Facilitating clinical trials of anemia in older adults: a point-of-care system to measure hemoglobin in the home and its agreement with a hospital core laboratory.

摘要

To The Editor: Heart failure in the setting of a preserved ejection fraction (HFPEF) is increasing in incidence and disproportionately afflicts older adult women with multiple concomitant comorbid conditions. Anemia is common in older adults with HFPEF, and erythropoietin (EPO) has been proposed as a potentially effective therapy in such individuals. Recruiting and retaining older adults in randomized clinical trials of HFPEF has been challenging for several reasons, including significant subject burden as the result of complex protocols and procedures that may require frequent hospital visits, which are especially difficult for frail older adults with impaired mobility and sensory deficits. EPO requires weekly monitoring of hemoglobin to avoid rapid increases that can be associated with adverse events and careful monitoring of blood pressure, making the subject burden imposed by weekly clinic visits too great for many older adults. Accordingly, in the absence of a novel approach to clinical trial design, the paradox exists that those most in need of being included in such trials will not be.