1. Alignment of Comparative Effectiveness through MedaMACS
Monica R. Shah, M.D.
Deputy Chief, Heart Failure & Arrhythmias
National Heart, Lung, and Blood Institute (NHLBI)
May 5, 2014

2. Comparative Effectiveness Research & Patient-Centered Care
Definitions & National Priorities
How Does MedaMACS Address These Priorities?

3. Comparative Effectiveness Research
What is It?
How Does MedaMACS Address It?
Comparative Effectiveness Research
(CER)
Direct comparison of existing health care interventions to determine which work best for which patients & which pose greatest benefit and harm
Purpose of CER is to assist stakeholders to make informed decisions to improve health care at individual and population level
Key elements – direct comparison of effective interventions, study of patients in routine care, tailoring decisions to needs of individual patients
2009 American Recovery and Reinvestment Act (ARRA) – $1 billion appropriated to accelerate CER
Provides data on various outcomes in ambulatory patients with HF (INTERMACS profile 4-7 not on inotropes and not listed for transplant)
Outcomes – survival, quality of life, functioning and satisfaction with medical therapy
Will provide data for comparison of outcomes with medical therapy to LVAD
Initial National Priorities for Comparative Effectiveness Research, IOM, 2009

4. Patient-Centered Care & Shared Decision Making
What is It?
How Does MedaMACS Address It?
Patient-Centered Care & Shared Decision Making
Care that is respectful of and responsive to individual patient preferences, needs, and values
Patient values guide clinical decisions
Institute of Medicine has identified patient-centered care as one of the fundamental approaches to improving quality of US health care
Process by which optimal decision is reached called “shared decision making” – asking not just “What is the matter?” but “What matters to you?”
Will provide data to better understand patients not receiving LVAD for various reasons including contraindications, personal preferences, identification as “less sick”
Will provide data to understand key factors that should inform discussions & decisions about medical therapy vs. LVAD
Crossing the Quality Chasm, National Research Council, National Academies Press, 2001
Shared Decision Making – The Pinnacle of Patient-Centered Care, Barry MJ, NEJM, 2012

5. MedaMACS: CER & Patient-Centered Care
Triage Guided by INTERMACS Profiles
Importance of defining severity of disease before comparing therapies
Frailty and Quality Adjusted Survival
Importance of using frailty to inform patient selection and decision making
Estimating Benefit in Ambulatory HF Patients
Understanding patient-centered, non-survival outcomes