We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.
To save content items to your account,
please confirm that you agree to abide by our usage policies.
If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account.
Find out more about saving content to .
To save content items to your Kindle, first ensure no-reply@cambridge.org
is added to your Approved Personal Document E-mail List under your Personal Document Settings
on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part
of your Kindle email address below.
Find out more about saving to your Kindle.
Note you can select to save to either the @free.kindle.com or @kindle.com variations.
‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi.
‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.
Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health’s National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial’s duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator’s institution. The Initial Consultation process focuses on the study’s scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.
Recent changes to US research funding are having far-reaching consequences that imperil the integrity of science and the provision of care to vulnerable populations. Resisting these changes, the BJPsych Portfolio reaffirms its commitment to publishing mental science and advancing psychiatric knowledge that improves the mental health of one and all.
COVID-19 changed the epidemiology of community-acquired respiratory viruses. We explored patterns of respiratory viral testing to understand which tests are most clinically useful in the postpandemic era.
Methods:
We conducted a retrospective observational study of discharge data from PINC-AI (formerly Premier), a large administrative database. Use of multiplex nucleic acid amplification respiratory panels in acute care, including small (2–5 targets), medium (6–11), and large panels (>11), were compared between the early pandemic (03/2020–10/2020), late pandemic (11/2020–4/2021), and prepandemic respiratory season (11/2019 - 02/2020) using ANOVA.
Results:
A median of 160.5 facilities contributed testing data per quarter (IQR 155.5–169.5). Prepandemic, facilities averaged 103 respiratory panels monthly (sd 138), including 79 large (sd 126), 7 medium (sd 31), and 16 small panels (sd 73). Relative to prepandemic, utilization decreased during the early pandemic (62 panels monthly/facility; sd 112) but returned to the prepandemic baseline by the late pandemic (107 panels monthly/facility; sd 211). Relative to prepandemic, late pandemic testing involved more small panel use (58 monthly/facility, sd 156) and less large panel use (47 monthly/facility, sd 116). Comparisons among periods demonstrated significant differences in overall testing (P < 0.0001), large panel use (P < 0.0001), and small panel use (P < 0.0001).
Conclusions:
Postpandemic, clinical use of respiratory panel testing shifted from predominantly large panels to predominantly small panels. Factors driving this change may include resource availability, costs, and the clinical utility of targeting important pathogenic viruses instead of testing “for everything.”
Studies using the dietary inflammatory index often perform complete case analyses (CCA) to handle missing data, which may reduce the sample size and increase the risk of bias. Furthermore, population-level socio-economic differences in the energy-adjusted dietary inflammatory index (E-DII) have not been recently studied. Therefore, we aimed to describe socio-demographic differences in E-DII scores among American adults and compare the results using two statistical approaches for handling missing data, i.e. CCA and multiple imputation (MI).
Design:
Cross-sectional analysis. E-DII scores were computed using a 24-hour dietary recall. Linear regression was used to compare the E-DII scores by age, sex, race/ethnicity, education and income using both CCA and MI.
Setting:
USA.
Participants:
This study included 34 547 non-Hispanic White, non-Hispanic Black and Hispanic adults aged ≥ 20 years from the 2005–2018 National Health and Nutrition Examination Survey.
Results:
The MI and CCA subpopulations comprised 34 547 and 23 955 participants, respectively. Overall, 57 % of the American adults reported 24-hour dietary intakes associated with inflammation. Both methods showed similar patterns wherein 24-hour dietary intakes associated with high inflammation were commonly reported among males, younger adults, non-Hispanic Black adults and those with lower education or income. Differences in point estimates between CCA and MI were mostly modest at ≤ 20 %.
Conclusions:
The two approaches for handling missing data produced comparable point estimates and 95 % CI. Differences in the E-DII scores by age, sex, race/ethnicity, education and income suggest that socio-economic disparities in health may be partially explained by the inflammatory potential of diet.
Auditory verbal hallucinations (AVHs) in schizophrenia have been suggested to arise from failure of corollary discharge mechanisms to correctly predict and suppress self-initiated inner speech. However, it is unclear whether such dysfunction is related to motor preparation of inner speech during which sensorimotor predictions are formed. The contingent negative variation (CNV) is a slow-going negative event-related potential that occurs prior to executing an action. A recent meta-analysis has revealed a large effect for CNV blunting in schizophrenia. Given that inner speech, similar to overt speech, has been shown to be preceded by a CNV, the present study tested the notion that AVHs are associated with inner speech-specific motor preparation deficits.
Objectives
The present study aimed to provide a useful framework for directly testing the long-held idea that AVHs may be related to inner speech-specific CNV blunting in patients with schizophrenia. This may hold promise for a reliable biomarker of AVHs.
Methods
Hallucinating (n=52) and non-hallucinating (n=45) patients with schizophrenia, along with matched healthy controls (n=42), participated in a novel electroencephalographic (EEG) paradigm. In the Active condition, they were asked to imagine a single phoneme at a cue moment while, precisely at the same time, being presented with an auditory probe. In the Passive condition, they were asked to passively listen to the auditory probes. The amplitude of the CNV preceding the production of inner speech was examined.
Results
Healthy controls showed a larger CNV amplitude (p = .002, d = .50) in the Active compared to the Passive condition, replicating previous results of a CNV preceding inner speech. However, both patient groups did not show a difference between the two conditions (p > .05). Importantly, a repeated measure ANOVA revealed a significant interaction effect (p = .007, ηp2 = .05). Follow-up contrasts showed that healthy controls exhibited a larger CNV amplitude in the Active condition than both the hallucinating (p = .013, d = .52) and non-hallucinating patients (p < .001, d = .88). No difference was found between the two patient groups (p = .320, d = .20).
Conclusions
The results indicated that motor preparation of inner speech in schizophrenia was disrupted. While the production of inner speech resulted in a larger CNV than passive listening in healthy controls, which was indicative of the involvement of motor planning, patients exhibited markedly blunted motor preparatory activity to inner speech. This may reflect dysfunction in the formation of corollary discharges. Interestingly, the deficits did not differ between hallucinating and non-hallucinating patients. Future work is needed to elucidate the specificity of inner speech-specific motor preparation deficits with AVHs. Overall, this study provides evidence in support of atypical inner speech monitoring in schizophrenia.
Transient acquisition of methicillin-resistant Staphylococcus aureus (MRSA) on healthcare personnel (HCP) gloves and gowns following patient care has been examined. However, the potential for transmission to the subsequent patient has not been studied. We explored the frequency of MRSA transmission from patient to HCP, and then in separate encounters from contaminated HCP gloves and gowns to a subsequent simulated patient as well as the factors associated with these 2 transmission pathways.
Methods:
We conducted a prospective cohort study with 2 parts. In objective 1, we studied MRSA transmission from random MRSA-positive patients to HCP gloves and gowns after specific routine patient care activities. In objective 2, we simulated subsequent transmission from random HCP gloves and gowns without hand hygiene to the next patient using a manikin proxy.
Results:
For the first objective, among 98 MRSA-positive patients with 333 randomly selected individual patient–HCP interactions, HCP gloves or gowns were contaminated in 54 interactions (16.2%). In a multivariable analysis, performing endotracheal tube care had the greatest odds of glove or gown contamination (OR, 4.06; 95% CI, 1.3–12.6 relative to physical examination). For the second objective, after 147 simulated HCP–patient interactions, the subsequent transmission of MRSA to the manikin proxy occurred 15 times (10.2%).
Conclusion:
After caring for a patient with MRSA, contamination of HCP gloves and gown and transmission to subsequent patients following HCP-patient interactions occurs frequently if contact precautions are not used. Proper infection control practices, including the use of gloves and gown, can prevent this potential subsequent transmission.
Simple extended constant capacitance surface complexation models have been developed to represent the adsorption of polyaromatic dyes (9-aminoacridine, 3,6-diaminoacridine, azure A and safranin O) to kaolinite, and the competitive adsorption of the dyes with Cd. The formulation of the models was based on data from recent publications, including quantitative adsorption measurements over a range of conditions (varying pH and concentration), acid-base titrations and attenuated total reflectance-Fourier transform infrared spectroscopic data. In the models the dye molecules adsorb as aggregates of three or four, forming outer-sphere complexes with sites on the silica face of kaolinite. Both electrostatic and hydrophobic interactions are implicated in the adsorption processes. Despite their simplicity, the models fit a wide range of experimental data, thereby supporting the underlying hypothesis that the flat, hydrophobic, but slightly charged silica faces of kaolinite facilitate the aggregation and adsorption of the flat, aromatic, cationic dye molecules.
The gold standard for hand hygiene (HH) while wearing gloves requires removing gloves, performing HH, and donning new gloves between WHO moments. The novel strategy of applying alcohol-based hand rub (ABHR) directly to gloved hands might be effective and efficient.
Design:
A mixed-method, multicenter, 3-arm, randomized trial.
Setting:
Adult and pediatric medical-surgical, intermediate, and intensive care units at 4 hospitals.
Participants:
Healthcare personnel (HCP).
Interventions:
HCP were randomized to 3 groups: ABHR applied directly to gloved hands, the current standard, or usual care.
Methods:
Gloved hands were sampled via direct imprint. Gold-standard and usual-care arms were compared with the ABHR intervention.
Results:
Bacteria were identified on gloved hands after 432 (67.4%) of 641 observations in the gold-standard arm versus 548 (82.8%) of 662 observations in the intervention arm (P < .01). HH required a mean of 14 seconds in the intervention and a mean of 28.7 seconds in the gold-standard arm (P < .01). Bacteria were identified on gloved hands after 133 (98.5%) of 135 observations in the usual-care arm versus 173 (76.6%) of 226 observations in the intervention arm (P < .01). Of 331 gloves tested 6 (1.8%) were found to have microperforations; all were identified in the intervention arm [6 (2.9%) of 205].
Conclusions:
Compared with usual care, contamination of gloved hands was significantly reduced by applying ABHR directly to gloved hands but statistically higher than the gold standard. Given time savings and microbiological benefit over usual care and lack of feasibility of adhering to the gold standard, the Centers for Disease Control and Prevention and the World Health Organization should consider advising HCP to decontaminate gloved hands with ABHR when HH moments arise during single-patient encounters.
Misdiagnosis of bacterial pneumonia increases risk of exposure to inappropriate antibiotics and adverse events. We developed a diagnosis calculator (https://calculator.testingwisely.com) to inform clinical diagnosis of community-acquired bacterial pneumonia using objective indicators, including incidence of disease, risk factors, and sensitivity and specificity of diagnostic tests, that were identified through literature review.
To evaluate the efficacy of a new continuously active disinfectant (CAD) to decrease bioburden on high-touch environmental surfaces compared to a standard disinfectant in the intensive care unit.
Design:
A single-blind randomized controlled trial with 1:1 allocation.
Setting:
Medical intensive care unit (MICU) at an urban tertiary-care hospital.
Participants:
Adult patients admitted to the MICU and on contact precautions.
Intervention:
A new CAD wipe used for daily cleaning.
Methods:
Samples were collected from 5 high-touch environmental surfaces before cleaning and at 1, 4, and 24 hours after cleaning. The primary outcome was the mean bioburden 24 hours after cleaning. The secondary outcome was the detection of any epidemiologically important pathogen (EIP) 24 hours after cleaning.
Results:
In total, 843 environmental samples were collected from 43 unique patient rooms. At 24 hours, the mean bioburden recovered from the patient rooms cleaned with the new CAD wipe (intervention) was 52 CFU/mL, and the mean bioburden was 92 CFU/mL in the rooms cleaned the standard disinfectant (control). After log transformation for multivariable analysis, the mean difference in bioburden between the intervention and control arm was −0.59 (95% CI, −1.45 to 0.27). The odds of EIP detection were 14% lower in the rooms cleaned with the CAD wipe (OR, 0.86; 95% CI, 0.31–2.32).
Conclusions:
The bacterial bioburden and odds of detection of EIPs were not statistically different in rooms cleaned with the CAD compared to the standard disinfectant after 24 hours. Although CAD technology appears promising in vitro, larger studies may be warranted to evaluate efficacy in clinical settings.
Previously published guidelines have provided comprehensive recommendations for detecting and preventing healthcare-associated infections (HAIs). The intent of this document is to highlight practical recommendations in a concise format designed to assist acute-care hospitals in implementing and prioritizing efforts to prevent methicillin-resistant Staphylococcus aureus (MRSA) transmission and infection. This document updates the “Strategies to Prevent Methicillin-Resistant Staphylococcus aureus Transmission and Infection in Acute Care Hospitals” published in 2014.1 This expert guidance document is sponsored by the Society for Healthcare Epidemiology of America (SHEA). It is the product of a collaborative effort led by SHEA, the Infectious Diseases Society of America (IDSA), the Association for Professionals in Infection Control and Epidemiology (APIC), the American Hospital Association (AHA), and The Joint Commission, with major contributions from representatives of a number of organizations and societies with content expertise.
Known concentrations of Staphylococcus aureus and Candida auris were applied on gloves and gowns then sampled with E-swabs and BBL liquid Amies swabs. The mean numbers of colony-forming units per milliliter (CFU/mL) obtained from culture of the 2 swab types were not different, suggesting that either can be used for recovery of these two pathogens from personal protective equipment.
Multiplex polymerase chain reaction (PCR) respiratory panels are rapid, highly sensitive tests for viral and bacterial pathogens that cause respiratory infections. In this study, we (1) described best practices in the implementation of respiratory panels based on expert perspectives and (2) identified tools for diagnostic stewardship to enhance the usefulness of testing.
Methods:
We conducted a survey of the Society for Healthcare Epidemiology of America Research Network to explore current and future approaches to diagnostic stewardship of multiplex PCR respiratory panels.
Results:
In total, 41 sites completed the survey (response rate, 50%). Multiplex PCR respiratory panels were perceived as supporting accurate diagnoses at 35 sites (85%), supporting more efficient patient care at 33 sites (80%), and improving patient outcomes at 23 sites (56%). Thirteen sites (32%) reported that testing may support diagnosis or patient care without improving patient outcomes. Furthermore, 24 sites (58%) had implemented diagnostic stewardship, with a median of 3 interventions (interquartile range, 1–4) per site. The interventions most frequently reported as effective were structured order sets to guide test ordering (4 sites), restrictions on test ordering based on clinician or patient characteristics (3 sites), and structured communication of results (2 sites). Education was reported as “helpful” but with limitations (3 sites).
Conclusions:
Many hospital epidemiologists and experts in infectious diseases perceive multiplex PCR respiratory panels as useful tests that can improve diagnosis, patient care, and patient outcomes. However, institutions frequently employ diagnostic stewardship to enhance the usefulness of testing, including most commonly clinical decision support to guide test ordering.
Prenatal adversity has been linked to later psychopathology. Yet, research on cumulative prenatal adversity, as well as its interaction with offspring genotype, on brain and behavioral development is scarce. With this study, we aimed to address this gap. In Finnish mother–infant dyads, we investigated the association of a cumulative prenatal adversity sum score (PRE-AS) with (a) child emotional and behavioral problems assessed with the Strengths and Difficulties Questionnaire at 4 and 5 years (N = 1568, 45.3% female), (b) infant amygdalar and hippocampal volumes (subsample N = 122), and (c) its moderation by a hippocampal-specific coexpression polygenic risk score based on the serotonin transporter (SLC6A4) gene. We found that higher PRE-AS was linked to greater child emotional and behavioral problems at both time points, with partly stronger associations in boys than in girls. Higher PRE-AS was associated with larger bilateral infant amygdalar volumes in girls compared to boys, while no associations were found for hippocampal volumes. Further, hyperactivity/inattention in 4-year-old girls was related to both genotype and PRE-AS, the latter partially mediated by right amygdalar volumes as preliminary evidence suggests. Our study is the first to demonstrate a dose-dependent sexually dimorphic relationship between cumulative prenatal adversity and infant amygdalar volumes.
In total, 50 healthcare facilities completed a survey in 2021 to characterize changes in infection prevention and control and antibiotic stewardship practices. Notable findings include sustained surveillance for multidrug-resistant organisms but decreased use of human resource-intensive interventions compared to previous surveys in 2013 and 2018 conducted prior to the COVID-19 pandemic.
Flight crews’ capacity to conduct take-off and landing in near zero visibility conditions has been partially addressed by advanced surveillance and cockpit display technology. This capability is yet to be realised within the context of manoeuvring aircraft within airport terminal areas. In this paper the performance and workload benefits of user-centre designed visual and haptic taxi navigational cues, presented via a head-up display (HUD) and active sidestick, respectively, were evaluated in simulated taxiing trials by 12 professional pilots. In addition, the trials sought to examine pilot acceptance of side stick nose wheel steering. The HUD navigational cues demonstrated a significant task-specific benefit by reducing centreline deviation during turns and the frequency of major taxiway deviations. In parallel, the visual cues reduced self-report workload. Pilot’s appraisal of nose wheel steering by sidestick was positive, and active sidestick cues increased confidence in the multimodal guidance construct. The study presents the first examination of how a multimodal display, combining visual and haptic cues, could support the safety and efficiency in which pilots are able to conduct a taxi navigation task in low-visibility conditions.
Childhood adversities (CAs) predict heightened risks of posttraumatic stress disorder (PTSD) and major depressive episode (MDE) among people exposed to adult traumatic events. Identifying which CAs put individuals at greatest risk for these adverse posttraumatic neuropsychiatric sequelae (APNS) is important for targeting prevention interventions.
Methods
Data came from n = 999 patients ages 18–75 presenting to 29 U.S. emergency departments after a motor vehicle collision (MVC) and followed for 3 months, the amount of time traditionally used to define chronic PTSD, in the Advancing Understanding of Recovery After Trauma (AURORA) study. Six CA types were self-reported at baseline: physical abuse, sexual abuse, emotional abuse, physical neglect, emotional neglect and bullying. Both dichotomous measures of ever experiencing each CA type and numeric measures of exposure frequency were included in the analysis. Risk ratios (RRs) of these CA measures as well as complex interactions among these measures were examined as predictors of APNS 3 months post-MVC. APNS was defined as meeting self-reported criteria for either PTSD based on the PTSD Checklist for DSM-5 and/or MDE based on the PROMIS Depression Short-Form 8b. We controlled for pre-MVC lifetime histories of PTSD and MDE. We also examined mediating effects through peritraumatic symptoms assessed in the emergency department and PTSD and MDE assessed in 2-week and 8-week follow-up surveys. Analyses were carried out with robust Poisson regression models.
Results
Most participants (90.9%) reported at least rarely having experienced some CA. Ever experiencing each CA other than emotional neglect was univariably associated with 3-month APNS (RRs = 1.31–1.60). Each CA frequency was also univariably associated with 3-month APNS (RRs = 1.65–2.45). In multivariable models, joint associations of CAs with 3-month APNS were additive, with frequency of emotional abuse (RR = 2.03; 95% CI = 1.43–2.87) and bullying (RR = 1.44; 95% CI = 0.99–2.10) being the strongest predictors. Control variable analyses found that these associations were largely explained by pre-MVC histories of PTSD and MDE.
Conclusions
Although individuals who experience frequent emotional abuse and bullying in childhood have a heightened risk of experiencing APNS after an adult MVC, these associations are largely mediated by prior histories of PTSD and MDE.
Excavated over two centuries ago, the Upton Lovell G2a ‘Wessex Culture’ burial has held a prominent place in research on Bronze Age Britain. In particular, was it the grave of a ‘shaman’ or a metalworker? We take a new approach to the grave goods, employing microwear analysis and scanning electron microscopy to map a history of interactions between people and materials, identifying evidence for the presence of Bronze Age gold on five artefacts, four for the first time. Advancing a new materialist approach, we identify a goldworking toolkit, linking gold, stone and copper objects within a chaîne opératoire, concluding that modern categorisations of these materials miss much of their complexity.
Many clinical trials leverage real-world data. Typically, these data are manually abstracted from electronic health records (EHRs) and entered into electronic case report forms (CRFs), a time and labor-intensive process that is also error-prone and may miss information. Automated transfer of data from EHRs to eCRFs has the potential to reduce data abstraction and entry burden as well as improve data quality and safety.
Methods:
We conducted a test of automated EHR-to-CRF data transfer for 40 participants in a clinical trial of hospitalized COVID-19 patients. We determined which coordinator-entered data could be automated from the EHR (coverage), and the frequency with which the values from the automated EHR feed and values entered by study personnel for the actual study matched exactly (concordance).
Results:
The automated EHR feed populated 10,081/11,952 (84%) coordinator-completed values. For fields where both the automation and study personnel provided data, the values matched exactly 89% of the time. Highest concordance was for daily lab results (94%), which also required the most personnel resources (30 minutes per participant). In a detailed analysis of 196 instances where personnel and automation entered values differed, both a study coordinator and a data analyst agreed that 152 (78%) instances were a result of data entry error.
Conclusions:
An automated EHR feed has the potential to significantly decrease study personnel effort while improving the accuracy of CRF data.
Hospital readmission is unsettling to patients and caregivers, costly to the healthcare system, and may leave patients at additional risk for hospital-acquired infections and other complications. We evaluated the association between comorbidities present during index coronavirus disease 2019 (COVID-19) hospitalization and the risk of 30-day readmission.
Design, setting, and participants:
We used the Premier Healthcare database to perform a retrospective cohort study of COVID-19 hospitalized patients discharged between April 2020 and March 2021 who were followed for 30 days after discharge to capture readmission to the same hospital.
Results:
Among the 331,136 unique patients in the index cohort, 36,827 (11.1%) had at least 1 all-cause readmission within 30 days. Of the readmitted patients, 11,382 (3.4%) were readmitted with COVID-19 as the primary diagnosis. In the multivariable model adjusted for demographics, hospital characteristics, coexisting comorbidities, and COVID-19 severity, each additional comorbidity category was associated with an 18% increase in the odds of all-cause readmission (adjusted odds ratio [aOR], 1.18; 95% confidence interval [CI], 1.17–1.19) and a 10% increase in the odds of readmission with COVID-19 as the primary readmission diagnosis (aOR, 1.10; 95% CI, 1.09–1.11). Lymphoma (aOR, 1.86; 95% CI, 1.58–2.19), renal failure (aOR, 1.32; 95% CI, 1.25–1.40), and chronic lung disease (aOR, 1.29; 95% CI, 1.24–1.34) were most associated with readmission for COVID-19.
Conclusions:
Readmission within 30 days was common among COVID-19 survivors. A better understanding of comorbidities associated with readmission will aid hospital care teams in improving postdischarge care. Additionally, it will assist hospital epidemiologists and quality administrators in planning resources, allocating staff, and managing bed-flow issues to improve patient care and safety.