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1.  A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery 
The New England journal of medicine  2016;374(7):647-655.
Preoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States.
In this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine–alcohol for preoperative skin antisepsis was superior to the use of iodine–alcohol for the prevention of surgical-site infection after cesarean delivery. We randomly assigned patients undergoing cesarean delivery to skin preparation with either chlorhexidine–alcohol or iodine–alcohol. The primary outcome was superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of definitions from the Centers for Disease Control and Prevention.
From September 2011 through June 2015, a total of 1147 patients were enrolled; 572 patients were assigned to chlorhexidine–alcohol and 575 to iodine–alcohol. In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine–alcohol group and in 42 (7.3%) in the iodine–alcohol group (relative risk, 0.55; 95% confidence interval, 0.34 to 0.90; P = 0.02). The rate of superficial surgical-site infection was 3.0% in the chlorhexidine–alcohol group and 4.9% in the iodine–alcohol group (P = 0.10); the rate of deep infection was 1.0% and 2.4%, respectively (P = 0.07). The frequency of adverse skin reactions was similar in the two groups.
The use of chlorhexidine–alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine–alcohol. (Funded by the National Institutes of Health and Washington University School of Medicine in St. Louis; number, NCT01472549.)
PMCID: PMC4777327  PMID: 26844840
2.  Piloting a Structured Practice Audit to Assess ACGME Milestones in Written Handoff Communication in Internal Medicine 
Written communication skills are integral to patient care handoffs. Residency programs require feasible assessment tools that provide timely formative and summative feedback, ideally linked to the Accreditation Council for Graduate Medical Education Milestones.
We describe the use of 1 such tool—UPDATED—to assess written handoff communication skills in internal medicine interns.
During 2012–2013, the authors piloted a structured practice audit at 1 academic institution to audit written sign-outs completed by 45 interns, using the UPDATED tool, which scores 7 aspects of sign-out communication linked to milestones. Intern sign-outs were audited by trained faculty members throughout the year. Results were incorporated into intern performance reviews and Clinical Competency Committees.
A total of 136 sign-outs were audited (averaging 3.1 audits per intern). In the first trimester, 14 interns (31%) had satisfactory audit results. Five interns (11%) had critical deficiencies and received immediate feedback, and the remaining 26 (58%) were assigned future audits due to missing audits or unsatisfactory scores. In the second trimester, 21 interns (68%) had satisfactory results, 1 had critical deficiencies, and 9 (29%) required future audits. Nine of the 10 remaining interns in the final trimester had satisfactory audits. Faculty time was estimated at 10 to 15 minutes per sign-out audited.
The UPDATED audit is a milestone-based tool that can be used to assess written sign-out communication skills in internal medicine residency programs. Future work is planned to adapt the tool for use by senior supervisory residents to appraise sign-outs in real time.
PMCID: PMC4512797  PMID: 26221442
3.  Characterization of a Cynomolgus Macaque Model of Pneumonic Plague for Evaluation of Vaccine Efficacy 
The efficacy of a recombinant plague vaccine (rF1V) was evaluated in cynomolgus macaques (CMs) to establish the relationship among vaccine doses, antibody titers, and survival following an aerosol challenge with a lethal dose of Yersinia pestis strain Colorado 92. CMs were vaccinated with a range of rF1V doses on a three-dose schedule (days 0, 56, and 121) to provide a range of survival outcomes. The humoral immune response following vaccination was evaluated with anti-rF1, anti-rV, and anti-rF1V bridge enzyme-linked immunosorbent assays (ELISAs). Animals were challenged via aerosol exposure on day 149. Vaccine doses and antibody responses were each significantly associated with the probability of CM survival (P < 0.0001). Vaccination also decreased signs of pneumonic plague in a dose-dependent manner. There were statistically significant correlations between the vaccine dose and the time to onset of fever (P < 0.0001), the time from onset of fever to death (P < 0.0001), the time to onset of elevated respiratory rate (P = 0.0003), and the time to onset of decreased activity (P = 0.0251) postinfection in animals exhibiting these clinical signs. Delays in the onset of these clinical signs of disease were associated with larger doses of rF1V. Immunization with ≥12 μg of rF1V resulted in 100% CM survival. Since both the vaccine dose and anti-rF1V antibody titers correlate with survival, rF1V bridge ELISA titers can be used as a correlate of protection.
PMCID: PMC4550665  PMID: 26224691
4.  Results from the First Year of Implementation of CONSULT: Consultation with Novel Methods and Simulation for UME Longitudinal Training 
An important area of communication in healthcare is the consultation. Existing literature suggests that formal training in consultation communication is lacking. We aimed to conduct a targeted needs assessment of third-year students on their experience calling consultations, and based on these results, develop, pilot, and evaluate the effectiveness of a consultation curriculum for different learner levels that can be implemented as a longitudinal curriculum.
Baseline needs assessment data were gathered using a survey completed by third-year students at the conclusion of the clinical clerkships. The survey assessed students’ knowledge of the standardized consultation, experience and comfort calling consultations, and previous instruction received on consultation communication. Implementation of the consultation curriculum began the following academic year. Second-year students were introduced to Kessler’s 5 Cs consultation model through a didactic session consisting of a lecture, viewing of “trigger” videos illustrating standardized and informal consults, followed by reflection and discussion. Curriculum effectiveness was assessed through pre- and post- curriculum surveys that assessed knowledge of and comfort with the consultation process. Fourth-year students participated in a consultation curriculum that provided instruction on the 5 Cs model and allowed for continued practice of consultation skills through simulation during the Emergency Medicine clerkship. Proficiency in consult communication in this cohort was assessed using two assessment tools, the Global Rating Scale and the 5 Cs Checklist.
The targeted needs assessment of third-year students indicated that 93% of students have called a consultation during their clerkships, but only 24% received feedback. Post-curriculum, second-year students identified more components of the 5 Cs model (4.04 vs. 4.81, p<0.001) and reported greater comfort with the consultation process (0% vs. 69%, p<0.001). Post- curriculum, fourth-year students scored higher in all criteria measuring consultation effectiveness (p<0.001 for all) and included more necessary items in simulated consultations (62% vs. 77%, p<0.001).
While third-year medical students reported calling consultations, few felt comfortable and formal training was lacking. A curriculum in consult communication for different levels of learners can improve knowledge and comfort prior to clinical clerkships and improve consultation skills prior to residency training.
PMCID: PMC4651580  PMID: 26594276
7.  A Multisystem Approach for Development and Evaluation of Inactivated Vaccines for Venezuelan Equine Encephalitis Virus (VEEV) 
A multisystem approach was used to assess the efficiency of several methods for inactivation of Venezuelan equine encephalitis virus (VEEV) vaccine candidates. A combination of diverse assays (plaque, in vitro cytopathology and mouse neurovirulence) was used to verify virus inactivation, along with the use of a specific ELISA to measure retention of VEEV envelope glycoprotein epitopes in the development of several inactivated VEEV candidate vaccines derived from an attenuated strain of VEEV (V3526). Incubation of V3526 aliquots at temperatures in excess of 64°C for periods >30 minutes inactivated the virus, but substantially reduced VEEV specific monoclonal antibody binding of the inactivated material. In contrast, V3526 treated either with formalin at concentrations of 0.1% or 0.5% v/v for 4 or 24 hours, or irradiated with 50 kilogray gamma radiation rendered the virus non-infectious while retaining significant levels of monoclonal antibody binding. Loss of infectivity of both the formalin inactivated (fV3526) and gamma irradiated (gV3526) preparations was confirmed via five successive blind passages on BHK-21 cells. Similarly, loss of neurovirulence for fV3526 and gV3526 was demonstrated via intracerebral inoculation of suckling BALB/c mice. Excellent protection against subcutaneous challenge with VEEV IA/B Trinidad donkey strain was demonstrated using a two dose immunization regimen with either fV3526 or gV3526. The combination of in vitro and in vivo assays provides a practical approach to optimize manufacturing process parameters for development of other inactivated viral vaccines.
PMCID: PMC2815040  PMID: 19903494
Venezuelan equine encephalitis virus (VEEV); Formalin inactivated vaccines; Gamma irradiated vaccines; Neurovirulence; Alphavirus
9.  Telemetric analysis to detect febrile responses in mice following vaccination with a live-attenuated virus vaccine 
Vaccine  2009;27(49):6814-6823.
Nonhuman primates (NHP) are considered to be the most appropriate model for predicting how humans will respond to many infectious diseases. Due to ethical and monetary concerns associated with the use of NHP, rodent models that are as predictive of responses likely to be seen in human vaccine recipients are warranted. Using implanted telemetry devices, body temperature and activity were monitored in inbred and outbred mouse strains following administration of the live-attenuated vaccine for Venezuelan equine encephalitis virus (VEEV), V3526. Following analysis of individual mouse data, only outbred mouse strains showed changes in diurnal temperature and activity profiles following vaccination. Similar changes were observed following VEEV challenge of vaccinated outbred mice. From these studies, we conclude, outbred mouse strains implanted with telemeters are a sensitive model for predicting responses in humans following vaccination.
PMCID: PMC2783281  PMID: 19761841
vaccine; mouse; telemetry
10.  Hospital, Employment, and Price Indicators for the Health Care Industry: Third Quarter 1999 
Health Care Financing Review  2000;21(3):231-273.
This feature presents highlights from statistics on health care utilization, prices, expenses, employment, and work hours, as well as on national economic activity, with brief analysis of these economic indicators. These statistics provide an early indication of changes occurring in the health care sector and within the general economy. Although most statistics include data for third quarter of 1999, American Hospital Association (AHA) data are through the third quarter of 1998.
PMCID: PMC4194671  PMID: 11481757

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