Clinical Practice Guidelines: Clinical Practice Guidelines Can t Live With Them; Can t Live Without Them

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1 Clinical Practice Guidelines: Can t Live With Them Can t Live Without Them Larry M. Lopez, Pharm.D., F.C.C.P. Professor Emeritus of Pharmacy & Medicine University of Florida College of Pharmacy Clinical Practice Guidelines Can t Live With Them; Can t Live Without Them Goals & Objectives 1. Describe extent of currently available clinical guidelines 2. Describe process(es) by which clinical guidelines are produced 3. Compare & contrast strengths and weaknesses of current clinical guidelines 1

2 Clinical Practice Guidelines Can t Live With Them; Can t Live Without Them Disclosures Stockholder: Pfizer, GlaxoSmithKline Biases 1. Can t Live With Them Guidelines are for those who don t treat patients 2. Can t Live Without Them Third Party Financial Support May Depend on Their Aggressive Application. Clinical Practice Guidelines What Are They? OFFICIALLY/IDEALLY Statements that include recommendations intended to optimize patient care that are informed by a systematic review of the evidence and an assessment of the benefits and harms of alternative care options. Institute of Medicine,

3 Clinical Practice Guidelines What Are They? PERCEPTION widely perceived as evidence based, not authority based, and, therefore, as unbiased and valid. Because they are sponsored by organizations, staffed by experts, and conducted according to apparently formal processes, the products of the exercise, the guidelines, are generally assumed to have the same level of certainty and security as conclusions generated by the conventional scientific method. For many clinicians, guideline have become the final arbiters of care. JAMA 2009;301: Clinical Practice Guidelines What Are They? 3

4 Clinical Practice Guidelines What Are They? Clinical Practice Guidelines What s Out There? Featured Prophylaxis Pain HIV and More Infection CAP HAI Prevention MRSA and More Cardiology UA/NSTEMI Atrial Fib Stroke and More Metabolism Diabetes Hyperglycemia Lipids and More 4

5 Clinical Practice Guidelines What s Out There? Allergy/Immunology 8 Otolaryngology 4 Cardiovascular 20 Pain 3 Dermatology 2 Pediatrics 0 Endocrinology 11 Podiatry 1 Gastroenterology 7 Psychiatry 2 Gen l Practice 0 Pulmonology 4 Hematology 5 Rheumatology 0 Infectious Diseases 27 Sleep Med 1 Neurology 10 Surgery 4 Oncology 1 Urology 0 GRAND TOTAL 110!! Clinical Practice Guidelines How Good Are They? JAMA 2006;295: ; Rev Cardiovasc Med 2003;4 Suppl 7:S21 S30 CRUSADE (Can Rapid Risk Reduction of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of ACC/AHA Guidelines?) 10% Reduction in in hospital mortality for very 10% increase in adherence to Class I ACC/AHA Guidelines ADHERE (Acute Decompensated Heart Failure National Registry) Significant reduction in in hospital mortality and LOS when patients were treated according to HF performance indicators 5

6 Clinical Practice Guidelines Are They Utilized? JAMA 1999;282: Why Don t Physicians Follow Clinical Practice Guidelines Objective: Review barriers to MD adherence to CPGs Data Sources: MEDLINE Search Study Selection: 76 pubs describing 1 barrier Results: 120 different surveys with 293 potential barriers Clinical Practice Guidelines Are They Utilized? JAMA 1999;282: Why Don t Physicians Follow Clinical Practice Guidelines Results (cont d) 57%: 0 89% 1 91% 26%: 8 90% 10% (Median:Range) 13%: 1 65% 54%: 1 84% 42%: 23 66% 6

7 Clinical Practice Guidelines What Are Their Limitations? JAMA 2009; CPG Committee Conflict(s) of Interest or Relations with Industry Retrospective Out of date (?) Lack of Independent Review Absence of Controversies Absence of co morbidities Extreme Reading Absence of Patient Input Variable Methodology Clinical Practice Guidelines What Are Their Limitations? The CPG Committee Mandate, membership, & dissemination emanates from Professional Organizations No rules for membership on CPG Committee Under representation of patients, epidemiologists, economists Promoter and defender of resultant CPG 7

8 Clinical Practice Guidelines What Are Their Limitations? Conflict of Interest Types: Intellectual or Financial Perception: Questionable validity & reliability of CPGs since they are written by individuals with perceived COI Relationship(s) with Industry (RWI) Reality: No evidence to confirm or deny perception Absence of experts would undermine credibility Nearly 90% of CPG authors have some form of RWI Fewer than half of CPGs provide this info Service on a CPG Committee is time consuming Clinical Practice Guidelines What Are Their Limitations? Retrospective/Out of Date (?) JNC VII 2003; JNC VIII (?) 2014 ACC/AHA 4.6 to 8.2 years Absence of formal procedures for updating 8

9 Clinical Practice Guidelines What Are Their Limitations? Lack of Independent Review Peer Review Frequently published as submitted Clinical Practice Guidelines What Are Their Limitations? Absence of Co Morbidities/Controversies Patients seldom have single disease Management of such complexity is absent from most CPGs Rarely is a CPG useful for actual individualization of patient care Greatest need for guidance where evidence is lacking or is controversial Lack of quality studies 9

10 Clinical Practice Guidelines What Are Their Limitations? Extreme Reading Too many 10 different adult pharyngitis CPGs Current Chest Guidelines weigh 3½ pounds!! Unanimity in CPGs Unrealistic expectation Contradictory Recommendations LDL vs Apo B as marker of vascular disease Clinical Practice Guidelines What Are Their Limitations? Absence of Patient Input Refers to: 1. patient perspective(s), beliefs, expectations, & goals 2. processes used to consider potential benefits, harms, costs, inconveniences of mgt options Unanswered questions 1. Who should be invited? Gen l public? Patients? Care givers? 2. How would they provide input? 3. Patient perspective vs Clinician perspective? 4. Tokenism? 10

11 Clinical Practice Guidelines What Are Their Limitations? Variable Methodology Over reliance on expert opinion 48% of recommendations based on level C evidence (expert opinion, case studies) Guidelines vs Expert Consensus Reports Use of Clinical Trials vs Meta Analyses vs Case Reports Lack of Independent Review Frequently published as is Clinical Practice Guidelines Making Them Better? Standard 1 Establish Transparency Standard 2 Mgt of Conflict of Interest Standard 3 Development Group Composition Standard 4 Systematic Review Standard 5 Strength of Recommendations Standard 6 Articulation of Recommendations Standard 7 External Review Standard 8 Updating Graham R, Mancher M, Wolman, DM et al. Committee on Standards for Development of Trustworthy Clinical Practice Guidelines; Board on Health Care Services. Clinical Practice Guidelines We Can Trust. Washington, D.C.: National Academies Press,

12 Clinical Practice Guidelines Making Them Better? Institute of Medicine 1. Transparency explicit description & public accessibility of CPG development 2. Conflict of Interest Disclosure of GDG members Divestment (?) Exclusion (?) 3. GDG Composition Multidisciplinary Clinicians, Methods Experts Patients, Public 4. Systematic (Peer) Review Clinical Practice Guidelines Making Them Better? Institute of Medicine 5. Strength of Recommendations Benefits & Harms (qualitative, quantitative) Relevant Evidence & Gaps Ratings of confidence, strength AWA explanation 6. Recommendations 7. External Review Relevant stakeholders (scientific, clinical experts, agencies, patients, & public) 8. Updating Date of Future Update(s) Regular monitoring of relevant literature update when new evidence suggests the need 12

13 Failure of Clinical Practice Guidelines to Meet IOM Standards Arch Int Med : Methods Review of 114 Separate Guidelines Comparison with current IOM Standards (N = 18) Comparison with a previous survey (JAMA 1999; 281: ) Failure of Clinical Practice Guidelines to Meet IOM Standards Results Arch Int Med :

14 Failure of Clinical Practice Guidelines Conclusions Arch Int Med : Analysis of a random sample of clinical practice guidelines archived on the NGC website as of June 2011 demonstrated poor compliance with IOM standards, with little if any improvement over the past 2 decades Clinical Practice Guidelines The Missing Piece? Circ 2013;127: Implementation 14

15 Clinical Practice Guidelines A New Perception? Clinical Practice Guidelines The ACC/AHA Story First one Guidelines for permanent cardiac pacemaker implantation, May 1984: A report of the Joint American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovascular Procedures (Subcommittee on Pacemaker Implantation) Circulation 1984;70:331A 339A Subsequently 23 CPGs Recently updated the process based on recommendations from IOM 15

16 Clinical Practice Guidelines The ACC/AHA Process Task Force on Practice Guidelines Continuous oversight & direction of CPG development process & methodology Selection of topic New, Revised, or Update Selection of Guideline Writing Committee (GWC) Chair, Members RWI, Practitioners, Age, Race, Sex, Ethnicity, Lay Rep (pts, consumer orgs) Clinical Practice Guidelines The ACC/AHA Process The Guideline Writing Committee (GWC) Outline document content Perform detailed & specific evidence acquisition & review Input from Evidence Review Committee (ERC) Separate and distinct Draft recommendations Based on strength and quality of evidence Ratified by majority vote (those with relevant RWI are recused) Finished document then undergoes extensive peer review 16

17 The AHA/ACC Process Class (Strength) of Recommendations Clinical Practice Guidelines The ACC/AHA Process The Evidence Review Committee (ERC) oincludes biostaticians, methodologists, epidemiologists, clinicians otasked with a formal systematic review of evidence, identification, abstraction, and quality assessment of evidence 17

18 The ACC/AHA Process Peer Review 18

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