Fit to Study: Reflections on designing and implementing a large-scale randomized controlled trial in secondary schools

Background. The randomised controlled trial (RCT) design is increasingly common among studies seeking good-quality evidence to advance educational neuroscience, but conducting RCTs in schools is challenging. Fit to Study, one of six such trials funded by the Education Endowment Foundation and Wellcome Trust, tested an intervention to increase vigorous physical activity during PE lessons on maths attainment among pupils aged 12–13. This review of designing and conducting an RCT in 104 schools is intended as a resource on which researchers might draw for future studies. Method. We consider intervention design and delivery; recruitment, retention, trial management, data collection and analysis including ethical considerations and working with evaluators. Results. Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources. Conclusion. Simple interventions, with few outcome measures and minimal missing data, are preferable to more complex designs

Managing Injuries of the Neck Trial (MINT) : design of a randomised controlled trial of treatments for whiplash associated disorders

Background: A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods: Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion: This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised

A critical re-evaluation of the Thorne-Zytkow object candidate HV 2112

It has been argued in the literature that the star HV 2112 in the Small Magellanic Cloud (SMC) is the first known example of a Thorne–Żytkow object (TŻO), a red supergiant with a degenerate neutron core. This claim is based on the star having a high luminosity (log (L/L⊙) ≳ 5), an extremely cool effective temperature, and a surface enriched in in lithium, calcium, and various irp-process elements. In this paper we re-examine this evidence, and present new measurements of the stellar properties. By compiling archival photometry from blue to mid-infrared for HV 2112 and integrating under its spectral energy distribution, we find a bolometric luminosity in the range of log (L/L⊙) = 4.70–4.91, lower than that found in previous work and comparable to bright asymptotic giant branch (AGB) stars. We compare a VLT+XSHOOTER spectrum of HV 2112 to other late-type, luminous SMC stars, finding no evidence for enhancements in Rb, Ca, or K, though there does seem to be an enrichment in Li. We therefore conclude that a much more likely explanation for HV 2112 is that it is an intermediate mass (∼5 M⊙) AGB star. However, from our sample of comparison stars we identify a new TŻO candidate, HV 11417, which seems to be enriched in Rb but for which we cannot determine a Li abundance

Spectropolarimetry of the Type Ib Supernova iPTF 13bvn: revealing the complex explosion geometry of a stripped-envelope core-collapse supernova

We present six epochs of spectropolarimetric observations and one epoch of spectroscopy of the Type Ib SN iPTF 13bvn. The epochs of these observations correspond to −10 to +61 d with respect to the r-band light-curve maximum. The continuum is intrinsically polarized to the 0.2–0.4 per cent level throughout the observations, implying asphericities of ∼10 per cent in the shape of the photosphere. We observe significant line polarization associated with the spectral features of Ca II IR3, He I/Na I D, He I λλ6678, 7065, Fe II λ4924 and O I λ7774. We propose that an absorption feature at ∼6200 Å, usually identified as Si II λ6355, is most likely to be high-velocity H α at −16 400 km s−1. Two distinctly polarized components, separated in velocity, are detected for both He I/Na I D and Ca II IR3 , indicating the presence of two discrete line-forming regions in the ejecta in both radial velocity space and in the plane of the sky. We use the polarization of He I λ5876 as a tracer of sources of non-thermal excitation in the ejecta; finding that the bulk of the radioactive nickel was constrained to lie interior to ∼50–65 per cent of the ejecta radius. The observed polarization is also discussed in the context of the possible progenitor system of iPTF 13bvn, with our observations favouring the explosion of a star with an extended, distorted envelope rather than a compact Wolf–Rayet star

Head Position in Stroke Trial (HeadPoST)- sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial

Background Positioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial. We therefore initiated the Head Position in Stroke Trial (HeadPoST) to determine the effects of lying-flat (0°) compared with sitting-up (≥30°) head positioning in the first 24 hours of hospital admission for patients with acute stroke. Methods/Design We plan to conduct an international, cluster randomised, crossover, open, blinded outcome-assessed clinical trial involving 140 study hospitals (clusters) with established acute stroke care programs. Each hospital will be randomly assigned to sequential policies of lying-flat (0°) or sitting-up (≥30°) head position as a ‘business as usual’ stroke care policy during the first 24 hours of admittance. Each hospital is required to recruit 60 consecutive patients with acute ischaemic stroke (AIS), and all patients with acute intracerebral haemorrhage (ICH) (an estimated average of 10), in the first randomised head position policy before crossing over to the second head position policy with a similar recruitment target. After collection of in-hospital clinical and management data and 7-day outcomes, central trained blinded assessors will conduct a telephone disability assessment with the modified Rankin Scale at 90 days. The primary outcome for analysis is a shift (defined as improvement) in death or disability on this scale. For a cluster size of 60 patients with AIS per intervention and with various assumptions including an intracluster correlation coefficient of 0.03, a sample size of 16,800 patients at 140 centres will provide 90 % power (α 0.05) to detect at least a 16 % relative improvement (shift) in an ordinal logistic regression analysis of the primary outcome. The treatment effect will also be assessed in all patients with ICH who are recruited during each treatment study period. Discussion HeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke. Trial registration ClinicalTrials.gov identifier: NCT02162017 (date of registration: 27 April 2014); ANZCTR identifier: ACTRN12614000483651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014

Dietary and Lifestyle Patterns in the Spanish Pediatric Population (One to <10 Years Old): Design, Protocol, and Methodology of the EsNuPI Study

The interest in a healthy diet and lifestyle during the early stages of life increased, pointing out its role in the development of noncommunicable chronic diseases throughout adult life. Dietary habits and dietary patterns begin to be established in early childhood and persist during adulthood. Therefore, the EsNuPI (“Nutritional Study in Spanish Pediatric Population”) study aims to depict the dietary patterns, physical activity, and sedentary behaviors in Spanish children aged from one to <10 years old. This prospective, cross-sectional, observational study recruited a total of 1514 children from Spanish cities with >50,000 inhabitants, stratified by Nielsen areas. Participants were involved in one face-to-face survey, followed by a telephone survey after at least one week. Information about dietary intake and habits was obtained using a quantitative food frequency questionnaire and two 24-h dietary recalls. Physical activity and sedentary behaviors were registered using a specific questionnaire based on a seven-day record. Data were processed and stratified by categorical variables to be statistically analyzed in order to meet the study objectives. This study is the first of its kind in a Spanish reference population of this age range and the first to evaluate whether the consumption of adapted milk formulas and dairy products is associated with healthier dietary patterns and better diet quality and lifestyles in this group.This research was funded by Instituto Puleva de Nutrición (IPN)

The importance of different frailty domains in a population based sample in England

Background: The aim was to estimate the prevalence of frailty and relative contribution of physical/balance, nutritive, cognitive and sensory frailty to important adverse health states (falls, physical activity levels, outdoor mobility, problems in self-care or usual activities, and lack of energy or accomplishment) in an English cohort by age and sex. Methods: Analysis of baseline data from a cohort of 9803 community-dwelling participants in a clinical trial. The sample was drawn from a random selection of all people aged 70 or more registered with 63 general practices across England. Data were collected by postal questionnaire. Frailty was measured with the Strawbridge questionnaire. We used cross sectional, multivariate logistic regression to estimate the association between frailty domains and known correlates and adjusted for age. Some models were stratified by sex. Results: Mean age of participants was 78 years (sd 5.7), range 70 to 101 and 47.5% (4653/9803) were men. The prevalence of overall frailty was 20.7% (2005/9671) and there was no difference in prevalence by sex (Odds Ratio 0.98; 95% Confidence Interval 0.89 to 1.08). Sensory frailty was the most common and this was reported by more men (1823/4586) than women (1469/5056; Odds Ratio for sensory frailty 0.62, 95% Confidence Interval 0.57 to 0.68). Men were less likely than women to have physical or nutritive frailty. Physical frailty had the strongest independent associations with adverse health states. However, sensory frailty was independently associated with falls, less frequent walking, problems in self-care and usual activities, lack of energy and accomplishment. Conclusions: Physical frailty was more strongly associated with adverse health states, but sensory frailty was much more common. The health gain from intervention for sensory frailty in England is likely to be substantial, particularly for older men. Sensory frailty should be explored further as an important target of intervention to improve health outcomes for older people both at clinical and population level.This article is freely available via Open Access. Click on the Publisher URL to access it via the publisher's site.08/14/41/DH_/Department of Health/United Kingdom Project number 08/14/41/Health Technology Assessment Programmepre-print, post-print, publisher's version/PD

Evidence of patchy hydrogen reionization from an extreme Lyα trough below redshift six

We report the discovery of an extremely long (∼110 Mpc/h) and dark (τeff≳7) Lyα trough extending down to z≃5.5 towards the zem≃6.0 quasar ULAS J0148+0600. We use these new data in combination with Lyα forest measurements from 42 quasars at 4.5≤zem≤6.4 to conduct an updated analysis of the line-of-sight variance in the intergalactic Lyα opacity over 4≤z≤6. We find that the scatter in transmission among lines of sight near z∼6 significantly exceeds theoretical expectations for either a uniform ultraviolet background (UVB) or simple fluctuating UVB models in which the mean free path to ionizing photons is spatially invariant. The data, particularly near z≃5.6-5.8, instead require fluctuations in the volume-weighted hydrogen neutral fraction that are a factor of 3 or more beyond those expected from density variations alone. We argue that these fluctuations are most likely driven by large-scale variations in the mean free path, consistent with expectations for the final stages of inhomogeneous hydrogen reionization. Even by z≃5.6, however, a large fraction of the data are consistent with a uniform UVB, and by z∼5 the data are fully consistent with opacity fluctuations arising solely from the density field. This suggests that while reionization may be ongoing at z∼6, it has fully completed by z∼5