Clinical Practice Guideline Development Serving on Guideline Panels Peter Robertson, MPA Analyst, Research and Quality Improvement, American Academy of Otolaryngology-Head and Neck Surgery Barbara Warren National Coalition for LGBT Health
AAO-HNS Clinical Practice Guideline Development Process http://www.entnet.org
National Guideline Clearinghouse http:www.guidelines.gov Summary Usage Report 1/1/2010 - 12/31/2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation Title Date Released to NGC # of Page Views Clinical Practice Guideline: Acute Otitis Externa 7/14/2006 11,907 Clinical Practice Guideline: Adult Sinusitis 8/22/2008 12,706 Clinical Practice Guideline: Benign Paroxysmal Positional Vertigo 4/17/2009 10,572 Clinical Practice Guideline: Cerumen Impaction 4/17/2009 7,745 Clinical Practice Guideline: Hoarseness (dysphonia) 4/23/2010 7,042 49,972 A page view represents the first time a summary is viewed during a session
Impetus for Developing Guidelines Rising costs of healthcare Practice Variation $ $
Clinical Practice Guideline Development: A Quality-Driven Approach for Translating Evidence into Action
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
Rosenfeld & Shiffman, Otolaryngol Head Neck Surg 2009; 140(Suppl):S1-43
The Guideline Development Process Institute of Medicine of the National Academies http://iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Press-Release.aspx
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
Statement 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. 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 <38.3 O C or 101 O F) 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 Action Statement of Fact
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
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.
Key Action Statements on Benign Paroxysmal Positional Vertigo (BPPV) Bhattacharyya et al, Otolaryngol Head Neck Surg 2008; 139(Suppl):S47-81 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
Action Palate for Guideline Recommendations Never use the word CONSIDER to describe an action! 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
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
Classifying Recommendations for Practice Guidelines AAP Steering Committee on Quality Improvement and Management Pediatrics 2004; 114:874-877
Action Statements as Behavior Constraints 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; In press.
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.
AAO-HNS Tonsillectomy Clinical Practice Guideline
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
Otolaryngol Head Neck Surg 2011; In press
Pediatrics 2004; 114:874-877 Classifying Recommendations for Practice Guidelines AAP Steering Committee on Quality Improvement and Management
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.
AAO-HNS Hoarseness Clinical Practice Guideline
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
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
Is the Guideline Actionable? Guideline Implementability Appraisal (GLIA) Yale Center for Medical Informatics BMC Med Informatics Decis Making 2005; 5:23-31