Rapid Guideline Development For Professional Medical Associations. Richard Rosenfeld, SUNY Downstate Stephanie Jones, AAO-HNSF

Transcription

1 Rapid Guideline Development For Professional Medical Associations Richard Rosenfeld, SUNY Downstate Stephanie Jones, AAO-HNSF

2 Rapid Guideline Development For Professional Medical Associations Learning Objectives Recognize characteristics of trustworthy guidelines Understand principles of rapid & efficient guideline development Identify strategies for conflict prevention and resolution Competing Interests Richard Rosenfeld: Journal Editor AAO-HNSF Stephanie Jones: Director Research & Quality AAO-HNSF

3 Who are we? 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 EMPOWERING PHYSICIANS TO DELIVER THE BEST PATIENT CARE

4 AAO-HNSF Staffing (4 FTE) 0.5 FTE Stephanie Jones, BS, Director, Research & Quality Improvement 0.5 FTE Gene Cunningham, MS, Senior Manager, Quality Measurement/Nat l Coalitions 1 FTE Leslie Caspersen, MBA, Senior Manager, Guideline Dissemination & Implementation 1 FTE Maureen D Antuono Corrigan, BA, Analyst 1 FTE Vacant, Analyst AAO-HNSF Volunteers Richard M. Rosenfeld, MD, MPH, Methodologist & Sr. Advisor Quality & Guideline Seth R. Schwartz, MD, MPH, Methodologist & Chair, Guideline Task Force Sujana S. Chandrasekhar, MD, Methodologist

5 AAO-HNSF Guideline Usage Summary The following table contains the cumulative number of page views for each AAO-HNSF guideline listed on the National Guideline Clearinghouse (NGC) website from the time the guideline was posted to the NGC through June 2013 Title Date released Page views Clinical Practice Guideline: Acute Otitis Externa 7/14/ ,288 Clinical Practice Guideline: Adult Sinusitis 8/22/ ,861 Clinical Practice Guideline: Benign Paroxysmal Positional Vertigo 4/17/ ,068 Clinical Practice Guideline: Cerumen Impaction 4/17/ ,974 Clinical Practice Guideline: Hoarseness (dysphonia) 4/23/ ,771 Clinical Practice Guideline: Tonsillectomy in children 3/15/ ,246 Clinical Practice Guideline: Polysomnography for Sleep Disordered Breathing Prior to Tonsillectomy in Children 12/1/ ,824 Clinical Practice Guideline: Sudden Hearing Loss 4/1/ ,305 Clinical Practice Guideline: Improving Voice Outcomes after Thyroid Surgery 6/1/2013 * Clinical Practice Guideline: Tympanostomy Tubes in Children 7/1/2013 * * Submitted to the NGC, but not yet posted TOTAL 319,337

6 Rapid Guideline Development For Professional Medical Associations Have a plan and follow it

7 Learn from Others: Conferences, Workshops, Webinars, Publications AAO-HNSF G-I-N Scholars Training Program

8 Francis Bacon, Sr. English lawyer and philosopher, Reading maketh a full man; Conference a ready man; and writing an exact man. Rosenfeld s addendum: Publishing and postpublication peer review maketh a wise man.

9 Clinical Practice Guideline Development Manual: Third Edition Rosenfeld, Shiffman, and Robertson Pragmatic, transparent approach to creating guidelines for performance assessment Evidence-based, multidisciplinary process leading to publication in months Emphasizes a focused set of key action statements to promote quality improvement Uses action statement profiles to summarize decisions in recommendations Otolaryngol Head Neck Surg 2013; 148(Suppl):S1-55

10 AAO-HNS CPG Manual, 3 rd ed. Otolaryngol Head Neck Surg 2013; 148(Suppl):S3

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12 Standards for Developing Trustworthy Clinical Practice Guidelines Standard 1. Transparency 1.1 The processes by which a CPG is developed and funded should be detailed explicitly and publicly accessible

13 Clinical Practice Guideline Development Manual: Third Edition

14 Rapid Guideline Development For Professional Medical Associations Have a plan and follow it Get the right people on the bus

15 Who s on Your Guideline Bus? Most people assume that great bus drivers (read: business leaders) immediately start the journey by announcing to the people on the bus where they re going by setting a new direction or by articulating a fresh corporate vision. In fact, leaders of companies that go from good to great start not with where but with who. They start by getting the right people on the bus, the wrong people off the bus, and the right people in the right seats. Jim Collins. Good to Great New York: Harper Business 2001

16 Keeping the Wrong People Off the Bus Standard 2. Conflict of Interest 2.1 Guideline development group (GDG) members should declare all interests 2.2 All COIs should be disclosed and discussed within the GDG 2.4 Chair should not have a COI, only a minority of members should have COI, funders have no role in CPG development

17 Intellectual Conflict of Interest a.k.a. Anti-Rapid CPG Development Poison Pill Academic activities that create the potential for an attachment to a specific point of view that could unduly affect an individual s judgment Guyatt Research, publications, or grant support related to the guideline Being a chair or member of a related guideline committee Membership in a related lobbying or advocacy organization Leadership in a group that may gain from a guideline development group member s opinion Acting as an expert witness or having membership in a related advisory or governing board with other organizations or funders Family members with the target condition Graham R, CPGs We Can Trust, IOM 2011 Norris SL, PloS ONE 2011; 6:e25153 and Guyatt G, Intern Med 2010; 152:

18 Getting the Right People on the Bus Standard 3. Guideline Development Group (GDG) Composition 3.1 The GDG should be multidisciplinary and balanced, comprising a variety of methodological experts and clinicians, and populations expected to be affected by the guideline.

19 Multidisciplinary Guideline Panels Why Bother to Diversify? Increases the probability that all relevant scientific evidence will be located and critically evaluated Increases the chances that the panel will address practical problems relating to application of the guidelines Helps build support among the groups for whom the guideline is intended May produce more reliable results by balancing biases of the various individuals on the panel Shekelle et al. Clinical guidelines: developing guidelines. BMJ 1999; 318:593-6 Institute of Medicine. Clinical practice guidelines. Washington DC: Nat l Academy Press, 1990

20 Guideline Development Group Composition AAO-HNS CPG Manual, 3 rd ed. Otolaryngol Head Neck Surg 2013; 148(Suppl):S10

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

22 Consumer Involvement in Guidelines What are the Possibilities? What do Consumers contribute to GDGs? Common Sense Perspective Skepticism Respect for harms Patient education Shared decisions

23 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

24 Begin with the End in Mind Habit #2, Stephen Covey Consumers Consumers do not have to be content experts! (the same applies to clinicians of whom experts should be a minority)

25 AAO-HNS Guideline Panels Principles for Rapid Guideline Development Avoid surprises and sabotage by ensuring that all stakeholders are represented on the guideline development group Identify participants who are qualified to represent their constituency and communicate with leadership Ensure that participants truly understand their role and represent their constituency (beware of experts ) Schedule dates and times for calls and meetings in advance, and make availability a prerequisite of participation Promote ownership through authorship, including staff

26 Rapid Guideline Development For Professional Medical Associations Have a plan and follow it Get the right people on the bus Keep the scope manageable

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

28 Keeping Guideline Scope Manageable Principles for Rapid Guideline Development Discuss purpose before scope: Why was the topic picked? What are the QI goals? What is the intended impact? Define target condition (procedure), target patient, intended audience and practice settings, outcomes Acknowledge that some issues important to some stakeholders will inevitably be left out of the guideline Move from broad topics to answerable questions

29 Ranked Topic List for AAO-HNS Guideline on Voice Outcomes after Thyroid Surgery

30 Standards for Developing Trustworthy Clinical Practice Guidelines Standard 4. Systematic Reviews 4.1 CPG developers should use systematic reviews that meet IOM standards. 4.2 When reviews are conducted specifically to inform particular guidelines, the GDG and systematic review team should interact regarding the scope, approach, and output of both processes.

31 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. 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.

32 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

33 Rapid Guideline Development For Professional Medical Associations Have a plan and follow it Get the right people on the bus Keep the scope manageable Make group time productive

34 Group Facilitation Principles for Rapid Guideline Development Have an agenda, follow it, and appoint a time keeper; focus on issues requiring group interaction and exchange Remind group members they are representing a specific point or view or discipline, not serving as an official spokesperson Encourage all to contribute; use round-robin when necessary Beware of unbridled passion (and potential intellectual conflicts) from experts & leaders Defer discussions to a later time if an impasse is reached (lets passion cool and reason return)

35 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.

36 Key Action Statement Clear Methodology and Format Facilitates Group Consensus Action Statement Profile Supporting & Amplifying Text

37 Standards for Developing Trustworthy Clinical Practice Guidelines Standard 5. Evidence Foundations 5.1 For each recommendation provide: Clear description of benefits & harms Quality, quantity, and consistency of the available aggregate evidence Role of values, opinion, theory, and clinical experience in deriving the recommendation Rating of confidence in the evidence Rating of the strength of recommendation Explanation of any differences of opinion

38 Rosenfeld RM, et al. CPG: Tympanostomy Tubes in Children. Otolaryngol HNS 2013; 149:S1-35

39 Key action statement with recommendation strength and justification Supporting text for key action statement Action statement profile: 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: 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

40 Executive Summary: Tympanostomy Tubes in Children. Otolaryngol HNS 2013; 149:8-16

41 Building Better Guidelines with BRIDGE-Wiz Shiffman Rosenfeld et al, JAMIA 2012 Description of a software assistant for structured action statement creation to promote clarity, transparency and implementability 1. Choose an action type 2. Choose a verb 3. Define the object for the verb 4. Add actions 5. Check executability 6. Define conditions for the action 7. Check decidability 8. Describe benefits, risks, harms & costs 9. Judge the benefit-harms balance 10. Select aggregate evidence quality 11. Review proposed strength of recommendation and level of obligation 12. Define the actor 13. Choose recommendation style 14. Edit the final statement J Am Med Inform Assoc 2002; 19:

42 Aristotle Philosopher, Scientist, Physician BC It is the mark of an educated mind to rest satisfied with the degree of precision which the nature of the subject admits and not to seek exactness where only an approximation is possible.

43 Adapted from GRADE

44 AAO-HNS CPG Manual, 3 rd ed. Otolaryngol Head Neck Surg 2013; 148(Suppl):S40

45 Rapid Guideline Development For Professional Medical Associations Have a plan and follow it Get the right people on the bus Keep the scope manageable Make group time productive Plan for efficient review

46 Internal Guideline Review Guideline Implementability Appraisal (GLIA) Yale Center for Medical Informatics Decidability Executability Effect on process of care Presentation and formatting Measurable outcomes Apparent validity Novelty / innovation Flexibility Precisely under what circumstances to do something Exactly what to do under the circumstances defined Degree to which the recommendation impacts workflow in a typical case setting Degree to which the recommendation is recognizable and succinct Degree to which the guideline identifies markers or endpoints to track the effects of implementation Degree to which the recommendation reflects the intent of the developer and the strength of evidence Degree to which the recommendation proposes behaviors considered unconventional Degree to which a recommendation permits interpretation and allows for alternatives in execution BMC Med Informatics Decis Making 2005; 5:23-31

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48 Standards for Developing Trustworthy Clinical Practice Guidelines Standard 7. External Review 7.1 External reviewers should comprise a full spectrum of relevant stakeholders, including scientific and clinical experts, organizations, agencies, patients, and representatives of the public. 7.3 The GDG should consider all external reviewer comments and keep a written record of the rationale for modifying or not modifying a CPG in response to comments.

49 Written Record of Reviewer Comment Disposition

50 External Review of Draft Guideline Principles for Rapid Guideline Development Identify reviewers through organizational outreach; must include all relevant stakeholders Reviewers complete COI and confidentiality forms; informed in advance of strict date for comment submission Ensure understanding of the process: comment disposition, differences from standard peer-review, feedback to reviewers Staff collate and organize all comments into a master grid with reviewer names removed Chair and assistant chairs triage comments with group review

51 AAO-HNS CPG Manual, 3 rd ed. Otolaryngol Head Neck Surg 2013; 148(Suppl):S50

52 Additional External Review Public Comment Board of Directors Journal Peer- Review Final CPG

53 Oliver Wendell Holmes, Jr. US Supreme Court Justice, Certitude is not the test of certainty. We have been cocksure of many things that were not so.

54 Rapid Guideline Development For Professional Medical Associations Have a plan and follow it Get the right people on the bus Keep the scope manageable Make group time productive Plan for efficient review richrosenfeld@msn.com SLJones@entnet.org