Beyond the P Value

Abstract

Ischemic heart disease is highly prevalent in the United States, affecting 17.6 million patients (≈7.9% of the adult population), and is associated with increased mortality, hospitalizations, and an estimated annual cost of $177 billion.1 Diabetes mellitus is a coexistent complication for many of the patients living with ischemic heart disease with similar short-term outcomes whether it predates or is diagnosed at the time of the initial acute coronary syndrome.2 Targets of therapy for these ischemic heart disease patients are focused on improved mortality and reduced major adverse nonfatal cardiovascular events, including myocardial infarction, unstable angina, stroke, and need for repeat revascularization. As a result in part of research advances in the management of acute coronary syndromes and implementation of primary and secondary prevention efforts, overall mortality rates attributable to ischemic heart disease in the United States have decreased dramatically since 1970 with an additional 36% decrement between 1996 and 2006.1,3 Because more patients are living with ischemic heart disease, improving quality of life or health status has emerged as an important additional target of therapy. Article see p 1690 Health status is a concept that measures the impact of a patient's illness on various parts of his or her daily life related to symptom burden, functional limitations, and quality of life.4 Although some tools such as the New York Heart Association functional classification have traditionally been assessed by physicians, more recent trends allow patients to report their health status directly, grouped as patient-reported outcomes. Quality of life is a complex measure resulting from the patient's integration of biological variables related to the disease process, symptom burden, disconnect between the desired and actual functional status, perceived prognosis, and general health perceptions.5 These concepts can be quantified with tools that have established psychometric properties and …