Consumer Involvement in Guideline Development Why Every Guideline Needs It Richard M. Rosenfeld, MD, MPH Professor and Chairman of Otolaryngology, SUNY Downstate Senior Consultant for Guidelines and Quality, AAO-HNS Chair Emeritus, Guidelines Int’l Network – North America

EMPOWERING PHYSICIANS TO DELIVER THE BEST PATIENT CARE The American Academy of Otolaryngology— Head and Neck Surgery (AAO-HNS) is the world's largest organization representing specialists who treat the ear, nose, throat, and related structures of the head and neck. The Academy represents more than 12,000 otolaryngologist—head and neck surgeons who diagnose and treat disorders of those areas. Headquarters in Alexandria, VA Who are we?

Guideline title Date released Page views (NGC) 8/14 Citations (GS) 8/14 Acute otitis externa7/14/06 102, Adult sinusitis8/22/08 61, Cerumen impaction4/17/09 49,35366 Benign paroxysmal positional vertigo4/17/09 57, Hoarseness (dysphonia)4/23/10 46, Tonsillectomy in children3/15/11 48, PSG for SDB prior to tonsillectomy in children12/1/11 32,32463 Sudden hearing loss4/1/12 42, Improving voice outcomes after thyroid surgery6/1/13 8,44527 Tympanostomy tubes in children7/1/13 8,66234 Bell’s palsy11/4/13 6,0439 TOTAL 464,2421,663 AAO-HNS Guideline Usage Summary National Guideline Clearinghouse & Google Scholars

Institute of Medicine 2001 – 83 Standards 20 Standards

Standards for Developing Trustworthy Clinical Practice Guidelines Standard 3. Guideline Development Group (GDG) Composition 3.2 Patient and public involvement should be facilitated by including (at least at the time of clinical question formulation and draft CPG review) a current or former patient, and a patient advocate or patient/consumer organization representative in the GDG

Ann Intern Med 2012; 156:

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

Begin with the End in Mind Consumers do not have to be content experts! (the same applies to clinicians) Habit #2, Stephen Covey X Consumers

The clinician should advocate for pain management after tonsillectomy and educate caregivers about the importance of managing and reassessing pain. The clinician should advocate for pain management after tonsillectomy and educate caregivers about the importance of managing and reassessing pain. The clinician should educate the patient about the potential impact of thyroid surgery on voice once a decision has been made to have surgery. The clinician should educate the patient about the potential impact of thyroid surgery on voice once a decision has been made to have surgery. Clinicians should educate patients with idiopathic sudden sensorineural hearing loss about the natural history of the condition, the benefits and risk of interventions, and the limitations of existing evidence regarding efficacy. Clinicians should educate patients with idiopathic sudden sensorineural hearing loss about the natural history of the condition, the benefits and risk of interventions, and the limitations of existing evidence regarding efficacy. In the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications. In the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications. Clinicians should inform patients how to administer topical drops for acute otitis externa (swimmer’s ear). Clinicians should inform patients how to administer topical drops for acute otitis externa (swimmer’s ear). Source: AAO-HNS Clinical Practice Guidelines AAO-HNS Guideline Action Statements with Strong Consumer Influence

Post-Tonsillectomy Pain Management 1.Throat pain is greatest the first few days and may last up to 2 weeks 2.Encourage your child to tell you if he or she has throat pain since pain may not always be expressed or recognized promptly 3.Make sure your child drinks plenty of fluids after surgery. Staying well hydrated is associated with less pain. 4.Ibuprofen can be used safely for pain control after surgery. 5.Many clinicians recommend not waiting until your child complains of pain. Instead, the pain medication should be given on a regular schedule. 6.Expect your child to complain more about pain in the mornings; this is normal. Call your health care provider if you are unable to adequately control your child’s pain. Education for Caregivers AAO-HNS Tonsillectomy CPG. Otolaryngol Head Neck Surg 2011; 14(Suppl):S1-S30

Clinical Infectious Diseases Advance Access, September 9, 2012

Sir William Osler Canadian Physician, Common sense in medical matters is rare, and is usually in inverse ratio to the degree of education.

What do Consumers contribute to GDGs? Consumer Involvement in Guidelines What are the Possibilities? PassionPerspectiveSkepticism Respect for harms Patient education Shared decisions

Arch Intern Med 2012; doi: /2013.jamaintermed.56

Barriers to Capacious, Non-Foreclosed Thought Lack of Time Habits and Routines Narrow Range of Thought Fear of Novelty & Uncertainty Rita Charon, MD, PhD Director, Narrative Medicine Program, Columbia, University Foreclosed = rule out or prevent (a course of action)

Policy Statements as Behavior Constraints Pediatrics 2004; 114: Policy strengthImplication for cliniciansPt. preference Strong recommendation Follow unless a clear and compelling rationale for alternative approach is present Limited role RecommendationGenerally follow a recommendation, but remain alert to new information Should be considered OptionBe flexible in decision making regarding appropriate practice, although bounds may be set on alternatives Substantial influencing role No recommendation Feel little restraint in decision making and be alert to new published evidence that clarifies the balance of benefit vs. harm Substantial influencing role

Action Statement Profiles and Guideline Development 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 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 Key action statement with recommendation strength and justification Action statement profile:  QI opportunity:  Aggregate evidence quality:  Confidence in evidence:  Benefit:  Risk, harm, cost:  Benefit-harm assessment:  Value judgments:  Intentional vagueness:  Role of patient preferences:  Differences of opinion:  Exclusions:

EMPOWERING PHYSICIANS TO DELIVER THE BEST PATIENT CARE Recurrent Acute Otitis Media (AOM) with Middle Ear Effusion (MEE) Clinicians should offer bilateral tympanostomy tube insertion in children with recurrent AOM who have unilateral or bilateral MEE at the time of assessment for tube candidacy. Recommendation based on RCTs with minimal limitations and a preponderance of benefit over harm. Benefits: Mean decrease of about 3 episodes of AOM per year; ability to treat future episodes with topical antibiotics instead of systemic; reduces pain with future AOM Level of confidence in evidence: Medium; some uncertainty regarding the magnitude of clinical benefit, because of heterogeneity in the design and outcomes of trials Value judgments: In addition to the benefits seen in RCTs, the presence of effusion at the time of assessment served as a marker of diagnostic accuracy for AOM Role of patient preferences: Substantial role for shared decision making regarding the decision to proceed with, or to decline, tympanostomy tube insertion Otolaryngol Head Neck Surg 2013; 149(Suppl):S1-35 Tympanostomy Tube CPG

Plain Language Guideline Summaries 1.Statement of purpose 2.Description of how guideline was developed and to whom it applies 3.Definitions, diagnostic criteria, natural history, prognosis 4.Summary of key action statements (recommendations) 5.Decision aids, especially when role for shared decisions is significant 6.Comparisons of harms and benefits for main treatment alternatives 7.Instruction aids, self-care advice 8.Information to help patients navigate the health care system What Belongs in Patient and Consumer Versions? Inspired by: Santesso NAM. Dissemination of Clinical Practice Guidelines to Patients and the Public. Graduate Thesis; McMaster University, 2014

Thank You for Your Kind Attention! Richard M. Rosenfeld, MD, MPH – An Educated Consumer…Can be the Best Member of a Guideline Development Group The challenge is now for the medical profession to…develop alliances with consumers to move forward toward a wider recognition of the uncertainty and weaknesses of medicine and the biases in the process of setting research priorities. Alessandro Liberati BMJ 1997; 315:499