Estimating Community Disruption from Nighttime Gunshots in 6 U.S. Cities, 2015 to 2021.

BACKGROUND: Gunshots affect those directly involved in an incident and those in the surrounding community. The community-level impact of nighttime gunshots, which may be particularly disruptive to the sleep of nearby community members, is unknown. OBJECTIVE: Our aim is to estimate the number of people potentially affected by nighttime gunshots and the relationship between nighttime gunshots and median household income in the USA. DESIGN: We collected publicly available data on the timing and location of gunshots in six U.S. cities (Baltimore, MD; Boston, MA; Washington, D.C.; New York, NY; Philadelphia, PA; and Portland, OR) from 2015 to 2021. We then analyzed the data by computing rate ratios (RRs) to compare the frequency of gunshots during nighttime hours (6:00 pm to 5:59 am) versus daytime hours (6:00 am to 5:59 pm). Additionally, we used geospatial mapping to create choropleth maps to visualize the variation in nighttime gunshot density across cities. We estimated, using city-wide population, person-nights potentially impacted by the sound of gunshots within areas of 0.2- (low) and 0.5-mile (high) radius. Finally, for five of six cities where data on median household income were available by census tract, we built nonlinear regression models to estimate the relationship between the number of nighttime gunshots and median household income. KEY RESULTS: We analyzed 72,236 gunshots. Gunshots were more common during the nighttime than daytime (overall RR = 2.5). Analyses demonstrated that the low estimates for the mean annual number of person-nights impacted by nighttime gunshots were 0.4 million in Baltimore and Portland, 1.3 million in Philadelphia, 1.6 million in Boston, 2.9 million in New York City, and 5.9 million in Washington. The number of nighttime gunshots was inversely related to median household income. CONCLUSIONS: Nighttime gunshots are prevalent, particularly in low-income neighborhoods, and may have under-recognized effects on the surrounding community.

How Treatment Effect Heterogeneity Works.

How Treatment Effect Heterogeneity WorksThis Stats, STAT! animated video explores the concept of treatment effect heterogeneity. Differences in the effectiveness of treatments across participants in a clinical trial is important to understand when deciding how to apply clinical trial results to clinical practice.

Characterizing Gun Violence by Time, Day of the Week, Holidays, and Month in 6 US Cities, 2015-2021.

Developing interventions to prevent firearm-related violence and to address its consequences requires an improved understanding of when these violent events are most likely to occur. We explored gunshot events in 6 of the most populated cities in the United States by time of day, day of week, holiday/non-holiday, and month using publicly available datasets. In some of these cities, gunshot events occurred most often at nighttime, on holidays and weekends, and during summer months, with significant interaction effects. There were also time-related changes in characteristics of the victims. Primary prevention efforts aimed at curbing firearm-related violence should consider these differential risks.

Firearm Injuries In Children And Adolescents: Health And Economic Consequences Among Survivors And Family Members.

More US children and adolescents today die from firearms than any other cause, and many more sustain firearm injuries and survive. The clinical and economic impact of these firearm injuries on survivors and family members remains poorly understood. Using 2007-21 commercial health insurance claims data, we studied 2,052 child and adolescent survivors compared to 9,983 matched controls who did not incur firearm injuries, along with 6,209 family members of survivors compared to 29,877 matched controls, and 265 family members of decedents compared to 1,263 matched controls. Through one year after firearm injury, child and adolescent survivors experienced a 117 percent increase in pain disorders, a 68 percent increase in psychiatric disorders, and a 144 percent increase in substance use disorders relative to the controls. Survivors' health care spending increased by an average of $34,884-a 17.1-fold increase-with 95 percent paid by insurers or employers. Parents of survivors experienced a 30-31 percent increase in psychiatric disorders, with 75 percent more mental health visits by mothers, and 5-14 percent reductions in mothers' and siblings' routine medical care. Family members of decedents experienced substantially larger 2.3- to 5.3-fold increases in psychiatric disorders, with at least 15.3-fold more mental health visits among parents. Firearm injuries in youth have notable health implications for the whole family, along with large effects on societal spending.

Press Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals: an Observational Study.

IMPORTANCE: Results from high-profile randomized controlled trials (RCTs) are routinely reported through press release months prior to peer-reviewed publication. There are potential benefits to press releases (e.g., knowledge dissemination, ensuring regulatory compliance), but also potential drawbacks (e.g., selective reporting, positive "spin"). OBJECTIVE: To characterize the practice of press release predating the publication of a drug-related RCT in a peer-reviewed journal ("preemptive press release"), including factors associated with this practice. DESIGN, SETTING, AND PARTICIPANTS: We systematically reviewed all RCTs of medications published between 2015 and 2019 in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), and Lancet. Press releases were identified using a systematic search of the grey literature (e.g., press release databases, study sponsor websites). An RCT was considered to have a preemptive press release if the press release was published at least three months (90 days) prior to the date of publication in a peer-reviewed journal. MAIN OUTCOMES AND MEASURES: Presence of preemptive press release, defined as a press-release at least 90 days prior to the date of publication in a peer-reviewed journal. As secondary measures for dissemination, we also assessed citation count and Altmetric score. RESULTS: We identified 988 RCTs, of which 172 (17%) had a press release published at least 90 days before the date of peer-reviewed publication. Press releases were published a median of 246 days (interquartile range [IQR] 169-366 days) before publication in a peer-reviewed journal. In the multivariable logistic regression model, the strongest predictor of having a preemptive press release was funding by a pharmaceutical company (odds ratio 13, 95% CI 7, 25). Approximately 85% of RCTs with preemptive press releases had a positive primary outcome and, concordantly, 81% of the corresponding press releases had a positive headline. Multivariable regression models identified studies with a preemptive press release had a similar Altmetric score (median - 15, 95% CI - 33, 12) and higher median citation count (median 22 [95% CI 10 to 33] compared to studies without a preemptive press release. CONCLUSIONS AND RELEVANCE: Preemptive press releases were common, most often issued for trials funded by a pharmaceutical company, and typically preceded publication in a peer-reviewed journal by approximately eight months.

Rapid, accurate publication and dissemination of clinical trial results: benefits and challenges.

Large-scale clinical trials are essential in cardiology and require rapid, accurate publication, and dissemination. Whereas conference presentations, press releases, and social media disseminate information quickly and often receive considerable coverage by mainstream and healthcare media, they lack detail, may emphasize selected data, and can be open to misinterpretation. Preprint servers speed access to research manuscripts while awaiting acceptance for publication by a journal, but these articles are not formally peer-reviewed and sometimes overstate the findings. Publication of trial results in a major journal is very demanding but the use of existing checklists can help accelerate the process. In case of rejection, procedures such as easing formatting requirements and possibly carrying over peer-review to other journals could speed resubmission. Secondary publications can help maximize benefits from clinical trials; publications of secondary endpoints and subgroup analyses further define treatment effects and the patient populations most likely to benefit. These rely on data access, and although data sharing is becoming more common, many challenges remain. Beyond publication in medical journals, there is a need for wider knowledge dissemination to maximize impact on clinical practice. This might be facilitated through plain language summary publications. Social media, websites, mainstream news outlets, and other publications, although not peer-reviewed, are important sources of medical information for both the public and for clinicians. This underscores the importance of ensuring that the information is understandable, accessible, balanced, and trustworthy. This report is based on discussions held on December 2021, at the 18th Global Cardiovascular Clinical Trialists meeting, involving a panel of editors of some of the top medical journals, as well as members of the lay press, industry, and clinical trialists.

Coding for Physical Restraint Status Among Hospitalized Patients: a 2019 National Inpatient Sample Analysis.

BACKGROUND: The reduction of physical restraint utilization in the hospital setting is a key goal of high-quality care, but little is known about the rate of restraint use in general hospitals in the USA. OBJECTIVE: This study reports the rate of physical restraint coding among acute care hospital discharges in the USA and explores associated demographic and diagnostic factors. DESIGN: The National Inpatient Sample, a de-identified all-payors database of acute care hospital discharges in the USA, was queried for patients aged 18 and older with a diagnosis code for physical restraint status in 2019. PARTICIPANTS: Hospitalized patients aged 18 and older. MAIN MEASURES: Demographics, discharge diagnoses, in-hospital mortality, length of stay, total hospital charges. KEY RESULTS: In total, 220,470 (95% CI: 208,114 to 232,826) hospitalizations, or 0.7% of overall hospitalizations, included a discharge code for physical restraint status. There was a 700-fold difference in coding for restraint utilization based on diagnosis, with 7.4% of patients with encephalitis receiving restraint diagnosis codes compared to < 0.01% of patients with uncomplicated diabetes. In an adjusted model, male sex was associated with an odds ratio of 1.4 (95% CI: 1.4 to 1.5) for restraint utilization coding, and Black race was associated with an odds ratio of 1.3 (95% CI: 1.2 to 1.4) relative to white race. CONCLUSIONS: In the general hospital setting, there is variability in physical restraint coding by sex, race, and clinical diagnosis. More research is needed into the appropriate utilization of restraints in the hospital setting and possible inequities in restraint utilization.

Identifying drugs with the greatest increases and decreases in spending per beneficiary using Medicare Part D: A cross-sectional study.

IMPORTANCE: In the US, there are no effective regulations controlling how much the price of a medication can increase. A patchwork of studies examining the reasons for soaring prices has focused on medications that have received considerable media attention, like insulin, epinephrine, and colchicine. OBJECTIVE: To identify the 50 medications with the greatest increase in average spending per beneficiary and the 50 medications with the greatest decrease in average spending per beneficiary, and to identify the factors associated with spending increases. DESIGN, PARTICIPANTS: This cross-sectional study used publicly available data from the Medicare Part D Prescription Drug Program from 2014 to 2020. We included drugs dispensed to > 1000 beneficiaries in each study year and excluded those primarily administered intravenously. MAIN MEASURES: Percentage change in average spending per beneficiary from 2014 to 2020 was calculated for each drug. For each drug, we extracted the number of beneficiaries, the number of manufacturers, and the drug-specific total annual spending reported in the Medicare Part D data set. An online database search was conducted to identify the primary clinical indication, the availability of any generic versions, and the date of FDA approval for each drug. RESULTS: The 50 medications with the greatest increase in spending per beneficiary had a median increase of 362.4% (interquartile range [IQR]: 286.6%-563.0%), with a cumulative spending of almost $5 billion in 2020 alone. Most drugs with the greatest increases in spending per beneficiary had generic versions available (68%) and were approved by the FDA over 10 years ago (66%). Medications with the greatest increase in spending per beneficiary had a median of 1 manufacturer (IQR: 1-2), while medications with the greatest decrease in spending per beneficiary had a median of 9.5 manufacturers (IQR: 5-14). CONCLUSIONS: This study identified rapidly increasing costs of medications under Medicare Part D. Our findings demonstrate that off-patent medications can skyrocket in price, especially when there are few manufacturers of a given medication.

Where Are the Questions About Firearms?: An Analysis of US Federal Public Health Survey Data Infrastructure.

OBJECTIVE: To evaluate existing federal survey data infrastructure pertaining to firearms and firearm-related violence. BACKGROUND: Firearm-related violence results in >40,000 deaths in the United States each year. Limited federal investments over the past 25 years have restricted a systematic approach to federal data collection related to firearms. METHODS: We conducted a systematized review of the 22 continuously administered public health surveys in the US Federal Statistical System conducted between 1995 and 2020. Surveys were included if they addressed 1 of 4 areas of inquiry: (1) firearms; (2) exposure to or experience of firearm-related, intimate partner, or other interpersonal violence; (3) substance use and substance use disorder; (4) behavioral health. Descriptive statistics were used to report the frequency of relevant questions. RESULTS: Nine of 22 surveys were focused on one of these domains and included in this analysis, 7 focused on adults (total 128 survey administrations over the study period) and 2 on youth and adolescents (total 30 administrations). Among all adult surveys, questions related to firearm use were asked 20% of the time, firearm-related violence 4%, firearm ownership 23%; in youth surveys, firearm use was addressed 0 times, firearm-related violence 57%, and firearm ownership 90%. CONCLUSIONS: Reliable national data are critical to understanding firearm-related violence as well as to developing, implementing, and evaluating public health measures to address it. Improving the consistency of questions pertaining to firearm access and experiences of violence in federal surveys offers an opportunity to improve national data infrastructure.

Of Climate Change and Competing Risks.

Of Climate Change and Competing Risks This Stats, STAT! animated video explores the concept of competing risks - and discusses why it is so important for investigators to consider whether the occurrence of one event can prevent or change the likelihood of the occurrence of another.

Good Intentions to Treat.

Good Intentions to Treat This Stats, STAT! animated video explores common approaches to analyzing data from randomized controlled trials, including intention-to-treat, per-protocol, and as-treated analyses.

How Statistical Power Works.

How Statistical Power WorksThis Stats, STAT! animated video explores the concept of statistical power and explains how clinical investigators determine how many participants to enroll in a randomized trial.

Bayesian Way.

Bayesian WayThis animated video explores two possible approaches to analyzing data in a randomized controlled trial: "Frequentist" versus "Bayesian."

Large Language Models.

Large Language ModelsIn the latest edition of Stats, STAT!, Fralick and colleagues explain the statistics behind large language models - used in chat bots like ChatGPT and Bard. While these new tools may seem remarkably intelligent, at their core they just assemble sentences based on statistics from large amounts of text.

How Censoring Works.

How Censoring WorksA common challenge in clinical research is determining the time to occurrence of a given event. This animated video explores the concept of censoring in survival analysis and how investigators deal with ambiguity in the time of an event's occurrence.

The association between non-English primary language and COVID-19 clinical trial eligibility and enrollment: A retrospective cohort study.

BACKGROUND: Establishing equitable access to COVID-19 clinical trials is an important step in mitigating outcomes disparities. Historically, language has served as a barrier to equitable clinical trial participation. METHODS: A centralized research infrastructure was established at our institution to screen potential trial participants and to promote efficient and equitable access to COVID-19 clinical trials. Rates of eligibility and enrollment in COVID-19 clinical trials by primary language between April 9 and July 31, 2020 (during the first regional COVID-19 surge) were evaluated using logistic regression. Estimates were adjusted for potential confounders including age, sex, and time. RESULTS: A total of 1245 patients were admitted to the hospital with COVID-19 during the study period and screened for clinical trial eligibility. Among all screened patients, 487 (39%) had a non-English primary language. After adjustment, patients with a non-English primary language had 1.98 times higher odds (CI 1.51 to 2.59) of being eligible for 1 or more COVID-19 clinical trials. Among eligible patients, those with a non-English primary language had 1.83 times higher odds (CI 1.36 to 2.47) of enrolling in COVID-19 clinical trials than patients with English as the primary language. CONCULSION: These findings suggest that there are modifiable barriers that can be addressed to lessen the impact of language discordance on access to clinical trials and provide an opportunity to further investigate factors associated with clinical trial participation for patients whose primary language is not English.

Racial and Social Determinants of Civilian Gunshot Wounds to the Head.

Objective: To assess the clinical, racial, and social characteristics of victims of Gunshot wounds (GSWs) to the head and assess for associations between these factors and outcomes. Summary Background Data: Previous literature has not focused on the association of race and socioeconomic factors with these specific injuries. Methods: We identified patients with GSWs to the head who presented to 2 urban academic medical centers between 1998 and 2020, and extracted patient-level demographic data, information about the clinical and surgical course, and outcomes at discharge and follow-up. Results: The cohort included 250 patients, 90% (n = 226) of whom were male, with a mean age of 28 years. Forty-five percent were white (n = 112), 19% Black (n = 48), 18% Latinx (n = 45), with 6% "other" (n = 16), and 12% "unknown" (n = 29). The majority of patients presented with assault-related trauma (n = 153, 61%) as compared to self-inflicted injuries (n = 97, 39%). Across the entire cohort, sex, age, race, and median income by ZIP code were not significant predictors of outcome. Victims of assault by GSW to the head were more likely to be age 18 or younger (OR 5.26, P = 0.01), between the ages of 19 and 33 years (OR 4.7, P = 0.001), Black (OR 6.66, P < .001), and Latinx (OR 2.65, P = 0.03). Most patients (n = 155, 63%) had a poor functional outcome (modified Rankin Score 3-6) at discharge. Conclusion: Age, race, and income status were not independent predictors of mortality or functional outcome at discharge in our population. Assault-related GSWs to the head mostly involved young Black or Latinx men of lower socioeconomic status, while self-inflicted injuries were largely seen in older white men.