AAP Policy

BACKGROUND: Although the FDA Accelerated Approval Program (AAP) has come under scrutiny, the population-level health benefit of the program has not been quantified. Therefore, the objective of this study was to estimate the number of life years gained among patients with cancer that can be attributable to the therapies receiving FDA accelerated approvals in oncology between 2006 and 2022 in the United States. METHODS: The data sources used were FDA listings, FDA approval letters and labels, published clinical trial data and other publications including relative effectiveness estimates, and the Ipsos Oncology Uptake Tool for product uptake...

Road users (drivers, passengers, pedestrians, and Animals) are exposed to hazardous events during their commute. With 23 % of global fatalities among pedestrians, their safety continues to be a principal interest for policymakers worldwide. Owing to limited budgets available, there is a growing emphasis on data-driven stochastic models to decide on policies. However, statistical models have limitations due to crash data having redundant features, inherent heterogeneity, and unobserved characteristics. The random parameter model framework addresses the unobserved heterogeneity, but redundant features and inherent heterogeneity among the data's characteristics still compute the biased estimates...

This editorial is both an introduction to the papers that make up this special issue (on the Relationship between Crash Causation, Countermeasures, and Policy) and an attempt at drawing conclusions. To assist the reader, we begin with a brief description of the subject matter of each paper. As expected, the authors tackle different aspects of this general topic and often differ in their conclusions. We follow up by asking: Are in-depth crash causation studies helpful? Can the need for understanding causation be defended? Does the Swiss Cheese Metaphor require revision? What are the building blocks on which the crash injury prevention programs rest? Can one really avoid comparing costs and benefits? These are some of the issues we raise and discuss...

Today, cities seek to transition to more sustainable transportation modes. Cycling is critical in this shift, promoting a more beneficial lifestyle for most. However, cyclists are exposed to many hazardous circumstances or environments, resulting in accidents, injuries, and even death. Transport authorities must understand why accidents occur, to reduce the risk of those who cycle. This study applies a new modeling framework to analyze cycling accident severities. We employ a latent class discrete outcome model, where classes are derived from a Gaussian-Bernoulli mixture, applied to data from Berlin, and augmented with volunteered geographic information...

The long-term effects of the Vision-Zero (VZ) approach in Scandinavia are well documented. In contrast, information regarding the immediate effects of VZ at the starting phase upon gradual implementation is scarce. Taking New York City as the case study, we analyzed both the local and global effects of the Vision-Zero gradual implementation on pedestrian crashes in the early stage of implementation starting from 2014. The data analysis comprised 8,165 pedestrian injury crashes. Using location data, the crashes were matched to VZ infrastructure improvement location, start and completion dates...

Human drivers are gradually being replaced by highly automated driving systems, and this trend is expected to persist. The response of autonomous vehicles to Ambiguous Driving Scenarios (ADS) is crucial for legal and safety reasons. Our research focuses on establishing a robust framework for developing ADS in autonomous vehicles and classifying them based on AV user perceptions. To achieve this, we conducted extensive literature reviews, in-depth interviews with industry experts, a comprehensive questionnaire survey, and factor analysis...

BACKGROUND: Premedication in neonates undergoing elective intubation effectively minimizes the negative physiological events of bradycardia, systemic hypertension, intracranial hypertension, and hypoxia. Premedication decreases procedure-related pain and discomfort. This study aimed to evaluate the current practice of pre-intubation medications for non-emergent intubations in preterm and term neonates in the United States. STUDY DESIGN: A cross-sectional survey (Appendix) was sent via e-mail to all level 3 and 4 Neonatal Intensive Care Units (NICUs) of the Organization of Neonatal Perinatal Medicine Training Program Directors (ONTPD), NICU directors with pediatric residency only, and Baylor Scott and White Health, Mednax, and Envision health services systems...

Personal Mobility Devices (PMDs) have witnessed an extraordinary surge in popularity, emerging as a favored mode of urban transportation. This has sparked significant safety concerns, paralleled by a stark increase in PMD-involved crashes. Research indicates that PMD user behavior, especially in urban areas, is crucial in these crashes, underscoring the need for an extensive investigation into key factors, particularly those causing fatal/severe outcomes. Remarkably, there exists a noticeable gap in the research concerning the analysis of determinants behind fatal/severe PMD crashes, specifically in PMD rider-at-fault collisions...

The objective of this study is to explore the contributing risky factors to Autonomous Vehicle (AV) crashes and their interdependencies. AV crash data between 2015 and 2023 were collected from the autonomous vehicle collision report published by California Department of Motor Vehicles (DMV). AV crashes were categorized into four types based on vehicle damage. AV crashes features including crash location and time, driving mode, vehicle movements, crash type and vehicle damage, traffic conditions, and among others were used as potential risk factors...

The Safe System Approach (SSA) has emerged as a comprehensive framework for enhancing traffic safety through system-wide interventions. This systematic review, conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, analyzes 82 relevant studies categorized based on the SSA pillars: safe road users, safe vehicles, safe speeds, safe roads, and post-crash care. The review provides insights into SSA's effectiveness in reducing road traffic fatalities and injuries, exploring implementation challenges and opportunities, including policy initiatives, institutional frameworks, and stakeholder collaborations...

Understanding why children die is necessary to implement strategies to prevent future deaths and improve the health of any community. Child fatality review teams (CFRTs) have existed since the 1970s and provide a necessary framework to ensure that proper questions are asked about a child's death. CFRTs provide a vital function in a community to ensure that preventable causes of deaths are identified. Pediatricians are necessary members of CFRTs because they provide medical expertise and context around a child's death...

Supporting optimal newborn nutrition and the positive maternal-infant relationship, while encouraging safe sleep practices, are essential components of maternal and newborn care in the hospital setting following birth. Breastfeeding is widely recognized as best practice to support the nutritional needs and well-being of the infant, and recommendations have been developed by the World Health Organization (WHO), the American Academy of Pediatrics (AAP) and the US Centers for Disease Control (CDC) to encourage and successfully support breastfeeding efforts prior to hospital discharge...

Ghana exemplifies the contribution of road crashes to mortality and morbidity in Africa, partly due to a growing population and increasing car ownership, where fatalities have increased by 12 to 15 % annually since 2008 (National Road Safety Authority (NRSA), 2017). The study described in this paper focused on understanding driver behavior at unsignalized junctions in the Ashanti Region of Ghana. Understanding driver behavior at unsignalized junctions is particularly important since failure to stop or yield can seriously affect vulnerable road users...

UNLABELLED: Objective. To compare resource utilization and costs associated with 3 alternative screening approaches to identify early-onset sepsis (EOS) in infants born at ≥35 wk of gestational age, as recommended by the American Academy of Pediatrics (AAP) in 2018. Study Design. Decision tree-based cost analysis of the 3 AAP-recommended approaches: 1) categorical risk assessment (categorization by chorioamnionitis exposure status), 2) neonatal sepsis calculator (a multivariate prediction model based on perinatal risk factors), and 3) enhanced clinical observation (assessment based on serial clinical examinations)...

Novice drivers are at a greatly inflated risk of crashing. This led in the 20th century to numerous attempts to develop training programs that could reduce their crash risk. Yet, none proved effective. Novice drivers were largely considered careless, not clueless. This article is a case study in the United States of how a better understanding of the causes of novice driver crashes led to training countermeasures targeting teen driving behaviors with known associations with crashes. These effects on behaviors were large enough and long-lasting enough to convince insurance companies to develop training programs that they offered around the country to teen drivers...

BACKGROUND/PURPOSE: License suspensions are a strategy to address alcohol-impaired driving behavior and recidivism following an alcohol driving while impaired (alcohol-DWI) conviction. Little is known about the specific impacts of conviction-related suspensions on safety outcomes and given recent fluctuations in alcohol-impaired driving behavior, crashes, and suspension trends, updated and focused assessments of this intervention are necessary. This study aimed to 1) examine the association between type of recent alcohol-DWI suspension and having a secondary alcohol-related license outcome and/or future crash event in North Carolina (NC) between 2007 and 2016; and 2) assess potential modification of these associations by race/ethnicity...

BACKGROUND AND OBJECTIVE: Androgen-deprivation therapy is the mainstay of treatment for patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). However, the intensification of treatment with either docetaxel or novel anti-androgens (abiraterone-acetate plus prednisone [AAP], enzalutamide, and apalutamide) is being recommended based on the improved clinical outcomes and quality of life among patients. This study aimed to determine the most cost-effective drug for treatment intensification for patients with mHSPC in India...

OBJECTIVES: Healthcare payers often implement coverage policies that restrict the utilization of costly new first-line treatments. Cost-effectiveness analysis can be conducted to inform these decisions by comparing the new treatment with an existing one. However, this approach may overlook important factors such as treatment effect heterogeneity and endogenous treatment selection, policy implementation costs, and diverse patient preferences across multiple treatment options. We aimed to develop a cost-effectiveness analysis framework that considers these real-world factors, facilitating the evaluation of alternative policies related to expanding or restricting first-line treatment choices...

CONTEXT: Childhood obesity is a growing health problem in the United States, with those affected having an increased likelihood of developing chronic diseases at a younger age. Social determinants of health (SDOH) are known to influence overall health. Families who are of low socioeconomic status (SES) have also been shown to be more likely to experience food insecurity. OBJECTIVES: Our primary objective was to utilize the National Survey of Children's Health (NSCH) 2021 data to determine the current associations between childhood obesity and SDOH...

Truck-involved crashes persist as a significant concern, yielding noteworthy human casualties and causing economic ramifications, particularly in developing countries. This paper aims to undertake a comprehensive analysis of the associated factors influencing injury severity in truck-involved crashes, with a particular emphasis on discerning variations between single-vehicle and multi-vehicle incidents, as well as accounting for heterogeneity and temporal stability. The data analysis involves a meticulous examination of crash data spanning the entirety of Thailand from 2017 to 2020...