NOURISH, Nutritional OUtcomes from a Randomised Investigation of Intradialytic oral nutritional Supplements in patients receiving Haemodialysis: a pilot randomised controlled trial

Background The study was done to assess the feasibility of conducting a trial evaluating the use of an intradialytic oral nutritional supplement (ONS) on nutritional status. Methods The study design is a single centre, parallel group, external pilot randomised controlled trial (RCT). The setting was at a haemodialysis unit in Sheffield, UK. The aim was to recruit 30 trial participants to allow at least 12 evaluable patients per arm, but the actual study sample consisted of 10 adults with a body mass index (BMI) ≤22 kg/m2, receiving thrice weekly haemodialysis. All participants received nutritional advice from a renal dietitian as per usual practice. The intervention included the provision of an intradialytic ONS. Feasibility outcomes included recruitment to time and retention of participants along with palatability of ONS. Secondary outcomes were clinical parameters to obtain variance and estimates of effect size to inform the sample size calculation for a definitive trial. Results Recruitment was undertaken for a fixed period of 6 weeks. Rates were lower than expected mainly due to ineligibility with only 7% of screened patients (19/265) being eligible and 4% (10/265) of these being recruited. Due to the small proportion of patients eligible for the trial, all haemodialysis patients at the specified unit were assessed for eligibility. Data completion rates were low for session questionnaires (23%). Sample sizes derived from variance in secondary outcome measure of handgrip strength and adjusted for a dropout rate of 20% indicate that 189 patients would be required for a definitive RCT, requiring 19 UK haemodialysis units to participate. Conclusions A definitive RCT is feasible with some adaptation to exclusion criteria and methodology. The exclusion criteria could be adapted to include an increase in upper limit for BMI. The use of questionnaires at each dialysis session may not be feasible but the inclusion of appetite and supplement consumption data collection at the main assessments would provide similar outcome data. Quality of life assessment using SF-12 would be acceptable

Nonlocality vs. complementarity: a conservative approach to the information problem

A proposal for resolution of the information paradox is that "nice slice" states, which have been viewed as providing a sharp argument for information loss, do not in fact do so as they do not give a fully accurate description of the quantum state of a black hole. This however leaves an information *problem*, which is to provide a consistent description of how information escapes when a black hole evaporates. While a rather extreme form of nonlocality has been advocated in the form of complementarity, this paper argues that is not necessary, and more modest nonlocality could solve the information problem. One possible distinguishing characteristic of scenarios is the information retention time. The question of whether such nonlocality implies acausality, and particularly inconsistency, is briefly addressed. The need for such nonlocality, and its apparent tension with our empirical observations of local quantum field theory, may be a critical missing piece in understanding the principles of quantum gravity.Comment: 11 pages of text and figures, + references. v2 minor text. v3 small revisions to match final journal versio

Magnetic Field Measurements Based on Terfenol Coated Photonic Crystal Fibers

A magnetic field sensor based on the integration of a high birefringence photonic crystal fiber and a composite material made of Terfenol particles and an epoxy resin is proposed. An in-fiber modal interferometer is assembled by evenly exciting both eigenemodes of the HiBi fiber. Changes in the cavity length as well as the effective refractive index are induced by exposing the sensor head to magnetic fields. The magnetic field sensor has a sensitivity of 0.006 (nm/mT) over a range from 0 to 300 mT with a resolution about ±1 mT. A fiber Bragg grating magnetic field sensor is also fabricated and employed to characterize the response of Terfenol composite to the magnetic field

Scientific mindfulness: a foundation for future themes in international business

We conceptualize new ways to qualify what themes should dominate the future IB research agenda by examining three questions: Whom should we ask? What should we ask and which selection criteria should we apply? What are the contextual forces? We propose scientific mindfulness as the way forward for generating themes in IB research

Preventing and Lessening Exacerbations of Asthma in School-aged children Associated with a New Term (PLEASANT): Recruiting Primary Care Research Sites-the PLEASANT experience

Background: Recruitment of general practices and their patients into research studies is frequently reported as a challenge. The Preventing and Lessening Exacerbations of Asthma in School-aged children Associated with a New Term (PLEASANT) trial recruited 142 general practices, across England and Wales and delivered the study intervention to time and target. Aims: To describe the process of recruitment used within the cluster randomised PLEASANT trial and present results on factors that influenced recruitment. Methods: Data were collected on the number of and types of contact used to gain expression of interest and subsequent randomisation into the PLEASANT trial. Practice size and previous research experience were also collected. Results: The mean number of contacts required to gain expression of interest were m=3.01 (s.d. 1.6) and total number of contacts from initial invitation to randomisation m=6.8 (s.d. 3.5). Previous randomised controlled trial involvement (hazard ratio (HR)=1.81 (confidence interval (CI) 95%, 1.55–2.11) P<0.001) and number of studies a practice had previously engaged in (odds ratio (OR) 1.91 (CI 95%, (1.52–2.42)) P<0.001), significantly influenced whether a practice would participate in PLEASANT. Practice size was not a significant deciding factor (OR=1.04 (95% CI 0.99–1.08) P=0.137). Conclusions: Recruitment to time and target can be achieved in general practice. The amount of resource required for site recruitment should not, however, be underestimated and multiple strategies for contacting practices should be considered. General practitioners with more research experience are more likely to participate in studies

Determining the Performance of an Arid Zone Radioactive Waste Site Through Site Characterization, Modeling, and Monitoring

A strategy of site characterization, modeling, and monitoring are used to evaluate the performance of an interim cover at a low-level radioactive waste management site. The soil water migration papthway must be evaluated to assure the long-term isolation of low-level radioactive waste. Water balance studies using precision weighing lysimeters have been conducted for five years near the radioactive waste site ath the Nevada Test Site. The numerical flow models UNSAT-H and HYDRUS-2D were tested using the weighing lysimeter data and then used to evaluate various cover design issues including cover thickness, presence of vegetation, and monitoring system design

Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials

BACKGROUND: Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts. METHODS/DESIGN: The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies. DISCUSSION: Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention. TRIAL REGISTRATION: The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial

Comparative evaluation of anopheline sampling methods in three localities in Indonesia

Background: The effectiveness of vector control efforts can vary based on the interventions used and local mosquito behaviour and adaptability. In many settings, biting patterns of Anopheles mosquitoes can shift in response to interventions targeting indoor-biting mosquitoes, often resulting in higher proportions of mosquitoes feeding outside or at times when people are not protected. These behaviourally resistant mosquitoes have been shown to sustain residual malaria transmission and limit control efforts. Therefore, it is important to accurately sample mosquitoes to understand their behaviour. Methods: A variety of traps were evaluated in three geographically diverse sites in malaria-endemic Indonesia to investigate local mosquito feeding behaviour and determine effective traps for surveillance. Results: Eight traps were evaluated in three sites: Canti village, Lampung, Kaliharjo village, Purworejo, and Saketa village, Halmahera, Indonesia, including the gold standard human landing collection (HLC) and a variety of traps targeting host-seeking and resting mosquitoes both indoors and outdoors. Trapping, using indoor and outdoor HLC, the Ifakara tent trap C, goat and human-occupied tents, resting pots and boxes, and CDC miniature light traps was conducted for 16 nights in two sites and 8 nights in a third site, using a Latin square design. Trap efficacy varied by site, with outdoor HLC yielding the highest catch rates in Canti and Kaliharjo and a goat-baited tent trap proving most effective in Saketa. In Canti village, anthropophilic Anopheles sundaicus were caught indoors and outdoors using HLCs, peaking in the early morning. In Kaliharjo, a variety of mosquitoes were caught, mostly outdoors throughout the night. HLC was ineffective in Saketa, the only site where a goat-baited tent trap was tested. This trap was effective in catching zoophilic vectors outdoors before midnight. Conclusions: Different trapping methods were suitable for different species, likely reflecting differences in behaviour among species. The three villages, each located on a different island in the Indonesian archipelago, contained mosquito populations with unique behaviours. These data suggest that the effectiveness of specific vector monitoring and control measures may vary by location

Building a recruitment database for asthma trials: a conceptual framework for the creation of the UK Database of Asthma Research Volunteers

Funded by Asthma UK as part of the Asthma UK Centre for Applied Research (AUK-AC-2012-01). In addition, BN, IS, CS and AS acknowledge the support of the Farr Institute, which is funded by the MRC and its consortium of funders

A re-randomisation design for clinical trials

Background: Recruitment to clinical trials is often problematic, with many trials failing to recruit to their target sample size. As a result, patient care may be based on suboptimal evidence from underpowered trials or non-randomised studies. Methods: For many conditions patients will require treatment on several occasions, for example, to treat symptoms of an underlying chronic condition (such as migraines, where treatment is required each time a new episode occurs), or until they achieve treatment success (such as fertility, where patients undergo treatment on multiple occasions until they become pregnant). We describe a re-randomisation design for these scenarios, which allows each patient to be independently randomised on multiple occasions. We discuss the circumstances in which this design can be used. Results: The re-randomisation design will give asymptotically unbiased estimates of treatment effect and correct type I error rates under the following conditions: (a) patients are only re-randomised after the follow-up period from their previous randomisation is complete; (b) randomisations for the same patient are performed independently; and (c) the treatment effect is constant across all randomisations. Provided the analysis accounts for correlation between observations from the same patient, this design will typically have higher power than a parallel group trial with an equivalent number of observations. Conclusions: If used appropriately, the re-randomisation design can increase the recruitment rate for clinical trials while still providing an unbiased estimate of treatment effect and correct type I error rates. In many situations, it can increase the power compared to a parallel group design with an equivalent number of observations