Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study.

BACKGROUND: Acute febrile illness is a common presentation for patients at hospitals globally. Assays that can diagnose a variety of common pathogens in blood could help to establish a diagnosis for targeted disease management. We aimed to evaluate the performance of the BioFire Global Fever Panel (GF Panel), a multiplex nucleic acid amplification test performed on whole blood specimens run on the BioFire FilmArray System, in the diagnosis of several pathogens that cause acute febrile illness. METHODS: We did a prospective, multicentre, cross-sectional diagnostic accuracy study to evaluate the GF Panel. Consenting adults and children older than 6 months presenting with fever in the previous 2 days were enrolled consecutively in sub-Saharan Africa (Ghana, Kenya, Tanzania, Uganda), southeast Asia (Cambodia, Thailand), central and South America (Honduras, Peru), and the USA (Washington, DC; St Louis, MO). We assessed the performance of six analytes (chikungunya virus, dengue virus [serotypes 1-4], Leptospira spp, Plasmodium spp, Plasmodium falciparum, and Plasmodium vivax or Plasmodium ovale) on the GF Panel. The performance of the GF Panel was assessed using comparator PCR assays with different primers followed by bidirectional sequencing on nucleic acid extracts from the same specimen. We calculated the positive percent agreement and negative percent agreement of the GF Panel with respect to the comparator assays. This study is registered with ClinicalTrials.gov, NCT02968355. FINDINGS: From March 26, 2018, to Sept 30, 2019, 1965 participants were enrolled at ten sites worldwide. Of the 1875 participants with analysable results, 980 (52·3%) were female and the median age was 22 years (range 0-100). At least one analyte was detected in 657 (35·0%) of 1875 specimens. The GF Panel had a positive percent agreement for the six analytes evaluated as follows: chikungunya virus 100% (95% CI 86·3-100), dengue virus 94·0% (90·6-96·5), Leptospira spp 93·8% (69·8-99·8), Plasmodium spp 98·3% (96·3-99·4), P falciparum 92·7% (88·8-95·6), and P vivax or P ovale 92·7% (86·7-96·6). The GF Panel had a negative percent agreement equal to or greater than 99·2% (98·6-99·6) for all analytes. INTERPRETATION: This 1 h sample-to-answer, molecular device can detect common causative agents of acute febrile illness with excellent positive percent agreement and negative percent agreement directly in whole blood. The targets of the assay are prevalent in tropical and subtropical regions globally, and the assay could help to provide both public health surveillance and individual diagnoses. FUNDING: BioFire Defense, Joint Project Manager for Medical Countermeasure Systems and US Army Medical Materiel Development Activity, and National Institute of Allergy and Infectious Diseases.

Comparison of capillary and venous blood for malaria detection using two PCR-based assays in febrile patients in Sierra Leone.

BACKGROUND: Rapid and sensitive diagnostics are critical tools for clinical case management and public health control efforts. Both capillary and venous blood are currently used for malaria detection and while diagnostic technologies may not be equally sensitive with both materials, the published data on this subject are scarce and not conclusive. METHODS: Paired clinical samples of venous and capillary blood from 141 febrile individuals in Bo, Sierra Leone, were obtained between January and May 2019 and tested for the presence of Plasmodium parasites using two multiplexed PCR assays: the FilmArray-based Global Fever Panel (GFP) and the TaqMan-based Malaria Multiplex Sample Ready (MMSR) assay. RESULTS: No significant differences in Plasmodium parasite detection between capillary and venous blood for both assays were observed. The GFP assay was more sensitive than MMSR for all markers that could be compared (Plasmodium spp. and Plasmodium falciparum) in both venous and capillary blood. CONCLUSIONS: No difference was found in malaria detection between venous and capillary blood using two different PCR-based detection assays. This data gives support for use of capillary blood, a material which can be obtained easier by less invasive methods, for PCR-based malaria diagnostics, independent of the platform.

Incidence and Early Course of Retinopathy of Prematurity.

In the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (ROP), 4099 infants weighing less than 1251 g at birth underwent sequential ophthalmic examinations, beginning at age 4 to 6 weeks, to monitor the incidence and course of ROP. Overall, 65.8% of the infants developed ROP to some degree; 81.6% for infants of less than 1000 g birth weight. As expected, ROP incidence and severity were higher in lower birth weight and gestational age categories. Black infants appeared less susceptible to ROP, of all severity categories, than nonblack infants. The timing of retinal vascular events correlated more closely with postconceptional age than with postnatal age, implicating the level of maturity more than postnatal environmental influences in governing the timing of these vascular events. These results include the current incidence of various severity stages of ROP found in the United States and provide new. insight into the development of ROP.

Discovering metformin-induced vitamin B12 deficiency in patients with type 2 diabetes in primary care.

BACKGROUND: Although metformin is the preferred initial pharmacological choice in type 2 diabetes, there is evidence that reveals a link between metformin use and vitamin B12 deficiency. The American Diabetes Association (ADA) has recently recommended periodic measurement of B12 levels for all patients on metformin. LOCAL PROBLEM: Medical record data collected for the preintervention period showed that only 5% (n = 23) of patients diagnosed with diabetes and on metformin had B12 levels checked at an internal medicine primary care practice. METHODS: This was a quasi-experimental project of preintervention and postintervention design using a checklist containing important measures of diabetes control. The project sample population consisted of data of adults with type 2 diabetes aged 18 years and older who were prescribed metformin in the previous year at the primary care practice. INTERVENTIONS: The intervention focused on revising an existing diabetes measures checklist to include a prompt for an annual measurement of B12 levels. RESULTS: There was significant improvement in monitoring vitamin B12 levels and discovery of low vitamin B12 levels. These data show that the number of B12 levels checked increased from 23 during the preintervention to 155 during the intervention (p ≤ 0.0000). CONCLUSIONS: This project supports a conclusion that including a prompt to check B12 levels to an existing checklist increases B12 monitoring in this patient population. Results may encourage other providers to follow the ADA guidelines for monitoring vitamin B12 levels for patients taking metformin.

The NASA Roadmap to Ocean Worlds.

In this article, we summarize the work of the NASA Outer Planets Assessment Group (OPAG) Roadmaps to Ocean Worlds (ROW) group. The aim of this group is to assemble the scientific framework that will guide the exploration of ocean worlds, and to identify and prioritize science objectives for ocean worlds over the next several decades. The overarching goal of an Ocean Worlds exploration program as defined by ROW is to "identify ocean worlds, characterize their oceans, evaluate their habitability, search for life, and ultimately understand any life we find." The ROW team supports the creation of an exploration program that studies the full spectrum of ocean worlds, that is, not just the exploration of known ocean worlds such as Europa but candidate ocean worlds such as Triton as well. The ROW team finds that the confirmed ocean worlds Enceladus, Titan, and Europa are the highest priority bodies to target in the near term to address ROW goals. Triton is the highest priority candidate ocean world to target in the near term. A major finding of this study is that, to map out a coherent Ocean Worlds Program, significant input is required from studies here on Earth; rigorous Research and Analysis studies are called for to enable some future ocean worlds missions to be thoughtfully planned and undertaken. A second finding is that progress needs to be made in the area of collaborations between Earth ocean scientists and extraterrestrial ocean scientists.

Clinical evaluation of the BioFire FilmArray® BioThreat-E test for the diagnosis of Ebola Virus Disease in Guinea.

BACKGROUND: The recent West Africa Ebola outbreak highlighted the need to provide access to rapid, safe and reliable Ebola Virus Disease diagnostics. OBJECTIVES: The objective of this field study was to assess the clinical performance of the FilmArray® BioThreat-E test for the detection of Ebola Zaïre virus in whole blood in symptomatic patients suspected of Ebola Virus Disease in Conakry (Guinea) from March to July 2015. STUDY DESIGN: The BioThreat-E test was compared to the two RT-PCRs, using serum, implemented at Donka Hospital in the emergency context: an in-house developed quantitative one-step RT-PCR adapted from the Weidmann technique, and the RealStar® Filovirus RT-PCR Kit 1.0 (Altona-Diagnostics). We also assessed the performance of this assay in noninvasive specimens (urine and saliva) to detect infected patients. RESULTS: Of 135 patients enrolled and eligible for performance assessment on whole blood, the sensitivity was 95.7% [95% CI: 85.5-99.5] and specificity 100% [95% CI: 95.9-100]. Of the 37 symptomatic infected patients able to provide saliva and/or urine samples, 34 of the 35 saliva samples and all 3 of the urine samples were positive with the BioThreat-E test. CONCLUSIONS: This study showed that the FilmArray BioThreat-E test performs comparably to conventional molecular tests under field conditions, providing results and interpretation in approximately 1h. Due to its operational characteristics, it can be easily deployed in the field during an epidemic and could also be a useful tool for post-outbreak surveillance.

Nurses' Perceptions of Quality Care.

Limited research has been conducted on how nurses define or perceive "quality nursing care." We conducted focus groups to identify nurses' perceptions of quality care at a Midwestern academic medical center. Transcripts of the focus group sessions were analyzed using thematic analysis techniques, and 11 themes emerged: Leadership, Staffing, Resources, Timeliness, Effective Communication/Collaboration, Professionalism, Relationship-Based Care, Environment/Culture, Simplicity, Outcomes, and Patient Experience.

Impact of an Advanced Cardiac Life Support Simulation Laboratory Experience on Pharmacy Student Confidence and Knowledge.

Objective. To assess the impact of an advanced cardiac life support (ACLS) simulation on pharmacy student confidence and knowledge. Design. Third-year pharmacy students participated in a simulation experience that consisted of team roles training, high-fidelity ACLS simulations, and debriefing. Students completed a pre/postsimulation confidence and knowledge assessment. Assessment. Overall, student knowledge assessment scores and student confidence scores improved significantly. Student confidence and knowledge changes from baseline were not significantly correlated. Conversely, a significant, weak positive correlation between presimulation studying and both presimulation confidence and presimulation knowledge was discovered. Conclusions. Overall, student confidence and knowledge assessment scores in ACLS significantly improved from baseline; however, student confidence and knowledge were not significantly correlated.

The impact of dementia on antidiabetic drug use in Medicare beneficiaries with diabetes: findings post-Medicare part D.

AIM: The objectives of the study were to measure the utilization rates of antidiabetic drugs in diabetic patients with dementia and to assess the impact of dementia on antidiabetic drug use. MATERIALS & METHODS: This study was a pooled cross-sectional study of the Medicare Current Beneficiaries Survey from 2006 to 2010. RESULTS & CONCLUSION: Lower utilizations of biguanides, DPP-4 inhibitors and thiazolidinediones were observed in dementia patients. The likelihood of using antidiabetic drugs was about 30% (odds ratio: 0.69; 95% CI: 0.56-0.84) lower in dementia patients and 40% (odds ratio: 0.61; 95% CI: 0.44-0.84) lower in patients with Alzheimer's disease. Healthcare providers should be aware of underuse of antidiabetic drugs in patients with dementia.

Implementation and Evaluation of a School-Based Human Papillomavirus Vaccination Program in Rural Kentucky.

INTRODUCTION: Human papillomavirus (HPV) vaccination rates remain marginal across the U.S., including Kentucky, a state recognized for increased HPV-related cancer burden. School-based HPV immunization programs may be a viable approach to improving vaccination initiation and completion rates among youth. Therefore, the purpose of this study was to design, implement, and evaluate a school-based HPV vaccination program conducted in rural south-central Kentucky. METHODS: Guided by evidence-based approaches to increasing immunization rates, the practical expertise of school nursing staff, and a detailed study protocol, academic and health department-based investigators implemented an HPV vaccination project in two high schools during the 2012-2013 academic year; data were analyzed in 2013-2014. Rates of returned parental consent forms, parental consent/declination, and HPV vaccination rates were documented. RESULTS: At the beginning of the school year, all 935 students at the two schools were given HPV vaccination parental consent forms. Five hundred eleven students returned consent forms (55% return rate), and 447 of these students were HPV vaccine naïve (87%). Of these students, 315 (70%) initiated the vaccine series, with 276 (62%) completing the entire three-dose series, so that 88% of students initiating the vaccine series successfully completed the series. In estimating rates for the entire school body, 45% of students had received all three doses by the end of the project. CONCLUSIONS: Despite study design limitations, results of this project provide further evidence about school-based immunization programs as an effective strategy for improving HPV vaccination rates among Kentucky and U.S. adolescents.

Incorporating Standardized Colleague Simulations in a Clinical Assessment Course and Evaluating the Impact on Interprofessional Communication.

OBJECTIVE: To determine the impact of incorporating standardized colleague simulations on pharmacy students' confidence and interprofessional communication skills. DESIGN: Four simulations using standardized colleagues portraying attending physicians in inpatient and outpatient settings were integrated into a required course. Pharmacy students interacted with the standardized colleagues using the Situation, Background, Assessment, Request/Recommendation (SBAR) communication technique and were evaluated on providing recommendations while on simulated inpatient rounds and in an outpatient clinic. Additionally, changes in student attitudes and confidence toward interprofessional communication were assessed with a survey before and after the standardized colleague simulations. ASSESSMENT: One hundred seventy-one pharmacy students participated in the simulations. Student interprofessional communication skills improved after each simulation. Student confidence with interprofessional communication in both inpatient and outpatient settings significantly improved. CONCLUSION: Incorporation of simulations using standardized colleagues improves interprofessional communication skills and self-confidence of pharmacy students.

Use of the FilmArray System for Detection of Zaire ebolavirus in a Small Hospital in Bo, Sierra Leone.

Laboratories associated with small hospitals often have limited expertise, personnel, and equipment to rapidly identify rare and emerging infectious diseases. We describe the successful use of the FilmArray system for rapid detection of Ebola virus directly from clinical samples in 6 out of 83 tested subjects in a small health care center in Sierra Leone.

Incorporating a diabetes certificate program in a pharmacy curriculum.

OBJECTIVE: To determine student competency and confidence in the provision of diabetes care and satisfaction with incorporation of the American Pharmacist Association/American Association of Diabetes Educators (APhA/AADE) diabetes certificate program into the required doctor of pharmacy (PharmD) curriculum. DESIGN: Material from the diabetes certificate program was incorporated longitudinally into the third-year curriculum skills laboratory courses. Educational techniques used included self-study modules with case questions, lectures using the program's slides and live seminar materials, and active-learning techniques including instructor-led modeling and role-playing exercises, small group activities, objective structured learning exercises (OSLE) using standardized patients, and a week-long diabetes simulation. EVALUATION: Students achieved a 100% pass rate on a diabetes certificate program examination and earned a mean score of 71.8 out of 100 points on a medication therapy management (MTM) objective structured clinical examination (OSCE). A student survey demonstrated high student confidence in their ability to provide diabetes care (mean scores 4.2 to 4.8) and satisfaction with the program (mean scores 4.5 to 4.8). CONCLUSION: Longitudinal integration of a nationally recognized diabetes certificate program into the required PharmD curriculum produced satisfied students competent in providing diabetes pharmaceutical care.

Tolerating the community detection resolution limit with edge weighting.

Communities of vertices within a giant network such as the World Wide Web are likely to be vastly smaller than the network itself. However, Fortunato and Barthélemy have proved that modularity maximization algorithms for community detection may fail to resolve communities with fewer than √L/2 edges, where L is the number of edges in the entire network. This resolution limit leads modularity maximization algorithms to have notoriously poor accuracy on many real networks. Fortunato and Barthélemy's argument can be extended to networks with weighted edges as well, and we derive this corollary argument. We conclude that weighted modularity algorithms may fail to resolve communities with less than √Wε/2 total edge weight, where W is the total edge weight in the network and ε is the maximum weight of an intercommunity edge. If ε is small, then small communities can be resolved. Given a weighted or unweighted network, we describe how to derive new edge weights in order to achieve a low ε, we modify the Clauset, Newman, and Moore (CNM) community detection algorithm to maximize weighted modularity, and we show that the resulting algorithm has greatly improved accuracy. In experiments with an emerging community standard benchmark, we find that our simple CNM variant is competitive with the most accurate community detection methods yet proposed.

A week-long diabetes simulation for pharmacy students.

OBJECTIVE: To assess students' attitudes and confidence about type 2 diabetes mellitus and diabetes self-management education before and after participation in Living With Diabetes Week simulation. DESIGN: Third-year pharmacy students took part in diabetes lectures, interactive laboratory sessions, and a week-long simulation of life as a patient with diabetes in the Clinical Assessment course. Pre-/postintervention survey instruments and experimental and control group comparisons were completed assessing attitudes and confidence relating to knowledge about diabetes. ASSESSMENT: The understanding that diabetes has a psychosocial impact, patient autonomy is necessary, and the seriousness of the disease increased. Students' confidence in their diabetes self-management education skills also increased. CONCLUSION: The Living With Diabetes Week simulation changed pharmacy students' attitudes toward patients with diabetes and increased confidence in diabetes education skills.

Local health department responses during the 2004-2005 influenza vaccine shortage.

During the 2004-2005 influenza vaccine shortage, the Centers for Disease Control and Prevention (CDC) coordinated distribution of post-October 5th 2004 doses of influenza vaccine to state and local health departments (LHDs), who subsequently distributed vaccine to community providers. The National Association of County and City Health Officials (NACCHO) conducted three Web-based surveys throughout the 2004-2005 influenza season to assess in real-time how LHDs were 1) dealing with the vaccine shortage, 2) implementing the interim recommendations from the Advisory Committee on Immunization Practices (ACIP), and 3) making efforts to reallocate and redistribute doses of influenza vaccine toward high-priority populations within their communities. This paper highlights LHD responses that alleviated adverse impacts during this public health emergency. The first survey asked LHDs to quantify their community's vaccine supply; the second survey asked them to describe their specific responses to the crisis; and the third survey asked them to reflect and evaluate the effectiveness of their efforts to vaccinate high-priority groups during the crisis. Six hundred five (605) of 717 (84%) LHDs in 44 states responded to the three surveys. Results show that LHDs leveraged preparedness plans, formed strategic community partnerships, and practiced vaccination drills to address the problems of vaccinating high-priority and hard-to-reach populations that arose out of the vaccine shortage. The practices used by LHDs during this shortage may provide valuable response lessons to minimize the impact of future influenza vaccine shortages and other public health emergencies.

Dykes and tykes: a virtual lesbian parenting community.

This article is a collaborative project by six members of an Internet community of lesbian mothers called MOMS. MOMS is a diverse community of lesbian mothers that is inclusive of bisexual and transgender women, as well those planning to become parents. The article outlines the history of the group and how the moderators have created an environment that encourages diversity. Members of the MOMS community differ in age, race, ethnicity, and nationality, as well as political, religious, and social expressions. Additionally, they became parents in diverse ways and parent children in distinct and often disparate styles. Nonetheless, MOMS is a high-volume list with a large membership that remains a close-knit and intimate discussion group. This article outlines some of the discussion topics common on the MOMS list. Some of these are particular to parenting, and others involve a broad spectrum of subjects including racism, butch/femme dynamics, vegetarianism, circumcision, breast versus bottle feeding, and transgender politics. To subscribe to the MOMS list, send an e-mail message to majordomo@groups.queernet.org. Write "subscribe moms" in the body of the e-mail, without quotation marks.

Extending the REACH of health coverage: a program for the uninsured in Anne Arundel County, Maryland.

The Anne Arundel County Department of Health, in Maryland, is expanding access to care for the uninsured through the development of the Residents Access to a Coalition of Health (REACH) program. The goals of REACH, developed in collaboration with the county medical society, are to improve the quality of health care, decrease unnecessary hospitalizations, and reduce usage of emergency room services among county residents who are ages 19 to 64. This is accomplished through a voluntary network of partners who have formally agreed to accept discounted fees for services. Over 3,200 county residents with a network of 400 providers and three hospitals have received over 4.8 million US dollars of uncompensated care since the program's inception in 1999.