Comparison of a Valveless Trocar System and Conventional Insufflation in Pediatric Urologic Surgery.

Background: Conventional operative insufflation uses a one-way trocar to handle instruments while maintaining pneumoperitoneum. In 2007, the AirSeal® valveless trocar insufflation system was introduced, which maintains stable pneumoperitoneum while continuously evacuating smoke. Although this device has been validated in adult patients, it has not been extensively validated in the pediatric population. Materials and Methods: A retrospective cohort study of pediatric urology patients aged 0 to 21 who underwent laparoscopic pyeloplasty between March 2016 and October 2021 was performed. Intraoperative physiologic parameters, procedure characteristics, postoperative outcomes, and demographics of each patient in whom either AirSeal insufflation system (AIS) or conventional insufflation system (CIS) was utilized were obtained from hospital records. Data were compared across the AIS and CIS cohorts. The primary outcomes were intraoperative anesthetic and physiologic parameters, including end tidal carbon dioxide, oxygen saturation, body temperature, positive inspiratory pressure, systolic blood pressure, and heart rate. Results: There were no significant differences in the anesthetic and physiologic parameters in the AIS and CIS groups. In addition, no differences in demographics, procedural characteristics, or complication rates were found between the cohorts. Conclusion: The AirSeal valveless trocar insufflation system demonstrates comparable intraoperative anesthetic and physiologic outcomes compared to conventional one-way valve insufflation in pediatric laparoscopic pyeloplasty. Certain surgeon-related qualitative metrics are underappreciated in this study, however, including improved visualization with vigorous suctioning and pressure maintenance with frequent instrument exchanges. Surgeon experience may mask the benefits of these characteristics as it pertains to quantitative surgical outcomes such as estimated blood loss, operative time, and perioperative complications.

A Framework for Engaging Healthcare Professional Trainees as Continuing Education Activity Planners and Speakers.

Health professional education and post-graduate training programs, including residencies, fellowships, and other post-graduate training experiences, may encourage or require trainee participation in continuing education (CE) activity planning and development. Providers of CE should ensure appropriate mentorship and faculty guidance during development of the activity and provide direction on the expectations of adult learning principles (e.g. identification of an educational gap; development of measurable learning objectives; inclusion of independent, balanced, and evidenced-based content; use of active learning techniques; and incorporation of learning assessment methods). Nonetheless, there is no established best practice or approach for how CE providers should ensure trainees are prepared to serve as CE activity faculty. New practitioners provided with an opportunity to participate may be unsure of where to begin and may be hesitant to engage in this new activity. In this manuscript, authors delineate key principles to incorporate when introducing trainees to CE activity development and share outcomes associated with a comparison of trainee- vs. faculty-developed and delivered CE.

Evaluation of temperature excursions from USP <659> recommendations during mail transit.

BACKGROUND: Patients use mail delivery as a convenient alternative to acquiring medications in person. Federal laws require nonspecialty oral medications to be stored at controlled room temperature during distribution; however, no laws or regulations govern temperature requirements for medication transport among patients, which may expose medications to harmful temperature excursions. OBJECTIVE: The purpose of this study was to evaluate temperature excursions during mail transit based on the shipment method, carrier, and season. METHODS: This prospective study monitored temperature fluctuations during simulated mail transit between New Jersey, California, and Tennessee over winter (December 2019-February 2020) and summer (August-September 2020) time frames. Packages with data-logging thermometers were shipped to 3 U.S. destinations via 3 common mail carriers and 2 popular shipping methods. Three packages were mailed for each combination of season, carrier, and shipping method, representing 36 individual packages. The primary end point was percent of transit time out of range (OOR) based on the United States Pharmacopeia <659> recommended range, 68°F to 77°F. Additional end points include package transit durations and extreme temperatures. RESULTS: Evaluated packages spent an average of 68.3% of transit time OOR. In winter, 3-day and next business day packages spent similar time OOR (80.1% vs. 78%). In summer, 3-day packages spent more time OOR compared with next business day shipping (43.1% vs. 13.6%). Mean transit time was statistically significantly longer for 3-day packages (406.6 hours vs. 303.1 hours; P < 0.0001). Mean winter transit time was statistically significantly longer than summer (475.7 hours vs. 233.9 hours; P < 0.001) regardless of the shipping method. The minimum and maximum temperatures recorded were 5.1°F and 102.3°F, respectively. CONCLUSION: Package temperatures were outside of the recommended range for most of the transit time regardless of the shipping method, carrier, or season.

Chemotherapy Refractory Spindle-Cell Rhabdomyosarcoma of the Bladder Treated With Consolidative Ovarian-Sparing Radical Surgery.

We present a case of chemotherapy refractory spindle cell rhabdomyosarcoma of the lower urinary tract in a 15-month-old female that ultimately required consolidative surgery with cystectomy, urethrectomy, ovarian-sparing hysterectomy, bilateral salpingectomy, anterior vaginal wall resection, and bilateral pelvic lymph node dissection. Genitourinary reconstruction was performed by ileal conduit creation and vaginoplasty. After completion of her maintenance postoperative chemotherapy regimen, the patient has remained disease-free for approximately 27 months.

Health Literacy Level and Comprehension of Prescription and Nonprescription Drug Information.

The aim of this study was to investigate the level of misunderstanding of medication information in Korean adults after stratifying by level of health literacy and to identify the factors influencing the misunderstanding of medication information and reading amounts of information on OTC drug labels. A cross-sectional survey was performed with 375 adult participants using the survey instrument. Multiple linear regression analyses were performed to identify factors which influence misunderstanding of medication information. Participants misunderstood 20% of words on OTC drug labels, 9% of prescription drug instructions, and 9% of pictograms. Participants on average read 59% of the overall contents of the OTC drug labels. As prescription drugs' dosing regimens became more complicated, the level of misunderstanding instructions increased. The level of misunderstanding words on OTC drug labels significantly decreased as participants had adequate health literacy (ß = −18.11, p < 0.001) and higher education levels (ß = −6.83, p < 0.001), after adjusting for the study variables. The level of misunderstanding instructions for prescription drugs increased as participants became older (ß = 8.81, p < 0.001) and had lower education levels (ß = −5.05, p < 0.001), after adjusting for the study variables. The level of misunderstanding pictograms was similar to that of misunderstanding instructions for prescription drug labels. The amount of reading information on OTC drug labels significantly increased as respondents had adequate health literacy (ß = 9.27, p < 0.001), were older (ß = 12.49, p < 0.001), or had chronic diseases (ß = 7.49, p = 0.007). Individuals' health literacy level, reading behaviors, and complexity of medication instructions are associated with misunderstanding of medication information. Appropriate word choices in drug labels and an improved format of medication instructions could increase understanding of medication information and prevent adverse drug reactions.

Opioid abuse risk among student pharmacists.

OBJECTIVE: To benchmark opioid abuse risk among student pharmacists attending three northeast pharmacy schools utilizing the opioid risk tool (ORT). DESIGN: A cross-sectional, anonymous risk assessment questionnaire. SETTING: Three pharmacy schools in the northeast United States. PARTICIPANTS: Professional year 1 (P1) through professional year 3 (P3) student pharmacists. METHODS: ORT was collected and scored by investigators and inputted into an electronic format for analysis. Students voluntarily participated, and 812 surveys were completed during one course meeting time and day at each school. RESULTS: The majority of students were in the low-risk category (n = 581, 71.6 percent). Additionally, 137 (16.9 percent) patients were categorized as moderate risk and 94 (11.6 percent) as high risk. No statistically significant differences existed when comparing risk groups across the first through third professional year student pharmacist cohorts. There were no statistically significant differences in the proportion of risk groups among the three pharmacy cohorts between low-risk versus the high-risk groups. When comparing risk groups by gender, males were found to have a statistically significant higher proportion of being classified as moderate or high risk. CONCLUSIONS: The results of this study demonstrate that there may be some student pharmacists with an increased risk for opioid abuse potential. There is potential need for education regarding opioid risk awareness and abuse prevention, which may serve as a call to action for professional school students and practitioners to understand baseline opioid abuse risk if they require chronic pain therapy.

Survival of nonseminomatous germ cell tumors in pediatric patients and young adults - A stage group stratified analysis.

INTRODUCTION: Testicular germ cell tumors, particularly nonseminomatous germ cell tumors (NSGCT), comprise the most common solid malignancy in male children and younger adults. While these patients experience excellent survival outcomes, few studies have characterized their survival by age. Thus, we aimed to characterize the relative survival of NSGCT by age, stratifying patients by stage group. METHODS: Using the Surveillance Epidemiology and End Results (SEER) database, we divided patients with NSGCT into pediatric patients and adolescents (<19 years), young adults (19-30 years), and older adults (>30 years). Survival analysis, using Cox proportional hazards models and Kaplan Meier curves, described overall and cancer-specific survival (CSS) of each age category for Stage I-III NSGCT by stage group. RESULTS: A total of 14,786 patients met inclusion criteria and comprised the age groups <19 years (N=1,287), 19 to 30 years (N=7,729), and >30 years (N=5,770). Stage group distribution at presentation was similar between each group. Survival analysis demonstrated no differences in cancer-specific survival (CSS) among Stage I or II NSGCT. However, among Stage III tumors, multivariable models noted worse CSS in patients >30 years (HR=3.35 (95%CI: 1.45-7.73), P=0.005) and those 19-30 years (HR=2.28 (95%CI: 0.99-5.21), P=0.053) compared to pediatric and adolescent patients. CONCLUSIONS: Younger NSGCT patients experience excellent oncologic outcomes compared to their older counterparts. These survival differences by age group are largely driven by differential survival among Stage III neoplasms. Furthermore, our report lends additional evidence that age is an important prognostic factor in advanced NSGCT, including pediatric and adolescent patients.

Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials.

BACKGROUND: Melanoma is a skin cancer with a rising worldwide incidence of just over 280,000 individuals with the greatest burden of illness in European, New Zealander, and Australian populations. Patients are diagnosed with melanoma with the mean and median ages being 65 and 59 years old, respectively. Phase 3 trials not only provide a wide representation of the target population but also study the efficacy for a certain intervention. OBJECTIVE: The objective of this literature review is to analyze patient demographics of phase 3 trials for melanoma and identify if there is a true disparity between the clinical trial age demographics and the natural epidemiological age demographics. DATA SOURCES: The authors conducted a search on clinicaltrials.gov, a publicly available resource that lists clinical trials and their data. The reported mean and median ages for each trial were extracted after determining if each trial meets our inclusion criteria. Weighted mean and median ages were calculated using an online calculator. Data from 35 trials were evaluated with 30 trials reporting a weighted mean age of 55.85 years and 5 trials reporting a weighted median age of 55.14 years. CONCLUSION: Based on the results, melanoma clinical trials enroll patients who are younger than the epidemiological mean and median ages. Due to this underrepresentation of the elderly patients with melanoma, clinical trials may provide limited application for the use of their results.

Pharmacists' Perceptions and Drivers of Immunization Practices for COVID-19 Vaccines: Results of a Nationwide Survey Prior to COVID-19 Vaccine Emergency Use Authorization.

BACKGROUND: Pharmacists play a vital role in recommending and providing vaccines to improve public health and are on the front line of mass immunization efforts. AIM: The objective of this study is to evaluate pharmacists' perceptions on COVID-19 vaccines prior to emergency use authorization (EUA) amid a global pandemic. METHODS: A voluntary, anonymous, cross-sectional survey was conducted between September and November 2020. Survey respondents included a convenience sample of licensed pharmacists in the United States. The primary outcomes were pharmacists' willingness to receive and recommend hypothetical COVID-19 vaccines. Covariates assessed in the survey included COVID-19 exposure or personal experience, primary pharmacy practice setting, background in training, geographic region, and prioritization of clinical data. The data were analyzed using descriptive and inferential statistics. RESULTS: This study surveyed 763 pharmacists and results from 632 participants were included in final analysis. Overall, 67.1% of the pharmacists were willing to receive a COVID-19 vaccine and 63.4% of the pharmacists were willing to recommend a COVID-19 vaccine at ≤1 year from the time of vaccine approval. At >1 year after vaccine approval, 78% of the pharmacists were willing to receive a COVID-19 vaccine and 81.2% of the pharmacists were willing to recommend a COVID-19 vaccine. CONCLUSIONS: Survey findings suggest that, while a majority of pharmacists surveyed indicate acceptance of hypothetical COVID-19 vaccines, there remains to be hesitancy among pharmacists to receive or recommend vaccination.

Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial.

BACKGROUND: Maturation of multiple neurobehavioral systems, including autonomic regulation, is altered by preterm birth. The purpose of this study was to determine the long-term effects of Family Nurture Intervention (FNI) in the NICU on autonomic regulation of preterm infants and their mothers. METHOD: A subset of infants and mothers (48% of infants, 51% of mothers) randomly assigned to either standard are (SC), or SC plus the FNI in the NICU in a prior RCT (ClincalTrials.gov; NCT01439269) returned for follow-up assessments when the children were 4 to 5 years corrected age (CA). ECGs were collected for 10 minutes in mothers and their children while children were in their mothers' laps. Heart rate, standard deviation for heart rate, respiratory sinus arrhythmia (RSA)-an index of parasympathetic regulation, and a measure of vagal efficiency were quantified. RESULTS: Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031). In addition, RSA increased more rapidly in FNI children between infancy and the 4 to 5-year follow-up time point (SC = +3.11±0.16 loge msec2, +3.67±0.19 loge msec2 for FNI, p<0.05). These results show that the rate of increase in RSA from infancy to childhood is more rapid in FNI subjects. CONCLUSION: Although these preliminary follow-up results are based on approximately half of subjects originally enrolled in the RCT, they suggest that FNI-NICU led to healthier autonomic regulation in both mother and child, when measured during a brief face-to-face socioemotional interaction. A Pavlovian autonomic co-conditioning mechanism may underly these findings that can be exploited therapeutically.

Age demographics of subjects enrolled in interventional phase 3 multiple myeloma clinical trials.

The mean and median ages of diagnosis of multiple myeloma range from 70 to 73 years old, with 63% of patients being over the age of 65. Phase 3 clinical trials are designed to study efficacy in the target disease population and are meant to have the most representative subject pool. The purpose of this review is to identify the age demographic of subjects participating in interventional phase 3 clinical trials that aim to treat multiple myeloma and to determine if they encompass the true age demographic of the disease. To complete this review, a search of phase 3 multiple myeloma research trials with reported results was conducted on clinicaltrials.gov, a national, publicly available resource listing clinical trials. Reported mean or median ages of subjects were identified for each trial, and adjusted averages of these values were calculated. Data from 81 clinical trials were assessed, with 42 trials reporting an average mean age of 65.78 years and 15 trials reporting an average median age of 63.29 years. Based on these results, it was determined that the clinical trials reported in this study enrolled patients that were younger than the true age demographic of the disease. There is an unmet need in research in the older population of patients with multiple myeloma, and this may hinder the generalizability and utility of clinical trial results.

Family nurture intervention alters relationships between preterm infant EEG delta brush characteristics and term age EEG power.

OBJECTIVE: Family Nurture Intervention (FNI) facilitates mother/infant emotional connection, improves neurodevelopmental outcomes and increases electroencephalogram (EEG) power at term age. Here we explored whether delta brushes (DB), early EEG bursts that shape brain development, are altered by FNI and mediate later effects of FNI on EEG. METHODS: We assessed DB characteristics in EEG data from a randomized controlled trial comparing infants with standard care (SC, n = 31) versus SC + FNI (n = 33) at ~35 and ~40 weeks GA. RESULTS: Compared to SC infants, FNI infant DB amplitude increased more from ~35 to ~40 weeks, and FNI infants had longer duration DBs. DB parameters (rate, amplitude, brush frequency) at ~35 weeks were correlated with power at ~40 weeks, but only in SC infants. FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term. CONCLUSIONS: DBs are related to subsequent brain activity and FNI alters DB parameters. However, FNI's effects on electrocortical activity at term age are not dependent on its earlier effects on DBs. SIGNIFICANCE: While early DBs can have important effects on later brain activity in preterm infants, facilitating emotional connection with FNI may allow brain maturation to be less dependent on early bursts.

Testicular torsion in brothers.

Testicular torsion is a common pediatric emergency. Predisposing factors and other risk factors for testicular torsion have not been fully elucidated. This case report highlights teenage brothers who each experienced right-sided testicular torsion at nearly the same age, just 1 year apart. Because of their parents' urgency in seeking medical attention, the affected testicles in both patients were salvaged. We also review the current literature in regards to etiology, inheritance, and patient and parental education.

Sentiment of Media Coverage and Reputation of the Pharmaceutical Industry.

BACKGROUND: Patients and health care professionals receive information about pharmaceutical companies through various sources, including but not limited to print media, social media, and electronic media. The objective of this research was to benchmark the sentiment of electronic newspaper media coverage between 2014 and 2016 and investigate the potential relationship to the public perception of the select pharmaceutical companies. METHODS: Reputation Institute's RepTrak System report was used for selection of 5 highly rated pharmaceutical companies (A-E). Electronic newspapers were selected based on US circulation within the selected time period. Lexalytics sentiment analysis software was used for analysis of relevant articles appearing in the selected newspapers. RESULTS: A total of 797 articles were analyzed; 63% were assessed as neutral, 24% as negative, and 14% as positive. The overall median sentiment scores (scale ranging from -2 through [Formula: see text]2) for companies A through E across all newspapers were determined to be [Formula: see text]0.026, [Formula: see text]0.03, [Formula: see text]0.028, [Formula: see text]0.034, and [Formula: see text]0.033, respectively. The most frequent topics were merger/acquisition/ re-structuring, finances/stocks/profits, and other, which included topics such as transparency of pharmaceutical industry data, lack of drug efficacy, and innovation. CONCLUSION: Overall, pharmaceutical companies were represented similarly across newspapers and most articles were assessed as neutral. However, on analysis of all nonneutral articles, all categories were assessed as negative with the exception of finances/stocks/profits.

Early Life Maternal Separation and Maternal Behaviour Modulate Acoustic Characteristics of Rat Pup Ultrasonic Vocalizations.

Early separation of preterm infants from their mothers has adverse, long-term neurodevelopmental consequences. We investigated the effects of daily maternal separation (MS) of rat pups from postnatal days 2-10 (PND2-10) on neurobehavioural responses to brief isolation at PND12 compared with pups receiving controlled handling without MS. Ultrasonic vocalizations (USV) were measured at PND12 during two, 3-minute isolations occurring immediately before and after a 3-minute maternal reunion. There were no significant differences in acoustic characteristics between MS and control animals in the first isolation. However, in the second isolation, MS pups produced a greater proportion of high (~60 kHz) vs low (~40 kHz) frequency calls. During this isolation, control pups made longer and louder low frequency calls compared to the first isolation, whereas MS pups did the opposite. Maternal behaviour of control and MS mothers modulated pup acoustic characteristics in opposite directions; higher maternal care was associated with more low frequency calls in control pups but more high frequency calls in MS pups. We hypothesize that MS results in USV emission patterns reflective of a greater stress response to isolation. This translational model can be used to identify mechanisms and interventions that may be exploited to overcome the negative, long-term effects of MS.

Perinatal antibiotics alter preterm infant EEG and neurobehavior in the Family Nurture Intervention trial.

Early exposure to antibiotics has been shown to increase risk for poor neurobehavioral development, particularly with regard to attention deficit disorders. Clinically, electroencephalography (EEG) is increasingly used as a biomarker of these deficits. Less is known about the effects of antibiotics on neurobehavioral and neurophysiological outcomes in preterm infants, a population at particularly high risk for attention deficits and perinatal antibiotic exposure. This study examines the effects of perinatal antibiotic exposure on neonatal EEG and attention deficits as measured by the Child Behavior Checklist in 4- to 5-year-old children who were enrolled in an NICU-based randomized controlled trial comparing Family Nurture Intervention (FNI) to standard care. Antibiotic-exposed infants had increased attention problems and there was a main effect of antibiotic exposure such that exposed infants had higher EEG power. This effect was fourfold greater in infants who received standard NICU care compared to those who received the intervention, suggesting a buffering effect of the intervention. We hypothesize that the relationship between antibiotic exposure and altered neurodevelopment may be due to effects of antibiotics on the microbiome, and that FNI may buffer these adverse consequences.

Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements.

BACKGROUND: The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas. METHODS: The study reviews prescription drug TV advertisements between the years 2010 and 2015 separated by therapeutic class. Indicators to assess risk versus benefit are as follows: total benefit time, total risk time, total ad time, percentage proportion of risk, and number of serious adverse effects (SAEs) listed in the package insert. The objective is establishing proportion of risk-to-benefit narration across therapeutic areas and the proportion of risk narration compared to the number of SAEs in the package insert. These outcomes will reflect whether TV advertisements abide by the "fair balance" rule and if the time spent on risk narrations is proportional to the number of SAEs across therapeutic areas. RESULTS: An analysis of risk versus benefit showed that there was a vast range of percentage differences in risk versus benefit narration across the products selected. The majority of the products narrated showed a 40% to 60% risk-to-benefit ratio. Six out of the 10 products evaluated communicated applicable black box warnings. There was variability among the SAE percentages presented between products. CONCLUSION: Lack of consistency exists between risks versus benefit proportions among different drug products.

Disaster Preparedness: Biological Threats and Treatment Options.

Biological disasters can be natural, accidental, or intentional. Biological threats have made a lasting impact on civilization. This review focuses on agents of clinical significance, bioterrorism, and national security, specifically Category A agents (anthrax, botulism, plague, tularemia, and smallpox), as well as briefly discusses other naturally emerging infections of public health significance, Ebola virus (also a Category A agent) and Zika virus. The role of pharmacists in disaster preparedness and disaster response is multifaceted and important. Their expertise includes clinical knowledge, which can aid in drug information consultation, patient-specific treatment decision making, and development of local treatment plans. To fulfill this role, pharmacists must have a comprehensive understanding of medical countermeasures for these significant biological threats across all health care settings. New and reemerging infectious disease threats will continue to challenge the world. Pharmacists will be at the forefront of preparedness and response, sharing knowledge and clinical expertise with responders, official decision makers, and the general public.