Transcript Update on BOLD

What Do We Need Standards For &
What Can We Learn?
A. Sonia Buist M.D.
Oregon Health & Science
University,
Portland, Oregon, USA
Words….Words….Words
 Standard of care
 Quality of care
 Guidelines
 Disease management
 Quality assurance
 Quality improvement
First National Report Card on
Quality of Health Care in America.
“On average, patients receive
55% of recommended
processes, including
preventive care, acute care
and care for chronic
conditions.”
RAND
Elizabeth McGlynn, PhD
Aggressive vs Conservative
Care, Medicare patients in US
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Dartmouth Atlas of Health care study of seriously ill pts
in ~3000 hospitals in US, 2001-2005
In last 2 years of life, pts 65≥ yrs saw a Dr average of
109 times in LA, 88 x in Manhattan, 45x in Seattle
Pts in study were 65≥ yrs & treated for top 9 leading
causes of death (including COPD)
Sizable variation in aggressiveness of treatment
“on average, aggressive hospitals do not have better
outcomes & may be worse”
www.consumerreportshealth.org June ‘08
Huge Variation in Cost of End-of-Life
Treatment for Medicare Patients in US
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Dartmouth Atlas of Health Care study of seriously ill pts in ~3000
hospitals in US, 2001-2005
Total Medicare spending for last 2 years of life ranges from
$93,842 (UCLA) to $53,432 (Mayo Clinic—all docs sallaried). JHU
$85,729; MGH $78,729; Cleveland Clinic $55,333
“Some chronically ill and dying Americans are receiving too much
care—more than they & their families want or benefit from” JE
Wennberg, Dartmouth Medical School
“Contrary to popular assumptions, it’s the volume of services, not
the price per service, that account for most of the variation in
Medicare spending” ibid
Dartmouth Atlas of Health Care 2008
Why Do We Need Standards?
 To reduce variation in management and
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outcomes
To reduce misdiagnosis
To reduce over-treatment
To reduce under-treatment
To provide optimal treatment
Why Standards?
 In early 1890s Halsted developed radical
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mastectomy for breast cancer
Halsted procedure performed for >80 years
without systematic evidence for success
Introduction of randomized controlled trials led to
surprising finding that radical mastectomy no
advantage over simpler operations (NEJM 1981)
Hierarchy of evidentiary rigor established
GOLD Workshop Report
Evidence Category Sources of Evidence
A
B
C
D
Randomized clinical trials
Rich body of data
Randomized clinical trials
Limited body of data
Non-randomized trials
Observational studies
Panel judgment consensus
Gap Between Evidence &
Practice Grol & Grimshaw Lancet 2003; 363: 1225-30
 ~10,000 new RCTs are included in MEDLINE
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every year
Results from studies in US & Netherlands
suggest that ~30-40% of patients do not receive
care according to present scientific evidence
~20-30% of care provided is not needed or is
potentially harmful
The Science of Improvement
Improved clinical evidence
+
Improved process of care
=
Improved quality of care
Why the Gap Between Evidence &
Practice Grol & Grimshaw Lancet 2003; 363: 1225-30
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~10,000 new RCTs are included in MEDLINE every year
Takes 15-20 years for implement of new knowledge
 So our time frame has to be very
LONG
Quality Movement
Defects in the processes and outcomes of care
documented including:
 High rates of unscientific care
 Inappropriate care
 Geographic variations in practice
 Latent disagreements among specialists
 Often unrecognized medical injury to patients
Berwick JAMA 2008: 299: 1182-4
Quality Movement
 In 1999 & 2001, Institute of Medicine published 2
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landmark reports on evidence of quality failure
Redesign of care systems called for to achieve
improvements
Kohn et al: To Err is Human: Building a Safe Health System. National
Academies Press 1999
Hurtado et al: Crossing the Quality Chasm: a New Health Care System for the
21st Century. National Academies Press, 2001
Quality Chasm
Crossing the Quality Chasm: A New Health System
for the 21st Century. IOM 2001
Crossing the Quality Chasm: Six Aims
for Improvement
 Safe
 Effective
 Patient-centered
 Timely
 Efficient
 Equitable
Crossing the Quality Chasm: A New Health System for the
21st Century. IOM 2001
Crossing the Quality Chasm: Ten
Rules for Redesign (1)
 Care is based on continuous healing
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relationships
Care is customized according to patient needs &
values
The patient is the source of control
Knowledge is shared & information flows freely
Decision making is evidence based
Safety is a system priority
Crossing the Quality Chasm: A New Health System for the
21st Century. IOM 2001
Crossing the Quality Chasm: Ten
Rules for Redesign (2)
 Safety is a system priority
 Transparency is necessary
 Needs are anticipated
 Waste is continuously decreased
 Cooperation among clinicians is a priority
Crossing the Quality Chasm: A New Health System for the
21st Century. IOM 2001
Crossing the Quality Chasm:
Changing the Environment
 Applying evidence to health care delivery
 Using information technology
 Aligning payment policies with quality
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improvement
Preparing the workforce
Crossing the Quality Chasm: A New Health System for the
21st Century. IOM 2001
Challenges in Assessing Quality
“Many of the things you can count,
don’t count. Many of the things
you can’t count, really count.”
Einstein
Example of Use of Technology
For each spontaneously reported medical error:
 Chart review found 10 medical errors
 Electronic “crawling” of medical records showed
100 medical errors
Intermountain safety review in US
Who Needs to Be Included in
Setting Standards of Care
 Patient
 Healthcare provider
 Healthcare system
 Society
 Employer, school
 Decision makers
Physician’s Dilemma
Outcome-based
privileging/credentialing
Local
guidelines and
pathways
National
guidelines
Risk
management
CME
Medical
records
Patients
Coding
Informatics
Formularies
>2000
guidelines
www.guideline.gov
Types of Guideline
Development Processes
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Experts prepare without explicit decision rules
Experts prepare with formal consensus development
process
Evidence-based approach-systematic & complete review
of relevant literature: strength of recommendation linked
to evidence
Explicit approach—the evidence used to document
benefits, harms, & costs of treatment options are
specified
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I
What Happened in the SmokeFilled Rooms?
 Group of “experts” got together
 Reviewed the literature in un-standardized way
 Wrote guidelines
 Sent them for review to other “experts”
 Disseminated the guidelines
 Sat back satisfied
 Usually had no long term plan (or budget) for
regular updating
1995-2008: 40++ Clinical Practice
Guidelines for COPD including:
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British Thoracic Society
UK National Institute for Clinical Excellence (NICE)
Canadian Thoracic Society
International Primary Care Group
Norwegian Institute of Pharmacotherapy
Polish Physiopneumonological Society
Societe de Pneumologie de Langue Francaise
Spanish Society of Pneumonology and Thoracic Surgery
Swiss Society of Pneumology
Thoracic Society of Australia and New Zealand
Global Initiative for Chronic Obstructive Lung Disease (GOLD)
ATS/ERS
American College of Physicians and American Society of Internal Medicine
GUIDELINE
Development
Process
How?
Which
method?
External
review.
Who?
Mostly
ignored
Maybe?
Literature
review
Guidelines
developed
Guidelines
disseminated
Better pt
outcomes
What do Guidelines Change?
“Most studies of the effect of practice
guidelines have examined changes in
physicians’ practices, not changes in
patient outcomes”
Peter Greco/John Eisenberg NEJM 1993;329:1271–73
How Guidelines are used by
Physicians
 Self-assessment of current practices
 Aid to improving practices
 Palm Pilot algorithms
 Setting standards
 Developing institutional guidelines
 Raising awareness of a disease
Ways Guidelines are Used by
Decision Makers
 Setting standards
 Allocation of resources
 Developing institutional guidelines
 Allocation of specialists/generalists
 Raise awareness of a disease
Why is Adherence to Guidelines
Poor?
 Lack of perceived need
 Aversion to “cookbook” medicine
 Lack of awareness or familiarity with guidelines
 Lack of confidence in developer
 Suspicion that only purpose is cost control
Barriers to Implementing
Guidelines
 No sense of ownership (developed by a group
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of ‘experts’)
Disagree with recommendations (personal
experience or weak scientific base)
Too complicated, not ‘user-friendly’ (eg, too
much text, not enough tables/figures)
Too expensive or other practical barriers
Guidelines More Likely to be
Followed When:
 Easy to implement
 Specific
 Useful
 Come from highly respected source
 Strong science base for recommendations eg
good RCTs
Feasibility of Using Guidelines in
General Practice
 Descriptive study of care in 14 practices (16 GPs)
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in The Netherlands, n=413
GPs instructed in asthma/COPD guidelines and
compliance assessed by patient report at 1 year
Compliance best for peak flow at every visit
(98%), allergy test (78%), smoking advice (82%)
Lower compliance for spirometry (33%), checking
MDI technique (38%)
Jans et al Int J Qual in Health Care 1998;10:27
Quality of Obstructive Lung
Disease Care for Adults in US
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Telephone survey of adults in 12 communities
representing US urban population: 20K + in starting
sample
Medical record extraction for 2 yrs from 6,712 with ≥1
health care visit who agreed to do survey & at least 1
record was obtained
Quality indicators derived from RAND Quality
Assessment Tools System
2,394 care events among 260 asthma pts; 1,664 events
among169 pts
Mularski et al CHEST 2006; 130: 1844-50
Americans with Obstructive Lung Disease
Received 55% of Appropriate Health Care
100%
Overall
80%
60%
Routine
Exacerbation
67%
60%
58%
54%
48%
46%
40%
20%
0%
Asthma
COPD
4058 EPISODES OF CARE
Mularski RA et al. Chest 2006; 130(6):1844-1850.
Quality of Obstructive Lung
Disease Care for Adults in US…
Conclusion:
“Americans with obstructive lung disease received
only 55% of recommended care. The deficits and
variability in the quality of care for obstructive
lung disease present opportunities for quality
improvement. Future endeavors should assess
reasons for low adherence to recommend
processes of care and access barriers in delivery
of care”
Mularski et al CHEST 2006; 130: 1844-50
Quality of Obstructive Lung
Disease Care for Adults in US…
Conclusion: …strategies to improve care may
include:
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Increasing the use of information technology
Increasing quality improvement and continuous
assessment
Better chronic disease management
Improved care coordination
Establishing performance measures with active
monitoring
Linking quality performance to reimbursement
Mularski et al CHEST 2006; 130: 1844-50
Feasibility of Using Guidelines
in General Practice
Barriers to conforming to guidelines identified:
 Time
 Checking MDI technique, medication compliance
is time consuming
 GPs and patients unconvinced of need for
long-term use of ICS in asthma
 Spirometry not readily available
Jans et al Int J Qual in Health Care 1998;10:27
Why is there a Move to Re-examine
the Way Guidelines are Developed?
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Development of high quality clinical practice guidelines is
resource and time-intensive and requires dedication by
guideline developers
Rigorous guideline development & updating
methodology now exists
GRADE
Grades of Recommendation
Assessment, Development and
Evaluation
BMJ, 2004
About GRADE
Began as informal working group in 2000
Researchers/guideline developers with interest in
guideline methodology from around the world
Aim: to develop a common system for grading the
quality of evidence and the strength of
recommendations that is sensible and to explore the
range of interventions and contexts for which it might
be useful
Grade Working Group. CMAJ 2003, BMJ 2004, BMC 2004, BMC 2005
Other Efforts to Improve
Quality
 Robert Wood Johnson Foundation’s “Aligning
Forces for Quality” designed to drive regional
Quality Improvement through combining:
 Public reporting of physician-level performance data to create
consumer choice and create marketplace pressure for
improvement
 QI capacity building (in particular, stimulation & support of
provider & institutional efforts to develop QI infrastructure)
 Consumer engagement
We Still Aren’t There
“There us a considerable need to close the gap
between existing assessment methods and where
we need to be” Don Berwick
 Adequate methods for assessing physician competencies,
other than medical knowledge don’t yet exist
 No valid systems-based assessment approaches for
assessing performance
 The market has failed to create comprehensive
assessment methods that appeal to patients & physicians