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The objective of this study is to identify how predisposing characteristics, enabling factors, and health needs are jointly and individually associated with epidemiological patterns of outpatient healthcare utilization for patients who already interact and engage with a large healthcare system. We retrospectively analyzed electronic medical record data from 1,423,166 outpatient clinic visits from 474,674 patients in a large healthcare system from June 2018-March 2019. We evaluated patients who exclusively visited rural clinics versus patients who exclusively visited urban clinics using Chi-square tests and the generalized estimating equation Poisson regression methodology. The outcome was healthcare use defined by the number of outpatient visits to clinics within the healthcare system and independent variables included age, gender, race, ethnicity, smoking status, health status, and rural or urban clinic location. Supplementary analyses were conducted observing healthcare use patterns within rural and urban clinics separately and within primary care and specialty clinics separately. Patients in rural clinics vs. urban clinics had worse health status [χ2 = 935.1, df = 3, p<0.0001]. Additionally, patients in rural clinics had lower healthcare utilization than patients in urban clinics, adjusting for age, race, ethnicity, gender, smoking, and health status [2.49 vs. 3.18 visits, RR = 0.61, 95%CI = (0.55,0.68), p<0.0001]. Further, patients in rural clinics had lower utilization for both primary care and specialty care visits. Within the large healthcare system, patients in rural clinics had lower outpatient healthcare utilization compared to their urban counterparts despite having potentially elevated health needs reflected by a higher number of unique health diagnoses documented in their electronic health records after adjusting for multiple factors. This work can inform future studies exploring the roots and ramifications of rural-urban healthcare utilization differences and rural healthcare disparities.

In this single-center trial comparing chlorhexidine–alcohol with iodine–alcohol for skin antisepsis before cesarean delivery, the use of chlorhexidine–alcohol resulted in a risk of surgical-site infection that was significantly lower than that associated with iodine–alcohol. Cesarean delivery is the most common major surgical procedure among women in the United States. 1 In 2013, more than 32.7% (1.3 million) of the 3.9 million births were by cesarean section. 2 Surgical-site infections complicate 2 to 5% of all surgical procedures and 5 to 12% of cesarean deliveries. 3 – 6 Infection occurring after delivery places an extra burden on the new mother and may impair mother–infant bonding and breast-feeding. The average attributable hospital cost per surgical-site infection after cesarean delivery is estimated to be $3,529. 7 The skin is a major source of pathogens that cause surgical-site infections. Therefore, preoperative skin antisepsis . . .

VEGF, a key mediator of angiogenesis and resistance to immunotherapy, is overexpressed in head and neck squamous cell carcinoma (HNSCC). We aimed to determine the recommended phase 2 dose of ramucirumab, a selective VEGFR2 inhibitor, given with pembrolizumab and the objective response rate of this combination as first-line treatment for recurrent or metastatic HNSCC. In this single-centre, phase 1/2 trial, which was done at Washington University (St Louis, MO, USA), eligible patients were aged 18 years or older with incurable recurrent or metastatic HNSCC and an Eastern Cooperative Oncology Group performance status of 0–2. Patients in phase 2 were required to have had no previous systemic therapy for recurrent or metastatic disease. In a dose de-escalation phase 1 design, patients received ramucirumab (starting dose 10 mg/kg given intravenously) and pembrolizumab (200 mg intravenously) on day 1 of each 21-day cycle. The recommended phase 2 dose of ramucirumab was defined as the highest dose at which one or fewer of three patients had dose-limiting toxicity during cycle one (primary endpoint of phase 1). In a Simon's two-stage phase 2 design, patients received the recommended phase 2 dose of ramucirumab and pembrolizumab. Tumour response (primary endpoint of phase 2) was assessed by Response Evaluation Criteria in Solid Tumours (version 1.1). We hypothesised that there would be an objective response rate of 32% or higher (null ≤13%). Eight or more responses among 33 evaluable patients (those with at least one response assessment) was evidence for activity (80% power; one-sided α=0·05). Analyses were done per protocol. The trial is registered with ClinicalTrials.gov, NCT03650764, and is closed to enrolment. Between June 18, 2019, and Feb 11, 2021, three patients enrolled and were treated in phase 1 and 37 patients in phase 2. Median age of all patients was 64 years (IQR 59–72). 36 (90%) of 40 patients were men and four (10%) were women, and 36 (90%) patients were White, three (8%) were Black or African American, and one (3%) was Asian. In phase 1, no dose-limiting toxicity event occurred. The recommended phase 2 dose of ramucirumab was 10 mg/kg. Median follow-up for patients on phase 2 was 14·8 months (IQR 4·9–31·0). In phase 2, 18 (55%; 95% CI 38–70) of 33 evaluable patients had an objective response, including confirmed complete response in 11 patients, confirmed partial response in six patients, and unconfirmed partial response in one patient. The most common grade 3 or worse adverse events were dysphagia (14 [38%] of 37 patients), lung infection (11 [30%]), lymphocyte count decrease (ten [27%]), hypophosphataemia (nine [24%]), and hypertension (eight [22%]). No treatment-related deaths were recorded. Ramucirumab and pembrolizumab were safe to administer to patients with recurrent or metastatic HNSCC, and the objective response rate with this combination as first-line treatment for recurrent or metastatic HNSCC was favourable. Further studies of ramucirumab and pembrolizumab in patients with recurrent or metastatic HNSCC are warranted. Lilly and the Joseph Sanchez Foundation.

Pre-exposure prophylaxis (PrEP) can reduce U.S. HIV incidence. We assessed insurance coverage and its association with PrEP utilization. We reviewed patient data at three PrEP clinics (Jackson, Mississippi; St. Louis, Missouri; Providence, Rhode Island) from 2014-2015. The outcome, PrEP utilization, was defined as patient PrEP use at three months. Multivariable logistic regression was performed to determine the association between insurance coverage and PrEP utilization. Of 201 patients (Jackson: 34%; St. Louis: 28%; Providence: 28%), 91% were male, 51% were White, median age was 29 years, and 21% were uninsured; 82% of patients reported taking PrEP at three months. Insurance coverage was significantly associated with PrEP utilization. After adjusting for Medicaid-expansion and individual socio-demographics, insured patients were four times as likely to use PrEP services compared to the uninsured (OR: 4.49, 95% CI: 1.68-12.01; p = 0.003). Disparities in insurance coverage are important considerations in implementation programs and may impede PrEP utilization.

Purpose To identify peri-operative risk factors and time to onset of pancreatic endocrine/exocrine insufficiency. Methods We retrospectively analyzed a single institutional series of patients who underwent pancreaticoduodenectomy (PD) or distal pancreatectomy (DP) between 2000 and 2015. Endocrine/exocrine insufficiencies were defined as need for new pharmacologic intervention. Cox proportional modeling was used to identify peri-operative variables to determine their impact on post-operative pancreatic insufficiency. Results A total of 1717 patient records were analyzed (75.47% PD, 24.53% DP) at median follow-up 17.88 months. Average age was 62.62 years, 51.78% were male, and surgery was for malignancy in 74.35% of patients. Post-operative endocrine insufficiency was present in 20.15% ( n  = 346). Male gender ( p  = 0.015), increased body mass index (BMI) ( p  < 0.001), tobacco use ( p  = 0.011), family history of diabetes (DM) ( p  < 0.001), personal history of DM ( p ≤  0.001), and DP ( p ≤  0.001) were correlated with increased risk. Mean time to onset was 20.80 ± 33.60 (IQR: 0.49–28.37) months. Post-operative exocrine insufficiency was present in 36.23% ( n  = 622). Race ( p  = 0.014), lower BMI ( p  < 0.001), family history of DM ( p  = 0.007 ) , steatorrhea ( p  < 0.001), elevated pre-operative bilirubin ( p  = 0.019), and PD ( p ≤  0.001) were correlated with increased risk. Mean time to onset was 14.20 ± 26.90 (IQR: 0.89–12.69) months. Conclusions In this large series of pancreatectomy patients, 20.15% and 36.23% of patients developed post-operative endocrine and exocrine insufficiency at a mean time to onset of 20.80 and 14.20 months, respectively. Patients should be educated regarding post-resection insufficiencies and providers should have heightened awareness long-term.

Background In recent years there is increasing interest in modeling the effect of early longitudinal biomarker data on future time-to-event or other outcomes. Sometimes investigators are also interested in knowing whether the variability of biomarkers is independently predictive of clinical outcomes. This question in most applications is addressed via a two-stage approach where summary statistics such as variance are calculated in the first stage and then used in models as covariates to predict clinical outcome in the second stage. The objective of this study is to compare the relative performance of various methods in estimating the effect of biomarker variability. Methods A joint model and 4 different two-stage approaches (naïve, landmark analysis, time-dependent Cox model, and regression calibration) were illustrated using data from a large multi-center randomized phase III trial, the Ocular Hypertension Treatment Study (OHTS), regarding the association between the variability of intraocular pressure (IOP) and the development of primary open-angle glaucoma (POAG). The model performance was also evaluated in terms of bias using simulated data from the joint model of longitudinal IOP and time to POAG. The parameters for simulation were chosen after OHTS data, and the association between longitudinal and survival data was introduced via underlying, unobserved, and error-free parameters including subject-specific variance. Results In the OHTS data, joint modeling and two-stage methods reached consistent conclusion that IOP variability showed no significant association with the risk of POAG. In the simulated data with no association between IOP variability and time-to-POAG, all the two-stage methods (except the naïve approach) provided a reliable estimation. When a moderate effect of IOP variability on POAG was imposed, all the two-stage methods underestimated the true association as compared with the joint modeling while the model-based two-stage method (regression calibration) resulted in the least bias. Conclusion Regression calibration and joint modelling are the preferred methods in assessing the effect of biomarker variability. Two-stage methods with sample-based measures should be used with caution unless there exists a relatively long series of longitudinal measurements and/or strong effect size (NCT00000125).

Standard-of-care (SoC) imaging for assessing colorectal polyps during colonoscopy, based on white-light colonoscopy (WLC) and narrow-band imaging (NBI), does not have sufficient accuracy to assess the invasion depth of complex polyps non-invasively during colonoscopy. We aimed to evaluate the feasibility of a custom endoscopic optical coherence tomography (OCT) probe for assessing colorectal polyps during routine colonoscopy. Patients referred for endoscopic treatment of large colorectal polyps were enrolled in this pilot clinical study, which used a side-viewing OCT catheter developed for use with an adult colonoscope. OCT images of polyps were captured during colonoscopy immediately before SoC treatment. A deep learning model was trained to differentiate benign from deeply invasive lesions for real-time diagnosis. 35 polyps from 32 patients were included. OCT imaging added on average 3:40 min (range 1:54–8:20) to the total procedure time. No complications due to OCT were observed. OCT revealed distinct subsurface tissue structures that correlated with histological findings, including tubular adenoma ( n  = 20), tubulovillous adenoma ( n  = 10), sessile serrated polyps ( n  = 3), and invasive cancer ( n  = 2). The deep learning model achieved an area under the receiver operating characteristic curve (AUROC) of 0.984 (95%CI 0.972–0.996) and Cohen’s kappa of 0.845 (95%CI 0.774–0.915) when compared to gold standard histopathology. OCT is feasible and safe for polyp assessment during routine colonoscopy. When combined with deep learning, OCT offers clinicians increase confidence in identifying deeply invasive cancers, potentially improving clinical decision-making. Compared to previous studies, ours offers a nuanced comparison between not just benign and malignant lesions, but across multiple histological subtypes of polyps.

Background Antimicrobial stewardship programs (ASP) often function naturally as facilitators within clinical hospital settings, by working with individuals and teams to reduce unnecessary antibiotics. Within implementation science, facilitation has been studied and evaluated as an implementation strategy that can accelerate and improve fidelity to implementation efforts. This study describes a novel, virtual facilitation strategy developed and served as an intervention within the optimizing perioperative antibiotics for children trial (OPERATIC trial). This paper: (1) describes ASP team’s preferences for and use of a facilitation workshop and (2) describes sustained use of facilitation skills throughout the study period. Methods Study participants included antimicrobial stewardship team members from the nine children’s hospitals that participated in this study and completed facilitation training. All individuals who completed facilitation training were asked to evaluate the training through an online survey. Additionally, site leads were interviewed by the site coordinator every other month and asked about their team’s use of facilitation skills throughout the rest of the study period. Survey data were managed and coded in R, and qualitative interview data were analyzed using rapid methodology. Results 30 individuals, including both physicians and pharmacists, completed the evaluation. Individuals largely rated themselves as novice facilitators (53%). Individuals reported satisfaction with virtual facilitation and identified different components of the workshops as valuable. An additional 108 interviews were performed throughout the study period. These interviews found that facilitators reported using all skills throughout the study period and described varied use of skills over time. All nine sites applied facilitation strategies, team building techniques, and communication/conflict skills at some point during the intervention phase. Conclusion We describe the use of virtual facilitation as an acceptable and appropriate strategy to enhance facilitation skills for ASP teams working to reduce unnecessary postoperative antibiotics. Participants reported different useful components of facilitation training and described using differing facilitation skills throughout the trial. Overall, the use of facilitation skills continued throughout the duration of the study period. This paper outlines how facilitation training can be conducted virtually in a way that is feasible and acceptable to clinicians. Trial registration NCT04366440, April 24, 2020.

The implementation of ridge-furrow with plastic film mulching has the potential to enhance crop yields and water productivity, particularly in black soil regions. However, the synergistic impacts of combining ridge-furrow with plastic mulching alongside with various organic amendments on maize yield and nitrogen fertilizer utilization efficiency remain unclear. Using 15 N-labeled tracing technology, we investigated fertilizer-N recovery of maize, distribution, fertilizer-N residual in soil, and nitrogen fertilizer loss across six treatments: non-mulched flat with non-organic amendment (FN), non-mulched flat with straw amendment (FS), non-mulched flat with biochar amendment (FBC), ridge-furrow with plastic mulching without organic amendment (RN), ridge-furrow with plastic mulching with straw amendment (RS), and ridge-furrow with plastic mulching with biochar amendment (RBC). The results revealed that ridge-furrow with plastic mulching in comparison to non-mulched flat, led to a significant increase in maize dry biomass accumulation, yield, and the rate of fertilizer-N recovery in maize (NRE) by 8.57%–12.36%, 10.08%–15.13%, and 2.22%–3.18%, respectively. The rate of fertilizer-N residual in soil (NSR) and fertilizer-N loss (NLS) decreased by 0.5%–2.04% and 0.78%–3.21%, respectively. In addition, the straw and biochar amendments under different planting methods promoted NRE in plants and NSR in soil, reducing NLS. Compared with non-organic amendment treatments, the inclusion of straw and biochar amendments resulted in increased NRE and NRS by 1.64%–6.20% and 0.12%–2.18%, while NLS decreased by 1.76%–7.78%. Biochar amendment treatment exhibited significantly higher nitrogen accumulation and NRE compared to the straw amendment treatment. Overall, ridge-furrow with plastic mulching combined with biochar amendment proved to be an effective method to enhance nitrogen fertilizer utilization of maize in the black soil regions, improving both yield and nitrogen fertilizer utilization efficiency.

Establishing an effective method to improve stem cell differentiation is crucial in stem cell transplantation. Here we aimed to explore whether and how sodium butyrate (NaB) induces rat bone marrow mesenchymal stem cells (MSCs) to differentiate into bladder smooth muscle cells (SMCs). We found that NaB significantly suppressed MSC proliferation and promoted MSCs differentiation into SMCs, as evidenced by the enhanced expression of SMC specific genes in the MSCs. Co-culturing the MSCs with SMCs in a transwell system promoted the differentiation of MSCs into SMCs. NaB again promoted MSC differentiation in this system. Furthermore, NaB enhanced the acetylation of SMC gene-associated H3K9 and H4, and decreased the expression of HDAC2 and down-regulated the recruitment of HDAC2 to the promoter regions of SMC specific genes. Finally, we found that NaB significantly promoted MSC depolarization and increased the intracellular calcium level of MSCs upon carbachol stimulation. These results demonstrated that NaB effectively promotes MSC differentiation into SMCs, possibly by the marked inhibition of HDAC2 expression and disassociation of HDAC2 recruitment to SMC specific genes in MSCs, which further induces high levels of H3K9ace and H4ace and the enhanced expression of target genes, and this strategy could potentially be applied in clinical tissue engineering and cell transplantation.