PURPOSE There are significant disparities in care and outcomes for patients with leukemias and multiple myeloma (MM). To evaluate the extent to which clinical trials (CTs) match the demographic and geographic diversity of populations affected by leukemias and MM. METHODS CTs leading to drug approval were identified from the US Food and Drug Administration databases. Demographic and geographic data were collected from ClinicalTrials.gov and primary manuscripts. Standard descriptive statistics were used to summarize the data in frequencies and proportions, including 95% CIs, by race, ethnicity, sex, and malignancy subtypes. RESULTS A total of 41 (67.2%) trials leading to drug approval reported data on race and 20 (48.8%) on ethnicity. These trials included 13,731 patients, of whom 11,209 (81.6%) were White. Among minorities, Asian-Pacific Islanders and Blacks had the highest representation in chronic myeloid leukemia, 147 (12.7%) and 61 (5.3%), and lowest in chronic lymphocytic leukemia, 55 (3%) and 20 (1.1%), respectively. Proportions for Blacks, Native Americans, and Hispanics were significantly low, reflecting under-representation in trials compared with the proportion in the general population. Females were also under-represented in acute myeloid leukemia (44.7% v 60.5%, P < .0001), and males in MM (55.3% v 60.2%, P < .0001) and chronic myeloid leukemia (55.2% v 62.9%, P < .0001). The geographic distribution of trials showed inadequate regional and state participation compared with mortality for all malignancies except MM. CONCLUSION There are significant demographic and geographic under-representation and imbalances in pivotal CTs leading to drug approvals for leukemias and MM compared with the population affected. These disparities need to be addressed to make results applicable to all relevant populations.

A primary goal in pain treatment is restoration of behaviors that are disrupted by pain. Measures of pain interference indicate the degree to which pain interferes with activities in pain patients, and these measures are used to evaluate the effects of analgesic drugs. As a result of the emphasis on the expression and treatment of functional impairment in clinical settings, preclinical pain researchers have attempted to develop procedures for evaluation of pain-related functional impairment in laboratory animals. The goal of the present study was to develop and validate a low cost procedure for the objective evaluation of pain-related depression of home cage behavior in mice. On test days, a 5 × 5 cm Nestlet was weighed prior to being suspended from the wire lid of the home cage of individually housed male and female ICR mice. Over the course of experimental sessions, mice removed pieces of the suspended Nestlet, and began to build a nest with the material they removed. Thus, the weight of the pieces of Nestlet that remained suspended at various time points in the session provided an indicator of the rate of this behavior. The results indicate that Nestlet shredding was stable with repeated testing, and shredding was depressed by intra-peritoneal injection of 0.32% lactic acid. The non-steroidal anti-inflammatory drug ketoprofen blocked 0.32% lactic acid-induced depression of shredding, but did not block depression of shredding by a pharmacological stimulus, the kappa opioid receptor agonist U69,593. The μ-opioid receptor agonist morphine did not block 0.32% lactic acid-induced depression of shredding when tested up to doses that depressed shredding in the absence of lactic acid. When noxious stimulus intensity was reduced by decreasing the lactic acid concentration to 0.18%, morphine was effective at blocking pain-related depression of behavior. In summary, the data from the present study support consideration of the Nestlet shredding procedure for use in studies examining mechanisms, expression, and treatment of pain-related functional impairment.

The COVID-19 pandemic has fostered an environment for increased risk of child maltreatment (CM) as families experience increased psychosocial and financial burdens and spend unprecedented amounts of time together in the home. This narrative review aimed to summarize empirical findings on existing or new pandemic-related risk factors among caregivers. A combination of search terms related to CM and COVID-19 were used to identify articles published within five databases between February 2020 and July 2022. Literature searches produced 113 articles, of which 26 published across 12 countries met inclusion criteria. Four previously well-established risk factors for CM perpetration continued to persist during the pandemic, including stress, parental mental health, financial concerns, and parental substance use. Of note, inconsistent definitions and measures were used to capture these risk factors. Several additional emerging and understudied risk factors were also identified among limited articles, such as food insecurity and parental education. Findings emphasize the ongoing need for evidence-based interventions to address CM risk during the pandemic, including parent training programs. However, consolidated measures and consistent conceptualization of risk factors are needed to advance the study of CM. Going forward, practitioners and researchers should (a) strengthen the identification process for families at greatest risk for CM, and particularly those vulnerable to pandemic-related stressors; and (b) augment delivery of CM prevention strategies and evidence-based programs to fit the pandemic context.

A primary goal in the treatment of pain is restoration of behaviors that are disrupted by pain. Preclinical pain researchers have attempted to develop procedures for evaluation of pain‐related functional impairment in laboratory animals. The goal of the present study was to develop and validate a simple, low cost procedure for the objective evaluation of pain‐related depression of home cage behavior in mice. On test days, a 5 × 5 cm Nestlet was weighed prior to being suspended from the wire lid of the home cage of individually housed male and female ICR mice. Over the course of experimental sessions, mice removed pieces of the suspended Nestlet, and began to build a nest with the material they removed. Thus, the weight of the pieces of Nestlet that remained suspended at various time points in the session provided an indicator of the rate of this behavior. The results indicate that Nestlet shredding was stable with repeated testing, and shredding was depressed by intraperitoneal injection of lactic acid. The nonsteroidal anti‐inflammatory drug ketoprofen blocked pain‐related depression of shredding, but did not block depression of shredding by a non‐pain stimulus, the kappa opioid receptor agonist U69,593. These findings support the validity of this procedure for assessing the expression and treatment of pain‐related functional impairment in mice. In contrast, the µ‐opioid receptor agonist morphine did not block pain‐related depression of shredding when tested up to doses that depressed shredding in the absence of lactic acid. This finding does not support the validity of this procedure for assessing the expression and treatment of pain‐related functional impairment in mice. Two observations from the morphine experiments suggest further research with this procedure is warranted. First, unlike ketoprofen, morphine disrupted shredding when administered in the absence of lactic acid. Thus, it is possible that functional impairment produced by morphine is incompatible with antinociception as defined in this procedure, and manipulations that attenuate morphine‐induced functional impairment might unmask antinociception. Second, the current study includes male and female mice, and the data from each sex were pooled for the primary analyses. When the data for male and female mice were segregated, the data suggest that studies designed and powered to examine sex differences might be worthwhile. For instance, males appear to be more sensitive to morphine‐induced depression of shredding than females. The findings of the present study raise questions about the ability of this procedure to contribute to improvements in predictive validity in analgesic drug development, but the findings complement previous research on pain‐related functional impairment. A growing body of research indicates that drug effects in the absence of pain‐stimuli and the behavioral endpoint are key determinants of the effects of established analgesic drugs in these procedures. Understanding these and other behavioral and environmental variables will be ...

E-cigarettes (electronic cigarettes) have been the most used tobacco product among US youth since 2014, reaching a plateau during the COVID-19 pandemic. Youth e-cigarette use is associated with negative health consequences such as impaired cognitive functioning. For many, the COVID-19 pandemic altered social interactions, harm perceptions, and product availability. This changed the frequency and locations in which youth use e-cigarettes. To better understand youth e-cigarette use, we need more information on factors that can alter e-cigarette use, specifically, how the pandemic changed e-cigarette use among youth. In 2020-2021, we conducted online, individual interviews with 19 youth (aged 13-17) e-cigarette users living in the US to explore how COVID-19 impacted their e-cigarette use. Youth described a progression of e-cigarette use from initial experimentation, regular social use, and ultimately to nicotine addiction demonstrated by individual use in isolation. Many youth initiated e-cigarette use due to influences by friends or family members. Youth discussed progression to social use, with social interactions as an important reason for use and an avenue for expanding one’s knowledge of e-cigarettes. After a period of time, youth began to recognize that the social interactions mattered less, suggesting to them that they had become addicted. This realization became more apparent during COVID-19, which changed how youth used e-cigarettes, especially around where use was occurring, health concerns, and use behavior and frequency. In our interviews, youth trajectory began with an initiation with family and friends, progressed to social use, and eventually developed to addiction, at which point social use was no longer the primary motivation for e-cigarette use. Understanding the trajectory of e-cigarette use will allow for effective interventions that reduce harm to youth from e-cigarette use.