Safety Adverse Events Research Articles

‘You don’t see what I see’: Co-designing simulation to uncover and address cognitive bias in healthcare

Educational challenge Each year, adverse events are reported in healthcare, of which many relate to healthcare workforce cognitive bias. The active involvement of workforce and consumers in the review and co-design of effective training for the healthcare workforce to recognise, monitor, and manage unconscious bias is required. Proposed solution We used participatory action research to co-design an innovative, interprofessional simulation based on ‘real world’ clinical incidents and lived experiences to improve the delivery of safe, high quality, consumer-focused healthcare. Following ethics approval, content analysis of serious adverse patient safety events involving cognitive bias was conducted. These data informed audio-recorded interviews with the healthcare workforce and consumers to explore their experiences of cognitive bias. Following thematic analysis, key themes of communication, stigma, diagnostic overshadowing, and fragmented systems were uncovered. Guided by consumers, these themes were interwoven into a simulation scenario that included real places, stories, and verbatim quotes delivered through mixed media artefacts. This heightened the immersive and experiential learning that aimed to uncover unconscious bias and help learners recognise its impact on clinical decisions and practice. Potential benefits and next steps To our knowledge, this is the first interprofessional, co-designed simulation to specifically address cognitive bias in current and future healthcare workforce. Plans to translate this research into a practical framework on how to work with key stakeholders (including consumers) to identify ‘real-world’ health service risks and co-design targeted simulations to address these gaps are described, including lessons learned.

Noninvasive Treatment of Venous Pulsatile Tinnitus with an Internal Jugular Vein Compression Collar.

The study was conducted to evaluate the safety and efficacy of mild internal jugular (IJV) compression via an FDA approved compression collar for symptomatic treatment of venous pulsatile tinnitus. This is a prospective study that recruited 20 adult patients with venous pulsatile tinnitus. Participants completed the Tinnitus Handicap Inventory (THI), were fitted with the collar, and rated symptom intensity on a 10-point tinnitus intensity scale before and during collar use. Once weekly for 4 weeks, they answered a survey quantifying days used, average tinnitus intensity before and after wearing the collar each day of use, and any safety concerns. Lastly, they completed an exit interview. The primary outcome was symptomatic relief, with secondary outcomes of safety, effect of treatment setting, effect of time, and quality of life assessed via nonparametric testing. 18 participants completed the study, and 276 paired daily before use/during use intensity scores were submitted. The median symptom intensity without the collar was 6 (IQR 4, 7), whereas with the collar it was 3 (IQR 2, 5), for a median symptomatic relief of 50%. The collar had a significant effect in reducing symptom intensity (p < 0.0001) and burden of illness via the THI (p < 0.0001). There was no effect of setting, frequency, or time on symptomatic relief with the collar. There were no adverse safety events reported aside from minor discomfort upon initial application. Venous compression collars offer acute symptom relief for patients with venous pulsatile tinnitus. Further study is needed to assess safety and efficacy of longitudinal use. 4 Laryngoscope, 134:3342-3348, 2024.

Use of cognitive aids in paediatric out-of-hospital cardiac arrest

Background: Paediatric cardiac arrest resuscitation is a high-stakes, rare event that can cause high stress levels in emergency medical services (EMS) practitioners. The demands of this work could raise cognitive load on practitioners, which may contribute to adverse safety events. Methods: An EMS agency survey was developed as part of a larger study into organisation-level factors that affect paediatric out-of-hospital cardiac arrest care. Questions focused on the types and numbers of cognitive aids, and whether a paediatric emergency care coordinator (PECC) was present. The number and frequency of these aids were analysed, and statistical significance assessed. The number and type of aids were stratified according to the presence of a PECC and paediatric call volumes. Results: The number of available resources ranged from 0 to 4, with a mean of 2.6 and a median of 3; the average number used was 2.0. These figures are higher than for adults. The most commonly available resources were local protocols, followed by local medication/equipment guides and Broselow tape. The least commonly available were paediatric advanced life support cards. No significant differences were found between the number of resources and the presence of a PECC or call volume. Conclusion: There is wide variability of resources to support EMS providers in the resuscitation of infants and children in out-of-hospital cardiac arrest.

Adverse Safety Events in Emergency Medical Services Care of Children With Out-of-Hospital Cardiac Arrest

Survival for children with out-of-hospital cardiac arrest (OHCA) remains poor despite improvements in adult OHCA survival. To characterize the frequency of and factors associated with adverse safety events (ASEs) in pediatric OHCA. This population-based retrospective cohort study examined patient care reports from 51 emergency medical services (EMS) agencies in California, Georgia, Oregon, Pennsylvania, Texas, and Wisconsin for children younger than 18 years with an OHCA in which resuscitation was attempted by EMS personnel between 2013 and 2019. Medical record review was conducted from January 2019 to April 2022 and data analysis from October 2022 to February 2023. Severe ASEs during the patient encounter (eg, failure to give an indicated medication, 10-fold medication overdose). A total of 1019 encounters of EMS-treated pediatric OHCA were evaluated; 465 patients (46%) were younger than 12 months. At least 1 severe ASE occurred in 610 patients (60%), and 310 patients (30%) had 2 or more. Neonates had the highest frequency of ASEs. The most common severe ASEs involved epinephrine administration (332 [30%]), vascular access (212 [19%]), and ventilation (160 [14%]). In multivariable logistic regression, the only factor associated with severe ASEs was young age. Neonates with birth-related and non-birth-related OHCA had greater odds of a severe ASE compared with adolescents (birth-related: odds ratio [OR], 7.0; 95% CI, 3.1-16.1; non-birth-related: OR, 3.4; 95% CI, 1.2-9.6). In this large geographically diverse cohort of children with EMS-treated OHCA, 60% of all patients experienced at least 1 severe ASE. The odds of a severe ASE were higher for neonates than adolescents and even higher when the cardiac arrest was birth related. Given the national increase in out-of-hospital births and ongoing poor outcomes of OHCA in young children, these findings represent an urgent call to action to improve care delivery and training for this population.

A qualitative exploration of the challenges providers experience during peripartum management of patients with a body mass index ≥ 50 kg/m2 and recommendations for improvement.

The objective of this research was to conduct a qualitative study among a diverse group of providers to identify their clinical needs, barriers, and adverse safety events in the peripartum care of people with a body mass index (BMI) ≥ 50 kg/m2. Obstetricians, anesthesiologists, certified nurse midwives, nurse practitioners, and nurses were invited to participate in focus group discussions if they were employed at the hospital for >6 months. Key concepts in the focus group guide included: (1) Discussion of challenging situations, (2) Current peripartum management approaches, (3) Patient and family knowledge and counseling, (4) Design and implementation of a guideline (e.g., checklist or toolkit) for peripartum care. The audiotaped focus groups were transcribed verbatim, uploaded to a qualitative analysis software program, and analyzed using inductive and constant comparative approaches. Emerging themes were summarized along with representative quotes. Five focus groups of 27 providers were completed in 2023. The themes included staffing (level of experience, nursing-patient ratios, safety concerns), equipment (limitations of transfer mats, need for larger sizes, location for blood pressure cuff, patient embarrassment), titrating oxytocin (lack of guidelines, range of uses), monitoring fetal heart rate and contractions, patient positioning, and communication (lack of patient feedback, need for bias training, need for interdisciplinary relationships). Providers gave examples of items to include in a "BMI cart" and suggestions for a guideline including designated rooms for patients with a BMI ≥ 50 kg/m2, defining nursing ratios and oxytocin titration plans, postpartum incentive spirometer, and touch points with providers (nursing, physicians) at every shift change. Providers discussed a range of challenges and described how current approaches to care may negatively affect the peripartum experience and pose threats to safety for patients with a BMI ≥ 50 kg/m2 and their providers. We gathered information on improving equipment and communication among providers.

Ten-year follow-up of very-high risk hypertensive patients undergoing renal sympathetic denervation.

Renal denervation (RDN) has been proven to be effective in lowering blood pressure (BP) in patients, but previous studies have had short follow-ups and have not examined the effects of RDN on major cardiovascular outcomes. This study aimed to demonstrate the effectiveness and safety of RDN in the long-term treatment of hypertension and to determine if it has an effect on cardiovascular outcomes. All patients with resistant hypertension who underwent RDN between 2011 and 2015 at Tianjin First Central Hospital were included in the study. Patients were followed up at 1,5 and 10 years and the longest follow-up was 12 years. Data were collected on office BP, home BP, ambulatory BP monitoring (ABPM), renal function, antihypertensive drug regimen, major adverse events (including acute myocardial infarction, stroke, cardiovascular death and all cause death) and safety events. A total of 60 participants with mean age 50.37 ± 15.19 years (43.33% female individuals) completed long-term follow-up investigations with a mean of 10.02 ± 1.72 years post-RDN. Baseline office SBP and DBP were 179.08 ± 22.05 and 101.17 ± 16.57 mmHg under a mean number of 4.22 ± 1.09 defined daily doses (DDD), with a reduction of -35.93/-14.76 mmHg as compared with baseline estimates ( P < 0.0001). Compared with baseline, ambulatory SBP and DBP after 10-years follow-up were reduced by 14.31 ± 10.18 ( P < 0.001) and 9 ± 4.35 ( P < 0.001) mmHg, respectively. In comparison to baseline, participants were taking fewer antihypertensive medications ( P < 0.001), and their mean heart rate had decreased ( P < 0.001). Changes in renal function, as assessed by estimated glomerular filtration rate (eGFR) and creatinine, were within the expected rate of age-related decline. No major adverse events related to the RDN procedure were observed in long-term consequences. All-cause mortality and cardiovascular mortality rates were 10 and 8.34%, respectively, for the 10-year period. The BP-lowering effect of RDN was safely sustained for at least 10 years post-procedure. More importantly, to the best of my knowledge, this is the first study to explore cardiovascular and all-cause mortality at 10 years after RDN.

Sex-related difference analyses of efficacy and safety in clinical trials of direct-acting antivirals to treat chronic HCV genotype 1 and 3 infections.

This study aims to identify clinically meaningful sex differences in efficacy and selected safety adverse events for the treatment of chronic hepatitis C virus infection (HCV) or HIV/HCV co-infection in those receiving combination direct-acting antiviral (DAA) regimens. Our assessment was based on adult trial participants treated at the approved DAA dosage and treatment duration from 40 phase 3 clinical trials submitted to the FDA. Female enrollment ranged from 11% to 54% (overall mean 38%). Females with HCV genotype (GT) 1 or 3 infection had statistically significant higher unadjusted or covariant-adjusted odds of achieving sustained virologic response at post-treatment Week 12 (SVR12) compared with males. Odds ratios favouring females were observed among Whites and those ≥40 years of age with HCV GT1 or 3 infections, and among those ≥50 years of age, non-cirrhotic and those with HCV GT3 infection who were treatment-experienced. These differences were not clinically relevant due to the high SVR12 rate achieved by females and males, overall or in subgroups. No differences were observed in SVR12 rates between HCV GT1 mono-infected and HCV GT1/ HIV-1 co-infected participants. Numerically, more females reported headache, fatigue and nausea compared to males, but the differences were small and predominately Grade 1 or 2 severity. Discontinuation rates for any reason or due to an adverse event were low and similar between the sexes. Our study demonstrated females successfully complete DAA regimens and achieve high SVR12 rates despite numerically higher adverse events for certain commonly reported events.

Second Victim Symptoms and Desired Support Strategies Among Italian Health Care Workers in Friuli-Venezia Giulia: Cross-Sectional Survey and Latent Profile Analysis.

The second victim (SV) phenomenon concerns health care workers (HCWs) whose involvement in a medical error, as well as non-error patient safety events, has affected their well-being. Its prevalence ranges from 10% to 75% and can predispose HCWs to burnout, increasing the probability of committing errors. The primary aim of our study was to determine the prevalence of HCWs involved in an adverse patient safety event in Friuli Venezia Giulia Region (Italy). The secondary aims were to use latent profile analysis to identify profiles of SVs and factors influencing profile membership, and to evaluate the relationship between the severity of symptoms and desired support options. A cross-sectional survey through the Italian version of the Second Victim Experience and Support Tool tool was conducted in 5 local health authorities. Descriptive statistics were conducted for all variables. Associations and correlations were assessed with statistical tests, as appropriate. Latent profile analysis was based on the scores of dimensions measuring SVs' symptoms. Factors affecting profile membership were assessed through multinomial logistic regression. A total of 733 HCWs participated. Of them, 305 (41.6%) experienced at least 1 adverse event. Among dimensions measuring SVs' symptoms, psychological distress had the highest percentage of agreement (30.2%). Three latent profiles were identified: mild (58.7%), moderate (24.3%), and severe (17.0%) symptoms. Severe symptoms profile was positively associated with the agreement for extraoccupational support and negatively associated with the agreement for organizational support. A respected colleague with whom to discuss the details of the incident (78.7%) and free counseling outside of work (71.2%) were the support options most desired by HCWs. The severity of symptoms was directly associated with the desire for support strategies. The prevalence of HCWs involved in adverse events is consistent with the literature. Three latent profiles have been identified according to SV symptoms, and the higher the severity of symptoms, the greater the reliance on extraoccupational support.

Abstract PR018: Feasibility of serial microbiome collection in a multi-site neoadjuvant pancreatic cancer clinical trial allowing for a diverse patient population

Abstract Background: Pancreatic cancer portends a very poor prognosis. It is the third leading cause of cancer deaths in the United States. African Americans have a 50- 90% increased incidence of pancreatic cancer in comparison to other racial groups. 20% of patients with pancreatic cancer present with early-stage disease and will have a median overall survival of 2.5 years if able to undergo surgical resection. There is a desperate need to discover novel ways of treating pancreatic cancer. Understanding of the microbiome may be informative to overcoming chemotherapy resistance, toxicity and improving outcomes and disparities. The aim of this study is to (1) identify changes in the intestinal microbiota during neoadjuvant treatment of pancreatic ductal adenocarcinoma that correlate with treatment response and (2) identify changes in the intestinal microbiota during neoadjuvant treatment of pancreatic ductal adenocarcinoma that correlate with treatment toxicity in a diverse patient population. Methods: Patients with resectable or borderline resectable pancreatic cancer who are enrolled in a multi-site clinical trial (NCT03483038) receiving neoadjuvant NEO-Nali-IRI (oxaliplatin, liposomal irinotecan and 5- FU) followed by surgical resection were asked to provide serial microbiome collections of saliva, urine, blood, and stool with a dietary log during the following four (or five) time points: at baseline, mid-therapy (after C4), at completion of chemotherapy (after C8), after radiation if applicable, and at 4-6 weeks post-operative. Participants were given stool collection kits during clinic visits for home sample acquisition. All stool samples were mailed to the University of Florida Health Cancer Center Microbiome Biorepository. Saliva, urine and blood were collected during clinic visits. Demographics, stage, medical history and concurrent medications including antimicrobics and probiotics, chemotherapy dose-reductions, delays, discontinuations, adverse events, safety adverse events, attribution of causality, and hospitalizations were obtained. Outcomes include imaging response using RECIST criteria, CA 19-9 trend, development of metastatic disease, and the ability to proceed to definitive surgical resection. DNA will be extracted from stool and analyzed using 16S rRNA sequencing methods to determine signatures and biodiversity. Descriptive statistics and correlative analysis will be reported. Continuous and categorical variables will be compared with Student’s t-test and Chi-squared test. Multiple groups will be compared by ANOVA. Kaplan-Meier logistic regression will be performed to compare outcomes between the different microbiota groupings. Conclusion: Serial microbiome collection from a multi-site clinical trial is feasible during neoadjuvant chemotherapy for pancreatic cancer and can increase the diversity of the sample population. Citation Format: Sherise C. Rogers, Ibrahim Nassour, Ryan Thomas, Ilyas Sahin, Brian Ramnaraign, Karen Russell, Steven Hughes, Kathryn Hitchcock, Omar Kayaleh, Anita Turk, Ji-Hyun Lee, David DeRemer, Carmen Allegra, Thomas George. Feasibility of serial microbiome collection in a multi-site neoadjuvant pancreatic cancer clinical trial allowing for a diverse patient population [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr PR018.

Characteristics of United States nursing homes with high percentages of stage 2-4 pressure injuries among high-risk nursing home residents with obesity.

Obesity rates in nursing homes (NHs) are increasing. Residents with obesity are at risk for poor outcomes such as pressure injuries (PIs) due to special care needs such as bariatric medical equipment and special protocols for skin care. PIs among resident populations is a sign of poor quality NH care. The purpose of this retrospective observational study was to identify characteristics of NHs with high rates of stage 2-4 PIs among their high-risk residents with obesity. Resident assessment data were aggregated to the NH level. NH structure and process of care and antecedent conditions of the residents and environment measures were used in bivariate comparisons and multivariate logistic regression models to identify associations with NHs having high rates of stage 2-4 PIs among high-risk residents with obesity. We identified three characteristics for which the effect on the odds was at least 10% for clinical significance - for-profit status, large facilities, and the hours of certified nursing assistants (CNAs) per patient day (HRPPD). This study identified several NH characteristics that are associated with higher risk for PIs, which can be targeted with evidence-based interventions to reduce the risk of these adverse safety events occurring.

The importance of NHS patient safety lesson learning.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses the importance of learning from previous patient safety adverse events and the introduction of Martha's Rule.

A pilot study on Paxlovid therapy for hemodialysis patients with severe acute respiratory syndrome coronavirus 2 infections.

We aimed to investigate the safety and efficacy of nirmatrelvir/ritonavir (Paxlovid) therapy for hemodialysis-dependent patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Thirteen hemodialysis patients infected with the Omicron variant of SARS-CoV-2 from April 3 to May 30, 2022, were recruited. Laboratory parameters and chest CT (computed tomography) imaging were analyzed. The treatment group included six patients who received 150 mg/100 mg of Paxlovid orally once daily for 5 days, whereas the control group included seven patients who received basic treatment. No serious adverse reactions or safety events were recorded. Four control patients progressed to moderate disease, and none in the treatment group showed progression of chest CT findings (P < 0.05). Paxlovid therapy tended toward early viral clearance and low viral load on Day 8. Moreover, 83.3% of the patients in the treatment group and 57.1% of the patients in the control group turned negative within 22 days. In the Paxlovid treatment group, we found significantly increased levels of lymphocytes (P=0.03) and eosinophils (P=0.02) and decreased levels of D-dimer on Day 8 compared with those on Day 1. Paxlovid therapy showed a potential therapeutic effect with good tolerance in hemodialysis patients. The optimal dose and effectiveness evaluation must be further investigated in a largeer cohort.

Abstract 330: Severe Adverse Safety Events in Pediatric Out-of-Hospital Cardiac Arrest Resuscitation

Introduction: Survival for children with out-of-hospital cardiac arrest (OHCA) remains poor in spite of improvements in adult OHCA survival. Hypothesis: We hypothesized that severe adverse safety events (ASEs) are common during pediatric OHCA resuscitation and that specific patterns can be identified. Methods: Retrospective cohort study of patient care reports from 51 Emergency Medical Services (EMS) agencies across the US for children less than 18 years of age with an OHCA where resuscitation was attempted by EMS providers between 2013-2019. Results: We evaluated 1,019 encounters of EMS-treated pediatric OHCA; 46% were under 12 months of age. At least one severe ASE occurred in 610 patients (60%), and 310 patients (30%) had two or more. Children under 28 days of age had the highest frequency of ASEs. The most common severe ASEs involved epinephrine administration (30%), ventilation (14%), and vascular access (19%). Logistic regression modeling found that the only factor consistently associated with severe ASEs was young age. Birth-related OHCA had 4-fold greater odds of a severe ASE compared to adolescents (95% CI 1.7-10.7) and neonates with non-birth-related OHCA had 3.2-fold greater odds of a severe ASE (95% CI 1.1-9.0). Conclusions: In this large geographically diverse cohort of children with EMS-treated OHCA, 60% experienced at least one severe ASE. The odds of a severe ASE were over 3-fold higher for neonates than adolescents, and even higher when the cardiac arrest was birth-related. Given the national increase in out of hospital births and ongoing poor outcomes of OHCA in young children, these findings are an important and urgent call to action to focus on improving care delivery and training.

Andrew Mayes’ expert analysis of a case of memory distortion

In this single-case study of memory distortion where Andrew Mayes was involved as an expert witness, a surgeon falsely recalled aspects of a patient safety adverse event in which he was involved, and where he was put through an investigatory process by a regulatory body. Andrew Mayes’ expert analysis of the role of memory distortion in this case resulted in the surgeon being exonerated.

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications

BackgroundRenal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications. ObjectivesThis trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications. MethodsSPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis. ResultsThe treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; −6.5 ± 10.7 mm Hg) and sham control group (n = 131; −4.5 ± 10.3 mm Hg) was −1.9 mm Hg (95% CI: −4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: −0.03 mm Hg [95% CI: −2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: −4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients. ConclusionsThere was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775)

The Price of Perfection: The Cost of Error

In this book proposal, Charles L. Bosk synthesizes 50 years of ethnographic research to consider a key question: Why have decades of patient safety initiatives to reduce preventable deaths and adverse safety events failed to make traction on either one? With his incomparable wit and dry humor, Bosk takes us through the changes to the medical system that accompany his own evolution from a doctoral student to accomplished professional. Bosk's last work prods us to think deeply about the nature of medical error, our attempts to fix it, and what it means to improve medical care.

Effects of Combined Therapy of Olanzapine and Samidorphan on Safety and Metabolic Parameters in Schizophrenia Patients: A Meta-Analysis.

This meta-analysis intended to evaluate the safety and metabolic effects of the combination of olanzapine (OLZ) and samidorphan (SAM) in the treatment of schizophrenia (SCZ) patients. We searched for the English and Chinese databases for randomized controlled trials (RCTs) on the OLZ combined with SAM for SCZ. The English databases included PubMed, Web of Science, EMbase, and Cochrane Library, however, Chinese databases included Chinese Biology Medicine (CBM), VIP, Wanfang, and China National Knowledge Infrastructure (CNKI). All database searches were due by May 31, 2023. Using Review Manager 5.4 software, a meta-analysis was conducted following a literature review and data extraction. This study included five RCTs involving 1781 patients. Regarding safety, the meta-analysis revealed that the probability of weight gain was reduced in the OLZ and SAM group than in the OLZ group (RR = 0.83, 95% CI (0.69, 0.99), P < 0.05). Statistically, the incidence of severe adverse safety events, dry mouth, headache, drowsiness, death, and suicidal perception events was insignificant (P > 0.05); in terms of metabolism, compared with the OLZ group, the OLZ plus SAM group reduced total cholesterol (TC) levels (MD = -3.58, 95% CI (-6.81, -0.34), P < 0.05). However, it had no significant effect on metabolic indices, including low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, glucose, and insulin index (P > 0.05). In patients with SCZ, treatment with the combination of OLZ and SAM decreased the incidence of weight gain adverse events and TC levels; nevertheless, it did not affect other adverse events or metabolic parameters. These findings provide clinicians with evidence-based guidance and support for drug selection. However, it is crucial to confirm these findings through further high-quality research.

Frequency, Type, and Degree of Potential Harm of Adverse Safety Events among Pediatric Emergency Medical Services Encounters

Background Only 5–10% of emergency medical services (EMS) patients are children, and most pediatric encounters are low-acuity. EMS chart review has been used to identify adverse safety events (ASEs) in high-acuity and high-risk pediatric encounters. The objective of this work was to evaluate the frequency, type, and potential harm of ASEs in varied acuity pediatric EMS encounters. Methods This cross-sectional study evaluated pediatric (ages 0–18 years) prehospital records from 15 EMS agencies among three states (Colorado, Connecticut, and Rhode Island) between November 2019 and October 2021. Research associates used a previously validated tool to analyze electronic EMS and hospital records. Adverse safety events were recorded in six care categories, grouped into four levels for analysis: assessment/diagnosis/clinical decision-making, procedures, medication administration (including O2), and fluid administration, and defined across five types of ASEs: Unintended injuries or consequences, Near misses, Suboptimal actions, Errors, and Management complications (UNSEMs). Type and frequency of ASEs in each category were rated in three harm severities: Harm Unlikely, Mild/Temporary, or Permanent/Severe. Three physicians verified ASEs determined by research associates. Frequency of ASEs and harm likelihood are reported. Results Records for 508 EMS patients were reviewed, with 63 (12.4%) transported using lights and sirens. At least one clinical intervention beyond assessment/diagnosis/clinical decision-making was documented for 183 (36.1%, 95% CI: 31.8, 40.4) patients. A total of 162 ASEs were identified for 112 patients (22.1%, 95% CI: 18.5, 25.7). Suboptimal actions were the most frequent UNSEM (n = 66, 40.7%; 95% CI: 33.1, 48.3). For ASEs, (n = 162), the most frequent associations were with procedures 39.5% (95% CI: 32.0, 47.0) or assessment/diagnosis/clinical decision making, 32.1%, (95% CI: 24.9, 39.3). Among care categories, fluid administration was associated with significantly more UNSEMs (58.1%, 95% CI:53.8, 62.4). Most ASEs were determined to be ‘Harm Unlikely’ 62.4% (95% CI: 54.4, 70.4), with assessment/diagnosis/clinical decision making having significantly fewer ASEs with documented harm (22.4%, 95% CI: 10.7, 34.1) compared to other care categories. Conclusion Over 20% of pediatric EMS encounters had an identified ASE, and most were unlikely to cause harm. Most frequent ASEs were likely to be associated with procedures and assessment/diagnosis/clinical decision-making.

Development and Implementation of an Escalation Protocol for Internal Medicine Trainees.

Overnight, physicians in training receive less direct supervision. Decreased direct supervision requires trainees to appropriately assess patients at risk of clinical deterioration and escalate to supervising physicians. Failure of trainees to escalate contributes to adverse patient safety events. To standardize the evaluation of patients at risk of deterioration overnight by internal medicine residents, increase communication between residents and supervising physicians, and improve perceptions of patient safety at a tertiary academic medical center. A multidisciplinary stakeholder team developed an overnight escalation-of-care protocol for residents. The protocol was implemented with badge buddies and an educational campaign targeted at residents, supervising physicians, and nursing staff. Residents and supervising physicians completed anonymous surveys to assess the use of the protocol; the frequency of overnight communication between residents and supervising physicians; and perceptions of escalation and patient safety before, immediately after ("early postintervention"), and 8 months after ("delayed postintervention") the intervention. Seventy-five (100%) residents participated in the intervention, and 57-89% of those invited to complete surveys at the various time points responded. After the intervention, 82% of residents reported using the protocol, though no change was observed in the frequency of communication between residents and supervising physicians. After the implementation, residents perceived that patient care was safer (early postintervention, 47%; delayed postintervention, 72%; P = 0.02), and interns expressed decreased fear of waking and being criticized by supervising physicians. An escalation-of-care protocol was developed and successfully implemented using a multimodal approach. The implementation and dissemination of the protocol standardized resident escalation overnight and improved resident-perceived patient safety and interns' comfort with escalation.

ASSESSMENT OF THE ATTITUDE OF INTENSIVE CARE UNITS NURSES OF THE DIMENSIONS OF A SAFETY CULTURE

To assess intensive care unit nurse’s attitude towards patient safety dimensions.&#x0D; Methods. The study was conducted at two hospitals, from 2022 April till June in Intensive Care Units. 156 nurses participated in the study. The questionnaire was made by authors according to the „Manchester Patient Safety Framework. Acute” literature.&#x0D; Results. Nurses with a university education agreed more often than those with a non-university education that their department takes a responsible approach to patient safety issues (respectively, n=52; 96.3% and n=93; 95.9%), p=0.05, that departments have a correct understanding of why it is necessary to report adverse patient safety events (respectively, n=51; 80.0% and n=80; 51.0%), p=0.04.&#x0D; Non-university-educated nurses indicated more often than university-educated nurses that their department constantly assesses risks related to patient safety and looks for ways to improve quality (respectively, n=92; 93.9% n=43; 79.6%), p=0.02 that adverse patient safety events are not seen as an opportunity to blame the nurse or other staff (respectively, n=62; 64.6% and n=25; 46.3%,), p=0.04. Nurses with a non-university education more often agreed that there is no prevailing culture of blame in the department (respectively, n=65; 67.7% n=25; 46.3%), p=0.02, more often report potential adverse events (respectively, n =26; 48.1% and n=58, 61.1%), p=0.01, than nurses with university education.&#x0D; Conclusions. Critical care and intensive care nurses pay sufficient attention to patient safety, system error and individual responsibility, and adverse event recording and best practice dimensions. However, in the opinion of university-educated nurses, risks related to patient safety are still not sufficiently assessed in the workplace and ways to improve quality are sought, there is a lack of safety culture.