Comparing prospectively assigned trial and real-world lung cancer patients.

Aim: To evaluate the comparability of a probable clinical trial (CT) cohort derived from electronic medical records (EMR) data with a real-world cohort treated with the same therapy and identified using the same inclusion and exclusion criteria to emulate an external control. Methods: We utilized de-identified patient-level structured data sourced from EMRs. We then compared patterns of overall survival (OS) between probable CT patients with those drawn from non-contemporaneous real-world data (RWD) using a two-sided log-rank test, hazard ratios (HRs) using a Cox proportional-hazards model and Kaplan-Meier (KM) survival curves. Each regression estimate was calculated with a corresponding 95% confidence interval. We additionally conducted multiple matching methods to assess their relative performance. Results: Median (standard deviation) OS was 10.2 (0.7) months for the RWD arm and 11.3 (1.3) for the probable CT arm with a Log rank p-value equal to 0.4771. OS in both cohorts is longer than the reported CT median OS of 9.2 (0.6). The HRs generated under all five assessed matching methods (including without adjustment) were not statistically significant at the 95% confidence level. Conclusion: Our results suggest, with caveats noted, that survival patterns between real-world and CT cohorts in this NSCLC setting are not statistically significantly different.

Improving Real-World Mortality Data Quality in Oncology Research: Augmenting Electronic Medical Records With Obituary, Social Security Death Index, and Commercial Claims Data.

PURPOSE: This study evaluated the relative improvements in mortality data capture of adding different external data to enriched electronic medical records (EMRs) for patients with melanoma. METHODS: An enriched EMR database, containing structured and unstructured data, was used to evaluate the incremental mortality data capture of the following external data sources: Social Security Administration (SSA), public obituary, and an administrative open-claims database for the claims data set. Overall survival (OS) was assessed for each data set and the composite data set using the Kaplan-Meier method. RESULTS: A total of 3,882 patients were included in the study. The enriched EMR data set identified 1,085 patients with a death record. The SSA data set identified 213 patients (73 unique when combined with enriched EMR) with a death record, while the obituary data set identified 1,127 patients (241 unique). The administrative claims data set identified 378 patients (73 unique) with a death record; however, all these unique patients were already accounted for in the combined SSA and obituary data set. The composite data set yielded a median OS of 13.39 years, about 4 years shorter than the enriched EMR data set alone (17.63 years). CONCLUSION: When the enriched EMR data set was augmented with one external data set, the obituary data set provided the most additional value, followed by claims, and then SSA. The augmentation of all the data sources had a significant impact on the OS results compared with enriched EMR alone.

Evidence for a Multimodal Pain Management Regimen in Reduction of Postoperative Opioid Use in Pediatric Patients Receiving Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: This project aims to evaluate the relationship between increased use of intraoperative nonopioid analgesics, muscle relaxers, and anesthetics and postoperative outcomes, including opioid utilization, time until ambulation, and hospital length of stay. SUMMARY OF BACKGROUND DATA: Adolescent idiopathic scoliosis (AIS) is a structural deformity of the spine that occurs in otherwise healthy adolescents, occurring with a frequency of 1% to 3%. Up to 60% of patients receiving spinal surgeries, particularly posterior spinal fusion (PSF), experience at least 1 day of moderate-to-severe pain after surgery. PATIENTS AND METHODS: This is a retrospective chart review of pediatric patients aged 10 to 17 having received PSF with >5 levels fused for AIS at a dedicated children's hospital and a regional tertiary referral center with a dedicated pediatric spine program between January 2018 and September 2022. A linear regression model was used to evaluate the influence of baseline characteristics and intraoperative medications on the total amount of postoperative morphine milligram equivalents received. RESULTS: There were no significant differences in the background characteristics of the two patient populations. Patients receiving PSF at the tertiary referral center received equivalent or greater amounts of all nonopioid pain medications and demonstrated decreased time until ambulation (19.3 vs . 22.3 h), postoperative opioid use (56.1 vs . 70.1 MME), and postoperative hospital length of stay (35.9 vs . 58.3 h). Hospital location was not individually associated with a difference in postoperative opioid use. There was not a significant difference in postoperative pain ratings. When accounting for all other variables, liposomal bupivacaine had the greatest contribution to the decrease in postoperative opioid use. CONCLUSION: Patients receiving greater amounts of nonopioid intraoperative medications utilized 20% fewer postoperative morphine milligram equivalents, were discharged 22.3 hours earlier and had earlier recorded evidence of mobility. Postoperatively, nonopioid analgesics were as effective as opioids in the reduction of subjective pain ratings. This study further demonstrates the efficacy of multimodal pain management regimens in pediatric patients receiving PSF for AIS.

Characteristics of substance-addicted mothers that predict graduation from the family treatment court.

INTRODUCTION: In the United States, substance addiction is a major contributing factor to incarceration of mothers and separation of children from their families. Five hundred Family Treatment Courts (FTC) operate across the country to combat the growing problem of women addicted to drugs. The FTC model provides mothers with substance addiction treatment, intensive judicial monitoring, repeated drug testing, counseling, incentives or sanctions, and case management with the goal of reaching long-term sobriety and reunification with their children. DESIGN: This retrospective study examined the relationship between sociodemographic characteristics and substance use characteristics, in predicting participants' graduations from the FTC program. METHODS: Data were gathered from 317 participants from five Family Treatment Courts in the southeastern United States and analyzed using logistic regression. RESULTS: Participants who completed the FTC program were more likely to be older, completed Cognitive Behavioral Training, completed high school, and Caucasian. CONCLUSION: Age and completion of Cognitive Behavioral Therapy were the greatest predictors of graduating from the Family Treatment Court. These results convey the need for development of interventions tailored to each participant's age to maximize the success of the FTC participants. In addition, Cognitive Behavioral Therapy should be integrated into all FTC programs. CLINICAL RELEVANCE: The findings from this study will offer research scholars a foundation for designing future studies, aid researchers in creating interventions to increase success in substance addiction treatment programs, and contribute to the framework for theory development. In addition, understanding characteristics that may influence graduation from the Family Treatment Court will provide valuable information on developing interventions to support participants' success.

Knowledge of immediate newborn care and management of complications among midwives in Ghana.

OBJECTIVE: Midwives are instrumental in improving maternal/newborn health outcomes. Since complications after childbirth are leading causes of maternal deaths, midwives' knowledge of how to manage complications and care for the newborn is important. This study assessed midwives' knowledge of immediate newborn care and management of postpartum complications. DESIGN: A cross-sectional descriptive survey design was used. SETTING: Four hospitals that provide inpatient maternity services in Tamale, Ghana. PARTICIPANTS: 245 midwives who worked in the four hospitals. MEASUREMENTS: Data were collected in December 2018 using an electronic survey questionnaire by the Johns Hopkins Program for International Education in Gynecology and Obstetrics, and analyzed using descriptive, bivariate, and multivariate statistics. FINDINGS: About 98% of midwives were female. The mean age of midwives was 31.87 years. The percentage of midwives who responded correctly to questions on newborn care and management of postpartum complications ranged from 29.80% to 89.39%, and 32.17% to 91.43% respectively. Midwives were most knowledgeable about breastfeeding and immediate hemorrhage intervention, and least knowledgeable about cord care, thermal protection, newborn resuscitation, contraindications for vacuum extraction, treating metritis, and performing a cervical repair. Years of experience and age are predictive factors of midwives' knowledge. CONCLUSION/IMPLICATIONS: There remains the opportunity for continuing education on complication management. Additional training of midwives on newborn resuscitation is recommended.

A Longitudinal Study Identifying the Characteristics and Content Knowledge of Those Seeking Certification to Teach Secondary Biology in the United States.

Teacher content knowledge has been identified as a key prerequisite to effective instruction, and current educational policies require measurement of teacher content knowledge to assess candidacy for licensure. The primary instruments used in the United States are the Praxis Subject Assessment exams, which are designed to measure the subject-specific content knowledge needed to be a teacher. The Praxis Biology Subject Assessment exam, used by 42 U.S. states in the past decade, is the most common national measure used to determine biology content knowledge for teacher certification. Demographic and performance data from examinees (N = 43,798) who took the Praxis Biology Subject Assessment from 2006 to 2015 were compared to present a much-needed picture of who is seeking certification to teach biology, how different groups of aspiring biology teachers have performed, and how demographic makeup of prospective biology teachers compares with reports in previous studies describing the composition of the biology teacher workforce. Results indicate the majority of students self-reported as White (76%), female (66%), having undergraduate grade point averages (GPAs) at or above a 3.0 (76%) and majoring in biology (45%). Additionally, the demographic data were included in a linear regression model to determine the factors that explained the most variance in performance of the examinee. The model revealed substantial differences in average performance and pass rates between examinees of different genders, races, undergraduate majors, undergraduate GPAs, and census regions. This suggests that if the examinee is a White science, technology, engineering, and mathematics major, man with a 3.5 or higher undergraduate GPA, resides in the western United States, or plans to teach in a suburban school, the examinee will on average outperform their counterparts on the exam. From our analyses, we suggest several measures for the improvement of the biology teaching workforce and establish potential issues in the teacher pipeline that may impact the quality and diversity of U.S. biology teachers.

Characterizing managing physicians by claims sequences in episodes of care.

Value-based healthcare in the US is a payment structure that ties reimbursement to quality rather than volume alone. One model of value-based care is the Tennessee Division of TennCare's Episodes of Care program, which groups common health conditions into episodes using specified time windows, medical code sets and quality metrics as defined in each episode's Detailed Business Requirements [1,2]. Tennessee's program assigns responsibility for an episode to a managing physician, presenting a unique opportunity to study physician variability in cost and quality within these structured episodes. This paper proposes a pipeline for analysis demonstrated using a cohort of 599 Outpatient and Non-Acute Inpatient Cholecystectomy episodes managed by BlueCross BlueShield of Tennessee in 2016. We sorted episode claims by date of service, then calculated the pairwise Levenshtein distance between all episodes. Next, we adjusted the resulting matrix by cost dissimilarity and performed agglomerative clustering. We then examined the lowest and highest average episode cost clusters for patterns in cost and quality. Our results indicate that the facility type where the surgery takes place is important: outpatient ambulatory care center for the lowest cost cluster, and hospital operating room for the highest cost cluster. Average patient risk scores were higher in the highest cost cluster than the lowest cost cluster. Readmission rate (a quality metric tied to managing physician performance) was low for the whole cohort. Lastly, we explain how our analytical pipeline can be generalized and extended to domains beyond Episodes of Care.

Vasopressors and Inotropes as Predictors of Mortality in Acute Severe Cardiogenic Shock Treated With the Impella Device.

BACKGROUND: Vasopressors and inotropes are the primary pharmacologic agents in the management of cardiogenic shock. Increased use of these agents in the setting of cardiogenic shock treated with the Impella is associated with increased mortality. This study evaluates the use of vasopressors and inotropes as predictors of mortality in patients treated with the Impella for acute cardiogenic shock. METHODS: This retrospective study included 276 patients treated with the Impella 2.5, Impella CP, or Impella 5.0 from March 2011 to January 2020 at a single, tertiary referral center for acute cardiogenic shock. RESULTS: All-cause in-hospital mortality was 44.6%. Mortality significantly increased with escalating use of vasopressors and inotropes, with the most significant increase in mortality from use of 2 agents to the use of 3 agents (8.1% vs 39.7%, p < 0.001). There was no difference in mortality whether dobutamine or milrinone was used (44.4% vs 35.7%, p = 0.41); there was increased mortality with use of multiple inotropes. Patients treated with only vasopressors had increased mortality compared to those treated with a combination of agents that included 1 inotrope. CONCLUSIONS: The escalating need for vasopressors and inotropes and particular combinations of these agents are significant predictors of mortality that may help determine whether the Impella or higher level of support is more appropriate to treat acute cardiogenic shock.

Knowledge of postpartum care and postbirth warning signs among midwives in Ghana.

BACKGROUND: In Ghana, midwives are the primary maternity care practitioners. Their knowledge of postpartum care is critical for preventing and reducing maternal deaths because it affects the quality of care provided to women. In addition, midwives' knowledge of postbirth warning signs is important for early identification and management of complications. This study assessed midwives' knowledge of postpartum care and postbirth warning signs to develop interventions to improve patient care. METHODS: A cross-sectional survey of 246 midwives was conducted in the four main hospitals of Tamale, Ghana. Data were collected using a postpartum care knowledge questionnaire developed by JHPIEGO. Data were analyzed in SAS version 9.4 using descriptive, bivariate, and multivariate statistics. RESULTS: Mean age of midwives was 31.9 years. The percentage of midwives who responded correctly to each postpartum care question ranged from 41.6% to 84.9%. Most midwives were knowledgeable about breastfeeding-however, knowledge about fundus location, postpartum examination, and care during first 2 hours postpartum was low. Hospital was associated with knowledge of postpartum care (P < .001). Only 28.1% of midwives identified all nine warning signs of complications. Most midwives could identify severe bleeding, severe headaches, and high temperature as warning signs-however, knowledge of warning signs of some life-threatening complications such as chest pain, obstructed breathing, and thoughts of hurting oneself was low. More years of experience was associated with better knowledge of postbirth warning signs (P = .03). DISCUSSION: Findings suggest a need for additional training of midwives in how to care for postpartum patients and accurately identify warning signs for life-threatening complications.

Diagnosing the current state of out-of-field teaching in high school science and mathematics.

The U.S. government has acknowledged the critical role that teachers play in the production of Science, Technology, Engineering, and Mathematics (STEM) professionals who will drive our nation's economy. The No Child Left Behind Act of 2001 (NCLB) was passed to improve the quality of education nationwide, in part, by decreasing the number of out-of-field (OOF) teachers. However, the impact of NCLB and related efforts on the current state of OOF teaching in high school science and mathematics has yet to be examined. Our analysis of data from the National Teacher and Principal Survey (NTPS) indicates that from 2003-2016, the proportion of OOF teachers in chemistry and physics has increased, and there has been an increase in the number of students assigned to OOF teachers across subjects. We discuss the societal impact of our results and the critical role that policymakers, school administrators, and academic institutions, particularly university faculty, can play in its solution.

Predictors of Mortality and Outcomes of Acute Severe Cardiogenic Shock Treated with the Impella Device.

The Impella (Abiomed, Danvers, Massachusetts) device is increasingly used for mechanical circulatory support (MCS) to treat acute severe cardiogenic shock (CS). Initial and continued determination of the appropriate degree of MCS is challenging. This study evaluates predictors of mortality in patients treated with the Impella for acute severe CS and outcomes associated with prolonged Impella use. This retrospective single-center study included 204 patients treated with the Impella 2.5, Impella CP, or Impella 5.0 from 2011 to 2018 for acute severe CS. The primary end point was all-cause in-hospital mortality. All-cause in-hospital mortality was 45.1%. Nonsurvivors had a lower initial pH (7.24 vs 7.32, hazard ratio [HR] 1.03, p <0.0001), lower serum CO2 (19.1 vs 21.3 mmol/L, HR 1.08, p = 0.002), higher lactate (6.8 vs 3.3 mmol/L, HR 1.17, p <0.0001), and used a greater number of vasopressors and inotropes (4.3 vs 2.6, HR 1.44, p <0.0001). Patients with the Impella >4 days (n = 45) had a longer intensive care unit stay (12.6 vs 6.9 days, p <0.001), longer total hospital stay (16.4 vs 11.6 days, p = 0.03), longer mechanical ventilation use (7.8 vs 4.4 days, p = 0.002), and trend toward increased mortality (57.8 vs 41.5%, p = 0.051). In conclusion, in patients treated with the Impella for acute severe CS, initial biochemical parameters and need for vasopressors and inotropes are significant predictors of mortality that can serve as valuable indicators of whether the Impella or higher level of MCS is more appropriate. Patients treated with the Impella beyond 4 days have poorer outcomes and may benefit from escalation of care.

Setting a Standard for Chemistry Education in the Next Generation: A Retrosynthetic Analysis.

A diverse and highly qualified chemistry teaching workforce is critical for preparing equally diverse, qualified STEM professionals. Here, we analyze National Center for Education Statistics (NCES) Schools and Staffing Survey (SASS) data to provide a demographic comparison of the U.S. secondary chemistry teaching population in high-needs and non-high-needs public schools as well as private schools during the 2011-2012 academic year. Our analysis reveals that the chemistry teaching workforce is predominantly white and significantly lacks in-field degrees or certification across school types, though high-needs and private schools are most affected by this lack of teacher qualification. Given these results, we attempt to retrosynthetically identify the pathway yielding a qualified chemistry teaching workforce to draw attention to the various steps in this scheme where reform efforts on the part of individual faculty, academic institutions, and organizations can be concentrated.

Flexible bivariate phase II clinical trial design incorporating toxicity and response on different schedules.

The single-arm, two-stage clinical trial is a popular design utilized to evaluate oncology treatments. The designs are typically augmented with an ad hoc toxicity monitoring rule that is imposed outside of the formal two-stage design. In this work, we present a flexible bivariate single-arm clinical trial design that incorporates both response and toxicity. The design is considered flexible because it can monitor toxicity on a different schedule from the response. An example is considered in which toxicity is measured at four equally spaced times, which correspond to the data monitoring committee's meeting schedule while evaluating the response only at the second and fourth toxicity evaluations. The effect of the correlation on the types I and II error rates is examined through simulation. The simulations also examine the power over the response rates when the toxicity rate is fixed in the alternative region and vice versa.

Statistical Analysis of Repeated MicroRNA High-Throughput Data with Application to Human Heart Failure: A Review of Methodology.

Complex experimental designs present unique challenges in the analysis of microRNA (miRNA) Cycle to Threshold (Ct) values. In this manuscript, we discuss various statistical techniques and their application in an analysis performed at the JG Brown Cancer Center. We consider data quality evaluation, data normalization, and statistical hypothesis procedures all in context of the example. The experiment utilized as the motivating example involved repeated sampling over time. The intra-subject correlation created by the repeated sampling should be incorporated into the analysis resulting in additional significant miRNAs. The statistical techniques leveraged to analyze miRNA Ct values resulting from qPCR should incorporate key features of the experimental design. It discusses potential issues with the commonly used methodologies when the experiment collects multiple samples from the same individuals over time.