Cost-effectiveness analysis of radiosurgical capsulotomy versus treatment as usual for treatment-resistant obsessive-compulsive disorder.

OBJECTIVE: Stereotactic radiosurgical capsulotomy (SRS-C) is an effective neurosurgical option for patients with treatment-resistant obsessive-compulsive disorder (TROCD). Unlike other procedures such as deep brain stimulation and radiofrequency ablation, the cost-effectiveness of SRS-C for TROCD has not been investigated. The authors herein report the first cost-effectiveness analysis of SRS-C for TROCD. METHODS: Using a decision analytic model, the authors compared the cost-effectiveness of SRS-C to treatment as usual (TAU) for TROCD. Treatment response and complication rates were derived from a review of relevant clinical trials. Published algorithms were used to convert Yale-Brown Obsessive Compulsive Scale scores into utility scores reflecting improvements in quality of life. Costs were approached from the healthcare sector perspective and were drawn from Medicare reimbursement rates and available healthcare economics data. A Monte Carlo simulation and probabilistic sensitivity analysis were performed to estimate the incremental cost-effectiveness ratio. RESULTS: One hundred fifty-eight TROCD patients across 9 studies who had undergone SRS-C and had at least 36 months of follow-up were included in the model. Compared to TAU, SRS-C was more cost-effective, with an estimated incremental cost-effectiveness ratio of $28,960 per quality-adjusted life year (QALY) gained. Within the 3-year time horizon, net QALYs gained were greater in the SRS-C group than the TAU group by 0.27 (95% CI 0.2698-0.2702, p < 0.0001). At willingness-to-pay thresholds of $50,000 and $100,000 per QALY, the Monte Carlo simulation revealed that SRS-C was more cost-effective than TAU in 83% and 100% of iterations, respectively. CONCLUSIONS: Compared to TAU, SRS-C for TROCD is more cost-effective under a range of possible cost and effectiveness values.

Years of life lost associated with COVID-19 deaths in the USA during the first 2 years of the pandemic.

BACKGROUND: Prior estimates of the years of life lost (YLLs) in the USA associated with coronavirus disease 2019 (COVID-19) were 1.2 million through 11 July 2020 and 3.9 million through 31 January 2021 (which roughly coincides with the first full year of the pandemic). The aim of this study is to update YLL estimates through the first 2 years of the pandemic. METHODS: We employed data regarding COVID-19 deaths through 5 February 2022 by jurisdiction, gender and age group. We used actuarial life expectancy tables by gender and age to estimate YLLs. RESULTS: We estimated roughly 9.7 million YLLs due to COVID-19 deaths. The number of YLLs per 10 000 capita was 297.5, with the highest rate in Mississippi (482.7) and the lowest in Vermont (61.4). There was substantial interstate variation in the timing of YLLs and differences in YLLs by gender. YLLs per death increased from 9.2 in the first year of the pandemic to 10.8 through the first 2 years. CONCLUSIONS: Our findings improve our understanding of how the mortality effects of COVID-19 have evolved. This insight can be valuable to public health officials as the disease moves to an endemic phase.

Outbreak of Multidrug-Resistant Salmonella Heidelberg Infections Linked to Dairy Calf Exposure, United States, 2015-2018.

In August 2016, the Wisconsin Department of Health Services notified the U.S. Centers for Disease Control and Prevention of multidrug-resistant (MDR) Salmonella enterica serovar Heidelberg infections in people who reported contact with dairy calves. Federal and state partners investigated this to identify the source and scope of the outbreak and to prevent further illnesses. Cases were defined as human Salmonella Heidelberg infection caused by a strain that had one of seven pulsed-field gel electrophoresis (PFGE) patterns or was related by whole genome sequencing (WGS), with illness onset from January 1, 2015, through July 2, 2018. Patient exposure and calf purchase information was collected and analyzed; calves were traced back from the point of purchase. Isolates obtained from animal and environmental samples collected on-farm were supplied by veterinary diagnostic laboratories and compared with patient isolates using PFGE and WGS. Antimicrobial susceptibility testing by standardized broth microdilution was performed. Sixty-eight patients from 17 states were identified. Forty (63%) of 64 patients noted cattle contact before illness. Thirteen (33%) of 40 patients with exposure to calves reported that calves were sick or had died. Seven individuals purchased calves from a single Wisconsin livestock market. One hundred forty cattle from 14 states were infected with the outbreak strain. WGS indicated that human, cattle, and environmental isolates from the livestock market were genetically closely related. Most isolates (88%) had resistance or reduced susceptibility to antibiotics of ≥5 antibiotic classes. This resistance profile included first-line antibiotic treatments for patients with severe salmonellosis, including ampicillin, ceftriaxone, and ciprofloxacin. In this outbreak, MDR Salmonella Heidelberg likely spread from sick calves to humans, emphasizing the importance of illness surveillance in animal populations to prevent future spillover of this zoonotic disease.

Years of life lost associated with COVID-19 deaths in the USA during the first year of the pandemic.

BACKGROUND: Years of Life Lost (YLLs) measure the shortfall in life expectancy due to a medical condition and have been used in multiple contexts. Previously it was estimated that there were 1.2 million YLLs associated with coronavirus disease 2019 (COVID-19) deaths in the USA through 11 July 2020. The aim of this study is to update YLL estimates for the first full year of the pandemic. METHODS: We employed data regarding COVID-19 deaths in the USA through 31 January 2021 by jurisdiction, gender and age group. We used actuarial life expectancy tables by gender and age to estimate YLLs. RESULTS: We estimated roughly 3.9 million YLLs due to COVID-19 deaths, which correspond to roughly 9.2 YLLs per death. We observed a large range across states in YLLs per 10 000 capita, with New York City at 298 and Vermont at 12. Nationally, the YLLs per 10 000 capita were greater for males than females (136.3 versus 102.3), but there was significant variation in the differences across states. CONCLUSIONS: Our estimates provide further insight into the mortality effects of COVID-19. The observed differences across states and genders demonstrate the need for disaggregated analyses of the pandemic's effects.

Intervention cost-effectiveness for pediatric anxiety and OCD: A systematic review and integrated database model.

BACKGROUND: While multiple treatments for pediatric anxiety and obsessive compulsive disorder (OCD) are efficacious, little is known about their cost-effectiveness. In response, we sought to provide relevant information through systematic review and cost-effectiveness simulation. METHODS: We evaluated the cost-effectiveness of treatment for pediatric anxiety and OCD in two ways. First, we conducted a systematic review following PRISMA guidelines. Second, we evaluated cost-effectiveness for antidepressant medication, cognitive behavioral therapy, and their combination via a simulation that integrated information from the Truven MarketScan database and the NIMH National Database for Clinical Trials Related to Mental Illness. RESULTS: Both systematic review and simulation found antidepressant medication and cognitive behavioral therapy to be cost-effective for pediatric anxiety and OCD. Antidepressant medication was the least costly approach, and cognitive behavioral therapy provided additional cost-effectiveness, especially for OCD. LIMITATIONS: During systematic review, relatively few articles provided information about both costs and effectiveness. While there was a notable margin of error to support multiple interventions as cost-effective, limited prior research decreased precision of point estimates and comparisons between interventions. CONCLUSIONS: Both antidepressant medication and cognitive behavioral therapy were found to be cost-effective for pediatric anxiety and OCD. Results supported investment from third party payers, who serve as critical gatekeepers that can increase treatment dissemination. However, more precise information would better inform the exact amount of investment needed, especially with regard to selection decisions between active interventions. Cost-effectiveness research would benefit from systematic collection of data on treatment costs and quality of life in future clinical trials.

Cost-effectiveness analysis of deep transcranial magnetic stimulation relative to evidence-based strategies for treatment-refractory obsessive-compulsive disorder.

OBJECTIVE: This study examined the cost-effectiveness of deep transcranial magnetic stimulation (dTMS) for treatment refractory obsessive-compulsive disorder (OCD) relative to other established treatment options, including antidepressant medication (ADM), ADM + antipsychotic augmentation, real-world cognitive-behavioral therapy (ADM + CBT Effectiveness), clinical trial CBT (ADM + CBT), intensive outpatient program (IOP), partial hospitalization program (PHP), and PHP to IOP stepdown. METHODS: A decision analytic model was developed to evaluate the cost-effectiveness of dTMS relative to other established treatment alternatives for adults (18-64 years old) with refractory OCD. Building on Gregory et al. (2018), the model was parameterized with probabilistic and deterministic parameters from the literature and an outcomes database to perform a Monte Carlo simulation of a hypothetical cohort of 100,000 adults with OCD to estimate costs, and incremental cost-effectiveness ratio (ICER) for dTMS relative to each treatment strategy. Encounters took place from 2012 to 2015. Data for dTMS were taken from a recent multisite study. RESULTS: Although dTMS fit between ADM and ADM + CBT in overall costs, ADM + CBT had the lowest ICER and thus would be chosen before dTMS. dTMS was determined to be more cost effective relative to PHP/IOP stepdown, PHP, and IOP. CONCLUSION: dTMS is cost-effective, along the treatment continuum from outpatient medication management and CBT to more intensive, facilities-based approaches, and may be an incremental strategy to employ when higher intensity strategies are either not available, not financially feasible, or whilst on extended waits for admission to these higher levels of care.

Evaluation of the Onclarity HPV assay on the high-throughput COR system.

Background: Here we compare the performance of the high-throughput BD COR System (COR) to the Viper LT System (Viper) using the BD Onclarity HPV assay.Research Design and Methods: Remnant clinical specimens, contrived specimens in SurePath (BD) and PreservCyt (Hologic) media, and prospective clinical specimens in BD Cervical Brush Diluent (CBD) were tested. Outcomes included intra-laboratory agreement of Onclarity results on COR and inter-system agreement between COR and Viper.Results: Onclarity reproducibility on COR resulted in standard deviation and correlation of variation of Ct values ranging from 0.14 to 1.98 and 0.49% to 2.15%, respectively, for contrived specimens, and 0.9-3.08 and 2.89-9.21%, respectively, for clinical specimens. In the COR and Viper clinical agreement study, OPA for Onclarity ranged from 97.1%-98.9%, depending on the collection media type. PPA values for pooled, HPV(+) specimens at low positive (C95), and moderate positive (3XC95) target concentrations were ≥95.0% and 100%, respectively; PPA values associated with HPV 16, 18, 31, 45, 33/58, 52, 35/39/68, 51, and 56/59/66, individually, ranged from 93.8%-100%.Conclusions: Onclarity performance on COR is equivalent to Viper, and is accurate and reproducible for detection of all high-risk HPV genotypes, with a throughput of 330 results from a single 8-hour shift.

Modeling the Effect of Tylosin Phosphate on Macrolide-Resistant Enterococci in Feedlots and Reducing Resistance Transmission.

Tylosin phosphate (TYL) is administered to more than 50% of U.S. beef cattle to reduce the incidence of liver abscesses but may increase the risk of macrolide-lincosamide-streptogramin-resistant bacteria disseminating from the feedlot. Limited evidence has been collected to understand how TYL affects the proportion of resistant bacteria in cattle or the feedlot environment. We created a mathematical model to investigate the effects of TYL administration on Enterococcus dynamics and examined preharvest strategies to mitigate the impact of TYL administration on resistance. The model simulated the physiological pharmacokinetics of orally administered TYL and estimated the pharmacodynamic effects of TYL on populations of resistant and susceptible Enterococcus within the cattle large intestine, feedlot pen, water trough, and feed bunk. The model parameters' population distributions were based on the available literature; 1000 Monte Carlo simulations were performed to estimate the likely distribution of outcomes. At the end of the simulated treatment period, the median estimated proportion of macrolide-resistant enterococci was only 1 percentage point higher within treated cattle compared with cattle not fed TYL, in part because the TYL concentrations in the large intestine were substantially lower than the enterococci minimum inhibitory concentrations. However, 25% of the simulated cattle had a >10 percentage point increase in the proportion of resistant enterococci associated with TYL administration, termed the TYL effect. The model predicts withdrawing TYL treatment and moving cattle to an antimicrobial-free terminal pen with a low prevalence of resistant environmental enterococci for as few as 6 days could reduce the TYL effect by up to 14 percentage points. Additional investigation of the importance of this subset of cattle to the overall risk of resistance transmission from feedlots will aid in the interpretation and implementation of resistance mitigation strategies.

Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening.

BACKGROUND: Primary high-risk human papillomavirus (hr-HPV) testing of self-collected cervico-vaginal swabs could increase cervical cancer screening coverage, although triage strategies are needed to reduce unnecessary colposcopies. We evaluated the use of extended hr-HPV genotyping of self-collected samples for cervical cancer screening. METHODS: We recruited women ages 25-65 years at two colposcopy clinics in North Carolina between November 2016 and January 2019, and obtained self-collected cervico-vaginal samples, provider-collected cervical samples, and cervical biopsies from all enrolled women. Self- and provider-collected samples were tested for 14 hr-HPV genotypes using the Onclarity Assay (Becton Dickinson). We calculated hr-HPV genotype-specific prevalence and assessed agreement between results in self- and provider-collected samples. We ranked the hr-HPV genotypes according to their positive predictive value (PPV) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+). RESULTS: A total of 314 women participated (median age, 36 years); 85 women (27%) had CIN2+. More women tested positive for any hr-HPV on self-collected (76%) than on provider-collected samples (70%; P = 0.009) with type-specific agreement ranging from substantial to almost perfect. HPV-16 was the most common genotype in self-collected (27%) and provider-collected samples (20%), and HPV-16 prevalence was higher in self- than provider-collected samples (P < 0.001). In self- and provider-collected samples, HPV-16 had the highest PPV for CIN2+ detection. CONCLUSIONS: Overall sensitivity for CIN2+ detection was similar for both sample types, but the higher HPV-16 prevalence in self-collected samples could result in increased colposcopy referral rates. IMPACT: Additional molecular markers might be helpful to improve the triage of women who are hr-HPV positive on self-collected samples.

Years of life lost associated with COVID-19 deaths in the United States.

BACKGROUND: The mortality effects of COVID-19 are a critical aspect of the disease's impact. Years of life lost (YLLs) can provide greater insight than the number of deaths by conveying the shortfall in life expectancy and thus the age profile of the decedents. METHODS: We employed data regarding COVID-19 deaths in the USA by jurisdiction, gender and age group for the period 1 February 2020 through 11 July 2020. We used actuarial life expectancy tables by gender and age to estimate YLLs. RESULTS: We estimated roughly 1.2 million YLLs due to COVID-19 deaths. The YLLs for the top six jurisdictions exceeded those for the remaining 43. On a per-capita basis, female YLLs were generally higher than male YLLs throughout the country. CONCLUSIONS: Our estimates offer new insight into the effects of COVID-19. Our findings of heterogenous rates of YLLs by geography and gender highlight variation in the magnitude of the pandemic's effects that may inform effective policy responses.

Cost-Effectiveness of Treatment Alternatives for Treatment-Refractory Pediatric Obsessive-Compulsive Disorder.

PURPOSE: Current guidelines for first-line treatment of childhood OCD are cognitive-behavioral therapy (CBT) utilizing exposure and response prevention (ERP), and/or antidepressant (ADM) pharmacotherapy, specifically serotonin reuptake inhibitors (SRI). Given that first-line are relatively similar in terms of clinical effectiveness, the role of costs to provide such services may help influence treatment decisions. In the case of treatment refractory pediatric OCD, this cost-effectiveness analysis (CEA) aims to further evaluate two additional, higher intensity combination therapies, namely OCD-specific Intensive Outpatient (IOP) and Partial Hospitalization Programs (PHP), to determine the additional benefits, in terms of effectiveness, that may result, and the corresponding increase in costs for these higher-intensity courses of therapy. RESULTS: IOP was the most cost-effective strategy in terms of change in CY-BOCS, pre/post treatment, equal to 16.42 units, followed by PHP and CBT monotherapy augmented with ADM CBT-monotherapy augmented with additional CBT and ADM-only augmented with CBT followed closely with 15.56 and 14.75 unit improvements in CY-BOCS. IOP accomplished its superior cost-effectiveness with an Incremental Cost-Effectiveness Ratio (ICER), of $48,834, lower than either of the established willingness to Pay thresholds. CONCLUSIONS: Lack of access to high fidelity, high dose CBT paired with pharmacotherapy is an issue for OCD patients and families. Among youth who were treatment non-responsive, these results indicate the superiority of a high dosage CBT strategy, indicating the need to increase access to these treatments.

An Organizational Intervention to Reduce Physician Burnout.

EXECUTIVE SUMMARY: Burnout is an individual's specific, personal, and intimate stress reaction to the workplace, characterized by emotional exhaustion, depersonalization, and reduced self-efficacy. Even though it particularly affects the helping professions, there has been relatively little exploration into the causes and determinants of burnout among physicians; instead, the focus has been on documenting the prevalence and consequences of physician burnout. Furthermore, while the theory of burnout is based on the relationship between the individual and his or her workplace, interventions have focused on improving the resilience of an individual to withstand this imbalance rather than identifying and ameliorating the cause.This study observed a natural experiment to measure changes in primary care providers' burnout before and after the implementation of a workload intervention that changed the work process within primary care clinics. Four clinics received the intervention, while four others served as comparisons. Among physicians in clinics receiving the intervention, the results show significant impacts, with an improvement in workload of 0.61 units (p = 0.037) and a decrease in the emotional exhaustion dimension of burnout of 6.989 units (p = 0.039).Self-care interventions are inconsistent with the theory of burnout; success of such interventions may be due to participants self-selecting these interventions, and individuals' inability to change their workplace without management approval. Leaders need to consider the impact of the workplace itself on physicians, in addition to results or outcomes.

Hormonal Contraception, depression, and Academic Performance among females attending college in the United States.

Associations between Hormonal Contraception (HC) and Depression have been previously reported, and indicate increased risk to younger women. These relationships need be explored and expanded to include measures of impact on Academic Performance (AP). Data was acquired from the National College Health Assessment (NCHA), administered from Fall 2008 to Spring 2015 across 370 schools nationwide. The most popular HC method was oral, followed by an IUD, and vaginal ring. HC use increased across all ages groups 18-29, and then decreased in the 30-34 age group. HC use significantly increased the odds of ever being diagnosed with depression in all age groups. HC use was found to have significantly increased odds of reporting AP issues in the 18-19 age group and to have significantly decreased odds of reporting AP issues in the 25-29 age group. Adding depression as a moderator, HC use continued to significantly increase the odds of AP issues. Women and their providers should balance the risks and benefits of initiating HC. Specifically, younger women, and be advised of the risks that HC presents in terms of a potential association with depression. Efforts to develop standardized protocols for discussing the risk-benefits for HC therapy should be pursued.

Treatment-Refractory Obsessive-Compulsive Disorder in Adults: A Cost-Effectiveness Analysis of Treatment Strategies.

OBJECTIVE: This study sought to assess the cost-effectiveness of 7 treatment strategies for treatment-refractory obsessive-compulsive disorder (OCD) in adults. METHODS: A model was developed to evaluate treatment alternatives for adults (18-64 years old) that consisted of 2 parts: a decision analytic model and a Markov model. The decision analytic model stratified 7 outpatient treatment strategies, and the Markov model accumulated benefits and costs across the life expectancy of a simulated cohort of individuals. The model was parameterized with probabilistic and deterministic parameters from the literature and an outcomes database to perform a Monte Carlo simulation of a hypothetical cohort of 100,000 adults with OCD to estimate net health benefits (NHBs), costs, and incremental cost-effectiveness ratio (ICER) for each treatment strategy. OCD was considered treatment refractory in adults with an OCD diagnosis who failed first-line therapies. Encounters took place from 2012 to 2015, and the analyses were performed from November 2016 to February 2017. RESULTS: Partial hospitalization with step-down to intensive outpatient treatment was the most cost-effective of the 7 strategies, with an estimated ICER of $7,983 and mean (SD) NHB of 10.96 (0.53) quality-adjusted life-years (QALYs) remaining. This result was 2.2 QALYs greater than that of the trial-based antidepressant and cognitive-behavioral therapy (ADM + CBT) strategy. Three additional ADM + CBT strategies were estimated not to be statistically significantly different from each other. These 4 ADM + CBT strategies outperformed both pharmacotherapy-only strategies. CONCLUSIONS: Treatment strategies that include higher-intensity CBT, with effectiveness outcomes that approached efficacy estimates, were superior to real-world CBT strategies. However, given the limited availability of high-quality CBT, especially through use of commercial insurance networks, specialized treatment programs offer greater effectiveness than real-world therapies in achieving wellness for this severe patient population.

Utilization of Mental Health Services by Children Displaced by Hurricane Katrina.

OBJECTIVE: This study examined changes in utilization of mental health services after Hurricane Katrina among children with preexisting conditions who were displaced from their homes in Louisiana disaster counties and resettled in Texas. METHODS: A retrospective analysis was performed on Medicaid claims data for 101,950 children from 2004 to 2006. Pre-post changes in utilization of mental health services by the displaced children and three control groups were compared. The control groups were children from Louisiana disaster counties who were not displaced, Louisiana children from nondisaster counties, and Texas children enrolled in Medicaid. RESULTS: The proportion of children who had a prescription fill for psychotropic medication and the average days' supply per child decreased in each group, but the decreases were significantly larger for the displaced group than for the control groups. The decreases in both measures were largest for stimulants and antidepressants, the two most common medication classes. By contrast, changes in the proportion of children with an encounter involving psychiatric services and the average number of psychiatric services encounters per child did not vary systematically across the displaced and control groups. CONCLUSIONS: The contrast between the results for medication utilization and encounters reveals a potential gap in post-Katrina provision of care. Although the findings for encounters indicate that, on average, displaced children did not experience a disruption in provider visits, the medication estimates suggest that they often did not obtain pharmaceutical treatment. Future disaster responses may be improved by addressing logistical impediments faced by disaster victims in filling their prescriptions for psychiatric medications.

Psychopharmacology Utilization Among Children with Anxiety and Obsessive-Compulsive and Related Disorders Following Hurricane Katrina.

This study aimed to examine the impact of Hurricane Katrina exposure on medication utilization among children with pre-existing anxiety and obsessive-compulsive and related disorders (OCRDs). Medicaid claims data from 2004 to 2006 were analyzed. Children with pre-existing anxiety/OCRDs were compared as a function of those living in a Louisiana disaster area, Louisiana non-disaster area, or Texas in terms of filled prescriptions and average days medication supply. This was further examined as a function of disorder/medication type. Prescriptions filled and average days medication supply were lower for those who resided in the disaster area of Louisiana relative to non-disaster zones in Texas (but not Louisiana). Children with OCD who lived in a disaster zone in Louisiana had 16.6 fewer days supply of antidepressants relative to youth in Texas. Similarly, children with PTSD who lived in a disaster zone in Louisiana had approximately 7 fewer days supply of stimulant medication relative to those who lived in Texas. Medication utilization was reduced for those youth directly exposed to Katrina relative to children in Texas, suggesting potential service disruption. Children with OCD and PTSD may be more likely to experience treatment disruption. Following disasters, particular attention should be given to ensuring continued treatment access for youth with pre-existing anxiety and OCRDs (as well as other conditions).

Intramuscular delivery of replication-defective herpes simplex virus gives antigen expression in muscle syncytia and improved protection against pathogenic HSV-2 strains.

Herpes simplex virus 2 (HSV-2) is the leading cause of genital herpes and increases the risk of HIV infection, but there is no effective vaccine. A replication-defective HSV-2 mutant virus, dl5-29, is effective in animal models and has been in a phase I trial. Previous studies have shown that dl5-29 gives higher antibody responses and better protection when inoculated intramuscularly (IM) as compared with subcutaneously (SC). However, the basis for this effect has not been defined. We confirmed that IM inoculation of dl5-29 is more immunogenic and provides better protection than SC inoculation. IM inoculation of HSV-2 strains produced higher levels of a luciferase transgene than SC inoculation, as measured by intravital bioluminescence imaging. Intramuscular immunization also showed better protection against infection with a highly pathogenic African HSV-2, demonstrating that this single vaccine can be efficacious against HSV-2 strains from different geographic regions.

Contemporary issues in anaphylaxis and the evolution of epinephrine autoinjectors: What will the future bring?

BACKGROUND: Food allergy and anaphylaxis appear to be increasing in the United States, especially in young children, and preparedness is paramount to successful emergency management in the community. Although the treatment of choice for anaphylaxis is epinephrine delivered by autoinjection, some devices are challenged by less user-friendly designs or pose the risk of injury, especially in young patients. Human factors engineering has played a larger role in the development of more recent epinephrine autoinjector technologies and will continue to play a role in the evolution and future design of epinephrine autoinjectors. OBJECTIVE: To discuss contemporary issues related to the identification and management of anaphylaxis, current and future epinephrine autoinjector design, and unmet needs for the treatment of special populations, namely, young children weighing less than 15 kg. METHODS: The literature was reviewed and select articles retrieved to support expert clinical opinions on the need for improved recognition of anaphylaxis, epinephrine autoinjector design, and unmet needs in special populations. RESULTS: Anaphylaxis may be underrecognized and poorly defined in infant- and toddler-aged children, current devices may not be adequate to safely treat these patients (ie, inappropriate needle length), and health care professionals may not be aware of these issues. CONCLUSION: As epinephrine autoinjector technology continues to evolve, device characteristics that promote safe, user-friendly experiences and give clinicians and their patients confidence to successfully treat anaphylaxis during an emergency, without injury, will be favored.

Novel multiplex assay platforms to detect influenza A hemagglutinin subtype-specific antibody responses for high-throughput and in-field applications.

BACKGROUND: Detections of influenza A subtype-specific antibody responses are often complicated by the presence of cross-reactive antibodies. We developed two novel multiplex platforms for antibody detection. The multiplexed magnetic fluorescence microsphere immunoassay (MAGPIX) is a high-throughput laboratory-based assay. Chembio Dual Path Platform (DPP) is a portable and rapid test that could be used in the field. METHODS: Twelve recombinant globular head domain hemagglutinin (GH HA1) antigens from A(H1N1)pdm09 (pH1N1), A(H2N2), A(H3N2), A(H5N1), A(H7N9), A(H9N2), A(H13N9), B/Victoria lineage, B/Yamagata lineage viruses, and protein A control were used. Human sera from U.S. residents either vaccinated (with H5N1 or pH1N1) or infected with pH1N1 influenza viruses and sera from live bird market workers in Bangladesh (BDPW) were evaluated. GH HA1 antigens and serum adsorption using full ectodomain recombinant hemagglutinins from A(pH1N1) and A(H3N2) were introduced into the platforms to reduce cross-reactivity. RESULTS: Serum adsorption reduced cross-reactivity to novel subtype HAs. Compared to traditional hemagglutination inhibition or microneutralization assays, when serum adsorption and the highest fold rise in signals were used to determine positivity, the correct subtype-specific responses were identified in 86%-100% of U.S. residents exposed to influenza antigens through vaccination or infection (N=49). For detection of H5N1-specific antibodies in sera collected from BDPW, H5 sensitivity was 100% (six of six) for MAGPIX, 83% (five of six) for DPP, H5 specificity was 100% (15/15), and cross-reactivity against other subtype was 0% (zero of six) for both platforms. CONCLUSION: MAGPIX and DPP platforms can be utilized for high-throughput and in-field detection of novel influenza virus infections.

Multicenter neonatal databases: Trends in research uses.

BACKGROUND: In the US, approximately 12.7% of all live births are preterm, 8.2% of live births were low birth weight (LBW), and 1.5% are very low birth weight (VLBW). Although technological advances have improved mortality rates among preterm and LBW infants, improving overall rates of prematurity and LBW remains a national priority. Monitoring short- and long-term outcomes is critical for advancing medical treatment and minimizing morbidities associated with prematurity or LBW; however, studying these infants can be challenging. Several large, multi-center neonatal databases have been developed to improve research and quality improvement of treatments for and outcomes of premature and LBW infants. The purpose of this systematic review was to describe three multi-center neonatal databases. METHODS: We conducted a literature search using PubMed and Google Scholar over the period 1990 to August 2014. Studies were included in our review if one of the databases was used as a primary source of data or comparison. Included studies were categorized by year of publication; study design employed, and research focus. RESULTS: A total of 343 studies published between 1991 and 2014 were included. Studies of premature and LBW infants using these databases have increased over time, and provide evidence for both neonatology and community-based pediatric practice. CONCLUSIONS: Research into treatment and outcomes of premature and LBW infants is expanding, partially due to the availability of large, multicenter databases. The consistency of clinical conditions and neonatal outcomes studied since 1990 demonstrates that there are dedicated research agendas and resources that allow for long-term, and potentially replicable, studies within this population.