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Judy Munday,1– 4 Niall Higgins,1,2,5 Saira Mathew,1,2 Lizanne Dalgleish,1,2,5 Anthony S Batterbury,1,2,5 Luke Burgess,1,2,4 Jill Campbell,1,2,5 Lori J Delaney,1,2,6 Bronwyn R Griffin,1,2 James A Hughes,1,2,5 Jessica Ingleman,1,2 Samantha Keogh,1,2,5,7 Fiona Coyer1,2,5 1Centre for Healthcare Transformation, Faculty of Health, Queensland University of Technology (QUT), Brisbane, QLD, Australia; 2School of Nursing, Queensland University of Technology (QUT), Brisbane, QLD, Australia; 3 Department of Health and Nursing Science, University of Agder, Grimstad, 4879, Norway; 4Mater Research Institute-UQ, South Brisbane, QLD 4101, Australia; 5Royal Brisbane and Women’s Hospital, Herston, QLD 4029, Australia; 6Colleges of Health and Medicine, Australian National University, Acton, ACT 2601, Australia; 7Alliance for Vascular Access Teaching and Research, Griffith University, Brisbane, QLD, 4111, AustraliaCorrespondence: Judy MundaySchool of Nursing, Rm 529, Level 5, N Block, Victoria Park Road, Kelvin Grove, QLD 4059, AustraliaTel +61 3138 8209Email judy.munday@qut.edu.auPurpose: Nurses provide care at each phase of the complex, perioperative pathway and are well placed to identify areas of care requiring investigation in randomized controlled trials. Yet, currently, the scope of nurse-led randomized controlled trials conducted within the perioperative setting are unknown. This scoping review aims to identify areas of perioperative care in which nurse-led randomized controlled trials have been conducted, to identify issues impacting upon the quality of these trials and identify gaps for future investigation.Methods: This scoping review was conducted in reference to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Searches were conducted in PubMed, Embase, Cumulative Index for Nursing and Allied Health Literature and the Cochrane Central Register of Controlled Trials, with a date range of 2014– 19. Sources of unpublished literature included Open Grey, and ProQuest Dissertation and Theses, Clinical Trials.gov and the Australian and New Zealand Clinical Trials Registry. After title and abstract checking, full-text retrieval and data extraction, studies were appraised using the Joanna Briggs Institute Critical Appraisal Checklists for randomized controlled trials. Data were synthesized according to the main objectives. Key information was tabulated.Results: From the 86 included studies, key areas where nurses have led randomized controlled trials include patient or caregiver anxiety; postoperative pain relief; surgical site infection prevention: patient and caregiver knowledge; perioperative hypothermia prevention; postoperative nausea and vomiting; in addition to other diverse outcomes. Issues impacting upon quality (including poorly reported randomization), and gaps for future investigation (including a focus on vulnerable populations), are evident.Conclusion: Nurse-led randomized controlled trials in the perioperative setting have focused on key areas of perioperative care. Yet, opportunities exist for nurses to lead experimental research in other perioperative priority areas and within different populations that have been neglected, such as in the population of older adults undergoing surgery.Keywords: perioperative, nursing, randomized controlled trial, scoping review

During responses to outbreaks, the collection and analysis of data on employed case patients' industry and occupation are necessary to better understand the relationship between work and health outcomes. The occurrence of mpox by occupation and industry has not previously been assessed in the context of the 2022 outbreak. We analyzed employment data from 2548 mpox cases reported to the U.S. Centers for Disease Control and Prevention from surveillance systems in seven U.S. jurisdictions and population-based reference data on employment patterns from the U.S. Bureau of Labor Statistics to describe the differential proportionate distribution of cases across occupation and industry groups using the proportionate morbidity ratio. In gender-specific analyses, we found that men employed in certain occupations and industries had a higher relative risk of mpox than others. While occupational transmission cannot be ruled out, it is more likely that individuals with personal and behavioral risk factors for mpox were more likely to work in these occupations and industries. This analysis provides an example of collecting and analyzing occupation and industry data in case reports to understand possible differences in risk by occupation and industry in infectious disease outbreak investigation and help inform resource allocation, messaging, and response.

Background and Objective: Erectile dysfunction (ED) is a common condition in men, and many patients refractory to conservative treatment may undergo penile prostheses (PPs) placement. The primary concern following PP implantation is device infection. Although antibiotic and hydrophilic coatings have reduced the incidence of inflatable PP (IPP) infections, there remains room for improvement. Optimization of PP outcomes requires a practical in vivo model to better understand mechanisms of infection and to test new infection control strategies. We aimed to describe a new rabbit model which contains a functional IPP and review previously reported animal PP models., Methods: An IPP was placed into rabbit flanks and cycled for functionality testing. Rabbits were evaluated for signs of pain and distress over 14 days. Separately, narrative review methodology was utilized to search the PubMed and Scopus databases for all publications through March 21, 2023, which studied PP within an in vivo setting. Three independent reviewers ultimately selected 12 papers from 1992-2021 for inclusion., Key Content and Findings: Several animal studies highlighted the initial functionality or feasibility of devices for ED before their introduction in the clinical setting. There are several subsequent studies aimed at optimizing the type of antibiotic use or coating material using segments of PP material in an in vivo setting. However, the literature lacks a contemporary animal model containing a functional IPP. Our novel rabbit model offers a safe, practical way to implant a functioning IPP and investigate new perioperative infection prevention and treatment strategies before trials in the clinical setting., Conclusions: Animal models have played a key role in testing medical devices, including PPs, prior to their clinical introduction. Our review uncovered no modern animal studies involving placement of a functional PP. A new animal model can facilitate study of evolving microorganism profiles, novel methods to enhance antibiotic delivery, and proposed treatment options., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-23-353/coif). The series “Genitourinary Prosthesis Infection” was commissioned by the editorial office without any funding or sponsorship. P.H.C. served as the unpaid Guest Editor of the series and serves as an unpaid editorial board member of Translational Andrology and Urology. P.H.C. consults for and receives research support from Coloplast and Boston Scientific. C.E.W. is a clinical consultant for Bracco Diagnostics and Canon Medical Systems USA. N.J.H. consults for SINTX technologies. F.F. receives research support from Bracco, the Butterfly Network, Canon Medical Systems USA, GE HealthCare, Lantheus Medical Imaging and Siemens Healthineers. He is also a consultant or advisor for Exact Therapeutics, Lantheus, Longeviti Neuro Solutions and Sonothera. The authors have no other conflicts of interest to declare., (2024 Translational Andrology and Urology. All rights reserved.)

Objectives: Bacterial infection following spinal fusion is a major clinical concern with up to 20% incidence. An ultrasound-triggered bulk-release system to combat postsurgical bacterial survival was designed and evaluated., Methods: Polylactic acid (PLA) clips were loaded with vancomycin (VAN) and microbubbles (Sonazoid, GE HealthCare) in vitro. Stability was determined over 14 days. VAN-loaded clips were submerged in water and insonated using a Logiq E10 scanner (GE HealthCare) with a curvilinear C6 probe. Doppler-induced VAN release was quantified using spectrophotometry. For in vivo testing, clips were loaded with methylene blue (MeB) solution and Sonazoid. These clips were implanted into a rabbit along the spine at L2 and L5, as well as a pig at L1 and L3, then insonated in Doppler mode using the C6 probe., Results: Sonazoid microbubbles were better preserved when incubated in VAN compared with distilled water at 4°C, 25°C, and 37°C incubation temperatures (P = .0131). Contrast enhancement was observed from both solutions when incubated at 4°C storage conditions. Insonated clips achieved average cumulative VAN release of 101.8 ± 2.8% (81.4 ± 2.8 mg) after 72 hours. Uninsonated clips had only 0.3 ± 0.1% (0.3 ± 0.1 mg) average cumulative VAN release (P < .0001). Clips retrieved from the rabbit did not rupture with insonation nor produce MeB staining of surrounding tissues. In the pig, the PLA film was visibly ruptured and MeB tissue was observed following insonation, whereas the uninsonated clip was intact., Conclusion: These results demonstrate ultrasound-triggered release of an encapsulated prophylactic solution and provide an important proof-of-concept for continuing large animal evaluations for translational merit., (© 2023 The Authors. Journal of Ultrasound in Medicine published by Wiley Periodicals LLC on behalf of American Institute of Ultrasound in Medicine.)

Objective: Gaps and complexities exist in cancer referral and diagnosis in Australia, leading to delays in cancer treatments. Developing evidence-based referral pathways is important for promoting better and more timely cancer diagnosis and care. Type of program or service: This paper describes a toolkit endorsed by the Cancer Institute NSW as a guide for promoting best practice in localising cancer referral and diagnosis pathways in line with the national Optimal Care Pathways. Use of toolkit: Employing methods in the toolkit yielded an increased understanding of cancer care pathways, strengthened collaboration between tertiary and primary sector stakeholders, and enhanced the project skills of Cancer System Innovation Managers. The toolkit has become a valuable guide for consolidating referral pathways for various cancers in the NSW local health districts and could apply to cancer services in other jurisdictions., Lessons Learnt: The pilot project showed that the toolkit is useful in developing referral pathways and reflects best stakeholder engagement practices. Local evidence should be generated to support systematic change and should include the perspectives of cancer patients and clinicians. NSW local health districts continue to use the toolkit methods to optimise care to improve outcomes for people living with cancer., Competing Interests: None declared.

Background: Sleep disturbance is common in intensive care patients. Understanding the accuracy of simple, feasible sleep measurement techniques is essential to informing their possible role in usual clinical care., Objective: The aim of the study was to investigate whether sleep monitoring techniques such as actigraphy (ACTG), behavioural assessments, and patient surveys are comparable with polysomnography (PSG) in accurately reporting sleep quantity and quality among conscious, intensive care patients., Methods: An observational study was conducted in 20 patients admitted to the intensive care unit (ICU) for a minimum duration of 24 h, who underwent concurrent sleep monitoring via PSG, ACTG, nursing-based observations, and self-reported assessment using the Richards-Campbell Sleep Questionnaire., Results: The reported total sleep time (TST) for the 20 participants measured by PSG was 328.2 min (±106 min) compared with ACTG (362.4 min [±62.1 min]; mean difference = 34.22 min [±129 min]). Bland-Altman analysis indicated that PSG and ACTG demonstrated clinical agreement and did not perform differently across a number of sleep variables including TST, awakening, sleep-onset latency, and sleep efficiency. Nursing observations overestimated sleep duration compared to PSG TST (mean difference = 9.95 ± 136.3 min, p > 0.05), and patient-reported TST was underestimated compared to PSG TST (mean difference = -51.81 ± 144.1 7, p > 0.05)., Conclusions: Amongst conscious patients treated in the ICU, sleep characteristics measured by ACTG were similar to those measured by PSG. ACTG may provide a clinically feasible and acceptable proxy approach to sleep monitoring in conscious ICU patients., (Copyright © 2022 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.)

In July 2021, we conducted environmental sampling at the residence of a person in Dallas, Texas, USA, who had travel-associated human West African monkeypox virus (MPXV-WA). Targeted environmental swab sampling was conducted 15 days after the person who had monkeypox left the household. Results indicate extensive MPXV-WA DNA contamination, and viable virus from 7 samples was successfully isolated in cell culture. There was no statistical difference (p = 0.94) between MPXV-WA PCR positivity of porous (9/10, 90%) vs. nonporous (19/21, 90.5%) surfaces, but there was a significant difference (p<0.01) between viable virus detected in cultures of porous (6/10, 60%) vs. nonporous (1/21, 5%) surfaces. These findings indicate that porous surfaces (e.g., bedding, clothing) may pose more of a MPXV exposure risk than nonporous surfaces (e.g., metal, plastic). Viable MPXV was detected on household surfaces after at least 15 days. However, low titers (<10 2 PFU) indicate a limited potential for indirect transmission.

Background: Penile prosthesis (PP) is a gold standard for treatment of erectile dysfunction given its reliability and efficacy. Infection remains the most feared complication of prosthetic surgery, which usually results in device removal, and places a significant economic burden on the healthcare system. While biofilms have shown to support the persistence of microorganisms, the degree by which this matrix is truly pathogenic remains unknown given its high prevalence even in asymptomatic patients. We aim to review and summarize the current literature pertaining to biofilm formation in the setting of PP surgeries in clinically infected and non-infected cases., Methods: Searches were performed in the MEDLINE online database through PubMed using a combination of keywords "penile prosthetic" OR "penile prosthesis" OR "penile implant" AND "biofilm" OR "revision" OR "removal" OR "infection" OR "explant". Eleven articles met inclusion criteria. There were only three studies that explicitly listed the number of biofilms identified in their cohort, but we also included eight articles that mentioned swabbing and culturing of any bacterial biofilm during revision procedures for both clinically infected and non-infected implants., Results: Infected PP yielded a 11-100% rate of biofilm presence, while non-infected PP yielded a 3-70% rate of biofilm presence. Time to reoperation from initial PP placement were also largely variable, ranging from 2 weeks to over 2 years. Coagulase-negative staphylococcus (i.e., Staphylococcus epidermidis ) were the most commonly reported organisms among non-infected implants, however, newer studies have identified a change towards more virulent organisms., Conclusions: Since the advent of PP surgery, diabetes control, revision washout protocols and antibiotic-impregnated devices have led to an overall decrease in biofilm formation and infectious complications. There is an overall paradigm shift in microbial profiles with more virulent organisms, such as Escherichia coli , Pseudomonas aeruginosa , Enterococcus species, and even fungal species beginning to replace the more common coagulase-negative staphylococcal species, especially in clinically infected implants. Additional studies are necessary to define the significance of bacterial presence in biofilms using impactful technologies such as next-generation sequencing. Currently, preliminary and experimental biofilm-control strategies are also underway to further address this clinical issue., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-22-195/coif). PHC serves as an unpaid editorial board member of Translational Andrology and Urology from December 2021 to November 2023. GDH consults for and receives research support from Boston Scientific, MicroGenDx, Coloplast, Signati Medical. PHC consults for and receives research support from Boston Scientific and Coloplast. The other authors have no conflicts of interest to declare., (2022 Translational Andrology and Urology. All rights reserved.)

Aim: The aim of this scoping review was to identify empirical literature on simulation used to develop undergraduate nursing student's clinical assessment skills to recognise and respond to patient deterioration., Background: Early recognition and response to clinical deterioration is necessary to ensure the best outcome for the patient. Undergraduate nursing students have limited exposure to deteriorating patient situations, therefore simulation is widely implemented in nursing courses to address this educational need. It is imperative to identify the simulation modalities and features that best optimise student learning., Design: Scoping review using the Joanna Briggs Institute scoping reviews methodology and the Arksey and O'Malley framework., Review Methods: Seven health databases were searched electronically for relevant literature and complemented with hand searching for additional relevant sources. A total of 344 potential articles were identified from the seven databases: Cumulative Index to Nursing and Allied Health Literature (n = 234); PubMed (n = 16); Medline (n = 51); Scopus (n = 21); Embase (n = 3); American Psychological Association PsychInfo (n = 13); and JBI (n = 6). After applying inclusion and exclusion criteria, 15 research articles were included in the review., Results: Most research on clinical deterioration simulation was quantitative (n = 12), two were qualitative and one used a mixed method approach. Findings included a lack of situational awareness, distractors causing incomplete patient assessment and failure to recognise deterioration. Repeated simulation showed positive results., Conclusions: Findings of this review suggest students lack situational awareness, perform incomplete assessment and fixate on single cues rather than an entire clinical picture. The use of a variety of simulation modalities was effective in improving student performance. Repeated practice within a single simulated learning experience, was shown to improve performance and situational awareness. This approach to simulation is under-researched in nursing and needs further exploration., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Administration of drugs through oral and intravenous routes is a mainstay of modern medicine, but this approach suffers from limitations associated with off-target side effects and narrow therapeutic windows. It is often apparent that a controlled delivery of drugs, either localized to a specific site or during a specific time, can increase efficacy and bypass problems with systemic toxicity and insufficient local availability. To overcome some of these issues, local delivery systems have been devised, but most are still restricted in terms of elution kinetics, duration, and temporal control. Ultrasound-targeted drug delivery offers a powerful approach to increase delivery, therapeutic efficacy, and temporal release of drugs ranging from chemotherapeutics to antibiotics. The use of ultrasound can focus on increasing tissue sensitivity to the drug or actually be a critical component of the drug delivery. The high spatial and temporal resolution of ultrasound enables precise location, targeting, and timing of drug delivery and tissue sensitization. Thus, this noninvasive, non-ionizing, and relatively inexpensive modality makes the implementation of ultrasound-mediated drug delivery a powerful method that can be readily translated into the clinical arena. This review covers key concepts and areas applied in the design of different ultrasound-mediated drug delivery systems across a variety of clinical applications., Competing Interests: Lauren Delaney, Selin Isguven, and Noreen Hickok do not have any conflicts of interest to report. John Eisenbrey reports equipment, contrast agent, and grant support from GE Healthcare, equipment support from Siemens, contrast agent support and speaker fees from Lantheus Medical Imaging, and royalties from Elsevier. Flemming Forsberg reports equipment support from Canon Medical Systems, GE Healthcare, and Siemens Healthineers, as well as contrast agent support from Bracco, GE Healthcare, and Lantheus Medical Imaging. Flemming Forsberg is a speaker for GE Healthcare and a consultant for Exact Therapeutics., (This journal is © The Royal Society of Chemistry.)

Orthopaedic surgical site infections, especially when a hardware is involved, are associated with biofilm formation. Clinical strategies for biofilm eradication still fall short. The present study used a novel animal model of long-bone fixation with vancomycin- or gentamicin-controlled release and measured the levels of antibiotic achieved at the site of release and in the surrounding tissue. Then, using fluids that contain serum proteins (synovial fluid or diluted serum), the levels of vancomycin or gentamicin required to substantially reduce colonising bacteria were measured in a model representative of either prophylaxis or established biofilms. In the in vivo model, while the levels immediately adjacent to the antibiotic release system were up to 50× the minimal inhibitory concentration in the first 24 h, they rapidly dropped. At peripheral sites, values never reached these levels. In the in vitro experiments, Staphylococcus aureus biofilms formed in serum or in synovial fluid showed a 5-10 fold increase in antibiotic tolerance. Importantly, concentrations required were much higher than those achieved in the local delivery systems. Finally, the study determined that the staged addition of vancomycin and gentamicin was not more efficacious than simultaneous vancomycin and gentamicin administration when using planktonic bacteria. On the other hand, for biofilms, the staged addition seemed more efficacious than adding the antibiotics simultaneously. Overall, data showed that the antibiotics' concentrations near the implant in the animal model fall short of the concentrations required to eradicate biofilms formed in either synovial fluid or serum.

Purpose: Left ventricular assist device (LVAD) support is associated with peripheral vascular abnormalities beyond those associated with heart failure (HF). These abnormalities are associated with persistent functional impairments that adversely impact quality of life (QoL). Methods for measuring peripheral vascular function in this population are needed., Methods: This pilot study investigated the use of contrast-enhanced ultrasound (CEUS) using standardized protocols to estimate changes in peripheral (quadriceps) muscle perfusion among patients with HF (INTERMACS profile 3) undergoing LVAD implantation (n = 7). Patients were then stratified by those who did ("responders", n = 4) and did not ("nonresponders", n = 3) report QoL improvement with LVAD support., Results: Serial measurements obtained preoperatively and 3 months following LVAD implantation showed no significant change (P > .23) in muscle perfusion by all CEUS-based measures at rest or with an exercise stimulus for the overall population. Responders exhibited improved muscle perfusion at rest (P = .043) and decreased time to peak contrast enhancement (P = .010) at 3 months compared with baseline, suggesting improved delivery of blood to the extremities post-LVAD. Nonresponders showed unchanged resting muscle perfusion (P > .99), time to peak contrast enhancement (P = .59), and response to exercise stimulus (P > .99) following LVAD therapy., Conclusion: Our findings suggest that CEUS evaluation is a promising noninvasive, quantitative modality for real-time assessment of peripheral vasculature and muscle perfusion as an indication of treatment response in LVAD recipients and that this modality may capture perfusion measures important to QoL following LVAD implantation., (© 2021 American Institute of Ultrasound in Medicine.)

Conventional cross-sectional imaging done shortly after radioembolization of hepatocellular carcinoma (HCC) does not reliably predict long-term response to treatment. This study evaluated whether quantitative contrast-enhanced ultrasound (CEUS) can predict the long-term response of HCC to yttrium-90 (Y-90) treatment. Fifteen patients underwent CEUS at three time points: immediately following treatment and 1 and 2 wk post-treatment. Response 3-6 mo after treatment was categorized on contrast-enhanced magnetic resonance imaging by two experienced radiologists using the Modified Response Evaluation Criteria in Solid Tumors. CEUS data were analyzed by quantifying tumor perfusion and residual fractional vascularity using time-intensity curves. Patients with stable disease on magnetic resonance imaging had significantly greater fractional vascularity 2 wk post-treatment (65.15%) than those with partial or complete response (13.8 ± 9.9%, p = 0.007, and 14.9 ± 15.4%, p = 0.009, respectively). Complete responders had lower tumor vascularity at 2 wk than at post-operative examination (-38.3 ± 15.4%, p = 0.045). Thus, this pilot study suggests CEUS may provide an earlier indication of Y-90 treatment response than cross-sectional imaging., Competing Interests: Conflict of interest disclosure The authors declare no competing interests., (Copyright © 2021 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.)

Ultrasound imaging presents many positive attributes, including safety, real-time imaging, universal accessibility, and cost. However, inherent difficulties in discrimination between soft tissues and tumors prompted development of stabilized microbubble contrast agents. This presents the opportunity to develop agents in which drug is entrapped in the microbubble shell. We describe preparation and characterization of theranostic poly(lactide) (PLA) and pegylated PLA (PEG-PLA) shelled microbubbles that entrap gemcitabine, a commonly used drug for pancreatic cancer (PDAC). Entrapping 6 wt% gemcitabine did not significantly affect drug activity, microbubble morphology, or ultrasound contrast activity compared with unmodified microbubbles. In vitro microbubble concentrations yielding ≥ 500nM entrapped gemcitabine were needed for complete cell death in MIA PaCa-2 PDAC drug sensitivity assays, compared with 62.5 nM free gemcitabine. In vivo administration of gemcitabine-loaded microbubbles to xenograft MIA PaCa-2 PDAC tumors in athymic mice was well tolerated and provided substantial tumoral image enhancement before and after destructive ultrasound pulses. However, no significant differences in tumor growth were observed among treatment groups, in keeping with the in vitro observation that much higher doses of gemcitabine are required to mirror free gemcitabine activity. STATEMENT OF SIGNIFICANCE: The preliminary results shown here are encouraging and support further investigation into increased gemcitabine loading. Encapsulation of gemcitabine within polylactic acid (PLA) microbubbles does not damage its activity towards pancreatic cancer (pancreatic ductal adenocarcinoma, PDAC) cells. Excellent imaging and evidence of penetration into the highly desmoplastic PDAC tumors is demonstrated. Microbubble destruction was confirmed in vivo, showing that elevated mechanical index shatters the microbubbles for enhanced delivery. The potential to slow PDAC growth in vivo is shown, but higher gemcitabine concentrations are required. Current efforts are directed at increasing drug loading by inclusion of drug-carrying nanoparticles for effective in vivo treatment., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Flemming Forsberg acknowledges equipment support from Siemens Healthineers. John Eisenbrey acknowledges equipment support from Siemens, grant funding and equipment support from GE Healthcare, and drug support and speaker fees from Lantheus Medical Imaging. Lauren Delaney, David Brown, Jonathan Brody, Masaya Jimbo, Brian Oeffinger, Maria Stanczak, Ji-Bin Liu, and Margaret Wheatley have no competing interests to report., (Copyright © 2021. Published by Elsevier Ltd.)

Sleep in intensive care is hampered due to many factors; the clinical environment itself exacerbates sleep disturbance. Research suggests that interventions aimed at improving sleep quality have produced positive effects in reducing incidences and duration of delirium. Sleep disturbance is well documented among intensive care patients; however, its prognostic impact is not fully understood. Delirium, disproportionally prevalent among intensive care patients, has significant prognostic factors related to patient outcomes, in which sleep disturbance often is present. The relationship between sleep disturbance and delirium is complex, sharing commonalities in relation to neurobiological and neurohormonal alterations, which may contribute to a bidirectional relationship., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background US contrast agents are gas-filled microbubbles (MBs) that can be locally destroyed by using external US. Among other bioeffects, US-triggered MB destruction, also known as UTMD, has been shown to sensitize solid tumors to radiation in preclinical models through localized insult to the vascular endothelial cells. Purpose To evaluate the safety and preliminary efficacy of combining US-triggered MB destruction and transarterial radioembolization (TARE) in participants with hepatocellular carcinoma (HCC). Materials and Methods In this pilot clinical trial, participants with HCC scheduled for sublobar TARE were randomized to undergo either TARE or TARE with US-triggered MB destruction 1-4 hours and approximately 1 and 2 weeks after TARE. Enrollment took place between July 2017 and February 2020. Safety of US-triggered MB destruction was evaluated by physiologic monitoring, changes in liver function tests, adverse events, and radiopharmaceutical distribution. Treatment efficacy was evaluated by using modified Response Evaluation Criteria in Solid Tumors (mRECIST) on cross-sectional images, time to required next treatment, transplant rates, and overall survival. Differences across mRECIST reads were compared by using a Mann-Whitney U test, and the difference in prevalence of tumor response was evaluated by Fisher exact test, whereas differences in time to required next treatment and overall survival curves were compared by using a log-rank (Mantel-Cox) test. Results Safety results from 28 participants (mean age, 70 years ± 10 [standard deviation]; 17 men) demonstrated no significant changes in temperature ( P = .31), heart rate ( P = .92), diastolic pressure ( P = .31), or systolic pressure ( P = .06) before and after US-triggered MB destruction. No changes in liver function tests between treatment arms were observed 1 month after TARE ( P > .15). Preliminary efficacy results showed a greater prevalence of tumor response (14 of 15 [93%; 95% CI: 68, 100] vs five of 10 [50%; 95% CI: 19, 81]; P = .02) in participants who underwent both US-triggered MB destruction and TARE ( P = .02). Conclusion The combination of US-triggered microbubble destruction and transarterial radioembolization is feasible with an excellent safety profile in this patient population and appears to result in improved hepatocellular carcinoma treatment response. © RSNA, 2020.

Background: Sleep amongst intensive care patients is reduced and highly fragmented which may adversely impact on recovery. The current challenge for Intensive Care clinicians is identifying feasible and accurate assessments of sleep that can be widely implemented. The objective of this study was to investigate the feasibility and reliability of a minimally invasive sleep monitoring technique compared to the gold standard, polysomnography, for sleep monitoring., Methods: Prospective observational study employing a within subject design in adult patients admitted to an Intensive Care Unit. Sleep monitoring was undertaken amongst minimally sedated patients via concurrent polysomnography and actigraphy monitoring over a 24-h duration to assess agreement between the two methods; total sleep time and wake time., Results: We recruited 80 patients who were mechanically ventilated (24%) and non-ventilated (76%) within the intensive care unit. Sleep was found to be highly fragmented, composed of numerous sleep bouts and characterized by abnormal sleep architecture. Actigraphy was found to have a moderate level of overall agreement in identifying sleep and wake states with polysomnography (69.4%; K = 0.386, p < 0.05) in an epoch by epoch analysis, with a moderate level of sensitivity (65.5%) and specificity (76.1%). Monitoring accuracy via actigraphy was improved amongst non-ventilated patients (specificity 83.7%; sensitivity 56.7%). Actigraphy was found to have a moderate correlation with polysomnography reported total sleep time (r = 0.359, p < 0.05) and wakefulness (r = 0.371, p < 0.05). Bland-Altman plots indicated that sleep was underestimated by actigraphy, with wakeful states overestimated., Conclusions: Actigraphy was easy and safe to use, provided moderate level of agreement with polysomnography in distinguishing between sleep and wakeful states, and may be a reasonable alternative to measure sleep in intensive care patients. Clinical Trial Registration number ACTRN12615000945527 (Registered 9/9/2015).

The implantation of penile protheses for the surgical treatment of erectile dysfunction has risen in popularity over the past several decades. Considerable advances have been made in surgical protocol and device design, specifically targeting infection prevention. Despite these efforts, device infection remains a critical problem, which causes significant physical and emotional burden to the patient. The aim of this review is to broaden the discussion of best practices by not only examining practices in urology, but additionally delving into the field of orthopedic surgery to identify techniques and approaches that may be applied to penile prothesis surgery., (Copyright © 2020 Elsevier Inc. All rights reserved.)

N95 respirators are personal protective equipment most often used to control exposures to infections transmitted via the airborne route. Supplies of N95 respirators can become depleted during pandemics or when otherwise in high demand. In this paper, we offer strategies for optimizing supplies of N95 respirators in health care settings while maximizing the level of protection offered to health care personnel when there is limited supply in the United States during the 2019 coronavirus disease pandemic. The strategies are intended for use by professionals who manage respiratory protection programs, occupational health services, and infection prevention programs in health care facilities to protect health care personnel from job-related risks of exposure to infectious respiratory illnesses. Consultation with federal, state, and local public health officials is also important. We use the framework of surge capacity and the occupational health and safety hierarchy of controls approach to discuss specific engineering control, administrative control, and personal protective equipment measures that may help in optimizing N95 respirator supplies.

Neuroblastoma (NB) is the most common extracranial solid tumor in infants and children, and imposes significant morbidity and mortality in this population. The aggressive chemoradiotherapy required to treat high-risk NB results in survival of less than 50%, yet is associated with significant long-term adverse effects in survivors. Boosting efficacy and reducing morbidity are therefore key goals of treatment for affected children. We hypothesize that these may be achieved by developing strategies that both focus and limit toxic therapies to the region of the tumor. One such strategy is the use of targeted image-guided drug delivery (IGDD), which is growing in popularity in personalized therapy to simultaneously improve on-target drug deposition and assess drug pharmacodynamics in individual patients. IGDD strategies can utilize a variety of imaging modalities and methods of actively targeting pharmaceutical drugs, however in vivo imaging in combination with focused ultrasound is one of the most promising approaches already being deployed for clinical applications. Over the last two decades, IGDD using focused ultrasound with "microbubble" ultrasound contrast agents (UCAs) has been increasingly explored as a method of targeting a wide variety of diseases, including cancer. This technique, known as sonopermeation, mechanically augments vascular permeability, enabling increased penetration of drugs into target tissue. However, to date, methods of monitoring the vascular bioeffects of sonopermeation in vivo are lacking. UCAs are excellent vascular probes in contrast-enhanced ultrasound (CEUS) imaging, and are thus uniquely suited for monitoring the effects of sonopermeation in tumors. Methods : To monitor the therapeutic efficacy of sonopermeation in vivo, we developed a novel system using 2D and 3D quantitative contrast-enhanced ultrasound imaging (qCEUS). 3D tumor volume and contrast enhancement was used to evaluate changes in blood volume during sonopermeation. 2D qCEUS-derived time-intensity curves (TICs) were used to assess reperfusion rates following sonopermeation therapy. Intratumoral doxorubicin (and liposome) uptake in NB was evalauted ex vivo along with associated vascular changes. Results : In this study, we demonstrate that combining focused ultrasound therapy with UCAs can significantly enhance chemotherapeutic payload to NB in an orthotopic xenograft model, by improving delivery and tumoral uptake of long-circulating liposomal doxorubicin (L-DOX) nanoparticles. qCEUS imaging suggests that changes in flow rates are highly sensitive to sonopermeation and could be used to monitor the efficacy of treatment in vivo . Additionally, initial tumor perfusion may be a good predictor of drug uptake during sonopermeation. Following sonopermeation treatment, vascular biomarkers show increased permeability due to reduced pericyte coverage and rapid onset of doxorubicin-induced apoptosis of NB cells but without damage to blood vessels. Conclusion : Our results suggest that significant L-DOX uptake can occur by increasing tumor vascular permeability with microbubble sonopermeation without otherwise damaging the vasculature, as confirmed by in vivo qCEUS imaging and ex vivo analysis. The use of qCEUS imaging to monitor sonopermeation efficiency and predict drug uptake could potentially provide real-time feedback to clinicians for determining treatment efficacy in tumors, leading to better and more efficient personalized therapies. Finally, we demonstrate how the IGDD strategy outlined in this study could be implemented in human patients using a single case study., Competing Interests: Competing Interests: The authors have declared that no competing interest exists., (© The author(s).)

Congregate work and residential locations are at increased risk for infectious disease transmission including respiratory illness outbreaks. SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), is primarily spread person to person through respiratory droplets. Nationwide, the meat and poultry processing industry, an essential component of the U.S. food infrastructure, employs approximately 500,000 persons, many of whom work in proximity to other workers (1). Because of reports of initial cases of COVID-19, in some meat processing facilities, states were asked to provide aggregated data concerning the number of meat and poultry processing facilities affected by COVID-19 and the number of workers with COVID-19 in these facilities, including COVID-19-related deaths. Qualitative data gathered by CDC during on-site and remote assessments were analyzed and summarized. During April 9-27, aggregate data on COVID-19 cases among 115 meat or poultry processing facilities in 19 states were reported to CDC. Among these facilities, COVID-19 was diagnosed in 4,913 (approximately 3%) workers, and 20 COVID-19-related deaths were reported. Facility barriers to effective prevention and control of COVID-19 included difficulty distancing workers at least 6 feet (2 meters) from one another (2) and in implementing COVID-19-specific disinfection guidelines.* Among workers, socioeconomic challenges might contribute to working while feeling ill, particularly if there are management practices such as bonuses that incentivize attendance. Methods to decrease transmission within the facility include worker symptom screening programs, policies to discourage working while experiencing symptoms compatible with COVID-19, and social distancing by workers. Source control measures (e.g., the use of cloth face covers) as well as increased disinfection of high-touch surfaces are also important means of preventing SARS-CoV-2 exposure. Mitigation efforts to reduce transmission in the community should also be considered. Many of these measures might also reduce asymptomatic and presymptomatic transmission (3). Implementation of these public health strategies will help protect workers from COVID-19 in this industry and assist in preserving the critical meat and poultry production infrastructure (4)., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

Objectives: This pilot study evaluated whether contrast-enhanced subharmonic imaging (SHI) could be used to characterize adnexal masses before surgical intervention., Methods: Ten women (with 12 lesions) scheduled for surgery of an ovarian mass underwent an SHI examination of their adnexal region using a modified LOGIQ E9 scanner (GE Healthcare, Waukesha, WI) with an endocavitary transducer, in which digital clips were acquired by pulse destruction-replenishment SHI across the lesions. Time-intensity curves were created offline to quantitatively evaluate SHI parameters (fractional tumor perfusion, peak contrast intensity, time to peak contrast enhancement, and area under the time-intensity curve), which were compared to pathologic characterizations of the lesions., Results: Of the 12 masses, 8 were benign, and 4 were malignant. A qualitative analysis of the SHI images by an experienced radiologist resulted in diagnostic accuracy of 70%, compared to 56% without contrast, whereas an inexperienced radiologist improved from 50% to 58% accuracy, demonstrating the benefit of SHI. A quantitative analysis of SHI parameters produced diagnostic accuracy as high as 81%. Peak contrast intensity was significantly greater in malignant than benign masses (mean ± SD, 0.109 ± 0.088 versus 0.046 ± 0.030 arbitrary units; P = .046). Malignant masses also showed significantly greater perfusion than benign masses (24.79% ± 25.34% versus 7.62% ± 6.50%; P = .045). When the radiologist reads were combined with the most predictive quantitative SHI parameter (percent perfusion), diagnostic accuracy improved to 84% for the experienced radiologist and 96% for the novice radiologist., Conclusions: Results indicate that SHI for presurgical characterization of adnexal masses may improve the determination of malignancy and diagnostic accuracy, albeit based on a small sample size., (© 2019 by the American Institute of Ultrasound in Medicine.)

Background: The causative agents for the current national outbreak of electronic-cigarette, or vaping, product use-associated lung injury (EVALI) have not been established. Detection of toxicants in bronchoalveolar-lavage (BAL) fluid from patients with EVALI can provide direct information on exposure within the lung., Methods: BAL fluids were collected from 51 patients with EVALI in 16 states and from 99 healthy participants who were part of an ongoing study of smoking involving nonsmokers, exclusive users of e-cigarettes or vaping products, and exclusive cigarette smokers that was initiated in 2015. Using the BAL fluid, we performed isotope dilution mass spectrometry to measure several priority toxicants: vitamin E acetate, plant oils, medium-chain triglyceride oil, coconut oil, petroleum distillates, and diluent terpenes., Results: State and local health departments assigned EVALI case status as confirmed for 25 patients and as probable for 26 patients. Vitamin E acetate was identified in BAL fluid obtained from 48 of 51 case patients (94%) in 16 states but not in such fluid obtained from the healthy comparator group. No other priority toxicants were found in BAL fluid from the case patients or the comparator group, except for coconut oil and limonene, which were found in 1 patient each. Among the case patients for whom laboratory or epidemiologic data were available, 47 of 50 (94%) had detectable tetrahydrocannabinol (THC) or its metabolites in BAL fluid or had reported vaping THC products in the 90 days before the onset of illness. Nicotine or its metabolites were detected in 30 of 47 of the case patients (64%)., Conclusions: Vitamin E acetate was associated with EVALI in a convenience sample of 51 patients in 16 states across the United States. (Funded by the National Cancer Institute and others.)., (Copyright © 2019 Massachusetts Medical Society.)

Post-operative infection is a catastrophic complication of spinal fusion surgery, with rates as high as 10%, and existing preventative measures (i.e., peri-operative antibiotics) are only partially successful. To combat this clinical problem, we have designed a drug delivery system around polyether ether ketone clips to be used for prophylactic post-surgical release of antibiotics upon application of ultrasound. The overall hypothesis is that antimicrobial release from this system will aggressively combat post-surgical bacterial survival. This study investigated a set of acoustic parameters optimized for in vitro ultrasound-triggered coating rupture and subsequent release of encapsulated prophylactic antibiotics. We determined that a transducer frequency of 1.7 MHz produced the most consistent burst release and that, at this frequency, a pulse repetition frequency of 6.4 kHz and acoustic output power of 100% (3.41 MPa) produced the greatest release, representing an important proof of principle and the basis for continued development of this novel drug delivery system., (Copyright © 2019 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.)

To describe the baseline hemodynamic variables and response time of hemodynamic changes associated with the Valsalva maneuver using noninvasive continuous cardiac output monitoring (Nexfin). Hemodynamic monitoring provides an integral component of advanced clinical care and the ability to monitor response to treatment interventions. The emergence of noninvasive hemodynamic monitoring provides clinicians with an opportunity to monitor and assess patients rapidly with ease of implementation. However, the responsiveness of this method in tracking dynamic changes that occur has not been fully elucidated. A prospective observational study was conducted involving 44 healthy volunteers (age = 38 ±12 years). Participants performed a Valsalva maneuvers to illicit dynamic changes in blood pressure, cardiac output, cardiac index, systemic vascular resistance index (SVRI), and stroke volume. Changes in these hemodynamic parameters were monitored while performing repeated standardized Valsalva maneuvers. Baseline hemodynamic values were obtained in all 44 participants, and showed an interaction with age, accompanying a significant decline in cardiac index ( r = -.66, p < .05) and stroke volume ( r = -.68, p < .05), and an increase in SVRI ( r = .67, p < .05) with increasing age. The Valsalva maneuver, performed in 20 participants, resulted in a change of 10% from baseline blood pressure and cardiac index, which was detected within 4.53 s ( SD = 4.36) and 3.31 s ( SD = 2.21), respectively. Noninvasive continuous cardiac monitoring demonstrated the ability to rapidly detect logical and predictable hemodynamic changes. These observations suggest that such Nexfin technology may have useful clinical applications.

Objectives: Hypoxic cancer cells have been shown to be more resistant to radiation therapy than normoxic cells. Hence, this study investigated whether ultrasound (US)-induced rupture of oxygen-carrying microbubbles (MBs) would enhance the response of breast cancer metastases to radiation., Methods: Nude mice (n = 15) received stereotactic injections of brain-seeking MDA-MB-231 breast cancer cells into the right hemisphere. Animals were randomly assigned into 1 of 5 treatment groups: no intervention, 10 Gy radiation using a small-animal radiation research platform, nitrogen-carrying MBs combined with US-mediated MB rupture immediately before 10 Gy radiation, oxygen-carrying MBs immediately before 10 Gy radiation, and oxygen-carrying MBs with US-mediated MB rupture immediately before 10 Gy radiation. Tumor progression was monitored with 3-dimensional US, and overall survival was noted., Results: All groups except those treated with oxygen-carrying MB rupture and radiation had continued rapid tumor growth after treatment. Tumors treated with radiation alone showed a mean increase in volume ± SD of 337% ± 214% during the week after treatment. Tumors treated with oxygen-carrying MBs and radiation without MB rupture showed an increase in volume of 383% ± 226%. Tumors treated with radiation immediately after rupture of oxygen-carrying MBs showed an increase in volume of only 41% ± 1% (P = 0.045), and this group also showed a 1 week increase in survival time., Conclusions: Adding US-ruptured oxygen-carrying MBs to radiation therapy appears to delay tumor progression and improve survival in a murine model of metastatic breast cancer., (© 2019 by the American Institute of Ultrasound in Medicine.)

CDC, the Food and Drug Administration (FDA), state and local health departments, and public health and clinical stakeholders are investigating a nationwide outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI) (1). CDC has published recommendations for health care providers regarding EVALI (2-4). Recently, researchers from Utah and New York published proposed diagnosis and treatment algorithms for EVALI (5,6). EVALI remains a diagnosis of exclusion because, at present, no specific test or marker exists for its diagnosis, and evaluation should be guided by clinical judgment. Because patients with EVALI can experience symptoms similar to those associated with influenza or other respiratory infections (e.g., fever, cough, headache, myalgias, or fatigue), it might be difficult to differentiate EVALI from influenza or community-acquired pneumonia on initial assessment; EVALI might also co-occur with respiratory infections. This report summarizes recommendations for health care providers managing patients with suspected or known EVALI when respiratory infections such as influenza are more prevalent in the community than they have been in recent months (7). Recommendations include 1) asking patients with respiratory, gastrointestinal, or constitutional symptoms about the use of e-cigarette, or vaping, products; 2) evaluating those suspected to have EVALI with pulse oximetry and obtaining chest imaging, as clinically indicated; 3) considering outpatient management for clinically stable EVALI patients who meet certain criteria; 4) testing patients for influenza, particularly during influenza season, and administering antimicrobials, including antivirals, in accordance with established guidelines; 5) using caution when considering prescribing corticosteroids for outpatients, because this treatment modality has not been well studied among outpatients, and corticosteroids could worsen respiratory infections; 6) recommending evidence-based treatment strategies, including behavioral counseling, to help patients discontinue using e-cigarette, or vaping, products; and 7) emphasizing the importance of annual influenza vaccination for all persons aged ≥6 months, including patients who use e-cigarette, or vaping products., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

CDC, the Food and Drug Administration (FDA), state and local health departments, and public health and clinical stakeholders are investigating a nationwide outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI) (1). As of November 13, 2019, 49 states, the District of Columbia, and two U.S. territories (Puerto Rico and U.S. Virgin Islands) have reported 2,172 EVALI cases to CDC, including 42 (1.9%) EVALI-associated deaths. To inform EVALI surveillance, including during the 2019-20 influenza season, case report information supplied by states for hospitalized and nonhospitalized patients with EVALI were analyzed using data collected as of November 5, 2019. Among 2,016 EVALI patients with available data on hospitalization status, 1,906 (95%) were hospitalized, and 110 (5%) were not hospitalized. Demographic characteristics of hospitalized and nonhospitalized patients were similar; most were male (68% of hospitalized versus 65% of nonhospitalized patients), and most were aged <35 years (78% of hospitalized versus 74% of nonhospitalized patients). These patients also reported similar use of tetrahydrocannabinol (THC)-containing products (83% of hospitalized versus 84% of nonhospitalized patients). Given the similarity between hospitalized and nonhospitalized EVALI patients, the potential for large numbers of respiratory infections during the emerging 2019-20 influenza season, and the potential difficulty in distinguishing EVALI from respiratory infections, CDC will no longer collect national data on nonhospitalized EVALI patients. Further collection of data on nonhospitalized patients will be at the discretion of individual state, local, and territorial health departments. Candidates for outpatient management of EVALI should have normal oxygen saturation (≥95% while breathing room air), no respiratory distress, no comorbidities that might compromise pulmonary reserve, reliable access to care, strong social support systems, and should be able to ensure follow-up within 24-48 hours of initial evaluation and to seek medical care promptly if respiratory symptoms worsen. Health care providers should emphasize the importance of annual influenza vaccination for all persons aged ≥6 months, including persons who use e-cigarette, or vaping, products (2,3)., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

Introduction: Complementary and alternative therapies (CATs) are widely used by cancer patients but are infrequently disclosed and documented. This study aimed to improve radiation therapy staff knowledge, confidence, views and documentation of radiation oncology patients' use of CATs., Method: Participants completed a baseline questionnaire regarding their knowledge, confidence, views and documentation relating to patients' CAT use. An intervention was undertaken whereby participants attended an educational session and a CAT screening tool was implemented simultaneously. Participants immediately completed a post-intervention questionnaire and later a 6-month follow-up questionnaire. A patient record audit was conducted to measure the documentation of CAT use pre- and post-intervention., Results: From baseline to post-intervention, there was a statistically significant shift in staff knowledge and confidence (P = 0.001-0.01). The observed shift was sustained over a 6-month period, (P = 0.453-1.00). Participants' perceived views of CATs did not change as a result of the intervention (P = 0.261-1.000). The post-intervention audit compared to the baseline audit yielded a statistically significant increase in documentation. There was an increase in CAT use mentioned in patient records from 14% (15/108) to 40% (35/88) (P < 0.001)., Conclusions: The implementation of a screening tool and staff education increased radiation therapy staff knowledge of CATs and increased staff confidence when discussing CAT use with patients. Documentation of CATs in the patient record increased post-intervention. These changes positively affected radiation therapy staff understanding the use of CATs by cancer patients., (© 2019 The Authors. Journal of Medical Radiation Sciences published by John Wiley & Sons Australia, Ltd on behalf of Australian Society of Medical Imaging and Radiation Therapy and New Zealand Institute of Medical Radiation Technology.)

Despite aggressive peri-operative antibiotic treatments, up to 10% of patients undergoing instrumented spinal surgery develop an infection. Like most implant-associated infections, spinal infections persist through colonization and biofilm formation on spinal instrumentation, which can include metal screws and rods for fixation and an intervertebral cage commonly comprised of polyether ether ketone (PEEK). We have designed a PEEK antibiotic reservoir that would clip to the metal fixation rod and that would achieve slow antibiotic release over several days, followed by a bolus release of antibiotics triggered by ultrasound (US) rupture of a reservoir membrane. We have found using human physiological fluid (synovial fluid), that higher levels (100-500 μg) of vancomycin are required to achieve a marked reduction in adherent bacteria vs. that seen in the common bacterial medium, trypticase soy broth. To achieve these levels of release, we applied a polylactic acid coating to a porous PEEK puck, which exhibited both slow and US-triggered release. This design was further refined to a one-hole or two-hole cylindrical PEEK reservoir that can clip onto a spinal rod for clinical use. Short-term release of high levels of antibiotic (340 ± 168 μg), followed by US-triggered release was measured (7420 ± 2992 μg at 48 h). These levels are sufficient to prevent adhesion of Staphylococcus aureus to implant materials. This study demonstrates the feasibility of an US-mediated antibiotic delivery device, which could be a potent weapon against spinal surgical site infection. STATEMENT OF SIGNIFICANCE: Spinal surgical sites are prone to bacterial colonization, due to presence of instrumentation, long surgical times, and the surgical creation of a dead space (≥5 cm 3 ) that is filled with wound exudate. Accordingly, it is critical that new approaches are developed to prevent bacterial colonization of spinal implants, especially as neither bulk release systems nor controlled release systems are available for the spine. This new device uses non-invasive ultrasound (US) to trigger bulk release of supra-therapeutic doses of antibiotics from materials commonly used in existing surgical implants. Thus, our new delivery system satisfies this critical need to eradicate surviving bacteria, prevent resistance, and markedly lower spinal infection rates., (Copyright © 2019 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.)

NEHA strives to provide up-to-date and relevant information on environmental health and to build partnerships in the profession. In pursuit of these goals, we feature this column on environmental health services from the Centers for Disease Control and Prevention (CDC) in every issue of the Journal . In these columns, authors from CDC's Water, Food, and Environmental Health Services Branch, as well as guest authors, will share insights and information about environmental health programs, trends, issues, and resources. The conclusions in these columns are those of the author(s) and do not necessarily represent the official position of CDC. Kerton Victory is an environmental health specialist and emergency coordinator with the National Institute for Occupational Safety and Health's (NIOSH) Emergency Preparedness and Response Office (EPRO). Jill Shugart is a senior environmental health specialist and the Emergency Responder Health Monitoring and Surveillance coordinator with NIOSH EPRO. Sherry Burrer is a senior epidemiologist and emergency coordinator with NIOSH EPRO. Chad Dowell is the NIOSH deputy associate director for emergency preparedness and response. Lisa Delaney is the NIOSH associate director for emergency preparedness and response.

Background: Poor sleep is known to adversely affect hospital patients' recovery and rehabilitation. The aim of the study was to investigate the perceived duration and quality of patient sleep and identify any environmental factors associated with patient-reported poor sleep in hospital., Method: A cross-sectional study was conducted involving 15 clinical units within a 672-bed tertiary-referral hospital in Australia. Semi-structured interviews to determine perceptions of sleep quantity and quality and factors that disturb nocturnal sleep were conducted with patients and nursing staff. Environmental noise, light and temperature were monitored overnight, with concurrent logging of noise sources by observers., Results: Patients reported a mean reduction in hospital sleep duration, compared to home, of 1.8 h (5.3 vs. 7.1 h; p < 0.001). The proportions of patients reporting their sleep quality to be poor/very poor, fair and of good quality were 41.6, 34.2 and 24.2% respectively. Patients reported poorer sleep quality than nurses (p < 0.05). Patients, nurses and observers all reported the main factors associated with poor sleep as clinical care interventions (34.3%) and environmental noise (32.1%). Noise levels in all 15 clinical areas exceeded WHO recommended levels of < 30 dB [A] by 36.7 to 82.6%, with peak noise levels of 51.3 to 103.3 dB (A)., Conclusion: Hospital in-patients are exposed to factors which reduce the duration and quality of their sleep. These extrinsic factors are potentially modifiable through behaviour change and reconfiguration of the clinical environment. The findings from this study provided the foundation for a quality improvement project currently underway to improve patients' sleep.

Background: Didactic clinical skills training employing low fidelity simulation has been the traditional approach to teaching undergraduate nursing students the insertion of an indwelling urinary catheter. This approach, however, does not adequately prepare students for the intricacies and complexity of this procedure in the real world, which is associated with high rates of infection secondary to procedural contamination., Objectives: To explore students' confidence levels in developing clinical psychomotor skills associated with the insertion of an indwelling urinary catheter in a high-fidelity simulation using Mask-Ed., Methods: A mixed methods study was conducted involving final year Bachelor of Nursing students. Preproceduraland postprocedural confidence was rated by students using a 5-point Likert scale. A focus group consisting of eleven students was conducted to further explore student's experience of engaging with a Mask-Ed character and the procedural experience from a learning perspective., Results: The findings indicated that students increased their procedure confidence when engaging with the Mask-Ed simulation (P=0.025). The ability to maintain procedural asepsis and ability to accurately identify the correct anatomical structures related to indwelling urinary catheter insertion were found to be related ( r s = 0.71, P<0.05). Three primary themes were identified: caring of a person, intimate care and communication., Conclusion: Psychomotor skills related to communication, support and maintaining procedural asepsis were areas that required further clinical development, which are not concurrently integrated into the simulation approach using manikin based simulation. Mask-Ed provided a unique learning opportunity to replicate a clinically and anatomically realistic experience., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Sleep is a state of quiescence that facilitates the significant restorative processes that enhance individuals' physiological and psychological well-being. Patients admitted to the intensive care unit (ICU) experience substantial sleep disturbance. Despite the biological importance of sleep, sleep monitoring does not form part of standard clinical care for critically ill patients. There exists an unmet need to assess the feasibility and accuracy of a range of sleep assessment techniques that have the potential to allow widespread implementation of sleep monitoring in the ICU., Key Measures: The coprimary outcome measures of this study are to: determine the accuracy and feasibility of motion accelerometer monitoring (ie, actigraphy) and subjective assessments of sleep (nursing-based observations and patient self-reports) to the gold standard of sleep monitoring (ie, polysomnography) in evaluating sleep continuity and disturbance. The secondary outcome measures of the study will include: (1) the association between sleep disturbance and environmental factors (eg, noise, light and clinical interactions) and (2) to describe the sleep architecture of intensive care patients., Methods and Analysis: A prospective, single centre observational design with a within subjects' assessment of sleep monitoring techniques. The sample will comprise 80 adults (aged 18 years or more) inclusive of ventilated and non-ventilated patients, admitted to a tertiary ICU with a Richmond Agitation-Sedation Scale score between +2 (agitated) and -3 (moderate sedation) and an anticipated length of stay >24 hours. Patients' sleep quality, total sleep time and sleep fragmentations will be continuously monitored for 24 hours using polysomnography and actigraphy. Behavioural assessments (nursing observations) and patients' self-reports of sleep quality will be assessed during the 24-hour period using the Richards-Campbell Sleep Questionnaire, subjective sleepiness evaluated via the Karolinska Sleepiness Scale, along with a prehospital discharge survey regarding patients' perception of sleep quality and disturbing factors using the Little Sleep Questionnaire will be undertaken. Associations between sleep disturbance, noise and light levels, and the frequency of clinical interactions will also be investigated. Sound and luminance levels will be recorded at 1 s epochs via Extech SDL600 and SDL400 monitoring devices. Clinical interactions will be logged via the electronic patient record system Metavision which documents patient monitoring and clinical care., Ethics and Dissemination: The relevant institutions have approved the study protocol and consent procedures. The findings of the study will contribute to the understanding of sleep disturbance, and the ability to implement sleep monitoring methods within ICUs. Understanding the contribution of a clinical environment on sleep disturbance may provide insight into the need to address clinical environmental issues that may positively influence patient outcomes, and could dispel notions that the environment is a primary factor in sleep disturbance. The research findings will be disseminated via presentations at national and international conferences, proceedings and published articles in peer-reviewed journals., Trial Registration Number: ACTRN12615000945527; Pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: The intensive care unit (ICU) environment exposes patients to noise levels that may result in substantial sleep disruption. There is a need to accurately describe the intensity pattern and source of noise in the ICU in order to develop effective sound abatement strategies. The objectives of this study were to determine nocturnal noise levels and their variability and the related sources of noise within an Australian tertiary ICU., Methods: An observational cross-sectional study was conducted in a 24-bed open-plan ICU. Sound levels were recorded overnight during three nights at 5-s epochs using Extech (SDL 600) sound monitors. Noise sources were concurrently logged by two research assistants., Results: The mean recorded ambient noise level in the ICU was 52.85 decibels (dB) (standard deviation (SD) 5.89), with a maximum noise recording at 98.3 dB (A). All recorded measurements exceeded the WHO recommendations. Noise variability per minute ranged from 9.9 to 44 dB (A), with peak noise levels >70 dB (A) occurring 10 times/hour (SD 11.4). Staff were identified as the most common source accounting for 35% of all noise. Mean noise levels in single-patient rooms compared with open-bed areas were 53.5 vs 53 dB ( p  = 0.37), respectively., Conclusion: Mean noise levels exceeded those recommended by the WHO resulting in an acoustical intensity of 193 times greater than the recommended and demonstrated a high degree of unpredictable variability, with the primary noise sources coming from staff conversations. The lack of protective effects of single rooms and the contributing effects that staffs have on noise levels are important factors when considering sound abatement strategies.

Sleep disturbance is commonly encountered amongst intensive care patients and has significant psychophysiological effects, which protract recovery and increases mortality. Bio-physiological monitoring of intensive care patients reveal alterations in sleep architecture, with reduced sleep quality and continuity. The etiological causes of sleep disturbance are considered to be multifactorial, although environmental stressors namely, noise, light and clinical care interactions have been frequently cited in both subjective and objective studies. As a result, interventions are targeted towards modifiable factors to ameliorate their impact. This paper reviews normal sleep physiology and the impact that sleep disturbance has on patient psychophysiological recovery, and the contribution that the clinical environment has on intensive care patients' sleep.

CDC is investigating reports of potential occupational exposure to human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Mycobacterium tuberculosis among workers performing preparation and dissection procedures on human nontransplant anatomical materials at a nontransplant anatomical donation center in Arizona. CDC is working with Arizona public health officials to inform persons exposed to these potentially infected materials. Nontransplant anatomical centers around the United States process thousands of donated cadavers annually. These materials (which might be fresh, frozen, or chemically preserved) are used by universities and surgical instrument and pharmaceutical companies for medical education and research. The American Association of Tissue Banks has developed accreditation policies for nontransplant anatomical donation organizations. It also has written standards that specify exclusion criteria for donor material, as well as use of proper environmental controls and safe work practices to prevent transmission of infectious agents during receipt and handling of nontransplant anatomical materials. At the center under investigation, which is now closed, these standards might not have been consistently implemented.

Nursing education is undergoing radical change worldwide. There is criticism surrounding the content of education and the delivery. As a result, traditional methods of teaching and learning have been replaced by strategies that place greater emphasis on active learner interaction, critical thinking, and decision-making. Assisting pre-registration nurses to become competent and confident in clinical practice requires immersion in practice with sufficient support and coaching based on real life scenarios. Simulation via an unfolding case study approach is one way to provide interactive learning experiences where students acquire new skills that advance their clinical judgment with the aim of becoming safe, competent practitioners. Lessons learned from implementing an unfolding case study are discussed in this paper., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Objective: To evaluate both the cholinesterase monitoring program and newer field methods of determining coumaphos exposure among tick eradication workers., Methods: Measured blood cholinesterase by the Ellman and field testing methods and tested urine for chlorferon pre- and postshift; conducted personal air sampling, patch sampling of clothing, and wipe sampling of hands for coumaphos., Results: Fifteen workers had normal plasma cholinesterase and acetylcholinesterase levels. No significant changes occurred pre- to postshift. High correlation was found between plasma cholinesterase and acetylcholinesterase levels by field testing and Ellman methods (r = 0.91, P < 0.01 and r = 0.63, P < 0.01, respectively). Chlorferon levels rose 4 to 6 hours after use (P < 0.01). Airborne coumaphos was detected in only one sample, in a trace amount. The majority of patch and hand wipe samples detected coumaphos., Conclusions: Dermal exposure to coumaphos resulted in significant increases in urinary metabolites of coumaphos.

Emerging zoonotic diseases are of increasing regional and global importance. Preventing occupational exposure to zoonotic diseases protects workers as well as their families, communities, and the public health. Workers can be protected from zoonotic diseases most effectively by preventing and controlling diseases in animals, reducing workplace exposures, and educating workers. Certain avian influenza viruses are potential zoonotic disease agents that may be transmitted from infected birds to humans. Poultry workers are at risk of becoming infected with these viruses if they are exposed to infected birds or virus-contaminated materials or environments. Critical components of worker protection include educating employers and training poultry workers about occupational exposure to avian influenza viruses. Other recommendations for protecting poultry workers include the use of good hygiene and work practices, personal protective clothing and equipment, vaccination for seasonal influenza viruses, antiviral medication, and medical surveillance. Current recommendations for protecting poultry workers from exposure to avian influenza viruses are summarized in this article.

A negative pressure user seal check (NPUSC) method was evaluated for its ability to adequately detect known exhalation valve leakage into a respirator. Three valves with different types of damage were included. Twenty-six test subjects, wearing full facepiece respirators, were asked to perform a NPUSC. Their responses as to whether they passed or failed the user seal check were compared to fit testing results from two quantitative fit test methods: ambient aerosol and controlled negative pressure. In addition, equipment developed at the University of Cincinnati was used to measure in-mask pressures that are generated during the performance of NPUSCs. This technique was employed to assess the ability of respirator wearers to properly conduct user seal checks. The data were analyzed to determine if the user seal check procedure is an effective method for detecting known exhalation valve damage. All test subjects reported passing the user seal check with the undamaged valve. With the warped valve installed, 95 percent of test subjects reported passing the user seal check. With the slit valve installed, 73 percent of test subjects reported passing. With the dirty valve installed, 65 percent reported passing. All fit factors, measured with the damaged valves, were below the Occupational Safety and Health Administration-recognized pass/fail criteria except one fit test with the respirator equipped with the slit valve. Results from the in-mask pressure measurements confirmed whether or not the subject properly conducted a user seal check, but did not detect respirator leakage. In conclusion, the performance of a NPUSC rarely helped to identify damaged exhalation valves. These results support the need for respirator inspection prior to donning with periodic fit testing and the performance of user seal checks as necessary components of an adequate respiratory protection program.

Monoclonal antibody (MAb) B72.3 reacts with a tumor-associated glycoprotein, designated TAG-72. TAG-72 has been identified in many human carcinomas but generally is not found in normal human tissues. Because of its proven utility in the diagnosis of human carcinomas, MAb B72.3 was applied to several different types of canine carcinomas. Five types of formalin-fixed, paraffin-embedded canine carcinomas were evaluated for immunoreactivity with MAb B72.3 by use of an avidin biotin immunoperoxidase complex method. Samples were considered positive when > or = 5% of all malignant cells contained a distinct intracellular stain. Immunoreactivity for MAb B72.3 was observed in 6/9 (67%) pulmonary adenocarcinomas, 7/13 (54%) transitional cell carcinomas, 7/11 (64%) mammary adenocarcinomas, 7/11 (64%) nasal adenocarcinomas, and 1/2 (50%) prostatic adenocarcinomas. The average cellular staining for positive carcinomas was 25%. Normal canine tissues from similar anatomic sites had little or no individual cell immunoreactivity. These preliminary results indicate that some canine carcinomas may express a tumor-associated antigen that is similar to TAG-72 and that MAb B72.3 immunoreactivity may be of diagnostic significance in classifying animal tumors.