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Making Guidelines Actionable

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.

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Making Guidelines Actionable

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  1. 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

  2. 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

  3. Begin with the End in Mind Habit #2, Stephen Covey Covey S. The 7 Habits of Highly Effective People. Fireside Press, 1989

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

  5. American Academy of OtolaryngologyHead and Neck Surgery (AAO-HNS) Guidelines as Springboards for Quality Improvement BestMethods + BestEvidence + BestConsensus Best (Actionable) Practice

  6. 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

  7. 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

  8. Diagnosis & Management of Sinusitis:A Practice Parameter Update Slavin et al, J All Clin Immunol 2005 • 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” 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. J All Clin Immunol 2005; 116(Suppl): S13-S47

  9. Action Gather Interpret Perform Dispose Test Conclude Prescribe Procedure Educate Consult Monitor Advocate Document Prepare Guidelines ARE NOT Review Articles! Guidelines contain key statements that are action-oriented prescriptions of specific behavior from a clinician

  10. 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.

  11. 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

  12. Quality-Driven Guideline Development • Define topic and scope • Create a list of quality improvement topics and opportunities, independent of presumed evidence level

  13. Ranked Topic List for Sudden Hearing Loss Guideline

  14. 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

  15. Quality Improvement Opportunities • Promote appropriate care • Reduce inappropriate or harmful care • Reduce variations in delivery of care • Improve access to care • Facilitate ethical care • Educate & empower clinicians & patients • Facilitate coordination & continuity of care • 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

  16. Quality-Driven Guideline Development • Define topic and scope • Create a list of quality improvement topics and opportunities, independent of presumed evidence level • Refine list based on existing guidelines, systematic reviews, and randomized trials • Prioritize topics and draft key action statements

  17. 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 testingin 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

  18. Forbes Magazine – November 30, 2009

  19. Action Palate for Guideline Recommendations Essaihi et al, AMIA Ann Symp Proc 2003; 220-4 Never use the word CONSIDER to describe an action!

  20. Quality-Driven Guideline Development • Define topic and scope • Create a list of quality improvement topics and opportunities, independent of presumed evidence level • Refine list based on existing guidelines, systematic reviews, and randomized trials • Prioritize topics and draft key action statements • Use evidence profiles to refine statements and determine corresponding strength of action

  21. 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: • Encourage an explicit and transparent approach to guideline writing • Force guideline developers to discuss and document the decision making process • Create “organizational memory” to avoidre-discussing already agreed upon issues • Allow guideline users to rapidly understand how and why statements were developed • Facilitate identifying aspects of guideline best suited to performance assessment

  22. AAO-HNS Adult Sinusitis Clinical Practice Guideline • 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

  23. Classifying Recommendations for Practice Guidelines AAP Steering Committee on Quality Improvement and Management Pediatrics 2004; 114:874-877

  24. Obligation level MUST or SHOULD SHOULD MAY 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 Action Statements as Behavior Constraints Policy strength Implication for clinicians Strong recommendation Follow unless a clear and compelling rationale for alternative approach exists Recommendation Generally follow a recommendation, but remain alert to new information Option Be flexible in decision making regarding appropriate practice, although bounds may be set on alternatives

  25. 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. Tonsillectomy in Children AAO-HNS Clinical Practice Guideline Otolaryngol Head Neck Surg 2011; 14(Suppl):S1-S30

  26. 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, 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

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

  28. Classifying Recommendations for Practice Guidelines AAP Steering Committee on Quality Improvement and Management Pediatrics 2004; 114:874-877

  29. 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

  30. Consumer Involvement in Guidelines What are the Possibilities? Antoine Boivin, MD, PhD(c), G-I-N 6th Conference, Lisbon, 11-09

  31. Decidability Precisely under what circumstances to do something Executability Exactly what to do under the circumstances defined Effect on process of care Degree to which the recommendation impacts workflow in a 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 Is the Guideline Actionable? Guideline Implementability Appraisal (GLIA)Yale Center for Medical Informatics BMC Med Informatics Decis Making 2005; 5:23-31

  32. 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@msn.com

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