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Refugee and migrant populations have increased vulnerability to antimicrobial resistance, yet stewardship guidance is lacking. We addressed this gap through a cross-sectional survey, finding that these populations and immigrants from low and middle-income countries had lower health literacy on the issue compared to native-born Americans and those from high-income countries.
Background: Antimicrobial resistance (AMR) is a global health threat, particularly in refugee populations, due to challenges posed by migration. Little guidance has been provided by public health agencies regarding antimicrobial stewardship specific to this demographic. Studies have primarily focused on encampment areas abroad. We sought to better understand health literacy and beliefs regarding AMR in local refugee and immigrant populations in southeastern Michigan. Methods: From November 1, 2022 to March 10, 2023, we distributed an anonymous questionnaire to adult patients at four primary care clinics in Southeastern Michigan and made it available online. The questionnaire collected demographic information and used 5-point Likert scale responses regarding antibiotic use in children with symptoms of respiratory infection. We binarized the questions and responses to determine whether respondents provided the preferred response and added these to create an overall health literacy score, then used simple linear and multivariable linear regression modeling to identify demographic variables independently associated with the health literacy score. Chi-squared and Mann-Whitney tests were also performed where appropriate. Results: Immigrants and refugees/asylum-seekers from low or middle-income countries (group A, n = 109) were compared to native-born Americans and immigrants from high-income countries (group B, n = 171) with participants from 40 countries (Figure 1). Age distribution did not differ between groups, while group B had generally longer duration of living in the United States (Figure 2). Differences were found in other demographic categories except female gender, with group B reporting higher income, educational levels, and English ability (Figure 3). Simple linear regression revealed that all demographic variables except age significantly correlated with responses (Figure 4). Multivariable linear regression showed that female gender, educational level, and age correlated with greater health literacy, while being in group A trended towards significance with respect to correlating with lesser health literacy (Figure 5). Conclusions: Immigrants and refugees/asylum-seekers from LMICs demonstrated beliefs suggesting deficits in knowledge of AMR compared to native-born Americans and those from high-income countries, independent of other potentially confounding demographic characteristics. Female gender, educational level, and age independently correlated with greater health literacy. These results could inform future patient-centered antimicrobial stewardship educational interventions in certain target populations such as immigrants and refugees/asylum-seekers in the United States.
The coronavirus disease 2019 (COVID-19) pandemic highlighted the lack of agreement regarding the definition of aerosol-generating procedures and potential risk to healthcare personnel. We convened a group of Massachusetts healthcare epidemiologists to develop consensus through expert opinion in an area where broader guidance was lacking at the time.
This chapter examines the FDA’s role in regulating ART devices. The FDA’s statutorily defined purview to regulate devices includes [things] “used in” or “intended to affect…man or other animals.” This chapter considers the FDA’s jurisdiction over devices that affect or diagnose pre-embryos, embryos, or fetuses that are not generally considered people or animals under US law. It discusses the legal and ethical implications of the FDA’s claim over ART devices without changing or clarifying its regulatory charge to include such organisms and whether or not the FDA has overstepped its power by regulating these instruments as devices. It also reviews the FDA’s existing classification of devices involved in ART (Class II). In light of the catastrophic and painful consequences that can follow malfunction of these devices (such as cryobanks thawing or embryo swapping) and that anecdotal accounts suggest such malfunctions are happening more frequently, this chapter questions if ART devices should be reclassified or if an alternative regulatory mechanism could more effectively protect consumers in the ART industry.
Antimicrobial resistance is a well-known global health threat that has higher prevalence in the refugee population. Although guidance has been provided by the World Health Organization and Centers for Disease Control and Prevention on implementing antimicrobial stewardship in lower- and middle-income countries, as well as by the United Nations Refugee Agency on other infection prevention and control efforts, no specific guidance exists for implementation of stewardship in this population. We highlight challenges specific to this population, review recent studies of interest within this space, and propose a research agenda to help move stewardship forward in the refugee population. We advocate for the importance of this issue, particularly given recent current events of geopolitical volatility that render this population more vulnerable, in the setting of its already well-known numerous health challenges.
To assess preventability of hospital-onset bacteremia and fungemia (HOB), we developed and evaluated a structured rating guide accounting for intrinsic patient and extrinsic healthcare-related risks.
HOB preventability rating guide was compared against a reference standard expert panel.
A 10-member panel of clinical experts was assembled as the standard of preventability assessment, and 2 physician reviewers applied the rating guide for comparison.
The expert panel independently rated 82 hypothetical HOB scenarios using a 6-point Likert scale collapsed into 3 categories: preventable, uncertain, or not preventable. Consensus was defined as concurrence on the same category among ≥70% experts. Scenarios without consensus were deliberated and followed by a second round of rating.
Two reviewers independently applied the rating guide to adjudicate the same 82 scenarios in 2 rounds, with interim revisions. Interrater reliability was evaluated using the κ (kappa) statistic.
Expert panel consensus criteria were met for 52 scenarios (63%) after 2 rounds.
After 2 rounds, guide-based rating matched expert panel consensus in 40 of 52 (77%) and 39 of 52 (75%) cases for reviewers 1 and 2, respectively. Agreement rates between the 2 reviewers were 84% overall (κ, 0.76; 95% confidence interval [CI], 0.64–0.88]) and 87% (κ, 0.79; 95% CI, 0.65–0.94) for the 52 scenarios with expert consensus.
Preventability ratings of HOB scenarios by 2 reviewers using a rating guide matched expert consensus in most cases with moderately high interreviewer reliability. Although diversity of expert opinions and uncertainty of preventability merit further exploration, this is a step toward standardized assessment of HOB preventability.
Background: The COVID-19 pandemic has created personal protective equipment (PPE) shortages, particularly of N95 respirators. Institutions have used decontamination strategies including vaporous hydrogen peroxide (VHP) to augment respirator supplies. VHP can be used to decontaminate nonporous surfaces without compromising material integrity. However, little is known about its impact on N95 respirator efficacy. We assessed whether repeated VHP reprocessing altered 4 key respirator efficacy qualities: quantitative fit, qualitative fit, seal check, and filtration rate. Methods: We conducted a prospective cohort study from June 15 to August 31, 2020. In total, 7 participants were fitted to a 3M 1860 small or regular N95 respirator based on qualitative and quantitative fit testing. Respirators underwent 25 disinfection cycles with the Bioquell BQ-50 VHP generator. After each cycle, participants donned and doffed respirators and performed a seal check. Participants were given 2 attempts to pass their seal check. Every 10 cycles, qualitative fit testing was done using an aerosolized Bitrex solution. Quantitative fit testing was conducted using a PortaCount Pro 8038 Fit Tester to generate a fit factor score. Appropriate fit is defined as a fit factor score of 100 or greater. Quantitative testing was done at cycles 1, 3, 5, 7, 10, 15, 20, and 25. Filtration efficiencies of particles ≥0.3 µm in diameter were measured using the TSI Optical Particle Sizer 3330 at cycles 1, 5, 10, 15, 20, and 25. The Fisher exact test was used to assess qualitative fit and seal check. The Kruskal-Wallis test was used to analyze quantitative fit and filtration rate. Results: We observed no seal-check or quantitative-fit test failures during the study window. All participants passed qualitative fit testing. Although there was a significant degree of variability in fit factor scores across disinfection cycles (mean score 163.5, p <0.05), there was no significant difference between participants (p = 0.6) (Figure 1). There was no statistically significant change in mean filtration rate from cycle 10 to 25 (P = .05), and the filtration rate remained >95% by cycle 25 (Figure 2). Conclusions: VHP reprocessing did not diminish the efficacy of N95 respirators based on the 4 metrics we assessed: filtration rate, seal check, qualitative fit, and quantitative fit. Of significance, the filtration rate remained well above the 95% standard filtration for N95 respirators—even through 25 cycles of reprocessing. VHP reprocessing is a safe, viable strategy to disinfect N95 respirators and extend their use, particularly during supply shortages.
Background: In the spring of 2020, we identified 3 patients with organ-space surgical site infections (SSIs) secondary to Mycobacterium abscessus (Table 1). All 3 patients underwent cardiac surgery in the same operating room (OR) during which the CardioQuip Modular Cooler-Heaters (MCHs) were used. We describe key aspects of our cluster investigation, which ultimately led to release of a national safety alert by the Food and Drug Administration (FDA). Methods: For environmental cultures, we obtained samples from 9 MCHs in circulation; 2 scrub sink samples; ice from the OR ice machine; water samples from sinks in the cardiovascular critical care unit, and water samples from floors above the cardiac ORs. All samples were sent for molecular genotyping. For pathway studies, an external environmental engineering team was consulted who conducted smoke pathway tests in 3 different ORs. The team also conducted a particle generator experiment, simulating the set-up of a cardiac bypass surgery case. To assess disinfection practices, we reviewed the manufacturer instructions for use (IFU) protocol of the MCHs and audited our own policies and procedures to ensure compliance. Results: For environmental cultures, molecular typing from 5 of 9 MCHs and all 3 patient SSI isolates returned positive for the identical hybrid species M. abscessus bolleti. All other samples with mycobacterial growth returned with different species. For pathway studies, the particle-generator experiment demonstrated particle movement from the MCH to the sterile field with facilities-guidelines–compliant OR ventilation and despite MCH manufacturing design. For disinfection practices, despite compliance with the stated IFU, and in consultation with experts, we implemented disinfection of associated Quick-connect devices (otherwise not stated in the IFU), and we also initiated a precleaning step prior to disinfection. Conclusions: Our investigation concluded that 3 patients developed SSIs with Mycobacterium abscessus that was aerosolized from the CardioQuip MCH. This finding led to the national FDA safety report alerting providers to risks associated with the device and the need for continued vigilance around disinfection. In addition, we implemented other control measures including placement of MCHs outside all ORs; creation of a separate MCH fleet for non-OR use; and use of modified disinfection protocols. To date, no additional cases have been identified.
Background: Hospital-onset bacteremia and fungemia (HOB) may be a preventable hospital-acquired condition and a potential healthcare quality measure. We developed and evaluated a tool to assess the preventability of HOB and compared it to a more traditional consensus panel approach. Methods: A 10-member healthcare epidemiology expert panel independently rated the preventability of 82 hypothetical HOB case scenarios using a 6-point Likert scale (range, 1= “Definitively or Almost Certainly Preventable” to 6= “Definitely or Almost Certainly Not Preventable”). Ratings on the 6-point scale were collapsed into 3 categories: Preventable (1–2), Uncertain (3–4), or Not preventable (5–6). Consensus was defined as concurrence on the same category among ≥70% expert raters. Cases without consensus were deliberated via teleconference, web-based discussion, and a second round of rating. The proportion meeting consensus, overall and by predefined HOB source attribution, was calculated. A structured HOB preventability rating tool was developed to explicitly account for patient intrinsic and extrinsic healthcare-related risks (Fig. 1). Two additional physician reviewers independently applied this tool to adjudicate the same 82 case scenarios. The tool was iteratively revised based on reviewer feedback followed by repeat independent tool-based adjudication. Interrater reliability was evaluated using the Kappa statistic. Proportion of cases where tool-based preventability category matched expert consensus was calculated. Results: After expert panel round 1, consensus criteria were met for 29 cases (35%), which increased to 52 (63%) after round 2. Expert consensus was achieved more frequently for respiratory or surgical site infections than urinary tract and central-line–associated bloodstream infections (Fig. 2a). Most likely to be rated preventable were vascular catheter infections (64%) and contaminants (100%). For tool-based adjudication, following 2 rounds of rating with interim tool revisions, agreement between the 2 reviewers was 84% for cases overall (κ, 0.76; 95% CI, 0.64–0.88]), and 87% for the 52 cases with expert consensus (κ, 0.79; 95% CI, 0.65–0.94). Among cases with expert consensus, tool-based rating matched expert consensus in 40 of 52 (77%) and 39 of 52 (75%) cases for reviewer 1 and reviewer 2, respectively. The proportion of cases rated “uncertain“ was lower among tool-based adjudicated cases with reviewer agreement (15 of 69) than among cases with expert consensus (23 of 52) (Fig. 2b). Conclusions: Healthcare epidemiology experts hold varying perspectives on HOB preventability. Structured tool-based preventability rating had high interreviewer reliability, matched expert consensus in most cases, and rated fewer cases with uncertain preventability compared to expert consensus. This tool is a step toward standardized assessment of preventability in future HOB evaluations.
Background: Resin-containing blood culture bottles (RBB) are used to increase the isolation of microorganisms by binding antimicrobials in sampled blood. Since RBB implementation in April 2018, our infection preventionists noted an increase in positive blood cultures on routine surveillance. Objective: To describe the change in bacterial isolation post-RBB implementation. Methods: All positive blood culture sets drawn in adult inpatient units or the emergency room between October 2017 and September 2018 and their associated organisms were obtained from the hospital laboratory database. Then, regardless of central-line placement or “present on admission” designation, the 2019 NHSN surveillance definitions for laboratory-confirmed bloodstream infection (LCBI-1 and LCBI-2) were applied to categorize all positive cultures as “common commensals” (CCs) or pathogens. A univariate analysis was performed using the Mantel-Haenszel χ2 test (OpenEpi version 3.01). Results: Although the number of monthly blood cultures drawn remained effectively stable before and after implementation (pre-RBB median, 3,512.5; post-RBB median, 3,626), the rate ratio of positive cultures increased by 1.36 times: pre-RBB median, 127 sets per month and post-RBB median, 172.5 sets per month (χ2 = 5.785; P = .008). The rate ratio of pathogen-containing cultures increased by 1.40 times (pre-RBB median, 98 sets per month and post-RBB median, 137.5 sets per month; χ² = 5.615; P = .009) with only a 1.24 increase in CCs (pre-RBB median, 29 and post-RBB median, 36; χ² = 0.553; P = .229) (Fig. 1). Conclusions: After RBB implementation, the monthly incidence rate of pathogen-containing sets increased. Additionally, the increase in these sets as well as of overall positive blood cultures was statistically significant. Current literature on RBBs does not suggest preferential increased isolation of pathogens. Further study is needed to determine whether our findings are related to blood-culturing practices or the RBBs themselves.
The attributable cost of Clostridium difficile infection (CDI) in children is unknown. We sought to determine a national estimate of attributable cost and length of stay (LOS) of CDI occurring during hospitalization in children.
DESIGN AND METHODS
We analyzed discharge records of patients between 2 and 18 years of age from the Agency for Healthcare Research and Quality (AHRQ) Kids’ Inpatient Database. We created a logistic regression model to predict CDI during hospitalization based on demographic and clinical characteristics. Predicted probabilities from the logistic regression model were then used as propensity scores to match 1:2 CDI to non-CDI cases. Charges were converted to costs and compared between patients with CDI and propensity-score–matched controls. In a sensitivity analysis, we adjusted for LOS as a confounder by including it in both the propensity score and a generalized linear model predicting cost.
We identified 8,527 pediatric hospitalizations (0.53%) with a diagnosis of CDI and 1,597,513 discharges without CDI. In our matched cohorts, the attributable cost of CDI occurring during a hospitalization ranged from $1,917 to $8,317, depending on whether model was adjusted for LOS. When not adjusting for LOS, CDI-associated hospitalizations cost 1.6 times more than non-CDI associated hospitalizations. Attributable LOS of CDI was approximately 4 days.
Clostridium difficile infection in hospitalized children is associated with an economic burden similar to adult estimates. This finding supports a continued focus on preventing CDI in children as a priority. Pediatric CDI cost analyses should account for LOS as an important confounder of cost.
Infection prevention in electrophysiology (EP) laboratories is poorly characterized; thus, we conducted a cross-sectional survey using the SHEA Research Network. We found limited uptake of basic interventions, such as surveillance and appropriate peri-procedural antimicrobial use. Further study is needed to identify ways to improve infection prevention in this setting.
To determine whether use of contact precautions on hospital ward patients is associated with patient adverse events
Individually matched prospective cohort study
The University of Maryland Medical Center, a tertiary care hospital in Baltimore, Maryland
A total of 296 medical or surgical inpatients admitted to non–intensive care unit hospital wards were enrolled at admission from January to November 2010. Patients on contact precautions were individually matched by hospital unit after an initial 3-day length of stay to patients not on contact precautions. Adverse events were detected by physician chart review and categorized as noninfectious, preventable and severe noninfectious, and infectious adverse events during the patient’s stay using the standardized Institute for Healthcare Improvement’s Global Trigger Tool.
The cohort of 148 patients on contact precautions at admission was matched with a cohort of 148 patients not on contact precautions. Of the total 296 subjects, 104 (35.1%) experienced at least 1 adverse event during their hospital stay. Contact precautions were associated with fewer noninfectious adverse events (rate ratio [RtR], 0.70; 95% confidence interval [CI], 0.51–0.95; P=.02) and although not statistically significant, with fewer severe adverse events (RtR, 0.69; 95% CI, 0.46–1.03; P=.07). Preventable adverse events did not significantly differ between patients on contact precautions and patients not on contact precautions (RtR, 0.85; 95% CI, 0.59–1.24; P=.41).
Hospital ward patients on contact precautions were less likely to experience noninfectious adverse events during their hospital stay than patients not on contact precautions.
Infect. Control Hosp. Epidemiol. 2015;36(11):1268–1274
Contact precautions decrease healthcare worker-patient contact and may impact patient satisfaction. To determine the association between contact precautions and patient satisfaction, we used a standardized interview for perceived issues with care.
Prospective cohort study of inpatients, evaluated at admission and on hospital days 3, 7, and 14 (until discharged). At each point, patients underwent a standardized interview to identify perceived problems with care. After discharge, the standardized interview and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey were administered by telephone. Responses were recorded, transcribed, and coded by 2 physician reviewers.
A total of 528 medical or surgical patients not admitted to the intensive care unit.
A total of 528 patients were included in the primary analysis, of whom 104 (20%) perceived some issue with their care. On multivariable logistic regression, contact precautions were independently associated with a greater number of perceived concerns with care (odds ratio, 2.05 [95% confidence interval, 1.31–3.21]; P<.01), including poor coordination of care (P = .02) and a lack of respect for patient needs and preferences (P = .001). Eighty-eight patients were included in the secondary analysis of HCAHPS. Patients under contact precautions did not have different HCAHPS scores than those not under contact precautions (odds ratio, 1.79 [95% confidence interval, 0.64–5.00]; P = .27).
Patients under contact precautions were more likely to perceive problems with their care, especially poor coordination of care and a lack of respect for patient preferences.
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