Concurrent Progestogen and Cerclage to Reduce Preterm Birth: a multicenter international retrospective cohort.

OBJECTIVE: We aimed to evaluate whether cerclage with progestogen therapy was superior to cerclage alone in the prevention of spontaneous preterm birth (sPTB) in singleton pregnancies METHODS: : This is an international retrospective cohort study of singleton pregnancies, without major anomaly or aneuploidy, and with cerclage placed at 10 different institutions in the United States and Colombia from June 2016-June 2020. Exclusion criteria were: lack of documentation regarding whether progestogen was or was not prescribed, delivery outcome unavailable, and pregnancy termination (spontaneous or induced) prior to 16 weeks' gestation. Exposure of interest was progestogen use with cerclage placement, which included those who were continued on progestogen or who started progestogen after cerclage. Comparator was those without progestogen use after cerclage placement, which included those who had no progestogen use the whole pregnancy, or who initiated progestogen and then stopped it after cerclage placement. Progestogen type, cerclage indication, maternal baseline characteristics, and maternal/neonatal outcomes were collected. Primary outcome was sPTB <37 weeks. Secondary outcomes were sPTB <34 weeks, gestational age at delivery, composite neonatal outcome including ≥1 of the following: perinatal mortality, confirmed sepsis, Grade III or IV intraventricular hemorrhage, retinopathy of prematurity, respiratory distress syndrome, bronchopulmonary dysplasia. There was planned subgroup analyses by cerclage indication, progestogen type (vaginal progesterone vs 17-hydroxyprogesterone caproate (17-OHPC)), preterm birth history, and site. Continuous variables compared in adjusted analyses with ANCOVA and categorical variables compared with multivariable logistic regression adjusting for potential confounders with adjusted odds ratio (aOR). Cox regression survival curve was generated to compare latency to spontaneous delivery, censored after 37 weeks. RESULTS: During the study period, a total of 699 singletons met inclusion, N=561 in the progestogen with cerclage group, and N=138 with cerclage alone. Baseline characteristics were similar, except those in the progestogen group were more likely to have had a prior sPTB (61% vs 41%, p<0.001). Within the progestogen group, 52% were on 17-OHPC weekly, 44% on vaginal progesterone daily, and 3% on oral progesterone daily. Progestogen with cerclage was associated with a significantly lower frequency of sPTB<37 (31% vs 39% aOR 0.59 (0.39 - 0.89), p=0.01) and <34 weeks (19% vs 27%, aOR 0.55 (0.35 - 0.87), p=0.01), increased latency to spontaneous delivery (Hazard ratio to sPTB <37wk, 0.66 (0.49-0.90), p=0.009), and lower frequency of perinatal death (7% vs 16%, aOR 0.37 (0.20-0.67), p=0.001). In planned subgroup analyses, association with reduced odds of preterm birth <37 weeks persisted in those on vaginal progesterone, those without a prior preterm birth, those with ultrasound or exam-indicated cerclage, those that started progestogen therapy prior to cerclage, and in sites restricted to the United States. CONCLUSION: Use of progestogen with cerclage was associated with reduced rates of sPTB and early sPTB compared to cerclage alone. Although not powered for subgroups, the strength of evidence for benefit appeared greatest for those with ultrasound or exam-indicated cerclage, and with vaginal progesterone.

Association of Metabolic Syndrome Components and Colonic Diverticulosis in the Very Elderly: A Tertiary Health Network Study.

Introduction There is scarce data about the association of metabolic syndrome (MetS) or its components with the development of colonic diverticulosis (CD) in the elderly. We aim to determine the association of MetS and its components with CD in the elderly aged ≥75 years. Methods We conducted a retrospective chart review at St. Luke's University Health Network to identify patients who underwent a colonoscopy between 2011 and 2020. We collected data on patient demographics, comorbidities, and colonoscopy findings. Statistical analyses were conducted to compute means and frequencies of patient characteristics and rates of CD, as well as to test for associations between potential risk factors and the presence of CD.  Results A total of 1239 patients were included with a median age of 80 years, 57.6% females, 89.5% Caucasians, 72.9% with CD, and 66.7% having a left-sided disease. On bivariate analysis, the older age group (p=0.02), Caucasian ethnicity (p=0.01), and hypertension (p=0.04) were found to be significant risk factors for developing CD. Multivariate regression analysis showed older age group and hypertension (OR=1.47, 95% CI: 1.66-2.02, p=0.02) were major risk factors. A significant proportion of patients with left-sided disease had Caucasian ethnicity (p<0.001), while female gender, obesity, and iron deficiency anemia were also seen more frequently, although without statistical significance.  Conclusion In the elderly (>75 years old), our study found hypertension to be associated with an increased risk of CD, while impaired fasting glucose (IFG) was protective. Most patients exhibited isolated left-sided diverticulosis, with pan-diverticulosis associated with higher proportions of adverse health indicators, including American Society of Anesthesiologists (ASA) score ≥3, IFG, hypertriglyceridemia, hypertension, and hypothyroidism. Further research with larger sample sizes in similar age groups is needed to expand upon these findings.

Effect of Standardized Reminder Calls on Trauma Patient No-Show Rate.

BACKGROUND: Most patients who sustain a traumatic injury require outpatient follow-up. A common barrier to outpatient postadmission care is patient failure to follow-up. One of the most significant factors resulting in failure to follow-up is age more than 35 years. Recent work has shown that follow-up telephone calls reduce readmission rates. Our aim was to decrease no-show appointments by 10% in 12 months. STUDY DESIGN: The electronic medical records at our level I and II trauma centers were queried for all outpatient appointments for trauma between July 1, 2020, and June 9, 2021, and whether the patient attended their follow-up appointment. Patients with visits scheduled after August 1, 2021, received 24- and 48-hour previsit reminder calls. Patients with visits scheduled between July 1, 2020, and August 1, 2021, did not receive previsit calls. Both groups were compared using multivariable direct logistic regression models. RESULTS: A total of 1,822 follow-up opportunities were included in the study. During the pre-implementation phase, there was a no-show rate of 30.9% (329 of 1,064 visits). Postintervention, a 12.2% reduction in overall no-show rate occurred. A statistically significant 11.2% decrease (p < 0.001) was seen in elderly patients. Multivariate analysis showed standardized calls resulted in significantly decreased odds of failing to keep an appointment (adjusted odds ratio = 0.610, p < 0.001). CONCLUSIONS: Reminder calls led to a 12.2% reduction in no-show rate and were an independent predictor of a patient's likelihood of attending their appointment. Other predictors of attendance included insurance status and abdominal injury.

Improving Operating Room Efficiency of Robotic-Assisted Metabolic and Bariatric Surgery Through Standardization.

INTRODUCTION: The use of robotic-assisted (RA) surgery in the field of metabolic and bariatric surgery (MBS) is controversial because of cost concerns and issues related to efficiency. The objective of this study is to evaluate the operating room efficiency in performing RA-MBS prior and after the implementation of a standardized surgical approach. MATERIALS AND METHODS: All MBS cases entered into our database between October 2017 and October 2022 were collected and analyzed before and after the introduction of the standardized approach (SA). The outcome variables consisted of operation time (OT), turnover time (TT), wheels in-wheels out (WW), and console time (CT). Procedures were divided into Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and revisional bariatric surgery (RBS). RESULTS: For RYGB (n = 185), we found a significant reduction in OT, TT, and WW after SA (129 min vs 139 min; 37 min vs 73 min; 165 min vs 175 min, respectively, p < 0.05). For SG (n = 253), we found a significant reduction in turnover time (TT) after SA. For RBS (n = 201), we also found a significant reduction in OT, TT, WW, and CT after SA ( 157 min vs 177 min; 36 min vs 72 min; 194 min vs 216 min; 119 min vs 134 min, respectively, p < 0.05). CONCLUSION: Using a standardized surgical approach, we were able to demonstrate improved operation room efficiency as demonstrated by a reduction in operation length, turnover time, and the overall time of the procedure for primary RYGB and revisional procedures and turnover time for primary sleeve procedures.

Outcomes of Staple Line Reinforcement Following Robotic Assisted Sleeve Gastrectomy Based on MBSAQIP Database.

INTRODUCTION: The objective of this study is to evaluate the outcomes for Staple Line Reinforcement (SLR) in RA-SG based on the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database for 2019. MATERIALS AND METHODS: We selected patients who underwent RA-SG in the MBSAQIP PUF (Public Utility File) for the year 2019 and grouped them based on their SLR status: Oversewing (OS), Buttressing (BR), both OS and BR and neither. Our primary outcomes were bleeding, organ space infection (OSI), and adverse events (AEs), and our secondary outcomes were operation length, hospital length of stay, readmissions, and conversion to open rates. We conducted separate chi square or one-way analysis of variance (ANOVA) as appropriate and multivariable direct logistic regression models for the categorical outcomes. RESULTS: We found 115,621 patients with complete data of which there were 16,494 who underwent RA-SG. Our results did not show a statistically significant decrease in incidence of postoperative bleeding for BR and OS (Adjusted OR = 0.782, p = 0.2291 and Adjusted OR of 0.482, p = 0.054 for BR and OS respectively). There was a statistically significant effect for SLR status on operation length, with OS patients having the highest operative times (log-transformed mean = 2.03), followed by both BR + OS patients (log-transformed mean = 1.99). BR patients had the shortest operation length. CONCLUSION: SLR did not result in any significant differences related to bleeding, OSI or AEs following RA-SG according to MBSAQIP for the year 2019. However, OS resulted in significantly longer operative time compared to BR alone.

Implementation of an enhanced recovery after surgery (ERAS) protocol for total abdominal hysterectomies in the division of gynecologic oncology: a network-wide quality improvement initiative.

CONTEXT: Enhanced Recovery After Surgery (ERAS) protocols have been shown to decrease length of stay and postoperative opioid usage in colorectal and bariatric surgeries performed at large academic centers. Hysterectomies are the second most common surgical procedure among women in the United States. Hysterectomies performed in an open fashion, or total abdominal hysterectomies (TAHs), account for a large portion of procedures performed by gynecologic oncologists secondary to current oncology guidelines and surgical complexity. Implementation of an ERAS protocol for gynecologic oncology TAHs is one way in which patient outcomes may be improved. OBJECTIVES: An ERAS protocol for gynecologic oncology surgeries performed in a community hospital was instituted with the goal to optimize patient outcomes preoperatively. The primary outcome of interest was to reduce patient opioid usage. Secondary outcomes included compliance with the ERAS protocol, length of stay, and cost. Thirdly, this study aimed to demonstrate the unique challenges of implementing a large-scale protocol across a community network. METHODS: An ERAS protocol was implemented in 2018, with multidisciplinary input from the Departments of Gynecologic Oncology, Anesthesia, Pharmacy, Nursing, Information Technology, and Quality Improvement to develop a comprehensive ERAS order set. This was implemented across a 12-site hospital system network that consisted of both urban and rural hospital settings. A retrospective review of patient charts was performed to assess measured outcomes. Parametric and nonparametric tests were utilized for statistical analysis with p<0.05 denoting statistical significance. If the p value was >0.05 and <0.09, this was considered a trend toward significant. RESULTS: A total of 124 patients underwent a TAH utilizing the ERAS protocol during 2018 and 2019. The control arm consisted of 59 patients who underwent a TAH prior to the ERAS protocol intervention, which was the standard of care in 2017. After 2 years of implementation of the ERAS protocol intervention, we found that 48 % of the ERAS patients had minimal opioid requirements after surgery (oral morphine equivalent [OME] range 0-40) with decreased postoperative opioid requirements in the ERAS group (p=0.03). Although not statistically significant, utilization of the ERAS protocol for gynecologic oncology TAHs trended toward shorter hospital length of stay from 5.18 to 4.17 days (p=0.07). The median total hospital costs per patient also showed a nonsignificant decrease in cost from $13,342.00 in the non-ERAS cohort and $13,703.00 in the ERAS cohort (p=0.8). CONCLUSIONS: A large-scale quality improvement (QI) initiative is feasible utilizing a multidisciplinary team to implement an ERAS protocol for TAHs in the division of Gynecologic Oncology with promising results. This large-scale QI result was comparable to studies that conducted quality-improvement ERAS initiatives at single academic institutions and should be considered within community networks.

Outcomes of Robotic-Assisted Bariatric Surgery Compared to Standard Laparoscopic Approach Using a Standardized Definition: First Look at the 2020 Metabolic and Bariatric Surgery Accreditation Quality Improvement Project (MBSAQIP) Data.

PURPOSE: The primary objective of this study is to evaluate the outcomes of robotic-assisted (RA-) approach compared to the standard laparoscopic (L-) approach using the 2020 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) registry Public Use File (PUF). Our secondary objective is to establish standards for the reporting of outcomes using PUF. MATERIALS AND METHODS: Using the PUF database (n = 168,568), patients were divided into sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), revisions, and conversions and then analyzed separately. We created balanced covariate through propensity score matching and inverse probability treatment weighting (IPTW). We also conducted multivariable relative risk regression to confirm our results. RESULTS: For RYGB, the incidence of "transfusion" was significantly lower in the RA-RYGB compared to the L-RYGB. There was no significant difference in the rate of Serious Event Occurrences (SEOs) or rate of intervention at 30 days. For SG, there was a higher rate of "transfusion" in the RA group. Incidence of SEOs was also significantly higher in the RA-group. There was no significant difference in SEOs for conversions; however, revisions had a trend toward a lower rate of SEOs favoring the robotic approach. Operative times were significantly higher for all RA-groups. CONCLUSION: RA- approach in metabolic and bariatric surgery (MBS) remains controversial because of differences in outcomes. The use of SEOs as reported by MBSAQIP in its semi-annual report can be used as a composite score to assess outcomes while using PUF. Further studies are needed to compare RA- to L- MBS.

Cost analysis of robotic assisted general surgery cases in a single academic institution.

Laparoscopy is currently the standard approach for minimally invasive general surgery procedures. However, robotic surgery is now increasingly being used in general surgery. Robotic surgery provides several advantages such as 3D-visualization, articulated instruments, improved ergonomics, and increased dexterity, but is also associated with an increased overall cost which limits its widespread use. In our institution, the robotic assisted approach is frequently used for the performance of general surgery cases including inguinal hernias, cholecystectomies and paraesophageal hernia (PEH) repairs. The primary aim of the study was to evaluate the differences in cost between a robotic and laparoscopic approach for the above-mentioned cases. With IRB approval, we conducted a retrospective cost analysis of patients undergoing inguinal hernia repairs, cholecystectomies and PEH repairs between June 2018 and November 2020. Patients who had a concomitant procedure, a revisional surgery, or bilateral inguinal hernia repair were excluded from the study. Cost analysis was performed using a micro-costing approach. Statistical significance was denoted by p < 0.05. There were no differences among the different groups in relation to age, gender, ethnicity, and BMI. The overall cost of the robotic (R-) approach compared to a laparoscopic (L-) approach was significantly lower for cholecystectomy ($3,199.96 vs $4019.89, p < 0.05). For inguinal hernia repairs and PEH repairs without mesh, we found no significant difference in overall costs between the R- and L- approach (R- $3835.06 vs L- $3783.50, p = 0.69) and (R- $6852.41 vs L- $6819.69, p = 0.97), respectively. However, the overall cost of PEH with mesh was significantly higher for the R- group compared to the L- group (R- $7,511.09 vs L- $6,443.32, p < 0.05). Based on our institutional cost data, use of a robotic approach when performing certain general surgery cases does not seem to be cost prohibitive.

Direct medical costs of robotic sleeve gastrectomy compared to laparoscopic approach in a single academic center.

BACKGROUND: The use of the robotic platform in bariatric surgery remains controversial because of lack of level I evidence to support its superiority compared to the laparoscopic approach and because of cost concerns. Recently, an extended use program (EUP) for robotic instruments was also introduced at our institution to help reduce the associated direct medical costs of robotic surgery. OBJECTIVES:  To evaluate the direct medical costs of a robotic sleeve gastrectomy (R-SG) and compare it to a standard laparoscopic approach (L-SG). SETTING:  Academic, tertiary care center. METHODS:  The analysis included the last 50 R-SG performed at our institution between June 1st 2019 and October 31st 2020. Those cases were compared to the L-SG cases (29 cases) performed in the same time period. All revisions or conversions were then excluded which resulted in a total of 74 primary SG (R-SG = 45 and L-SG = 29). Direct medical costs included operating room cost, instrument cost, miscellaneous cost, and cost of hospital stay. Direct cost data was generated using the StrataJazz reporting module, which is fed daily from EPIC, our electronic health record system. Patients who underwent a primary SG or a primary SG with a concomitant Paraesophageal Hernia Repair (PEH) were analyzed separately using Mann-Whitney rank sum tests and Student's t tests. An additional analysis and subanalysis of the groups was also performed after applying the potential savings of the Extended Use Program (EUP). RESULTS:  Overall, the direct medical cost of R-SG was comparable to L-SG ($6330.77 vs $6804.12 respectively, p = 0.07). The direct medical cost of patients undergoing SG alone without PEH was significantly lower in the R-group compared to the L-group ($5927.08 vs $6508.01, respectively, p = 0.04). When applying the EUP savings to our data, the predicted direct medical cost of R-SG becomes significantly lower than L-SG ($6145.77 vs $6804.12 respectively, p = 0.01). CONCLUSION:  At our academic medical center, we found no difference in direct medical costs between R-SG and L-SG. With the application of the EUP, direct medical costs of R-SG can be significantly lowered compared to L-SG. It is important to consider that cost data are largely dependent upon the academic medical center of interest, and surgeons need to collect their own cost data to evaluate whether robotic surgery is feasible at their institution.

Current Trends in the Utilization of a Robotic Approach in the Field of Bariatric Surgery.

PURPOSE: The utilization rate of robotic surgery for bariatric procedures is not well-described. Our study identified the proportion of metabolic and bariatric surgery (MBS) procedures in the United States between 2015 and 2020 performed using a robotic (R-) or laparoscopic (L-) approach. MATERIALS AND METHODS: A descriptive analysis of the 2015-2020 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Participant User Data File (PUF) datasets was performed. The primary outcome was (1) surgical cases performed annually and (2) proportion of cases performed using a R- or L- approach. Analysis was done separately for sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), biliopancreatic diversion with duodenal switch (BPD-DS), and revisional bariatric surgery (RBS). Statistical analysis consisted of means and proportions, fold difference, annual slope, and Student's t tests or chi-square tests as appropriate, with statistical significance set to p < .05. RESULTS: A total of 1,135, 214 procedures were captured between 2015 and 2020. R-RYGB increased from 2554 to 6198 (6.8% to 16.7%), R-SG increased from 5229 to 17,063 (6.0% to 17.2%), R-RBS increased from 993 to 3386 (4.7% to 17.4%), and R-BPD-DS increased from 221 to 393 (22.0% to 28.4%). The greatest annual increase was observed among R-RBS and R-SG (3.70-fold difference; slope 2.4% per year and 2.87-fold difference; slope 2.2% per year, respectively). CONCLUSION: There is a nationwide increase in the utilization of a R- approach in bariatric surgery. There are concerns related to the potential increase in healthcare expenditures related to robotics. Further studies are needed to establish key performance indicators along with guidelines for training, adoption and utilization of a R- approach.

Opioid Use and Disposal Patterns of Emergency Department Patients.

Introduction: To date, there is limited literature to guide emergency providers (EPs) on the proper dosing of prescription opioids. Our study aims to assess the self-reported opioid use, storage, and disposal practices of patients presenting to the emergency department (ED) with acute pain. Methods: This prospective cohort study employed a validated, cross-sectional survey of subjects identified using electronic medical records. The survey link was e-mailed to a continuous sample of eligible participants 3-4 weeks following ED discharge. Nonrespondents were surveyed through telephone after 1 week. We used descriptive and nonparametric statistics to report survey results. Results: Of 500 eligible subjects, 97 completed the questionnaire. Only 28% of respondents reported that they took all of the prescribed pills. Of the remaining responses, 20% stated that they did not take any pills, 33% took about one-fourth, 7.2% took about half, and 12.4% took about three-fourths of the pills. Among those who did not take any pills, 42% filled the prescription. Most (71.2%) reported storing their leftover pills; among those who stored their pills, less than one-fourth (23.8%) used a locked storage location. Conclusions: Our findings suggest that less than one-third of patients who receive prescriptions in the ED for acute pain use all of their prescribed pills, suggesting that many patients are unnecessarily prescribed opioids for acute conditions. The findings of this study also suggest that many patients with unused prescription opioids do not practice safe storage or proper disposal of leftover pills. This represents a potential opportunity for EPs to improve medication safety by educating patients on proper storage and disposal practices. Limitations include low response rate and the use of self-reporting.

Comparison of Pneumonitis Rates and Severity in Patients With Lung Cancer Treated by Immunotherapy, Radiotherapy, and Immunoradiotherapy.

Introduction Radiation pneumonitis (RP) is a common dose-limiting toxicity of radiotherapy to the chest in lung cancer patients. Similarly, the revolutionary use of immune checkpoint inhibitors (ICIs) to treat lung cancer can be complicated by immune-related adverse events (irAEs), particularly checkpoint inhibitor pneumonitis (CIP). Our study aimed to assess the effect of immunotherapy, with and without radiotherapy, on pneumonitis and other outcomes. Methods We performed a retrospective chart review of 680 lung cancer patients treated with either radiotherapy, immunotherapy, or both at St. Luke's University Health Network to determine the incidence rates of pneumonitis. Then, a more extensive review of 346 patients was completed, 181 of whom had pneumonitis, to investigate risk factors and outcomes. Results All-grade pneumonitis incidence was 26.6% while more severe pneumonitis (grade 3 or higher) was 13%. Receiving programmed cell death-1 (PD-1) or ligand-1 (PD-L1) inhibitors, having squamous cell carcinoma (SCC), and having poorer performance status were independently and significantly associated with increased risk of pneumonitis, with AOR (adjusted odds ratios) of 8.32, 4.10, 2.91, and 1.71, respectively. Among those who had pneumonitis, more severe cases (grade 3 or higher) were related to immunotherapy, either alone (58.32%) or with radiation (55.7%), compared to radiation therapy alone (36.2%). Poorer performance status (defined as a higher Eastern Cooperative Oncology Group (ECOG) score) was the only covariate we found to be significantly and independently associated with reduced odds of 18-months survival. More of the patients treated with both lung radiation and immunotherapy had progressive disease (53.8%) compared to those treated with only radiation (30.4%) or immunotherapy (36.7). Progressive disease occurred more in patients with pneumonitis grade 3 or higher (48.3%) than those with no or low-grade pneumonitis (27.2%). Conclusion Receiving PD-L1 and PD-1 inhibitors, either with or without radiotherapy, was associated with a higher risk of more severe pneumonitis (PD-L1 > PD-1) than radiotherapy alone. Given its high incidence and complications, more about therapy-induced pneumonitis is yet to be studied. Learning more about pneumonitis' risk factors and complications is of great clinical importance, as it may result in better treatment planning and improved outcomes. Future studies are needed to investigate the suggested association between symptomatic pneumonitis and poorer response to treatment and whether SCC increases the risk of higher-grade pneumonitis.

Does the Combined Use of Aspirin and Immunotherapy Result in Better Outcomes in Non-Small Cell Lung Cancer Than Immunotherapy Alone?

INTRODUCTION:  Immunotherapy works by stimulating the immune system against cancer cells. Resistance to immunotherapy represents a significant challenge in the field of medical oncology. The mechanisms by which cancer cells evade immunotherapy are not well understood. Prior research suggested overexpression of prostaglandin E-2 (PGE-2) by cancer cells, which bind to EP-2 and EP-4 receptors on the tumor-specific cytotoxic T-lymphocytes (CTLs) and suppress their anticancer role. This immunosuppressive effect is involved in evading the programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) blockade of immunotherapy, which fuels cancer cell growth and recurrence. Studies found that combining PGE-2 blockade and a PD-1 signaling inhibitor helped promote the anticancer immunity cells. If confirmed in a clinical setting, the above in vitro findings could be of great clinical significance. METHODS:  Given that aspirin (ASA) blocks PGE-2 production, this work aimed to evaluate whether ASA use with immunotherapy results in better outcomes than immunotherapy alone. We performed a retrospective chart review of 500 non-small cell lung cancer (NSCLC) patients aged 21 years or older treated with PD-1 and/or PD-L1 directed immunotherapy at St. Luke's University Health Network between July 2015 and July 2021. Relevant patient, disease, and treatment-related variables were collected, including ASA use (≥ 81 mg daily) and the type of immunotherapy. Bivariate analyses were conducted to determine which variables to include in a multivariable model.  The four primary outcomes included survival at 18-months, both after diagnosis and starting immunotherapy, achieving complete remission (CR), and having a progressive disease (PD), as defined by RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Secondary outcomes included therapy-related toxicities and complications in the different treatment groups.   Results: After bivariate analysis, no statistical significance was found for a difference in 18-month survival between ASA and non-ASA groups (50.3% vs 49.7%, p-value = 0.79). ASA with PD-L1 inhibitor showed a trend towards a higher likelihood of achieving CR [adjusted odds ratio (AOR) 1.85] with a p-value close to statistical significance (0.06). However, ASA with PD-L1 showed high statistical significance as an independent variable associated with a decreased likelihood of having PD (AOR 0.44, p < 0.001). These findings suggest that NSCLC patients receiving PD-L1 inhibitors could benefit more from daily ASA than patients treated with PD-1 inhibitors. Our study emphasizes using the Eastern Cooperative Oncology Group (ECOG) scoring of the performance status (PS) in NSCLC patients. Poorer PS was associated with lower survival, decreased likelihood of CR, and more PD. Other variables associated with worse outcomes were advanced cancer stage at diagnosis and male gender. Low-PD-L1 expression in NSCLC was associated with an increased likelihood of survival; this could be of clinical significance, especially with previous studies suggesting better outcomes of using ASA in PD-L1 low tumors.  Conclusion: These findings suggest that daily ASA use with PD-L1 inhibitors is associated with more favorable outcomes in NSCLC. More studies are needed to investigate further the potential benefits vs. risks of using ASA with different immunotherapies and the other possible variables affecting treatment outcomes.

Proton pump inhibitor therapy usage and associated hospitalization rates and critical care outcomes of COVID-19 patients.

Proton Pump Inhibitors (PPI) are one of the most prescribed medications in the United States. However, PPIs have been shown to increase the risk of enteric infections. Our study aims to evaluate the correlation between PPI and COVID-19 severity. We performed a retrospective cohort study on patients who tested positive for SARS-CoV-2 from March to August 2020. Patients were categorized based on PPI user status. Primary outcomes included need for hospital or ICU admission and 30-day mortality. Secondary outcomes looked to determine the severity of COVID-19 infection and effect of comorbid conditions. 2,594 patients were reviewed. The primary outcomes of our study found that neither active nor past PPI use was associated with increased hospital admission or 30-day mortality following completion of multivariate analysis. Additionally, there was no association between COVID-19 infection and the strength of PPI dosing (low, standard, high). However, the following covariates were independently and significantly associated with increased admission: age, male gender, diabetes, COPD, composite cardiovascular disease, kidney disease, and obesity. The following covariates were associated with increased mortality: age, male gender, COPD, and kidney disease. In conclusion, the high risk features and comorbidities of PPI users were found to have a stronger correlation to severe COVID-19 infection and poor outcomes as opposed to the use of PPI therapy.

Comparison of Early and Late Intubation in COVID-19 and Its Effect on Mortality.

BACKGROUND: Best practices for management of COVID-19 patients with acute respiratory failure continue to evolve. Initial debate existed over whether patients should be intubated in the emergency department or trialed on noninvasive methods prior to intubation outside the emergency department. OBJECTIVES: To determine whether emergency department intubations in COVID-19 affect mortality. METHODS: We conducted a retrospective observational chart review of patients who had a confirmed positive COVID-19 test and required endotracheal intubation during their hospital course between 1 March 2020 and 1 June 2020. Patients were divided into two groups based on location of intubation: early intubation in the emergency department or late intubation performed outside the emergency department. Clinical and demographic information was collected including comorbid medical conditions, qSOFA score, and patient mortality. RESULTS: Of the 131 COVID-19-positive patients requiring intubation, 30 (22.9%) patients were intubated in the emergency department. No statistically significant difference existed in age, gender, ethnicity, or smoking status between the two groups at baseline. Patients in the early intubation cohort had a greater number of existing comorbidities (2.5, p = 0.06) and a higher median qSOFA score (3, p ≤ 0.001). Patients managed with early intubation had a statistically significant higher mortality rate (19/30, 63.3%) compared to the late intubation group (42/101, 41.6%). CONCLUSION: COVID-19 patients intubated in the emergency department had a higher qSOFA score and a greater number of pre-existing comorbidities. All-cause mortality in COVID-19 was greater in patients intubated in the emergency department compared to patients intubated outside the emergency department.

A Search for Novel Risk Factors for Obstetric Anal Sphincter Injury.

OBJECTIVE: The objective of this study is to evaluate factors associated with obstetric anal sphincter injury and identify modifiable risks. METHODS: A retrospective case-control study was performed in women who gave birth at our institution between May 2008 and December 2012. Patients who had a third- or fourth-degree lacerations were compared with those who did not. Parity, stretch marks, age, body mass index, tobacco use, fetal weight, operative delivery, labor, and second stage duration were compared between groups. Multivariate direct logistic regression was conducted on all patients who had complete data to calculate the adjusted odds ratio. RESULTS: We identified 299 patients with third- or fourth-degree lacerations and 8,459 patients without third- or fourth-degree lacerations during the time frame. Duration of second stage between 1 hour and 2 hours (P < 0.0001), duration of second stage greater than 2 hours (P < 0.0001), midline or unknown type episiotomy (P < 0.0001), mediolateral episiotomy (P < 0.0001), vacuum delivery (P < 0.0001), forceps delivery (P < 0.0001), fetal weight greater than 4,000 g (P < 0.0001), and antepartum stress urinary incontinence (P < 0.006) were associated with a significant increase in high-risk lacerations. This study did not find a statistically significant association between parity and these lacerations. CONCLUSIONS: We, as others, found that episiotomy and operative delivery were modifiable risks of obstetrical care. Furthermore, even a short second stage of labor (1-2 hours) was associated with significant risk of injury.

Predicting 30 - Day outcomes in emergency department patients discharged with COVID-19.

INTRODUCTION: Determining disposition for COVID-19 patients can be difficult for emergency medicine clinicians. Previous studies have demonstrated risk factors which predict severe infection and mortality however little is known about which risk factors are associated with failure of outpatient management and subsequent admission for COVID-19 patients. METHODS: We conducted a retrospective observational chart review of patients who had a confirmed positive COVID-19 test collected during an ED visit between March 1, 2020 and October 11, 2020. Patients were divided into two groups based on presence or absence of a subsequent 30-day hospitalization. Clinical and demographic information were collected including chief complaint, triage vital signs and comorbid medical conditions. RESULTS: 1038 patients were seen and discharged from a network ED with a positive SARS-CoV-2 PCR test. 94 patients (9.1%) were admitted to a hospital within 30 days of the index ED visit while 944 (90.9%) were not admitted to a network hospital within 30 days. Patients that were admitted were more likely to be older (aOR = 1.04 (95% CI 1.03-1.06)), hypoxic (aOR = 2.16 (95% CI 1.14-4.10)) and tachycardic (aOR = 2.13 (95% CI 1.34-3.38)) on initial ED presentation. Preexisting hypertension, diabetes mellitus, coronary artery disease, chronic kidney disease and malignancy were all highly significant risk factors for 30-day hospital admission following initial ED discharge (p < 0.0001). CONCLUSION: Emergency Department providers should consider age, chief complaint, vital signs and comorbid medical conditions when determining disposition for patients diagnosed with COVID-19.

The Efficacy of Bamlanivimab in Reducing Emergency Department Visits and Hospitalizations in a Real-world Setting.

Bamlanivimab, a monoclonal antibody targeting the spike protein of severe acute respiratory syndrome coronavirus 2, is available for ambulatory treatment of coronavirus disease 2019 (COVID-19). This real-world study confirms the efficacy of bamlanivimab in reducing hospital admissions and emergency department visits among high-risk outpatients with mild to moderate COVID-19 illness and reveals a trend toward improved mortality.