Changes in Residency Applicant Cancellation Patterns with Virtual Interviews: A Single-site Analysis.

Background: Residency programs transitioned to primarily virtual interviews due to the COVID-19 pandemic. This shift raised questions regarding expectations and patterns of applicant cancellation timeliness. The purpose of this study was to examine changes in applicant cancellations after transitioning to virtual interviews. Methods: This was a retrospective cohort study of interview data from a three-year emergency medicine residency at a tertiary-care academic medical center. Using archived data from Interview Broker, we examined scheduling patterns between one in-person (2019-2020) and two virtual interview cohorts (2020-2021 and 2021-2022). Our outcomes were the overall cancellation rates relative to interview slots as well as the proportion of cancellations that occurred within 7 or 14 days of the interview date. Results: There were 453 interview slots and 568 applicants invited. Overall, applicants canceled 17.1% of scheduled interviews. Compared with in-person interviews, applicants canceled significantly fewer virtual interviews (in person: 40/128 (31.3%), virtual year 1: 22/178 (12.4%), virtual year 2: 15/143 (10.5%), P = 0.001). Conversely, applicants canceled significantly more virtual interviews within both the 14-day threshold (in person: 8/40 (20%), virtual year 1: 12/22 (55.5%), virtual year 2: 12/15 (80%), P < 0.001) and the 7-day threshold (in person: 0/40 (0%), virtual year 1: 3/22 (13.6%), virtual year 2: 4/15 (26.7%), P = 0.004). Conclusion: While limited, at our site, changing to a virtual interview format correlated with fewer cancellations overall. The proportion of cancellations within 14 days was much higher during virtual interview seasons, with most cancellations occurring during that time frame. Additional studies are needed to determine the effects of cancellation patterns on emergency medicine recruitment.

A retrospective review of the association between maternal body mass index and the risk of congenital anomalies.

The objective of the study was to examine the association of congenital anomalies with the specific classes of pre-pregnancy BMI. An IRB-approved retrospective cohort study was performed using the data from the Natality Public Use File from the National Center for Health Statistics (2019). We included all singleton live births and excluded pregnancies with suspected or confirmed chromosomal abnormalities and people with pre-existing diabetes mellitus and missing pertinent data. The primary outcome was the incidence of any major congenital anomalies in liveborn infants. The incidence of anomaly was analyzed across all BMI classes, using individuals with BMI between 18.5 and 24.9 kg/m2 as the comparison group. A test of trend was also performed to determine if the risk increased as the BMI class increased. A total of 3 047 382 maternal-neonatal dyads were included in the analysis. A non-significant higher incidence of any major anomaly was noted among people who had underweight and class III BMI. The risk of open neural tube defects, omphalocele, and cleft lip/palate increased and the risk of gastroschisis decreased with an increase in maternal BMI class (p < 0.05). The incidence of congenital anomalies increases as the pre-pregnancy BMI increases. Individuals should be encouraged to optimize their weight prior to conception and if feasible, they should obtain screening for fetal anatomy assessment by a Maternal-Fetal Medicine specialist.

Association between missed appointments and hospitalization for child physical abuse.

Missed cases of child physical abuse (CPA) persist despite known risk factors. Prior studies have not evaluated missed medical appointments as a risk factor for CPA. The objective of this study was to determine if an association exists between missed appointments and hospitalization for CPA. We conducted a 20-year, single health system, retrospective chart review of hospitalized patients ≤36 months of age meeting International Classification of Diseases (ICD) 9/10 criteria for CPA with ≥1 scheduled appointment in our system prior to their admission. Cases were categorized as definite CPA, high likelihood, or no concern for CPA/unable to be determined. Cases identified as definite or high likelihood of CPA were matched (5:1) with controls based on age, distance to primary care provider's (PCP's) office, sex, prior hospitalization, and race. Missed appointments were compared between cases (n = 146) and controls (n = 730). A significant difference was identified between cases and controls (26 % vs 9 %, p < 0.001) for the median proportion of missed appointments. After adjusting for matched and significant covariates, there was a 3 % increase in a patient's odds of admission for CPA for every 1 % increase in missed appointments. We found an association between missed appointments and future admission for CPA. This finding has potential to assist clinicians with CPA risk stratification and future child abuse research. Limitations include single healthcare system, ICD criteria determined by research team, and narrow definition of definite CPA.

Improvement in Resident Scholarly Output with Implementation of a Scholarly Activity Guideline and Point System.

Introduction: Ensuring high-quality scholarly output by graduate medical trainees can be a challenge. Within many specialties, including emergency medicine (EM), it is unclear what constitutes appropriate resident scholarly activity. We hypothesized that the quantity and quality of scholarly activity would improve with a clearer guideline, including a point system for eligible scholarly activities. Methods: A resident Scholarly Activity Guideline was implemented for EM residents in a university setting. The guideline consists of a point system in which point values, ranging from 1-10, are assigned to various types of scholarly activities. Residents must earn at least 10 points and present their work to meet their scholarly graduation requirement. We tracked scholarly activities for graduates from the classes of 2014-2020, with the guideline being implemented for the class of 2016. In a blind analysis, we compared median total points per resident, mean counts of the Boyer model of scholarship components per resident, and mean counts of significant scholarly output per resident before vs after the guideline was implemented. Significant scholarly output was defined as an implemented protocol, a research project with data collection and analysis, a research abstract presentation, or an oral abstract presentation. Results: Among 64 residents analyzed, 48 residents used the guideline. We found that median points per resident increased after the guideline was implemented (median, interquartile range: before 7 [7], after 11 [10, 13], P = 0.002). Post-guideline scholarly activities were found to represent more of Boyer's components of scholarship [mean before 0.81 [SD 0.40], mean after 1.52 [SD 0.71], mean difference 0.71, 95% confidence interval [CI] 0.332 ± 1.09, P < 0.001. There was no difference in the mean significant scholarly output per resident (mean before 1.38 [SD 1.02], mean after 1.02 [SD 1.00], mean difference 0.35, 95% CI 0.93 ± 0.23, P = 0.23). Conclusion: Implementation of a Scholarly Activity Guideline point system significantly increased the quantity and, by one of two measures, increased the quality of scholarly output in our program. Our point-based guideline successfully incorporated traditional and modern forms of scholarship that can be tailored to resident interests.

Circulating Tumor DNA Monitoring on Chemo-immunotherapy for Risk Stratification in Advanced Non-Small Cell Lung Cancer.

PURPOSE: Chemoimmunotherapy (chemoIO) is a prevalent first-line treatment for advanced driver-negative non-small cell lung cancer (NSCLC), with maintenance therapy given after induction. However, there is significant clinical variability in the duration, dosing, and timing of maintenance therapy after induction chemoIO. We used circulating tumor DNA (ctDNA) monitoring to inform outcomes in patients with advanced NSCLC receiving chemoIO. EXPERIMENTAL DESIGN: This retrospective study included 221 patients from a phase III trial of atezolizumab+carboplatin+nab-paclitaxel versus carboplatin+nab-paclitaxel in squamous NSCLC (IMpower131). ctDNA monitoring used the FoundationOne Tracker involving comprehensive genomic profiling of pretreatment tumor tissue, variant selection using an algorithm to exclude nontumor variants, and multiplex PCR of up to 16 variants to detect and quantify ctDNA. RESULTS: ctDNA was detected (ctDNA+) in 96% of pretreatment samples (median, 93 mean tumor molecules/mL), and similar ctDNA dynamics were noted across treatment arms during chemoIO. ctDNA decrease from baseline to C4D1 was associated with improved outcomes across multiple cutoffs for patients treated with chemoIO. When including patients with missing plasma or ctDNA- at baseline, patients with ctDNA- at C4D1 (clearance), had more favorable progression-free survival (median 8.8 vs. 3.5 months; HR, 0.32;0.20-0.52) and OS (median not reached vs. 8.9 months; HR, 0.22; 0.12-0.39) from C4D1 than ctDNA+ patients. CONCLUSIONS: ctDNA monitoring during induction chemoIO can inform treatment outcomes in patients with advanced NSCLC. Importantly, monitoring remains feasible and informative for patients missing baseline ctDNA. ctDNA testing during induction chemoIO identifies patients at higher risk for disease progression and may inform patient selection for novel personalized maintenance or second-line treatment strategies.

Systematic review: emotion dysregulation and challenging behavior interventions for children and adolescents on the autism spectrum with graded key evidence-based strategy recommendations.

Challenging behavior, such as aggression, is highly prevalent in children and adolescents on the autism spectrum and can have a devastating impact. Previous reviews of challenging behavior interventions did not include interventions targeting emotion dysregulation, a common cause of challenging behavior. We reviewed emotion dysregulation and challenging behavior interventions for preschoolers to adolescents to determine which evidence-based strategies have the most empirical support for reducing/preventing emotion dysregulation/challenging behavior. We reviewed 95 studies, including 29 group and 66 single case designs. We excluded non-behavioral/psychosocial interventions and those targeting internalizing symptoms only. We applied a coding system to identify discrete strategies based on autism practice guidelines with the addition of strategies common in childhood mental health disorders, and an evidence grading system. Strategies with the highest quality evidence (multiple randomized controlled trials with low bias risk) were Parent-Implemented Intervention, Emotion Regulation Training, Reinforcement, Visual Supports, Cognitive Behavioral/Instructional Strategies and Antecedent-Based Interventions. Regarding outcomes, most studies included challenging behavior measures, while few included emotion dysregulation measures. This review highlights the importance of teaching emotion regulation skills explicitly, positively reinforcing replacement/alternative behaviors, using visuals and metacognition, addressing stressors proactively, and involving parents. It also calls for more rigorously designed studies and for including emotion dysregulation as an outcome/mediator in future trials.

Radiation Therapy in the Last Month of Life: Association With Aggressive Care at the End of Life.

CONTEXT: Half of the patients with cancer who undergo radiation therapy do so with palliative intent. OBJECTIVES: To determine the proportion of undergoing radiation in the last month of life, patient characteristics, cancer course, the type and duration of radiation, whether palliative care was involved, and the of radiation with aggressive cancer care metrics. METHODS: One thousand seven hundred twenty-seven patients who died of cancer between January 1, 2018, and December 31, 2019, were included. Demographics, cancer stage, palliative care referral, advance directives, use of home health care, radiation timing, and survival were collected. Type of radiation, course, and intent were reviewed. Chi-square analysis was utilized for categorical variables, and Kruskal-Wallis tests for continuous variables. A stepwise selection was used to build a Cox proportional hazard model. RESULTS: Two hundred thirty-three patients underwent radiation in the last month of life. Younger patients underwent radiation 67.3 years (SD 11.52) versus 69.2 years (SD 11.96). 42.6% had radiation within two weeks of death. The average fraction number was 5.5. Individuals undergoing radiation were more likely to start chemotherapy within the last 30 days of life, continue chemotherapy within two weeks of death, be admitted to the ICU, and have two or more hospitalizations or emergency room visits. Survival measured from the date of diagnosis was shorter for those undergoing radiation, 122 days (IQR 58-462) versus 474 days (IQR 225-1150). Palliative care consultations occurred later in those undergoing radiation therapy. CONCLUSION: Radiation therapy in the last month of life occurs in younger patients with rapidly progressive cancer, who are subject to more aggressive cancer care, and have late palliative care consults.

Cognitive Skills and DNA Methylation Are Correlating in Healthy and Novice College Students Practicing Preksha Dhyana Meditation.

The impact of different meditation protocols on human health is explored at the cognitive and cellular levels. Preksha Dhyana meditation has been observed to seemingly affect the cognitive performance, transcriptome, and methylome of healthy and novice participant practitioners. In this study, we performed correlation analyses to investigate the presence of any relationships in the changes in cognitive performance and DNA methylation in a group of college students practicing Preksha Dhyana (N = 34). Nine factors of cognitive performance were assessed at baseline and 8 weeks postintervention timepoints in the participants. Statistically significant improvements were observed in six of the nine assessments, which were predominantly relating to memory and affect. Using Illumina 850 K microarray technology, 470 differentially methylated sites (DMS) were identified between the two timepoints (baseline and 8 weeks), using a threshold of p-value < 0.05 and methylation levels beyond -3% to 3% at every site. Correlation analysis between the changes in performance on each of the nine assessments and every DMS unveiled statistically significant positive and negative relationships at several of these sites. The identified DMS were in proximity of essential genes involved in signaling and other important metabolic processes. Interestingly, we identified a set of sites that can be considered as biomarkers for Preksha meditation improvements at the genome level.

Molecular residual disease detection in resected, muscle-invasive urothelial cancer with a tissue-based comprehensive genomic profiling-informed personalized monitoring assay.

Introduction: Circulating tumor DNA (ctDNA) detection postoperatively may identify patients with urothelial cancer at a high risk of relapse. Pragmatic tools building off clinical tumor next-generation sequencing (NGS) platforms could have the potential to increase assay accessibility. Methods: We evaluated the widely available Foundation Medicine comprehensive genomic profiling (CGP) platform as a source of variants for tracking of ctDNA when analyzing residual samples from IMvigor010 (ClinicalTrials.gov identifier NCT02450331), a randomized adjuvant study comparing atezolizumab with observation after bladder cancer surgery. Current methods often involve germline sampling, which is not always feasible or practical. Rather than performing white blood cell sequencing to filter germline and clonal hematopoiesis (CH) variants, we applied a bioinformatic approach to select tumor (non-germline/CH) variants for molecular residual disease detection. Tissue-informed personalized multiplex polymerase chain reaction-NGS assay was used to detect ctDNA postsurgically (Natera). Results: Across 396 analyzed patients, prevalence of potentially actionable alterations was comparable with the expected prevalence in advanced disease (13% FGFR2/3, 20% PIK3CA, 13% ERBB2, and 37% with elevated tumor mutational burden ≥10 mutations/megabase). In the observation arm, 66 of the 184 (36%) ctDNA-positive patients had shorter disease-free survival [DFS; hazard ratio (HR) = 5.77; 95% confidence interval (CI), 3.84-8.67; P < 0.0001] and overall survival (OS; HR = 5.81; 95% CI, 3.41-9.91; P < 0.0001) compared with ctDNA-negative patients. ctDNA-positive patients had improved DFS and OS with atezolizumab compared with those in observation (DFS HR = 0.56; 95% CI, 0.38-0.83; P = 0.003; OS HR = 0.66; 95% CI, 0.42-1.05). Clinical sensitivity and specificity for detection of postsurgical recurrence were 58% (60/103) and 93% (75/81), respectively. Conclusion: We present a personalized ctDNA monitoring assay utilizing tissue-based FoundationOne® CDx CGP, which is a pragmatic and potentially clinically scalable method that can detect low levels of residual ctDNA in patients with resected, muscle-invasive bladder cancer without germline sampling.

Distribution of emergency medicine programs by location and reproductive rights: A cross-sectional study of the 2023 Match.

INTRODUCTION: The 2023 Match saw over 500 unfilled positions in emergency medicine (EM). Geographic location is the third most important factor for all United States (US) EM-bound senior medical students when selecting programs to rank and can be affected by political climate. Given the perceived importance of geography on program selection and recent changes to reproductive rights in the US, we sought to evaluate the impact of geography and reproductive rights on unmatched positions among EM programs. METHODS: This was a cross-sectional study assessing Match rates in EM by program US state, region, and degree of reproductive rights. We included all EM programs participating in the 2023 Match year. Our primary outcome was to determine the unfilled programs and positions rate per US state. Secondary outcomes included Match rates by region and by degree of reproductive rights. RESULTS: We found notable differences in unfilled programs by US state, with the highest percentage of unfilled programs and positions in Arkansas (100%, 56.3%), Nevada (100%, 35.5%), Kansas (100%, 40.0%), Ohio (81.3%, 33.3%), and Michigan (80.0%, (36.8%). Among regions, the highest percentage of unfilled programs (62.5%) and residency positions (26.0%) was East North Central (IL, IN, MI, OH, WI). US states with limited reproductive rights had the highest percent (52.9%) of programs with unmatched positions and the highest percent (20.5%) of unfilled positions. CONCLUSION: We identified notable differences in unmatched positions by US state and region, as well as the highest rate of unmatched positions in US states with more limited reproductive rights.

Nonfatal Injuries Sustained in Mass Shootings in the US, 2012-2019: Injury Diagnosis Matrix, Incident Context, and Public Health Considerations.

INTRODUCTION: The epidemic of gun violence in the United States (US) is exacerbated by frequent mass shootings. In 2021, there were 698 mass shootings in the US, resulting in 705 deaths and 2,830 injuries. This is a companion paper to a publication in JAMA Network Open, in which the nonfatal outcomes of victims of mass shootings have been only partially described. METHODS: We gathered clinical and logistic information from 31 hospitals in the US about 403 survivors of 13 mass shootings, each event involving greater than 10 injuries, from 2012-19. Local champions in emergency medicine and trauma surgery provided clinical data from electronic health records within 24 hours of a mass shooting. We organized descriptive statistics of individual-level diagnoses recorded in medical records using International Classification of Diseases codes, according to the Barell Injury Diagnosis Matrix (BIDM), a standardized tool that classifies 12 types of injuries within 36 body regions. RESULTS: Of the 403 patients who were evaluated at a hospital, 364 sustained physical injuries-252 by gunshot wound (GSW) and 112 by non-ballistic trauma-and 39 were uninjured. Fifty patients had 75 psychiatric diagnoses. Nearly 10% of victims came to the hospital for symptoms triggered by, but not directly related to, the shooting, or for exacerbations of underlying conditions. There were 362 gunshot wounds recorded in the Barell Matrix (1.44 per patient). The Emergency Severity Index (ESI) distribution was skewed toward higher acuity than typical for an emergency department (ED), with 15.1% ESI 1 and 17.6% ESI 2 patients. Semi-automatic firearms were used in 100% of these civilian public mass shootings, with 50 total weapons for 13 shootings (Route 91 Harvest Festival, Las Vegas. 24). Assailant motivations were reported to be associated with hate crimes in 23.1%. CONCLUSION: Survivors of mass shootings have substantial morbidity and characteristic injury distribution, but 37% of victims had no GSW. Law enforcement, emergency medical systems, and hospital and ED disaster planners can use this information for injury mitigation and public policy planning. The BIDM is useful to organize data regarding gun violence injuries. We call for additional research funding to prevent and mitigate interpersonal firearm injuries, and for the National Violent Death Reporting System to expand tracking of injuries, their sequelae, complications, and societal costs.

Workshop in Simulation Debriefing for Educators in Medicine: Creation, implementation, and evaluation of a debriefing curriculum for novice simulation educators.

Objectives: Debriefing is an integral component of simulation education, and effective debriefing education is required to maintain effective simulation programs. However, many educators report financial and logistical barriers to accessing formal debriefing training. Due to limited educator development opportunities, simulation program leaders are often compelled to utilize educators with insufficient debriefing training, which can limit the impact of simulation-based education. To address these concerns, the SAEM Simulation Academy Debriefing Workgroup authored the Workshop in Simulation Debriefing for Educators in Medicine (WiSDEM), a freely available, concise, and ready-to-deploy debriefing curriculum with a target audience of novice educators without formal debriefing training. In this study, we describe the development, initial implementation, and evaluation of the WiSDEM curriculum. Methods: The Debriefing Workgroup iteratively developed the WiSDEM curriculum by expert consensus. The targeted level of content expertise was introductory. The curriculum's educational impact was assessed by surveying participants on their impressions of the curriculum and their confidence and self-efficacy in mastery of the material. Additionally, facilitators of the WiSDEM curriculum were surveyed on its content, usefulness, and future applicability. Results: The WiSDEM curriculum was deployed during the SAEM 2022 Annual Meeting as a didactic presentation. Thirty-nine of 44 participants completed the participant survey, and four of four facilitators completed the facilitator survey. Participant and facilitator feedback on the curriculum content was positive. Additionally, participants agreed that the WiSDEM curriculum improved their confidence and self-efficacy in future debriefing. All surveyed facilitators agreed that they would recommend the curriculum to others. Conclusions: The WiSDEM curriculum was effective at introducing basic debriefing principles to novice educators without formal debriefing training. Facilitators felt that the educational materials would be useful for providing debriefing training at other institutions. Consensus-driven, ready-to-deploy debriefing training materials such as the WiSDEM curriculum can address common barriers to developing basic debriefing proficiency in educators.

A Digital Mental Health App Incorporating Wearable Biosensing for Teachers of Children on the Autism Spectrum to Support Emotion Regulation: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: As much as 80% of children on the autism spectrum exhibit challenging behaviors (ie, behaviors dangerous to the self or others, behaviors that interfere with learning and development, and behaviors that interfere with socialization) that can have a devastating impact on personal and family well-being, contribute to teacher burnout, and even require hospitalization. Evidence-based practices to reduce these behaviors emphasize identifying triggers (events or antecedents that lead to challenging behaviors); however, parents and teachers often report that challenging behaviors surface with little warning. Exciting recent advances in biometric sensing and mobile computing technology allow the measurement of momentary emotion dysregulation using physiological indexes. OBJECTIVE: We present the framework and protocol for a pilot trial that will test a mobile digital mental health app, the KeepCalm app. School-based approaches to managing challenging behaviors in children on the autism spectrum are limited by 3 key factors: children on the autism spectrum often have difficulties in communicating their emotions; it is challenging to implement evidence-based, personalized strategies for individual children in group settings; and it is difficult for teachers to track which strategies are successful for each child. KeepCalm aims to address those barriers by communicating children's stress to their teachers using physiological signaling (emotion dysregulation detection), supporting the implementation of emotion regulation strategies via smartphone pop-up notifications of top strategies for each child according to their behavior (emotion regulation strategy implementation), and easing the task of tracking outcomes by providing the child's educational team with a tool to track the most effective emotion regulation strategies for that child based on physiological stress reduction data (emotion regulation strategy evaluation). METHODS: We will test KeepCalm with 20 educational teams of students on the autism spectrum with challenging behaviors (no exclusion based on IQ or speaking ability) in a pilot randomized waitlist-controlled field trial over a 3-month period. We will examine the usability, acceptability, feasibility, and appropriateness of KeepCalm as primary outcomes. Secondary preliminary efficacy outcomes include clinical decision support success, false positives or false negatives of stress alerts, and the reduction of challenging behaviors and emotion dysregulation. We will also examine technical outcomes, including the number of artifacts and the proportion of time children are engaged in high physical movement based on accelerometry data; test the feasibility of our recruitment strategies; and test the response rate and sensitivity to change of our measures, in preparation for a future fully powered large-scale randomized controlled trial. RESULTS: The pilot trial will begin by September 2023. CONCLUSIONS: Results will provide key data about important aspects of implementing KeepCalm in preschools and elementary schools and will provide preliminary data about its efficacy to reduce challenging behaviors and support emotion regulation in children on the autism spectrum. TRIAL REGISTRATION: ClinicalTrials.gov NCT05277194; https://www.clinicaltrials.gov/ct2/show/NCT05277194. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45852.

Systematic Review: Emotion Dysregulation and Challenging Behavior Interventions for Children andAdolescents with Autism with Graded Key Evidence-Based Strategy Recommendations.

Challenging behavior, such as aggression, is highly prevalent in children and adolescents with autism and can have a devastating impact. Previous reviews of challenging behavior interventions did not include interventions targeting emotion dysregulation, a common cause of challenging behavior. We reviewed emotion dysregulation and challenging behavior interventions for preschoolers to adolescents to determine which evidence-based strategies have the most empirical support for reducing/preventing emotion dysregulation/challenging behavior. We reviewed 95 studies, including 29 group and 66 single-case designs. We excluded non-behavioral/psychosocial interventions and those targeting internalizing symptoms only. We applied a coding system to identify discrete strategies based on autism practice guidelines with the addition of strategies common in childhood mental health disorders, and an evidence grading system. Strategies with the highest quality evidence (multiple randomized controlled trials with low bias risk) were Parent-Implemented Intervention, Emotion Regulation Training, Reinforcement, Visual Supports, Cognitive Behavioral/Instructional Strategies and Antecedent-Based Interventions. Regarding outcomes, most studies included challenging behaviors measures while few included emotion dysregulation measures. This review highlights the importance of teaching emotion-regulation skills explicitly, positively reinforcing replacement/alternative behaviors, using visuals and metacognition, addressing stressors proactively, and involving parents. It also calls for more rigorously-designed studies and for including emotion dysregulation as an outcome/mediator in future trials.

Comparison of three antepartum risk assessment tools to predict significant postpartum hemorrhage in livebirths.

BACKGROUND: To adequately predict significant postpartum hemorrhage (PPH) at hospital admission, we evaluated and compared the accuracy of three risk assessment tools: 1. California Maternal Quality Care Collaborative (CMQCC), 2. American College of Obstetrics and Gynecology Safe Motherhood Initiative (ACOG SMI) and 3. Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN). STUDY DESIGN AND METHODS: This is a retrospective cohort study of people who delivered liveborn infants from January 2018 to June 2021 at our center. Patients with comorbidities necessitating higher hemoglobin values, those who refused blood transfusions, and missing pertinent data were excluded. Significant PPH was defined as a blood transfusion within 48 hours following delivery. Diagnostic statistics were calculated for each tool. RESULTS: Of the 11,679 included pregnancies, 232 (1.9%) people had significant PPH. Amongst those diagnosed as high-risk by the CMQCC tool, 67/1485 (4.5%) had significant PPH; 62/1672 (3.7%) by the ACOG SMI tool, and 85/1864 (4.6%) by the AWHONN tool had significant PPH. All tools have low sensitivity and high negative predictive values. The area under the receiver operating characteristics curve of the three tools is moderately poor (CMQCC: 0.58, ACOG SMI: 0.55, AWHONN:0.61). DISCUSSION: Upon admission to labor and delivery, all three studied tools are poor predictors of significant PPH. The development and validation of better PPH risk stratification tools are required with the inclusion of additional important variables.

A longitudinal circulating tumor DNA-based model associated with survival in metastatic non-small-cell lung cancer.

One of the great challenges in therapeutic oncology is determining who might achieve survival benefits from a particular therapy. Studies on longitudinal circulating tumor DNA (ctDNA) dynamics for the prediction of survival have generally been small or nonrandomized. We assessed ctDNA across 5 time points in 466 non-small-cell lung cancer (NSCLC) patients from the randomized phase 3 IMpower150 study comparing chemotherapy-immune checkpoint inhibitor (chemo-ICI) combinations and used machine learning to jointly model multiple ctDNA metrics to predict overall survival (OS). ctDNA assessments through cycle 3 day 1 of treatment enabled risk stratification of patients with stable disease (hazard ratio (HR) = 3.2 (2.0-5.3), P < 0.001; median 7.1 versus 22.3 months for high- versus low-intermediate risk) and with partial response (HR = 3.3 (1.7-6.4), P < 0.001; median 8.8 versus 28.6 months). The model also identified high-risk patients in an external validation cohort from the randomized phase 3 OAK study of ICI versus chemo in NSCLC (OS HR = 3.73 (1.83-7.60), P = 0.00012). Simulations of clinical trial scenarios employing our ctDNA model suggested that early ctDNA testing outperforms early radiographic imaging for predicting trial outcomes. Overall, measuring ctDNA dynamics during treatment can improve patient risk stratification and may allow early differentiation between competing therapies during clinical trials.

Gene therapy in sickle cell disease: Attitudes and informational needs of patients and caregivers.

BACKGROUND: Sickle cell disease (SCD) is an inherited blood disorder that results in serious morbidity and early mortality. Novel therapies for SCD, most notably genetic therapies (GTs) and HLA-mismatched donor hematopoietic cell transplantation, are in clinical trials. While potentially curative, these interventions are some of the most intensive treatments for SCD and are associated with serious and life-altering side effects, which may manifest several years after treatment. Little is known about knowledge, beliefs, and attitudes of individuals with SCD, or their caregivers, toward existing and these emerging therapies. METHODS: Patients with SCD at least 13 years of age (n = 66) and caregivers (n = 38) were surveyed about knowledge, attitudes, and beliefs surrounding treatments for SCD. RESULTS: Only 4.8% felt "extremely knowledgeable" about GT for SCD while the majority (63.4%) reported little knowledge. Overall, health literacy was low among respondents. Most respondents had a neutral attitude regarding the safety of GT for SCD, and whether it was a good treatment for the disorder (56.7% and 58.6%, respectively). Only a few respondents endorsed the idea that GT was "unsafe" or "not a good treatment" (5.8% and 4.8%, respectively). There was an association between increasing knowledge about GT and agreement that it is safe (p = .012) and a good treatment for SCD (p = .031). CONCLUSIONS: Given that very few patients with SCD feel knowledgeable about GT and a majority have neutral feelings about the safety and utility of this new approach, culturally appropriate patient-centered education is urgently needed as these treatments get regulatory approval and proceed to the clinic.

Validation of the Surprise Question and the Development of a Multivariable Model.

CONTEXT: The Surprise Question (SQ) (would you be surprised if this patient died within a year?) is a prognostic variable explored in chronic illnesses. Validation is limited to sensitivity, specificity, and predictive values. OBJECTIVES: Our objective is to validate the SQ in cancer patients and develop a predictive model with additional variables. METHODS: A prospective cohort study of adult (age>18) cancer patients seen between October 1, 2019, through March 31, 2021, undergoing systemic therapies had the SQ completed by oncologists prior to each change in systemic therapy. The primary outcome was survival for one year. Secondary outcomes were predictions of survival at three, six, and nine months. Patients were grouped into negative SQ (not surprised) and positive SQ (surprised). Sensitivity, specificity, predictive values, and likelihood ratios (LR) were calculated for the SQ. Additional prognostic variables were age, gender, cancer stage, line of therapy, Charleson Comorbid Index (CCI), palliative care consultation (prior to, after the SQ, or not at all), and healthcare utilization (outpatient, inpatient, and emergency department (ED). Logistic regression and receiver operating characteristics (ROC) were used for discrimination and modeling. Akaike information criterion (AIC) was used to compare the model fit as each predictor. RESULTS: 1366 patients had 1 SQ; 784 died within a year. The SQ predicted survival at one year (P = 0.008), with a positive LR of 1.459 (95%CI 1.316-1.602) and a c-statistic of 0.565 (95%CI 0.530-0.600). Additional variables increased the c-statistic to 0.648 (95% CI 0.608-0.686). The total model best predicted survival at three months, c-statistic of 0.663 (95% CI 0.616-0.706). However, the total model c-statistic remained <0.70. CONCLUSIONS: The SQ, as a single factor, poorly predicts survival and should not be used to alter therapies. Adding additional objective variables improved prognostication, but further refinement and external validation are needed.

Pregnancy Outcomes in Patients Enrolled in the Healthy Beginnings Plus Program.

OBJECTIVE: To evaluate the effectiveness of enrollment in the Healthy Beginnings Plus Program (HB) on pregnancy outcomes. DESIGN: Retrospective cohort study of 12,299 singleton pregnancies birthed between January 2007 and December 2018. SETTING/LOCAL PROBLEM: Individuals of low socioeconomic status are at increased risk for adverse pregnancy outcomes, such as preterm birth (PTB) and low-birth-weight (LBW) neonates. Pennsylvania offers HB to pregnant individuals with Medical Assistance insurance to provide additional psychosocial and obstetric resources to routine prenatal care to minimize risk. PARTICIPANTS: Individuals with Medical Assistance insurance enrolled in HB (n = 4,645), individuals with Medical Assistance insurance not enrolled in HB (n = 2,874), and individuals with private insurance (n = 4,780). MEASUREMENTS: Primary outcomes were rates of PTB and LBW neonates. Secondary outcomes included rates of gestational diabetes, gestational hypertension, small-for-gestational-age neonates, and admission to the NICU. RESULTS: There were no differences in PTB (adjusted OR [aOR] = 0.93, 95% confidence interval [CI] [0.76, 1.13]) or LBW neonates (aOR = 1.06, 95% CI [0.86, 1.31]) between individuals with Medical Assistance enrolled in HB versus those with Medical Assistance insurance not enrolled in HB. Individuals with Medical Assistance enrolled in HB were less likely to develop gestational hypertension compared to individuals with Medical Assistance insurance not enrolled in HB (aOR = 1.41, 95% CI [1.25, 1.59]) and individuals with private insurance (aOR = 0.85, 95% CI [0.76, 0.96]). They also attended more prenatal visits than individuals with Medical Assistance insurance not enrolled in HB (12.0 vs. 14.0, p < .01). CONCLUSION: Although there was no significant difference between groups for the primary outcomes studied, individuals with Medical Assistance insurance enrolled in HB attended more prenatal visits than those who did not enroll in HB. Similar programs should evaluate outcomes and consider whether changes are needed.