Medical Adverse Events Research Articles

Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers

African American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the US, and effective treatment is needed for all smoking levels. To evaluate the efficacy of varenicline vs placebo among African American adults who are light, moderate, and heavy daily smokers. The Kick It at Swope IV (KIS-IV) trial was a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City. A total of 500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015 to December 2017; final follow-up was completed in June 2018. Participants were provided 6 sessions of culturally relevant individualized counseling and were randomized (in a 3:2 ratio) to receive varenicline (1 mg twice daily; n = 300) or placebo (n = 200) for 12 weeks. Randomization was stratified by sex and smoking level (1-10 cigarettes/d [light smokers] or >10 cigarettes/d [moderate to heavy smokers]). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26. The secondary outcome was 7-day point prevalence smoking abstinence at week 12, with subgroup analyses for light smokers (1-10 cigarettes/d) and moderate to heavy smokers (>10 cigarettes/d). Among 500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users), 441 (88%) completed the trial. Treating those lost to follow-up as smokers, participants receiving varenicline were significantly more likely than those receiving placebo to be abstinent at week 26 (15.7% vs 6.5%; difference, 9.2% [95% CI, 3.8%-14.5%]; odds ratio [OR], 2.7 [95% CI, 1.4-5.1]; P = .002). The varenicline group also demonstrated greater abstinence than the placebo group at the end of treatment week 12 (18.7% vs 7.0%; difference, 11.7% [95% CI, 6.0%-17.7%]; OR, 3.0 [95% CI, 1.7-5.6]; P < .001). Smoking abstinence at week 12 was significantly greater for individuals receiving varenicline compared with placebo among light smokers (22.1% vs 8.5%; difference, 13.6% [95% CI, 5.2%-22.0%]; OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96). Medication adverse events were generally comparable between treatment groups, with nausea reported more frequently in the varenicline group (163 of 293 [55.6%]) than the placebo group (90 of 196 [45.9%]). Among African American adults who are daily smokers, varenicline added to counseling resulted in a statistically significant improvement in the rates of 7-day point prevalence smoking abstinence at week 26 compared with counseling and placebo. The findings support the use of varenicline in addition to counseling for tobacco use treatment among African American adults who are daily smokers. ClinicalTrials.gov Identifier: NCT02360631.

Adverse Drug Events Related to Common Asthma Medications in US Hospitalized Children, 2000-2016.

The reduction in adverse drug events is a priority in healthcare. Medications are frequently prescribed for asthmatic children, but epidemiological trends of adverse drug events related to anti-asthmatic medications have not been described in hospitalized children. The objective of this study was to report incidence trends, risk factors, and healthcare utilization of adverse drug events related to anti-asthmatic medications by major drug classes in hospitalized children in the USA from 2000 to 2016. A population-based temporal analysis included those aged 0-20 years who were hospitalized with asthma from the 2000 to 2016 Kids Inpatient Database. Age-stratified weighted temporal trends of the inpatient incidence of adverse drug events related to anti-asthmatic medications (i.e., corticosteroids and bronchodilators) were estimated. Stepwise multivariate logistic regression models generated risk factors for adverse drug events. From 2000 to 2016, 12,640 out of 698,501 pediatric asthma discharges (1.7%) were associated with adverse drug events from anti-asthmatic medications. 0.83% were adverse drug events from corticosteroids, resulting in a 1.14-fold increase in the length of stay (days) and a 1.42-fold increase in hospitalization charges (dollars). The overall incidence (per 1000 discharges) of anti-asthmatic medication adverse drug events increased from 5.3 (95% confidence interval [CI] 4.6-6.1) in 2000 to 21.6 (95% CI 18.7-24.6) in 2016 (p-trend = 0.024). Children aged 0-4 years had the most dramatic increase in the incidence of bronchodilator adverse drug events from 0.2 (95% CI 0.1-0.4) to 19.3 (95% CI 15.2-23.4) [p-trend ≤0.001]. In general, discharges among asthmatic children with some comorbidities were associated with an approximately two to five times higher odds of adverse drug events. The incidence of adverse drug events from common anti-asthmatic medications quadrupled over the past decade, particularly among preschool-age children who used bronchodilators, resulting in substantial increased healthcare costs. Those asthmatic children with complex medical conditions may benefit the most from adverse drug event monitoring.

A retrospective chart review evaluating pre-operative dental extractions on patients with end-stage heart failure undergoing advanced surgical cardiac therapies

End-stage heart failure patients are functionally compromised by multiple physiologic mechanisms, placing them at increased risk of peri- and post-operative complications. This study aimed to evaluate if dental treatment performed before advanced cardiac interventions, including orthotopic heart transplant and mechanical circulatory support, increases the risk of adverse events. A retrospective chart review spanning January 2011 to December 2020 was performed. Inpatients with end-stage heart disease were evaluated by the hospital dentistry service at UCLA Ronald Reagan Medical Center. Three hundred and five consults met the inclusion criteria. The patients were divided into 2 groups: those who underwent dental treatment and those who did not require dental treatment. The wait time from dental consultation to cardiac intervention (days), dental complications, medical adverse events, and deaths were evaluated. Dental complications were only experienced in the form of intraoral bleeding. There was no significant difference in the number of medical adverse events or deaths between groups. The elimination of oral infection before advanced cardiac interventions does not increase the risk of morbidity or mortality.

PO-707-01 MINIATURIZED IMPLANTABLE CARDIAC MONITOR WITH A LONG SENSING VECTOR (BIOMONITOR III): INSIGHTS FROM MAUDE DATABASE

Implantable Cardiac Monitors (ICMs) are used to detect bradycardia, asystole, atrial fibrillation, or other heart rhythm disturbances. BIOMONITOR III (Biotronik, Berlin, Germany) is new generation ICM combining a long sensing vector in a miniaturized profile. We queried the FDA Manufacturer And User Facility Device Experience (MAUDE) database to assess complications types with BIOMONITOR III. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse (MDR) events representing a collection of both common and uncommon events. A MAUDE database search was conducted on November 23, 2021, for reports received between August 1, 2019 to October 31, 2021 to capture all adverse events. After removing duplicate entries, a total of 580 events were reported in 321 MDRs. 34.5% (n=200) were insertion-site events, while 16.4% (n=95) were malfunction related events. The most frequent device malfunction events were: failure to interrogate [24.2%, n=23 post-cardioversion and 1% (n=1) post MRI], sensing issues (20%, n=19), transmission failure (14.7%, n=14) and poor/loss of signals (12.6%, n=12). Of insertion-site events, device externalization (33%, n=66) followed by spontaneous device fall off (23.5%, n=47) and device infection (22%, n=44) were most common. Overall, 43.6% (n=253) underwent device explantation. Several concerns have been reported inherent to the device function (especially device failure post cardioversion), making this a unique reported event. Robust, transparent monitoring mechanisms are warranted especially with newer technologies

Summary of five years of operation of the out-of-court system for pursuing patient claims in Poland - a retrospective analysis of applications for evaluating medical events.

Providing health services involves a risk of medical events and adverse events. The transparency and quality of the healthcare system have a direct impact on patient's safety. One of the measures of the quality of health services is monitoring and reporting these irregularities, as well as analysing the causes of their occurrence. The aim of this study was to present the principles of the functioning of the Regional Commission for Evaluation of Medical Events in Szczecin and to analyse medical events in the West Pomeranian Voivodeship from 2012 to 2017. The analysis included applications for evaluating medical events and documentation collected for the purpose of conducting cases by the Regional Commission for Evaluation of Medical Events in Szczecin. The study was retrospective. All applications for evaluating medical events that were received by the Regional Commission for Evaluation of Medical Events in Szczecin in 2012-2017 were analysed. The study was conducted from October 2017 to December 2018. The retrospective analysis of the years 2012-2017 revealed 42 medical events and 120 adverse events. The most common medical events were health disorders (33.3%) and bodily injuries (30.9%). Out of the 42 medical events, 34 (80.9%) were for surgical procedures and childbirth. The most common procedures were orthopedic (26.6%) and surgical (23.5%) procedures. Medical events and adverse events should be reported so that they can be analyzed, conclusions can be drawn, and remedial measures can be introduced.

Therapeutic efficacy and cognitive adverse events of overactive bladder medication in patients with central nervous system Disorders—A cohort study

This cohort study evaluates therapeutic efficacy and adverse events (AEs) of various overactive bladder (OAB) medications for patients with central nervous system (CNS) disorders. Patients with OAB and CNS disorders were prospectively enrolled. They were randomly allocated to 3 different treatment subgroups: (1) mirabegron 50mg once daily (2) solifenacin 5mg per day, and (3) combined solifenacin 5mg and mirabegron 50mg once daily. Efficacy and safety questionnaires and objective parameters were compared among the subgroups, and subgroups between baseline and 3 and 6 months after treatment. AEs, including cognitive dysfunction, were assessed using the Mini-Mental State Examination (MMSE). 102 patients (mean age, 71.8±8.7 years) were enrolled, including 35, 36, and 31 patients received mirabegron monotherapy, solifenacin monotherapy, and combination therapy, respectively. OAB symptoms scores all significantly improved 3 months after treatment in different subgroup. However, PVR increased and VE decreased significantly after treatment in patients receiving solifenacin monotherapy and combination therapy. Dry mouth and constipation were the most common AEs, especially in the solifenacin and combination subgroups. Mild incidence of AEs was noted in patients receiving mirabegron monotherapy. No significant change in MMSE was noted among the subgroups after treatment. OAB medication had good therapeutic efficacy in patients who had OAB with CNS disorders, especially in cerebrovascular accident and parkinsonism. No OAB medication or their combination affected cognitive function, whereas minimal AEs were noted with mirabegron. Mirabegron could be recommended as the first choice for managing OAB in these patients.

Identifying Acute Neuropsychiatric Events in Children and Adolescents.

The objective of this study was to develop and validate an approach to accurately identify incident pediatric neuropsychiatric events (NPEs) requiring hospitalization by using administrative data. We performed a cross-sectional, multicenter study of children 5 to 18 years of age hospitalized at two US children's hospitals with an NPE. We developed and evaluated 3 NPE identification algorithms: (1) primary or secondary NPE International Classification of Diseases, 10th Revision diagnosis alone, (2) NPE diagnosis, the NPE was present on admission, and the primary diagnosis was not malignancy- or surgery-related, and (3) identical to algorithm 2 but without requiring the NPE be present on admission. The positive predictive value (PPV) of each algorithm was calculated overall and by diagnosis field (primary or secondary), clinical significance, and NPE subtype. There were 1098 NPE hospitalizations included in the study. A total of 857 confirmed NPEs were identified for algorithm 1, yielding a PPV of 0.78 (95% confidence interval [CI] 0.76-0.80). Algorithm 2 (n = 846) had an overall PPV of 0.89 (95% CI 0.87-0.91). For algorithm 3 (n = 938), the overall PPV was 0.86 (95% CI 0.83-0.88). PPVs varied by diagnosis order, NPE clinical significance, and subtype. The PPV for critical clinical significance was 0.99 (0.97-0.99) for all 3 algorithms. We identified a highly accurate method to identify neuropsychiatric adverse events in children and adolescents. The use of these approaches will improve the rigor of future studies of NPE, including the necessary evaluations of medication adverse events, infections, and chronic conditions.

Healthcare Disparities In Heart Failure Patients And Use Of Sodium Glucose Co-Transport Inhibitors (SGLT2-i)

Introduction Co-existence of heart failure (HF) and diabetes presents myriad of challenges in patientcare which are further complicated by socioeconomic disparities that disproportionately affect patients of color. To understand and address the unique challenges faced by socioeconomically disadvantaged HF-patient population in the Bronx county of New York City, we sought to phenotype the burden of diabetes, and understand any disparities including the use of SGLT2-i. Methods Consecutive adult(18years and older) HF patients [reduced and preserved left-ventricular ejection fraction (LVEF)] seen in the advanced-HF clinics were included in the analysis. Patients were categorized based on race/ethnicity and compared for baseline characteristics and associated outcomes including worsening HF event, all-cause hospitalization in the previous 1-year, and medication adverse-events. Results Of the 1218 HF-patients [n=556 non-Hispanic-Black (nH-Black), n=485 Hispanic, n=177 non-Hispanic-White (nH-White)]; 541(44.4%) had type-2 diabetes-mellitus (44.1% nH-Black, 47.0% Hispanic, 38.4% nH-White, p=0.14). In the HF-DM cohort, substantial proportion (20.9%) had poorly controlled diabetes (HgA1c 9% or higher) that did not vary with race/ethnicity. The median-household-income based on residential address was significantly lower for nH-Black $41,500 (33,490-58,392) and Hispanic $37,804 (29,579-54,278) cohorts compared to nH-White $65,399 (52,091-92,232) cohort. Overall use of SGLT2-i was low (5.7% overall, 0.9% in HF-NoDM and 11.7% HF-DM). On further analysis of HF-DM patients based on SGLT2-i use, patients on SGLT2-i were younger [62(54-69)vs.66(58-75)years], more nH-White (22.2%vs.11.3%); but were also more likely to have HF with reduced ejection fraction (HFrEF)(69.8%vs.54.2%), more poorly controlled DM (31.8%vs.19.5%) and higher median HgA1c levels[7.9(6.9-9.2)vs.7.0(6.3-8.4)%], all p<0.05. Based on race/ethnicity, while the three groups had statistically similar rates of worsening HF events (30.9% nH-Black, 26.0% Hispanic, 24.3% nH-White, p=0.104), the rate of all-cause hospitalization was higher in nH-Black(38.9% nH-Black, 32.2% Hispanic, 31.2% nH-White, p=0.040) . Using logistic-regression model, nH-Black had higher Odds-ratio (OR)=1.46(1.01-2.11), p=0.043 when compared to nH-White for all-cause hospitalization adjusted for age, gender, DM, hypertension, ischemic-cardiomyopathy and LVEF. However, this association was substantially attenuated (p=0.14) when the model was adjusted for median-household-income. Conclusion These findings highlight the complex relationships between income inequality, social determinants of health (including language barriers) and observed racial/ethnic differences in HF and diabetes. Co-existence of heart failure (HF) and diabetes presents myriad of challenges in patientcare which are further complicated by socioeconomic disparities that disproportionately affect patients of color. To understand and address the unique challenges faced by socioeconomically disadvantaged HF-patient population in the Bronx county of New York City, we sought to phenotype the burden of diabetes, and understand any disparities including the use of SGLT2-i. Consecutive adult(18years and older) HF patients [reduced and preserved left-ventricular ejection fraction (LVEF)] seen in the advanced-HF clinics were included in the analysis. Patients were categorized based on race/ethnicity and compared for baseline characteristics and associated outcomes including worsening HF event, all-cause hospitalization in the previous 1-year, and medication adverse-events. Of the 1218 HF-patients [n=556 non-Hispanic-Black (nH-Black), n=485 Hispanic, n=177 non-Hispanic-White (nH-White)]; 541(44.4%) had type-2 diabetes-mellitus (44.1% nH-Black, 47.0% Hispanic, 38.4% nH-White, p=0.14). In the HF-DM cohort, substantial proportion (20.9%) had poorly controlled diabetes (HgA1c 9% or higher) that did not vary with race/ethnicity. The median-household-income based on residential address was significantly lower for nH-Black $41,500 (33,490-58,392) and Hispanic $37,804 (29,579-54,278) cohorts compared to nH-White $65,399 (52,091-92,232) cohort. Overall use of SGLT2-i was low (5.7% overall, 0.9% in HF-NoDM and 11.7% HF-DM). On further analysis of HF-DM patients based on SGLT2-i use, patients on SGLT2-i were younger [62(54-69)vs.66(58-75)years], more nH-White (22.2%vs.11.3%); but were also more likely to have HF with reduced ejection fraction (HFrEF)(69.8%vs.54.2%), more poorly controlled DM (31.8%vs.19.5%) and higher median HgA1c levels[7.9(6.9-9.2)vs.7.0(6.3-8.4)%], all p<0.05. Based on race/ethnicity, while the three groups had statistically similar rates of worsening HF events (30.9% nH-Black, 26.0% Hispanic, 24.3% nH-White, p=0.104), the rate of all-cause hospitalization was higher in nH-Black(38.9% nH-Black, 32.2% Hispanic, 31.2% nH-White, p=0.040) . Using logistic-regression model, nH-Black had higher Odds-ratio (OR)=1.46(1.01-2.11), p=0.043 when compared to nH-White for all-cause hospitalization adjusted for age, gender, DM, hypertension, ischemic-cardiomyopathy and LVEF. However, this association was substantially attenuated (p=0.14) when the model was adjusted for median-household-income. These findings highlight the complex relationships between income inequality, social determinants of health (including language barriers) and observed racial/ethnic differences in HF and diabetes.

Critical Underdiagnosis and Undertreatment of Sexual Health Issues in Male Kidney Transplant Recipients

ABSTRACT Introduction Patients with end stage renal disease (ESRD) often endure a worse quality of life (QOL) than the general population. As a result of improved outcomes with kidney transplants, it has become increasingly important to address QOL. Sexual function is one such QOL domain in which kidney transplant (KT) patients are particularly affected by. Objective This study aims to elucidate the underdiagnosis and undertreatment of sexual health issues in male KT recipients, as well as the treatment profile for erectile dysfunction (ED) in these patients. Methods With IRB approval we retrospectively reviewed the charts of men age 18 and older who received a KT between January 2016 and February 2020 at an academic institute. We sought to identify those with a diagnosis of ED, low or decreased libido, hypogonadism, ejaculatory dysfunction, Peyronie's disease (PD), or male factor subfertility. Next, for those with a diagnosis of ED, information regarding time of initial diagnosis of ED, time when treatment was started, treatment profile and adverse events were documented. Causes of ESRD were obtained, but not controlled for. Results A total of 35 men were diagnosed with some form of sexual dysfunction, which represents 4.2% of the 833 men aged 18+ years who received a KT during this time. Seventy-one percent of men had a diagnosis of ED, 17.1% had ED and hypogonadism, 2.9% had ED and low libido, 8.6% had hypogonadism alone, and there were no diagnosis of ejaculatory dysfunction, PD, or infertility. Seventy-five percent of men with a diagnosis of ED were treated with phosphodiesterase-5 inhibitors (PDE5i), 25% with intracavernosal injections (ICI), 3.1% with intraurethral (IU) suppositories, and 9.4% with a penile prosthesis (PP). No severe medical or surgical adverse events were noted. Of those with ED, 87.5% were diagnosed prior to their transplant surgery and only 62.5% received any treatment prior to it. Conclusions In this study we show that a small fraction of men who received a KT had a diagnosis of a sexual health issue. This is in spite of the known high prevalence of ED in ESRD patients that can be as high as 75%, with up to a 10-20% improvement of ED with transplant alone. Furthermore, we note that KT recipients with ED are treated similarly to the general population and have a similar side effect profile, however, a significant number of patients do not receive treatment until after their transplant. Disclosure No

Meeting abstracts from the 15th international conference on neonatal and childhood pulmonary vascular disease

Meeting abstracts from the 15th international conference on neonatal and childhood pulmonary vascular disease

Postoperative, But Not Preoperative Coronavirus Disease 2019 (COVID-19), Is Associated With an Increased Rate of Medical Adverse Events Following Arthroscopic Procedures

PurposeTo characterize how severe acute respiratory syndrome coronavirus 2 infection in the perioperative period affects the medical adverse event (MAE) rates in arthroscopic sports medicine procedures.MethodsThe Mariner coronavirus disease 2019 (COVID-19) database was queried for all shoulder, hip, or knee arthroscopies, 2010 to 2020. Patients with COVID-19 in the 3 months before to 3 months after their surgery were matched by age, sex, and Charlson Comorbidity Index to patients with an arthroscopy but no perioperative COVID-19 infection, or a COVID-19 infection but no arthroscopic procedure. MAEs in the 3 months after surgery or illness were compared between groups.ResultsThe final cohort consisted of 1,299 matched patients in 3 groups: COVID-19 alone, arthroscopy and perioperative COVID-19, and arthroscopy alone. There were 265 MAEs if a patient had COVID-19 alone (20.4%), 200 MAEs if a patient had arthroscopy with COVID-19 (15.4%), and 71 (5.5%) MAEs if a patient had arthroscopy alone (P < .01). If a patient had an arthroscopy, having COVID-19 was associated with 3.1-fold elevated odds (95% confidence interval [CI] 2.9-3.4, P < .01) of MAE. Among patients with an arthroscopy, MAEs were more common if a patient acquired COVID-19 in the 3 months after their surgery (pooled odds ratio 7.39, 95% CI 5.49-9.95, P < .01) but not if a patient had preoperative COVID-19 (pooled odds ratio 0.66, 95% CI 0.42-1.03, P = .07).ConclusionsHaving COVID-19 during the postoperative period appears to confer a 7-fold elevated risk of MAEs after shoulder, hip, and knee arthroscopy compared with matched patients with arthroscopy and no perioperative COVID-19 but equivalent to that of patients with COVID-19 and no arthroscopy. However, there was no increase in postoperative MAEs if a patient had COVID-19 during the 3 months preceding surgery. Therefore, it appears safe to conduct an arthroscopic procedure shortly after recovery from COVID-19 without an increase in acute medical complication rates.Level of evidenceLevel III, retrospective cohort study.

Random Forest and LightGBM-Based Human Health Check for Medical Device Fault Detection.

Medical devices are items used directly or indirectly in the human body and are a prerequisite for hospital treatment of patients, and their quality can have a direct impact on the health of patients, so strengthening the quality control of medical device use is a hot spot of concern in the clinic. Current medical device testing can reduce the occurrence of adverse events, but it cannot be completely avoided, and its work still needs to be further strengthened. In this paper, we design a two-way feature selection algorithm based on PSO_RF. We use random forest to calculate the importance of the feature attributes of the sample data and sort the results in descending order, where a particle swarm algorithm is introduced to optimize the parameters of the random forest algorithm. The 245 medical device adverse event reports received by the testing center were selected, the occurrence and types of adverse events were analyzed retrospectively, and quality control countermeasures for medical device use were formulated.

Long-Term Follow-Up of Survivors of Extracorporeal Life Support Therapy for Cardiogenic Shock: Are They Really Survivors?

Background and Objectives: Cardiogenic shock (CS) is a medical emergency associated with a high mortality rate. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has become an accepted therapy for CS. Despite widely available data for short-term survival rates, there are only limited data available regarding long-term outcomes following successful VA-ECMO therapy. Materials and Methods: We analyzed the demographics, past medical history, adverse events, and outcomes of survivors who received VA-ECMO support for CS at our center from January 2012 to December 2019. Post-cardiotomy cases were excluded. Results: A total of 578 VA-ECMO implantations on 564 consecutive patients due to CS were identified during the study period. Successful weaning was achieved in 207 (36.7%) patients. Among the survivors, 126 (63%) patients received VA-ECMO therapy without preceding cardiac surgery during their current admission. A follow-up exceeding 12 (mean: 36 ± 20.9) months was available in a total of 55 (43.7%) survivors. The mean VA-ECMO perfusion time was 10.9 (±7.7) days with a mean intensive care unit (ICU) stay of 38.2 (±29.9) days and a mean hospital stay of 49.9 (±30.5) days. A total of 3 deaths were recorded during long-term follow-up (mean survival of 26 ± 5.3 months). Conclusions: Despite the high mortality associated with VA-ECMO therapy, a long-term follow-up with an acceptably low rate of negative cardiac events can be achieved in many survivors. We observed an acceptable low rate of new cardiac events. Further evaluation, including a quality-of-life assessment and a close follow-up for rarer complications in these patients, is needed to elucidate the longer-term outcomes for survivors of invasive VA-ECMO therapy.

Applying machine learning to explore the association between biological stress and near misses in emergency medicine residents.

Physician stress is associated with near misses and adverse medical events. However, little is known about physiological mechanisms linking stress to such events. We explored the utility of machine learning to determine whether the catabolic stress hormone cortisol and the anabolic, anti-stress hormone dehydroepiandrosterone sulfate (DHEA-S), as well as the cortisol to DHEA-S ratio relate to near misses in emergency medicine residents during active duty in a trauma 1 emergency department. Compared to statistical models better suited for inference, machine learning models allow for prediction in situations that have not yet occurred, and thus better suited for clinical applications. This exploratory study used multiple machine learning models to determine possible relationships between biomarkers and near misses. Of the various models tested, support vector machine with radial bias function kernels and support vector machine with linear kernels performed the best, with training accuracies of 85% and 79% respectively. When evaluated on a test dataset, both models had prediction accuracies of around 80%. The pre-shift cortisol to DHEA-S ratio was shown to be the most important predictor in interpretable models tested. Results suggest that interventions that help emergency room physicians relax before they begin their shift could reduce risk of errors and improve patient and physician outcomes. This pilot demonstrates promising results regarding using machine learning to better understand the stress biology of near misses. Future studies should use larger groups and relate these variables to information in electronic medical records, such as objective and patient-reported quality measures.

Medication Reconciliation During Admission to an Internal Medicine Department: A Pilot Study

The purpose of medication reconciliation is to promote patient safety by reducing medication errors and adverse events due to medication discrepancies in transition of care. The aim of this pilot study of medication reconciliation at the time of hospital admission was to identify the necessary resources for its implementation in clinical practice. Pilot study with 100 patients admitted to an Internal Medicine department between October and December 2019, aged 18 and over, and chronically taking at least one medicine. The best possible medication history was obtained systematically, with subsequent identification, classification and resolution of the discrepancies. The study sample, in general characterized by polypharmacy and by having multiple long-term conditions, presented a mean age of 77.04 ± 13.74 years, being 67.0% male. Overall, 791 discrepancies were identified. Intentional discrepancies were 95.7% and 50.9% of them were documented. The difficulties encountered were mainly related with the access and quality of therapeutic information and communication problems between different healthcare professionals. The key priority resources that were identified were related with the process, tools, and personnel categories. The data revealed weaknesses in the clinical records available at the primary/hospital care interface. Optimization of data sources, standardization and informatization of the process, multidisciplinary approach and definition of priority groups were identified as opportunities for optimization.

The association of postoperative dexmedetomidine with pain, opiate utilization, and hospital length of stay in children post-Chiari malformation decompression.

The aim of this study was to determine the association of postoperative dexmedetomidine with markers of pain in children undergoing Chiari malformation decompression. The authors hypothesized that patients receiving dexmedetomidine postoperatively would have decreased cumulative opiate use. They further hypothesized that there would be no difference in median pain scores, outcomes, or medication adverse events. An IRB-approved retrospective cohort study of patients undergoing Chiari malformation decompression from December 1, 2015, to December 31, 2018, was performed. Patients aged 0-21 years who underwent intradural Chiari malformation decompression at a single institution were included. Data for those who used dexmedetomidine postoperatively were compared with those who did not use dexmedetomidine. The primary outcome was cumulative opiate use throughout hospitalization. Secondary outcomes included pain scores, ancillary medication use, adverse events, hospital and ICU length of stay, readmission rates, and hospital cost. The authors reviewed the records of 172 patients who underwent Chiari malformation decompression. Of those patients, 86 received dexmedetomidine postoperatively and 86 did not. Demographics were not different between the groups. Patients who received dexmedetomidine postoperatively received more doses of dexamethasone and were also more frequently exposed to dexmedetomidine intraoperatively (p = 0.028). Patients who received dexmedetomidine postoperatively used fewer morphine equivalents during their admission (1.02 mg/kg vs 1.43 mg/kg, p = 0.003). The patients who received dexmedetomidine postoperatively also had lower median pain scores on postoperative day 0 (0 vs 2, p < 0.001), lower median pain scores throughout the entire admission (1 vs 2, p < 0.001), and lower maximum pain scores recorded (6 vs 8, p = 0.005). Adjusting for steroid dose number and intraoperative dexmedetomidine exposure, postoperative dexmedetomidine remained associated with lower opiate dosing, lower pain scores on postoperative day 0, lower scores throughout hospital stay, and lower maximum pain scores. Patients who received dexmedetomidine had shorter hospital lengths of stay by 19 hours (p < 0.001). There were no statistically significant differences in medication adverse events or hospital costs between the two groups. Postoperative dexmedetomidine use was associated with decreased opiate use, lower pain scores, and shorter hospital length of stay in this cohort. Dexmedetomidine may be considered as a safe adjuvant medication that may have opiate-sparing effects for this patient population.

Antiretrovirals for People with HIV on Dialysis.

In the era of widespread use of antiretroviral therapy (ART), people with HIV (PWH) have a near-normal life expectancy. However, PWH have high rates of kidney diseases and progression to end-stage renal disease at a younger age. PWH have multiple risks for developing acute and chronic kidney diseases, including traditional risk factors such as diabetes, hypertension, and HIV-related factors such as HIV-associated nephropathy and increased susceptibility to infections and exposure to nephrotoxic medications. Despite an improvement in access to kidney transplant among PWH, the number of PWH on dialysis continues to increase. The expansion of the number of antiretrovirals (ARVs) and kidney replacement modalities, the absence of pharmacokinetic data, and therapeutic drug monitoring make it very challenging for providers to dose ARVs appropriately leading to medication errors, adverse events, and higher mortality. Most of the recommendations are either based on small sample size studies or extrapolated based on physiochemical characteristics of ART. We aim to review the most available and most current literature on ART in PWH with renal insufficiency and ART dosing recommendations on dialysis to ensure that PWH are provided with the safest and most effective ART regimen.

Assessing patient safety culture in 15 intensive care units: a mixed-methods study

BackgroundWithin hospitals, intensive care units (ICUs) are particularly high-risk areas for medical errors and adverse events that could occur due to the complexity of care and the patients’ fragile medical conditions. Assessing patient safety culture (PSC) is essential to have a broad view on patient safety issues, to orientate future improvement actions and optimize quality of care and patient safety outcomes. This study aimed at assessing PSC in 15 Tunisian ICUs using mixed methods approach.MethodsA cross-sectional mixed methods approach using a sequential explanatory design was conducted from December 2019 to January 2020. The first quantitative stage was conducted in 15 ICUs belonging to the two university hospitals in the region of Sousse (Tunisia). All the 344 healthcare professionals (clinical staff) working for more than 1 month in these ICUs were contacted in order to take part in the study. In the second qualitative stage 12 participants were interviewed based on purposive sampling.ResultsAll of the PSC dimensions had a score of less than 50%. The developed dimension was ‘teamwork within units’ (48.8%). The less developed dimensions were ‘frequency of event reporting’ (20.8%), ‘communication openness’ (22.2%) and ‘non-punitive response to error’ (19.7%). Interviews’ thematic analysis revealed four main themes including “Hospital management/system failure”, “Teamwork and communication”, “Error management” and “Working conditions”.ConclusionThis research revealed that PSC is still in need of improvement and provided a clearer picture of the patient safety issues that require specific attention. Improving PSC through the use of quality management and error reporting systems may help to improve patient safety outcomes.

The case for decreased surgeon-reported complications due to surgical volume and fellowship status in the treatment of geriatric hip fracture: An analysis of the ABOS database.

American orthopaedists are increasingly seeking fellowship sub-specialization. One proposed benefit of fellowship training is decrease in complications, however, few studies have investigated the rates of medical and surgical complications for hip fracture patients between orthopedists from different fellowship backgrounds. This study aims to investigate the effect of fellowship training and case volume on medical and surgical outcomes of patient following hip fracture surgical intervention. 1999-2016 American Board of Orthopedic Surgery (ABOS) Part II Examination Case List data were used to assess patients treated by trauma or adult reconstruction fellowship-trained orthopedists versus all-other orthopaedists. Rates of surgeon-reported medical and surgical adverse events were compared between the three surgeon cohorts. Using binary multivariate logistic regression to control of demographic factors, independent factors were evaluated for their effect on surgical complications. Data from 73,427 patients were assessed. An increasing number of hip fractures are being treated by trauma fellowship trained surgeons (9.43% in 1999-2004 to 60.92% in 2011-2016). In multivariate analysis, there was no significant difference in type of fellowship, however, surgeons with increased case volume saw significantly decreased odds of complications (16-30 cases: OR = 0.91; 95% CI: 0.85-0.97; p = 0.003; 31+ cases: OR = 0.68; 95% CI: 0.61-0.76; p<0.001). Femoral neck hip fractures were associated with increased odds of surgical complications. Despite minor differences in incidence of surgical complications between different fellowship trained orthopaedists, there is no major difference in overall risk of surgical complications for hip fracture patients based on fellowship status of early orthopaedic surgeons. However, case volume does significantly decrease the risk of surgical complications among these patients and may stand as a proxy for fellowship training. Fellows required to take hip fracture call as part of their training regardless of fellowship status exhibited decreased complication risk for hip fracture patients, thus highlighting the importance of additional training.

The effect of mindfulness-based stress reduction therapy on maternal anxiety, depression, and sleep quality: A protocol for systematic review and meta-analysis.

Background:Depression and anxiety are common in the prenatal and postnatal periods, which significantly influence pregnant women and their unborn babies. Pharmacological interventions can negatively affect maternal and infant health outcomes, while psychotherapy can avoid adverse events of medication and improve maternal depression and anxiety. Whether mindfulness-based stress reduction (MBSR) can alleviate maternal anxiety and depression and improve sleep quality is still controversial. Therefore, we aim to conduct a meta-analysis by collecting randomized controlled trials (RCTs) reporting the effects of MBSR on maternal anxiety, depression, and sleep quality, thus providing evidence-based medical evidence for non-pharmacological interventions.Methods:RCTs reporting the effect of MBSR on maternal anxiety, depression, and sleep quality versus conventional obstetric care will be searched in online databases, including the Cochrane Central Register of Controlled Trials Repositories, PubMed, Embase, Web of Science, Chinese Science Citation Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, and Wan Fang Database. Literature selection, data extraction, risk of bias assessment, and meta-analyses will be independently completed by 2 researchers. Meta-analysis will be performed by using RevMan5.4.Results:The results of this meta-analysis will be submitted to a peer-reviewed journal for publication.Conclusion:This study will provide reliable evidence-based evidences for the effects of MBSR on improving maternal anxiety, depression, and sleep quality.