Oncology clinical trial disruption during the COVID-19 pandemic: a COVID-19 and cancer outcomes study.

BACKGROUND: COVID-19 disproportionately impacted patients with cancer as a result of direct infection, and delays in diagnosis and therapy. Oncological clinical trials are resource-intensive endeavors that could be particularly susceptible to disruption by the pandemic, but few studies have evaluated the impact of the pandemic on clinical trial conduct. PATIENTS AND METHODS: This prospective, multicenter study assesses the impact of the pandemic on therapeutic clinical trials at two large academic centers in the Northeastern United States between December 2019 and June 2021. The primary objective was to assess the enrollment on, accrual to, and activation of oncology therapeutic clinical trials during the pandemic using an institution-wide cohort of (i) new patient accruals to oncological trials, (ii) a manually curated cohort of patients with cancer, and (ii) a dataset of new trial activations. RESULTS: The institution-wide cohort included 4756 new patients enrolled to clinical trials from December 2019 to June 2021. A major decrease in the numbers of new patient accruals (-46%) was seen early in the pandemic, followed by a progressive recovery and return to higher-than-normal levels (+2.6%). A similar pattern (from -23.6% to +30.4%) was observed among 467 newly activated trials from June 2019 to June 2021. A more pronounced decline in new accruals was seen among academically sponsored trials (versus industry sponsored trials) (P < 0.05). In the manually curated cohort, which included 2361 patients with cancer, non-white patients tended to be more likely taken off trial in the early pandemic period (adjusted odds ratio: 2.60; 95% confidence interval 1.00-6.63), and substantial pandemic-related deviations were recorded. CONCLUSIONS: Substantial disruptions in clinical trial activities were observed early during the pandemic, with a gradual recovery during ensuing time periods, both from an enrollment and an activation standpoint. The observed decline was more prominent among academically sponsored trials, and racial disparities were seen among people taken off trial.

EVALUATIONS OF INVENTORY AND ACTIVITY CONCENTRATION OF RADIOCESIUM IN SOIL AT A RESIDENTIAL HOUSE 3 YEARS AFTER THE FUKUSHIMA NUCLEAR ACCIDENT.

Soil samples from the surface to a 5 cm depth were collected at a residential house in Koriyama City, Fukushima Prefecture using a scraper plate every three months from March 2014 to September 2014 to evaluate the vertical distribution profiles and inventories of 134Cs and 137Cs in soil. The vertical distribution profiles of radiocesium (134Cs and 137Cs) in soil showed that greater than 86% of the total radiocesium was absorbed in the upper 2 cm 3 years after the accident. Radiocesium in the surface layer seems to move to the lower layer over time. The migration of radiocesium in surface layer might be influenced by the ground surface runoff by rainfall. Radiocesium inventories in June increased significantly over the short period between March and June. In contrast, the radiocesium inventories in September did not increase significantly compared to the values in June. Radiocesium resuspension and deposition caused by decontamination work and meteorological events might be one possible reason for the increased radiocesium inventories observed in June.

Investigation and management of an outbreak of Salmonella Typhimurium DT8 associated with duck eggs, Ireland 2009 to 2011.

Salmonella Typhimurium DT8 was a very rare cause of human illness in Ireland between 2000 and 2008, with only four human isolates from three patients being identified. Over a 19-month period between August 2009 and February 2011, 34 confirmed cases and one probable case of Salmonella Typhimurium DT8 were detected, all of which had an MLVA pattern 2-10-NA-12-212 or a closely related pattern. The epidemiological investigations strongly supported a linkbetween illness and exposure to duck eggs. Moreover, S. Typhimurium with an MLVA pattern indistinguishable (or closely related) to the isolates from human cases, was identified in 22 commercial and backyard duck flocks, twelve of which were linked with known human cases. A range of control measures were taken at farm level, and advice was provided to consumers on the hygienic handling and cooking of duck eggs. Although no definitive link was established with a concurrent duck egg-related outbreak of S. Typhimurium DT8 in the United Kingdom, it seems likely that the two events were related. It may be appropriate for other countries with a tradition of consuming duck eggs to consider the need for measures to reduce the risk of similar outbreaks.

Blood-borne virus transmission in healthcare settings in Ireland: review of patient notification exercises 1997-2011.

A review of patient notification exercises (PNEs) carried out in Ireland between 1997 and 2011 to investigate potential exposure to blood-borne viruses (BBVs) in healthcare settings was undertaken to inform future policy and practice. A questionnaire was sent to key informants in the health services to identify all relevant PNEs. Structured interviews were conducted with key investigators, and available documentation was examined. Ten BBV-related PNEs were identified. Despite testing over 2000 patients, only one case of transmission was found. However, in-depth local investigations before undertaking the PNEs identified six cases of healthcare-associated transmission.

Umbilical cord blood as a replacement source for admission complete blood count in premature infants.

OBJECTIVE: We hypothesize that a complete blood count (CBC) with manual differential from umbilical cord blood is equivalent to a CBC with manual differential obtained from the neonate on admission. STUDY DESIGN: A CBC and manual differential was performed on 174 paired umbilical cord blood and admission blood samples from infants <35 weeks gestation. Paired t-test and Pearson's correlation coefficient were the primary statistical tools used for data analysis. RESULT: Cord and admission blood white blood cell (WBC) count, hemoglobin and platelet count all significantly (P<0.0001) correlated with paired neonatal samples (R=0.82, 0.72, 0.76). Admission blood WBC count fell within the variation of WBC count values from currently accepted neonatal admission blood sources. Cord blood hemoglobin was not clinically different than admission hemoglobin (1.0 g dl(-1)). Cord blood platelet counts were not different from admission blood platelet counts (5800 cells per µl, P=0.23). The immature to total granulocyte ratio was not different between samples (P=0.34). CONCLUSION: Umbilical cord blood can be used for admission CBC and differential in premature infants.

The effect of textured insoles on gait patterns of people with multiple sclerosis.

BACKGROUND: Somatosensory deficit is a common feature of MS. One method serving to combat impaired plantar sensation may be to provide enhanced sensory feedback from the sole of the foot by changing the characteristics of a shoe sole or surface. This study aimed to inspect the effect of textured insoles on gait patterns in a group of MS patients. METHODS: 14 patients with MS and 10 healthy control subjects were recruited for this study. Plantar sensation was evaluated using Semmes-Weinstein monofilaments. Kinematic, kinetic and EMG gait data were collected for MS patients walking with flat shoes only and again with shoes and a textured insole in contact with the sole of patients' feet. RESULTS: A reduction in plantar sensation was identified in the MS patient group compared to the control group. Wearing the textured insoles there was a significant increase in hip and knee sagittal plane excursion, maximum ankle dorsiflexion, knee flexion and in peak acceleration ground reaction force. Throughout the stance phase, EMG activity of shank muscles was typically found to increase whilst wearing the textured insoles. DISCUSSION AND CONCLUSION: Despite some positive changes in gait patterns when wearing textured insoles, an increased foot-shank angle in terminal stance suggests that patients did not propel their swing limb through increased contribution of ankle plantarflexor muscles, perhaps favouring more proximal muscle groups. Whilst the textured insoles may alter gait patterns in MS patients, their contribution to achieving a more regular gait pattern with sufficient propulsion from ankle plantarflexors remains uncertain.

Personality disorders and nonfatal unintentional injuries among US adults.

OBJECTIVE: To investigate the association between personality disorders and nonfatal unintentional injuries in a representative sample of US adults. METHODS: Data on self-reported nonfatal unintentional injuries during the 12 months before the interview were obtained from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC) were analyzed; 43,093 adults > or = 18 years participated in the NESARC wave I survey in 2001-02. Personality disorders were determined using the NIAAA Alcohol Use Disorders and Associated Disabilities Interview Schedule-DSM-IV. RESULTS: Individuals with at least one personality disorder had a significantly higher 12-month incidence of injuries than people without any personality disorder (p<0.001). After accounting for sociodemographic characteristics or other mental disorders, OR was 1.54 (95% CI 1.39 to 1.71) for individuals with one personality disorder and 1.80 (95% CI 1.58 to 2.05) for individuals with two or more personality disorders compared with people with no personality disorder. CONCLUSION: Personality disorders were associated with a significantly increased risk of unintentional injuries. This information has important implications for the treatment of patients with these disorders.

Joint Theater Trauma System implementation of burn resuscitation guidelines improves outcomes in severely burned military casualties.

BACKGROUND: Between March 2003 and June 2007, our burn center received 594 casualties from the conflicts in Iraq and Afghanistan. Ongoing acute burn resuscitation as severely burned casualties are evacuated over continents is very challenging. To help standardize care, burn resuscitation guidelines (BRG) were devised along with a burn flow sheet (BFS) and disseminated via the new operational Joint Theater Trauma System to assist deployed providers. METHODS: After the BRG was implemented in January 2006, BRF data were prospectively collected in consecutive military casualties with >30% total body surface area (TBSA) burns (BRG Group). Baseline demographic data and fluid requirements for the first 24 hours of the burn resuscitation were collected from the BFS. Percentage full thickness TBSA burns, presence of inhalation injury, injury severity score, resuscitation-related abdominal compartment syndrome, and mortality were collected from our database. Individual charts were reviewed to determine the presence of extremity fasciotomies and myonecrosis. These results were compared with consecutive military casualties admitted during the 2-year- period before the system-wide implementation of the BRG (control group). RESULTS: One hundred eighteen military casualties with burns >30% TBSA were admitted between January 2003 and June 2007, with n = 56 in the BRG group and n = 62 in the control group. The groups were different in age, but similar in %TBSA, %full thickness, presence of inhalation injury, and injury severity score. There was no difference in the rate of extremity fasciotomies or the incidence of myonecrosis between groups. CONCLUSIONS: The composite endpoint of abdominal compartment syndrome and mortality was significantly lower in the BRG group compared with the control group (p = 0.03). Implementation of the BRG and system-wide standardization of burn resuscitation improved outcomes in severely burned patients. Utilization of the joint theater trauma system to implement system-wide guidelines is effective and can help improve outcomes.

Learning by structural remodeling in a class of single cell models.

Changes in neural connectivity are thought to underlie the most permanent forms of memory in the brain. We consider two models, derived from the clusteron (Mel, Adv Neural Inf Process Syst 4:35-42, 1992), to study this method of learning. The models show a direct relationship between the speed of memory acquisition and the probability of forming appropriate synaptic connections. Moreover, the strength of learned associations grows with the number of fibers that have taken part in the learning process. We provide simple and intuitive explanations of these two results by analyzing the distribution of synaptic activations. The obtained insights are then used to extend the model to perform novel tasks: feature detection, and learning spatio-temporal patterns. We also provide an analytically tractable approximation to the model to put these observations on a firm basis. The behavior of both the numerical and analytical models correlate well with experimental results of learning tasks which are thought to require a reorganization of neuronal networks.

Comparison of retrospective and contemporary indoor radon measurements in a high-radon area of Serbia.

In Niska Banja, Serbia, which is a high-radon area, a comparison was made between two retrospective radon measuring methods and contemporary radon measurements. The two retrospective methods derive the radon concentrations that occurred in dwellings over longer periods in the past, based on the amount of trapped (210)Po on the surface of glass objects (surface traps, ST) or in the bulk of porous materials (volume traps, VT). Both surface implanted (210)Po in glass objects and contemporary radon in air were measured in 46 rooms, distributed in 32 houses of this radon spa-town, using a dual alpha track detector configuration (CR-39 and LR115) and CR-39 track etched detectors, respectively. In addition to the use of surface trap measurements, in 18 rooms (distributed in 15 houses) VT samples of suitable material were also collected, allowing to compare ST and VT retrospective radon concentration estimates. For each room, contemporary annual radon concentrations (CONT) were measured or estimated using seasonal correction factors. The distribution of the radon concentration in all data sets was found to be close to lognormal (Chi-square test>0.05). Geometric means (GM) are similar, ranging from 1040 to 1380 Bq m(-3), whereas geometric standard deviations (GSD) for both the retrospective methods are greater than for the CONT method, showing reasonable agreement between VT, ST and CONT measurements. A regression analysis, with respect to the lognormal distribution of each data set, shows that for VT-ST the correlation coefficient r is 0.85, for VT-CONT r is 0.82 and for ST-CONT r is 0.73. Comparison of retrospective and contemporary radon concentrations with regard to supposed long-term indoor radon changes further supports the principal agreement between the retrospective and conventional methods.

The lakes of Titan.

The surface of Saturn's haze-shrouded moon Titan has long been proposed to have oceans or lakes, on the basis of the stability of liquid methane at the surface. Initial visible and radar imaging failed to find any evidence of an ocean, although abundant evidence was found that flowing liquids have existed on the surface. Here we provide definitive evidence for the presence of lakes on the surface of Titan, obtained during the Cassini Radar flyby of Titan on 22 July 2006 (T16). The radar imaging polewards of 70 degrees north shows more than 75 circular to irregular radar-dark patches, in a region where liquid methane and ethane are expected to be abundant and stable on the surface. The radar-dark patches are interpreted as lakes on the basis of their very low radar reflectivity and morphological similarities to lakes, including associated channels and location in topographic depressions. Some of the lakes do not completely fill the depressions in which they lie, and apparently dry depressions are present. We interpret this to indicate that lakes are present in a number of states, including partly dry and liquid-filled. These northern-hemisphere lakes constitute the strongest evidence yet that a condensable-liquid hydrological cycle is active in Titan's surface and atmosphere, in which the lakes are filled through rainfall and/or intersection with the subsurface 'liquid methane' table.

Smoking, occupancy and staffing levels in a selection of Dublin pubs pre and post a national smoking ban, lessons for all.

BACKGROUND: On the 29th March 2004 the Irish government introduced a comprehensive workplace smoking ban to protect the health of workers. This study evaluates the impact the ban had on staffing levels, customer numbers and smoking rates in a sample of 38 public houses in Dublin. METHODS: A total of 38 public houses were visited prior to the introduction of the ban, each visit lasted at least three hours, and the number of staff, customers and the number of people smoking was recorded each hour. Follow-up visits were conducted exactly one year later, on the same day of the week and at the same time of day, allowing controlling for seasonal and weekday effects. RESULTS: There was a decrease (8.82%) in average staff levels while customer numbers increased by 11% and there was a dramatic reduction in numbers smoking on a visit to a pub (77.8%). CONCLUSIONS: The hospitality industry predicted major job losses as a consequence of the introduction of the smoking ban; this work has shown that there was no significant decrease in the number of staff employed or in customer numbers. There was full compliance, with no customers smoking inside the public houses following the introduction of the ban. The ban has been good for the industry, staff, and customers.

Titan Radar Mapper observations from Cassini's T3 fly-by.

Cassini's Titan Radar Mapper imaged the surface of Saturn's moon Titan on its February 2005 fly-by (denoted T3), collecting high-resolution synthetic-aperture radar and larger-scale radiometry and scatterometry data. These data provide the first definitive identification of impact craters on the surface of Titan, networks of fluvial channels and surficial dark streaks that may be longitudinal dunes. Here we describe this great diversity of landforms. We conclude that much of the surface thus far imaged by radar of the haze-shrouded Titan is very young, with persistent geologic activity.

The sand seas of Titan: Cassini RADAR observations of longitudinal dunes.

The most recent Cassini RADAR images of Titan show widespread regions (up to 1500 kilometers by 200 kilometers) of near-parallel radar-dark linear features that appear to be seas of longitudinal dunes similar to those seen in the Namib desert on Earth. The Ku-band (2.17-centimeter wavelength) images show approximately 100-meter ridges consistent with duneforms and reveal flow interactions with underlying hills. The distribution and orientation of the dunes support a model of fluctuating surface winds of approximately 0.5 meter per second resulting from the combination of an eastward flow with a variable tidal wind. The existence of dunes also requires geological processes that create sand-sized (100- to 300-micrometer) particulates and a lack of persistent equatorial surface liquids to act as sand traps.

Human brucellosis in the Mid-West 2002-3.

Human brucellosis remains a serious public health issue in Ireland. Clinical notifications in the Mid-Western Area (HSE-MWA) underestimate the burden of illness and attendant morbidity in the region. The diagnosis of acute and chronic human brucellosis depends on the clinical evidence and the results from laboratory serological testing or culture on rare occasion. This study examined the clinical evidence behind locally defined serological "positives" in the HSE-MWA from 2002 to 2003. Ninety cases were detected in 2002 and 31 in 2003. While sampling bias is likely to be present, aspects of brucellosis in Ireland were confirmed. Middle-aged males were most commonly affected. The majority of cases were linked to farming or veterinary practice. Symptoms such as sweats, fever and weight loss were commonly associated with acute brucellosis infection while malaise was common in acute and chronic brucellosis. A clear definition of what is notifiable is needed. Surveillance systems must appreciate the importance of both clinical and laboratory evidence to classify confirmed or probable brucellosis as paired sera were not common. Public health authorities must follow-up the clinical aspects for accurate national statistics. General practitioners in the Mid-West appear to be vigilant regarding brucellosis in their patients. Regional zoonoses committees are useful in monitoring disease prevalence in human and animal populations without compromising confidentiality.

Psychological symptoms and nonfatal unintentional injuries among Chinese adolescents: a prospective study.

PURPOSE: To describe patterns of nonfatal unintentional injuries and investigate the association of psychological symptoms with injury risk among adolescents in Guangxi, China. METHODS: Adolescents were selected from middle and high school students in Baise City, Guangxi, China. Psychological symptoms at baseline were measured using SCL-90-R and nonfatal unintentional injuries that occurred among participants were recorded using a standardized injury surveillance questionnaire. Annual injury rates per 100 adolescents by adolescents' demographic and family characteristics were calculated. Student's t-test and the Chi-square test were used to test differences in mean raw scores of SCL-90-R subscales and injury rates. Relative risks and odds ratios of injury with 95% confidence intervals were calculated in univariate analyses and multivariate logistic models. RESULTS: A total of 1474 middle and high school students finished the study. Of them, 442 reported nonfatal unintentional injuries during the study period, resulting in an annual injury rate of 30.3 per 100 adolescents. Boys had a significantly higher injury rate than girls (32.6% vs. 27.4%). Injury rate decreased as the adolescents' age increased. Compared with adolescents who were not injured, the injured adolescents had higher average raw scores of all subscales of SCL-90-R, with an exception of the subscale for hostility. All SCL-90-R subscales factors, except those for hostility and phobia, were associated with injury risk. After confounding effects of age, gender, and ethnicity were controlled using logistic regression models, SCL-90-R subscales for somatization (OR = 2.00, 95% CI 1.52-2.63), obsessive-compulsiveness (OR = 2.10, 95% CI 1.71-2.58), interpersonal-sensitivity (OR = 1.66, 95% CI 1.34-2.06), depression (OR = 2.00, 95% CI 1.59-2.51), anxiety (OR = 2.08, 95% CI 1.62-2.66), and psychoticism (OR = 1.60, 95% CI 1.26-2.03) were significantly associated with an elevated injury risk. CONCLUSION: Psychological symptoms are associated with an elevated risk of nonfatal unintentional injury among middle and high school students. Mental health services, such as psychological counseling, may help reduce the risk of nonfatal unintentional injuries among Chinese adolescents.

The incidence of S. aureus bacteraemia in acute hospitals of the Mid-Western Area, Ireland, 2002-2004.

Concerns about healthcare-associated infections and the global crisis in antimicrobial resistance has combined to accentuate the fears around so-called "superbugs". In Ireland there is no single agreed indicator regarded as a true measure of the level of methicillin resistant Staphylococcus aureus (MRSA) in hospitals. The objective of this study was to compare two crude measures of MRSA--the percentage of bacteraemia caused by MRSA and the incidence rate (per 1000 bed days used) of MRSA bacteraemia in six acute hospitals. We examined all blood cultures positive for S. aureus (methicillin sensitive and resistant) from 2002 to 2004 in the Health Service Executive (HSE) Mid-Western Area of Ireland. Hospital In-Patient Enquiry (HIPE) data was used to determine monthly in-patient bed days used. Of 245 patient episodes of bacteraemia, 119 were MRSA. The trends in the percentage of isolates that were MRSA and the incidence rate calculated were compared. The incidence rate appears to be a more reliable and robust indicator of MRSA in hospitals than the percentage. Despite many difficulties in interpreting indicators of MRSA they should not preclude the regular publication of data at least at regional level in Ireland.