The pursuit of “the right things”:
Lessons from Evidence Based Medicine 1.0
Paul Wallace MD
The Permanente Federation
Paul.Wallace@kp.org
About Kaiser Permanente

Pre-paid Integrated
Delivery System
Health Plan
Hospitals and
Clinics
Multi-specialty
Medical
Groups
Incentive
alignment

Key Shared
Investments
Research
Knowledge
Management
Health IT
The “right things”... Circa 1994
Making the right things
easier?
Kaiser Permanente and the Cox-2 NSAID Story
120%
100%
Kaiser Permanente
4%
Community
35%
80%
60%
96%
40%
65%
20%
0%
NSAIDs
Cox-2
How was this level of performance achieved?
Kaiser Permanente and the Cox-2 NSAID Story

Pharmacy Formulary and Therapeutics
Committee
Tight process led by, and trusted by, clinicians
Efficacy, safety, and cost concerns analyzed by staff and
committee
Identified evidence for a narrow role for medically
appropriate use of Cox-2 in select patients at high risk of GI
bleeding

Implementation
Physician communication and reminders from KP physician
leaders and pharmacists
Easily available decision support to select high-risk
members who would benefit from a Cox-2
Patient engagement materials addressing risks and benefits
Ongoing measurement and feedback
KP data on cardiovascular risk shared with U.S. FDA
Kaiser Permanente and the Cox-2 NSAID Story
Risk of Acute Myocardial Infarction and
Sudden Cardiac Death with Use of COX-2
Selective and Non-Selective NSAIDs:
Nested Case Control Study
Lancet 2005; 365 (9458): 475–481
DJ Graham,1 DH Campen,2 R Hui,2 M Spence,2
C Cheetham,2 S Shoor,2 G Levy,2 and WA Ray3
1Office of Drug Safety, US Food and Drug Administration
2Kaiser Permanente, California
3Vanderbilt University School of Medicine
Managing the “Gray Areas”...
The last 115 new technologies examined:
Medically
appropriate
38
?
7
Insufficient evidence
because the
evidence is:
Generally not
medically
appropriate
A. Of insufficient
quantity
66
and/or quality
B. Conflicting or
inconsistent 3
C. There is no
evidence
1
8
Managing the “Gray Areas”...
The last 115 new technologies examined:
Medically
appropriate
7
38
Insufficient evidence
because the
evidence is:
Generally not
medically
appropriate
A. Of insufficient
quantity
66
and/or quality
B. Conflicting or
inconsistent 3
C. There is no
evidence
1
9
Tools to support accountability - Registries
Knee Replacement (TKA) Implant Survival Registry
A
B
C
D
% Prob CVD death, MI or Stroke
Cardiovascular Risk Reduction for
Patients with Diabetes
-9%
Aspirin
Lisinopril
-25%
-25%
Lovastatin
-19%
-29%
-39%
-49%
-59%
-69%
•Anti-Platelet
Trialists
•HOT
•HOPE
•EUROPA
-30%
•4S
•HPS
-79%
-89%
There is strong evidence that
each of aspirin, lisinopril, and
lovastatin decrease
cardiovascular death, MI or
stroke, in high risk patients
Yusuf, S. Lancet 360: July 6, 2002
-99%
What happens if you do all
3, “A-L-L”, at the same time?
Evidence based
simulation modeling
of the health care
system
How would that compare to
other possibilities, like tight
glucose control?
Comparative effectiveness...
In patients with
Diabetes, ALL
as a
combination,
has a greater
impact on
cardiovascular
risk than
aggressive
HbA1c
(glucose)
control
Average annual risk of various events
0.045
0.04
Nothing
0.035
HbA1c control
0.03
ALL
0.025
0.02
0.015
0.01
0.005
0
MI
Stroke
ESRD
Blind
Dying
The projected savings begin immediately and average
$600/person/year
Annual cost per person
$6,000
$5,000
$4,000
$3,000
Nothing
$2,000
ALL
$1,000
HbA1c
$0
0
5
10
15
Years after start of program
20
25
Lessons from EBM 1.0

Engage practicing clinicians

Engage patients actively and aggressively

If incentives are not well aligned, better evidence alone is insufficient
to change clinician or patient behavior (e.g. CE is only part of reform)

Determining comparative effectiveness requires a portfolio of
prospective trials plus observational population based surveillance
plus predictive modeling

Promote learning as a shared accountability, over time
 Build trust in the process through involvement and transparency
 Give them tools relevant to their practice – e.g. registries
 Give them accountability for managing the gray areas of care – and
hold them to it
 Leverage who and what they trust
 National and local/regional
 Research and practice
 Payor and payee
 Clinician and Patient