Evidence-based%20Medicine%20as%20a%20Patient%20Safety%20Tool%20Key%20Concepts,%20Emerging%20Applications

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Evidence-based Medicine as a Patient Safety
ToolKey Concepts, Emerging Applications

• The Quality Colloquium at Harvard University
• Boston, Massachusetts
• Paul H. Keckley, Ph.D.
• Vanderbilt Medical Center
• August 20, 2006

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What well cover

• The momentum for safety
• EBM as a means to an end
• Implications for provider organizations

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ADMINISTRATORS/WATCHDOGS
Regulators
Media
Professional Societies/ Special Interests
BIOTECH
INNOVATORS
Insurers
Academic Medicine
Pharma
BioTech
Accrediting Agencies
Employers
HCIT
SERVICE PROVIDERS
Device
Hospitals
Outpatient Facilities
Long Term Care
Allied Health Professionals
Disease Management
CAM
Physicians
CONSUMERS
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6320 per person in the U.S.!
8.8 GDP
12.0 GDP
13.3 GDP
15.7 GDP(projected)
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The quality of care we get is far from the care
we should be getting Don Berwick, IHI

• Acute care deficiencies
• Antibiotic misuse 30-70
• Prenatal care 74

• Preventive care deficiencies
• Child immunizations 76
• Influenza vaccine 52
• Pap smear 82

Quality of Care Safe Effective Patient-centered
Timely Efficient Equitable

• Chronic care deficiencies
• Beta blockers 50
• Diabetes eye exam 53

• Surgery care deficiencies
• Inappropriate
• hysterectomy 16
• Inappropriate
• CABG surgeries 14

• Hospital care deficiencies
• Proper CHF care 50
• Preventable deaths 14
• Preventable ADEs 1.8/100 admits
• Life threatening 20
• Serious 43

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What the evidence says is what you get (half the
time)
McGlynn et al The Quality of Health Care
Delivered to Adults in the United States NEJM
June 26, 2003
Condition Recommended Care Received
Senile Cataract 78.7
Breast cancer 75.7
Prenatal Care 73.0
Low back pain 68.5
Coronary artery disease 68.0
Hypertension 64.7
Congestive heart failure 63.9
Cerebrovascular disease 59.1
Chronic obstructive pulmonary disease 58.0
Depression 57.7
Orthopedic conditions 57.2
Osteoarthritis 57.3
Colorectal cancer 53.9
Condition Recommended Care Received
Asthma 53.5
Benign prostatic hyperplasia 53.0
Hyperlipidemia 48.6
Diabetes mellitus 45.4
Headache 45.2
Urinary tract infection 40.7
Community acquired pneumonia 39.0
Sexually transmitted diseases 36.7
Dyspepsia/peptic ulcer disease 32.7
Atrial fibrillation 24.7
Hip fracture 22.7
Alcohol dependence 10.5
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Quality depends on where you live
Quartile Rank
First
Second
Third
Note State ranking based on 22 Medicare
performance measures.
Fourth
Source S.F. Jencks, E.D. Huff, and T. Cuerdon,
Change in the Quality of Care Delivered to
Medicare Beneficiaries, 19981999 to 20002001,
Journal of the American Medical Association 289,
no. 3 (Jan. 15, 2003) 305312.
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Errors abound

• Adverse drug events (ADEs, ADRs)
• Iatrogenic infections
• Post-operative deep wound infections
• Urinary tract infections (UTI)
• Lower respiratory infections (pneumonia or
  bronchitis)
• Bacteremias and septicemias
• Decubitus ulcers
• Mechanical device failures
• Complications of central and peripheral venous
  lines
• Deep venous thrombosis (DVT) / pulmonary embolism
  (PE)
• Strength, agility and cognition
• Blood product transfusion
• Patient transitions

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80 of ADEs avoidable
Class Description Avoidable?
Pharm Expected 28.0 Know drug reactions Yes
Physio Renal 23.0 Failure to adjust for decreased Renal function Yes
Physio Age 14.2 Failure to adjust for patient age Yes
Physio Weight 5.7 Failure to adjust for patient body mass Yes
Order Dosage 5.0 Error in dosage on order Yes
Physio Hernal 4.6 Failure to adjust for known hematologic Yes
Total preventable 80.3
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Study Health Care Costs, Error Rates Higher in
U.S. Than in Other Countries

• November 04, 2005For the report, researchers
  surveyed 6,957 adults between March and June 2005
  who recently had been hospitalized, had surgery
  or reported health problems in the U.S.,
  Australia, Canada, Britain, New Zealand and
  Germany. The survey, which is the largest to
  examine health care in several nations during the
  same time period, found that U.S. residents were
  more likely than patients in other nations to
  forego medical care because of costs. In
  addition, U.S. respondents reported the easiest
  access to specialists but the most difficulty
  getting care during nights and weekends
  (Washington Post, 11/4). Patients from all six
  countries reported medical errors, uncoordinated
  care and poor management of chronic diseases (CQ
  HealthBeat, 11/3). The study also found the
  following 34 of U.S. patients surveyed
  reported getting the wrong medication or dose,
  incorrect test results, a mistake in their
  treatment or late notification of abnormal test
  results, compared with 30 of Canadians, 27 of
  Australians, 25 of New Zealanders, 23 of
  Germans and 22 of BritonsAbout half of U.S.
  residents reported that they had decided not to
  fill a prescription, see a physician when sick or
  have recommended follow-up tests because of
  costs, compared with 38 of patients in New
  Zealand, 34 in Australia, 28 in Germany, 26 in
  Canada and 13 in BritainNearly one-third of
  U.S. patients reported paying more than 1,000 in
  out-of-pocket medical expenses in the past year,
  compared with 14 of Canadian and Australian
  patients and a much lower proportion of patients
  in the other countries (Washington Post, 11/4)
  7 of U.S. residents who had been hospitalized
  in the past two years reported developing an
  infection while in the hospital, compared with
  10 of Britons and 3 of Germans

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The system is in meltdown..
CHANGE
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Quality is our number one concern!!

• Evidence Based Care
• Patient Centered Approach
• System Orientation

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To most, quality means safe, accessible care

• Service Delivery Processes
• Satisfaction with care management processes
• Amenities to reduce anxiety, increase comfort

• Structural Processes
• Access to needed services in appropriate settings
• Paperwork/administrative procedures to access
  services
• and document transactions

• Clinical Processes
• Adherence to evidence-based pathways in the
• diagnosis and intervention planning with patients
• Safe, effective, timely, patient-centered care
• Collaborative care management

Supportive
Primary
Clinical Excellence!
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Evidence-based medicine is not understood
Evidence-based medicine is the judicious
application of relevant scientific studies to
patient preferences and values.
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Guidelines The Framework for Evidence-based
Medicine

• Systematically developed statements to assist
  practitioner and patient decisions about
  appropriate health care for specific clinical
  circumstances
• IOM 92

• Derived from
• 20,000 RCTs annually
• 4,000 guidelines since 1989
• 2,500 periodicals in NLS
• Every guideline is not evidence-based, and some
• guidelines are about who, what should be done

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PICO the framework for guidelines

• P whats the population?
• Iwhat intervention am I testing?
• C compared to what other intervention?
• O what outcome is being tested?

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Then evidence-linked algorithms form the
framework for guidelines
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Studies are graded using various schemes..
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In practice, tools are used to stay abreast..
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Better care is the result it is also a more
efficient way to operate a clinical enterprise
Ann. Epidemiology 200414669-675
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And then we draw conclusions what do we learn
by examining the evidence?
Observational Study (n1) why women live longer
than men!
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The data correlates adherence to evidence-based
practice with

• Improved outcomes
• Reduced variation
• Improved patient adherence
• Improved efficiency
• Reduced errors
• So why isnt evidence-based practice more
  consistently provided?

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Challenge Knowledge Explosion

• 20,000 biomedical journals
• gt150,000 medical articles published each month
• gt300,000 randomized controlled trials

We are drowning in information but starved for
knowledge.Naisbitt, 82
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Challenge Lack of Evidence
How many questions have any evidence? (BMJ 2000)
Answered 358
Beneficial .. 248 Ineffective or harmful
.. 43 Trade-off 67
Partial Answer 299
Likely to be beneficial . 235 Unlikely to be
beneficial . 64
Uncertain
375
Unknown effectiveness .. 375
Number of Interventions
0
50
100
150
200
250
300
350
400
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Challenge Source Credibility

• Shaneyfelt et al (JAMA, 1999)
• Of 279 guidelines developed by medical
  societies, most do not adhere to IOM standards
  for methodological review (evidence-grading)
• Grilli et al (Lancet, 2000)
• 431 guidelines reviewed 82 lack
  evidence-grading review assessment

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Challenge Reliability
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The solid line represents the Kaplan-Meier curve
for the Agency for Healthcare Research and
Quality (AHRQ) guidelines. Dashed lines
represent the 95
confidence interval (JAMA.
20012861461-1467)
Challenge Timeliness
YOU ARE HERE
?
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Challenge Commercial Interests

1. Digital imaging
2. Drug-coated stents
3. Oral cancer treatments
4. Minimally invasive surgery
5. Sepsis treatment
6. Implantable devices
7. Microscopic cameras
8. Diabetes devices
9. At-home health test kits
10. Embryonic stem cell research

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Challenge Media Attention
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Challenge Physician Training

• Provide patient centered care
• Work in interdisciplinary teams
• Employ evidence-based practice
• Apply quality improvement
• Utilize informatics
• Health Professions Education
• A Bridge to Quality
• Institute of Medicine 2003

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73 of patients depend on physicians to make
decisions for them!
Challenge Consumer Expectations
INFORMED PARENTAL
PATIENT AS DECISION-MAKER
INTERMEDIATE SHARED DECISION MAKING
4.8 Strongly disagree
17.1 Strongly Agree
45 Agree
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22.5 Disagree
Adapted from Guyatt et al. Incorporating Patient
Values in Guyatt et al. Users Guide to the
Medical Literature Essentials of Evidence based
Clinical Practice. JAMA 2001
Arora NK and McHorney CA. Med Care. 2000 38335
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Lots of explanations and excuses

• they dont pay for it..
• the tools arent available
• my patients dont care
• its a fad
• the only evidence I need is what I know
• So what does this have to do with safety?

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EBM, quality and safety are closely related

• Service Delivery Processes
• Satisfaction with care management processes
• Amenities to reduce anxiety, increase comfort

• Structural Processes
• Access to needed services in appropriate settings
• Paperwork/administrative procedures to access
• services and document transactions

• Clinical Processes
• Adherence to evidence-based pathways in the
• diagnosis and intervention planning with patients
• Safe, effective, timely, patient-centered care
• Collaborative care management

Supportive
Primary
Clinical Excellence!
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The application of EBM to safety is foundational
Its cookbook Medicine
we dont have the tools
we never did it that way before
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Safe, evidence-based care

• Service Delivery Processes
• Timeliness, Efficient
• Equitable

• Structural Processes
• Equitable
• Accessible

• Clinical Processes
• Effective
• Patient Centered

Supportive
Primary
Clinical Excellence!
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For a provider organization, there are six key
operational applications where EBM is central
Pathway Management Building and updating
pathways, order sets and guidelines for care
teams
Risk Management Avoiding error, conducting root
cause analysis
Care Team Management Recruiting, equipping and
holding accountable care teams
Outcome Management Measuring what works best
and why
Admissions Management Evaluating appropriately,
directing resources effectively
Discharge Management Teaching, equipping patients
for guided self-care, follow-up
Physician leadership is essential!
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Point of care decision-support tools are essential
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HCIT Where do we start selecting
companies? Numbers of companies currently
supporting these applications
129
259
197
165
246
Source 2005 Healthcare Informatics, Resource
Guide
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The cat is out of the bag!!
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Summary

• EBM is a journey to clinical excellence its
  about safety, quality improvement and
  evidence-based care
• Applying EBM to error avoidance is fundamental
  it leverages research about efficacy and
  effectiveness
• To deliver safe evidence-based care, an
  organization must invest in processes and
  information technologies to support leaders in
  the journey
• Our results will be public.

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Contact

• Paul H. Keckley, Ph.D.
• Executive Director
• Vanderbilt Center for Evidence-based Medicine
• Associate Professor
• Vanderbilt University School of Medicine
• D-3300 Medical Center North
• Nashville, TN 37232-2104
• paul.keckley_at_vanderbilt.edu
• 615-343-3922
• www.ebm.vanderbilt.edu