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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.
The attitudes toward genomics and precision medicine (AGPM) measure examines attitudes toward activities such as genetic testing, gene editing, and biobanking. This is a useful tool for research on the ethical, legal, and social implications of genomics, a major program within the National Institutes of Health. We updated the AGPM to explore controversies over mRNA vaccines. This brief report examines the factor structure of the updated AGPM using a sample of 4939 adults in the USA. The updated AGPM’s seven factors include health benefits, knowledge benefits, and concerns about the sacredness of life, privacy, gene editing, mRNA vaccines, and social justice.
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.
Community involvement in research is key to translating science into practice, and new approaches to engaging community members in research design and implementation are needed. The Community Scientist Program, established at the MD Anderson Cancer Center in Houston in 2018 and expanded to two other Texas institutions in 2021, provides researchers with rapid feedback from community members on study feasibility and design, cultural appropriateness, participant recruitment, and research implementation. This paper aims to describe the Community Scientist Program and assess Community Scientists' and researchers' satisfaction with the program. We present the analysis of the data collected from 116 Community Scientists and 64 researchers who attended 100 feedback sessions, across three regions of Texas including Northeast Texas, Houston, and Rio Grande Valley between June 2018 and December 2022. Community Scientists stated that the feedback sessions increased their knowledge and changed their perception of research. All researchers (100%) were satisfied with the feedback and reported that it influenced their current and future research methods. Our evaluation demonstrates that the key features of the Community Scientist Program such as follow-up evaluations, effective bi-directional communication, and fair compensation transform how research is conducted and contribute to reducing health disparities.
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.
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.
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.
Rotavirus (RV) was a common healthcare-associated infection prior to the introduction of the RV vaccine. Following widespread RV vaccination, healthcare-associated rotavirus cases are rare. We describe an investigation of a cluster of rotavirus infections in a pediatric hospital in which an uncommon genotype not typically circulating in the United States was detected.
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.
Admission laboratory screening for asymptomatic coronavirus disease 2019 (COVID-19) has been utilized to mitigate healthcare-associated severe acute respiratory coronavirus virus 2 (SARS-CoV-2) transmission. An understanding of the impact of such testing across a variety of patient populations is needed.
Methods:
SARS-CoV-2 nucleic acid amplification admission testing results for all asymptomatic patients across 4 distinct inpatient facilities between April 20, 2020, and June 14, 2021, were analyzed. Positivity rates and the number needed to test (NNT) to identify 1 asymptomatic infected patient were calculated. Admission results were compared to COVID-19 community incidence rates for the system’s surrounding metropolitan service area. Using a national survey of hospital epidemiologists, a clinically meaningful NNT of 1:100 was identified.
Results:
In total, 51,187 tests were collected (positivity rate, 1.8%). During periods of high transmission, the NNT met the clinically relevant threshold in all populations. The NNT approached or met the threshold for most locations during periods of lower transmission. For all transmission levels, the NNT for fully vaccinated patients did not meet the threshold.
Conclusions:
Implementing an asymptomatic patient admission testing program can provide clinically relevant data based on the NNT, even during periods of lower transmission and among different patient populations. Limiting admission testing to non–fully vaccinated patients during periods of lower transmission may be a strategy to address resource concerns around this practice. Although the impact of such testing on healthcare-associated COVID-19 among patients and healthcare workers could not be clearly determined, these data provide important information as facilities weigh the costs and benefits of such testing.
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.
To assess preventability of hospital-onset bacteremia and fungemia (HOB), we developed and evaluated a structured rating guide accounting for intrinsic patient and extrinsic healthcare-related risks.
Design:
HOB preventability rating guide was compared against a reference standard expert panel.
Participants:
A 10-member panel of clinical experts was assembled as the standard of preventability assessment, and 2 physician reviewers applied the rating guide for comparison.
Methods:
The expert panel independently rated 82 hypothetical HOB scenarios using a 6-point Likert scale collapsed into 3 categories: preventable, uncertain, or not preventable. Consensus was defined as concurrence on the same category among ≥70% experts. Scenarios without consensus were deliberated and followed by a second round of rating.
Two reviewers independently applied the rating guide to adjudicate the same 82 scenarios in 2 rounds, with interim revisions. Interrater reliability was evaluated using the κ (kappa) statistic.
Results:
Expert panel consensus criteria were met for 52 scenarios (63%) after 2 rounds.
After 2 rounds, guide-based rating matched expert panel consensus in 40 of 52 (77%) and 39 of 52 (75%) cases for reviewers 1 and 2, respectively. Agreement rates between the 2 reviewers were 84% overall (κ, 0.76; 95% confidence interval [CI], 0.64–0.88]) and 87% (κ, 0.79; 95% CI, 0.65–0.94) for the 52 scenarios with expert consensus.
Conclusions:
Preventability ratings of HOB scenarios by 2 reviewers using a rating guide matched expert consensus in most cases with moderately high interreviewer reliability. Although diversity of expert opinions and uncertainty of preventability merit further exploration, this is a step toward standardized assessment of HOB preventability.
Evidence supporting collection of follow-up blood cultures for Gram-negative bacteremia is mixed. We sought to understand why providers order follow-up blood cultures when managing P. aeruginosa bacteremia and whether follow-up blood cultures in this context are associated with short- and long-term survival.
Methods:
We conducted a retrospective cohort study of adult inpatients with P. aeruginosa bacteremia at the University of Maryland Medical Center in 2015–2020. Kaplan-Meier survival curves and Cox regression with time-varying covariates were used to evaluate the association between follow-up blood cultures and time to mortality within 30 days of first positive blood culture. Provider justifications for follow-up blood cultures were identified through chart review.
Results:
Of 159 eligible patients, 127 (80%) had follow-up blood cultures, including 9 (7%) that were positive for P. aeruginosa and 10 (8%) that were positive for other organisms. Follow-up blood cultures were typically collected “to ensure clearance” or “to guide antibiotic therapy.” Overall, 30-day mortality was 25.2%. After risk adjustment for patient characteristics, follow-up blood cultures were associated with a nonsignificant reduction in mortality risk (hazard ratio, 0.43; 95% confidence interval, 1.08; P = .071). In exploratory analyses, the potential mortality reduction from follow-up blood cultures was driven by their use in patients with Pitt bacteremia scores >0.
Conclusions:
Follow-up blood cultures are commonly collected for P. aeruginosa bacteremia but infrequently identify persistent bacteremia. Targeted use of follow-up blood cultures based on severity of illness may reduce unnecessary culturing.
The first demonstration of laser action in ruby was made in 1960 by T. H. Maiman of Hughes Research Laboratories, USA. Many laboratories worldwide began the search for lasers using different materials, operating at different wavelengths. In the UK, academia, industry and the central laboratories took up the challenge from the earliest days to develop these systems for a broad range of applications. This historical review looks at the contribution the UK has made to the advancement of the technology, the development of systems and components and their exploitation over the last 60 years.
This SHEA white paper identifies knowledge gaps and challenges in healthcare epidemiology research related to coronavirus disease 2019 (COVID-19) with a focus on core principles of healthcare epidemiology. These gaps, revealed during the worst phases of the COVID-19 pandemic, are described in 10 sections: epidemiology, outbreak investigation, surveillance, isolation precaution practices, personal protective equipment (PPE), environmental contamination and disinfection, drug and supply shortages, antimicrobial stewardship, healthcare personnel (HCP) occupational safety, and return to work policies. Each section highlights three critical healthcare epidemiology research questions with detailed description provided in supplementary materials. This research agenda calls for translational studies from laboratory-based basic science research to well-designed, large-scale studies and health outcomes research. Research gaps and challenges related to nursing homes and social disparities are included. Collaborations across various disciplines, expertise and across diverse geographic locations will be critical.