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With the number of patients living with congenital heart disease steadily increasing, relevant training in anesthesia care for these patients is becoming ever more important. Written by experts in the field, this highly illustrated book succinctly reviews the pathophysiology of congenital cardiac lesions along with important anesthetic implications for each. Case scenarios cover patients of wide-ranging ages, with a focus on care in non-cardiac operating room settings, including the general operating room, cardiac catheterization laboratory and radiology. Divided into sections corresponding to the anatomic classification of each cardiac lesion, the book includes keywords for easy cross-referencing. Several lesions have multiple scenarios presented in order to allow readers to learn how to discern more critically ill patients. The stepwise approach to understanding complex lesions provides a readily accessible guide for all anesthesia providers who care for patients with congenital heart disease. The book is also a useful tool for intraoperative teaching.
Background: Intravitreal injection of vascular endothelial growth factor inhibitors with or without steroids is a well-established, effective therapy for several ocular disorders. The expected rate of complications from these injections is low, with meta-analyses reporting 5–6 occurrences of infectious endophthalmitis per 10,000 injections. Through October 2019, our health system observed 8 cases of endophthalmitis among 7,693 injections (10.4 per 10,000 injections), compared to 1 case in 2018. This unusually high rate prompted an infection control investigation and a case control study to examine risk factors for the development of postintravitreal injection endophthalmitis. Methods: Infection control providers performed direct observation of several ophthalmologists performing intravitreal injections on 3 separate occasions to determine points of intervention to prevent infection. To define risk factors for postintravitreal injection endophthalmitis, we conducted a retrospective case-control study of the 8 affected patients. Four control patients were selected per case, matched by clinic location, drug injected, and date of injection (total subjects, N = 40). We extracted patient-level risk factors from medical records; documentation was not sufficient to compare procedure-level factors. We conducted unadjusted univariate Poisson regression and Mantel–Cox method rate ratios to identify significant risk predictors of endophthalmitis. Results: Direct observation yielded variable practice in use of masks, gloves, sterile lid speculum, and the duration of povidone-iodine contact on the ocular surface prior to injection. The location of alcohol hand gel relative to the procedure field was suboptimal. Due to patient volume, there were significant delays between procedure and patient prep and injection time. The mean age was 76 years among cases and 74.1 years among controls; 35% of patients were men. Age-related macular degeneration was the most common indication for injection (55%). Only 10% of injections were bilateral. Although not statistically significant, patients with coronary artery disease had a higher rate of infection than those without coronary artery disease (165.3 vs 16.3 per 10,000 person years; IRR = 3.0; 95% CI, 0.60–14.8; P = .18); current smokers were also at higher risk (86.9 per 10,000; IRR, 3.2; 95% CI, 0.33–30.4; P = .32). Conclusions: Coronary artery disease and smoking were risk factors for the development of postintravitreal injection endophthalmitis in a 2019 cluster of cases in our organization. We are continuing to work with our ophthalmologists to optimize infection prevention in the injection environment, including strict use of gloves, appropriate use of povidone-iodine, and routinely wearing a mask and encouraging a no-talking policy during injections.
This article provides an overview of selected ongoing international efforts that have been inspired by Edward Zigler's vision to improve programs and policies for young children and families in the United States. The efforts presented are in close alignment with three strategies articulated by Edward Zigler: (a) conduct research that will inform policy advocacy; (b) design, implement, and revise quality early childhood development (ECD) programs; and (c) invest in building the next generation of scholars and advocates in child development. The intergenerational legacy left by Edward Zigler has had an impact on young children not only in the United States, but also across the globe. More needs to be done. We need to work together with a full commitment to ensure the optimal development of each child.
Spinal muscular atrophy (SMA) is a devastating rare disease that affects individuals regardless of ethnicity, gender, and age. The first-approved disease-modifying therapy for SMA, nusinursen, was approved by Health Canada, as well as by American and European regulatory agencies following positive clinical trial outcomes. The trials were conducted in a narrow pediatric population defined by age, severity, and genotype. Broad approval of therapy necessitates close follow-up of potential rare adverse events and effectiveness in the larger real-world population.
The Canadian Neuromuscular Disease Registry (CNDR) undertook an iterative multi-stakeholder process to expand the existing SMA dataset to capture items relevant to patient outcomes in a post-marketing environment. The CNDR SMA expanded registry is a longitudinal, prospective, observational study of patients with SMA in Canada designed to evaluate the safety and effectiveness of novel therapies and provide practical information unattainable in trials.
The consensus expanded dataset includes items that address therapy effectiveness and safety and is collected in a multicenter, prospective, observational study, including SMA patients regardless of therapeutic status. The expanded dataset is aligned with global datasets to facilitate collaboration. Additionally, consensus dataset development aimed to standardize appropriate outcome measures across the network and broader Canadian community. Prospective outcome studies, data use, and analyses are independent of the funding partner.
Prospective outcome data collected will provide results on safety and effectiveness in a post-therapy approval era. These data are essential to inform improvements in care and access to therapy for all SMA patients.
OBJECTIVES/GOALS: Prenatal cannabinoid use is increasing and more studies are needed to describe the neurodevelopmental impact on the fetus. However, pregnant cannabinoid users are a “hidden population,” which makes identification of these individuals for research difficult. Our study will employ three methods of recruitment and evaluate the success of each method. METHODS/STUDY POPULATION: We will recruit a total of 40 women in the third trimester of pregnancy who regularly use cannabinoid products thought to contain tetrahydrocannabinol (THC) and/or cannabidiol (CBD) throughout their pregnancies, and 20 control pregnant women who do not use those products. The purpose of this study is to evaluate the effects of prenatal cannabinoid use on the neurodevelopment of their offspring over the first year of life. We will employ three recruitment methods. First, targeted recruitment will occur in two university-based obstetrical clinics, where the obstetrician will present the study material and contact information. Second, we will utilize social media advertisements targeted to a specific demographic of Facebook users. Finally, we will employ the traditional method of distributing flyers in a non-targeted manner. We will track methods of recruitment success and gather information from the mothers on their preferences for recruitment approaches. RESULTS/ANTICIPATED RESULTS: Recruitment will start in January 2020 and continue for several months. We anticipate that the targeted method will yield the highest number of participants, and participants with the best fit for the inclusion criteria. However, it is possible that those women will be deterred by fear of having their drug use status revealed to their care providers, even though all research activity will occur independently from clinic visits and will not be transmitted to the electronic health record. The inclusion of a control group will also help foster “anonymity” for participants. The social media method has the potential for the greatest reach, but we expect many of these potential participants will fail to meet inclusion/exclusion criteria, as this is not as targeted as the first method. We anticipate a similar issue with the flyer-based approach. DISCUSSION/SIGNIFICANCE OF IMPACT: Optimizing recruitment of hidden and sensitive populations is crucial for clinical and translational research. Our goal is to identify strategies that can lead to best practices for engagement of those populations. Our conclusions could be applied in recruitment of sensitive populations for other clinical and translational research projects.
OBJECTIVES/GOALS: Clinical trials are the gold standard for developing evidence-based medicine. However, 20% of pediatric randomized clinical trials are discontinued and about 30% of completed trials go unpublished. (Pica and Bourgeois, 2016) Although patient recruitment is the most cited barrier to completing clinical trials, trials funded by academia are more likely discontinued compared to those funded by industry. This study is an attempt to gain additional insights into clinical trials in academic pediatrics. METHODS/STUDY POPULATION: Junior pediatrics faculty (Instructors and Assistant Professors) were recruited to participate in an online survey through RedCAP. The physicians were asked if they had prior experiences with clinical trials and whether they have interest in participating in clinical trials. Those interested were asked three additional questions: what role they were interested in, barriers to participating and interventions they thought would educate them about participating in clinical trials. RESULTS/ANTICIPATED RESULTS: Ninety two (92) out of 119 (77%) junior pediatrics faculty completed the survey. Twenty (20) pediatric subspecialties were represented and respondents were on various academic pathways. A third of the respondents (35%) had previously participated in clinical trials. A majority of the faculty respondents (84; 70%) are on the clinical educator pathway. The 13 respondents who were not interested in clinical trials indicated their preference for patient care, education and quality improvement. Of those interested in clinical trials, the top three preferred roles were site co-investigator (68%), help designing future protocol (47%) and site principal investigator (44%). Other than time, the top barriers to participation were a lack of awareness of what it takes to lead or engage in clinical trials (53%) and a lack of training on clinical trials (45%). Mentoring from an experienced clinical trialist emerged as the top preferred intervention (78%). DISCUSSION/SIGNIFICANCE OF IMPACT: Although limited to one institution, the findings of this study provide insights into pediatric faculty interest in clinical trials. If academic pediatricians are provided with mentoring, there could be an uptick in completed and published clinical trials involving pediatric populations.
This study examined the relationship between patient performance on multiple memory measures and regional brain volumes using an FDA-cleared quantitative volumetric analysis program – Neuroreader™.
Ninety-two patients diagnosed with mild cognitive impairment (MCI) by a clinical neuropsychologist completed cognitive evaluations and underwent MR Neuroreader™ within 1 year of testing. Select brain regions were correlated with three widely used memory tests. Regression analyses were conducted to determine if using more than one memory measures would better predict hippocampal z-scores and to explore the added value of recognition memory to prediction models.
Memory performances were most strongly correlated with hippocampal volumes than other brain regions. After controlling for encoding/Immediate Recall standard scores, statistically significant correlations emerged between Delayed Recall and hippocampal volumes (rs ranging from .348 to .490). Regression analysis revealed that evaluating memory performance across multiple memory measures is a better predictor of hippocampal volume than individual memory performances. Recognition memory did not add further predictive utility to regression analyses.
This study provides support for use of MR Neuroreader™ hippocampal volumes as a clinically informative biomarker associated with memory performance, which is a critical diagnostic feature of MCI phenotype.
The ‘jumping to conclusions’ (JTC) bias is associated with both psychosis and general cognition but their relationship is unclear. In this study, we set out to clarify the relationship between the JTC bias, IQ, psychosis and polygenic liability to schizophrenia and IQ.
A total of 817 first episode psychosis patients and 1294 population-based controls completed assessments of general intelligence (IQ), and JTC, and provided blood or saliva samples from which we extracted DNA and computed polygenic risk scores for IQ and schizophrenia.
The estimated proportion of the total effect of case/control differences on JTC mediated by IQ was 79%. Schizophrenia polygenic risk score was non-significantly associated with a higher number of beads drawn (B = 0.47, 95% CI −0.21 to 1.16, p = 0.17); whereas IQ PRS (B = 0.51, 95% CI 0.25–0.76, p < 0.001) significantly predicted the number of beads drawn, and was thus associated with reduced JTC bias. The JTC was more strongly associated with the higher level of psychotic-like experiences (PLEs) in controls, including after controlling for IQ (B = −1.7, 95% CI −2.8 to −0.5, p = 0.006), but did not relate to delusions in patients.
Our findings suggest that the JTC reasoning bias in psychosis might not be a specific cognitive deficit but rather a manifestation or consequence, of general cognitive impairment. Whereas, in the general population, the JTC bias is related to PLEs, independent of IQ. The work has the potential to inform interventions targeting cognitive biases in early psychosis.
Daily use of high-potency cannabis has been reported to carry a high risk for developing a psychotic disorder. However, the evidence is mixed on whether any pattern of cannabis use is associated with a particular symptomatology in first-episode psychosis (FEP) patients.
We analysed data from 901 FEP patients and 1235 controls recruited across six countries, as part of the European Network of National Schizophrenia Networks Studying Gene-Environment Interactions (EU-GEI) study. We used item response modelling to estimate two bifactor models, which included general and specific dimensions of psychotic symptoms in patients and psychotic experiences in controls. The associations between these dimensions and cannabis use were evaluated using linear mixed-effects models analyses.
In patients, there was a linear relationship between the positive symptom dimension and the extent of lifetime exposure to cannabis, with daily users of high-potency cannabis having the highest score (B = 0.35; 95% CI 0.14–0.56). Moreover, negative symptoms were more common among patients who never used cannabis compared with those with any pattern of use (B = −0.22; 95% CI −0.37 to −0.07). In controls, psychotic experiences were associated with current use of cannabis but not with the extent of lifetime use. Neither patients nor controls presented differences in depressive dimension related to cannabis use.
Our findings provide the first large-scale evidence that FEP patients with a history of daily use of high-potency cannabis present with more positive and less negative symptoms, compared with those who never used cannabis or used low-potency types.
Light and intermittent smokers (LITS) represent almost 50% of all current smokers. Research is needed to understand smoking motives among adult light smokers.
To explore smoking cues and motivators among a racially diverse sample of adult LITS (≤10 CPD). In addition, we explored differences between native (always smoked ≤10), and converted (former heavier) LITS.
We used purposive sampling to recruit participants who were native and converted LITS and to include equal numbers of African Americans, Whites and Latinos. We coded and analyzed transcripts using a stage approach to identify themes.
Four main themes emerged that may be unique to light smokers and suggests potential strategies for intervention: (1) smoking in response to cues and control, (2) identifying as a smoker, (3) concern about health consequences, and (4) other priorities influencing smoking. There were some differences among smoking cues and motivators by race and ethnicity, and differences between native and converted LITS.
Overall, LITS reported drivers of smoking that were unrelated to symptoms of nicotine withdrawal. Even when experiencing salient cues, our LITS cohort expressed the ability to assert control over smoking by abstaining when situational contexts made smoking inconvenient.
This chapter presents reflections on next-generation ethical issues by four deans at the University of Southern California: Public Policy, Medicine, Business, and Engineering. Each of the deans was asked to reflect on some of the important ethical issues that they believe we face today or that we will face in the near future. Their responses follow.
Research participants want to receive results from studies in which they participate. However, health researchers rarely share the results of their studies beyond scientific publication. Little is known about the barriers researchers face in returning study results to participants.
Using a mixed-methods design, health researchers (N = 414) from more than 40 US universities were asked about barriers to providing results to participants. Respondents were recruited from universities with Clinical and Translational Science Award programs and Prevention Research Centers.
Respondents reported the percent of their research where they experienced each of the four barriers to disseminating results to participants: logistical/methodological, financial, systems, and regulatory. A fifth barrier, investigator capacity, emerged from data analysis. Training for research faculty and staff, promotion and tenure incentives, and funding agencies supporting dissemination of results to participants were solutions offered to overcoming barriers.
Study findings add to literature on research dissemination by documenting health researchers’ perceived barriers to sharing study results with participants. Implications for policy and practice suggest that additional resources and training could help reduce dissemination barriers and increase the return of results to participants.
Community advisory boards (CABs) are a valuable strategy for engaging and partnering with communities in research. Eighty-nine percent of Clinical and Translational Science Awardees (CTSA) responding to a 2011 survey reported having a CAB. CTSAs’ experiences with CABs are valuable for informing future practice. This study was conducted to describe common CAB implementation practices among CTSAs; document perceived benefits, challenges, and contributions; and examine their progress toward desirable outcomes. A cross-CTSA collaborative team collected survey data from respondents representing academic and/or community members affiliated with CTSAs with CABs. Data representing 44 CTSAs with CABs were analyzed using descriptive statistics. A majority of respondents reported practices reflecting respect for CAB members’ expertise and input such as compensation (75%), advisory purview beyond their CTSA’s Community Engagement program (88%), and influence over CAB operations. Three-quarters provide members with orientation and training on roles and responsibilities and 89% reported evaluating their CAB. Almost all respondents indicated their CTSA incorporates the feedback of their CABs to some degree; over half do so a lot or completely. This study profiles practices that inform CTSAs implementing a CAB and provide an evaluative benchmark for those with existing CABs.