A core outcome set for localised prostate cancer effectiveness trials

Objective: To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer. Background: Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio. This is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials. Subjects and methods: A list of 79 outcomes was derived from a systematic review of published localised prostate cancer effectiveness studies and semi-structured interviews with 15 prostate cancer patients. A two-stage consensus process involving 118 patients and 56 international healthcare professionals (HCPs) (cancer specialist nurses, urological surgeons and oncologists) was undertaken, consisting of a three-round Delphi survey followed by a face-to-face consensus panel meeting of 13 HCPs and 8 patients. Results: The final COS included 19 outcomes. Twelve apply to all interventions: death from prostate cancer, death from any cause, local disease recurrence, distant disease recurrence/metastases, disease progression, need for salvage therapy, overall quality of life, stress urinary incontinence, urinary function, bowel function, faecal incontinence, sexual function. Seven were intervention-specific: perioperative deaths (surgery), positive surgical margin (surgery), thromboembolic disease (surgery), bothersome or symptomatic urethral or anastomotic stricture (surgery), need for curative treatment (active surveillance), treatment failure (ablative therapy), and side effects of hormonal therapy (hormone therapy). The UK-centric participants may limit the generalisability to other countries, but trialists should reason why the COS would not be applicable. The default position should not be that a COS developed in one country will automatically not be applicable elsewhere. Conclusion: We have established a COS for trials of effectiveness in localised prostate cancer, applicable across all interventions which should be measured in all localised prostate cancer effectiveness trials

Residential mobility during pregnancy in the north of England

<p>Abstract</p> <p>Background</p> <p>Many epidemiological studies assign exposure to an individual's residence at a single time point, such as birth or death. This approach makes no allowance for migration and may result in exposure error, leading to reduced study power and biased risk estimates. Pregnancy outcomes are less susceptible to this bias, however data from North American populations indicate that pregnant women are a highly mobile group. We assessed mobility in pregnant women in the north of England using data from the Northern Congenital Abnormality Survey (NorCAS).</p> <p>Methods</p> <p>Data were extracted from NorCAS for 1985 to 2003. Eligible cases had a gestational age at delivery of ≥ 24 weeks (a viable delivery) (n = 11 559). We assessed mobility between booking appointment (average gestational age 13 weeks) and delivery for pregnancies where the address at booking appointment and delivery were known. The impacts on mobility of maternal age and area-level socio-economic indicators were explored using standard descriptive statistics. A sensitivity analysis and a small validation exercise were undertaken to assess the impact of missing data on the estimate of mobility.</p> <p>Results</p> <p>Out of 7 919 eligible cases for whom addresses at booking and delivery were known, 705 (8.9% (95% CI 8.3 - 9.5)) moved between booking and delivery; the mean and median moving distance was 9.7 and 1.4 km respectively. Movers were significantly younger (25.4 versus 27.3 years, p < 0.01) and lived in more deprived areas (index of multiple deprivation score 38.3 versus 33.7, p < 0.01) than non movers.</p> <p>Conclusion</p> <p>Mobility in the north of England (9%) is considerably lower than that reported in North America and the only other study from the UK (23%). Consistent with other studies, mobility was related to maternal age and socio-economic status, and the majority of moves were over a relatively short distance. Although this population appears relatively stable, the mobility we have observed may still introduce misclassification or error into an exposure assessment relying solely on postcode at delivery, and migration should still therefore be considered a potential source of bias in future studies.</p

A course-based research experience: how benefits change with increased investment in instructional time

There is widespread agreement that science, technology, engineering, and mathematics programs should provide undergraduates with research experience. Practical issues and limited resources, however, make this a challenge. We have developed a bioinformatics project that provides a course-based research experience for students at a diverse group of schools and offers the opportunity to tailor this experience to local curriculum and institution-specific student needs. We assessed both attitude and knowledge gains, looking for insights into how students respond given this wide range of curricular and institutional variables. While different approaches all appear to result in learning gains, we find that a significant investment of course time is required to enable students to show gains commensurate to a summer research experience. An alumni survey revealed that time spent on a research project is also a significant factor in the value former students assign to the experience one or more years later. We conclude: 1) implementation of a bioinformatics project within the biology curriculum provides a mechanism for successfully engaging large numbers of students in undergraduate research; 2) benefits to students are achievable at a wide variety of academic institutions; and 3) successful implementation of course-based research experiences requires significant investment of instructional time for students to gain full benefit

Comparison of Functional Reach in Fallers and Nonfallers in an Independent Retirement Community

The older population in America is steadily increasing. Additionally, falls increase dramatically with age. Balance disorders and postural control changes have been found to contribute to falls sustained by the elderly. Functional Reach (FR) has been proposed as a simple balance assessment tool which is valid, reliable, and sensitive to changes in balance. The aim of this study was to compare the FR of fallers and nonfallers living independently in a retirement community. Fifty-two subjects were divided into three age groups and categorized by fall status. The first three correctly performed FR trials were measured and recorded. After the age of 84 years, FR significantly decreases. There were no significant differences in the FR between fallers and nonfallers among community dwelling seniors. A simple standardized balance assessment tool needs to be developed to identify those older people at risk for falling. Functional Reach has the potential to be such a tool. However, FR needs to be standardized according to the age and activity level of the population being tested

Numerical investigations of 3D aspects of fire/atmosphere interactions

Idealized FIRETEC grassfire simulations were used to study some of the roles that three-dimensional aspects of coupled atmosphere/fire interactions play on fire behavior. Domains of various widths that were periodic in the cross-stream direction, simulating an infinite-length fireline, were used to isolate local fireline-scale threedimensional effects. Two-dimensional vertical plane (zero width) simulations were performed for comparison. Idealized finite-length fire simulations were used to study the larger fire-scale three-dimensional effects. In the infinitely long simulations the fireline remains fairly straight on a macroscale while significant heterogeneities develop along the fireline at fireline-scales. These simulations suggest that the nature of atmosphere–fire coupling and these heterogeneities are influenced by wind speed. At low wind speed, the spread rate is not significantly affected by the width of the domain (for domains greater than 10 m wide). For higher wind speeds, the flank of the simulated firelines is fingered and the front of the fireline exhibits lobes. The average spread rates vary by approximately 20% for the different domain widths. In the finite-length fireline simulations, the fireline shape was fairly parabolic and the headfire rate of spread (ROS) increased with wind speed and length of ignition line. The curvature of the fire was also influenced by the length of the ignition line. The indrafts of the headfire and flanking fire lines compete for upstream wind. For wider fires, the separation between the flanking fire lines is larger and more of the upstream wind is able to reach the headfire. These finite-length simulations also suggest that there might be an overall negative pressure gradient from upwind of the fireline to downwind of the fireline near the ground. This pressure gradient is believed to be tied to the penetration of wind through the fireline and the convective heating of unburned fuel. Streamwise-vorticity pairs contribute to the heterogeneous appearance of the fire front by feeding upward momentum in the location where towers are seen on the fireline and thrusting hot gases through the fireline and down to the unburned fuel in the troughs between the firelines. These streamwise vorticies have also been recognized in the periodic infinite length and finite-length simulated firelines as well as laboratory tests. In the two-dimensional simulations with wind speeds above 3 m/s, one major effect of the two-dimensional restrictions is to preclude the nominally streamwise-vorticity structures from forming upstream of the fireline. This thus diminishes the ability of the wind to mix through the heated plume and entrain hot gases down into the fuels ahead of the fire. These simulations suggest that caution should be used when attempting to use one or two-dimensional models to simulate wildland fires. These simulations also suggest the significant value of experiments in which details of both flow and fire dynamics can be studied at scales ranging from fireline scale to overall fire geometry scales in order to better understand fire behavior. The hypothesis generated here can help provide insight in support of experimental design and analysis

Total and specific IgE associations between New York City Head Start children and their parents.

BACKGROUND: Allergy and asthma risk share strong inherited components; however, the relative importance of maternal and paternal atopy in predicting child atopy remain unclear. OBJECTIVE: We sought to identify relationships between parents\u27 and children\u27s total and specific IgE levels within family units as predictors of allergic risk in children. METHODS: Total and allergen-specific IgE (to dust mite, cockroach, mouse, and cat) were determined by means of ImmunoCap (Phadia, Inc, Portage, Mich) in a sample of families participating in New York City Head Start programs. Regression models were developed to determine the associations of parents\u27 and children\u27s total IgE levels and sensitization patterns. RESULTS: Blood specimens were collected from 161 family triads of mother, father, and child (83 boys and 78 girls). At a mean age of 4 years, boys had significantly higher total IgE levels than girls. Boys\u27 total IgE levels were highly correlated with both mothers\u27 (P \u3c .002) and fathers\u27 (P = .002) total IgE levels; girls\u27 total IgE levels were not. Unlike total IgE levels, specific IgE levels among both boys and girls were associated with their mothers\u27 specific IgE levels. Dust mite sensitization among mothers was predictive of children\u27s sensitization to each of the 4 aeroallergens. CONCLUSION: The strong associations between parents\u27 and children\u27s IgE levels suggest that assessment of parents\u27 total and locally relevant allergen-specific IgE levels might have value in predicting atopy in children of preschool age