Update to the design and methods of the PATH Study, Wave 4 (2016-2017).

The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative study of the US population on tobacco use and its effects on health, with four waves of data collection between 2013 and 2017. Prior work described the methods of the first three waves. In this paper, we describe the methods of Wave 4, during which a replenishment sample was added to the ongoing cohort. We describe the design and estimation methods of the continuing Wave 1 cohort (with four waves of data) and the Wave 4 cohort (the new cohort created at Wave 4). We provide survey quality metrics, including response rates for both cohorts and a panel conditioning analysis, and guidance on understanding the target populations for both cohorts.

Tobacco-Product Use by Adults and Youths in the United States in 2013 and 2014.

BACKGROUND: Noncigarette tobacco products are evolving rapidly, with increasing popularity in the United States. METHODS: We present prevalence estimates for 12 types of tobacco products, using data from 45,971 adult and youth participants (≥12 years of age) from Wave 1 (September 2013 through December 2014) of the Population Assessment of Tobacco and Health (PATH) Study, a large, nationally representative, longitudinal study of tobacco use and health in the United States. Participants were asked about their use of cigarettes, e-cigarettes, traditional cigars, cigarillos, filtered cigars, pipe tobacco, hookah, snus pouches, other smokeless tobacco, dissolvable tobacco, bidis, and kreteks. Estimates of the prevalence of use for each product were determined according to use category (e.g., current use or use in the previous 30 days) and demographic subgroup, and the prevalence of multiple-product use was explored. RESULTS: More than a quarter (27.6%) of adults were current users of at least one type of tobacco product in 2013 and 2014, although the prevalence varied depending on use category. A total of 8.9% of youths had used a tobacco product in the previous 30 days; 1.6% of youths were daily users. Approximately 40% of tobacco users, adults and youths alike, used multiple tobacco products; cigarettes plus e-cigarettes was the most common combination. Young adults (18 to 24 years of age), male adults and youths, members of racial minorities, and members of sexual minorities generally had higher use of tobacco than their counterparts. CONCLUSIONS: During this study, 28% of U.S. adults were current users of tobacco, and 9% of youths had used tobacco in the previous 30 days. Use of multiple products was common among tobacco users. These findings will serve as baseline data to examine between-person differences and within-person changes over time in the use of tobacco products. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration.).

Design and methods of the Population Assessment of Tobacco and Health (PATH) Study.

BACKGROUND: This paper describes the methods and conceptual framework for Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study data collection. The National Institutes of Health, through the National Institute on Drug Abuse, is partnering with the Food and Drug Administration's (FDA) Center for Tobacco Products to conduct the PATH Study under a contract with Westat. METHODS: The PATH Study is a nationally representative, longitudinal cohort study of 45 971 adults and youth in the USA, aged 12 years and older. Wave 1 was conducted from 12 September 2013 to 15 December 2014 using Audio Computer-Assisted Self-Interviewing to collect information on tobacco-use patterns, risk perceptions and attitudes towards current and newly emerging tobacco products, tobacco initiation, cessation, relapse behaviours and health outcomes. The PATH Study's design allows for the longitudinal assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse and transitions between products, as well as factors associated with use patterns. Additionally, the PATH Study collects biospecimens from consenting adults aged 18 years and older and measures biomarkers of exposure and potential harm related to tobacco use. CONCLUSIONS: The cumulative, population-based data generated over time by the PATH Study will contribute to the evidence base to inform FDA's regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation's burden of tobacco-related death and disease.

Real-world data of a digitally enabled, time-restricted eating weight management program in public sector workers living with overweight and obesity in the United Kingdom: A service evaluation of the Roczen program.

Introduction: The health of the United Kingdom workforce is key; approximately 186 million days are lost to sickness each year. Obesity and type 2 diabetes (T2D) remain major global health challenges. The aim of this retrospective service evaluation was to assess the impact of a digitally enabled, time-restricted eating (TRE) intervention (Roczen Program, Reset Health Ltd) on weight and other health-related outcomes. Methods: This service evaluation was conducted in people living with overweight/obesity, with 89% referred from public sector employers. Participants were placed on a TRE, low-carbohydrate, moderate protein plan delivered by clinicians and mentors with regular follow up, dietary guidance, goal setting, feedback, and social support. Results: A total of 660 members enrolled and retention was 41% at 12 months. The majority were female (73.2%), 58.9% were of White ethnicity, with a mean (SD) age of 47.5 years (10.1), and a body mass index of 35.0 kg/m2 (5.7). Data were available for 82 members at 12-month. At 12-month, members mean actual and percentage weight loss was -9.0 kg (7.0; p < 0.001) and -9.2% (6.7, p < 0.001) respectively and waist circumference reduced by -10.3 cm (10.7 p < 0.001), with 45.1% of members achieving ≥10% weight loss. Glycated hemoglobin was significantly improved at 6 months in people living with T2D (-11 mmol/mol [5.7] p = 0.012). Binge eating score significantly reduced (-4.4 [7.0] p = 0.006), despite cognitive restraint increasing (0.37 [0.6] p = 0.006). Conclusion: Our service evaluation showed that the Roczen program led to clinically meaningful improvements in body weight, health-related outcomes and eating behaviors that were sustained at 12-month.

Endobronchial indocyanine green instillation to identify the intersegmental plane for successful segmentectomy.

The traditional indications for lobectomy for resectable Non-small Cell Lung Cancer (NSCLC) may be set to change. Recently, anatomical segmentectomy (AS) versus lobectomy as an approach for early-stage NSCLC has been described in phase 3 randomised controlled trials. The demand for methods to facilitate AS may increase as a consequence. We describe three cases of AS using the combination of endobronchial infiltration of indocyanine green (ICG) to identify the intersegmental plane (critical for the performance of AS), and Computed Tomography (CT) guided methylene blue injection for lesion localisation. The operations were completed successfully demonstrating satisfactory post-operative outcomes including lesion resection with clear surgical margins and acceptable length of stay. We believe that endobronchial instillation of ICG and CT-guided methylene blue injection for lesion localisation show promise as a technique to complement parenchymal sparing thoracic oncological surgery.

Agricultural injury among rural California public high school students.

OBJECTIVES: The University of California, Davis Youth Agricultural Injury Study characterized the farm work and agricultural injury experience among rural California Central Valley public high school students enrolled in an agricultural sciences curriculum. METHODS: We conducted a cross-sectional survey of agricultural injury among students from 10 California Central Valley high schools during the 2001-2005 school years. RESULTS: Of 1,783 subjects, 946 (53.1%) reported farm work in the previous year, including 97 (10.3%) reporting at least one farm work-related injury in the preceding year. After adjustment for sex, ethnicity, and hours spent in farm work, injury risk was associated with large-animal operations (OR 4.15; 95%CI: 1.18, 14.65), feeding large animals (OR 2.38; 95%CI: 1.15, 4.96), mixing chemicals (OR 1.86; 95%CI: 1.15, 3.03), welding (OR 2.09; 95%CI: 1.17, 3.72), non-use of seatbelts, and frequent riding in the back of an uncovered pick-up truck. Risky attitudes toward farm safety were significantly associated with injury. Girls were more likely to suffer an animal-related injury and boys to suffer injury related to motor vehicles, machinery, or tool use. CONCLUSIONS: Adolescents are at similar risk to adults for agricultural injury. Although limitations on hazardous tasks and time spent on farm work are likely to be the most efficacious means for reducing injury, education will play an important role. Educational measures should include inculcating healthy safety-related attitudes and focus on hazardous tasks, such as those involving animals (for girls) and motor vehicles and machinery (for boys).

Agricultural injury risk among rural California public high school students: prospective results.

OBJECTIVES: To characterize prospective agricultural injury experience among rural California Central Valley public high school students enrolled in agricultural sciences curriculum. METHODS: The University of California, Davis Youth Agricultural Injury Study (UCD-YAIS) examined prospective farm-work injury among students from 10 California Central Valley public high schools. RESULTS: Of eligible subjects, 882 (62.5%) completed at least one annual follow-up survey. Of these, 489 reported farm work in the previous year, including 40 (8.2%) with at least one farm work-related injury. Fractures were the most common injury, especially among girls. Girls were more likely to suffer animal-related injury and boys injury from motor vehicles, machinery, or tool use. Prospective injury risk was strongly associated with prior-year farm injury (OR 8.53; 95% CI 4.02, 18.1) and farm work hours. After adjustment for farm work hours, grade level, and sex, risk was significantly associated with machinery operation, applying chemicals, number of hazardous tasks performed, riding motorcycles or mopeds, riding in back of an uncovered pick-up truck, and smoking. Risky attitude toward farm safety was associated prospectively with injury in stepwise fashion. CONCLUSIONS: Adolescents are at risk for serious farm-work injuries. Although limitations on hazardous tasks and farm work hours are likely to be the most efficacious means for reducing injury, education will play an important role. Education should include inculcating safety-related attitudes and habits and focus on hazardous tasks, such as those involving animals (for girls) and motor vehicles and machinery (for boys), especially among youth with prior farm injury.

Ethnic and gender differences in farm tasks and safety practices among rural California farm youth.

Agricultural work is hazardous and is common among rural youth, especially those living on farms or ranches. Previous work has shown differences in farm work and injury patterns between boys and girls, but little data exist addressing ethnic differences. This study examined ethnic and gender differences in farm tasks, safety attitudes, and use of protective measures among rural California youth working on farms or ranches. The University of California, Davis Youth Agricultural Injury Study is a longitudinal study focusing on agricultural work experience among youth enrolled in an agricultural sciences curriculum in 10 public high schools in California's Central Valley during the 2001-2005 school years. Using cross-sectional data from the initial entrance survey, we studied 946 participants who reported farm work in the previous year. Median annual hours of farm work varied significantly between boys and girls (p < 0.001) and between ethnic groups (p < 0.05) (Hispanic boys: 624 hr; Hispanic girls: 189 hr; White/Other boys: 832 hr; White/Other girls: 468 hr). Girls and Hispanic students were less likely than boys and White/Other students, respectively, to perform hazardous tasks involving tractors, machinery, and chemicals. Median age for initiating work on selected hazardous tasks was up to 3 years later for Hispanic students. Use of task-appropriate safety measures was low in all groups for most hazardous tasks. Boys were more likely than girls to use task-appropriate safety measures, with the exception of seatbelt use when in a car or truck. Hispanic students were more likely than White/Other students to employ safety measures. Girls and Hispanic youth worked fewer farm hours and had reduced exposure to selected hazardous tasks. Use of task-appropriate safety measures was low for all groups but increased for Hispanic students. Further study should explore reasons for low use of safety measures and develop educational efforts to bring about social norm changes promoting their use.

The use of ion-milling to control clustering of nanostructured, columnar thin films.

We present the use of ion-milling to reduce the capillary-induced clustering of vertical post nanostructures grown by glancing angle deposition. Nanostructures of several heights were grown and ion-milled for various times to investigate effects on post clustering. No clustering was observed given sufficient ion-mill exposure time, with the characteristic time being lower for shorter posts. The results demonstrate that these strengthened nanostructures are suitable for use in liquid environments.

Adult perceptions of the relative harm of tobacco products and subsequent tobacco product use: Longitudinal findings from waves 1 and 2 of the population assessment of tobacco and health (PATH) study.

OBJECTIVES: To examine: (1) How perceptions of harm for seven non-cigarette tobacco products predict subsequent use; (2) How change in use is associated with changes in perceptions of product harm; (3) Whether sociodemographic variables moderate the association between perceptions and use. METHODS: Data are from the adult sample (18+) of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort survey conducted September 2013-December 2014 (Wave 1 (W1) n = 32,320) and October 2014-October 2015 (Wave 2 (W2) n = 28,362). RESULTS: Wave 1 users and non-users of e-cigarettes, filtered cigars, cigarillos, and pipes, who perceived these products as less harmful had greater odds of using the product at W2. For the other products, there was an interaction between W1 perceived harm and W1 use status in predicting W2 product use. At W2, a smaller percentage of U.S. adults rated e-cigarettes as less harmful than cigarettes compared to W1 (41.2% W1, 29.0% W2). Believing non-cigarette products to be less harmful than cigarettes was more strongly associated with subsequent product use in the oldest age group (55+ years) while weaker effects were observed in the youngest age group (18-24 years). This moderating effect of age was significant for e-cigarettes, hookah, traditional cigars, and cigarillos. CONCLUSIONS: Strategies to prevent initiation and promote cessation of these products may benefit from understanding and addressing perceptions of these products.

Anaemia management with subcutaneous epoetin delta in patients with chronic kidney disease (predialysis, haemodialysis, peritoneal dialysis): results of an open-label, 1-year study.

BACKGROUND: Anaemia is common in patients with chronic kidney disease (CKD) and can be managed by therapy with erythropoiesis-stimulating agents (ESAs). Epoetin delta (DYNEPO, Shire plc) is the only epoetin produced in a human cell line. The aim of this study was to demonstrate the safety and efficacy of subcutaneously administered epoetin delta for the management of anaemia in CKD patients (predialysis, peritoneal dialysis or haemodialysis) METHODS: This was a 1-year, multicentre, open-label study. Patients had previously received epoetin subcutaneously and were switched to epoetin delta at an identical dose to their previous therapy. Dose was titrated to maintain haemoglobin at 10.0-12.0 g/dL. The primary endpoint was mean haemoglobin over Weeks 12-24. Secondary analyses included long-term haemoglobin, haematocrit and dosing levels. Safety was assessed by monitoring adverse events, laboratory parameters and physical examinations. RESULTS: In total 478 patients received epoetin delta, forming the safety-evaluable population. Efficacy analyses were performed on data from 411 of these patients. Mean +/- SD haemoglobin over Weeks 12-24 was 11.3 +/- 1.1 g/dL. Mean +/- SD weekly dose over Weeks 12-24 was 84.4 +/- 72.7 IU/kg. Haemoglobin levels were maintained for the duration of the study. Epoetin delta was well tolerated, with adverse events occurring at rates expected for a CKD patient population; no patient developed anti-erythropoietin antibodies. CONCLUSION: Subcutaneously administered epoetin delta is an effective and well-tolerated agent for the management of anaemia in CKD patients, irrespective of dialysis status. TRIAL REGISTRATION: http://www.controlled-trials.com ISRCTN68321818.

Mortality of nontarget arthropods from an aerial application of pyrethrins.

Mortality of nontarget organisms from an ultra-low volume (ULV) aerial application of pyrethrins (Evergreen EC 60-6) was monitored by collecting arthropods from ground tarps placed at the interface of open and canopy areas. A larger number and greater diversity of arthropods were recovered from tarps in the ULV spray area. The observed mortality was approximately 10-fold greater than in the control area. Kruskal-Wallis tests revealed a significant difference in the abundance and diversity of arthropods collected at treatment and control sites at 1 and 12 h postspray. Arthropods, primarily insects, from the treatment area included representatives from 12 orders and > or = 34 families, as compared to 7 orders and 12 families in the control area. Chironomidae (midges) and Formicidae (ants) were the most commonly represented families, accounting for 61% of the arthropods collected from the treatment area; no large-bodied insects (>8 mm) were recovered. Mortality of sentinel mosquitoes in the treatment and control areas averaged 96% and <1%, respectively, at 24 h postexposure. This study supports previous work that the impact of a single ULV application of pyrethrins was limited to a variety of small-bodied arthropods.

U.S. adult perceptions of the harmfulness of tobacco products: descriptive findings from the 2013-14 baseline wave 1 of the path study.

INTRODUCTION: This study is the first nationally representative survey of U.S. adults (18+) to examine perceptions of the relative harms of eight non-cigarette tobacco products. METHODS: Data are from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study Adult Questionnaire, a nationally representative study of 32,320 adults in the United States conducted from September 2013 to December 2014. RESULTS: 40.7% of adults believed that electronic cigarettes were less harmful than cigarettes, and 17.8% of adults believed that hookah was less harmful than cigarettes. Those less knowledgeable about the health risks of smoking were more likely to believe that the non-cigarette products were less harmful than cigarettes. Current non-cigarette tobacco product users were more likely to perceive that product to be less harmful than cigarettes (except filtered cigars). There was a significant positive correlation between beliefs that cigarettes were harmful and the likelihood of using hookah; perceptions of the harmfulness of cigarettes was not associated with the likelihood of using any other product. CONCLUSIONS: Perceptions of harmfulness varied widely across non-cigarette tobacco products. E-cigarettes and hookah in particular are seen as less harmful compared to cigarettes.

Albumin induces interleukin-6 release from primary human proximal tubule epithelial cells.

BACKGROUND: Proximal tubule epithelial cells (PTECs) release proinflammatory and profibrogenic mediators when exposed to serum albumin that may contribute to progression of kidney disease. Interleukin 6 (IL-6) may influence renal fibrosis by modulating transforming growth factor beta1 (TGFbeta1) signalling. PTECs have been demonstrated to produce IL-6 in response to albumin treatment, but the mechanism has not been investigated. We hypothesized that albumin would induce release of IL-6 from PTECs, which would be sensitive to inhibition of PI3K, ERK1,2, p38 MAPK and NFkB. METHODS: Primary human PTECs were exposed to albumin (0.75-150 micronM) for 8 and 24 hours. IL-6 release was determined using enzyme-linked immunosorbent assay (ELISA). The effects of LY294002 (10 micronM), NH4Cl (10 mM), pyrrolidine dithiocarbamate (PDTC) (20 micronM), CAPE (17.5 micronM), PD098059 (20 micronM), SB202190 (5 micronM) and MG132 (10 micronM) on albumin-mediated IL-6 release were studied. RESULTS: Albumin caused a significant time- and concentration-dependent increase in IL-6 release by PTECs. LY294002, NH4Cl, CAPE, PD098059 and SB202190 all reduced albumin-mediated IL-6 release, but neither PDTC nor MG132 had any effect. CONCLUSIONS: These data demonstrate that albumin induces IL-6 release by primary human PTECs, and support a role for endocytosis, p38 MAPK, ERK1,2 and in this process.

Long-term efficacy and safety profile of lanthanum carbonate: results for up to 6 years of treatment.

BACKGROUND/AIMS: Lanthanum carbonate (LC, FOSRENOL) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. METHODS: Patients from four previous trials entered this study. RESULTS: Ninety-three patients started the extension, with 22 entering a sixth year of LC treatment. Two-thirds of all patients received LC doses of 2,250 or 3,000 mg/day. Reductions in serum phosphate and calcium x phosphate product were maintained for up to 6 years. There were no new or unexpected adverse events (AEs), and no increase in the incidence of events with increasing treatment exposure. Over the complete duration of therapy, treatment-related AEs occurred in 25.8% of patients and were primarily gastrointestinal in nature. No clinically relevant changes in liver function tests were observed and there was no evidence of adverse effects on the liver, bone or the central nervous system. CONCLUSIONS: LC monotherapy was effective and well tolerated for up to 6 years with no evidence of safety concerns or increased frequency of AEs.

Healthcare resource utilization for anemia management: current practice with erythropoiesis-stimulating agents and the impact of converting to once-monthly C.E.R.A.

UNLABELLED: Background andMethods: A prospective, observational study in 12 German and UK dialysis centers which quantified personnel time for anemia treatment using erythropoiesis-stimulating agents (ESAs). Tasks directly observable were measured through the time-and-motion method; time for non-observable tasks was estimated by healthcare staff. Using activity-based costing methods, time was converted into monetary units. Modeling was used to estimate potential time and cost savings using once-monthly C.E.R.A., a continuous erythropoietin receptor activator. RESULTS: For current ESAs in Germany and the UK, respectively: mean observed time was 1.67 and 2.67 min/patient/administration, corresponding to 31 and 42 days/year/center/100 patients; mean total time/center/100 patients/year was estimated at 79 and 95 days, equivalent to EUR 17,031 and GBP 18,739. Assuming 100% once-monthly C.E.R.A. uptake, the observed time/patient/year may decrease by 79 and 84% in Germany and the UK, respectively, compared with traditional ESAs. CONCLUSION: Conversion to once-monthly C.E.R.A. may offer the potential to reduce time spent on ESA administration in hemodialysis centers.

Mosquito production in stormwater treatment devices in the Lake Tahoe Basin, California.

In response to increasing evidence of mosquito production in structural stormwater Best Management Practices (BMPs), a collaborative project was developed to document the occurrence, species composition, and seasonal abundance of mosquitoes from selected urban and highway BMPs in the Lake Tahoe Basin, California. Structural and environmental factors associated with mosquito production in highway BMPs were identified and analyzed. Ten species of mosquitoes were collected from 47 BMPs, including Culex tarsalis, Culiseta incidens, Cs. inornata, and 7 species of Aedes. In and around South Lake Tahoe, immatures were most abundant in urban BMPs during the warmer summer and fall months, whereas natural water sources in the surrounding area harbored mosquitoes more often during the colder months of early spring. In BMPs installed along Lake Tahoe's perimeter highways, mosquitoes were observed in 11% of site visits conducted during a single season. Larval presence in highway BMPs was positively associated with water temperature and negatively associated with precipitation, sand, and unspecified organic matter. The significance of mosquito production in BMPs of the Tahoe Basin and the potential for increased transmission of mosquito-borne disease are discussed.

Development time of Culex mosquitoes in stormwater management structures in California.

A widely recommended strategy to minimize mosquito production in structural stormwater Best Management Practices (BMPs) is to ensure they hold captured water for no more than 72 h. However, this standard may be overly conservative for many mosquito species found in urban environments and may impede or prevent the capacity of BMPs to fulfill more stringent water quality standards in environmentally sensitive areas. Egg-to-pupa development of Culex tarsalis, Cx. pipiens, and Cx. quinquefasciatus were examined during July, August, and September 2006 in stormwater management basins and in water collected from these basins in 3 climatically distinct regions of California: the Lake Tahoe Basin, Sacramento Valley, and Los Angeles Basin. The observed minimum times to pupal development were 6 days for Cx. tarsalis and Cx. quinquefasciatus and 8 days for Cx. pipiens. Multiple linear regression models were used to estimate minimum predicted development times under optimal conditions for each region. The results suggest that water residence times of up to 96 h will not significantly increase the potential for Culex mosquito production in stormwater BMPs in the 3 regions included in this study.