There is growing interest in clinical outcomes assessments, such as patient-reported outcomes, and patient-centeredness across the healthcare ecosystem. For example, in 2019, the Food and Drug Administration will release two new guidance documents on clinical outcome assessment. The NHC seeks to ensure that the NHC membership is prepared to engage in conversations about clinical outcome assessment. We will post information about upcoming and past webinars, along with in-person meetings and other resources on this page.
Real-World Evidence: The Patient Perspective
The topic of real-world evidence (RWE) has gained considerable attention recently. As health researchers, policymakers, and regulators establish standards and structure for using real-world data (RWD) as evidence in regulatory and clinical decision making, patients must be the primary focus. Since the idea of RWD is new to many in the patient community, it is important to explore the patient community’s needs, concerns, and potential contributions and uses of RWE to ensure the patient voice is considered.
The National Health Council (NHC) envisions a society in which all people have access to quality health care that respects personal goals and aspirations and is designed around the patient experience to promote their best possible health outcomes. One of the biggest barriers to access is the rising cost of care, especially for the more than 160 million Americans with chronic diseases and disabilities.
Value frameworks are tools and approaches that seek to compare and quantify the positives, negatives, and costs for one or more treatments to assess which seems to be the best choice. Value frameworks and supporting models can help advance the national dialogue on value in health care, but only if they incorporate the patient voice throughout.
The NHC is focused on ensuring the voice of patients and patient organizations are included in the value discussion. The NHC has developed:
Whether shopping for a car, or a computer, or health insurance, having choices can be a good thing. But if you don't have all the information you need to do an accurate side-by-side comparison - or the information isn't presented in a way to make it easy to compare - the decision process becomes very frustrating. If a consumer picks health coverage that doesn't meet his or her unique health and budget needs, health care costs can add up.
There is little consensus-based guidance on how to conduct patient engagement or assess whether an approach to patient engagement will yield meaningful results for all parties involved. From a researcher and drug developer perspective, little guidance exists to determine who should be involved, how and what role the patient community should have, and at what points in the process the patient community should be engaged.
Prior to passage of the Affordable Care Act (ACA), an estimated 36 percent of Americans who tried to purchase health insurance directly from an insurance company were denied coverage, charged higher premiums, or received limited benefits because they had a pre-existing condition.