Trends and Correlates of Age-Disparate Sexual Partnerships in the United States: The National Health and Nutrition Examination Surveys.

ABSTRACT: This national survey demonstrates age-disparate (≥5 years; AD-5) sexual partnerships remain common among males and females aged 20 to 29 years in the United States (2005-2016). Females reported more older AD-5 partners, and males reported more younger AD-5 partners. Having AD-5 partners was associated with greater lifetime and recent number of sexual partners.

Missing data strategies for the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2.

PURPOSE: Missing scores complicate analysis of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) because patients with and without missing scores may systematically differ. We focus on optimal analysis methods for incomplete PRO-CTCAE items, with application to two randomized, double-blind, placebo-controlled, phase III trials. METHODS: In Alliance A091105 and COMET-2, patients completed PRO-CTCAE items before randomization and several times post-randomization (N = 64 and 107, respectively). For each trial, we conducted between-arm comparisons on the PRO-CTCAE via complete-case two-sample t-tests, mixed modeling with contrast, and multiple imputation followed by two-sample t-tests. Because interest lies in whether CTCAE grades can inform missing PRO-CTCAE scores, we performed multiple imputation with and without CTCAE grades as auxiliary variables to assess the added benefit of including them in the imputation model relative to only including PRO-CTCAE scores across all cycles. RESULTS: PRO-CTCAE completion rates ranged from 100.0 to 71.4% and 100.0 to 77.1% across time in A091105 and COMET-2, respectively. In both trials, mixed modeling and multiple imputation provided the most similar estimates of the average treatment effects. Including CTCAE grades in the imputation model did not consistently narrow confidence intervals of the average treatment effects because correlations for the same PRO-CTCAE item between different cycles were generally stronger than correlations between each PRO-CTCAE item and its corresponding CTCAE grade at the same cycle. CONCLUSION: For between-arm comparisons, mixed modeling and multiple imputation are informative techniques for handling missing PRO-CTCAE scores. CTCAE grades do not provide added benefit for informing missing PRO-CTCAE scores. CLINICALTRIALS: gov Identifiers: NCT02066181 (Alliance A091105); NCT01522443 (COMET-2).

Changes in Cytomegalovirus Seroprevalence Among U.S. Children Aged 1-5 Years: The National Health and Nutrition Examination Surveys.

Data from the cross-sectional National Health and Nutrition Examination Surveys (NHANES) indicate that the seroprevalence of cytomegalovirus immunoglobulin G (IgG) antibodies among US children aged 1-5 years was 20.7% (95% confidence interval [CI]: 14.0, 29.0) in 2011-2012 and 28.2% (95% CI: 23.1-34.0) in 2017-2018 (adjusted prevalence difference, +7.6% [95% CI: -.4, +15.6]).

Importance of Lifetime Sexual History on the Prevalence of Genital Human Papillomavirus (HPV) Among Unvaccinated Adults in the National Health and Nutrition Examination Surveys: Implications for Adult HPV Vaccination.

BACKGROUND: Although the United States Food and Drug Administration recently approved the human papillomavirus (HPV) vaccine for individuals aged 27-45 years, the Centers for Disease Control and Prevention did not change its guidelines for routine HPV vaccination. Since recommendations for adult vaccination emphasize shared clinical decision-making based on risk of new infections, we examined the relationship between HPV prevalence and sexual behavior. METHODS: This study was conducted among 5093 HPV-unvaccinated, sexually experienced adults aged 18-59 years in the National Health and Nutrition Examination Surveys (2013-2016). For each sex and age group, adjusted prevalences of 9-valent vaccine-specific, high-risk, and any HPV infection were estimated by number of lifetime sexual partners (LTSPs) using logistic regression. An analysis restricted to persons who did not have a new sexual partner in the past year (ie, removing those at highest risk of newly acquired HPV) was also conducted. RESULTS: In each age group, genital HPV prevalence was higher among persons with >5 LTSPs compared with 1-5 LTSPs in both males and females. There were only slight reductions in HPV prevalence after removing participants who reported a new sexual partner in the past year. For example, among females aged 27-45 years with >5 LTSPs, the adjusted prevalence of 9-valent vaccine-type HPV infection was 13.4% (95% confidence interval [CI], 9.9%-17.0%) in the full population compared to 12.1% (95% CI, 8.8%-15.4%) among those with no new sexual partners. CONCLUSIONS: Prevalent HPV infection was primarily reflective of cumulative exposures over time (higher LTSPs). New exposures had limited impact, emphasizing the need to consider sexual history in the decision-making process for adult HPV vaccination.

Seroprevalence of Chlamydia trachomatis Among Female Adults in the United States: The National Health and Nutrition Examination Surveys.

BACKGROUND: Chlamydia trachomatis is the most common nationally notifiable sexually transmitted infection in the United States; however, the seroprevalence of C. trachomatis infection is unknown. METHODS: This cross-sectional study was conducted among 1725 females aged 18 to 39 years who provided serum and urine samples in the 2013 through 2016 National Health and Nutrition Examination Surveys. Presence of anti-C. trachomatis Pgp3 immunoglobulin G (IgG) was determined using both an enzyme-linked immunosorbent assay (ELISA) and multiplex bead array (MBA). Weighted seroprevalence estimates were calculated. Correlates of seroprevalence were examined by multivariable Poisson regression. RESULTS: In 2013 through 2016, overall seroprevalence of C. trachomatis Pgp3 IgG was 30.0% (95% confidence interval [CI], 25.5-35.0) as measured by ELISA and 29.4% (95% CI, 25.8-33.0) as measured by the MBA assay. Overall agreement between tests was 87.1% (1503/1725). There was a high positive agreement by the MBA assay with current detection of chlamydia in urine (86% [36/42]), a past-year diagnosis of chlamydia (81.8% [27/33]), and a history of treatment for pelvic inflammatory disease (60.7% [37/61]). Seroprevalence of C. trachomatis Pgp3 IgG, as measured by MBA, was significantly higher among non-Hispanic Blacks (68.0%; adjusted prevalence ratio (aPR) = 2.7 [95% CI, 2.3-3.3]), Mexican Americans (30.9%; aPR = 1.5 [95% CI, 1.2-1.9]), and other Hispanics (35.0%; aPR = 1.9 [95% CI, 1.4-2.5]) compared with non-Hispanic Whites (21.4%). A higher lifetime number of sexual partners and a younger age at sexual debut was also associated with higher seroprevalence. CONCLUSION: Both the ELISA and MBA serologic assays revealed a high prevalence of antibodies to C. trachomatis Pgp3 in young adult females in the US household population. There were major racial/ethnic disparities in exposure to C. trachomatis, with increased vulnerability among non-Hispanic Black females.

Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study.

BACKGROUND: The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. METHODS AND FINDINGS: Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. CONCLUSIONS: These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT#: NCT04338360.

Blood transfusions in gunshot-wound-related emergency department visits and hospitalizations in the United States.

BACKGROUND: The United States (US) leads all high-income countries in gunshot wound (GSW) deaths. However, previous US studies have not evaluated the national blood transfusion utilization patterns in hospitalized GSW patients. METHODS: Data from 2016 to 2017 were analyzed from the Nationwide Emergency Department Sample (NEDS) and Nationwide Inpatient Sample (NIS), the largest all-payer emergency department (ED) and inpatient databases, respectively. Using stratified probability sampling, weights were applied to generate nationally representative estimates. Multivariable Poisson-regression models were used to estimate prevalence ratios (PR) of blood transfusion. RESULTS: There were 168,315 ED visits and 58,815 hospitalizations (age = 18-90 years) following a GSW. The majority of hospitalizations were men (88.5%), age 18-24 years (31.8%), and assault-related GSW (51.3%). Blacks had the largest proportion (48.7%) overall of all GSW hospitalizations; Whites accounted for the highest proportion of intentional self-harm injuries (72.4%). Blood transfusions occurred in 12.7% of hospitalizations (12.0% red blood cell [RBC], 4.9% plasma, and 2.5% platelet transfusions). Only 1.9% of cases were associated with transfusion of all three blood components. Hospitalizations with major/extreme severity of illness had significantly higher prevalence of transfusion versus those with mild/moderate severity [crude PR = 4.79 (95%CI:4.15-5.33, p < .001)]. Overall, 8.2% of hospitalizations with GSW died, of whom 26.8% required blood transfusions, which was significantly higher than survivors [crude PR = 2.34 (95%CI:2.10-2.61, p < .001)]. The vast majority (95%) of the transfusions among those who died were within 48 h since admission. CONCLUSIONS: Gun-related violence is a public health emergency in the US, and GSWs are a source of significant mortality, blood utilization, and health care costs.

Utilizing open-source platforms to build and deploy interactive patient-reported quality of life tracking tools for monitoring protocol adherence.

PURPOSE: Tracking patient-reported outcomes (PROs) and quality-of-life response rates is essential for clinical trials. Historically, rates are monitored through scheduled reports, which can require gathering, merging, and cleaning data from multiple databases. At the end of this process, if gaps are found, new data are entered and the cycle repeats, leaving a trail of reports that are not up-to-date or immediately accessible to the investigator. The financial and person-hour cost of utilizing clinical research staff for this purpose is impractical. Online dashboards are continuously updated to monitor data, providing on-demand access to promote successful research. METHODS: Dashboard implementation utilizes R, an open-source statistical programming language, RMarkdown, a markup language, Flexdashboard, which creates structural elements, and Shiny, allowing investigators the ability to interact with data within the dashboard. By leveraging these four elements, powerful, cost-effective interactive dashboards can be built. RESULTS: Numerous dashboards have been utilized to identify potentially missing data and increase protocol adherence. Immediate patient consultation can occur to retrieve protocol-related forms, reducing research staff and patient burden while improving trial effectiveness. Dashboards can monitor PROs, enrollment, demographics, toxicity, and biomarker data, clinical outcomes, and implemented predictive models, creating a single hub for on-demand clinical trial monitoring. CONCLUSION: By employing a set of freely available tools, the burden of utilizing study staff to continuously monitor trials is greatly reduced. These tools allow users to rapidly build and deploy dynamic dashboards capable of meeting the research needs of any investigator while limiting missing data through simplified monitoring of protocol adherence.

Comparative changes of pre-operative autologous transfusions and peri-operative cell salvage in the United States.

BACKGROUND: With improved safety of allogeneic blood supply, the use of preoperative autologous donations (PADs) and perioperative autologous cell salvage (PACS) has evolved. This study evaluated temporal trends in PAD and PACS use in the United States. METHODS: The National Inpatient Sample database, a stratified probability sample of 20% of hospitalizations in the United States, was used to compare temporal trends in hospitalizations reporting use of PADs and PACS from 1995 to 2015. Factors associated with their use were examined between 2012 and 2015 with use of multivariable Poisson regression. Sampling weights were applied to generate nationally representative estimates. RESULTS: There was a steady decrease in hospitalizations reporting PAD transfusions from 27.90 per 100 000 in 1995 to 1.48 per 100 000 hospitalizations in 2015 (P-trend <.001). In contrast, PACS increased from a rate of 1.16 per 100 000 in 1995 to peak of 20.51 per 100 000 hospitalizations in 2008 and then steadily declined (P-trend<.001). Higher odds of PACS and PADs were observed in older patients, elective procedures (vs urgent), and urban teaching/nonteaching hospitals (vs rural hospitals) (P < .001). PACS was more common in hospitalizations in patients with higher levels of severity of illness as compared to those with minor severity (adjusted prevalence ratio [adjPR], 2.39; 95% confidence interval [CI], 2.08-2.73; P<.001), while PADs were performed less often in patients with higher underlying severity of illness (All Patient Refined Diagnosis Related Groups, 4 vs 1, adjPR, 0.61; 95% CI, [0.39-0.95]; P = .028). CONCLUSIONS: There was a significant decrease in PAD red blood cell transfusions, while PACS has increased and subsequently decreased; PACS plays an important role in surgical blood conservation. The subsequent decline in PACS likely reflects further optimization of transfusion practice through patient blood management programs and improvement of surgical interventions.

Individual- and hospital-level correlates of red blood cell, platelet, and plasma transfusions among hospitalized children and neonates: a nationally representative study in the United States.

BACKGROUND: Factors associated with red blood cell (RBC), plasma, and platelet transfusions in hospitalized neonates and children across the United States have not been well characterized. METHODS: Data from the Kids' Inpatient Database (KID) 2016 were analyzed. KID is a random sample of 10% of all uncomplicated in-hospital births and 80% of remaining pediatric discharges from approximately 4200 US hospitals. Sampling weights were applied to generate nationally representative estimates. Primary outcome was one or more RBC transfusion procedures; plasma and platelet transfusions were assessed as secondary outcomes. Analysis was stratified by age: neonates (NEO; ≤28 d), and nonneonates (PED; >28 d and <18 y). Multivariable logistic regression was used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs). RESULTS: Among 5,604,984 total hospitalizations, overall prevalence of transfusions was 1.07% (95% CI, 0.94%-1.22%) for RBCs, 0.17% (95% CIs, 0.15%-0.21%) for plasma and 0.35% (95% CI, 0.30%-0.40%) for platelet transfusions. RBC transfusions occurred among 0.43% NEO admissions and 2.63% PED admissions. For NEO admissions, RBC transfusion was positively associated with nonwhite race, longer length of hospitalization, highest risk of mortality (aOR, 86.58; 95% CI, 64.77-115.73) and urban teaching hospital location. In addition to the above factors, among PED admissions, RBC transfusion was positively associated with older age, female sex (aOR, 1.10; 95% CI, 1.07-1.13), and elective admission status (aOR, 1.62; 95% CI, 1.46-1.80). Factors associated with plasma and platelet transfusions were largely similar to those associated with RBC transfusion, except older age groups had lower odds of plasma transfusion among PED admissions. CONCLUSIONS: While there is substantial variability in the proportion of neonates and nonneonatal children transfused nationally, there are several similar, yet unique, nonlaboratory predictors of transfusion identified in these age groups.

Malaria parasitemia among blood donors in Uganda.

BACKGROUND: Malaria remains a leading transfusion associated infectious risk in endemic areas. However, the prevalence of malaria parasitemia has not been well characterized in blood donor populations. This study sought to determine the prevalence of Plasmodium in red blood cell (RBC) and whole blood (WB) units after the rainy season in Uganda. METHODS AND MATERIALS: Between May and July 2018, blood was collected from the sample diversion pouch of 1000 WB donors in Kampala and Jinja, Uganda. The RBC pellet from ethylenediamine tetraacetic acid (EDTA) anticoagulated blood was stored at -80°C until testing. DNA was extracted and nested PCR was used to screen samples at the genus level for Plasmodium, with positive samples further tested for species identification. RESULTS: Malaria parasitemia among asymptomatic, eligible blood donors in two regions of Uganda was 15.4%; 87.7% (135/154) of infections were with P. falciparum, while P. malariae and P. ovale were also detected. There were 4.3% of blood donors who had mixed infection with multiple species. Older donors (>30 years vs. 17-19 years; aPR = 0.31 [95% CI = 0.17-0.58]), females (aPR = 0.60 [95% CI = 0.42-0.87]), repeat donors (aPR = 0.44 [95% CI = 0.27-0.72]) and those donating near the capital city of Kampala versus rural Jinja region (aPR = 0.49 [95% CI = 0.34-0.69]) had a lower prevalence of malaria parasitemia. CONCLUSIONS: A high proportion of asymptomatic blood donors residing in a malaria endemic region demonstrate evidence of parasitemia at time of donation. Further research is needed to quantify the risk and associated burden of transfusion-transmitted malaria (TTM) in order to inform strategies to prevent TTM.

Does IBD Portend Worse Outcomes in Patients with Rectal Cancer? A Case-Matched Analysis.

BACKGROUND: Patients with IBD are at increased risk for developing colorectal cancer. However, overall survival and disease-free survival for rectal cancer alone in patients with IBD has not been reported. OBJECTIVE: This study aimed to determine overall survival and disease-free survival for patients with rectal cancer in IBD versus non-IBD cohorts. DESIGN: This is a retrospective cohort study. SETTING: This study was conducted at an IBD referral center. PATIENTS: All consecutive adult patients with IBD diagnosed with rectal cancer and at least 1 year of postsurgery follow-up were included and matched in a 1:2 fashion (age, sex, preoperative stage) with patients with rectal cancer who did not have IBD. MAIN OUTCOMES MEASURES: Five-year overall survival and disease-free survival, 30-day postoperative complication, readmission, reoperation, and mortality rates were measured. METHODS: Survival rates were calculated using Kaplan-Meier estimates. The association of risk factors and long-term outcomes was assessed using Cox proportion hazard models. RESULTS: A total of 107 study patients with IBD who had rectal cancer were matched to 215 control patients; preoperative stages were as follows: 31% with stage I, 19% with stage II, 40% with stage III, and 10% with stage IV. Differences were observed (IBD vs non-IBD) in neoadjuvant chemotherapy (33.6% vs 52.6%, p = 0.001) and preoperative radiotherapy (35.5% vs 53.5%, p = 0.003). Postoperative complication rates were similar. On surgical pathology, patients with IBD had more lymphovascular invasion (12.9% vs 5.6%, p = 0.04) and positive circumferential resection margins (5.4% vs 0.9%, p = 0.03). On multivariable analysis, the diagnosis of IBD did not significantly impact long-term mortality (HR, 0.91; 95% CI, 0.53-1.57; p = 0.73) or disease-free survival (HR, 1.36; 95% CI, 0.84-2.21; p = 0.22). LIMITATIONS: This study was limited by its retrospective design and the use of single-center data. CONCLUSIONS: Patients have rectal cancer with IBD and without IBD have similar long-term and disease-free survival, despite lower rates of neoadjuvant treatment and higher margin positivity in patients with IBD. See Video Abstract at http://links.lww.com/DCR/B271. ¿LA ENFERMEDAD INFLAMATORIA INTESTINAL ACARREA PEORES RESULTADOS EN PACIENTES CON CÁNCER RECTAL? UN ANÁLISIS DE CASOS-COINCIDENTES: Los pacientes con enfermedad inflamatoria intestinal (EII) tienen un mayor riesgo de desarrollar cáncer colorrectal. Sin embargo, no se ha informado la supervivencia general y la supervivencia libre de enfermedad para el cáncer rectal solo en pacientes con EII.Determinar la supervivencia general y la supervivencia libre de enfermedad para pacientes con cáncer rectal en cohortes con EII versus sin EII.Estudio de cohorte retrospectivo.Centro de referencia para enfermedad inflamatoria intestinal.todos los pacientes adultos con EII diagnosticados con cáncer rectal, consecutives, y al menos un año de seguimiento postoperatorio se incluyeron y se emparejaron de manera 1: 2 (edad, sexo, etapa preoperatoria) con pacientes con cáncer rectal sin EII.Se midieron la supervivencia general a cinco años y la supervivencia libre de enfermedad, complicaciones postoperatorias a los 30 días, reingreso, reoperación y tasas de mortalidad.Las tasas de supervivencia se calcularon utilizando estimaciones de Kaplan-Meier. La asociación de factores de riesgo y resultados a largo plazo se evaluó mediante modelos de riesgo de proporción de Cox.Un total de 107 pacientes con EII y cáncer rectal se compararon con 215 pacientes de control; las etapas preoperatorias fueron las siguientes: 31% de Etapa I, 19% de Etapa II, 40% de Etapa III y 10% de Etapa IV. Se observaron diferencias (EII versus no EII) en quimioterapia neoadyuvante (33.6% frente a 52.6%, p = 0.001) y radioterapia preoperatoria (35.5% frente a 53.5%, p = 0.003). Las tasas de complicaciones postoperatorias fueron similares. En la patología quirúrgica, los pacientes con EII tuvieron más invasión linfovascular (12.9% frente a 5.6%, p = 0.04) y márgenes de resección circunferencial positivos (5.4% frente a 0.9%, p = 0.03). En el análisis multivariable, el diagnóstico de EII no tuvo un impacto significativo en la mortalidad a largo plazo (HR 0.91; IC del 95%: 0.53-1.57, p = 0.73) o la supervivencia libre de enfermedad (HR 1.36; IC del 95%: 0.84-2.21, p = 0.22)Diseño retrospectivo, centro único de datos.Los pacientes con EII y sin EII con cáncer rectal tienen una supervivencia similar a largo plazo y libre de enfermedad, a pesar de las tasas más bajas de tratamiento sneoadyuvante y un mayor margen positivo en pacientes con EII. Consulte Video Resumen en http://links.lww.com/DCR/B271.

Are Biologics Safe in the Immediate Postoperative Period? A Single-Center Evaluation of Consecutive Crohn's Surgical Patients.

BACKGROUND: There is no study to date examining the safety of initiating or restarting biologic therapy after major abdominal surgery for Crohn's disease. OBJECTIVE: The purpose of this study was to determine differences in the rates of 90-day superficial surgical site infections, intra-abdominal sepsis, and overall postoperative infectious complications among patients who were initiated on or restarted a biologic within 90 days postoperatively compared with those who were not. DESIGN: This was a retrospective cohort study. SETTINGS: The study was conducted at an IBD referral center. PATIENTS: Adult patients with Crohn's disease who received a biologic therapy within 90 days of a major abdominal operation between May 20, 2014, and December 31, 2018, were included. MAIN OUTCOMES MEASURES: Ninety-day superficial surgical site infection, intra-abdominal sepsis, and overall postoperative infectious complications were measured. RESULTS: A total of 680 patients with Crohn's disease were included: 351 were initiated on biologic therapy within 90 days after surgery and 329 were not. Patients exposed to biologic therapy postoperatively were younger (p < 0.001), had a lower BMI (p = 0.0014), were less often diabetic (p = 0.0011), and were more often exposed preoperatively to biologics (p < 0.0001) and immunomodulators (p < 0.0001) but not corticosteroids (p = 0.8399). Of those exposed postoperatively, nearly all (93.7%) had been on a biologics preoperatively, and most resumed the same biologic (68.0%). The median time to starting biologic therapy postoperatively was 31 days (range, 7-89 d). Postoperative biologic exposure was not associated with an increased risk of superficial surgical site infection (HR = 1.02 (95% CI, 0.95-1.09) per week; p = 0.59), intra-abdominal sepsis (HR = 1.07 (95% CI, 0.99-1.16); p = 0.73), or overall postoperative infectious complications (HR = 1.02 (95% CI, 0.98-1.07); p = 0.338); the overall rates of each at 90 days was 13%, 8%, and 28%. LIMITATIONS: The study was limited by its retrospective design and single-center data. CONCLUSIONS: Postoperative initiation or resumption of biologic therapy did not increase 90-day rates of superficial surgical site infection, intra-abdominal sepsis, or total infectious complications after major abdominal surgery for Crohn's disease. See Video Abstract at http://links.lww.com/DCR/B207. ¿SON SEGUROS LOS FÁRMACOS BIOLÓGICOS EN EL POSTOPERATORIO INMEDIATO? UNA EVALUACIÓN DE UN SOLO CENTRO DE PACIENTES QUIRÚRGICOS CONSECUTIVOS CON ENFERMEDAD DE CROHN: No hay ningún estudio hasta la fecha que examine la seguridad de iniciar o reiniciar la terapia biológica después de una cirugía abdominal mayor en enfermedad de Crohn.Determinar las diferencias en las tasas a 90 días de infecciones del sitio quirúrgico superficial, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales entre los pacientes en que se inició o reinició un biológico dentro de los 90 días después de la operación en comparación con aquellos que no lo recibieron.Estudio de cohorte retrospectivo.Centro de referencia de enfermedad inflamatoria intestinal.Pacientes adultos con enfermedad de Crohn que recibieron una terapia biológica dentro de los 90 días de una operación abdominal mayor entre el 20 de mayo de 2014 y el 31 de diciembre de 2018.Infección superficial del sitio quirúrgico, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales a 90 días.Se incluyeron un total de 680 pacientes con enfermedad de Crohn: 351 se iniciaron en terapia biológica dentro de los 90 días posteriores a la cirugía y 329 no. Los pacientes expuestos a terapia biológica después de la operación eran más jóvenes (p <0.001), tenían un índice de masa corporal más bajo (p = 0.0014), eran con menos frecuencia diabéticos (p = 0.0011) y estaban expuestos con mayor frecuencia preoperatoriamente a fármacos biológicos (p <0.0001) e inmunomoduladores (p <0.0001) pero no a corticosteroides (p = 0.8399). De los expuestos postoperatoriamente, casi todos (93.7%) habían estado en terapia biológica en el preoperatorio, y la mayoría reanudó la misma terapia biológica (68%). La mediana de tiempo para comenzar la terapia biológica después de la operación fue de 31 días (rango, 7-89 días). La exposición biológica postoperatoria no se asoció con un mayor riesgo de infección superficial del sitio quirúrgico (HR 1.02 (0.95-1.09) por semana, p = 0.59), sepsis intraabdominal. (HR: 1.07 (0.99-1.16), p = 0.73), o complicaciones infecciosas postoperatorias generales (HR: 1.02, intervalo de confianza del 95% 0.98-1.07, p = 0.338); las tasas generales de cada uno a los 90 días fue del 13%, 8% y 28%.Diseño retrospectivo, y datos de un centro único.El inicio o la reanudación en el postoperatorio de la terapia biológica no aumentaron las tasas a 90 días de infección superficial de sitio quirúrgico, sepsis intraabdominal o complicaciones infecciosas totales después de una cirugía abdominal mayor por enfermedad de Crohn. Consulte el Video Resumen en http://links.lww.com/DCR/B207. (Traducción-Dr Jorge Silva Velazco).

Methicillin-Resistant and Methicillin-Sensitive Staphylococcus aureus Hospitalizations: National Inpatient Sample, 2016-2019.

Data from the National Inpatient Sample demonstrate that methicillin-resistant Staphylococcus aureus (MRSA)-related septicemia hospitalizations increased from 1.67 (95% CI, 1.63-1.72) to 1.94 (95% CI, 1.88-2.00; P trend < .001) discharges per 1000 hospitalizations between 2016 and 2019. Regionally, the trends were similar. Rates of MSSA-related septicemia and pneumonia hospitalizations also increased significantly over this time period.

Biologically Effective Dose and Rectal Bleeding in Definitive Proton Therapy for Prostate Cancer.

Purpose and Objectives: With increasing use of hypofractionation and extreme hypofractionation for prostate cancer, rectal dose-volume histogram (DVH) parameters that apply across dose fractionations may be helpful for treatment planning in clinical practice. We present an exploratory analysis of biologically effective rectal dose (BED) and equivalent rectal dose in 2 Gy fractions (EQD2) for rectal bleeding in patients treated with proton therapy across dose fractionations. Materials and Methods: From 2016 to 2018, 243 patients with prostate cancer were treated with definitive proton therapy. Rectal DVH parameters were obtained from treatment plans, and rectal bleeding events were recorded. The BED and EQD2 transformations were applied to each rectal DVH parameter. Univariate analysis using logistic regression was used to determine DVH parameters that were significant predictors of grade ≥ 2 rectal bleeding. Youden index was used to determine optimum cutoffs for clinically meaningful DVH constraints. Stepwise model-selection criteria were then applied to fit a "best" multivariate logistic model for predicting Common Terminology Criteria for Adverse Events grade ≥ 2 rectal bleeding. Results: Conventional fractionation, hypofractionation, and extreme hypofractionation were prescribed to 117 (48%), 84 (34%), and 42 (17.3%) patients, respectively. With a median follow-up of 20 (2.5-40) months, 10 (4.1%) patients experienced rectal bleeding. On univariate analysis, multiple rectal DVH parameters were significantly associated with rectal bleeding across BED, EQD2, and nominal doses. The BED volume receiving 55 Gy > 13.91% was found to be statistically and clinically significant. The BED volume receiving 55 Gy remained statistically significant for an association with rectal bleeding in the multivariate model (odds ratio, 9.81; 95% confidence interval, 2.4-40.5; P = .002). Conclusion: In patients undergoing definitive proton therapy for prostate cancer, dose to the rectum and volume of the rectum receiving the dose were significantly associated with rectal bleeding across conventional fractionation, hypofractionation, and extreme hypofractionation when using BED and EQD2 transformations.

Clinical outcomes for hilar and extrahepatic cholangiocarcinoma with adjuvant, definitive, or liver transplant-based neoadjuvant chemoradiotherapy strategies: a single-center experience.

Background: We report our experience with 3 strategies for treating hilar and extrahepatic cholangiocarcinoma (CCA) including chemoradiotherapy: neoadjuvant chemoradiotherapy (nCRT) and orthotopic liver transplant, surgical resection and adjuvant chemoradiotherapy (aCRT), and definitive chemoradiotherapy (dCRT). Methods: We included patients treated from 1998 through 2019. Kaplan-Meier estimates, log-rank testing, and univariate/multivariate Cox models were used to assess outcomes (local progression-free survival, disease-free survival, and overall survival). Results: Sixty-five patients (nCRT, n=20; aCRT, n=16; dCRT, n=29) met inclusion criteria [median (range) age 65 years (27-84 years)]. Median posttreatment follow-up was 19.1 months (0.8-164.8 months) for all patients and 38.6, 24.3, and 9.0 months for the nCRT, aCRT, and dCRT groups, respectively. At 3 and 5 years, overall survival was 78% and 59% for the nCRT group; 47% and 35%, aCRT group; and 11% and 0%, dCRT group. Compared with the dCRT group, the nCRT group (hazard ratio =0.13, 95% CI: 0.05-0.33) and the aCRT group (hazard ratio =0.29, 95% CI: 0.14-0.64) had significantly improved overall survival (P<0.001). The 5-year local progression-free survival (50% nCRT vs. 30% aCRT vs. 0% dCRT, P<0.001) and 5-year disease-free survival (61% nCRT vs. 30% aCRT vs. 0% dCRT, P=0.01) were significantly better for strategies combined with surgery. Conclusions: Outcomes for patients with extrahepatic CCA were superior for those who underwent nCRT/orthotopic liver transplant or postsurgical aCRT than for patients treated with dCRT. The excellent outcomes after nCRT/orthotopic liver transplant provide additional independent data supporting the validity of this strategy. The poor survival of patients treated with dCRT highlights a need for better therapies when surgery is not possible.

Prescription Antibiotic Use Among the US population 1999-2018: National Health and Nutrition Examination Surveys.

BACKGROUND: Antibiotic resistance has been identified as a public health threat both in the United States and globally. The United States published the National Strategy for Combating Antibiotic Resistance in 2014, which included goals to reduce inappropriate outpatient antibiotic use. METHODS: This cross-sectional study was conducted using National Health and Nutrition Examination Surveys (NHANES) years 1999-2018. Weighted prevalence of past 30-day nontopical outpatient antibiotic use was calculated, as well as the change in prevalence from 1999-2002 to 2015-2018 and 2007-2010 to 2015-2018, both overall and for subgroups. Associations with past 30-day nontopical outpatient antibiotic use in 2015-2018 were examined using predictive margins calculated by multivariable logistic regression. RESULTS: The overall prevalence of past 30-day nontopical outpatient antibiotic use adjusted for age, sex, race/ethnicity, poverty status, time of year of the interview, and insurance status from 1999-2002 to 2015-2018 changed significantly from 4.9% (95% CI, 3.9% to 5.0%) to 3.0% (95% CI, 2.6% to 3.0%), with the largest decrease among children age 0-1 years. From 2007-2010 to 2015-2018, there was no significant change (adjusted prevalence ratio [adjPR], 1.0; 95% CI, 0.8 to 1.2). Age was significantly associated with antibiotic use, with children age 0-1 years having significantly higher antibiotic use than all other age categories >6 years. Being non-Hispanic Black was negatively associated with antibiotic use as compared with being non-Hispanic White (adjPR, 0.6; 95% CI, 0.4 to 0.8). CONCLUSIONS: While there were declines in antibiotic use from 1999-2002 to 2015-2018, there were no observed declines during the last decade.

Dose-volume histogram parameters and patient-reported EPIC-Bowel domain in prostate cancer proton therapy.

PURPOSE: To analyze rectal dose and changes in quality of life (QOL) measured with the Expanded Prostate and Cancer Index Composite (EPIC) bowel domain in patients being treated for prostate cancer with curative-intent proton beam therapy (PBT) within a large single-institution prospective registry. MATERIALS AND METHODS: Data was collected from 243 patients with localized prostate cancer treated with PBT from 2016 to 2018. The EPIC survey was administered at baseline, end-of-treatment, 3, 6, and 12 months, then annually. Dose-volume histogram (DVH) parameters for the rectum were computed, and rectal dose was analyzed using BED (α/ß = 3), EQD2Gy, and total dose. Repeated measures mixed models were implemented to determine the effect of patient, clinical, and treatment factors (including DVH) on patient-reported bowel symptom burden (EPIC-Bowel). RESULTS: Treatment overall resulted in changes in EPIC-Bowel scores (baseline score = 93.7), most notably at end-of-treatment (90.6) and 12 months (89.7). However, they returned to baseline at 36 months (92.9). On multivariate modeling, rectal BED D25 (Gy) ≥23% was significantly associated with decline in QOL scores measuring bother (p < 0.01; 4.06 points different). CONCLUSION: Rectal doses, specifically BED D25 (Gy) ≥23%, are significantly associated with decline in bowel bother-related QOL in patients undergoing definitive radiotherapy for localized prostate cancer. This study demonstrates BED as an independent predictor of bowel QOL across dose fractionations of PBT.

Clostridioides difficile Prevalence in the United States: National Inpatient Sample, 2016 to 2018.

Data from the National Inpatient Sample indicate that Clostridioides difficile prevalence decreased from 10.1 (95% confidence interval [CI] = 9.9-10.3) to 8.6 (95% CI = 8.5-8.8) per 1000 hospital discharges between 2016 and 2018, after accounting for age, sex, and race. There was heterogeneity in the prevalence and decrease in prevalence by geographic region in the United States.