Abstract 151: Patient Decision Support in Implanted Defibrillator Care

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Background: Shared decision making (SDM) is a mainstream component of cardiovascular disease care in the US. This is particularly true in light of support for SDM from the IOM, the ACA, the FDA 1-3, several professional societies, and Cochrane Review findings of improved patient-centered outcomes4. Given the complex nature of advanced CV therapies - characterized by the IOM as having “more to do, more to manage, and more people involved than ever before”5 - SDM programs are critical to patient-centered assessment of quality of care in CV.

Human rights-based approaches (HRBAs)6-7 are common in evaluations of programs targeting communicable disease in developing countries, but are underutilized in CVD care in the US. HRBAs ground assessment in international human rights law, and provide a normative framework for the design, implementation, monitoring and evaluation of interventions, policy, and programs. An HRBA to health aims to realize the right to the “highest attainable standard of health”—including the availability, accessibility, acceptability, and quality of health facilities, information, goods, and services—and other health-related human rights (including autonomy and full and informed decisionmaking, the right to participation, and accountability).8-12

Approach: Using decision support regarding ICDs as a model, we created a conceptual framework highlighting synergies between HRBAs and SDM. This model of HRBA assessment of SDM programs covers four stages of design/deployment of decision aids (design of tools; implementation; use of PtDAs with patients; monitoring, evaluation and accountability), with accompanying rights-based considerations for each. The model is replicable across decision support related to other complex therapies with preference-sensitive trade-offs.

Results & Implications: There is considerable synergy between HRBAs and SDM. Both empower patients, emphasize autonomy, and have potential to improve processes and outcomes. This model offers legal grounding and a normative framework through which one can evaluate SDM programming, improving decisionmaking processes and better aligning outcomes with patients’ values and goals. Research into the use of HRBA assessment of SDM is warranted; the goal being to respect, protect, and fulfill human rights obligations.

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