The pursuit of “the right things”: Lessons from Evidence Based Medicine 1.0 Paul Wallace MD The Permanente Federation

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 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 trust ed 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 Ray 3 1 Office of Drug Safety, US Food and Drug Administration 2 Kaiser Permanente, California 3 Vanderbilt University School of Medicine

Managing the “Gray Areas”... 8 Insufficient evidence because the evidence is: A.Of insufficient quantity and/or quality B. Conflicting or inconsistent C. There is no evidence Medically appropriate Generally not medically appropriate The last 115 new technologies examined: ?

Managing the “Gray Areas”... 9 Insufficient evidence because the evidence is: A.Of insufficient quantity and/or quality B. Conflicting or inconsistent C. There is no evidence Medically appropriate Generally not medically appropriate The last 115 new technologies examined:

Tools to support accountability - Registries ABCDABCD Knee Replacement (TKA) Implant Survival Registry

What happens if you do all 3, “A-L-L”, at the same time? How would that compare to other possibilities, like tight glucose control? 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 Anti-Platelet Trialists HOT HOPE EUROPA 4S HPS Cardiovascular Risk Reduction for Patients with Diabetes Evidence based simulation modeling of the health care system

Comparative effectiveness... In patients with Diabetes, ALL as a combination, has a greater impact on cardiovascular risk than aggressive HbA1c (glucose) control

The projected savings begin immediately and average $600/person/year

Lessons from EBM 1.0 Engage practicing clinicians  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 Engage patients actively and aggressively  Leverage who and what they trust 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  National and local/regional  Research and practice  Payor and payee  Clinician and Patient