Objective: Determine the clinical effectiveness of definitive treatment for non-small cell lung cancer (NSCLC) and perform a comparative effectiveness study of the different techniques, between surgical resection of lobectomy, radiation therapy (RT), and stereotactic body radiation (SBRT).

Patients and Methods: This study used data from the SEER Program, with 20,889 patients with Stage IA to IIIC. NSCLC The inclusion criteria were any patient identified from SEER from 2014 to 2016, over 18 years old.

Chi-squared tests were used to evaluate the differences in dichotomous variables between the treatment groups. Unadjusted Kaplan-Meier methods were used to estimate overall survival and cancer-specific survival, and we used log-rank tests to evaluate the differences in time-to-event outcomes. Two-sided p values were used, and significance level was set at 0.05. Adjusted Cox regression models assumed proportional hazards.

Results: A total of 13,760 NSCLC patients with clinical stage IA to IIIC treated with lobectomy were compared with 7,129 patients treated with radiotherapy. Adjusted multivariable Cox proportional hazards models found lobectomy to be associated with significantly better outcomes compared to radiotherapy for both early-stage (hazard ratio, T1N0, 0.31, P<.001) and advanced-stage (hazard ratio, T2N2, 0.43, P<.001). Additionally, patients undergoing lobectomy had improved mean cancer-specific survival for stages IA to IIIC.

Conclusion: Among NSCLC patients with clinical stage IA to IIIC in the SEER Database, surgical resection with lobectomy is associated with significantly improved outcomes compared to definitive radiation. Radiation for early stage disease (SBRT) or combined with chemotherapy for locally advanced-stage disease remains a good treatment option. However, when medical comorbidities and tumor characteristics permit, surgical resection should be pursued. For patients with unresectable disease, this study supports the consideration of chemoradiation as a tool to enable downstaging to achieve surgical resection.

Recent reconceptualizations of health literacy have expanded beyond traditional literacy and numeracy skills to look more broadly at how patients interact within the healthcare environment. With the widespread use of the internet for health information, health literacy needs to be reframed to include eHealth literacy skills required to find, evaluate, and apply electronic health information to solve health problems. There is only one instrument to measure eHealth literacy, the eHealth Literacy Scale (eHEALS), and this instrument was originally validated in a group of high school students without disease. This study reevaluated the reliability and validity of the 8-item eHEALS in an adult outpatient population. Attention was paid to determine whether subdimensions existed within eHEALS that could be used to develop subscales to better categorize eHealth literacy deficiencies, and to further understand associations between low eHealth literacy, patient characteristics, and health-related internet use. Varimax rotated factor analysis provided preliminary evidence to support two eHealth Literacy subscales: Utilizing info & Evaluating info. A multivariate linear regression model revealed statistically significant associations between low eHealth Literacy and patient characteristics including age, education, and access to smart phones. Furthermore, eHEALS demonstrated convergent validity in relation to the use of high quality websites. The likelihood of using high quality websites was significantly lower (OR = 0.26; 95% CI, 0.08 - 0.83; P = .02) for patients with low eHealth Literacy. Further research is needed to improve the eHealth Literacy Scale to better categorize patient deficits in finding, evaluating, and applying electronic health information to solve health problems.

IntroductionEndoscopy performance is highly variable among fellows and practicing physicians.1,2 The field lacks a standard endoscopy training curriculum. Moreover, the traditional training under the apprenticeship model has proven to be a slow and ineffective method. Trainees who underwent a simulation-based mastery learning (SBML) curriculum accelerated their acquisition of clinical competency, 2.5x faster than trainees who received traditional training under the apprenticeship model.3 During the COVID-19 pandemic, we adapted our SBML curriculum to train upper endoscopy (esophagogastroduodenoscopy [EGD]) to novice gastroenterology trainees through online virtual coaching. Herein, we performed a hypothesis-generating study to evaluate the effectiveness of SBML-based EGD training, comparing virtual to direct in-person coaching.

MethodsWe conducted a 7-day virtual SBML course across 7 academic centers in the USA and Asia. A minimum passing standard was set for each topic. Theoretical material was delivered using Canvas, an online learning management system. For technical skills training, a virtual coach supervised hand-on training at scheduled intervals. At the end of training, an independent rater assessed the trainees skills using a validated scoring system. After the course, we assessed the trainees’ clinical performance for the first 30 EGDs using the Assessment of Competency of Endoscopy (ACE) form. We compared the trainees’ scores to that of our historical control cohort trained using in-person SBML training. Our primary outcomes were competence scores on the written exam, endoscope tip control, standard EGD. Our secondary outcome was clinical EGD evaluations. We used non-inferiority t-test statistics and Fisher’s exact test.

ResultsThe virtual coaching group received similar scores as the direct coaching group for the written assessment (virtual coaching 81.9%+8.9% vs direct coaching 78.3%+8.2%, p=0.385). For endoscope handling analysis, the trainees reached the MPS for competency after 31.4+29.1 attempts and mastery after 51.9+36.7 attempts, similar to the control cohort that had undergone the training with direct coaching (competency: 32.5+22.8, p=0.93; mastery: 38.2+31.1, p=0.42). For Standard EGD, the mean scores for the general assessment of the UGI tract were similar between the intervention and control groups (4.6+0.6 vs 4.7+0.5, p=1.00). For clinical EGDs, there were no significant differences in scores for EGD 1-5, 11-15, 16-20, 21-25, and 26-30. For EGDs 6-10, the virtual coaching cohort performed significantly better than the direct coaching cohort (2.73+0.59 vs 1.65+0.59, p<0.001).

DiscussionThe COVID-19 pandemic shifted the way we deliver endoscopy training. An SBML curriculum, delivered through virtual coaching, shows significant promise in effectively teaching novice GI trainees how to perform upper endoscopy. Moreover, SBML with virtual coaching allows trainees to learn from experts despite geographical constraints and other barriers to high-quality training. This program has the potential to improve patient safety and training efficiency compared to traditional apprentice-based training methods. We recommend a future randomized controlled trial, with a robust clinical evaluation strategy, to better understand the feasibility and effectiveness of virtual training.

Objectives: Hyaluronan is a component of the anti-adhesive barrier HA-CMC and has been implicated in tumor growth and metastasis. The study aim was to determine if HA-CMC use is associated with adverse effects on disease progression or survival in patients undergoing surgical cytoreduction for primary treatment of advanced ovarian, fallopian tube, and peritoneal cancers.

Methods: Retrospective cohort study of patients undergoing optimal or complete cytoreduction between 1/95-12/08. The primary endpoints were progression free survival (PFS) and overall survival (OS). Fisher's exact test, Kaplan Meier survival analysis, and multivariate Cox proportional hazards regression were utilized.

Results: Two hundred eighty-eight cases were analyzed; HA-CMC was utilized in 130 procedures (45%). On univariate analysis, HA-CMC was associated with complete cytoreduction, high surgical complexity score, good performance-status, and being alive at last follow-up (all p<0.01). Neither PFS nor OS was significantly different between subjects with or without HA-CMC (median PFS 16.8 vs 16.4 months, p=0.36; median OS 40.6 vs 36 months, P=0.33). PFS was significantly shorter amongst high-risk subjects, independent of HA-CMC use, with age >50, Stage IV disease, PS >1, visible residual disease, or interval cytoreduction (all p<0.05). Additionally, major postoperative complications and platinum resistance were associated with shorter OS (p<0.05). After controlling for confounding factors using multivariate Cox proportional hazards regression, HA-CMC use did not independently predict PFS (HR 1.1; 95% CI:0.83-1.45) or OS (HR 0.98; 95% CI:0.73-1.32).

Conclusions: HA-CMC adhesion barrier placement at the time of primary or interval cytoreductive surgery for ovarian, fallopian tube, and peritoneal cancer does not impact recurrence or survival outcomes.

Background: Therapeutic Drug Monitoring is part of standard patient care and utilizes pharmacokinetic tests to measure trough drug levels in patients to guide patient therapy. Studies have suggested improved patient outcomes can be achieved by maintaining a target therapeutic trough concentration of drug through individualized patient dosage. However, the association between drug concentration in serum and patient outcomes is still poorly understood.

Objectives: Evaluate the association between serum drug levels, disease activity, and patient characteristics. Identify if an optimal therapeutic drug level in serum is associated with lower disease activity. Evaluate whether elevated drug levels in serum increase immune response against drug.

Design, setting, and participants: The study is a retrospective cohort study. Eligible study participants were identified through the arthritis internet registry from 2011 through 2016. The study included a total of 57 patients, 47 female and 10 males, 30 to 81 years of age, clinically diagnosed with rheumatoid arthritis and being treated with infliximab drug.

Methods: The study is a retrospective cohort study. Patient characteristics and disease outcomes were compared using independent sample t-tests for continuous variables and x2 tests for categorical variables. Regression analysis was conducted to establish the correlation between disease activity and drug level in serum.

Results: Therapeutic drug monitoring (TDM) guidelines for Infliximab trough levels for maintenance therapy did not show association with patient outcomes. Current Therapeutic drug monitoring (TDM) guidelines individualizing patient therapy show no difference in clinical or biological remission between patients maintaining recommended trough guidelines and those who do not. A significant association was observed between drug trough levels above 5 mcg/mL and anti-drug antibody levels. The results suggest that patients maintaining drug levels above 5 mcg/mL are less likely to develop anti-drug antibodies (p=0.020).

Discussion: TDM may benefit in individualizing patient dosage to maintain target drug levels to reduce immune response against anti-drug antibodies. However, a significant association between disease activity and trough drug levels was not observed

Introduction: Traumatic brain injuries (TBI) are a leading cause of mortality and morbidity. The Glasgow Coma Scale (GCS) is a clinical TBI severity grading system. CT scanning has also become a sensitive diagnostic tool in assessing TBIs. Currently, there is a widely varied practice in evaluation of patients with mild TBIs. We hypothesize that patients with an initially positive head CT and stable GCS (15) are less likely to have positive repeat CTs than patients who’s GCS has dropped below 15.

Methods: A 5 year retrospective analysis was done (Jan 2007-Dec 2011). Data points included ISS, ICU LOS, Hospital LOS, initial GCS, first head CT scan, lowest GCS between scans, and treatment after 2nd CT. Positive CT findings were considered an increase in contusion, bleed, edema, midline shift, or a new bleed.

Results: In 369 patients, those with a stable GCS (15) were less likely to have a positive repeat CT scan than patients who whose GCS dropped (12.9% vs. 24.9%, p<.01). They also tended to require less Interventions (0.8% vs. 4.0% , p=0.09). Unchanged patients were more likely to have a lower ISS (14 vs. 17, p<.01), ICU LOS (2 vs. 3 days, P<.01), and Hospital LOS ( 4 vs. 6, P<.01).

Conclusion: CT scans are a rapid, non-invasive diagnostic tool that can accurately diagnose a patient’s intracranial status. Our study shows that most patients who have initially positive CT scans and maintain a stable GCS of 15 can still safely forego the cost and radiation exposure of repeated scans.

This paper presents responses to a survey developed to gauge providers’ perceptions of telehealth during the COVID-19 pandemic. The survey was developed by faculty at the University of California, Irvine’s Health Policy and Research Institute following semi-structured discussions with focus group participants. A final draft survey was distributed to mostly primary care clinicians. Responses indicated overall favorable perceptions of telehealth. Notable perceived challenges including care by telehealth of medically complex patients, patients with language barriers, and patients with poor access or understanding of technology. Continued evaluation and revision of the survey measure will be needed to improve its generalizability and appropriateness for distribution to a larger participant group.

Objective To examine the microbiology and outcomes related to bloodstream infections (BSIs) in neonates with intestinal failure (IF) due to necrotizing enterocolitis (NEC).

Study Design I performed a retrospective review of very low birth weight (VLBW) neonates with late-onset BSI at a single center over 8.5 years. Recurrence and frequencies of BSI pathogens were compared between neonates with and without IF. Pathogen frequencies and mortality were compared for NEC-associated BSI (≤72 hours from NEC diagnosis) and post-NEC BSI (>72 hours after NEC diagnosis) in neonates with and without IF.

Results 177 neonates with 234 BSIs were studied. Compared to other VLBW neonates with BSI, IF patients (n=45) suffered more often from recurrent BSI (44% vs. 20%, p=0.01), and frequently had gut-bacteria BSI (51% vs. 28%, p=0.01). NEC-associated BSIs in IF patients had similar pathogen profiles to BSIs in other VLWB neonates, while post-NEC BSIs in IF patients were more commonly due to gut bacteria (48% vs. 23%, p<0.00). Mortality for IF patients with post-NEC BSI was the same as for the cohort as a whole (17%). IF patients with NEC-associated BSI had higher odds of death (OR 3.9) than other neonates (35% vs. 15%, p=0.02).

Conclusions IF patients commonly have recurrent BSI and gut-bacteria BSI. The microbiologic etiology of post-NEC BSI in neonates with IF is different from BSI in other VLBW neonates, and is more commonly of gut origin. IF patients with NEC-associated BSI have a significantly higher odds of death than other VLBW neonates with BSI.

Objective: To study children’s self-reporting health measures, as obtained from the Child Health Ratings Inventories (CHRIs) tool, according to race/ethnicity and/or socioeconomic status in order to understand and better improve the health quality of the pediatric patient population.

Patients and Methods: Longitudinal data was collected from a larger PCORI study developing and testing an animated computer survey, termed CHRIs, for the measurement of health amongst children. Pediatric surgical patients (4-12 years old) were surveyed with the CHRIs tool at three specific timepoints (pre-surgery, 2-days post, and 7-days post-surgery) to better understand their health status before and after their surgical procedure. The surveys inquired into the functional capacity or quality of life of the pediatric patients, who were read survey questions and then were able to select from survey responses represented as animations that illustrate the various possible health statuses. An aggregated dataset at the baseline timepoint, along with demographic information obtained from surveying of accompanying parents, were used for the analyses. The primary variables of education and annual income were used to create a composite variable that then was analyzed as a binary grouping variable called socioeconomic status (SES). The racial/ethnic profile of the pediatric population was examined in a binary manner as well -Hispanic or Non-Hispanic. From which, a composite variable examining both race/ethnicity and SES was developed and utilized in comprehending how children’s self-reported health measures may vary based on such.

Results: SES was distinguished as low or high depending on the respective education and income metrics reported from the pediatric patients’ guardians. Race/ethnicity was differentiated as either Hispanic or Non-Hispanic, in which there were no identified confounding variables in choosing to group all racial/ethnic groups, excluding Hispanics, as a mixed categorical variable. In total, all racial/ethnic groups, other than Hispanics, represented a lower sample size as compared to the Hispanic only group, and no major differences were observed when comparing Non-Hispanic White only to the mixed grouping of Non-Hispanics, which was inclusive of Whites, Asians, and other minorities. To maintain the dataset with as much of the patient population captured, the holistic Non-Hispanic group was utilized for racial/ethnic comparisons against Hispanics. Overall, pediatric patients who identified as either Low SES or Hispanic were more likely to report lower CHRIs health measures scores, thus poorer health, than their High SES or Non-Hispanic counterparts. Further, pediatric patients, who were Low SES and Hispanic, tended to report the worst health as compared to those who were Low SES Non-Hispanic, High SES Hispanic, or High SES Non-Hispanic.

Conclusions: There is a demonstrated relationship between race/ethnicity and SES, in which the two variables intersect and impact one another. Trends suggest that being Low SES or Hispanic results in poorer health than the counterparts of being High SES or Non-Hispanic. When examining both SES and race/ethnicity together, being Hispanic and of Low SES suggests lower health reporting. The analyses of race/ethnicity and SES with regards to child’s reporting of health demonstrates how considering the context and the demographic profile of patients through categorical variables, like race/ethnicity and SES, lend to better understanding of their health status. There is utility in self-reporting mechanisms, like the CHRIs tool, in which direct reporting from vulnerable populations, such as children, can allow for more targeted health diagnoses and better treatment plans.

Background: Hospital readmissions are burdensome to patients and costly to the healthcare system. Readmissions may be the result of poor transitional care and targeted interventions may help prevent unnecessary hospitalizations. Identifying patients that are at high risk for hospital readmission could help hospitals focus their resources towards preventing these events.

Methods: In a retrospective study at the University of California, Irvine Medical Center, multiple patient-level variables, including the LACE index and HOSPITAL score, were collected on patient admissions from February 1, 2017 to April 30, 2017 to determine which variables were significant predictors of 30-day hospital readmission.

Results: The analysis included data for 827 discharges within the study period. The prediction model using the LACE index demonstrated a C-statistic of 0.83 (95% CI, 0.81-0.86). The C-statistic for the model using the HOSPITAL score was 0.77 (95% CI, 0.74-0.80). A prediction model that utilized the LACE index, plus two other significant variables (number of hospital admissions within the previous 12 months and presence of an abnormal vital sign within 24 hours of discharge), demonstrated a C-statistic of 0.91 (95% CI, 0.89-0.93). The Hosmer-Lemeshow goodness of fit test for the LACE “plus” model had a chi-squared value of 1.63 with a p-value of 0.99. The HOSPITAL score, plus three additional significant variables (the Charlson Comorbidity Index, discharge by the Hospitalist service, and an abnormal vital sign within 24 hours of discharge), showed a C-statistic of 0.88 (95% CI, 0.85-0.90). The Hosmer-Lemeshow goodness of fit test for the HOSPITAL “plus” model had a chi-squared value of 10.99 with a p-value of 0.20.

Interpretation: Both the LACE index and HOSPITAL score performed well in predicting hospital readmissions in this retrospective study. The addition of other significant variables to these scores improved the discrimination of the prediction models, suggesting that the addition of other variables may improve the ability of these scores to predict 30-day hospital readmissions.