Effectiveness of the 2023-2024 Formulation of the Coronavirus Disease 2019 mRNA Vaccine.

BACKGROUND: The purpose of this study was to evaluate whether the 2023-2024 formulation of the COVID-19 mRNA vaccine protects against COVID-19. METHODS: Employees of Cleveland Clinic in employment when the 2023-2024 formulation of the COVID-19 mRNA vaccine became available to employees, were included. Cumulative incidence of COVID-19 over the following 17 weeks was examined prospectively. Protection provided by vaccination (analyzed as a time-dependent covariate) was evaluated using Cox proportional hazards regression, with time-dependent coefficients used to separate effects before and after the JN.1 lineage became dominant. The analysis was adjusted for the propensity to get tested, age, sex, pandemic phase when the last prior COVID-19 episode occurred, and the number of prior vaccine doses. RESULTS: Among 48210 employees, COVID-19 occurred in 2462 (5.1%) during the 17 weeks of observation. In multivariable analysis, the 2023-2024 formula vaccinated state was associated with a significantly lower risk of COVID-19 before the JN.1 lineage became dominant (HR, .58; 95% C.I., .49-.68, p-value < .001), and lower risk but one that did not reach statistical significance after (HR, .81; 95% C.I., .65-1.01, p-value 0.06). Estimated vaccine effectiveness (VE) was 42% (95% C.I., 32%-51%) before the JN.1 lineage became dominant, and 19% (C.I., -1%-35%) after. Risk of COVID-19 was lower among those previously infected with an XBB or more recent lineage, and increased with the number of vaccine doses previously received. CONCLUSIONS: The 2023-2024 formula COVID-19 vaccine given to working-aged adults afforded modest protection overall against COVID-19 before the JN.1 lineage became dominant, and less protection after.

Association Between Causative Pathogen and Occurrence of Infection-Related Glomerulonephritis in Infective Endocarditis.

Among patients with pathologically proven infective endocarditis, the association of pathogen with occurrence of infection-related glomerulonephritis (IRGN) was examined in 48 case patients with IRGN and 192 propensity score-matched controls. Bartonella was very strongly associated with IRGN (odds ratio, 38.2 [95% confidence interval, 6.7-718.8]; P < .001); other microorganisms were not.

Left ventricular assist device infection on 18F-flourodeoxyglucose positron emission tomography.

The rising prevalence of heart failure with limited transplant availability has resulted in increased use of continuous left ventricular assist device (LVAD) support. LVAD driveline remains exposed to environment which predisposes it to high rates of infection. We describe a case of a persistent driveline infection in a patient for which 18F-FDG PET/CT was utilized to diagnose deep-seated infection.

Duration of Severe Acute Respiratory Syndrome Coronavirus 2 Natural Immunity and Protection Against the Delta Variant: A Retrospective Cohort Study.

BACKGROUND: Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been shown to be highly protective against reinfection and symptomatic disease. However, effectiveness against the Delta variant and duration of natural immunity remain unknown. METHODS: This retrospective cohort study included 325 157 patients tested for SARS-CoV-2 via polymerase chain reaction (PCR) from 9 March 2020 to 31 December 2020 (Delta variant analysis) and 152 656 patients tested from 9 March 2020 to 30 August 2020 (long-term effectiveness analysis) with subsequent testing through 9 September 2021. The primary outcome was reinfection, defined as a positive PCR test >90 days after the initial positive test. RESULTS: Among 325 157 patients tested before 31 December 2020, 50 327 (15.5%) tested positive. After 1 July 2021 (Delta dominant period), 40 (0.08%) initially positive and 1494 (0.5%) initially negative patients tested positive. Protection of prior infection against reinfection with Delta was 85.4% (95% confidence interval [CI], 80.0-89.3). For the long-term effectiveness analysis, among 152 656 patients tested before 30 August 2020, 11 186 (7.3%) tested positive. After at least 90 days, 81 (0.7%) initially positive and 7167 (5.1%) initially negative patients tested positive. Overall protection of previous infection was 85.7% (95% CI, 82.2-88.5) and lasted up to 13 months. Patients aged >65 years had slightly lower protection. CONCLUSIONS: SARS-CoV-2 infection is highly protective against reinfection with Delta. Immunity from prior infection lasts at least 13 months. Countries facing vaccine shortages should consider delaying vaccinations for previously infected patients to increase access.

Coronavirus Disease 2019 Vaccine Boosting in Previously Infected or Vaccinated Individuals.

BACKGROUND: The purpose of this study was to determine whether boosting previously infected or vaccinated individuals with a vaccine developed for an earlier variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protects against the Omicron variant. METHODS: Employees of Cleveland Clinic, previously infected with or vaccinated against coronavirus disease 2019 (COVID-19) and working the day the Omicron variant was declared a variant of concern, were included. The cumulative incidence of COVID-19 was examined over 2 months during an Omicron variant surge. Protection provided by boosting was evaluated using Cox proportional hazards regression. Analyses were adjusted for time since proximate SARS-CoV-2 exposure. RESULTS: Among 39 766 employees, 8037 (20%) previously infected and the remaining previously vaccinated, COVID-19 occurred in 6230 (16%) during the study. Risk of COVID-19 increased with time since proximate SARS-CoV-2 exposure, and boosting protected those >6 months since prior infection or vaccination. In multivariable analysis, boosting was independently associated with lower risk of COVID-19 among those vaccinated but not previously infected (hazard ratio [HR], .43; 95% confidence interval [CI], .41-.46) as well as those previously infected (HR, .66; 95% CI, .58-.76). Among those previously infected, receipt of 2 compared with 1 dose of vaccine was associated with higher risk of COVID-19 (HR, 1.54; 95% CI, 1.21-1.97). CONCLUSIONS: Administering a COVID-19 vaccine not designed for the Omicron variant >6 months after prior infection or vaccination protects against Omicron variant infection. There is no advantage to administering more than 1 dose of vaccine to previously infected persons.

Necessity of Coronavirus Disease 2019 (COVID-19) Vaccination in Persons Who Have Already Had COVID-19.

BACKGROUND: The aim was to evaluate the necessity of coronavirus disease 2019 (COVID-19) vaccination in persons with prior COVID-19. METHODS: Employees of the Cleveland Clinic working in Ohio on 16 December 2020, the day COVID-19 vaccination was started, were included. Anyone who tested positive for COVID-19 at least once before the study start date was considered previously infected. One was considered vaccinated 14 days after receiving the second dose of COVID-19 mRNA vaccine. Cumulative incidences of COVID-19, symptomatic COVID-19, and hospitalizations for COVID-19 were examined over the next year. RESULTS: Among 52 238 employees, 4718 (9%) were previously infected and 36 922 (71%) were vaccinated by the study's end. Cumulative incidence of COVID-19 was substantially higher throughout for those previously uninfected who remained unvaccinated than for all other groups, lower for the vaccinated than unvaccinated, and lower for those previously infected than those not. Incidence of COVID-19 increased dramatically in all groups after the Omicron variant emerged. In multivariable Cox proportional hazards regression, both prior COVID-19 and vaccination were independently associated with significantly lower risk of COVID-19. Among previously infected subjects, a lower risk of COVID-19 overall was not demonstrated, but vaccination was associated with a significantly lower risk of symptomatic COVID-19 in both pre-Omicron (HR, .60; 95% CI, .40-.90) and Omicron (HR, .36; 95% CI, .23-.57) phases. CONCLUSIONS: Both previous infection and vaccination provide substantial protection against COVID-19. Vaccination of previously infected individuals does not provide additional protection against COVID-19 for several months, but after that provides significant protection at least against symptomatic COVID-19.

Clinical and Echocardiographic Characteristics of Bartonella Infective Endocarditis: An 8-Year Single-Centre Experience in the United States.

BACKGROUND: Infective endocarditis due to Bartonella species is rare. The clinical and echocardiographic characteristics are not well defined. We aimed to investigate the clinical and echocardiographic findings of Bartonella endocarditis in the contemporary era. METHODS: The infective endocarditis (IE) registry and echocardiographic database at our institution were retrospectively analysed to evaluate the clinical and echocardiographic features of Bartonella endocarditis. RESULTS: Between January 2008 and December 2015, there were 11 patients with Bartonella IE (0.84% among a total of 1,308 cases of definite IE): median age 54 (30-69) years, all male, 9 Caucasian, 10 had a history of cat exposure, 10 had a pre-existing valvulopathy including 6 patients with a prosthetic valve with prosthesis age range between 3 to 5 years and 1 patient with implantable cardioverter defibrillator (ICD). Bartonella henselae was responsible for all the cases. Echocardiographic evidence of IE was found in 6 of 11 patients on transthoracic echocardiography (TTE), and 6 of 8 on transoesophageal echocardiography (TEE). Bartonella IE was associated with significant valvular destruction and dysfunction on echocardiography. Nine (9) patients were managed surgically with excellent outcomes, including two patients who failed initial medical therapy. Two (2) patients who were managed medically had progression of valvular dysfunction. At a median follow-up of 6 months, there were no deaths attributable to IE or other cardiovascular causes. CONCLUSION: In a contemporary single-centre cohort in the United States, Bartonella IE remains rare, but should be considered when pathogen could not be identified in patients with suspected IE, especially those with prosthetic valves or bicuspid aortic valve (BAV). The vast majority of patients with Bartonella IE were managed surgically with excellent outcomes.

Who Helps Refugees in South Africa? An Examination of Cultural and Social Factors.

Pro-refugee philanthropy is beneficial for refugee integration and an important contributor to intergroup relations in a South African context. No study, however, has provided an in-depth quantitative analysis of what factors drive this type of behaviour. This article investigates what cultural, social and religious factors may predict participation in charitable behaviour towards refugees in South Africa. Three types of behaviours were examined: (i) material donations; (ii) volunteer activities; and (iii) information sharing. Using data from a 2019 Ipsos Migration Survey, the study found that intergroup threat was a robust predictor of charitable behaviour of all kinds. Friendship contact with a pro-refugee volunteer was also positively associated with philanthropic behaviour. Institutional trust and religious orientation were correlated with volunteer activities and information sharing but not donations. Study findings can be utilised to design interventions that increase public participation in actions that help refugees in an African context.

Utilization of Prophylactic Antibiotics After Nasal Packing for Epistaxis.

BACKGROUND: There have been few investigations examining the benefits, consequences, and patterns of use for prophylactic antibiotics for nasal packing in the emergency department setting. Given the frequency of epistaxis in the emergency department, it is an ideal setting to study the efficacy and utilization patterns of prophylactic antibiotics in nasal packing. OBJECTIVE: Our aim was to assess both rates of utilization and evidence of benefit for prophylactic antibiotics in patients with nasal packing for epistaxis. METHODS: A single-institution retrospective review of 275 cases of anterior nasal packing in an urban emergency department between September 2013 and April 2017 was performed. Chi-square statistical analysis was used to evaluate results. RESULTS: Among 275 cases studied, there were no instances of toxic shock syndrome. Roughly 73% of patients with nonabsorbable packing received prophylactic antibiotics. Only one (1.1%) case of sinusitis was noted among the nonabsorbable packing with prophylaxis group, with no such complication in the nonprophylaxis group. In contrast, 95% of patients with absorbable nasal packing were not given prophylactic antibiotics. Analysis of all cases given prophylactic antibiotics vs. no prophylaxis, regardless of packing type, revealed no statistically significant difference in the development of acute sinusitis (1% vs. 0.56%; p = 0.6793). CONCLUSIONS: There was no observed advantage or disadvantage to using prophylactic antibiotics in anterior nasal packing in the emergency department, regardless of whether patients received absorbable or nonabsorbable packing. However, patients who receive nonabsorbable nasal packing were more likely to receive antibiotic prophylaxis.

Distribution of Transmission Potential During Nonsevere COVID-19 Illness.

BACKGROUND: Patients recovering from coronavirus disease 2019 (COVID-19) often continue to test positive for the causative virus by polymerase chain reaction (PCR) even after clinical recovery, thereby complicating return-to-work plans. The purpose of this study was to evaluate transmission potential of COVID-19 by examining viral load with respect to time. METHODS: Health care personnel (HCP) at Cleveland Clinic diagnosed with COVID-19, who recovered without needing hospitalization, were identified. Threshold cycles (Ct) for positive PCR tests were obtained and viral loads calculated. The association of viral load with days since symptom onset was examined in a multivariable regression model, which was reduced by stepwise backward selection to only keep variables significant at a level of .05. Viral loads by day since symptom onset were predicted using the model and transmission potential evaluated by examination of a viral load-time curve. RESULTS: Over 6 weeks, 230 HCP had 528 tests performed. Viral loads declined by orders of magnitude within a few days of symptom onset. The only variable significantly associated with viral load was time since onset of symptoms. Of the area under the curve (AUC) spanning symptom onset to 30 days, 96.9% lay within the first 7 days, and 99.7% within 10 days. Findings were very similar when validated using split-sample and 10-fold cross-validation. CONCLUSIONS: Among patients with nonsevere COVID-19, viral loads in upper respiratory specimens peak by 2 or 3 days from symptom onset and decrease rapidly thereafter. The vast majority of the viral load-time AUC lies within 10 days of symptom onset.

Impact of the COVID-19 Pandemic on Healthcare Workers' Risk of Infection and Outcomes in a Large, Integrated Health System.

BACKGROUND: Understanding the impact of the COVID-19 pandemic on healthcare workers (HCW) is crucial. OBJECTIVE: Utilizing a health system COVID-19 research registry, we assessed HCW risk for COVID-19 infection, hospitalization, and intensive care unit (ICU) admission. DESIGN: Retrospective cohort study with overlap propensity score weighting. PARTICIPANTS: Individuals tested for SARS-CoV-2 infection in a large academic healthcare system (N = 72,909) from March 8-June 9, 2020, stratified by HCW and patient-facing status. MAIN MEASURES: SARS-CoV-2 test result, hospitalization, and ICU admission for COVID-19 infection. KEY RESULTS: Of 72,909 individuals tested, 9.0% (551) of 6145 HCW tested positive for SARS-CoV-2 compared to 6.5% (4353) of 66,764 non-HCW. The HCW were younger than the non-HCW (median age 39.7 vs. 57.5, p < 0.001) with more females (proportion of males 21.5 vs. 44.9%, p < 0.001), higher reporting of COVID-19 exposure (72 vs. 17%, p < 0.001), and fewer comorbidities. However, the overlap propensity score weighted proportions were 8.9 vs. 7.7 for HCW vs. non-HCW having a positive test with weighted odds ratio (OR) 1.17, 95% confidence interval (CI) 0.99-1.38. Among those testing positive, weighted proportions for hospitalization were 7.4 vs. 15.9 for HCW vs. non-HCW with OR of 0.42 (CI 0.26-0.66) and for ICU admission: 2.2 vs. 4.5 for HCW vs. non-HCW with OR of 0.48 (CI 0.20-1.04). Those HCW identified as patient facing compared to not had increased odds of a positive SARS-CoV-2 test (OR 1.60, CI 1.08-2.39, proportions 8.6 vs. 5.5), but no statistically significant increase in hospitalization (OR 0.88, CI 0.20-3.66, proportions 10.2 vs. 11.4) and ICU admission (OR 0.34, CI 0.01-3.97, proportions 1.8 vs. 5.2). CONCLUSIONS: In a large healthcare system, HCW had similar odds for testing SARS-CoV-2 positive, but lower odds of hospitalization compared to non-HCW. Patient-facing HCW had higher odds of a positive test. These results are key to understanding HCW risk mitigation during the COVID-19 pandemic.

Midpoint Relay Selection Using Social Trust and Battery Level to Enhance Throughput in Cooperative Device-to-Device Communications.

Device-to-device communications in underlay mode has emerged as a promising way to enhance spectrum efficiency in cellular networks. Recently, relay selection in D2D communications underlaying cellular networks is gaining more research interest. In this paper, we propose two relay selection schemes for D2D communications underlaying cellular networks, Midpoint Relay Selection using Social Trust and Battery Level (MRS-ST-BL) and Midpoint Relay Selection using Social Distance and Battery Level (MRS-SD-BL). These proposed schemes utilize battery power level information of devices together with social trust information of users in the network for relay selection. For performance evaluation, initially we show that the throughput of state-of-the-art schemes Hybrid Relay Selection (HRS) and our previously proposed schemes Midpoint Relay Selection using Social Trust (MRS-ST) and Midpoint Relay Selection Using Social Distance (MRS-SD) decrease, when relays have varying battery power. Then, we compare the performance of our proposed schemes against existing schemes including HRS, MRS-ST and MRS-SD. The performance comparison is done at various social trust scenarios and device densities. We show that our proposed schemes can significantly improve the throughput of D2D communications, particularly when relays have different battery power levels in weak social trust scenarios. Finally, we show that the performance of our proposed scheme MRS-ST-BL varies with the change in battery power threshold.

Contemporary Outcomes of Pulmonary Valve Endocarditis: A 16-Year Single Centre Experience.

BACKGROUND: Limited data exist regarding the clinical characteristics and contemporary outcomes of patients with pulmonary valve (PoV) infective endocarditis (IE). METHODS: This is a retrospective cohort study of patients with a confirmed diagnosis of IE affecting the PoV at our centre between January 2002 and October 2018. Electronic medical records were reviewed to gather the clinical and echocardiographic variables. The population was subdivided according to risk factor profiles: group 1: miscellaneous risk factors; group 2: patients with congenital heart disease (CHD); and group 3: patients who inject drugs (PWID). The primary outcome was all-cause mortality. RESULTS: Out of 2,124 cases of IE during the study period, 24 (1.1%) patients had PoV IE. The majority of cases of PoV IE occurred in patients with prosthetic valves (54.2%). Coagulase-negative Staphylococci species were the most common micro-organisms. Seventy-five per cent (75%) of the patients required surgical management. The median follow-up was 2.8 years (interquartile range: 0.2-5.3 years). Patients with miscellaneous risk factors were older (p<0.01), and had higher rates of hypertension (p=0.01) and hyperlipidaemia (p=0.04). There was a statistically significant difference in survival between the groups (p=0.03), mainly driven by better outcomes of patients with CHD, compared to those with miscellaneous risk factors. CONCLUSIONS: In a contemporary 16-year series, a high proportion of patients with PoV IE required surgical management. Patients with PoV IE and CHD had better survival, compared to patients with miscellaneous risk factors at a median follow-up of 2.8 years.

Value of perioperative inhaled epoprostenol with low tidal volume ventilation for complex endocarditis surgery.

BACKGROUND AND AIM: To compare outcomes of patients treated with inhaled epoprostenol and low tidal volume ventilation during cardiopulmonary bypass with those who did not receive this medication in the operating room at all, and those who received it as a rescue therapy at the end of the case. METHODS: Retrospective chart review between 2014 and 2017, follow-up included the entire hospital stay. RESULTS: Seventy-one patients were included, and mean age was 54 years. 78.9% of the patients were male. Procedures included 96% (n = 68) aortic valve replacement, 28% (n = 20) reconstruction of the intravalvular fibrosa, and 13% (n = 9) repair of an endocarditis-related intracardiac fistula. Patients who received epoprostenol (iEpo) (treatment and rescue groups), when compared with the control group had more intra-aortic balloon pump placement (23% vs 2.5%, P = .018), open chest after surgery (32% vs 7.5%, P = .012), and duration of mechanical ventilation (8.3 ± 2.7 vs. 2.4 ± 0.4 days, P = 0.01). There was no significant difference between the two groups in terms of extracorporeal circulatory support (6.5% vs 2.5%, P = .577) and hospital death (13% vs 10%, P = .72). In a subanalysis, hospital death and duration of mechanical ventilation were higher in the recue group when compared with the treatment group (P = .004 and .056, respectively). CONCLUSIONS: Prophylactic application of iEpo with low tidal volume ventilation for an anticipated complex endocarditis operation may contribute to favorable outcome when compared with postoperative epoprostenol rescue.

Emergency department visits during outpatient parenteral antimicrobial therapy: a retrospective cohort study.

Objectives: Patients receiving outpatient parenteral antimicrobial therapy (OPAT) may require emergency department (ED) visits to manage complications. This study's purpose was to identify risk factors for ED visits during OPAT and risk factors for hospitalization among patients with ED visits. Methods: All OPAT courses initiated between 1 January 2013 and 1 January 2017 at Cleveland Clinic were identified. The first OPAT course per patient was included. For these, ED visits within 30 days were identified. Reasons and risk factors for these visits were sought, as were risk factors for hospitalization among patients visiting the ED. Results: Among 8263 patients on OPAT, 381 (4.6%) had at least one ED visit, an additional 1133 (14%) were hospitalized and an additional 50 (0.6%) died, within 30 days. One hundred and ninety-three ED visits (51%) were OPAT related. In a multivariable subdistribution proportional hazards competing risks regression model, prior ED visit (preceding year) was most strongly associated with ED visits (HR 2.29, 95% CI 1.76-2.98, P = 8.1 × 10-10). Eighty-five visits (22%) led to hospitalization. Compared with non-OPAT-related reasons, visits for vascular access complications were associated with lower odds of hospitalization (OR 0.36, 95% CI 0.14-0.83, P = 0.022) and visits for worsening infection with higher odds (OR 18.95, 95% CI 5.50-79.85, P = 1.2 × 10-7). Conclusions: Compared with patients without, patients with prior ED visit have a 2.3-fold higher hazard of an ED visit within 30 days of OPAT initiation. Visits for worsening infection are much more likely to result in hospitalization than those for vascular access complications.

Outcomes of Outpatient Parenteral Antimicrobial Therapy in Patients With Injection Drug Use.

BACKGROUND: Historically, there has been a restrictive approach toward outpatient parenteral antimicrobial therapy (OPAT) in patients with injection drug use (IDU) due to the fear that they might utilize the intravenous catheter to inject illicit substances. OBJECTIVE: We tested the hypothesis that patients with current IDU on OPAT would have less favorable treatment outcomes compared to those without current IDU. METHODS: In this retrospective cohort chart review study of Cleveland Clinic OPAT registry, we identified patients with current IDU by both electronic and manual review. For each patient with current IDU, we identified 3 matched controls among those on OPAT and without current IDU, by propensity score matching on age, sex, OPAT year, and OPAT diagnosis. We compared treatment failure, infection relapse, line infection, hospital readmission, number of emergency room visits, and 90-day mortality, for patients with current IDU and their matched controls. RESULTS: We identified 39 patients with current IDU and 117 matched controls. Most patients with current IDU (82%) were discharged to skilled nursing facilities, whereas the majority of the control group (74%) was treated at home (p < 0.01). There was no significant difference in the examined treatment outcomes between the 2 groups. CONCLUSIONS: Patients with current IDU on OPAT did not have less favorable treatment outcomes compared to those without current IDU. Although the reason for this finding could potentially be related to difference in disposition, more studies need to be done to assess safety of home disposition among these patients.

Verifying Safety Messages Using Relative-Time and Zone Priority in Vehicular Ad Hoc Networks.

In high-density road networks, with each vehicle broadcasting multiple messages per second, the arrival rate of safety messages can easily exceed the rate at which digital signatures can be verified. Since not all messages can be verified, algorithms for selecting which messages to verify are required to ensure that each vehicle receives appropriate awareness about neighbouring vehicles. This paper presents a novel scheme to select important safety messages for verification in vehicular ad hoc networks (VANETs). The proposed scheme uses location and direction of the sender, as well as proximity and relative-time between vehicles, to reduce the number of irrelevant messages verified (i.e., messages from vehicles that are unlikely to cause an accident). Compared with other existing schemes, the analysis results show that the proposed scheme can verify messages from nearby vehicles with lower inter-message delay and reduced packet loss and thus provides high level of awareness of the nearby vehicles.

Evaluation of Antimicrobial Stewardship-Related Alerts Using a Clinical Decision Support System.

Background: Information technology, including clinical decision support systems (CDSS), have an increasingly important and growing role in identifying opportunities for antimicrobial stewardship-related interventions. Objective: The aim of this study was to describe and compare types and outcomes of CDSS-built antimicrobial stewardship alerts. Methods: Fifteen alerts were evaluated in the initial antimicrobial stewardship program (ASP) review. Preimplementation, alerts were reviewed retrospectively. Postimplementation, alerts were reviewed in real-time. Data collection included total number of actionable alerts, recommendation acceptance rates, and time spent on each alert. Time to de-escalation to narrower spectrum agents was collected. Results: In total, 749 alerts were evaluated. Overall, 306 (41%) alerts were actionable (173 preimplementation, 133 postimplementation). Rates of actionable alerts were similar for custom-built and prebuilt alert types (39% [53 of 135] vs 41% [253 of 614], P = .68]. In the postimplementation group, an intervention was attempted in 97% of actionable alerts and 70% of interventions were accepted. The median time spent per alert was 7 minutes (interquartile range [IQR], 5-13 minutes; 15 [12-17] minutes for actionable alerts vs 6 [5-7] minutes for nonactionable alerts, P < .001). In cases where the antimicrobial was eventually de-escalated, the median time to de-escalation was 28.8 hours (95% confidence interval [CI], 10.0-69.1 hours) preimplementation vs 4.7 hours (95% CI, 2.4-22.1 hours) postimplementation, P < .001. Conclusions: CDSS have played an important role in ASPs to help identify opportunities to optimize antimicrobial use through prebuilt and custom-built alerts. As ASP roles continue to expand, focusing time on customizing institution specific alerts will be of vital importance to help redistribute time needed to manage other ASP tasks and opportunities.

Vascular access complications during outpatient parenteral antimicrobial therapy at home: a retrospective cohort study.

OBJECTIVES: The need for indwelling vascular access for outpatient parenteral antimicrobial therapy (OPAT) places patients at risk of vascular access complications. The purpose of this study was to describe vascular access complications during OPAT at home, and identify factors associated with their occurrence. METHODS: All OPAT courses carried out at home for patients at Cleveland Clinic in 2013 were identified from the institution's OPAT registry. The first OPAT course per patient was included. Vascular access complications that occurred during the treatment course were abstracted from the electronic medical record. Only complications that triggered a clinical intervention were included. RESULTS: The 1461 included OPAT courses encompassed 33,579 OPAT days of treatment. One-hundred-and-forty-four vascular access complications occurred in 131 OPAT courses (9% of OPAT courses, 4.29 complications per 1000 OPAT days). The most common complication was occlusion (53% of all complications). Hickman catheters [incidence rate ratio (IRR) 0.20, 95% CI 0.03-0.63] and indwelling ports (IRR 0.25, 95% CI 0.04-0.78) were associated with lower complication rates than peripherally inserted central catheters, as was increasing age (IRR 0.99, 95% CI 0.98-1.00). Log OPAT duration (IRR 1.60, 95% CI 1.28-2.03), female sex (IRR 1.62, 95% CI 1.16-2.28) and injection drug use (IRR 3.32, 1.16-7.46) were associated with increased risk of vascular access complications. CONCLUSIONS: Nine percent of OPAT courses at home have at least one vascular access complication requiring clinical intervention. Longer OPAT duration, younger age, female sex and injection drug use are associated with increased risk of vascular access complications.

A prospective long-term study of external trigeminal nerve stimulation for drug-resistant epilepsy.

BACKGROUND: External trigeminal nerve stimulation (eTNS) is an emerging noninvasive therapy for drug-resistant epilepsy (DRE). We report the long-term safety and efficacy of eTNS after completion of a phase II randomized controlled clinical trial for drug-resistant epilepsy. METHODS: This was a prospective open-label long-term study. Subjects who completed the phase II randomized controlled trial of eTNS for DRE were offered long-term follow-up for 1year. Subjects who were originally randomized to control settings were crossed over to effective device parameters (30s on, 30s off, pulse duration of 250s, frequency of 120Hz). Efficacy was assessed using last observation carried forward or parametric imputation methods for missing data points. Outcomes included change in median seizure frequency, RRATIO, and 50% responder rate. RESULTS: Thirty-five of 50 subjects from the acute double-blind randomized controlled study continued in the long-term study. External trigeminal nerve stimulation was well tolerated. No serious device-related adverse events occurred through 12months of long-term treatment. At six and twelve months, the median seizure frequency for the original treatment group decreased by -2.39 seizures per month at 6 months (-27.4%) and -3.03 seizures per month at 12 months (-34.8%), respectively, from the initial baseline (p<0.05, signed-rank test). The 50% responder rates at three, six, and twelve months were 36.8% for the treatment group and 30.6% for all subjects. CONCLUSION: The results provide long-term evidence that external trigeminal nerve stimulation is a safe and promising long-term treatment for drug-resistant epilepsy.