10/27/2014 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
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Can’t Live With Them Can’t Live Without Them 2 Clinical Practice Guidelines ‐Can’t Live With Them; Can’t Live Without Them Disclosures ‐Stockholder: Pfizer, GlaxoSmithKline
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Transcript
10/27/2014
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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
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Clinical Practice Guidelines ‐ Can’t Live With Them; Can’t Live Without Them
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, 2011
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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;301:429‐431
Clinical Practice Guidelines – What Are They?
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Clinical Practice Guidelines – What Are They?
Clinical Practice Guidelines – What’s Out There?
Featured
‐Prophylaxis
‐Pain
‐HIV
‐and More
Cardiology
‐UA/NSTEMI
‐Atrial Fib
‐Stroke
‐and More
Metabolism
‐Diabetes
‐Hyperglycemia
‐Lipids
‐and More
Infection
‐CAP
‐HAI Prevention
‐MRSA
‐and More
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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;295:1912‐1920; 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
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Clinical Practice Guidelines – Are They Utilized?JAMA 1999;282:1458‐1465
“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;282:1458‐1465
“Why Don’t Physicians Follow Clinical Practice Guidelines” – Results (cont’d)
57%: 0‐89%
54%: 1‐84%
1‐91%
26%: 8‐90%
13%: 1‐65%
42%: 23‐66%
≥ 10%
(Median:Range)
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Clinical Practice Guidelines – What Are Their Limitations?JAMA 2009;301‐429‐431
CPG Committee
Conflict(s) of Interest
or Relations with Industry
RetrospectiveOut of date (?)
Lack of Independent Review
Absence of ControversiesAbsence 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
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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
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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
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Clinical Practice Guidelines – What Are Their Limitations?
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 questions1. Who should be invited?
Gen’l public? Patients? Care givers?
2. How would they provide input?
3. Patient perspective vs Clinician perspective?
4. Tokenism?
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Clinical Practice Guidelines – What Are Their Limitations?
Variable Methodology
Over reliance on expert opinion48% 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 ReviewFrequently published as is
Clinical Practice Guidelines – Making Them Better?
Standard 1 ‐ Establish TransparencyStandard 2 ‐Mgt of Conflict of InterestStandard 3 ‐ Development Group Composition Standard 4 ‐ Systematic Review
Standard 5 ‐ Strength of RecommendationsStandard 6 ‐ Articulation of RecommendationsStandard 7 ‐ External ReviewStandard 8 ‐ Updating
Graham R, Mancher M, Wolman, DM et al. Committee on Standards for Development of Trustworthy ClinicalPractice Guidelines; Board on Health Care Services. Clinical Practice Guidelines We Can Trust. Washington, D.C.:National Academies Press, 2011
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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
Failure of Clinical Practice Guidelines to Meet IOM StandardsArch Int Med 2012 172:1628‐1633
Methods
• Review of 114 Separate Guidelines
• Comparison with current IOM Standards (N = 18)
• Comparison with a previous survey (JAMA 1999; 281: 1900‐1905)
Failure of Clinical Practice Guidelines to Meet IOM Standards ‐Results
Arch Int Med 2012 172:1628‐1633
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Failure of Clinical Practice Guidelines ConclusionsArch Int Med 2012 172:1628‐1633
“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;127:1730‐1753
Implementation
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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
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Clinical Practice Guidelines – The ACC/AHA Process
Task Force on Practice Guidelines
Continuous oversight & direction of CPG development process & methodology