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 . . .
IMPORTANCE: It is unclear whether the timing of second stage pushing efforts affects spontaneous vaginal delivery rates and reduces morbidities. OBJECTIVE: To evaluate whether immediate or delayed ...pushing results in higher rates of spontaneous vaginal delivery and lower rates of maternal and neonatal morbidities. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic randomized clinical trial of nulliparous women at or beyond 37 weeks’ gestation admitted for spontaneous or induced labor with neuraxial analgesia between May 2014 and December 2017 at 6 US medical centers. The interim analysis suggested futility for the primary outcome and recruitment was terminated with 2414 of 3184 planned participants. Follow-up ended January 4, 2018. INTERVENTIONS: Randomization occurred when participants reached complete cervical dilation. Immediate group participants (n = 1200) began pushing immediately. Delayed group participants (n = 1204) were instructed to wait 60 minutes. MAIN OUTCOMES AND MEASURES: The primary outcome was spontaneous vaginal delivery. Secondary outcomes included total duration of the second stage, duration of active pushing, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, chorioamnionitis, endometritis, perineal lacerations (≥second degree), and a composite outcome of neonatal morbidity that included neonatal death and 9 other adverse outcomes. RESULTS: Among 2414 women randomized (mean age, 26.5 years), 2404 (99.6%) completed the trial. The rate of spontaneous vaginal delivery was 85.9% in the immediate group vs 86.5% in the delayed group, and was not significantly different (absolute difference, −0.6% 95% CI, −3.4% to 2.1%; relative risk, 0.99 95% CI, 0.96 to 1.03). There was no significant difference in 5 of the 9 prespecified secondary outcomes reported, including the composite outcome of neonatal morbidity (7.3% for the immediate group vs 8.9% for the delayed group; between-group difference, −1.6% 95% CI, −3.8% to 0.5%) and perineal lacerations (45.9% vs 46.4%, respectively; between-group difference, −0.4% 95% CI, −4.4% to 3.6%). The immediate group had significantly shorter mean duration of the second stage compared with the delayed group (102.4 vs 134.2 minutes, respectively; mean difference, −31.8 minutes 95% CI, −36.7 to −26.9, P < .001), despite a significantly longer mean duration of active pushing (83.7 vs 74.5 minutes; mean difference, 9.2 minutes 95% CI, 5.8 to 12.6, P < .001), lower rates of chorioamnionitis (6.7% vs 9.1%; between-group difference, −2.5% 95% CI, −4.6% to −0.3%, P = .005), and fewer postpartum hemorrhages (2.3% vs 4.0%; between-group difference, −1.7% 95% CI, −3.1% to −0.4%, P = .03). CONCLUSIONS AND RELEVANCE: Among nulliparous women receiving neuraxial anesthesia, the timing of second stage pushing efforts did not affect the rate of spontaneous vaginal delivery. These findings may help inform decisions about the preferred timing of second stage pushing efforts, when considered with other maternal and neonatal outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02137200
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.
Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer. The Exercise and Nutrition to Enhance Recovery and ...Good Health for You (ENERGY) study is the largest weight loss intervention trial among survivors of breast cancer to date.
In this multicenter trial, 692 overweight/obese women who were, on average, 2 years since primary treatment for early-stage breast cancer were randomly assigned to either a group-based behavioral intervention, supplemented with telephone counseling and tailored newsletters, to support weight loss or a less intensive control intervention and observed for 2 years. Weight and blood pressure were measured at 6, 12, 18, and 24 months. Longitudinal mixed models were used to analyze change over time.
At 12 months, mean weight loss was 6.0% of initial weight in the intervention group and 1.5% in the control group (P<.001). At 24 months, mean weight loss in the intervention and control groups was 3.7% and 1.3%, respectively (P<.001). Favorable effects of the intervention on physical activity and blood pressure were observed. The weight loss intervention was more effective among women older than 55 years than among younger women.
A behavioral weight loss intervention can lead to clinically meaningful weight loss in overweight/obese survivors of breast cancer. These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival.
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.
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.
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.
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.
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).
Patients with advanced hepatocellular carcinoma (HCC) will almost always develop acquired tolerance after sorafenib therapy, and the molecular mechanism of sorafenib tolerance remains poorly ...characterized. Here, using our established sorafenib-resistant HCC cell and xenograft models, we identified a novel gene, KIAA1199, which was markedly elevated among the differentially expressed genes involved in sorafenib tolerance. Moreover, elevated expression of KIAA1199 was positively correlated with a high risk of recurrence and metastasis and advanced TNM stage in HCC patients. Functionally, loss- and gain-of-function studies showed that KIAA1199 promoted the migration, invasion, and metastasis of sorafenib-resistant HCC cells. Mechanistically, KIAA1199 is required for EGF-induced epithelial-mesenchymal transition (EMT) in sorafenib-resistant HCC cells by aiding in EGFR phosphorylation. In summary, our data uncover KIAA1199 as a novel sorafenib-tolerant promoting gene that plays an indispensable role in maintaining sorafenib-resistant HCC cell metastasis.
•Sorafenib-resistant HCC xenografts models were established to illustrate sorafenib resistance in HCC.•KIAA1199 was positively correlated to high risk of recurrence and metastasis in HCC patients.•KIAA1199 enhanced the metastasis of sorafenib-resistant HCC cells by activation of EGF/EGFR-dependent EMT programs.
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.
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. The Affordable Care Act allows uninsured individuals to select health insurance from numerous private plans, a challenging decision-making process. This study examined the effectiveness ...of strategies to support health insurance decisions among the uninsured. Methods. Participants (N = 343) from urban, suburban, and rural areas were randomized to 1 of 3 conditions: 1) a plain language table; 2) a visual condition where participants chose what information to view and in what order; and 3) a narrative condition. We administered measures assessing knowledge (true/false responses about key features of health insurance), confidence in choices (uncertainty subscale of the Decisional Conflict Scale), satisfaction (items from the Health Information National Trends Survey), preferences for insurance features (measured on a Likert scale from not at all important to very important), and plan choice. Results. Although we did not find significant differences in knowledge, confidence in choice, or satisfaction across condition, participants across conditions made value-consistent choices, selecting plans that aligned with their preferences for key insurance features. In addition, those with adequate health literacy skills as measured by the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) had higher knowledge overall (
x
¯
= 6.1 v. 4.8, P < 0.001) and preferred the plain language table to the visual (P = 0.04) and visual to narrative (P = 0.0002) conditions, while those with inadequate health literacy skills showed no preference for study condition. A similar pattern was seen for those with higher subjective numeracy skills and higher versus lower education with regard to health insurance knowledge. Individuals with higher income felt less confident in their choices (
x
¯
= 28.7 v. 10.0, where higher numbers indicate less confidence/more uncertainty; P = 0.004). Conclusions. Those developing materials about the health insurance marketplace to support health insurance decisions might consider starting with plain language tables, presenting health insurance terminology in context, and organizing information according to ways the uninsured might use and value insurance features. Individuals with limited health literacy and numeracy skills and those with lower education face unique challenges selecting health insurance and weighing tradeoffs between cost and coverage.