Reducing intravenous antibiotics in neonates born ≥35 weeks' gestation: A quality improvement study.

AIM: To assess the impact of the Early Onset Sepsis (EOS) calculator, implemented as a quality improvement study, to reduce the rate of unnecessary antibiotics in neonates born ≥35 weeks' gestation. METHODS: An audit of routinely collected hospital data from January 2008 to March 2014 (retrospective) and from January 2018 to September 2019 (prospective) determined baseline incidence of EOS intravenous antibiotic use in neonates born ≥35 weeks' gestation in a tertiary level perinatal centre. Plan-do-study-act (PDSA) cycles were applied to implement the EOS calculator. Statistical process control methodology and time series analysis assessments were used to assess the potential impact of the PDSA cycles on the rate of intravenous antibiotics, blood culture collection, EOS, length of stay and health care costs (not adjusted for potential confounders). RESULTS: In the study population, from January 2008 to March 2014, the baseline incidence of intravenous antibiotic use was 10.49% (2970/28290), whilst only 0.067% (19/28290) neonates had culture proven EOS. From January 2018 to October 2019, prior to implementation of the EOS calculator, 13.3% (1119/8411) neonates were treated with intravenous antibiotic and the use decreased to 8.3% (61/734) post-implementation. The rate of blood culture collection decreased from 14.4% (1211/8411) to 11.9% (87/734). There were no cases of missed EOS. Length of stay decreased from 2.68 to 2.39 days, with an estimated cost saving of $366 per patient per admission. CONCLUSION: Implementing the EOS calculator in a tertiary hospital setting reduced invasive investigations for EOS and intravenous antibiotic use among neonates ≥35 weeks' gestation. This can result in reduced length of neonatal hospital stays, and associated health care cost savings and may reduce separation of mother and baby.

COVID-19 Admission Rates and Changes in Care Quality in US Hospitals.

Importance: Unprecedented increases in hospital occupancy rates during COVID-19 surges in 2020 caused concern over hospital care quality for patients without COVID-19. Objective: To examine changes in hospital nonsurgical care quality for patients without COVID-19 during periods of high and low COVID-19 admissions. Design, Setting, and Participants: This cross-sectional study used data from the 2019 and 2020 Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project State Inpatient Databases. Data were obtained for all nonfederal, acute care hospitals in 36 states with admissions in 2019 and 2020, and patients without a diagnosis of COVID-19 or pneumonia who were at risk for selected quality indicators were included. The data analysis was performed between January 1, 2023, and March 15, 2024. Exposure: Each hospital and week in 2020 was categorized based on the number of COVID-19 admissions per 100 beds: less than 1.0, 1.0 to 4.9, 5.0 to 9.9, 10.0 to 14.9, and 15.0 or greater. Main Outcomes and Measures: The main outcomes were rates of adverse outcomes for selected quality indicators, including pressure ulcers and in-hospital mortality for acute myocardial infarction, heart failure, acute stroke, gastrointestinal hemorrhage, hip fracture, and percutaneous coronary intervention. Changes in 2020 compared with 2019 were calculated for each level of the weekly COVID-19 admission rate, adjusting for case-mix and hospital-month fixed effects. Changes during weeks with high COVID-19 admissions (≥15 per 100 beds) were compared with changes during weeks with low COVID-19 admissions (<1 per 100 beds). Results: The analysis included 19 111 629 discharges (50.3% female; mean [SD] age, 63.0 [18.0] years) from 3283 hospitals in 36 states. In weeks 18 to 48 of 2020, 35 851 hospital-weeks (36.7%) had low COVID-19 admission rates, and 8094 (8.3%) had high rates. Quality indicators for patients without COVID-19 significantly worsened in 2020 during weeks with high vs low COVID-19 admissions. Pressure ulcer rates increased by 0.09 per 1000 admissions (95% CI, 0.01-0.17 per 1000 admissions; relative change, 24.3%), heart failure mortality increased by 0.40 per 100 admissions (95% CI, 0.18-0.63 per 100 admissions; relative change, 21.1%), hip fracture mortality increased by 0.40 per 100 admissions (95% CI, 0.04-0.77 per 100 admissions; relative change, 29.4%), and a weighted mean of mortality for the selected indicators increased by 0.30 per 100 admissions (95% CI, 0.14-0.45 per 100 admissions; relative change, 10.6%). Conclusions and Relevance: In this cross-sectional study, COVID-19 surges were associated with declines in hospital quality, highlighting the importance of identifying and implementing strategies to maintain care quality during periods of high hospital use.

Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019.

Importance: Patient safety is a US national priority, yet lacks a comprehensive assessment of progress over the past decade. Objective: To determine the change in the rate of adverse events in hospitalized patients. Design, Setting, and Participants: This serial cross-sectional study used data from the Medicare Patient Safety Monitoring System from 2010 to 2019 to assess in-hospital adverse events in patients. The study included 244 542 adult patients hospitalized in 3156 US acute care hospitals across 4 condition groups from 2010 through 2019: acute myocardial infarction (17%), heart failure (17%), pneumonia (21%), and major surgical procedures (22%); and patients hospitalized from 2012 through 2019 for all other conditions (22%). Exposures: Adults aged 18 years or older hospitalized during each included calendar year. Main Outcomes and Measures: Information on adverse events (abstracted from medical records) included 21 measures across 4 adverse event domains: adverse drug events, hospital-acquired infections, adverse events after a procedure, and general adverse events (hospital-acquired pressure ulcers and falls). The outcomes were the total change over time for the observed and risk-adjusted adverse event rates in the subpopulations. Results: The study sample included 190 286 hospital discharges combined in the 4 condition-based groups of acute myocardial infarction, heart failure, pneumonia, and major surgical procedures (mean age, 68.0 [SD, 15.9] years; 52.6% were female) and 54 256 hospital discharges for the group including all other conditions (mean age, 57.7 [SD, 20.7] years; 59.8% were female) from 3156 acute care hospitals across the US. From 2010 to 2019, the total change was from 218 to 139 adverse events per 1000 discharges for acute myocardial infarction, from 168 to 116 adverse events per 1000 discharges for heart failure, from 195 to 119 adverse events per 1000 discharges for pneumonia, and from 204 to 130 adverse events per 1000 discharges for major surgical procedures. From 2012 to 2019, the rate of adverse events for all other conditions remained unchanged at 70 adverse events per 1000 discharges. After adjustment for patient and hospital characteristics, the annual change represented by relative risk in all adverse events per 1000 discharges was 0.94 (95% CI, 0.93-0.94) for acute myocardial infarction, 0.95 (95% CI, 0.94-0.96) for heart failure, 0.94 (95% CI, 0.93-0.95) for pneumonia, 0.93 (95% CI, 0.92-0.94) for major surgical procedures, and 0.97 (95% CI, 0.96-0.99) for all other conditions. The risk-adjusted adverse event rates declined significantly in all patient groups for adverse drug events, hospital-acquired infections, and general adverse events. For patients in the major surgical procedures group, the risk-adjusted rates of events after a procedure declined significantly. Conclusions and Relevance: In the US between 2010 and 2019, there was a significant decrease in the rates of adverse events abstracted from medical records for patients admitted for acute myocardial infarction, heart failure, pneumonia, and major surgical procedures and there was a significant decrease in the adjusted rates of adverse events between 2012 and 2019 for all other conditions. Further research is needed to understand the extent to which these trends represent a change in patient safety.

Closing the evidence to practice gap in neonatal transfusion medicine.

Significant resources are directed towards world-class research projects, but the findings are not necessarily translated into better healthcare outcomes, either at all or in a sustained way. There is a clear need to dedicate further resources to understanding how to promote the uptake of evidence and effectively change neonatal transfusion practice to improve outcomes. Approaching blood transfusion behaviour change more systematically, and working across disciplines and involving families, holds the potential to increase the rate of uptake of emerging evidence in clinical practice. This approach holds the potential to save costs, conserve resources, and improve clinical outcomes. Our paper focuses on the use of quality improvement to bridge the gap between evidence-based knowledge and transfusion practice in neonatal units around the world.

Assessment of Automating Safety Surveillance From Electronic Health Records: Analysis for the Quality and Safety Review System.

BACKGROUND AND OBJECTIVES: In an effort to improve and standardize the collection of adverse event data, the Agency for Healthcare Research and Quality is developing and testing a patient safety surveillance system called the Quality and Safety Review System (QSRS). Its current abstraction from medical records is through manual human coders, taking an average of 75 minutes to complete the review and abstraction tasks for one patient record. With many healthcare systems across the country adopting electronic health record (EHR) technology, there is tremendous potential for more efficient abstraction by automatically populating QSRS. In the absence of real-world testing data and models, which require a substantial investment, we provide a heuristic assessment of the feasibility of automatically populating QSRS questions from EHR data. METHODS: To provide an assessment of the automation feasibility for QSRS, we first developed a heuristic framework, the Relative Abstraction Complexity Framework, to assess relative complexity of data abstraction questions. This framework assesses the relative complexity of characteristics or features of abstraction questions that should be considered when determining the feasibility of automating QSRS. Questions are assigned a final relative complexity score (RCS) of low, medium, or high by a team of clinicians, human factors, and natural language processing researchers. RESULTS: One hundred thirty-four QSRS questions were coded using this framework by a team of natural language processing and clinical experts. Fifty-five questions (41%) had high RCS and would be more difficult to automate, such as "Was use of a device associated with an adverse outcome(s)?" Forty-two questions (31%) had medium RCS, such as "Were there any injuries as a result of the fall(s)?" and 37 questions (28%) had low RCS, such as "Did the patient deliver during this stay?" These results suggest that Blood and Hospital Acquired Infections-Clostridium Difficile Infection (HAI-CDI) modules would be relatively easier to automate, whereas Surgery and HAI-Surgical Site Infection would be more difficult to automate. CONCLUSIONS: Although EHRs contain a wealth of information, abstracting information from these records is still very challenging, particularly for complex questions, such as those concerning patient adverse events. In this work, we developed a heuristic framework, which can be applied to help guide conversations around the feasibility of automating QSRS data abstraction. This framework does not aim to replace testing with real data but complement the process by providing initial guidance and direction to subject matter experts to help prioritize, which abstraction questions to test for feasibility using real data.

Pursuing Patient Safety at the Intersection of Design, Systems Engineering, and Health Care Delivery Research: An Ongoing Assessment.

OBJECTIVES: Despite endorsements for greater use of systems approaches and reports from national consensus bodies calling for closer engineering/health care partnerships to improve care delivery, there has been a scarcity of effort of actually engaging the design and engineering disciplines in patient safety projects. The article describes a grant initiative undertaken by the Agency for of Healthcare Research and Quality that brings these disciplines together to test new ideas that could make health care safer. METHODS: Collectively known as patient safety learning laboratories, grantee teams engage in phase-based activities that parallel a systems engineering process-problem analysis, design, development, implementation, and evaluation-to gain an in-depth understanding of related patient safety problems, generate fresh ideas and rapid prototypes, develop the prototypes, ensure that developed components are implemented as an integrated working system, and evaluate the system in a simulated or clinical setting. FINDINGS: Obstacles are described that can derail the best of intentions in deploying the systems engineering methodology. Based on feedback received from project teams, lessons learned are emerging that find considerable variation among project teams in deploying the methodology and a longer than anticipated amount of time in bringing team members from different disciplines together where they learn to communicate and function as a team. CONCLUSIONS: Three narratives are generated in terms of what success might look like. Much is yet to be learned about the limitations and successes of the ongoing learning laboratory initiative, which should be relevant to the broader scale interest in learning health systems.

Safety and efficacy of human milk-based fortifier in enterally fed preterm and/or low birthweight infants: a systematic review and meta-analysis.

OBJECTIVE: To conduct a systematic review and meta-analysis of the efficacy and safety of fortification of human milk with human milk-based fortifier versus cow's milk-based fortifier for use in preterm and/or very low birthweight infants. DESIGN: Randomised or quasi-randomised controlled trials comparing the effect of human milk fortification with human milk-based milk fortifier versus cow's milk-based fortifier in infants born <34 weeks' gestation and/or with birth weight <1500 g were identified by searching databases, clinical trial registries and reference lists until 5 November 2019. Two authors independently extracted data and assessed evidence quality. Meta-analyses were conducted using fixed or random effects models, as appropriate. MAIN OUTCOME MEASURES: Necrotising enterocolitis (Bell's stage II or higher) and late-onset sepsis. RESULTS: Of 863 unique records identified, 16 full-text trials were screened and 2 trials involving 334 infants were included. Primary outcome data were available for 332 infants. Use of human milk-based fortifier compared with cow's milk-based fortifier reduced the risk of necrotising enterocolitis (risk ratio 0.47, 95% CI 0.22 to 0.98). There was no clear evidence of an effect on late-onset sepsis or any other outcomes. The quality of evidence was low to very low due to imprecision and lack of blinding in one study. CONCLUSIONS: Findings suggest that there is a reduction in the incidence of necrotising enterocolitis with human milk-based fortifiers compared with cow's milk-based fortifiers. The overall quality of evidence is low. Further appropriately powered trials are required before this intervention can be routinely recommended for preterm infants.

Feasibility and accuracy of cord blood sampling for admission laboratory investigations: A pilot trial.

AIM: Phlebotomy losses greatly contribute to anaemia following preterm birth. Therefore, the possibility of drawing initial tests from the placenta seems attractive. There is a lack of literature regarding the feasibility and accuracy of pathology tests taken from umbilical arterial and venous (UAB/UVB) compared to blood collected from the newborn. METHODS: UAB and UVB complete blood pictures were compared with the initial neonatal blood test. The relationship between UAB, UVB and neonatal complete blood picture values was determined by Spearman's Rho correlation with absolute values compared by Kruskal-Wallis. P < 0.05 was considered significant. RESULTS: Neonatal haemoglobin, white cell count, immature/total ratio and platelets were significantly correlated to the corresponding values in the UAB and UVB (all P < 0.001). While UAB and UVB haemoglobin and white cell count were similar, both were significantly lower than the neonatal values (P < 0.001 and P = 0.014, respectively). No difference was seen for immature/total ratio and platelet concentrations. UVB blood culture (BC) was feasible (90%), even with delayed cord clamping, and the UVB BC volume was significantly higher (P < 0.001), with a low rate of BC contamination (1.5%). CONCLUSIONS: Our findings support the feasibility and accuracy of umbilical blood in place of blood collected from the newborn. This reduces the phlebotomy losses and allows higher blood volume collection which may increase the sensitivity of BC collection.

Fluid Therapy: Friend or Foe?

Many questions surround fluid bolus therapy and subsequent fluid management in neonatal critical care as they do in pediatric and adult critical care. This review explores the known key clinical aspects of fluid bolus therapy and fluid balance in the first 7 days of life and provides suggestions for further work in this area. It draws on the pediatric and adult critical care literature to provide thought-provoking data around the potential harms of excessive intravenous fluids, which may prove relevant to neonatology. Current data suggest that fluid bolus therapy and early-life positive fluid balance in neonates may be associated with harm.

Challenges in Health Care Simulation: Are We Learning Anything New?

The growth of health care simulation in schools of medicine and nursing is noteworthy, as is the increasingly sophisticated simulation technology, support from funding agencies and foundations for research, well-attended annual conferences, and continued interest of accreditation and certification groups. Yet there are concerns preventing the full value of health care simulation to be realized when examined from a patient safety perspective. Basic questions are asked by funders of patient safety research when assessing past simulation projects undertaken to advance patient safety: Are the safety and quality of care to patients actually improved, and is something new being learned regarding the optimal use of simulation? Concerns focus on pursuing the right research questions to learn something new about the most effective use of simulation; doing more with simulation than simply providing an interesting, stand-alone educational experience; attending more seriously to how skill acquisition, maintenance, and progression get managed; and encouraging investigators, funders, and reviewers to expand their vision regarding what constitutes important inquiry and evidence in health care simulation. Patient safety remains a multifaceted challenge in the United States, requiring multifaceted approaches. Simulation training is considered a promising approach for improving the safety and quality of health services delivery. While it takes time for any new approach to gain momentum and learn from past efforts, it also will require addressing a systematic range of essential questions to improve existing knowledge on the optimal use of simulation, and to realize similar gains in safety that other high-risk industries have made.