Validity of inpatient electronic health record-based measures of oxygen-related therapy in the United States: Lessons applicable for studying COVID-19 endpoints.

INTRODUCTION: During the COVID-19 pandemic, inpatient electronic health records (EHRs) have been used to conduct public health surveillance and assess treatments and outcomes. Invasive mechanical ventilation (MV) and supplemental oxygen (O2) use are markers of severe illness in hospitalized COVID-19 patients. In a large US system (n = 142 hospitals), we assessed documentation of MV and O2 use during COVID-19 hospitalization in administrative data versus nursing documentation. METHODS: We identified 319 553 adult hospitalizations with a COVID-19 diagnosis, February 2020-October 2022, and extracted coded, administrative data for MV or O2. Separately, we developed classification rules for MV or O2 supplementation from semi-structured nursing documentation. We assessed MV and O2 supplementation in administrative data versus nursing documentation and calculated ordinal endpoints of decreasing COVID-19 disease severity. Nursing documentation was considered the gold standard in sensitivity and positive predictive value (PPV) analyses. RESULTS: In nursing documentation, the prevalence of MV and O2 supplementation among COVID-19 hospitalizations was 14% and 75%, respectively. The sensitivity of administrative data was 83% for MV and 41% for O2, with both PPVs above 91%. Concordance between sources was 97% for MV (κ = 0.85), and 54% for O2 (κ = 0.21). For ordinal endpoints, administrative data accurately identified intensive care and MV but underestimated hospitalizations with O2 requirements (42% vs. 18%). CONCLUSIONS: In comparison to nursing documentation, administrative data under-ascertained O2 supplementation but accurately estimated severe endpoints such as MV. Nursing documentation improved ascertainment of O2 among COVID-19 hospitalizations and can capture oxygen requirements in adults hospitalized with COVID-19 or other respiratory illnesses.

Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.

Importance: Pneumonia is the most common infection requiring hospitalization and is a major reason for overuse of extended-spectrum antibiotics. Despite low risk of multidrug-resistant organism (MDRO) infection, clinical uncertainty often drives initial antibiotic selection. Strategies to limit empiric antibiotic overuse for patients with pneumonia are needed. Objective: To evaluate whether computerized provider order entry (CPOE) prompts providing patient- and pathogen-specific MDRO infection risk estimates could reduce empiric extended-spectrum antibiotics for non-critically ill patients admitted with pneumonia. Design, Setting, and Participants: Cluster-randomized trial in 59 US community hospitals comparing the effect of a CPOE stewardship bundle (education, feedback, and real-time MDRO risk-based CPOE prompts; n = 29 hospitals) vs routine stewardship (n = 30 hospitals) on antibiotic selection during the first 3 hospital days (empiric period) in non-critically ill adults (≥18 years) hospitalized with pneumonia. There was an 18-month baseline period from April 1, 2017, to September 30, 2018, and a 15-month intervention period from April 1, 2019, to June 30, 2020. Intervention: CPOE prompts recommending standard-spectrum antibiotics in patients ordered to receive extended-spectrum antibiotics during the empiric period who have low estimated absolute risk (<10%) of MDRO pneumonia, coupled with feedback and education. Main Outcomes and Measures: The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy. Secondary outcomes included empiric vancomycin and antipseudomonal days of therapy and safety outcomes included days to intensive care unit (ICU) transfer and hospital length of stay. Outcomes compared differences between baseline and intervention periods across strategies. Results: Among 59 hospitals with 96 451 (51 671 in the baseline period and 44 780 in the intervention period) adult patients admitted with pneumonia, the mean (SD) age of patients was 68.1 (17.0) years, 48.1% were men, and the median (IQR) Elixhauser comorbidity count was 4 (2-6). Compared with routine stewardship, the group using CPOE prompts had a 28.4% reduction in empiric extended-spectrum days of therapy (rate ratio, 0.72 [95% CI, 0.66-0.78]; P < .001). Safety outcomes of mean days to ICU transfer (6.5 vs 7.1 days) and hospital length of stay (6.8 vs 7.1 days) did not differ significantly between the routine and CPOE intervention groups. Conclusions and Relevance: Empiric extended-spectrum antibiotic use was significantly lower among adults admitted with pneumonia to non-ICU settings in hospitals using education, feedback, and CPOE prompts recommending standard-spectrum antibiotics for patients at low risk of MDRO infection, compared with routine stewardship practices. Hospital length of stay and days to ICU transfer were unchanged. Trial Registration: ClinicalTrials.gov Identifier: NCT03697070.

Stewardship Prompts to Improve Antibiotic Selection for Urinary Tract Infection: The INSPIRE Randomized Clinical Trial.

Importance: Urinary tract infection (UTI) is the second most common infection leading to hospitalization and is often associated with gram-negative multidrug-resistant organisms (MDROs). Clinicians overuse extended-spectrum antibiotics although most patients are at low risk for MDRO infection. Safe strategies to limit overuse of empiric antibiotics are needed. Objective: To evaluate whether computerized provider order entry (CPOE) prompts providing patient- and pathogen-specific MDRO risk estimates could reduce use of empiric extended-spectrum antibiotics for treatment of UTI. Design, Setting, and Participants: Cluster-randomized trial in 59 US community hospitals comparing the effect of a CPOE stewardship bundle (education, feedback, and real-time and risk-based CPOE prompts; 29 hospitals) vs routine stewardship (n = 30 hospitals) on antibiotic selection during the first 3 hospital days (empiric period) in noncritically ill adults (≥18 years) hospitalized with UTI with an 18-month baseline (April 1, 2017-September 30, 2018) and 15-month intervention period (April 1, 2019-June 30, 2020). Interventions: CPOE prompts recommending empiric standard-spectrum antibiotics in patients ordered to receive extended-spectrum antibiotics who have low estimated absolute risk (<10%) of MDRO UTI, coupled with feedback and education. Main Outcomes and Measures: The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy. Secondary outcomes included empiric vancomycin and antipseudomonal days of therapy. Safety outcomes included days to intensive care unit (ICU) transfer and hospital length of stay. Outcomes were assessed using generalized linear mixed-effect models to assess differences between the baseline and intervention periods. Results: Among 127 403 adult patients (71 991 baseline and 55 412 intervention period) admitted with UTI in 59 hospitals, the mean (SD) age was 69.4 (17.9) years, 30.5% were male, and the median Elixhauser Comorbidity Index count was 4 (IQR, 2-5). Compared with routine stewardship, the group using CPOE prompts had a 17.4% (95% CI, 11.2%-23.2%) reduction in empiric extended-spectrum days of therapy (rate ratio, 0.83 [95% CI, 0.77-0.89]; P < .001). The safety outcomes of mean days to ICU transfer (6.6 vs 7.0 days) and hospital length of stay (6.3 vs 6.5 days) did not differ significantly between the routine and intervention groups, respectively. Conclusions and Relevance: Compared with routine stewardship, CPOE prompts providing real-time recommendations for standard-spectrum antibiotics for patients with low MDRO risk coupled with feedback and education significantly reduced empiric extended-spectrum antibiotic use among noncritically ill adults admitted with UTI without changing hospital length of stay or days to ICU transfers. Trial Registration: ClinicalTrials.gov Identifier: NCT03697096.

Nasal Iodophor Antiseptic vs Nasal Mupirocin Antibiotic in the Setting of Chlorhexidine Bathing to Prevent Infections in Adult ICUs: A Randomized Clinical Trial.

Importance: Universal nasal mupirocin plus chlorhexidine gluconate (CHG) bathing in intensive care units (ICUs) prevents methicillin-resistant Staphylococcus aureus (MRSA) infections and all-cause bloodstream infections. Antibiotic resistance to mupirocin has raised questions about whether an antiseptic could be advantageous for ICU decolonization. Objective: To compare the effectiveness of iodophor vs mupirocin for universal ICU nasal decolonization in combination with CHG bathing. Design, Setting, and Participants: Two-group noninferiority, pragmatic, cluster-randomized trial conducted in US community hospitals, all of which used mupirocin-CHG for universal decolonization in ICUs at baseline. Adult ICU patients in 137 randomized hospitals during baseline (May 1, 2015-April 30, 2017) and intervention (November 1, 2017-April 30, 2019) were included. Intervention: Universal decolonization involving switching to iodophor-CHG (intervention) or continuing mupirocin-CHG (baseline). Main Outcomes and Measures: ICU-attributable S aureus clinical cultures (primary outcome), MRSA clinical cultures, and all-cause bloodstream infections were evaluated using proportional hazard models to assess differences from baseline to intervention periods between the strategies. Results were also compared with a 2009-2011 trial of mupirocin-CHG vs no decolonization in the same hospital network. The prespecified noninferiority margin for the primary outcome was 10%. Results: Among the 801 668 admissions in 233 ICUs, the participants' mean (SD) age was 63.4 (17.2) years, 46.3% were female, and the mean (SD) ICU length of stay was 4.8 (4.7) days. Hazard ratios (HRs) for S aureus clinical isolates in the intervention vs baseline periods were 1.17 for iodophor-CHG (raw rate: 5.0 vs 4.3/1000 ICU-attributable days) and 0.99 for mupirocin-CHG (raw rate: 4.1 vs 4.0/1000 ICU-attributable days) (HR difference in differences significantly lower by 18.4% [95% CI, 10.7%-26.6%] for mupirocin-CHG, P < .001). For MRSA clinical cultures, HRs were 1.13 for iodophor-CHG (raw rate: 2.3 vs 2.1/1000 ICU-attributable days) and 0.99 for mupirocin-CHG (raw rate: 2.0 vs 2.0/1000 ICU-attributable days) (HR difference in differences significantly lower by 14.1% [95% CI, 3.7%-25.5%] for mupirocin-CHG, P = .007). For all-pathogen bloodstream infections, HRs were 1.00 (2.7 vs 2.7/1000) for iodophor-CHG and 1.01 (2.6 vs 2.6/1000) for mupirocin-CHG (nonsignificant HR difference in differences, -0.9% [95% CI, -9.0% to 8.0%]; P = .84). Compared with the 2009-2011 trial, the 30-day relative reduction in hazards in the mupirocin-CHG group relative to no decolonization (2009-2011 trial) were as follows: S aureus clinical cultures (current trial: 48.1% [95% CI, 35.6%-60.1%]; 2009-2011 trial: 58.8% [95% CI, 47.5%-70.7%]) and bloodstream infection rates (current trial: 70.4% [95% CI, 62.9%-77.8%]; 2009-2011 trial: 60.1% [95% CI, 49.1%-70.7%]). Conclusions and Relevance: Nasal iodophor antiseptic did not meet criteria to be considered noninferior to nasal mupirocin antibiotic for the outcome of S aureus clinical cultures in adult ICU patients in the context of daily CHG bathing. In addition, the results were consistent with nasal iodophor being inferior to nasal mupirocin. Trial Registration: ClinicalTrials.gov Identifier: NCT03140423.

The Impact of Coronavirus Disease 2019 (COVID-19) on Healthcare-Associated Infections.

BACKGROUND: The profound changes wrought by coronavirus disease 2019 (COVID-19) on routine hospital operations may have influenced performance on hospital measures, including healthcare-associated infections (HAIs). We aimed to evaluate the association between COVID-19 surges and HAI and cluster rates. METHODS: In 148 HCA Healthcare-affiliated hospitals, from 1 March 2020 to 30 September 2020, and a subset of hospitals with microbiology and cluster data through 31 December 2020, we evaluated the association between COVID-19 surges and HAIs, hospital-onset pathogens, and cluster rates using negative binomial mixed models. To account for local variation in COVID-19 pandemic surge timing, we included the number of discharges with a laboratory-confirmed COVID-19 diagnosis per staffed bed per month. RESULTS: Central line-associated blood stream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), and methicillin-resistant Staphylococcus aureus (MRSA) bacteremia increased as COVID-19 burden increased. There were 60% (95% confidence interval [CI]: 23-108%) more CLABSI, 43% (95% CI: 8-90%) more CAUTI, and 44% (95% CI: 10-88%) more cases of MRSA bacteremia than expected over 7 months based on predicted HAIs had there not been COVID-19 cases. Clostridioides difficile infection was not significantly associated with COVID-19 burden. Microbiology data from 81 of the hospitals corroborated the findings. Notably, rates of hospital-onset bloodstream infections and multidrug resistant organisms, including MRSA, vancomycin-resistant enterococcus, and Gram-negative organisms, were each significantly associated with COVID-19 surges. Finally, clusters of hospital-onset pathogens increased as the COVID-19 burden increased. CONCLUSIONS: COVID-19 surges adversely impact HAI rates and clusters of infections within hospitals, emphasizing the need for balancing COVID-related demands with routine hospital infection prevention.

Real-World Effectiveness of Remdesivir in Adults Hospitalized With Coronavirus Disease 2019 (COVID-19): A Retrospective, Multicenter Comparative Effectiveness Study.

BACKGROUND: There is an urgent need to understand the real-world effectiveness of remdesivir in the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: This was a retrospective comparative effectiveness study. Individuals hospitalized in a large private healthcare network in the United States from 23 February 2020 through 11 February 2021 with a positive test for SARS-CoV-2 and ICD-10 diagnosis codes consistent with symptomatic coronavirus disease 2019 (COVID-19) were included. Remdesivir recipients were matched to controls using time-dependent propensity scores. The primary outcome was time to improvement with a secondary outcome of time to death. RESULTS: Of 96 859 COVID-19 patients, 42 473 (43.9%) received at least 1 remdesivir dose. The median age of remdesivir recipients was 65 years, 23 701 (55.8%) were male, and 22 819 (53.7%) were non-White. Matches were found for 18 328 patients (43.2%). Remdesivir recipients were significantly more likely to achieve clinical improvement by 28 days (adjusted hazard ratio [aHR] 1.19, 95% confidence interval [CI], 1.16-1.22). Remdesivir patients on no oxygen (aHR 1.30, 95% CI, 1.22-1.38) or low-flow oxygen (aHR 1.23, 95% CI, 1.19-1.27) were significantly more likely to achieve clinical improvement by 28 days. There was no significant impact on the likelihood of mortality overall (aHR 1.02, 95% CI, .97-1.08). Remdesivir recipients on low-flow oxygen were significantly less likely to die than controls (aHR 0.85, 95% CI, .77-.92; 28-day mortality 8.4% [865 deaths] for remdesivir patients, 12.5% [1334 deaths] for controls). CONCLUSIONS: These results support the use of remdesivir for hospitalized COVID-19 patients on no or low-flow oxygen. Routine initiation of remdesivir in more severely ill patients is unlikely to be beneficial.

Epidemiology, Outcomes, and Trends of Patients With Sepsis and Opioid-Related Hospitalizations in U.S. Hospitals.

OBJECTIVES: Widespread use and misuse of prescription and illicit opioids have exposed millions to health risks including serious infectious complications. Little is known, however, about the association between opioid use and sepsis. DESIGN: Retrospective cohort study. SETTING: About 373 U.S. hospitals. PATIENTS: Adults hospitalized between January 2009 and September 2015. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Sepsis was identified by clinical indicators of concurrent infection and organ dysfunction. Opioid-related hospitalizations were identified by the International Classification of Diseases, 9th Revision, Clinical Modification codes and/or inpatient orders for buprenorphine. Clinical characteristics and outcomes were compared by sepsis and opioid-related hospitalization status. The association between opioid-related hospitalization and all-cause, in-hospital mortality in patients with sepsis was assessed using mixed-effects logistic models to adjust for baseline characteristics and severity of illness.The cohort included 6,715,286 hospitalizations; 375,479 (5.6%) had sepsis, 130,399 (1.9%) had opioid-related hospitalizations, and 8,764 (0.1%) had both. Compared with sepsis patients without opioid-related hospitalizations (n = 366,715), sepsis patients with opioid-related hospitalizations (n = 8,764) were younger (mean 52.3 vs 66.9 yr) and healthier (mean Elixhauser score 5.4 vs 10.5), had more bloodstream infections from Gram-positive and fungal pathogens (68.9% vs 47.0% and 10.6% vs 6.4%, respectively), and had lower in-hospital mortality rates (10.6% vs 16.2%; adjusted odds ratio, 0.73; 95% CI, 0.60-0.79; p < 0.001 for all comparisons). Of 1,803 patients with opioid-related hospitalizations who died in-hospital, 928 (51.5%) had sepsis. Opioid-related hospitalizations accounted for 1.5% of all sepsis-associated deaths, including 5.7% of sepsis deaths among patients less than 50 years old. From 2009 to 2015, the proportion of sepsis hospitalizations that were opioid-related increased by 77% (95% CI, 40.7-123.5%). CONCLUSIONS: Sepsis is an important cause of morbidity and mortality in patients with opioid-related hospitalizations, and opioid-related hospitalizations contribute disproportionately to sepsis-associated deaths among younger patients. In addition to ongoing efforts to combat the opioid crisis, public health agencies should focus on raising awareness about sepsis among patients who use opioids and their providers.

A COVID-19-ready public health surveillance system: The Food and Drug Administration's Sentinel System.

The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post-market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID-19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID-19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi-pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID-19, validated a diagnosis-code based algorithm for identifying patients with COVID-19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID-19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID-19 prevention and treatment.

A Road Map for Advancing the Practice of Respect in Health Care: The Results of an Interdisciplinary Modified Delphi Consensus Study.

BACKGROUND: Most health care organizations' efforts to reduce harm focus on physical harm, but other forms of harm are both prevalent and important. These "nonphysical" harms can be framed using the concepts of respect and dignity: Disrespect is an affront to dignity and can cause harm. Organizations should strive to eliminate disrespect to patients, to families, and among health care professionals. METHODS: A diverse, interdisciplinary panel of experts was convened to discuss strategies to guide health care systems to embrace an expanded definition of patient harm that includes nonphysical harm. Subsequently, using a modified Delphi process, a guide was developed for health care professionals and organizations to improve the practice of respect across the continuum of care. RESULTS: Five rounds of surveys were required to reach predefined metrics of consensus. Delphi participants identified a total of 25 strategies associated with six high-level recommendations: "Leaders must champion a culture of respect and dignity"; with other professionals sharing the responsibility to "Promote accountability"; "Engage and support the health care workforce"; "Partner with patients and families"; "Establish systems to learn about and improve the practice of respect"; and "Expand the research agenda and measurement tools, and disseminate what is learned." CONCLUSION: Harm from disrespect is the next frontier in preventable harm. This consensus statement provides a road map for health care organizations and professionals interested in engaging in a reliable practice of respect. Further work is needed to develop the specific tactics that will lead health care organizations to prevent harm from disrespect.

A Multi-Stakeholder Consensus-Driven Research Agenda for Better Understanding and Supporting the Emotional Impact of Harmful Events on Patients and Families.

BACKGROUND: The nature and consequences of patient and family emotional harm stemming from preventable medical error, such as losing a loved one or surviving serious medical injury, is poorly understood. Patients and families, clinicians, social scientists, lawyers, and foundation/policy leaders were brought together to establish research priorities for this issue. METHODS: A one-day conference of diverse stakeholder groups to establish a consensus-driven research agenda focused on (1) priorities for research on the short-term and long-term emotional impact of harmful events on patients and families, (2) barriers and enablers to conducting such research, and (3) actionable steps toward better supporting harmed patients and families now. RESULTS: Stakeholders discussed patient and family experiences after serious harmful events, including profound isolation, psychological distress, damaging aspects of medical culture, health care aversion, and negative effects on communities. Stakeholder groups reached consensus, defining four research priorities: (1) Establish conceptual framework and patient-centered taxonomy of harm and healing; (2) Describe epidemiology of emotional harm; (3) Determine how to make emotional harm and long-term impacts visible to health care organizations and society at large; and (4) Develop and implement best practices for emotional support of patients and families. The group also created a strategy for overcoming research barriers and actionable "Do Now" approaches to improve the patient and family experience while research is ongoing. CONCLUSION: Emotional and other long-term impacts of harmful events can have profound consequences for patients and families. Stakeholders designed a path forward to inform approaches that better support harmed patients and families, with both immediately actionable and longer-term research strategies.

Development and validation of the PROcedural Sedation Assessment Survey (PROSAS) for assessment of procedural sedation quality.

BACKGROUND: More than 20 million invasive procedures are performed annually in the United States. The vast majority are performed with moderate sedation or deep sedation, yet there is limited understanding of the drivers of sedation quality and patient satisfaction. Currently, the major gap in quality assurance for invasive procedures is the lack of procedural sedation quality measures. OBJECTIVE: To develop and validate a robust, patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS). DESIGN: Through a series of interviews with patients, proceduralists, nurses, anesthesiologists, and an interactive patient focus group, major domains influencing procedural sedation quality were used to create a multipart survey. The pilot survey was administered and revised in sequential cohorts of adults receiving moderate sedation for GI endoscopy. After revision, the PROSAS was administered to a validation cohort. SETTING: GI endoscopy unit. PATIENTS: A expert panel of proceduralists, nurses, and anesthesiologists, an initial survey development cohort of 40 patients, and a validation cohort of 858 patients undergoing sedation for outpatient GI endoscopy with additional surveys completed by the gastroenterologist, procedure nurse, and recovery nurse. MAIN OUTCOMES AND MEASUREMENTS: Survey characteristics of the PROSAS. RESULTS: Patients were able to independently complete the PROSAS after procedural sedation before discharge. Of the patients, 91.6% reported minimal discomfort; however, 8.4% of patients reported significant discomfort and 2.4% of patients experienced hemodynamic and/or respiratory instability. There was a high correlation between patient-reported intraprocedure discomfort and both clinician assessments of procedural discomfort and patient recall of procedural pain 24 to 48 hours post procedure (P < .001 for all), suggesting high external validity. LIMITATIONS: Single-center study, variability of sedation technique between providers, inclusion of patients with chronic pain taking analgesics. CONCLUSIONS: The PROSAS is a clinically relevant, patient-centered, easily administered instrument that allows for standardized evaluation of procedural sedation quality. The PROSAS may be useful in both research and clinical settings.

Improved stone quality of life in patients with an obstructing ureteral stone on alpha-blocker medical expulsive therapy.

PURPOSE: Though controversial, alpha blockers are used widely for ureteral stone passage. However, its effects on the patient-reported Quality of life (QOL) is unknown. We compared the QoL of patients on alpha-blocker medical expulsive therapy (MET) to patients not on MET (noMET) utilizing the validated Wisconsin Stone Quality of Life (WISQOL). METHODS: This prospective study included patients prescribed either MET or noMET after presentation with symptomatic, obstructing ureteral stones. The treatment arm was decided at the point of care by the initial treating physician and included analgesia and antiemetics. Tamsulosin (0.4 mg daily) was prescribed for the MET group. The WISQOL survey was administered at baseline, 7-, 14-, 21- and 28-days following discharge from the ED or until stone expulsion. RESULTS: 197 patients were enrolled, of which 116 (59.2%) completed questionnaires for analysis, 91 in the MET group and 25 in noMET. Average ureteral stone size was 4.7 mm (SD 1.8) and 3.1 mm (SD 1.0) for MET and noMET, respectively. Of completed surveys, 105 (90%) were completed at day 7, 67 (57.6%) at day 14, 53 (45.7%) at day 21, and 40 (34.5%) at day 28. MET was associated with improved QoL scores across all WISQOL domains compared to noMET. Stone size, age, race, sex, comorbidity score and a prior stone history were not associated with reduced QoL. CONCLUSIONS: The use of MET was associated with improved QOL on all WISQOL metrics compared to noMET patients. Improved stone QOL may be an indication of alpha-blocker therapy in patients with ureteral stone colic.

Comparing Bladder Neck Contracture Rate Between Robotic Intracorporeal and Extracorporeal Neobladder Construction.

Robot-assisted radical cystectomy (RARC) has become more accessible to surgeons worldwide, and descriptions of intracorporeal urinary diversion techniques, such as orthotopic neobladder construction, have increased. In this study, we aim to compare the rate of bladder neck contracture (BNC) formation between RARC and two different urinary diversion techniques. We retrospectively reviewed our institutional database for patients with bladder cancer who underwent RARC with intracorporeal neobladder (ICNB) construction (n = 11) or extracorporeal neobladder (ECNB) construction (n = 11) between 2012 and 2020. BNC was defined by the need for an additional surgical procedure (e.g., dilatation, urethrotomy). Patients who underwent RARC with ICNB (n = 11) were compared to patients who underwent RARC with ECNB (n = 11) across patient characteristics and postoperative BNC formation rates. Kaplan-Meier curves were generated for freedom from BNC based on the neobladder approach and compared with the log-rank test. For patients who received an ECNB, 73% (8/11) developed a BNC; in comparison, none of the patients in the ICNB group experienced a BNC. Kaplan-Meier survival analysis demonstrates the ECNB group's median probability of freedom from BNC as 1.3 years, while the ICNB group was free of BNC over the study period (p < 0.001). RARC with ICNB creation demonstrated a significantly reduced BNC rate in contrast to RARC with ECNB construction. Longer-term follow-up is needed to assess the durability of this difference in BNC rates.

A Trial of Automated Outbreak Detection to Reduce Hospital Pathogen Spread.

BACKGROUND: Detection and containment of hospital outbreaks currently depend on variable and personnel-intensive surveillance methods. Whether automated statistical surveillance for outbreaks of health care-associated pathogens allows earlier containment efforts that would reduce the size of outbreaks is unknown. METHODS: We conducted a cluster-randomized trial in 82 community hospitals within a larger health care system. All hospitals followed an outbreak response protocol when outbreaks were detected by their infection prevention programs. Half of the hospitals additionally used statistical surveillance of microbiology data, which alerted infection prevention programs to outbreaks. Statistical surveillance was also applied to microbiology data from control hospitals without alerting their infection prevention programs. The primary outcome was the number of additional cases occurring after outbreak detection. Analyses assessed differences between the intervention period (July 2019 to January 2022) versus baseline period (February 2017 to January 2019) between randomized groups. A post hoc analysis separately assessed pre-coronavirus disease 2019 (Covid-19) and Covid-19 pandemic intervention periods. RESULTS: Real-time alerts did not significantly reduce the number of additional outbreak cases (intervention period versus baseline: statistical surveillance relative rate [RR]=1.41, control RR=1.81; difference-in-differences, 0.78; 95% confidence interval [CI], 0.40 to 1.52; P=0.46). Comparing only the prepandemic intervention with baseline periods, the statistical outbreak surveillance group was associated with a 64.1% reduction in additional cases (statistical surveillance RR=0.78, control RR=2.19; difference-in-differences, 0.36; 95% CI, 0.13 to 0.99). There was no similarly observed association between the pandemic versus baseline periods (statistical surveillance RR=1.56, control RR=1.66; difference-in-differences, 0.94; 95% CI, 0.46 to 1.92). CONCLUSIONS: Automated detection of hospital outbreaks using statistical surveillance did not reduce overall outbreak size in the context of an ongoing pandemic. (Funded by the Centers for Disease Control and Prevention; ClinicalTrials.gov number, NCT04053075. Support for HCA Healthcare's participation in the study was provided in kind by HCA.).

Miscount incidents: a novel approach to exploring risk factors for unintentionally retained surgical items.

BACKGROUND: An estimated 1,500 operations result in retained surgical items (RSIs) each year in the United States, resulting in substantial morbidity. The rarity of these events makes studying them difficult, but miscount incidents may provide a window into understanding risk factors for RSIs. METHODS: A cohort study of all consecutive operative cases during a 12-month period was conducted at a large academic medical center to identify risk factors for surgical miscounts. A multidisciplinary electronic miscount reconciliation checklist (necessitating both surgeon and nurse input) was introduced into the internally developed electronic Perioperative Information Management System to build a predictive model for RSI cases. RESULTS: Among 23,955 operations, 84 resulted in miscount incidents (0.35% [95% confidence interval: 0.28% to 0.43%]). Increased case duration was strongly associated with increased risk of a miscount in unadjusted analyses (p < .0001). In the nested case-control analysis, both the case duration and the number of providers present were independently associated with a more than doubling of the odds of a miscount, even after adjustment for one another, the elective/urgent/emergent status of a case, and personnel changes occurring during the case. CONCLUSIONS: The finding that both the length of the case and the number of providers involved in the case were independent risk factors for miscount incidents may offer insight into risk-targeted strategies to prevent RSIs, such as postoperative imaging, bar-coded surgical items, and radiofrequency technology. Miscounts trigger use of the Incorrect Count Safety Checklist, which can be used to determine whether a count completed at the procedure's conclusion is consistent across disciplines (circulating nurses, scrub persons, surgeons).

Enhanced popcorning using polyanionic chelating solutions as irrigation.

Poly-anionic compounds can chelate divalent cations and dissolve calcium oxalate stone. Our objective was to assess how much concurrent irrigation with poly-anionic chelating solutions during non-contact laser lithotripsy or popcorning could improve stone ablation rate. A popcorning model was created by lowering a ureteroscope with thulium fiber laser into a test tube calyx. Begostones of matching size and mass were placed in the test tube and treated with the laser while irrigating with different iso-osmolar poly-anionic solutions. We compared 0.9% sodium chloride (NaCl), sodium citrate, sodium hexa-metaphosphate, and sodium ethylenediaminetetraacetate (EDTA) solutions. After treatment, residual stones were passed through a 1 mm sieve, and remaining fragments greater than 1 mm were weighed as remaining stone mass. Average remaining stone mass after lithotripsy with NaCl irrigation was 27.8% (± 10.0%). The average remaining stone mass after lithotripsy with hexa-metaphosphate, sodium citrate, and EDTA irrigation was 28.9% (± 13.4%), 17.5% (± 10.5%), and 9.8% (± 5.7%) respectively. Compared with NaCl, there was a 37% reduction in remaining stone mass when using citrate (p = 0.008) and a 64.7% reduction when using EDTA irrigation during lithotripsy (p < 0.001). Concurrent irrigation with citrate or EDTA solutions synergistically enhances the efficacy laser lithotripsy in this in vitro popcorning model. This may lead to tangible improvements in endoscopic stone removal outcomes; however, the effectiveness on different stone types and safety during short duration lithotripsy should be further investigated.

Health Care-Associated Infections Among Hospitalized Patients With COVID-19, March 2020-March 2022.

Importance: The reported incidence of many health care-associated infections (HAIs) increased during the COVID-19 pandemic; however, it is unclear whether this is due to increased patient risk or to increased pressure on the health care system. Objective: To assess HAI occurrence among patients admitted to hospitals with and without COVID-19. Design, Setting, and Participants: A cross-sectional retrospective analysis of inpatients discharged both with and without laboratory-confirmed COVID-19 infection was conducted. Data were obtained between January 1, 2019, and March 31, 2022, from community hospitals affiliated with a large health care system in the US. Exposure: COVID-19 infection. Main Outcomes and Measures: Occurrence of central line-associated bloodstream infection (CLABSI), catheter-associated urinary tract infection (CAUTI), methicillin-resistant Staphylococcus aureus (MRSA) bacteremia, and Clostridioides difficile infection as reported to the National Healthcare Safety Network. Results: Among nearly 5 million hospitalizations in 182 hospitals between 2020 and 2022, the occurrence of health care-associated infections (HAIs) was high among the 313 200 COVID-19 inpatients (median [SD] age, 57 [27.3] years; 56.0% women). Incidence per 100 000 patient-days showed higher HAIs among those with COVID-19 compared with those without. For CLABSI, the incidence for the full 9 quarters of the study was nearly 4-fold higher among the COVID-19 population than the non-COVID-19 population (25.4 vs 6.9). For CAUTI, the incidence in the COVID-19 population was 2.7-fold higher in the COVID-19 population (16.5 vs 6.1), and for MRSA, 3.0-fold higher (11.2 vs 3.7). Quarterly trends were compared with the same quarter in 2019. The greatest increase in the incidence of HAI in comparison with the same quarter in 2019 for the entire population occurred in quarter 3 of 2020 for CLABSI (11.0 vs 7.3), quarter 4 of 2021 for CAUTI (7.8 vs 6.8), and quarter 3 of 2021 for MRSA (5.2 vs 3.9). When limited to the non-COVID-19 population, the increase in CLABSI incidence vs the 2019 incidence was eliminated, and the quarterly rates of MRSA and CAUTI were lower vs the prepandemic 2019 comparator quarter. Conclusions and Relevance: In this cross-sectional study of hospitals during the pandemic, HAI occurrence among inpatients without COVID-19 was similar to that during 2019 despite additional pressures for infection control and health care professionals. The findings suggest that patients with COVID-19 may be more susceptible to HAIs and may require additional prevention measures.

Intrarenal Pressure with Vacuum-Assisted Ureteral Access Sheaths Using an In Situ Cadaveric Porcine Model.

Introduction: Vacuum-assisted ureteral access sheaths (V-UASs) are a new tool designed to evacuate dust or small fragments during retrograde intrarenal surgery (RIRS). There are reports of increased stone-free rates, decreased infections, and decreased operative time with V-UAS usage. The optimal technique and setting for V-UAS has yet to be described. Herein, we investigate real-time intrarenal pressure (IRP) throughout a range of settings using V-UAS in a porcine RIRS model. Materials and Methods: Ureteroscopy was performed in three female porcine cadaver kidneys through a ClearPetra V-UAS. IRP was recorded through a percutaneous catheter at different inflow pressures, sheath sizes, sheath distance from the ureteropelvic junction, and suction settings. Magnitude of change in delta IRP (dIRP) was compared at various settings. Results: There was no statistical difference in IRP when comparing no suction with vent inactivated. As expected, IRP decreased with larger sheath size and lower irrigation pressures. Average IRP dropped ∼18 mm Hg with suction activation (42.30 mm Hg, vent inactivated; 24.45 mm Hg IRP, suction activated; p < 0.0001). Irrigation pressure and sheath size did not make a difference in the dIRP. dIRP was significantly greater at lower suction settings compared with max suction (25.44 dIRP at 200 mm Hg suction, 10.26 mm Hg dIRP at max suction, p = 0.04). In a subset of observations, IRP paradoxically increased to higher than IRP with no suction at all after >5 seconds of activated suction. Conclusion: Use of V-UAS during RIRS can lower mean IRP; however, this effect could reverse with extended suctioning especially under conditions of high vacuum (>200 mm Hg) owing to outflow tract collapse. Our results suggest urologists should use lower suction settings and short, <5-second bursts to maximize therapeutic benefit, and minimize potential shortcomings of V-UAS during RIRS.

Clinical Outcomes Associated With Overestimation of Oxygen Saturation by Pulse Oximetry in Patients Hospitalized With COVID-19.

Importance: Many pulse oximeters have been shown to overestimate oxygen saturation in persons of color, and this phenomenon has potential clinical implications. The relationship between overestimation of oxygen saturation with timing of COVID-19 medication delivery and clinical outcomes remains unknown. Objective: To investigate the association between overestimation of oxygen saturation by pulse oximetry and delay in administration of COVID-19 therapy, hospital length of stay, risk of hospital readmission, and in-hospital mortality. Design, Setting, and Participants: This cohort study included patients hospitalized for COVID-19 at 186 acute care facilities in the US with at least 1 functional arterial oxygen saturation (SaO2) measurement between March 2020 and October 2021. A subset of patients were admitted after July 1, 2020, without immediate need for COVID-19 therapy based on pulse oximeter saturation (SpO2 levels of 94% or higher without supplemental oxygen). Exposures: Self-reported race and ethnicity, difference between concurrent SaO2 and pulse oximeter saturation (SpO2) within 10 minutes, and initially unrecognized need for COVID-19 therapy (first SaO2 reading below 94% despite SpO2 levels of 94% or above). Main Outcome and Measures: The association of race and ethnicity with degree of pulse oximeter measurement error (SpO2 - SaO2) and odds of unrecognized need for COVID-19 therapy were determined using linear mixed-effects models. Associations of initially unrecognized need for treatment with time to receipt of therapy (remdesivir or dexamethasone), in-hospital mortality, 30-day hospital readmission, and length of stay were evaluated using mixed-effects models. All models accounted for demographics, clinical characteristics, and hospital site. Effect modification by race and ethnicity was evaluated using interaction terms. Results: Among 24 504 patients with concurrent SpO2 and SaO2 measurements (mean [SD] age, 63.9 [15.8] years; 10 263 female [41.9%]; 3922 Black [16.0%], 7895 Hispanic [32.2%], 2554 Asian, Native American or Alaskan Native, Hawaiian or Pacific Islander, or another race or ethnicity [10.4%], and 10 133 White [41.4%]), pulse oximetry overestimated SaO2 for Black (adjusted mean difference, 0.93 [95% CI, 0.74-1.12] percentage points), Hispanic (0.49 [95% CI, 0.34-0.63] percentage points), and other (0.53 [95% CI, 0.35-0.72] percentage points) patients compared with White patients. In a subset of 8635 patients with a concurrent SpO2 - SaO2 pair without immediate need for COVID-19 therapy, Black patients were significantly more likely to have pulse oximetry values that masked an indication for COVID-19 therapy compared with White patients (adjusted odds ratio [aOR], 1.65; 95% CI, 1.33-2.03). Patients with an unrecognized need for COVID-19 therapy were 10% less likely to receive COVID-19 therapy (adjusted hazard ratio, 0.90; 95% CI, 0.83-0.97) and higher odds of readmission (aOR, 2.41; 95% CI, 1.39-4.18) regardless of race (P for interaction = .45 and P = .14, respectively). There was no association of unrecognized need for COVID-19 therapy with in-hospital mortality (aOR, 0.84; 95% CI, 0.71-1.01) or length of stay (mean difference, -1.4 days; 95% CI, -3.1 to 0.2 days). Conclusions and Relevance: In this cohort study, overestimation of oxygen saturation by pulse oximetry led to delayed delivery of COVID-19 therapy and higher probability of readmission regardless of race. Black patients were more likely to have unrecognized need for therapy with potential implications for population-level health disparities.