Management of atrial flutter and atrial fibrillation with rapid ventricular response in patients with acute decompensated heart failure: A systematic review.

OBJECTIVE: The objective was to evaluate the comparative effectiveness and safety of pharmacological and nonpharmacological management options for atrial fibrillation/atrial flutter with rapid ventricular response (AFRVR) in patients with acute decompensated heart failure (ADHF) in the acute care setting. METHODS: This study was a systematic review of observational studies or randomized clinical trials (RCT) of adult patients with AFRVR and concomitant ADHF in the emergency department (ED), intensive care unit, or step-down unit. The primary effectiveness outcome was successful rate or rhythm control. Safety outcomes were adverse events, such as symptomatic hypotension and venous thromboembolism. RESULTS: A total of 6577 unique articles were identified. Five studies met inclusion criteria: one RCT in the inpatient setting and four retrospective studies, two in the ED and the other three in the inpatient setting. In the RCT of diltiazem versus placebo, 22 patients (100%) in the treatment group had a therapeutic response compared to 0/15 (0%) in the placebo group, with no significant safety differences between the two groups. For three of the observational studies, data were limited. One observation study showed no difference between metoprolol and diltiazem for successful rate control, but worsening heart failure symptoms occurred more frequently in those receiving diltiazem compared to metoprolol (19 patients [33%] vs. 10 patients [15%], p = 0.019). A single study included electrical cardioversion (one patient exposed with failure to convert to sinus rhythm) as nonpharmacological management. The overall risk of bias for included studies ranged from serious to critical. Missing data and heterogeneity of definitions for effectiveness and safety outcomes precluded the combination of results for quantitative meta-analysis. CONCLUSIONS: High-level evidence to inform clinical decision making regarding effective and safe management of AFRVR in patients with ADHF in the acute care setting is lacking.

A cross-sectional study of participant recruitment rates in published phase III influenza therapeutic randomized controlled trials conducted in the clinical setting.

OBJECTIVE: A recent academic-government partnership demonstrated the feasibility of utilizing Emergency Departments (ED) as a primary site for subject enrollment in clinical trials and achieved high rates of recruitment in two U.S. EDs. Given the ongoing need to test new therapeutics for influenza and other emerging infections, we sought to describe the historical rates of participant recruitment into influenza Phase III therapeutic RCTs in various clinical venues, including EDs. STUDY DESIGN: A cross-sectional study was performed of influenza therapeutic Phase III RCTs published in PubMed, Embase, Scopus, and Clinicaltrials.gov from January 2000 to June 2019. MAIN OUTCOME: To estimate the weighted-average number of influenza-positive participants enrolled per site per season in influenza therapeutic RCT conducted in clinical settings, and to describe basic trial site characteristics. RESULTS: 47 (0.7%) of 7008 articles were included for review of which 43 of 47 (91%) included information regarding enrollment sites; of these, 2 (5%) recruited exclusively from EDs with the remainder recruiting from mixed clinical settings (inpatient, outpatient, and ED). The median enrollment per study was 326 (IQR: 110, 502.5) with a median of 11 sites per study (IQR: 2, 59.5). Included studies reported a median of 201 (IQR: 74, 344.5) confirmed influenza-positive participants per study. The pooled number of participants enrolled per site per season was 11 (95% CI: 10, 12). The pooled enrollment numbers per clinical site after excluding the two 'ED only recruitment' studies were less [10.7 (95% CI: 9.9, 11.6)] than the pooled enrollment numbers per clinical site for the two 'ED only recruitment' studies [89.5 (95% CI 89.2-89.27)]. CONCLUSION AND RELEVANCE: Published RCTs evaluating influenza therapeutics in clinical settings recruit participants from multiple sites but enroll relatively few participants, per site, per season. The few ED-based studies reported recruited more subjects per site per season. Untapped opportunities likely exist for EDs to participate and/or lead therapeutic RCTs for influenza or other emerging respiratory pathogens.

Multisite implementation of a workflow-integrated machine learning system to optimize COVID-19 hospital admission decisions.

Demand has outstripped healthcare supply during the coronavirus disease 2019 (COVID-19) pandemic. Emergency departments (EDs) are tasked with distinguishing patients who require hospital resources from those who may be safely discharged to the community. The novelty and high variability of COVID-19 have made these determinations challenging. In this study, we developed, implemented and evaluated an electronic health record (EHR) embedded clinical decision support (CDS) system that leverages machine learning (ML) to estimate short-term risk for clinical deterioration in patients with or under investigation for COVID-19. The system translates model-generated risk for critical care needs within 24 h and inpatient care needs within 72 h into rapidly interpretable COVID-19 Deterioration Risk Levels made viewable within ED clinician workflow. ML models were derived in a retrospective cohort of 21,452 ED patients who visited one of five ED study sites and were prospectively validated in 15,670 ED visits that occurred before (n = 4322) or after (n = 11,348) CDS implementation; model performance and numerous patient-oriented outcomes including in-hospital mortality were measured across study periods. Incidence of critical care needs within 24 h and inpatient care needs within 72 h were 10.7% and 22.5%, respectively and were similar across study periods. ML model performance was excellent under all conditions, with AUC ranging from 0.85 to 0.91 for prediction of critical care needs and 0.80-0.90 for inpatient care needs. Total mortality was unchanged across study periods but was reduced among high-risk patients after CDS implementation.

Descriptive Epidemiology of Women in the Emergency Department With Gonorrhea and Chlamydial Infection in the United States.

Demographic characteristics, risk factors, and clinical variables associated with gonorrhea and chlamydial infection in women being treated in emergency departments (EDs) in the United States are incompletely characterized. We used univariable and multivariable regression analyses on 17,411 encounters from women 18 years and older who presented to EDs in northeast Ohio and were tested for gonorrhea or chlamydial infection. There were 1,360 women (7.8%) who had Chlamydia trachomatis infection and 510 (2.9%) who had Neisseria gonorrhoeae infection. Those infected with C. trachomatis or N. gonorrhoeae were younger (23.8 vs. 29.2 years), unmarried (97.7% vs. 90.1%), Black (93.3% vs. 88.0%), infected with Trichomonas vaginalis (39.9% vs. 27.2%), diagnosed with urinary tract infection (15.7% vs. 10.6%), and treated for gonorrhea and chlamydial infection during the ED visit (31.6% vs. 17.4%) (all ps < .001). Women infected with C. trachomatis or N. gonorrhoeae had more urine white blood cells (WBCs) (23.9 vs. 16.4 cells per high-power field [HPF]) and leukocyte esterase (1.2+ vs. 0.8+) on urinalysis. They had more WBCs (18.5 vs. 12.4 cells/HPF) and odds of having T. vaginalis infection (12.8% vs. 8.2%) on vaginal wet preparation (all ps < .001). Women infected with C. trachomatis were more likely to be younger and not Black; they were less likely to be treated for gonorrhea and chlamydial infection in the ED and to have lower levels of urine WBCs, leukocyte esterase, and blood than those infected with N gonorrhoeae (all ps ≤ .05).

A Comparison of Individuals with Diabetes and EMPA-REG Trial Participants: Exploring Aspects of External Validity.

BACKGROUND: There is increasing use of sodium glucose co-transporter 2 (SGLT2) inhibitors to treat diabetes. Since trials apply specific entry and exclusion criteria to ensure internal validity, comparisons of trial populations with nationally representative samples can inform the applicability of study findings to practice. OBJECTIVE: To compare individuals with diabetes from a nationally representative sample to patients who underwent randomization in the EMPA-REG trial. A secondary aim was to characterize what proportion of individuals prescribed an SGLT2 inhibitor in a nationally representative sample would have been included in the EMPA-REG trial. DESIGN: Retrospective cross-sectional study. PARTICIPANTS: Adults with diabetes who took part in the National Health and Nutrition Examination Survey (NHANES) between 2011-2014 (primary analysis corresponding to EMPA-REG enrollment) and 2015-2018 (secondary analysis corresponding to contemporary sample). MAIN MEASURES: The primary outcome was a comparison of demographic (age, sex, ethnicity, and pregnancy status), clinical (comorbidities and medication use), examination (weight, body mass index, and systolic and diastolic blood pressure), and laboratory (hgba1c, low- and high-density lipoprotein cholesterol, triglycerides, and estimated glomerular filtration rate) characteristics of NHANES respondents versus EMPA-REG trial participants. The secondary outcome was the proportion of NHANES respondents who had been prescribed an SGLT2 inhibitor that would have met inclusion criteria for the EMPA-REG trial. KEY RESULTS: There were 655 and 48 respondents, representing a weighted sample of 21,849,775 and 1,062,573 individuals, included in the primary and secondary analyses, respectively. Overall, 7.6% (95% CI 4.8-10.6%) of 2011-2014 NHANES respondents would have met all EMPA-REG trial inclusion criteria. NHANES respondents and EMPA-REG participants differed across demographic, clinical, examination, and laboratory domains. Of NHANES respondents from 2015 to 2018 who were prescribed an SGLT2 inhibitor, 10.6% (95% CI <1-24.7%) would have met all inclusion criteria for the EMPA-REG trial. CONCLUSIONS: The EMPA-REG population differed from a nationally representative sample, which could affect generalizability.

Prediction model for gonorrhea, chlamydia, and trichomoniasis in the emergency department.

OBJECTIVE: History and physical examination findings can be unreliable for prediction of genitourinary tract infections and differentiation of urinary tract infections from sexually transmitted infections (STIs). The study objective was to develop a prediction tool to more accurately identify patients with STIs. METHODS: A retrospective review of 64,490 emergency department (ED) encounters between April 18, 2014, and March 7, 2017, where patients age 18 years or older had urinalysis and urine culture or testing for gonorrhea, chlamydia, or trichomonas, was used to develop a prediction model for men and women with Neisseria gonorrhoeae or Chlamydia trachomatis, or both, and for women with Trichomonas vaginalis. The data set was randomly divided into two-thirds discovery and one-third validation. Groups were assigned through a random number generator. Backward step regression modeling was used to identify the best model for each outcome. RESULTS: With use of age, race, marital status, and findings from vaginal wet preparation (white blood cells [WBCs], clue cells, and yeast) and urinalysis (squamous epithelial cells, protein, leukocyte esterase, and WBCs), the models had areas under the receiver operating characteristic curve of 0.80 for men with N gonorrhoeae or C trachomatis, or both; 0.75 for women with N gonorrhoeae or C trachomatis, or both; and 0.73 for women with T vaginalis. CONCLUSIONS: The model estimated likelihood of ED patients having STIs was reasonably accurate with a limited number of demographic and laboratory variables. In the absence of point-of-care STI testing, use of a prediction tool for STIs may improve antimicrobial stewardship.

Decreasing Use of Primary Care: A Repeated Cross-Sectional Study of MEPS 2007-2017.

We sought to describe the proportion of patients in contact with a primary care physician, as well as the total number of primary care contacts over a 2-year period, using the 2002-2017 Medical Expenditure Panel Survey. The rate of any contact with a primary care physician for patients in the population decreased by 2.5% over the study period (adjusted odds ratio [aOR] = 0.99 per panel, 95% CI, 0.98-0.99; P <.001). The number of contacts with a primary care physician decreased among individuals with any contact by 0.5 contacts over 2 years (aOR = -0.04 per panel, 95% CI, -0.04 to -0.03, P <.001). The decreases were observed across all age groups at varying rates. The results of this study suggest that the driver for the previously reported decreases in primary care visits is secondary to fewer contacts per patient.