Eli Farhy1, Clarissa Jonas Diamantidis2,3, Rebecca M Doerfler1, Wanda J Fink1, Min Zhan4, Jeffrey C Fink5. 1. Departments of Medicine and. 2. Divisions of General Internal Medicine and. 3. Nephrology, Duke University School of Medicine, Durham, North Carolina. 4. Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland; and. 5. Departments of Medicine and jfink@som.umaryland.edu.
Abstract
BACKGROUND AND OBJECTIVES: Poor disease recognition may jeopardize the safety of CKD care. We examined safety events and outcomes in patients with CKD piloting a medical-alert accessory intended to improve disease recognition and an observational subcohort from the same population. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We recruited 350 patients with stage 2-5 predialysis CKD. The first (pilot) 108 participants were given a medical-alert accessory (bracelet or necklace) indicating the diagnosis of CKD and displaying a website with safe CKD practices. The subsequent (observation) subcohort (n=242) received usual care. All participants underwent annual visits with ascertainment of patient-reported events (class 1) and actionable safety findings (class 2). Secondary outcomes included 50% GFR reduction, ESKD, and death. Cox proportional hazards assessed the association of the medical-alert accessory with outcomes. RESULTS: Median follow-up of pilot and observation subcohorts were 52 (interquartile range, 44-63) and 37 (interquartile range, 27-47) months, respectively. The frequency of class 1 and class 2 safety events reported at annual visits was not different in the pilot versus observation group, with 108.7 and 100.6 events per 100 patient-visits (P=0.13), and 38.3 events and 41.2 events per 100 patient visits (P=0.23), respectively. The medical-alert accessory was associated with lower crude and adjusted rate of ESKD versus the observation group (hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.89; and hazard ratio, 0.38; 95% confidence interval, 0.16 to 0.94, respectively). The association of the medical-alert accessory with the composite endpoint of ESKD or 50% reduction GFR was variable over time but appeared to have an early benefit (up to 23 months) with its use. There was no significant difference in incidence of hospitalization, death, or a composite of all outcomes between medical-alert accessory users and the observational group. CONCLUSIONS: The medical-alert accessory was not associated with incidence of safety events but was associated with a lower rate of ESKD relative to usual care.
BACKGROUND AND OBJECTIVES: Poor disease recognition may jeopardize the safety of CKD care. We examined safety events and outcomes in patients with CKD piloting a medical-alert accessory intended to improve disease recognition and an observational subcohort from the same population. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We recruited 350 patients with stage 2-5 predialysis CKD. The first (pilot) 108 participants were given a medical-alert accessory (bracelet or necklace) indicating the diagnosis of CKD and displaying a website with safe CKD practices. The subsequent (observation) subcohort (n=242) received usual care. All participants underwent annual visits with ascertainment of patient-reported events (class 1) and actionable safety findings (class 2). Secondary outcomes included 50% GFR reduction, ESKD, and death. Cox proportional hazards assessed the association of the medical-alert accessory with outcomes. RESULTS: Median follow-up of pilot and observation subcohorts were 52 (interquartile range, 44-63) and 37 (interquartile range, 27-47) months, respectively. The frequency of class 1 and class 2 safety events reported at annual visits was not different in the pilot versus observation group, with 108.7 and 100.6 events per 100 patient-visits (P=0.13), and 38.3 events and 41.2 events per 100 patient visits (P=0.23), respectively. The medical-alert accessory was associated with lower crude and adjusted rate of ESKD versus the observation group (hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.89; and hazard ratio, 0.38; 95% confidence interval, 0.16 to 0.94, respectively). The association of the medical-alert accessory with the composite endpoint of ESKD or 50% reduction GFR was variable over time but appeared to have an early benefit (up to 23 months) with its use. There was no significant difference in incidence of hospitalization, death, or a composite of all outcomes between medical-alert accessory users and the observational group. CONCLUSIONS: The medical-alert accessory was not associated with incidence of safety events but was associated with a lower rate of ESKD relative to usual care.
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