Prospective Surveillance Research Articles

Viable mpox virus in the environment of a patient room

We conducted a prospective environmental surveillance study to investigate the air, surface, dust, and water contamination of a room occupied by a patient infected with mpox virus (MPXV) at various stages of the illness. The patient tested positive for MPXV from a throat swab and skin lesions. Environmental sampling was conducted in a negative pressure room with 12 unidirectional high efficiency particulate air filter (HEPA) air changes per hour and daily cleaning of the surfaces. A total of 179 environmental samples were collected on days 7, 8, 13, and 21 of illness. Among the days of sampling, air, surface, and dust contamination showed the highest contamination rates on day 7 and 8 of illness, with a gradual decline to the lowest contamination level by day 21. Viable MPXV was isolated from surfaces and dust samples and no viable virus was isolated from the air and water samples.

Clinical characteristics and outcomes of children with single or co-detected rhinovirus-associated acute respiratory infection in Middle Tennessee

BackgroundRhinovirus (RV) is one of the most common etiologic agents of acute respiratory infection (ARI), which is a leading cause of morbidity and mortality in young children. The clinical significance of RV co-detection with other respiratory viruses, including respiratory syncytial virus (RSV), remains unclear. We aimed to compare the clinical characteristics and outcomes of children with ARI-associated RV-only detection and those with RV co-detection—with an emphasis on RV/RSV co-detection.MethodsWe conducted a prospective viral surveillance study (11/2015–7/2016) in Nashville, Tennessee. Children < 18 years old who presented to the emergency department (ED) or were hospitalized with fever and/or respiratory symptoms of < 14 days duration were eligible if they resided in one of nine counties in Middle Tennessee. Demographics and clinical characteristics were collected by parental interviews and medical chart abstractions. Nasal and/or throat specimens were collected and tested for RV, RSV, metapneumovirus, adenovirus, parainfluenza 1–4, and influenza A–C using reverse transcription quantitative polymerase chain reaction assays. We compared the clinical characteristics and outcomes of children with RV-only detection and those with RV co-detection using Pearson’s χ2 test for categorical variables and the two-sample t-test with unequal variances for continuous variables.ResultsOf 1250 children, 904 (72.3%) were virus-positive. RV was the most common virus (n = 406; 44.9%), followed by RSV (n = 207; 19.3%). Of 406 children with RV, 289 (71.2%) had RV-only detection, and 117 (28.8%) had RV co-detection. The most common virus co-detected with RV was RSV (n = 43; 36.8%). Children with RV co-detection were less likely than those with RV-only detection to be diagnosed with asthma or reactive airway disease both in the ED and in-hospital. We did not identify differences in hospitalization, intensive care unit admission, supplemental oxygen use, or length of stay between children with RV-only detection and those with RV co-detection.ConclusionWe found no evidence that RV co-detection was associated with poorer outcomes. However, the clinical significance of RV co-detection is heterogeneous and varies by virus pair and age group. Future studies of RV co-detection should incorporate analyses of RV/non-RV pairs and include age as a key covariate of RV contribution to clinical manifestations and infection outcomes.

Real-world data on the incidence and risk of Guillain–Barré syndrome following SARS-CoV-2 vaccination: a prospective surveillance study

Increasing evidence suggests an association between SARS-CoV-2 vaccines and Guillain–Barré syndrome (GBS). Nevertheless, little is understood about the contributing risk factors and clinical characteristics of GBS post SARS-CoV-2 vaccination. In this prospective surveillance study of 38,828,691 SARS-CoV-2 vaccine doses administered from February 2021 to March 2022 in the Gyeonggi Province, South Korea, 55 cases of GBS were reported post vaccination. We estimated the incidence rate of GBS per million doses and the incidence rate ratio for the vaccine dose, mechanism, age, and sex. Additionally, we compared the clinical characteristics of GBS following mRNA-based and viral vector-based vaccinations. The overall incidence of GBS following SARS-CoV-2 vaccination was 1.42 per million doses. Viral vector-based vaccines were associated with a higher risk of GBS. Men were more likely to develop GBS than women. The third dose of vaccine was associated with a lower risk of developing GBS. Classic sensorimotor and pure motor subtypes were the predominant clinical subtypes, and demyelinating type was the predominant electrodiagnostic subtype. The initial dose of viral-vector based vaccine and later doses of mRNA-based vaccine were associated with GBS, respectively. GBS following SARS-CoV-2 vaccination may not be clinically distinct. However, physicians should pay close attention to the classic presentation of GBS in men receiving an initial dose of viral vector-based SARS-CoV-2 vaccines.

Antimicrobial Activity of Gepotidacin Tested against Escherichia coli and Staphylococcus saprophyticus Isolates Causing Urinary Tract Infections in Medical Centers Worldwide (2019 to 2020).

The in vitro activities of gepotidacin and comparator agents against 3,560 Escherichia coli and 344 Staphylococcus saprophyticus collected from female (81.1%) and male (18.9%) patients with urinary tract infections (UTIs) in a global prospective surveillance program in 2019 to 2020 were determined. Isolates collected from 92 medical centers in 25 countries, including the United States, Europe, Latin America, and Japan, were tested for susceptibility by reference methods in a central monitoring laboratory. Gepotidacin inhibited 98.0% (3,488/3,560 isolates) of E. coli and 100% (344/344 isolates) of S. saprophyticus at gepotidacin concentrations of ≤4 μg/mL and ≤0.25 μg/mL, respectively. This activity was largely unaffected with isolates that demonstrated resistance phenotypes to other oral standard-of-care antibiotics, including amoxicillin-clavulanic acid, cephalosporins, fluoroquinolones, fosfomycin, nitrofurantoin, and trimethoprim-sulfamethoxazole. Gepotidacin also inhibited 94.3% (581/616 isolates) of E. coli isolates with an extended-spectrum β-lactamase-producing phenotype, 97.2% (1,085/1,129 isolates) of E. coli isolates resistant to ciprofloxacin, 96.1% (874/899) of E. coli isolates resistant to trimethoprim-sulfamethoxazole, and 96.3% (235/244 isolates) of multidrug-resistant E. coli isolates at gepotidacin concentrations of ≤4 μg/mL. In summary, gepotidacin demonstrated potent activity against a large collection of contemporary UTI E. coli and S. saprophyticus strains collected from patients worldwide. These data support the further clinical development of gepotidacin as a potential treatment option for patients with uncomplicated UTIs.

Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study.

Concerns have been raised about the long-term performance of aortic stent grafts for the treatment of abdominal aortic aneurysms, in particular, unibody stent grafts (eg, Endologix AFX AAA stent grafts). Only limited data sets are available to evaluate the long-term risks related to these devices. The SAFE-AAA Study (Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries Study) was designed with the Food and Drug Administration to provide a longitudinal assessment of the safety of unibody aortic stent grafts among Medicare beneficiaries. The SAFE-AAA Study was a prespecified, retrospective cohort study evaluating whether unibody aortic stent grafts are noninferior to non-unibody aortic stent grafts with respect to the composite primary outcome of aortic reintervention, rupture, and mortality. Procedures were evaluated from August 1, 2011, through December 31, 2017. The primary end point was evaluated through December 31, 2019. Inverse probability weighting was used to account for imbalances in observed characteristics. Sensitivity analyses were used to evaluate the effect of unmeasured confounding, including assessment of the falsification end points heart failure, stroke, and pneumonia. A prespecified subgroup included patients treated from February 22, 2016, through December 31, 2017, corresponding to the market release of the most contemporary unibody aortic stent grafts (Endologix AFX2 AAA stent graft). Of 87 163 patients who underwent aortic stent grafting at 2146 US hospitals, 11 903 (13.7%) received a unibody device. The average age of the total cohort was 77.0±6.7 years, 21.1% were female, 93.5% were White, 90.8% had hypertension, and 35.8% used tobacco. The primary end point occurred in 73.4% of unibody device-treated patients versus 65.0% of non-unibody device-treated patients (hazard ratio, 1.19 [95% CI, 1.15-1.22]; noninferior P value of 1.00; median follow-up, 3.4 years). Falsification end points were negligibly different between groups. In the subgroup treated with contemporary unibody aortic stent grafts, the cumulative incidence of the primary end point occurred in 37.5% of unibody device-treated patients and 32.7% of non-unibody device-treated patients (hazard ratio, 1.06 [95% CI, 0.98-1.14]). In the SAFE-AAA Study, unibody aortic stent grafts failed to meet noninferiority compared with non-unibody aortic stent grafts with respect to aortic reintervention, rupture, and mortality. These data support the urgency of instituting a prospective longitudinal surveillance program for monitoring safety events related to aortic stent grafts.

Abstract P5-08-15: Reducing Rates of Chronic Breast Cancer Related Lymphedema with Screening &amp; Early Intervention: An Update of Recent Data

Abstract Background: Breast cancer related lymphedema (BCRL) represents a dreaded complication of breast cancer treatment that can lead to morbidity, diminished quality of life, and psychosocial harm and is associated with increased costs. Increasingly, data has supported the concept of prospective BCRL surveillance coupled with early intervention to mitigate these effects. Methods: We performed a systematic review of the literature searching for published randomized and prospective data evaluating prospective BCRL surveillance with early intervention. Results: We identified 12 studies (2,907 patients) including 4 randomized trials (1,203 patients) and 8 prospective studies (1,704 patients). Randomized data consistently demonstrate that early intervention reduces rates of progression to chronic BCRL with multiple paradigms and diagnostic modalities utilized; the strongest data in the review comes from the randomized PREVENT trial which demonstrated early detection with bioimpedance spectroscopy (BIS), coupled with a compression garment applied for 12 hours a day over 4 weeks, significantly reduced the rate of chronic BCRL compared to tape measurement. Conclusions: Current data support the role of prospective BCRL surveillance with early detection and intervention to reduce rates of chronic BCRL. Breast cancer patients at risk for BCRL should undergo prospective surveillance as part of survivorship. Given the level 1 data demonstrating that BIS is superior to conventional tape measure, it should be included as the standard BCRL diagnostic modality unless an equally effective modality is employed. Citation Format: Pat Whitworth, Frank Vicini, Stephanie Valente, Kirstyn Brownson, Beth Dupree, Manpreet Kohli, Laura Lawson, Chirag Shah. Reducing Rates of Chronic Breast Cancer Related Lymphedema with Screening &amp; Early Intervention: An Update of Recent Data [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-08-15.

Bloodstream Infections with Opportunistic Pathogens in COVID-19 Era: A Real Challenge Necessitates Stringent Infection Control.

Background : Bloodstream infections (BSI) due to opportunistic microbes in the coronavirus disease 2019 (COVID-19) pandemic lead to high morbidity and mortality among hospitalized patients. Thus, it is vital to find out the risk factors of BSI and to learn the ways to mitigate it. Aim : The aim of this study was to evaluate important risk factors of BSI due to opportunistic pathogens and to assess the role of the rigid infection control program to deal with this issue. Methods : A prospective, cross-sectional study was performed for 6 months on 150 patients admitted in both COVID-19 and non-COVID-19 intensive care units of our hospital. BSI was confirmed by the BACTEC and Vitek 2 compact system. Prospective surveillance and environmental sampling were carried out for source tracking along with rigorous infection control measures and the outcome was analyzed. Findings : Burkholderia cepacia, Elizabethkingia meningoseptica, Candida auris, vancomycin-resistant Enterococcus , and Achromobacter xylosoxidans were the common opportunistic pathogens isolated from a single or paired blood sample(s) in our study. Key risk factors were prolonged intensive care unit stay, central venous access, mechanical ventilation, immune-compromised condition, and use of biologics. Reverse osmosis water and used normal saline bottles were the common environmental source of infection. Following the implementation of precise infection control measures, there was a sharp decline in BSI cases, which was not attributed to the downfall of COVID-19 cases. Conclusion : Combined prospective surveillance and environmental sampling helped to find out the sources and implementation of an intensive and insistent infection control program that are needed to control opportunistic pathogens mediated BSI.

Abstract PD5-03: PD5-03 Comparison of a personalized sequencing assay and digital PCR for circulating tumor DNA based Molecular Residual Disease detection in early-stage triple negative breast cancer in the cTRAK-TN trial

Abstract Background: Detection of circulating tumour DNA (ctDNA) in patients (pts) who have completed treatment for early-stage breast cancer is associated with a high risk of future relapse. Identifying those at high risk of subsequent relapse may allow tailoring of further therapy to delay or prevent recurrence. Previous analysis of this cohort showed that tools capable of detecting ctDNA at lower concentrations are needed to increase sensitivity and lengthen the lead time between ctDNA detection and relapse. We compared ctDNA detection via a personalised sequencing assay to dPCR in patients from the cTRAK TN clinical trial. Methods: The cTRAK-TN trial recruited 161 pts into prospective ctDNA surveillance with dPCR, with ctDNA positive pts randomised to 1) CT staging plus pembrolizumab therapy for patients without relapse or 2) observation. Pts had serial post-treatment surveillance plasma samples collected every 3 months for up to 2 years. Whole exome sequencing (WES) was performed on tumor DNA from FFPE samples to design personalised Residual Disease and Recurrence (RaDaR®) multiplex PCR based NGS assays. Retrospectively, plasma DNA extracted from a minimum of 2mls banked plasma, was sequenced with personalised RaDaR assays, and ctDNA detection identified with a proprietary algorithm. dPCR assays tracked 1-2 mutations, as previously described. Primary endpoint was rate of positive ctDNA detection by 12 months from start of surveillance in both assays. Secondary endpoints were agreement in ctDNA detection between RaDaR and dPCR assays and lead-time between ctDNA detection and disease recurrence. Results: Overall, 147 pts and 241 tissue samples were subject to WES, and RaDaR assays were developed for 142 pts with sufficient plasma for testing. RaDaR assays tracked a median of 47 variants (range 33-56) per patient, and a total of 907 timepoints were analysed (median 6 timepoints per pt, range 1-11). With RaDaR, 39.4% (56/142) patients tested ctDNA positive during follow-up, with a median ctDNA detected level of 0.081% estimated variant allele fraction (eVAF). With dPCR, 35.2% (50/142) pts tested ctDNA positive. The ctDNA detection rate by 12 months from the start of ctDNA surveillance was 36.2% (95% CI; 27.6% – 43.7%) with RaDaR and 29.9% (95%CI; 21.6% – 37.3%) with dPCR. The overall test agreement between RaDaR and dPCR assays was 92.7% (95%CI; 90.7% – 94.4%). From a patient perspective, 58.7% pts were ctDNA negative for both assays, 32.9% ctDNA were positive for both assays and 8.6% presented discrepancies. ctDNA was detected by RaDaR but not by dPCR in 9 pts and it was detected by dPCR but not by RaDaR in 3 pts. Among ctDNA positive pts, 55.2% were first detected positive by RaDaR, 5.2% by dPCR, and 39.6% were detected at the same time-point (test of proportions, p&amp;lt; 0.001). The median lead time from ctDNA detection to relapse was 7.1 months (95% CI 5.9 – 15.9%) with RaDaR and 5.7 months (95% CI 3.2% – 7.4%) with dPCR. Conclusion: The RaDaR personalised multi-mutation sequencing assay detected MRD with a longer median lead time prior to relapse, and with higher sensitivity, than dPCR mutation tracking assays. These findings have implications for the choice of ctDNA assay in clinical trials designed to treat patients at the point of MRD detection. Citation Format: Maria Coakley, Prithika Sritharan, Guillermo Villacampa, Claire Swift, Kathryn Dunne, Lucy Kilburn, Katie Goddard, Patricia Rojas, Andy Joad, Warren Emmett, Charlene Knape, Karen Howarth, Peter S. Hall, Catherine Harper-Wynne, Tamas Hickish, Iain Macpherson, Alicia F. Okines, Andrew M. Wardley, Duncan Wheatley, Simon Waters, Rosalind Cutts, Isaac Garcia-Murillas, Judith Bliss, Nicholas Turner. PD5-03 Comparison of a personalized sequencing assay and digital PCR for circulating tumor DNA based Molecular Residual Disease detection in early-stage triple negative breast cancer in the cTRAK-TN trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD5-03.

Abstract P1-05-16: Bioimpedance Spectroscopy Monitoring Reduces Long-term Clinical Lymphedema Risk

Abstract Background: A prospective surveillance model (PSM) of care can reduce the risk of breast cancer related lymphedema (BCRL). Bioimpedance spectroscopy (BIS) devices can identify sub-clinical BCRL (sBCRL). A recent randomized controlled trial (RCT) demonstrated the benefit of a PSM model of care using BIS over tape measure (TM) but it did not look at the long-term risk following intervention. This work reports the actuarial risk of clinical lymphedema for those who have triggered an intervention for sBCRL by either BIS or TM. Materials and Methods: 879 women with breast cancer were randomized to lymphedema screening with either BIS (n=442) or TM (n=437). Following consent, patients underwent baseline pre-surgical measurements with BIS (L-Dex U400, ImpediMed) and volume (circumference) measurements (Gulick II tape) and randomized after surgery. Both the TM and BIS arms underwent planned post-operative assessments at 3, 6, 12, 18, 24, 30, and 36 months as well at the end of any intervention. Patients with a BIS change from baseline of ≥ 6.5 L-Dex units or TM volume change ≥ 5 and &amp;lt; 10% above pre-surgical baselines "triggered" for sBCRL form the basis of this study. Triggered patients underwent 4-weeks of wearing a class two (23–32 mmHg) compression sleeve and gauntlet for 12 hours per day. TM volume change ≥ 10% was considered clinical BCRL (cBCRL) for all patients who triggered by either BIS or TM. The cumulative incidence of cBCRL was calculated via the Kaplan-Meier method and compared by the Log-rank test. Results: 209 (23.8%) women triggered an intervention and completed treatment for sBCRL (BIS: 89 (20.1%), TM: 120 (27.5%)). The median follow up for the women who triggered was 32.2 months (IQR 17.0 – 33.9) with 30 women (14.4%) women developing cBCRL (BIS: 7 (7.9%), TM: 23 (19.2%)). There was a significant difference in risk between the groups over the follow up interval (log rank test p = 0.021) with the cumulative risk in the BIS group being lower compared to the TM group (Hazard Ratio = 0.38, 95%CI 0.19 – 0.79). The 2- year actuarial risk of cBCRL for triggered patients undergoing lymphedema screening by BIS was 5.0% versus 15.7% for TM screening (p = 0.021, HR = 0.30). The corresponding 3-year rates of cBCRL were 10.3% and 21.2%, (p = 0.031, HR = 0.40) respectively. Conclusions: BIS monitoring for sBCRL with subsequent intervention provides significantly lower risks of cBCRL. The lower triggering rates with BIS highlight its better discrimination of true sBCRL compared to TM and support its use for post-treatment surveillance to detect sBCRL and initiate early intervention. These data suggest that monitoring for sBCRL with BIS and subsequent intervention does not just delay the inevitable progression to cBCRL, but rather prevents it over the duration of the study. Citation Format: John Boyages, Frank Vicini, Chirag Shah. Bioimpedance Spectroscopy Monitoring Reduces Long-term Clinical Lymphedema Risk [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-05-16.

Epidemiology of hospitalisations due to chickenpox and quality of life lost in community and hospital settings: protocol for a prospective cohort study across two countries

IntroductionWhile still a ubiquitous disease of childhood, chickenpox has been effectively controlled in many countries through the use of vaccination. Previous health economic assessment of the use of these vaccines...

HeartFailure Burden by Autopsy, Guideline-Directed Medical Therapy, and ICD Utilization Among Sudden Deaths.

Studies of heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) report high sudden cardiac death (SCD) rates but presume cardiac cause. Underlying causes, guideline-directed medical therapy (GDMT), and implantable cardioverter-defibrillator (ICD) use in community sudden deaths with heart failure (HF) are unknown. This study aims to assess the burden of HF, GDMT, and ICD use among autopsied sudden deaths in the POST SCD (Postmortem Systematic Investigation of Sudden Cardiac Death) study, a countywide postmortem study of all presumed SCDs. Incident WHO-defined (presumed) SCDs for individuals of ages 18 to 90 years were autopsied via prospective surveillance of consecutive out-of-hospital deaths in San Francisco County from February 1, 2011, to March 1, 2014. Sudden arrhythmic deaths (SADs) had no identifiable nonarrhythmic cause (eg, pulmonary embolism), and are thus considered potentially rescuable with ICD. Of 525 presumed SCDs, 100 (19%) had HF. There were 85 patients with known HF (31 HFpEF, 54 HFrEF) and 15 with subclinical HF (postmortem evidence of cardiomyopathy and pulmonary edema without HF diagnosis). SADs comprised 56% (293 of 525) of all presumed SCDs, and 69% (69 of 100) of HF SCDs. The rates were similar in HFrEF (40 of 54 [74%]) and HFpEF (19 of 31 [61%], P=0.45). Four SAD patients (4%) had ICDs, 3 of which experienced device failure. Twenty-eight SCDs had ejection fraction≤35%: 22 (79%) with arrhythmic and 6 (21%) with noncardiac causes. Of the 22 SAD patients, 8 (36%) had no identifiable barrier to ICD referral. Complete use of GDMT in HFrEF was 6%. One in 5 community sudden deaths had HF; two-thirds had autopsy-confirmed arrhythmic causes. ICD prevention criteria captured only 8% (22 of 293) of all SAD cases countywide; GDMT and ICD use remain important targets for HF sudden death prevention.

Esophageal Surveillance Practices in Esophageal Atresia Patients: A Survey by the Eastern Pediatric Surgery Network

IntroductionEndoscopic surveillance guidelines for patients with repaired esophageal atresia (EA) rely primarily on expert opinion. Prior to embarking on a prospective EA surveillance registry, we sought to understand EA surveillance practices within the Eastern Pediatric Surgery Network (EPSN). MethodsAn anonymous, 23-question Qualtrics survey was emailed to 181 physicians (surgeons and gastroenterologists) at 19 member institutions. Likert scale questions gauged agreement with international EA surveillance guideline-derived statements. Multiple-choice questions assessed individual and institutional practices. ResultsThe response rate was 77%. Most respondents (80%) strongly agree or agree that EA surveillance endoscopy should follow a set schedule, while only 36% claimed to perform routine upper GI endoscopy regardless of symptoms. Many institutions (77%) have an aerodigestive clinic, even if some lack a multi-disciplinary EA team. Most physicians (72%) expressed strong interest in helping develop evidence-based guidelines. ConclusionsOur survey reveals physician agreement with current guidelines but weak adherence. Surveillance methods vary greatly, underscoring the lack of evidence-based data to guide EA care. Aerodigestive clinics may help implement surveillance schedules. Respondents support evidence-based protocols, which bodes well for care standardization. Results will inform the first multi-institutional EA databases in the United States (US), which will be essential for evidence-based care. Level of EvidenceThis is a prognosis study with level 4 evidence.

Acceptability, Feasibility, and Validity of Detecting Respiratory Pathogens During Acute Respiratory Illness in Participant-Collected Swabs in a Low-Income, Community Sample.

Community surveillance for acute respiratory illness (ARI) can include unsupervised participant-collected nasal swabs. Little is known about use of self-swabs in low-income populations or among households including extended family members and the validity of self-collected swabs. We assessed the acceptability, feasibility, and validity of unsupervised participant-collected nasal swabs in a low-income, community sample. This was a substudy of a larger prospective community-based ARI surveillance study in 405 households in New York City. Participating household members self-collected swabs on the day of a research home visit for an index case, and for 3-6 subsequent days. Demographics associated with agreement to participate and swab collection were assessed, and index case self-collected versus research staff-collected swab results were compared. Most households (n = 292 [89.6%]) agreed to participate, including 1310 members. Being <18 years old, female, and the household reporter or member of the nuclear family (parents and children) were associated with both agreement to participate and self-swab collection. Being born in the United States or immigrating ≥10 years ago was associated with participation, and being Spanish-speaking and having less than a high school education were associated with swab collection. In all, 84.4% collected at least 1 self-swabbed specimen; self-swabbing rates were highest during the first 4 collection days. Concordance between research staff-collected swabs and self-swabs was 88.4% for negative swabs, 75.0% for influenza, and 69.4% for noninfluenza pathogens. Self-swabbing was acceptable, feasible, and valid in this low-income, minoritized population. Some differences in participation and swab collection were identified that could be noted by future researchers and modelers.

A Surveillance Study of the Serotypes of Streptococci in the Throat and Skin Lesions in Acute Rheumatic Fever and Rheumatic Heart Disease Patients and their Families

Abstract Objectives: The objectives of this study were to determine the colonization of the throat and skin among patients of rheumatic heart disease (RHD) or acute rheumatic fever (ARF) and to elucidate the different Lancefield serotypes of streptococci (Group A, Group C, and Group G) among them. Methods: The prospective observational surveillance study was conducted from November 2016 to March 2018 among 161 enrolled family members belonging to 30 families with one of their patients being diagnosed with RHD/ARF. The outcome measures were period prevalence of serotypes of streptococci, streptococcal colonization of throat and skin lesions, and association of age and antibody titers with RHD/ARF. Results: Out of 30 families enrolled in our study, positive throat (n = 18)/skin (n = 1) cultures were found in 7 families (n = 19). The cultures were positive only for Group A streptococci (GAS), while none of the samples showed positivity for Group C or G serotypes. Overall period prevalence for our study period was 3.2%. Among the 18 members positive for GAS throat culture, 13 (72.2%) belonged to the age group &lt;15 years (P &lt; 0.025). The positive cultures in the throat sample were more in the ARF families than RHD families (P &lt; 0.001). There was no association of culture positivity with antibody titer (P &gt; 0.05). Conclusion: In conclusion, we found only GAS colonization in significantly higher proportion among the family members of cases of ARF in comparison to RHD. Rather there was no case of Group C and G streptococci colonization in cases or family members of RHD/ARF.

Circulation of Rhinoviruses and/or Enteroviruses in Pediatric Patients With Acute Respiratory Illness Before and During the COVID-19 Pandemic in the US

Rhinoviruses and/or enteroviruses, which continued to circulate during the COVID-19 pandemic, are commonly detected in pediatric patients with acute respiratory illness (ARI). Yet detailed characterization of rhinovirus and/or enterovirus detection over time is limited, especially by age group and health care setting. To quantify and characterize rhinovirus and/or enterovirus detection before and during the COVID-19 pandemic among children and adolescents seeking medical care for ARI at emergency departments (EDs) or hospitals. This cross-sectional study used data from the New Vaccine Surveillance Network (NVSN), a multicenter, active, prospective surveillance platform, for pediatric patients who sought medical care for fever and/or respiratory symptoms at 7 EDs or hospitals within NVSN across the US between December 2016 and February 2021. Persons younger than 18 years were enrolled in NVSN, and respiratory specimens were collected and tested for multiple viruses. Proportion of patients in whom rhinovirus and/or enterovirus, or another virus, was detected by calendar month and by prepandemic (December 1, 2016, to March 11, 2020) or pandemic (March 12, 2020, to February 28, 2021) periods. Month-specific adjusted odds ratios (aORs) for rhinovirus and/or enterovirus-positive test results (among all tested) by setting (ED or inpatient) and age group (<2, 2-4, or 5-17 years) were calculated, comparing each month during the pandemic to equivalent months of previous years. Of the 38 198 children and adolescents who were enrolled and tested, 11 303 (29.6%; mean [SD] age, 2.8 [3.7] years; 6733 boys [59.6%]) had rhinovirus and/or enterovirus-positive test results. In prepandemic and pandemic periods, rhinoviruses and/or enteroviruses were detected in 29.4% (9795 of 33 317) and 30.9% (1508 of 4881) of all patients who were enrolled and tested and in 42.2% (9795 of 23 236) and 73.0% (1508 of 2066) of those with test positivity for any virus, respectively. Rhinoviruses and/or enteroviruses were the most frequently detected viruses in both periods and all age groups in the ED and inpatient setting. From April to September 2020 (pandemic period), rhinoviruses and/or enteroviruses were detectable at similar or lower odds than in prepandemic years, with aORs ranging from 0.08 (95% CI, 0.04-0.19) to 0.76 (95% CI, 0.55-1.05) in the ED and 0.04 (95% CI, 0.01-0.11) to 0.71 (95% CI, 0.47-1.07) in the inpatient setting. However, unlike some other viruses, rhinoviruses and/or enteroviruses soon returned to prepandemic levels and from October 2020 to February 2021 were detected at similar or higher odds than in prepandemic months in both settings, with aORs ranging from 1.47 (95% CI, 1.12-1.93) to 3.01 (95% CI, 2.30-3.94) in the ED and 1.36 (95% CI, 1.03-1.79) to 2.44 (95% CI, 1.78-3.34) in the inpatient setting, and in all age groups. Compared with prepandemic years, during the pandemic, rhinoviruses and/or enteroviruses were detected in patients who were slightly older, although most (74.5% [1124 of 1508]) were younger than 5 years. Results of this study show that rhinoviruses and/or enteroviruses persisted and were the most common respiratory virus group detected across all pediatric age groups and in both ED and inpatient settings. Rhinoviruses and/or enteroviruses remain a leading factor in ARI health care burden, and active ARI surveillance in children and adolescents remains critical for defining the health care burden of respiratory viruses.

SG-APSIC1035: Prospective safety surveillance study of ACAM2000 smallpox vaccine in deployed military personnel

Objectives: We compared rates of myopericarditis adverse events and evaluated potential risk factors of development. We compared rates of dermatological–neurological adverse events (severe and serious) with other adverse events in a specific population of deployed US military personnel who received or did not receive ACAM2000 vaccine (ie, Vaccinia smallpox live vaccine). Methods: Up to 20,000 military personnel recipients were enrolled in a prospective observational cohort study: up to 15,000 ACAM2000 recipients in cohort 1 and up to 5,000 military personnel who were eligible for ACAM2000 vaccination but were not vaccinated due to recent vaccination or characteristics of their contacts in cohort 2. Enrollment was at a 3:1 ratio, respectively. Serum specimens and data were collected at the initial visit and 10 days later (cf, window of 6–17 days). Study participants with evidence, either clinical or laboratory, of possible myopericarditis were referred to a blinded independent review committee for further evaluation and adjudication. The primary analysis was logistic regression with adjudicated myopericarditis as the dependent variable and age, sex, race, and exercise regimen as the independent variables. Results: Initial data and serum specimens were obtained from 14,667 participants (cohort 1, N = 10,825; cohort 2, N = 3,842). According to protocol, 2 visits were completed by 12,110 participants (cohort 1, N = 8,945; cohort 2, N = 3,165), and 125 participants (cohort 1, N = 111; cohort 2, N = 14) were referred for myopericarditis adjudication, of whom 1 had confirmed myocarditis, 5 had suspected myocarditis, 1 had suspected pericarditis, and 54 (cohort 1, N = 44; cohort 2, N = 10) had subclinical myopericarditis. The unadjusted myopericarditis rates were 5.7 per 1,000 (95% CI, 4.3–7.5) for cohort 1 and 3.2 per 1,000 (95% CI, 1.7–5.8) for cohort 2. The unadjusted and adjusted odds ratios for myopericarditis for cohort 1 and cohort 2 were 1.8 (95% CI, 0.9–3.6) and 1.3 (95% CI, 0.6–2.6), respectively. At least 1 serious adverse event was experienced by 117 participants (1.1%) in cohort 1 and 13 (0.3%) in cohort 2. No serious and severe neurological or dermatological adverse events were reported. Conclusions: ACAM2000 vaccination was associated with a modest but nonsignificant increase in the risk of myopericarditis in this prudently screened, young and healthy service-member population. The adjusted OR was 1.3 and the unadjusted OR was 1.8. Overall, all but 7 cases were subclinical. Citation: Faix DJ, Gordon DM, Perry LN, et al. Prospective safety surveillance study of ACAM2000 smallpox vaccine in deploying military personnel. Vaccine 2020;38:7323–7330.

SG-APSIC1129: Long-term effect of a bundled care program in reducing central-line–associated bloodstream infections

Objectives: Central-line–associated bloodstream infection (CLABSI) has been the leading cause of healthcare-associated infections (HAIs) in the intensive care unit (ICU) setting. Previous studies have shown that a care bundle is effective in reducing CLABSI rates; however, the data on long-term sustainability and cost savings of bundled care are limited. Methods: From January 2011 to December 2020, a prospective surveillance was performed to monitor CLABSI at a university hospital in northern Taiwan. To reduce the CLABSI rate, a hospital-wide bundled care program for CLABSI prevention was implemented in 2013. We evaluated the long-term effect of the care bundle on CLABSI incidence and length of stay in the ICU. Results: During the study period, the overall CLABSI incidence decreased from 8.22 per 1,000 catheter days before the care bundle was implemented to 6.33 per 1,000 catheter days in 2020 (P for trend &lt;.01). The most common pathogens causing CLABSI were gut organisms (1,420 of 2,363, 60.1%), followed by environmental organisms (734 of 2,363, 31.1%) and skin organisms (177 of 2,363, 7.5%). The decreasing trend was statistically significant in the incidence of CLABSI caused by skin organisms (P for trend &lt; .01), but not in the incidence of CLABSI caused by environmental organisms (P for trend = .86) or gut organisms (P for trend = .06). In the multivariable analysis, implementation of this care bundle was independently associated with a decrease in the CLABSI rate (RR, 0.77; 95% CI, 0.66–0.88). Compared with patients without CLABSI, patients with CLABSI had a longer average ICU length of stay (27 vs 17 days). Conclusions: A sustainable reduction in the incidence of CLABSI caused by common commensals could be achieved through a cost-saving bundled care program.

Video-Assisted Laryngoscopy for Pediatric Tracheal Intubation in the Emergency Department: AMulticenter Study of Clinical Outcomes.

To explore the association between video-assisted laryngoscopy (use of a videolaryngoscope regardless of where laryngoscopists direct their gaze), first-attempt success, and adverse airway outcomes. We conducted an observational study using data from 2 airway consortiums that perform prospective surveillance: the National Emergency Airway Registry for Children (NEAR4KIDS) and a pediatric emergency medicine airway education collaborative. Data collected included patient and procedural characteristics and procedural outcomes. We performed multivariable analyses of the association of video-assisted laryngoscopy with individual patient outcomes and evaluated the association between site-level video-assisted laryngoscopy use and tracheal intubation outcomes. The study cohort included 1,412 tracheal intubation encounters performed from January 2017 to March 2021 across 11 participating sites. Overall, the first-attempt success was 70.0%. Video-assisted laryngoscopy was associated with increased odds of first-attempt success (odds ratio [OR] 2.01; 95% confidence interval [CI], 1.48 to 2.73) and decreased odds of severe adverse airway outcomes (OR 0.70; 95% CI, 0.58 to 0.85) including decreased severe hypoxia (OR 0.69; 95% CI, 0.55 to 0.87). Sites varied substantially in the use of video-assisted laryngoscopy (range from 12.9% to 97.8%), and sites with high use of video-assisted laryngoscopy (> 80%) experienced increased first-attempt success even after adjusting for individual patient laryngoscope use (OR 2.30; 95% CI, 1.79 to 2.95). Video-assisted laryngoscopy is associated with increased first-attempt success and fewer adverse airway outcomes for patients intubated in the pediatric emergency department. There is wide variability in the use of video-assisted laryngoscopy, and the high use is associated with increased odds of first-attempt success.

Breast Cancer–Related Lymphedema: the Prospective Surveillance Model, Early Intervention Strategies, and Role of Complete Decongestive Therapy

Breast Cancer–Related Lymphedema: the Prospective Surveillance Model, Early Intervention Strategies, and Role of Complete Decongestive Therapy

Current Diagnostic Tools for Breast Cancer-Related Lymphedema.

Breast cancer-related lymphedema (BCRL) can have a significant impact on breast cancer survivors quality of life. The purpose of this review is to evaluate diagnostic tools for the assessment of BCRL. Multiple BCRL diagnostic tools are available, though older diagnostic tools have low sensitivity, limiting the ability for sub-clinical BCRL diagnosis while BIS and perometry have increased sensitivity and theability to diagnose BCRL sub-clinically. Prospective studies have demonstrated such an approach coupled to early intervention is associated with low rates of chronic BCRLwhile a recently published randomized trial demonstrated that prospective surveillance with BIS coupled with early intervention reduced rates of chronic BCRL as compared to circumference measurements with compression garments. Prospective and randomized data support the use of prospective surveillance for BCRL. The strongest data available comes from the PREVENT trial and supports prospective BCRL surveillance with bioimpedance spectroscopy coupled to early intervention with a compression sleeve.