Shah, Nilay D.

OBJECTIVE We characterized annual trends of severe hypoglycemic and hyperglycemic crises (diabetic ketoacidosis/hyperglycemic hyperosmolar state) in patients with diabetes and end-stage kidney disease (ESKD). RESEARCH DESIGN AND METHODS This was a nationwide, retrospective study of adults (≥18 years old) with diabetes/ESKD, from the United States Renal Data System registry, between 2013 and 2017. Primary outcome was annual rates of emergency department visits or hospitalizations for hypoglycemic and hyperglycemic crises, reported as number of events/1,000 person-years. Event rates and risk factors were adjusted for patient age, sex, race/ethnicity, dialysis modality, comorbidities, treatment regimen, and U.S. region. RESULTS Among 521,789 adults with diabetes/ESKD (median age 65 years [interquartile range 57–73], 56.1% male, and 46% White), overall adjusted rates of hypoglycemic and hyperglycemic crises were 53.64 and 18.24 per 1,000 person-years, respectively. For both hypoglycemia and hyperglycemia crises, respectively, the risks decreased with age and were lowest in older patients (≥75 vs. 18–44 years old: incidence rate ratio 0.35, 95% CI 0.33–0.37, and 0.03, 0.02–0.03), women (1.09, 1.06–1.12, and 1.44, 1.35–1.54), and those with smoking (1.36, 1.28–1.43, and 1.71, 1.53–1.91), substance abuse (1.27, 1.15–1.42, and 1.53, 1.23–1.9), retinopathy (1.10, 1.06–1.15, and 1.36, 1.26–1.47), and insulin therapy (vs. no therapy; 0.60, 0.59–0.63, and 0.44, 0.39–0.48). For hypoglycemia, specifically, additional risk was conferred by Black race (1.11, 1.08–1.15) and amputation history (1.20, 1.13–1.27). CONCLUSIONS In this nationwide study of patients with diabetes/ESKD, hypoglycemic crises were threefold more common than hyperglycemic crises, greatly exceeding national reports in nondialysis patients with chronic kidney disease. Young, Black, and female patients were disproportionately affected.

Abstract Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation (AF). We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision making and clinician satisfaction, without affecting encounter length. Purpose We aimed to estimate the extent to which use of an SDM tool affected patient adherence to the decided care plan and clinical safety endpoints. Methods We conducted a multi-center, encounter-level randomized trial assessing the efficacy of UC with vs. without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice, AC) in patients with non-valvular AF considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months post-enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled [PDC] for DOAC, and as time in therapeutic range (TTR) for warfarin). We also followed for any safety outcomes (stroke [stroke or transient ischemic attack], major bleeding, or death). Results We enrolled 922 evaluable patient encounters (AC=463, UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary (78% of patients in AC filled their first prescription vs. 81% in UC) or secondary adherence to anticoagulation (see Figure, PDCDOAC was 74.1% in AC vs. 71.6% in UC; TTRwarfarin was 66.6% in AC vs. 64.4% in UC). PDCDOAC was better (65%) in AC than in UC (55%) (OR 1.49, CIs 1.00, 2.22). Safety outcomes, mostly bleeds, occurred in 13% (AC) of and 14% (UC) of participants. Conclusions This is the largest reported randomized trial in AF comparing usual care with and without an SDM tool to promote SDM. Although patients were more actively involved in SDM, we found no significant differences between arms in primary or secondary adherence to anticoagulation or clinical safety outcomes. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The trial was funded by and conducted independently of the National Heart, Lung, and Blood Institute (NHLBI) of the U.S. National Institutes of Health (RO1 HL131535-01). The funding body had no influence on the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Figure 1

Background: Physicians’ professional networks are an important source of new medical information and have been shown to influence the adoption of new treatments, but it is unknown how physician networks impact the de-adoption of harmful practices. Methods: We analyzed changes in physicians’ use of dronedarone after the PALLAS trial (Palbociclib Collaborative Adjuvant Study; November 2011) showed that dronedarone increased the risk of death from cardiovascular events among patients with permanent atrial fibrillation. Deidentified administrative claims from the OptumLabs Data Warehouse were combined with physicians’ demographic information from the Doximity database and publicly available data on physicians’ patient-sharing relationships compiled by the Centers for Medicare and Medicaid Services. We used a linear probability model with an interrupted linear time trend specification to model the impact of the PALLAS trial on physicians’ dronedarone usage between 2009 and 2014. Results: Before the PALLAS trial, the use of dronedarone was increasing by 0.22 percentage points per quarter (95% CI, 0.19–0.25) in our Medicare Advantage sample (N=343 429 patient-quarter observations) and 0.63 percentage points per quarter (95% CI, 0.52–0.75) in our commercially insured sample (N=44 402 patient-quarter observations). After the PALLAS trial and subsequent United States Food and Drug Administration black box warning, physicians in the Medicare Advantage sample with an above-median number of network connections to other physicians decreased their quarterly usage of dronedarone by 0.12 percentage points more per quarter (95% CI, −0.20 to −0.04; P =0.031) than physicians with equal to or below the median number of network connections. Similar patterns existed in the commercially insured sample ( P =0.0318). Conclusions: After controlling for a wide range of patient, physician, and geographic characteristics, physicians with a greater number of network connections were faster de-adopters of dronedarone for patients with permanent atrial fibrillation after the PALLAS trial and subsequent United States Food and Drug Administration black box warning detailed the harmfulness of dronedarone for these patients. Policies for improving physicians’ responsiveness to new medical information should consider utilizing the influence of these important professional network relationships.