IMPORTANCE Opportunistic screening for atrial fibrillation (AF) is recommended, and improved methods of early identification could allow for the initiation of appropriate therapies to prevent the adverse health outcomes associated with AF.OBJECTIVE To determine the effect of a self-applied wearable electrocardiogram (ECG) patch in detecting AF and the clinical consequences associated with such a detection strategy. DESIGN, SETTING, AND PARTICIPANTSA direct-to-participant randomized clinical trial and prospective matched observational cohort study were conducted among members of a large national health plan. Recruitment began November 17, 2015, and was completed on October 4, 2016, and 1-year claims-based follow-up concluded in January 2018. For the clinical trial, 2659 individuals were randomized to active home-based monitoring to start immediately or delayed by 4 months. For the observational study, 2 deidentified age-, sex-and CHA 2 DS 2 -VASc-matched controls were selected for each actively monitored individual. INTERVENTIONSThe actively monitored cohort wore a self-applied continuous ECG monitoring patch at home during routine activities for up to 4 weeks, initiated either immediately after enrolling (n = 1364) or delayed for 4 months after enrollment (n = 1291). MAIN OUTCOMES AND MEASURESThe primary end point was the incidence of a new diagnosis of AF at 4 months among those randomized to immediate monitoring vs delayed monitoring. A secondary end point was new AF diagnosis at 1 year in the combined actively monitored groups vs matched observational controls. Other outcomes included new prescriptions for anticoagulants and health care utilization (outpatient cardiology visits, primary care visits, or AF-related emergency department visits and hospitalizations) at 1 year. RESULTSThe randomized groups included 2659 participants (mean [SD] age, 72.4 [7.3] years; 38.6% women), of whom 1738 (65.4%) completed active monitoring. The observational study comprised 5214 (mean [SD] age, 73.7 [7.0] years; 40.5% women; median CHA 2 DS 2 -VASc score, 3.0), including 1738 actively monitored individuals from the randomized trial and 3476 matched controls. In the randomized study, new AF was identified by 4 months in 3.9% (53/1366) of the immediate group vs 0.9% (12/1293) in the delayed group (absolute difference, 3.0% [95% CI, 1.8%-4.1%]). At 1 year, AF was newly diagnosed in 109 monitored (6.7 per 100 person-years) and 81 unmonitored (2.6 per 100 person-years; difference, 4.1 [95% CI, 3.9-4.2]) individuals. Active monitoring was associated with increased initiation of anticoagulants (5.7 vs 3.7 per 100 personyears; difference, 2.0 [95% CI, 1.9-2.2]), outpatient cardiology visits (33.5 vs 26.0 per 100 personyears; difference, 7.5 [95% CI, 7.2-7.9), and primary care visits (83.5 vs 82.6 per 100 person-years; difference, 0.9 [95% CI, 0.4-1.5]). There was no difference in AF-related emergency department visits and hospitalizations (1.3 vs 1.4 per 100 person-years; difference, 0.1 [95% CI, −0.1 to 0]).CONCLUSIONS AND RELEVANCE ...

Background The optimal time to start antiretroviral therapy (ART) for HIV–infected adults in resource limited settings with a CD4+ T cell count of 200 – 350 cells per mm3 remains uncertain. Methods We conducted a randomized, open label, trial of early versus standard ART initiation in HIV-infected adults with no history of an AIDS illness and a confirmed CD4+ T cell count between 200 and 350 cells per mm3 in Haiti. The primary study end point was survival. Participants in both groups received monthly follow up, isoniazid and trimethoprim-sulfamethoxazole prophylaxis, and nutritional support. The early treatment group initiated zidovudine, lamivudine, and efavirenz within two weeks of enrollment. The standard group started the same ART regimen when participants developed a CD4+ T cell count ≤ 200 cells/mm3 or clinical AIDS. Results Between 2005 and 2008, 816 participants, 408 per group, were enrolled and followed for a median of 21 months. The CD4 T cell count at enrollment was ~ 280 cells per mm3 in both groups. There were 23 deaths in the standard group and 6 in the early group, p=0.0011, hazards ratio 4.0, 95% CI 1.6 to 9.8. There were 36 incident tuberculosis cases in the standard group and 18 in the early group, p = 0.0125, hazard ratio 2.0, 95% CI 1.2 to 3.6. Conclusions Early ART decreased mortality and incident tuberculosis infection. Access to ART should be expanded to all HIV–infected adults with a CD4+ T cell count < 350 cells per mm3, including those from resource limited settings.

BackgroundAlthough alert fatigue is blamed for high override rates in contemporary clinical decision support systems, the concept of alert fatigue is poorly defined. We tested hypotheses arising from two possible alert fatigue mechanisms: (A) cognitive overload associated with amount of work, complexity of work, and effort distinguishing informative from uninformative alerts, and (B) desensitization from repeated exposure to the same alert over time.MethodsRetrospective cohort study using electronic health record data (both drug alerts and clinical practice reminders) from January 2010 through June 2013 from 112 ambulatory primary care clinicians. The cognitive overload hypotheses were that alert acceptance would be lower with higher workload (number of encounters, number of patients), higher work complexity (patient comorbidity, alerts per encounter), and more alerts low in informational value (repeated alerts for the same patient in the same year). The desensitization hypothesis was that, for newly deployed alerts, acceptance rates would decline after an initial peak.ResultsOn average, one-quarter of drug alerts received by a primary care clinician, and one-third of clinical reminders, were repeats for the same patient within the same year. Alert acceptance was associated with work complexity and repeated alerts, but not with the amount of work. Likelihood of reminder acceptance dropped by 30% for each additional reminder received per encounter, and by 10% for each five percentage point increase in proportion of repeated reminders. The newly deployed reminders did not show a pattern of declining response rates over time, which would have been consistent with desensitization. Interestingly, nurse practitioners were 4 times as likely to accept drug alerts as physicians.ConclusionsClinicians became less likely to accept alerts as they received more of them, particularly more repeated alerts. There was no evidence of an effect of workload per se, or of desensitization over time for a newly deployed alert. Reducing within-patient repeats may be a promising target for reducing alert overrides and alert fatigue.

Background National guidelines disagree on who should be screened for undiagnosed diabetes. No existing diabetes risk score is highly generalizable or widely followed. Objectives To develop a new diabetes screening score and compare it to other available screening instruments (Centers for Disease Control and Prevention, American Diabetes Association (ADA) and U.S. Preventive Services Task Force guidelines; two ADA risk questionnaires; and Rotterdam model) Design Cross-sectional data. Setting National Health and Nutrition Examination Survey (NHANES) 1999–2004 for model development, and NHANES 2005–2006 plus a combined cohort of two community studies, Atherosclerosis Risk in Communities (ARIC) and Cardiovascular Health Study (CHS), for validation. Participants U.S. adults ≥20 years old. Measurements A risk scoring algorithm for undiagnosed diabetes, defined as fasting plasma glucose ≥7.0 mmol/L(126 mg/dL) without known diabetes, was developed in the development dataset. Logistic regression was used to determine participant characteristics that were independently associated with undiagnosed diabetes. The new algorithm and other methods were evaluated by standard diagnostic and feasibility measures. Results Age, sex, family history of diabetes, history of hypertension, obesity, and physical activity were associated with undiagnosed diabetes. In NHANES (in ARIC/CHS), the cutpoint of ≥5 selected 30(40)% of persons for diabetes screening and yielded sensitivity of 79(72)%, specificity of 67(62)%, positive predictive value of 10(10)% and likelihood ratio-positive of 2.39(1.89). In contrast, the comparison scores yielded sensitivity of 44–100%, specificity of 10–73%, positive predictive value of 5–8%, and likelihood ratio-positive of 1.11–1.98. Limitations Data during pregnancy were not available. Conclusions This new diabetes screening score, simple and easily implemented, seems to demonstrate improvements upon the existing methods. Future studies are needed to evaluate it in diverse populations in real world settings. Primary Funding Source Clinical and Translational Science Center at Cornell Medical College.

Objective: To examine the persistence of the original treatment effects 10 years after the Diabetes Control and Complications Trial (DCCT) in the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study. In the DCCT, intensive therapy aimed at nearnormal glycemia reduced the risk of microvascular complications of type 1 diabetes mellitus compared with conventional therapy.Methods: Retinopathy was evaluated by fundus photography in 1211 subjects at EDIC year 10. Further 3-step progression on the Early Treatment Diabetic Retinopathy Study scale from DCCT closeout was the primary outcome.Results: After 10 years of EDIC follow-up, there was no significant difference in mean glycated hemoglobin levels (8.07% vs 7.98%) between the original treatment groups. Nevertheless, compared with the former conven-tional treatment group, the former intensive group had significantly lower incidences from DCCT close of further retinopathy progression and proliferative retinopathy or worse (hazard reductions, 53%-56%; PϽ.001). The risk (hazard) reductions at 10 years of EDIC were attenuated compared with the 70% to 71% over the first 4 years of EDIC (PϽ.001). The persistent beneficial effects of former intensive therapy were largely explained by the difference in glycated hemoglobin levels during DCCT. Conclusion:The persistent difference in diabetic retinopathy between former intensive and conventional therapy ("metabolic memory") continues for at least 10 years but may be waning.