exclusions: None NoneOtolaryngol Head Neck Surg 2011; In pressOtolaryngol Head Neck Surg 2011; In press

Fowler RH. Tonsil Surgery. Philadelphia: F.A. Davis Company 1931Fowler RH. Tonsil Surgery. Philadelphia: F.A. Davis Company 1931

Classifying Recommendations for Practice GuidelinesClassifying Recommendations for Practice GuidelinesAAP Steering Committee on Quality Improvement and ManagementAAP Steering Committee on Quality Improvement and Management

Pediatrics 2004; 114:874-877Pediatrics 2004; 114:874-877

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

AAO-HNS Hoarseness Clinical Practice GuidelineAAO-HNS Hoarseness Clinical Practice Guideline

Evidence profile:Evidence profile: Aggregate evidence quality:Aggregate evidence quality: Grade B, randomized trials with limitations showing lack of Grade B, randomized trials with limitations showing lack of

benefits for anti-reflux therapy in patients with laryngeal symptoms, including hoarseness; benefits for anti-reflux therapy in patients with laryngeal symptoms, including hoarseness; observational studies with inconsistent or inconclusive results; inconclusive evidence observational studies with inconsistent or inconclusive results; inconclusive evidence regarding the prevalence of hoarseness as the only manifestation of reflux diseaseregarding the prevalence of hoarseness as the only manifestation of reflux disease

Benefits:Benefits: avoid unnecessary drugs and adverse events from unproven therapy avoid unnecessary drugs and adverse events from unproven therapy Harms:Harms: potential withholding of therapy from patients who may benefit potential withholding of therapy from patients who may benefit Cost:Cost: none none Benefits-harm assessment:Benefits-harm assessment: preponderance of benefit over harm preponderance of benefit over harm Value judgments:Value judgments: acknowledgment by the working group of the controversy surrounding acknowledgment by the working group of the controversy surrounding

laryngopharyngeal reflux, and the need for further research before definitive conclusions can laryngopharyngeal reflux, and the need for further research before definitive conclusions can be drawn; desire to avoid known adverse events from therapybe drawn; desire to avoid known adverse events from therapy

Intentional vagueness:Intentional vagueness: none none Patient preference:Patient preference: limited limited Exclusions:Exclusions: patients immediately before or after laryngeal surgery and patients with other patients immediately before or after laryngeal surgery and patients with other

diagnosed pathology of the larynxdiagnosed pathology of the larynxOtolaryngol Head Neck Surg 2009; 141(Suppl):S1-31Otolaryngol Head Neck Surg 2009; 141(Suppl):S1-31

Antoine Boivin, MD, PhD(c), G-I-N 6Antoine Boivin, MD, PhD(c), G-I-N 6 thth Conference, Lisbon, 11-09 Conference, Lisbon, 11-09

Consumer Involvement in GuidelinesConsumer Involvement in GuidelinesWhat are the Possibilities?What are the Possibilities?

Degree to which a recommendation permits interpretation and allows for alternatives in execution

Degree to which the recommendation proposes behaviors considered unconventional

Degree to which the recommendation reflects the intent of the developer and the strength of evidence

Degree to which the guideline identifies markers or endpoints to track the effects of implementation

Degree to which the recommendation is recognizable and succinct

Degree to which the recommendation impacts workflow in a typical case setting

Exactly what to do under the circumstances defined

Precisely under what circumstances to do something

Flexibility

Novelty / innovation

Apparent validity

Measurable outcomes

Presentation and formatting

Effect on process of care

Executability

Decidability

Is the Guideline Actionable?Is the Guideline Actionable?Guideline Implementability Appraisal (GLIA)Guideline Implementability Appraisal (GLIA)Yale Center for Medical InformaticsYale Center for Medical Informatics

BMC Med Informatics Decis Making 2005; 5:23-31BMC Med Informatics Decis Making 2005; 5:23-31

Guideline Statements Must Guideline Statements Must Be Actionable!Be Actionable!

Crafting an actionable guidelineCrafting an actionable guidelinerequires insight and planning:requires insight and planning:

1.1. Involve all stakeholdersInvolve all stakeholders

2.2. Narrow the focusNarrow the focus

3.3. Think quality improvementThink quality improvement

4.4. Use key action statementsUse key action statements

5.5. Develop evidence profilesDevelop evidence profiles

6.6. Get internal and external reviewGet internal and external review

7.7. ACTION, ACTION, ACTIONACTION, ACTION, ACTION

Thank you for your attention!Thank you for your attention!richrosenfeld@msn.comrichrosenfeld@msn.com