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Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic medical centers (AMCs) are likely to encounter EA requests, but it is unknown what support is available at these institutions for physicians seeking EA for patients. Methods: A landscape assessment was conducted at AMCs, focused on those within the Clinical and Translational Science Awards (CTSA) consortium. Results: Forty-seven responses were evaluated including 42 CTSA hubs. The large majority (43 of 47 respondents) reported using single-patient EA, while 37 reported multi-patient industry sponsored EA and 37 reported multi-patient investigator-initiated EA. Only half reported central tracking of EA requests. Support was available at 89% of sites for single-patient EA but less often for multi-patient EA. Types of support varied and were focused largely on the initial submission to the FDA. Conclusion: Use of and support for EA is widespread at AMCs, with support focused on single-patient requests. Gaps in support are common for activities after initial submission, such as FDA reporting and data collection.
To determine whether discontinuing active screening for vancomycin-resistant Enterococcus (VRE) in Alberta, Canada, acute-care facilities had an associated impact on the rate of rise of hospital-acquired (HA) VRE bloodstream infection (VRE-BSI).
Acute-care facilities in Alberta, Canada.
All patients who were admitted to Alberta Health Services or Covenant Health acute-care facilities between January 1, 2013, and March 31, 2020, and who met the definition for hospital-acquired VRE-BSI were included in the analyses.
An intervention time-series Poisson regression was used to determine the slope change in VRE incidence between the pre- and postintervention (screening) periods. The patient population was separated into 3 cohorts: group 1 (low risk, VRE screening stopped), group 2 (high risk, VRE screening stopped), and group 3 (high risk, VRE screening continued). For all groups, a level- and slope-change model was used.
We did not find a statistically significant difference in the slope change or rate of rise in VRE-BSI before and after the intervention, with incidence rate ratio (IRRs) of 1.015 (95% confidence interval [CI], 0.982–1.049), 1.025 (95% CI, 0.967–1.086), and 0.989 (95% CI, 0.924–1.059) for groups 1, 2 and 3, respectively.
In Alberta, the rate of HA VRE-BSI has remained consistent, and our findings indicate that there has been no increase in the rate of rise of HA VRE-BSI in sites or units that discontinued screening for VRE, regardless of patient risk group.
Asymptomatic coronavirus disease 2019 (COVID-19) has been reported as a significant driver of COVID-19 outbreaks. Our hospital ward outbreak analysis suggests that comprehensive symptoms and signs assessment, in combination with adequate follow-up, allows a more precise determination of COVID-19 symptoms. Asymptomatic infection was quite uncommon among adults in this setting.
The Canadian Nosocomial Infection Surveillance Program conducted point-prevalence surveys in acute-care hospitals in 2002, 2009, and 2017 to identify trends in antimicrobial use.
Eligible inpatients were identified from a 24-hour period in February of each survey year. Patients were eligible (1) if they were admitted for ≥48 hours or (2) if they had been admitted to the hospital within a month. Chart reviews were conducted. We calculated the prevalence of antimicrobial use as follows: patients receiving ≥1 antimicrobial during survey period per number of patients surveyed × 100%.
In each survey, 28−47 hospitals participated. In 2002, 2,460 (36.5%; 95% CI, 35.3%−37.6%) of 6,747 surveyed patients received ≥1 antimicrobial. In 2009, 3,566 (40.1%, 95% CI, 39.0%−41.1%) of 8,902 patients received ≥1 antimicrobial. In 2017, 3,936 (39.6%, 95% CI, 38.7%−40.6%) of 9,929 patients received ≥1 antimicrobial. Among patients who received ≥1 antimicrobial, penicillin use increased 36.8% between 2002 and 2017, and third-generation cephalosporin use increased from 13.9% to 18.1% (P < .0001). Between 2002 and 2017, fluoroquinolone use decreased from 25.7% to 16.3% (P < .0001) and clindamycin use decreased from 25.7% to 16.3% (P < .0001) among patients who received ≥1 antimicrobial. Aminoglycoside use decreased from 8.8% to 2.4% (P < .0001) and metronidazole use decreased from 18.1% to 9.4% (P < .0001). Carbapenem use increased from 3.9% in 2002 to 6.1% in 2009 (P < .0001) and increased by 4.8% between 2009 and 2017 (P = .60).
The prevalence of antimicrobial use increased between 2002 and 2009 and then stabilized between 2009 and 2017. These data provide important information for antimicrobial stewardship programs.
To understand how the different data collections methods of the Alberta Health Services Infection Prevention and Control Program (IPC) and the National Surgical Quality Improvement Program (NSQIP) are affecting reported rates of surgical site infections (SSIs) following total hip replacements (THRs) and total knee replacements (TKRs).
Retrospective cohort study.
Four hospitals in Alberta, Canada.
Those with THR or TKR surgeries between September 1, 2015, and March 31, 2018.
Demographic information, complex SSIs reported by IPC and NSQIP were compared and then IPC and NSQIP data were matched with percent agreement and Cohen’s κ calculated. Statistical analysis was performed for age, gender and complex SSIs. A P value <.05 was considered significant.
In total, 7,549 IPC and 2,037 NSQIP patients were compared. The complex SSI rate for NSQIP was higher compared to IPC (THR: 1.19 vs 0.68 [P = .147]; TKR: 0.92 vs 0.80 [P = .682]). After matching, 7 SSIs were identified by both IPC and NSQIP; 3 were identified only by IPC, and 12 were identified only by NSQIP (positive agreement, 0.48; negative agreement, 1.0; κ = 0.48).
Different approaches to monitor SSIs may lead to different results and trending patterns. NSQIP reports total SSI rates that are consistently higher than IPC. If systems are compared at any point in time, confidence on the data may be eroded. Stakeholders need to be aware of these variations and education provided to facilitate an understanding of differences and a consistent approach to SSI surveillance monitoring over time.
Adverse outcomes following Clostridioides difficile infection (CDI) are not often reported for long-term care facility (LTCF) residents. We focused on the adverse outcomes due to CDI identified in Alberta LTCFs.
All positive Clostridioides difficile stool specimens identified by laboratory-identified (LabID) event surveillance in Alberta from 2011 to 2018, along with Alberta Continuing Care Information System, were used to define CDI in Alberta LTCFs. CDI cases were classified as long-term care onset, hospital onset, and community onset. Laboratory records were linked to provincial databases to analyze acute-care admissions and mortality within 30-day post CDI. Age, sex, case classification, episode, and operator type, were investigated using logistic regression.
Overall, 902 CDI cases were identified in 762 LTCF residents. Of all CDI events, 860 (95.3%) were long-term care onset, 38 (4.2%) were hospital onset, and 4 (0.4%) were community onset. The CDI rate was 2.0 of 100,000 resident days. In total, 157 residents (20.6%) had 30-day all-cause mortality, 126 CDI cases (14.0%) had 30-day all-cause acute-care admissions. The 30-day all-cause mortality rate was significantly higher in residents aged >80 versus ≤80 years (24.9 vs 12.3 per 100 residents; P < .05). Residents aged >80 years, with hospital-onset CDI, and those staying in private or voluntary LTCFs were more likely to have 30-day all-cause acute-care admissions.
The prevalence of CDI adverse outcomes is in LTCFs was found to be high using LabID event surveillance. Annual review of CDI adverse outcomes using LabID event can minimize the burden of surveillance and standardize the process across all Alberta LTCFs.
Background: In Alberta, Canada, surgical site infections (SSIs) following total hip (THR) and knee replacements (TKR) are reported using 2 data sources: infection prevention and control (IPC), which surveys all THR and TKR using NHSN definitions and the Canadian International Classification of Disease, Tenth Revision (ICD-10-CA) codes, and the National Surgical Quality Improvement Program (NSQIP), which uses a systematic sampling process that involves an 8-day cycle schedule, modified NHSN definitions and current procedural terminology (CPT) codes. We compared the similarities and discrepancies in THR/TKR SSI reporting. Methods: A retrospective multisite cohort study of IPC and NSQIP THR/TKR SSI data at 4 hospitals was performed. SSI data were collected between September 1, 2015, and March 31, 2018. Demographic information and complex and total SSIs reported by IPC and NSQIP were compared for both THR and TKR surgeries. To determine whether both data sources reported similar trends over time, total SSIs by quarter were compared. Univariate analyses using a t test for age and the χ2 test for gender for complex SSIs and total SSIs was performed. The Pearson correlation and the Shapiro-Wilk test were used to assess the THR and TKR trends between the 2 data sources. A P value of <.05 was considered significant. Results: Following the removal of duplicates and missing data, 7,549 IPC and 2,037 NSQIP patients, respectively, were compared. Age, gender, and other demographic parameters were not significantly different. Total THR and TKR SSIs per 100 procedures using NSQIP data were significantly higher than the same rates using IPC data: THR, 2.25 versus 0.92 (P < .05) and TKR, 3.43 versus 1.26 (P < .05). Both IPC and NSQIP data indicated increasing total THR SSI rates over time, but with different magnitudes (r = 0.658). For total TKR SSI, the IPC rate decreased, whereas the NSQIP rate increased over the same period (r = 0.374). When superficial SSIs were excluded, the rates reported between IPC and NSQIP data by hospital and by procedure type were more comparable, with trends toward higher rates reported by NSQIP for THR than for TKR: THR, 1.19 versus 0.68 (P = 0.15) and TKR, 0.92 versus 0.80 (P = .68). Conclusions: Different approaches used to monitor SSIs following surgeries may lead to different results and trend patterns. NSQIP reports total SSI rates that are significantly higher than the IPC Alberta orthopedic population predominantly as a result of increased identification of superficial SSIs. Because the diagnosis of superficial SSIs may be less reliable, SSI reporting should focus on complex infections.
Background: This review describes the epidemiology of carbapenemase-producing organisms (CPO) in both the community and hospitalized populations in the province of Alberta. Methods: Newly identified CPO-positive individuals from April 1, 2013, to March 31, 2018, were retrospectively reviewed from 3 data sources, which shared a common provincial CPO case definition: (1) positive CPO results from the Provincial Laboratory for Public Health, which provides all referral and confirmatory CPO testing, (2) CPO cases reported to Alberta Health, and (3) CPO surveillance from Alberta Health Services Infection Prevention and Control (IPC). The 3 data sources were collated, and initial CPO cases were classified according to their likely location of acquisition: hospital-acquired, hospital-identified, on admission, and community-identified. Risk factors and adverse outcomes were obtained from linkage to administrative data. Results: In total, 171 unique individuals were newly identified with a first-time CPO case. Also, 15% (25 of 171) were hospital-acquired (HA), 21% (36 of 171) were hospital-identified (HI), 33% (57 of 171) were on admission, and 31% (53 of 171) were community identified. Overall, 9% (5 of 171) resided in long-term care facilities. Of all patients in acute-care facilities, 30% (35 of 118) had infections and 70% were colonized. Overall, 38% (65 of 171) had an acute-care admission in the 1 year prior to CPO identification; 59% (63 of 106) of those who did not have a previous admission had received healthcare outside Alberta. A large proportion of on-admission cases (81%, 46 of 57) and community-identified (66%, 33 of 53) cases did not have any acute-care admissions in Alberta in the previous year. Overall, 10% (14 of 171) had ICU admissions in Alberta within 30 days of CPO identification, and 5% (8 of 171) died within 30 days. The most common carbapenemase gene identified was NDM-1 (53%, 90 of 171). Conclusions: These findings highlight the robust nature of Alberta’s provincial CPO surveillance network. We reviewed 3 different databases (laboratory, health ministry, IPC) to obtain comprehensive data to better understand the epidemiology of CPO in both the community and hospital settings. More than half of the individuals with CPO were initially identified in the community or on admission. Most had received healthcare outside Alberta, and no acute-care admissions occurred in Alberta in the previous year. It is important to be aware of the growing reservoir of CPO outside the hospital setting because it could impact future screening and management practices.
Background: Bloodstream infections (BSIs) are an important cause of morbidity and mortality in severely ill patients, contributing to increased length of stay and a higher cost of care. Surveillance of hospital-acquired (HA) BSI is considered a measure of quality of care and has been performed provincially in Alberta since 2011. Prior to October 2015, a nonstandardized, risk-factor–based VRE screening process was used. Screening practices for antibiotic-resistant organisms (AROs) were aligned in October 2015 with a provincially standardized admission screening tool to allow for early initiation of contact precautions for patients colonized or infected with MRSA or VRE. In this data review, we sought to determine whether this admission screening change influenced ARO infections through review of HA-BSI rates. Methods: Prospectively, we reviewed reports of all patients admitted to Alberta Health Services/Covenant Health acute-care and acute-/tertiary-care rehabilitation facilities who met inclusion criteria: (1) positive blood culture identified with MRSA or VRE; (2) new episode for the patient; and (3) positive result occurred on or after calendar day 3 of admission. Data are presented as quarterly rates. Screening practices for MRSA and VRE were standardized provincially in October 2015 to include screening for MRSA on admission for patients who had an inpatient admission, received hemodialysis, or was an inmate in a correctional facility in the past 6 months. We also screened for VRE patients admitted to a solid-organ transplant unit or a hematology unit, regardless of risk factors. Results: We detected no changes in the quarterly rates of HA-BSI with MRSA or VRE after admission screening was standardized. Prior to standardized screening, MRSA BSI rates ranged from 0.12 to 0.25 per 10,000 patient days, with an overall rate of 0.18 per 10,000 patient days. After standardization, rates ranged from 0.09 to 0.30 per 10,000 patient days, with an overall rate of 0.17 per 10,000 patient days (P = .46). VRE BSI rates prior to standardization ranged from 0.03 to 0.13 per 10,000 patient days, with an overall rate of 0.08 per 10,000 patient days, which increased slightly to 0.09 per 10,000 patient days after standardized screening, ranging between 0.04 and 0.16 per 10,000 patient days (P = .61). Conclusions: Following the implementation of standardized admission screening and the early initiation of contact precautions, no significant changes were observed in rates of either HA-BSI with MRSA or VRE. Further investigation is required to identify the most effective strategies to reduce HA-BSIs caused by MRSA and VRE.
Background: Infection Prevention and Control (IPC) for Alberta Health Services and Covenant Health in the province of Alberta, Canada conducts surveillance for methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE) on all individuals admitted to acute-care and acute tertiary-care rehabilitation care facilities. Objective: The objective of this study was to determine the consistency and accuracy of infection decisions for MRSA and VRE. Methods: Surveillance cases of antibiotic-resistant organisms (AROs) collected using the provincial data entry surveillance platform between April 1, 2015, and March 31, 2017, across the province were reabstracted by infection control professionals and physicians using the NHSN infection definitions and compared to the original case severity decisions. Interrater agreement (Cohen’s ) and validity (sensitivity, specificity and predictive values) were calculated to compare the original and reabstracted infection decisions. Results: Collectively, 97% (87 of 90) of the IPC program staff and physicians who were initially invited re-abstracted 264 MRSA cases and 103 VRE cases within the review period. Provincially, 20% of the ARO cases reviewed (74 of 367) differed from the original infection decision. Among these 74 cases, 46 cases (34 MRSA and 12 VRE cases) changed from infection (original decision) to colonization (reabstracted decision) and 28 cases (21 MRSA and 7 VRE cases) changed from colonization to infection. The Cohen values for MRSA and VRE were 0.55 and 0.56, respectively, suggesting a moderate level of agreement for decisions made among IPC program staff. The sensitivity of the infection decision was higher with MRSA (86.5%) than for VRE (74.1%), meaning that there were more MRSA cases than VRE cases classified as infection in the original decision that remained infection following the review. Conclusions: Observed discordances on infection decisions were identified and may be attributed (1) to variations in the interpretation of the NHSN definitions, (2) to additional information that may have been available in the re-abstracted review compared to the original review, or (3) a difference in the information that was accessed to perform the original review compared to the reabstraction. This data-quality review provided an opportunity for IPC staff and physicians to become more familiar with infection definitions and such reviews will continue to be a regular process used to assess data quality within the IPC department.
Background: Antibiotic-resistant organisms (AROs) are associated with greater disease severity and poor outcomes. Previous studies have investigated AROs and healthcare-associated infections (HAIs) within larger urban acute-care settings, but similar data for rural settings are scarce. In this stud, we aimed to fill this gap. Methods: Data on antimicrobial resistance (AMR), additional precautions and HAI were collected from 8 rural Alberta acute-care facilities over a 24-hour period from February 4–28, 2019. Data were gathered as part of the national Canadian, Rural, and Northern Acute Care Point Prevalence (CNAPP) survey. All inpatients on included units were reviewed. CNAPP protocol surveillance definitions were used. Results: In total, 961 patients were surveyed, of whom 94 of 961 (9.8%) were on additional precautions. Contact precautions only were most common (54 of 94, 57.4%) and were predominantly in place for MRSA (30 of 94, 31.9%). Of 961 patients, 100 (~10%) met the surveillance definitions for any infection. The most common infections were skin and soft-tissue infections (29 of 100, 29.0%) and bloodstream infections (28 of 100, 28.0%). An HAI occurred in 30 of 961 patients (3.1%); the most common HAIs were surgical site infections (8 of 30, 26.7%) and urinary tract infections (8 of 30, 26.7%). An antimicrobial was prescribed to 333 of 961 patients (34.6%) at the time of the survey, with ceftriaxone the most commonly prescribed (68 of 333, 20.4%). Most patients receiving an antimicrobial (237 of 333, 71.2%) did not meet the surveillance definition for any infection. The most common reason for any antimicrobial administration was empiric therapy (167 of 333, 50.1%). Conclusions: Investigations into antimicrobial use and the burden of HAIs in rural acute-care settings have been limited. In this study, we (1) established provincial baseline data for burden of disease in these facilities due to HAIs and (2) demonstrated that antimicrobial use is common, though most patients who were prescribed an antimicrobial did not meet study definitions for infection. It will be important to continue this type of surveillance in this understudied population to monitor the burden of HAIs over time, to establish antimicrobial utilization trends, and to continue to identify potential antimicrobial stewardship initiatives.
Background: In Alberta, Canada, surgical site infections (SSIs) following total hip and knee replacements (THRs and TKRs) are reported using the infection prevention and control (IPC) surveillance system, which surveys all THRs and TKRs using the NHSN definitions; and the National Surgical Quality Improvement Program (NSQIP), which uses different definitions and sampling strategies. Deterministic matching of patient data from these sources was used to examine the overlap and discrepancies in SSI reporting. Methods: A retrospective multisite cohort study of IPC and NSQIP superficial, deep, and organ-space THR/TKR SSI data collected 30 days postoperatively from September 1, 2015, to March 31, 2018 was undertaken. To identify patients with procedures captured by both IPC and NSQIP, data were cleaned, duplicates removed, and patients matched 1:1 using year of birth, procedure facility, type, side, date, and time. Positive and negative agreement were assessed, and the Cohen κ values were calculated. The definitions and data capture methods used by both IPC and NSQIP were also compared. Results: There were 7,549 IPC and 2,037 NSQIP patients, respectively, with 1,798 matched patients: IPC (23.8%) and NSQIP (88.3%). Moreover, 17 SSIs were identified by both IPC and NSQIP, including 9 superficial and 8 complex by IPC and 6 superficial and 11 complex by NSQIP. Also, 7 SSIs were identified only by IPC, of which 5 were superficial, and 36 SSIs were identified only by NSQIP, of which 28 were superficial (positive agreement, 0.44; negative agreement, 0.99; κ = .43). Excluding superficial SSIs, 7 SSIs were identified by both IPC and NSQIP; 3 were identified only by IPC; and 12 were identified only by NSQIP (positive agreement, 0.48; negative agreement, 1.00; κ = 0.48). Conclusions: THR/TKR SSI rates reported by IPC and NSQIP were not comparable in this matched dataset. NSQIP identifies more superficial SSIs. Variations in data capture methods and definitions accounted for most of the discordance. Both surveillance systems are critically involved with improving patient outcomes following surgery. However, stakeholders need to be aware of these variations, and education should be provided to facilitate an understanding of the differences and their interpretation. Future work should explore other surgical procedures and larger data sets.
Decontamination of N95 respirators is being used by clinicians in the face of a global shortage of these devices. Some treatments for decontamination, such as some vaporized hydrogen peroxide methods or ultraviolet methods, had no impact on respiratory performance, while other treatments resulted in substantial damage to masks.
Faecal moisture content can determine whether faeces appear soft or firm, and faecal character can influence whether owners are satisfied with a dog food. In a previous study, dogs appeared to produce softer faeces after noon. The purpose of the present study was to determine whether time of defecation affected canine faecal water content. A total of eight hound dogs were fed one of four canned diets as a single meal each morning for 1 week per diet in a Latin square design. All four diets contained approximately 77 % moisture and, on a DM basis, 24 MJ/kg gross energy, 23 % crude protein, 32 % crude fat, 31 % N-free extract and 1 % crude fibre. The proportion of dietary protein from soya-derived texturised vegetable protein (TVP):beef was 0:100, 14:86, 29:71 and 57:43, respectively. Soya carbohydrate partially replaced maize starch as TVP increased. Faeces were collected by direct catch during the sixth morning and afternoon of each diet period. Mean faecal moisture content was greater in the afternoon than in the morning (79 v. 71 %; P = 0·01) and increased with dietary TVP (P ≤ 0·0001), and there was an interaction between time of day and percentage TVP (P = 0·003). Faecal moisture content differed from morning to afternoon only with TVP in the diet. Faecal wet weight was similar from morning to afternoon. This suggests that time of day and presence of TVP from soya should be taken into account when evaluating the effect of a diet on faecal form and moisture content in dogs fed once daily.