Mi Puente (My Bridge) Care Transitions Program for Hispanic/Latino Adults with Multimorbidity: Results of a Randomized Controlled Trial.

BACKGROUND: Multimorbidity frequently co-occurs with behavioral health concerns and leads to increased healthcare costs and reduced quality and quantity of life. Unplanned readmissions are a primary driver of high healthcare costs. OBJECTIVE: We tested the effectiveness of a culturally appropriate care transitions program for Latino adults with multiple cardiometabolic conditions and behavioral health concerns in reducing hospital utilization and improving patient-reported outcomes. DESIGN: Randomized, controlled, single-blind parallel-groups. PARTICIPANTS: Hispanic/Latino adults (N=536; 75% of those screened and eligible; M=62.3 years (SD=13.9); 48% women; 73% born in Mexico) with multiple chronic cardiometabolic conditions and at least one behavioral health concern (e.g., depression symptoms, alcohol misuse) hospitalized at a hospital that serves a large, mostly Hispanic/Latino, low-income population. INTERVENTIONS: Usual care (UC) involved best-practice discharge processes (e.g., discharge instructions, assistance with appointments). Mi Puente ("My Bridge"; MP) was a culturally appropriate program of UC plus inpatient and telephone encounters with a behavioral health nurse and community mentor team who addressed participants' social, medical, and behavioral health needs. MAIN MEASURES: The primary outcome was 30- and 180-day readmissions (inpatient, emergency, and observation visits). Patient-reported outcomes (quality of life, patient activation) and healthcare use were also examined. KEY RESULTS: In intention-to-treat models, the MP group evidenced a higher rate of recurrent hospitalization (15.9%) versus UC (9.4%) (OR=1.91 (95% CI 1.09, 3.33)), and a greater number of recurrent hospitalizations (M=0.20 (SD=0.49) MP versus 0.12 (SD=0.45) UC; P=0.02) at 30 days. Similar trends were observed at 180 days. Both groups showed improved patient-reported outcomes, with no advantage in the Mi Puente group. Results were similar in per protocol analyses. CONCLUSIONS: In this at-risk population, the MP group experienced increased hospital utilization and did not demonstrate an advantage in improved patient-reported outcomes, relative to UC. Possible reasons for these unexpected findings are discussed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02723019. Registered on 30 March 2016.

Importance of sex and trauma context on circulating cytokines and amygdalar GABAergic signaling in a comorbid model of posttraumatic stress and alcohol use disorders.

Alcohol use disorder (AUD) and anxiety disorders are frequently comorbid and share mechanisms that could be therapeutic targets. To facilitate mechanistic studies, we adapted an inhibitory avoidance-based "2-hit" rat model of posttraumatic stress disorder (PTSD) and identified predictors and biomarkers of comorbid alcohol (ethanol)/PTSD-like symptoms in these animals. Stressed Wistar rats received a single footshock on two occasions. The first footshock occurred when rats crossed into the dark chamber of a shuttle box. Forty-eight hours later, rats received the second footshock in a familiar (FAM) or novel (NOV) context. Rats then received 4 weeks of two-bottle choice (2BC) ethanol access. During subsequent abstinence, PTSD-like behavior responses, GABAergic synaptic transmission in the central amygdala (CeA), and circulating cytokine levels were measured. FAM and NOV stress more effectively increased 2BC drinking in males and females, respectively. Stressed male rats, especially drinking-vulnerable individuals (≥0.8 g/kg average 2-h ethanol intake with >50% ethanol preference), showed higher fear overgeneralization in novel contexts, increased GABAergic transmission in the CeA, and a profile of increased G-CSF, GM-CSF, IL-13, IL-6, IL-17a, leptin, and IL-4 that discriminated between stress context (NOV > FAM > Control). However, drinking-resilient males showed the highest G-CSF, IL-13, and leptin levels. Stressed females showed increased acoustic startle and decreased sleep maintenance, indicative of hyperarousal, with increased CeA GABAergic transmission in NOV females. This paradigm promotes key features of PTSD, including hyperarousal, fear generalization, avoidance, and sleep disturbance, with comorbid ethanol intake, in a sex-specific fashion that approximates clinical comorbidities better than existing models, and identifies increased CeA GABAergic signaling and a distinct pro-hematopoietic, proinflammatory, and pro-atopic cytokine profile that may aid in treatment.

An observational study of hospitalized COVID-19 patients with cancer in San Diego county.

Aim: To delineate clinical correlates of COVID-19 infection severity in hospitalized patients with malignancy. Methods: The authors conducted a retrospective review of all hospitalized patients with a hematologic and/or solid tumor malignancy presenting to the authors' institution between 1 March 2020 and 5 January 2021, with a laboratory confirmed diagnosis of COVID-19. Univariate and multivariate logistic regression analyses were used to determine associations between specific severity outcomes and clinical characteristics. Results: Among 2771 hospitalized patients with COVID-19, 246 (8.88%) met inclusion criteria. Patients who were actively receiving treatment had an increased rate of death following admission (odds ratio [OR]: 2.7). After adjusting for significant covariates, the odds ratio increased to 4.4. Patients with cancer involvement of the lungs had a trend toward increased odds of death after adjusting for covariates (OR: 2.3). Conclusions: Among COVID-19 positive hospitalized cancer patients, systemic anti-cancer therapy was associated with significantly increased odds of mortality.

Plain language summary Though cancer is a biologically heterogenous disease with a wide spectrum of clinical features and behavior, accumulating evidence suggests that cancer patients are at greater susceptibility to COVID-19 infection and more likely to experience morbidity and mortality from COVID-19 infection than non-cancer patients. In this study, the authors reviewed the clinical characteristics of patients with a diagnosis of cancer hospitalized with COVID-19 to assess potential correlates of COVID-19 severity in this population. Notably, analysis of the hospital data revealed a statistically significant increased incidence of mortality in cancer patients who were receiving systemic anti-cancer treatment, including chemotherapy, immunotherapy or targeted therapy, than in those not on therapy. Likewise, there was a trend toward increased mortality in those with either primary or metastatic tumor involvement of the lung compared with those without lung involvement.

Outcomes of Simplified Lung Ultrasound Exam in COVID-19: Implications for Self-Imaging.

OBJECTIVES: Lung ultrasound B-lines represent interstitial thickening or edema and relate to mortality in COVID-19. As B-lines can be detected with minimal training using point-of-care ultrasound (POCUS), we examined the frequency, clinical associations, and outcomes of B-lines when found using a simplified POCUS method in acutely ill patients with COVID-19. METHODS: In this retrospective cohort study, hospital data from COVID-19 patients who had undergone lung imaging during standard echocardiography or POCUS were reviewed for an ultrasound lung comet (ULC) sign, defined as the presence of ≥3 B-lines from images of only the antero-apex of either lung (ULC+). Clinical risk factors, oximetry and radiographic results, and disease severity were analyzed for associations with ULC+. Clinical risk factors and ULC+ were analyzed for associations with hospital mortality or the need for intensive care in multivariable models. RESULTS: Of N = 160 patients, age (mean ± standard deviation) was 64.8 ± 15.5 years, and 46 (29%) died. ULC+ was present in 100/160 (62%) of patients overall, in 81/103 (79%) of severe-or-greater disease versus 19/57 (33%) of moderate-or-less disease (P < .0001) and was associated with mortality (odds ratio [OR] = 2.4 [95% confidence interval [CI]: 1.1-5.4], P = .02) and the need for intensive care (OR = 5.23 [95% CI: 2.42-12.40], P < .0001). In the multivariable models, symptom duration and severe-or-greater disease were associated with ULC+, and ULC+, diabetes, and symptom duration were associated with the need for intensive care. CONCLUSIONS: B-lines in the upper chest were common and related to disease severity, intensive care, and hospital mortality in COVID-19. Validation of a simplified lung POCUS exam could provide the evidence basis for a self-imaging application during the pandemic.

Impact of Nares Swabs in the Operative Management of Distal Lower Extremity Infections.

Associations between nares surveillance cultures and lower extremity wound cultures remains a topic of discussion in the literature and in clinical practice. Reports are limited due to the questionable accuracy of bedside foot cultures. A retrospective review of our institution's lower extremity wounds requiring surgical management distal to the tibial tuberosity was conducted. Deep intraoperative tissue cultures collected in a sterile operating field were referenced against nares cultures from the same hospitalization. Accuracy, sensitivity, and specificity of nares cultures for predicting methicillin-resistant Staphylococcus aureus (MRSA) infection were determined. Four hundred and forty unique patients with both nares and wound cultures met inclusion criteria. Comorbid diagnoses revealed 66.82%, 30.68%, and 32.27% of patients had diabetes mellitus, chronic kidney disease, and/or peripheral arterial disease, respectively. Sensitivity and specificity were found to be 53.13% and 96.13%, respectively. Prevalence of MRSA in a lower extremity wound was 14.9%, and accuracy of nares culture was 90.04% (CI: 86.91%-92.65%). A review of 30 false negative cases was conducted. Using exclusion criteria of a hospital admission within 60 days of presentation, history of MRSA infection, and/or presentation from a long-term care facility, negative predictive value of MRSA nares colonization was 99.51%. A case of necrotizing fasciitis accounted for one outlier. This data demonstrates that nares surveillance swabs have excellent diagnostic performance in ruling out MRSA infections in foot and ankle wounds. Further analysis is required to determine whether this performance is improved in specialized subgroups or dependent on temporal proximity.

Sex and context differences in the effects of trauma on comorbid alcohol use and post-traumatic stress phenotypes in actively drinking rats.

Alcohol use disorder (AUD) and affective disorders are frequently comorbid and share underlying mechanisms that could be targets for comprehensive treatment. Post-traumatic stress disorder (PTSD) has high comorbidity with AUD, but comprehensive models of this overlap are nascent. We recently characterized a model of comorbid AUD and PTSD-like symptoms, wherein stressed rats receive an inhibitory avoidance (IA)-related footshock on two occasions followed by two-bottle choice (2BC) voluntary alcohol drinking. Stressed rats received the second footshock in a familiar (FAM, same IA box as the first footshock) or novel context (NOV, single-chambered apparatus); the FAM paradigm more effectively increased alcohol drinking in males and the NOV paradigm in females. During abstinence, stressed males displayed avoidance-like PTSD symptoms, and females showed hyperarousal-like PTSD symptoms. Rats in the model had altered spontaneous action potential-independent GABAergic transmission in the central amygdala (CeA), a brain region key in alcohol dependence and stress-related signaling. However, PTSD sufferers may have alcohol experience prior to their trauma. Here, we therefore modified our AUD/PTSD comorbidity model to provide 3 weeks of intermittent extended alcohol access before footshock and then studied the effects of NOV and FAM stress on drinking and PTSD phenotypes. NOV stress suppressed the escalation of alcohol intake and preference seen in male controls, but no stress effects were seen on drinking in females. Additionally, NOV males had decreased action potential-independent presynaptic GABA release and delayed postsynaptic GABAA receptor kinetics in the CeA compared to control and FAM males. Despite these changes to alcohol intake and CeA GABA signaling, stressed rats showed broadly similar anxiogenic-like behaviors to our previous comorbid model, suggesting decoupling of the PTSD symptoms from the AUD vulnerability for some of these animals. The collective results show the importance of alcohol history and trauma context in vulnerability to comorbid AUD/PTSD-like symptoms.

Provider recommendations and maternal practices when providing breast milk to children with immunoglobulin E-mediated food allergy.

BACKGROUND: There is limited research investigating maternal dietary practices and health care provider recommendations when providing breast milk (BM) to children with immunoglobulin (Ig) E-mediated food allergy. OBJECTIVE: To explore health care provider recommendations and maternal practices when providing BM to children with IgE-mediated food allergy and to assess for possible IgE-mediated reactions to BM while the mother consumed the food to which her child has allergy. METHODS: A web-based survey was distributed to breastfeeding (BF) mothers of children with IgE-mediated food allergies. Reported reactions to BM were scored by an allergist, provided only with the details of the possible reaction and not the suspect allergen or route of exposure, as to the likelihood that the reaction was IgE mediated. RESULTS: A total of 133 mothers completed the survey. After food allergy diagnosis, 47.4% (n = 63) of the mothers reported that they were advised by their health care provider to continue BF without dietary restriction, 17.3% (n = 23) were advised to avoid eating the food(s) their child has allergy to while BF, and in 28.6% (n = 38), this concern was not addressed. A few of the mothers (12%, 16/133) reported that their child experienced an allergic reaction to BM. An allergist evaluated most of these reactions (75%, 12/16) as not likely IgE mediated. CONCLUSION: This study exposed inconsistent recommendations for mothers providing BM to children with IgE-mediated food allergies. Most mothers were able to consume the food their child has allergy to without adverse sequelae. Standardized, evidence-based recommendations would enhance the well-being of these mother-infant dyads.

Medical Assistant Health Coaching for Type 2 Diabetes in Primary Care: Results From a Pragmatic Cluster Randomized Controlled Trial.

OBJECTIVE: This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance-based health system (Scripps Health). RESEARCH DESIGN AND METHODS: A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). RESULTS: All clinical outcomes improved significantly over 1 year in the overall sample (P < 0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = -0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = -1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. CONCLUSIONS: This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings.

Outcomes of the Dulce Digital-COVID Aware (DD-CA) discharge texting platform for US/Mexico border Hispanic individuals with diabetes.

BACKGROUND: Hispanic individuals have higher type 2 diabetes (T2D) prevalence, poorer outcomes, and are disproportionately affected by COVID-19. Culturally-tailored, diabetes educational text messaging has previously improved HbA1c in this population. METHODS: During the pandemic, hospitalized Hispanic adults with T2D (N = 172) were randomized to receive Dulce Digital-COVID Aware ("DD-CA") texting platform upon discharge plus diabetes transition service (DTS) or DTS alone. DD-CA includes diabetes educational messaging with additional COVID-safe messaging (e.g., promoting masking; social distancing; vaccination). FINDINGS: Among adults with poorly-controlled diabetes (Mean HbA1c = 9.6 ± 2.2 %), DD-CA did not reduce 30- or 90-day readmissions compared to standard care (28 % vs 15 %, p = .06; 37 % vs 35 %, p = .9, respectively). However, the improvement in HbA1c was larger among those in the DD-CA compared to DTS at 3 months (n = 56; -2.69 % vs. -1.45 %, p = .0496) with reduced effect at 6 months (n = 64; -2.03 % vs -0.91 %, p = .07). Low follow-up completion rates and the addition of covariates (to control for baseline group differences that existed despite randomization) impacted statistical power. INTERPRETATION: During the pandemic, DD-CA offered an alternative digital approach to diabetes and COVID education and support for a high-risk Hispanic population and achieved trends toward improvement in glycemic control despite relatively low engagement and not reducing hospital readmissions.

Effects of antineoplastic and immunomodulating agents on postvaccination SARS-CoV-2 breakthrough infections, antibody response, and serological cytokine profile.

BACKGROUND: Despite immunization, patients on antineoplastic and immunomodulating agents have a heightened risk of COVID-19 infection. However, accurately attributing this risk to specific medications remains challenging. METHODS: An observational cohort study from December 11, 2020 to September 22, 2022, within a large healthcare system in San Diego, California, USA was designed to identify medications associated with greatest risk of postimmunization SARS-CoV-2 infection. Adults prescribed WHO Anatomical Therapeutic Chemical (ATC) classified antineoplastic and immunomodulating medications were matched (by age, sex, race, and number of immunizations) with control patients not prescribed these medications yielding a population of 26 724 patients for analysis. From this population, 218 blood samples were collected from an enrolled subset to assess serological response and cytokine profile in relation to immunization. RESULTS: Prescription of WHO ATC classified antineoplastic and immunomodulatory agents was associated with elevated postimmunization SARS-CoV-2 infection risk (HR 1.50, 95% CI 1.38 to 1.63). While multiple immunization doses demonstrated a decreased association with postimmunization SARS-CoV-2 infection risk, antineoplastic and immunomodulatory treated patients with four doses remained at heightened risk (HR 1.23, 95% CI 1.06 to 1.43). Risk variation was identified among medication subclasses, with PD-1/PD-L1 inhibiting monoclonal antibodies, calcineurin inhibitors, and CD20 monoclonal antibody inhibitors identified to associate with increased risk of postimmunization SARS-CoV-2 infection. Antineoplastic and immunomodulatory treated patients also displayed a reduced IgG antibody response to SARS-CoV-2 epitopes alongside a unique serum cytokine profile. CONCLUSIONS: Antineoplastic and immunomodulating medications associate with an elevated risk of postimmunization SARS-CoV-2 infection in a drug-specific manner. This comprehensive, unbiased analysis of all WHO ATC classified antineoplastic and immunomodulating medications identifies medications associated with greatest risk. These findings are crucial in guiding and refining vaccination strategies for patients prescribed these treatments, ensuring optimized protection for this susceptible population in future COVID-19 variant surges and potentially for other RNA immunization targets.

Do patients with metastatic pancreatic adenocarcinoma to the lung have improved survival?

INTRODUCTION: Pancreatic ductal adenocarcinoma (PDAC) is a genetically heterogeneous disease often diagnosed with synchronous metastatic disease involving the liver. Tumors with extra-abdominal spread that bypass the liver are thought to represent a unique molecular subgroup and those with isolated pulmonary metastatic disease are thought to have a more favorable clinical phenotype. METHOD: We conducted a retrospective review of patients with pathologically confirmed PDAC treated between the years 2007 and 2020 at a Scripps Health hospital. The final study sample (N = 205) included patients with isolated pulmonary metastasis (IL), isolated liver metastasis or synchronous liver and lung metastasis (LL), or metastasis to any site other than the liver or lung (NLL). Primary endpoint was overall survival (OS). Progression-free survival (PFS) and recurrence-free survival (RFS) were analyzed as secondary endpoints. Each survival outcome was analyzed using Cox proportional hazards tests. RESULTS: No statistically significant differences were seen between the three groups in OS, PFS, or RFS. Median OS for the IL group was 561 days, 341 days for the LL group, and 441 days for the NLL group. Median RFS was 748 days for the IL group, 574 days for the LL group, and 545 days for the NLL group. Median PFS was 307 for the IL group, 236 for the LL group, and 265 for the NLL group. When comparing only the IL and LL groups, a statistically significant difference in OS was seen favoring the IL group (HR1.59 LL vs IL [ref], CI 1.04-2.41, p = 0.031) CONCLUSION: Though statistically significant differences in survival outcomes were not seen in our population, there was a trend toward improved survival for patients with isolated lung metastases. When comparing only the IL to LL group, statistically significant overall survival favoring the IL group was seen. These findings highlight a potential prognostic indicator of metastatic PDAC.

Actigraphy-based sleep and activity measurements in intensive care unit patients randomized to ramelteon or placebo for delirium prevention.

Patients in the ICU often sleep poorly for various reasons, which may predispose to delirium. We previously conducted a clinical trial in which we tested the efficacy of ramelteon, a melatonin-receptor agonist used to treat insomnia, versus placebo, in preventing ICU delirium in patients who underwent elective pulmonary thromboendarterectomy (PTE) surgery. Here we examine sleep, activity, and circadian patterns, measured with actigraphy, to understand changes in these metrics with our intervention and in those with and without delirium. Participants wore wrist actigraphy devices while recovering post-operatively in the ICU. For sleep analysis, we extracted total sleep time and sleep fragmentation metrics over the 22:00 to 06:00 period nightly, and daytime nap duration from the daytime period (0:600 to 22:00) for each participant. For activity analyses, we extracted the following metrics: total daytime activity count (AC), maximum daytime AC, total nighttime AC, and maximum nighttime AC. Next, we performed a nonparametric circadian analysis on ACs over each 24-h day and extracted the following: interdaily stability (IS), intra-daily variability (IV), relative amplitude (RA), and low and high periods of activity (L5 and M10) as well as their start times. These metrics were compared between patients who received ramelteon versus placebo, and between patients who became delirious versus those who did not develop delirium. We additionally made comparisons between groups for daytime and nighttime light levels. No differences in sleep, activity, circadian metrics or light levels were found between drug groups. Delirious patients, when compared to those who were never delirious, had a lower IS (0.35 ± 0.16 vs. 0.47 ± 0.23; P = 0.006). Otherewise, no differences in IV, L5, M10, or RA were found between groups. L5 and M10 activity values increased significantly over the post-extubation for the whole cohort. No differences were found for daytime or nighttime light levels between groups. Overall, ramelteon did not impact sleep or circadian metrics in this cohort. Consistent with clinical experience, delirious patients had less inter-daily stability in their rest-activity rhythms. These data suggest that actigraphy might have value for individual assessment of sleep in the ICU, and for determining and detecting the impact of interventions directed at improving sleep and circadian activity rhythms in the ICU.Trial registration: REGISTERED at CLINICALTRIALS.GOV: NCT02691013. Registered on February 24, 2016 by principal investigator, Dr. Robert L. Owens.

Real-Time Continuous Glucose Monitoring in the Hospital: A Real-World Experience.

BACKGROUND: Glycemic control in the hospital setting is imperative for improving outcomes among patients with diabetes. Bedside point-of-care (POC) glucose monitoring has remained the gold standard for decades, while only providing momentary glimpses into a patient's glycemic control. Continuous glucose monitoring (CGM) has been shown to improve glycemic control in the ambulatory setting. However, a paucity of inpatient experience and data remains a barrier to US Food and Drug Administration (FDA) approval and expanded/non-research use in the hospital setting. METHOD: Amid the COVID-19 pandemic, the FDA exercised its enforcement discretion to not object to the use of CGM systems for the treatment of patients in hospital settings to support COVID-19 health care-related efforts to reduce viral exposure of health care workers. Following this announcement, Scripps Health, a large not-for-profit health care system in San Diego, California, implemented CGM as the new "standard of care" (CGM as SOC) for glucose monitoring and management in the hospital. RESULTS: The present report serves to (1) detail the implementation procedures for employing this new SOC; (2) describe the patients receiving CGM as SOC, their glycemic control, and hospital outcomes; and (3) share lessons learned over two years and nearly 900 hospital encounters involving CGM. CONCLUSIONS: Here, we conclude that CGM is feasible in the hospital setting by using a dedicated diabetes care team and the CGM technology with remote monitoring.

Neoadjuvant chemotherapy and radiotherapy outcomes in borderline-resectable and locally-advanced pancreatic cancer patients.

BACKGROUND: There is no agreed upon standard of care for borderline-resectable pancreatic cancer (BRPC) or locally-advanced pancreatic cancer (LAPC) patients regarding the benefit of chemotherapy or radiation alone or in combination. PATIENTS AND METHODS: We completed a retrospective cohort analysis of BRPC and LAPC patients at a cancer center with expertise in multi-disciplinary pancreatic ductal adenocarcinoma (PDAC) treatment over a 5-year period from 03/01/2014 to 03/01/2019 (cut-off date). The total evaluable newly diagnosed, treatment naïve, BRPC, and LAPC patients with adequate organ function and ability to obtain treatment after multidisciplinary review was 52 patients. After analysis, patients were evaluated for rates of resection, extent of resection (R0 or R1), median progression-free survival (mPFS), and median overall survival (mOS). RESULTS: Patients were treated with chemotherapy alone (gemcitabine and nab-paclitaxel = 77% (20/26); FOLFIRINOX = 19% (5/26); single agent gemcitabine 3.8% (1/26)), or chemotherapy followed by chemoradiation (gemcitabine +5 Gy × 5 weeks), or chemoradiation alone prior to re-staging and potential resection. Of the 29% (15/52) of patients who went on to surgical resection, 73% (11/15) achieved R0 resection. An R0 resection was achieved in 35% (9/26) of patients treated with chemotherapy alone, 7.6% (1/13) in a patient treated with chemotherapy followed by radiation, and 7.6% (1/13) with concurrent chemoradiotherapy alone. Chemotherapy alone achieved a mPFS of 16.4 months (p < 0.0025) and mOS of 26.2 months (p < 0.0001), chemotherapy followed by chemoradiation was 13.0 months and 14.9 months respectively, while concurrent chemoradiotherapy was 6.9 months and 7.3 months. CONCLUSIONS AND RELEVANCE: BRPC and LAPC patients capable of surgery after only receiving neoadjuvant treatment with chemotherapy had higher rates of R0 resection with prolonged median PFS and OS compared with any patient needing combination chemotherapy with radiotherapy.

Impact of exercise on pulmonary artery pressure in patients with heart failure using an ambulatory pulmonary artery pressure monitor.

Background: In this multicenter prospective study, we explored the relationship between pulmonary artery pressure (PAP) at rest and in response to a 6-min walk test (6MWT) in ambulatory patients with heart failure (HF) with an implantable PAP sensor (CardioMEMS, Abbott). Methods: Between 5/2019 and 2/2021, HF patients with a CardioMEMS sensor were recruited from seven sites. PAP was recorded in the supine and seated position at rest and in the seated position immediately post-exercise. Results: In our cohort of 66 patients, mean age was 70 ± 12 years, 67% male, left ventricular ejection fraction (LVEF) < 50% in 53%, mean 6MWT distance was 277 ± 95 meters. Resting seated PAPs were 31 ± 15 mmHg (systolic), 13 ± 8 mmHg (diastolic), and 20 ± 11 mmHg (mean). The pressures were lower in the seated rather than the supine position. After 6MWT, the pressures increased to PAP systolic 37 ± 19 mmHg (p < 0.0001), diastolic 15 ± 10 mmHg (p = 0.006), and mean 24 ± 13 mmHg (p < 0.0001). Patients with elevated PAP diastolic at rest (>15 mmHg) demonstrated a greater increase in post-exercise PAP. Conclusion: The measurement of PAP with CardioMEMS is feasible immediately post-exercise. Despite being well-managed, patients had severely limited functional capacity. We observed a significant increase in PAP with ambulation which was greater in patients with higher baseline pressures.

Process evaluation of Dulce Digital-Me: an adaptive mobile health (mHealth) intervention for underserved Hispanics with diabetes.

Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption, including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations.

Type 2 diabetes disproportionately impacts ethnic minorities, including Hispanic individuals; however, these populations are often underrepresented in clinical research, especially in studies using digital technologies. The Dulce Digital-Me study was developed to provide diabetes self-management education and support using mobile health technologies with the goal of improving clinical outcomes by reducing barriers to accessing support. This analysis revealed that the Dulce Digital-Me study was successful at reaching the target population and engaging them with the intervention, while also delivering the study intervention with high fidelity. This process evaluation provides critical context for understanding the study's clinical outcomes and the potential for further dissemination.

Appraisal of the Real-World Effectiveness of Biologic Therapies in Aspirin-Exacerbated Respiratory Disease.

BACKGROUND: There are no head-to-head studies for patients with aspirin-exacerbated respiratory disease (AERD) comparing any of the 5 Food and Drug Administration-approved respiratory biologic therapies. OBJECTIVE: Explore outcomes in subjects with AERD using biologic therapies in a real-world clinic setting. METHODS: A retrospective pilot study was conducted for subjects with AERD who had been prescribed omalizumab (anti-IgE), mepolizumab (anti-IL-5), reslizumab (anti-IL-5), benralizumab (anti-IL-5 receptor alpha [anti-IL-5Rα]), or dupilumab (anti-IL-4 receptor alpha [anti-IL-4Rα]). Clinical outcomes pre- versus postinitiation of biologic therapy were explored including symptoms, 22-item sino-nasal outcome test scores, systemic corticosteroid and antibiotic prescriptions, and emergency room visits related to AERD. RESULTS: Of the 74 subjects, 58.1% (n = 43) had used 1 biologic, though many (41.9%, n = 31) trialed more than 1 biologic. Of the 50 subjects who had used anti-IL-4Rα therapy, 98% (49 of 50) still had this therapy prescribed at study completion compared with 48.6% (17 of 35) and 26.9% (7 of 26) of those who used anti-IgE and anti-IL-5 and anti-IL-5 receptor alpha (anti-IL-5/IL-5Rα) therapy, respectively. Among those on anti-IL-4Rα therapy, there was a significant reduction in median total 22-item sino-nasal outcome test scores (51 to 19, P = .0002), corticosteroid bursts (2 to 0, P < .0001), and median number of antibiotic courses for respiratory disease (1 to 0, P = .0469) prebiologic versus postbiologic initiation. No statistically significant difference in those outcomes was observed for individuals on anti-IgE or anti-IL-5/IL-5Rα therapy. CONCLUSIONS: Anti-IL-4Rα therapy led to significantly higher rates of clinical improvement in AERD when compared with anti-IL-5/IL-5Rα and anti-IgE biologic therapies. Prospective studies would help clarify best practices for the use of biologic therapies in AERD.

Simplified Lung Ultrasound Examination and Telehealth Feasibility in Early SARS-CoV-2 Infection.

BACKGROUND: In COVID-19, inpatient studies have demonstrated that lung ultrasound B-lines relate to disease severity and mortality and can occur in apical regions that can be imaged by patients themselves. However, as illness begins in an ambulatory setting, the aim of this study was to determine the prevalence of apical B-lines in early outpatient infection and then test the accuracy of their detection using telehealth and automated methods. METHODS: Consecutive adult patients (N = 201) with positive results for SARS-CoV-2, at least one clinical risk factor, and mild to moderate disease were prospectively enrolled at a monoclonal antibody infusion clinic. Physician imaging of the lung apices for three B-lines (ultrasound lung comet [ULC]) using 3-MHz ultrasound was performed on all patients for prevalence data and served as the standard for a nested subset (n = 50) to test the accuracy of telehealth methods, including patient self-imaging and automated B-line detection. Patient characteristics, vaccination data, and hospitalizations were analyzed for associations with the presence of ULC. RESULTS: Patients' mean age was 54 ± 15 years, and all lacked hypoxemia or fever. ULC was present in 55 of 201 patients (27%) at a median of 7 symptomatic days (interquartile range, 5-8 days) and in four of five patients who were later hospitalized (P = .03). Presence of ULC was associated with unvaccinated status (odds ratio [OR], 4.11; 95% CI, 1.85-9.33; P = .001), diabetes (OR, 2.56; 95% CI, 1.08-6.05; P = .03), male sex (OR, 2.14; 95% CI, 1.07-4.37; P = .03), and hypertension or cardiovascular disease (OR, 2.06; 95% CI, 1.02-4.23; P = .04), while adjusting for body mass index > 25 kg/m2. Telehealth and automated B-line detection had 84% and 82% accuracy, respectively. CONCLUSIONS: In high-risk outpatients, B-lines in the upper lungs were common in early SARS-CoV-2 infection, were related to subsequent hospitalization, and could be detected by telehealth and automated methods.