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

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

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

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

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