Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and industry. A broad spectrum of studies use real-world data (RWD) to produce RWE, ranging from randomized trials with outcomes assessed using RWD to fully observational studies. Yet, many proposals for generating RWE lack sufficient detail, and many analyses of RWD suffer from implausible assumptions, other methodological flaws, or inappropriate interpretations. The Causal Roadmap is an explicit, itemized, iterative process that guides investigators to prespecify study design and analysis plans; it addresses a wide range of guidance within a single framework. By supporting the transparent evaluation of causal assumptions and facilitating objective comparisons of design and analysis choices based on prespecified criteria, the Roadmap can help investigators to evaluate the quality of evidence that a given study is likely to produce, specify a study to generate high-quality RWE, and communicate effectively with regulatory agencies and other stakeholders. This paper aims to disseminate and extend the Causal Roadmap framework for use by clinical and translational researchers; three companion papers demonstrate applications of the Causal Roadmap for specific use cases.

Understanding the clinical risk factors for COVID-19 disease severity and outcomes requires a combination of data from electronic health records and patient reports. To facilitate the collection of patient-reported data, as well as accelerate and standardize the collection of data about host factors, we have constructed a COVID-19 survey. This survey is freely available to the scientific community to send electronically for patients to complete online. This patient survey is designed to be comprehensive, yet not overly burdensome, to gather data useful for a range of clinical investigations, and to accommodate a wide variety of implementation settings including at a COVID-19 testing site, at home during infection or after recovery, and/or for individuals while they are hospitalized. A widely adopted standardized survey that can be implemented online with minimal resources can serve as a critical tool for combining and comparing data across studies to improve our understanding of COVID-19 disease.

Introduction: Community Paramedics (CPs) require access to timely blood analysis in the field to guide treatment and transport decisions. Point of care testing (POCT), as opposed to traditional laboratory analysis, may offer a solution, but limited research exists on CP POCT. The objective of this study is to compare the validity of two POCT devices (Abbott i-STAT® and Alere epoc®) and their use by CPs in the community. Methods: In a CP programme responding to 6,000 annual patient care events, a split sample validation of POCT against traditional laboratory analysis for seven analytes (sodium, potassium, chloride, creatinine, hemoglobin, hematocrit, and glucose) was conducted on a consecutive sample of patients. The difference of proportion of discrepant results between POCT and laboratory was compared using a two sample proportion test. Usability was analysed by survey of CP experience, an expert heuristic evaluation of devices, a review of device-logged errors, coded observations of POCT use during quality control testing, and a linear mixed effects model of Systems Usability Scale (SUS) adjusted for CP clinical and POCT experience. Results: Of 1,649 CP calls for service screened for enrollment, 174 had a blood draw, with 108 patient care encounters (62.1%) enrolled from 73 participants. Participants had a mean age of 58.7 years (SD16.3); 49% were female. In 4 of 646 (0.6%) individual comparisons, POCT reported a critical value that the laboratory did not; with no statistically significant difference in the number of discrepant critical values reported with epoc® compared to i-STAT®. There were no instances of the laboratory reporting a critical value when POCT did not. In 88 of 1,046 (8.4%) individual comparisons, the a priori defined acceptable difference between POCT and the laboratory was exceeded; occurring more often in epoc® (10.7%;95%CI:8.1%,13.3%) compared to i-STAT® (6.1%;95%CI:4.1%,8.2%)(p=0.007). Eighteen of 19 CP surveys were returned, with 11/18 (61.1%) preferring i-STAT® over epoc®. The i-STAT® had a higher mean SUS score (higher usability) compared to the epoc® (84.0/100 vs. 59.6/100; p=0.011). Fewer field blood analysis device-logged errors occurred in i-STAT® (7.8%;95%CI:2.9%,12.7%) compared to epoc® (15.5%;95%CI:9.3%,21.7%) although not statistically significant (p=0.063). Conclusion: CP programs can expect valid results from POCT. Usability assessment suggests a preference for i-STAT.

Introduction: Gastroenteritis accounts for 1.7 million emergency department visits by children annually in the United States. We conducted a double-blind trial to determine whether twice daily probiotic administration for 5 days, improves outcomes. Methods: 886 children aged 348 months with gastroenteritis were enrolled in six Canadian pediatric emergency departments. Participants were randomly assigned to twice daily Lactobacillus rhamnosus R0011 and Lactobacillus helveticus R0052, 4.0 x 109 CFU, in a 95:5 ratio or placebo. Primary outcome was development of moderate-severe disease within 14 days of randomization defined by a Modified Vesikari Scale score 9. Secondary outcomes included duration of diarrhea and vomiting, subsequent physician visits and adverse events. Results: Moderate-severe disease occurred in 108 (26.1%) participants administered probiotics and 102 (24.7%) participants allocated to placebo (OR 1.06; 95%CI: 0.77, 1.46; P=0.72). After adjustment for site, age, and frequency of vomiting and diarrhea, treatment assignment did not predict moderate-severe disease (OR, 1.11, 95%CI, 0.80 to 1.56; P=0.53). In the probiotic versus placebo groups, there were no differences in the median duration of diarrhea [52.5 (18.3, 95.8) vs. 55.5 (20.2, 102.3) hours; P=0.31], vomiting [17.7 (0, 58.6) vs. 18.7 (0, 51.6) hours; P=0.18], physician visits (30.2% vs. 26.6%; OR 1.19; 95% CI0.87. 1.62; P=0.27), or adverse events (32.9% vs. 36.8%; OR 0.83; 95%CI 0.62. 1.11; P=0.21). Conclusion: In children presenting to an emergency department with gastroenteritis, twice daily administration of 4.0 x 109 CFU of a Lactobacillus rhamnosus/helveticus probiotic does not prevent development of moderate-severe disease or improvements in other outcomes measured.

An updated compilation of published and new data of major-ion (Ca, Cl, K, Mg, Na, NO3, SO4) and methylsulfonate (MS) concentrations in snow from 520 Antarctic sites is provided by the national ITASE (International Trans-Antarctic Scientific Expedition) programmes of Australia, Brazil, China, Germany, Italy, Japan, Korea, New Zealand, Norway, the United Kingdom, the United States and the national Antarctic programme of Finland. The comparison shows that snow chemistry concentrations vary by up to four orders of magnitude across Antarctica and exhibit distinct geographical patterns. The Antarctic-wide comparison of glaciochemical records provides a unique opportunity to improve our understanding of the fundamental factors that ultimately control the chemistry of snow or ice samples. This paper aims to initiate data compilation and administration in order to provide a framework for facilitation of Antarctic-wide snow chemistry discussions across all ITASE nations and other contributing groups. The data are made available through the ITASE web page (http://www2.umaine.edu/itase/content/syngroups/snowchem.html) and will be updated with new data as they are provided. In addition, recommendations for future research efforts are summarized.

In an attempt to distill what we know about the effects of workplace mindfulness-based training, Hyland, Lee, and Mills (2015) cast a wide net with regard to the array of studies included in their review. For example, they include studies that investigate the benefits associated with workplace mindfulness training (e.g., Wolever et al., 2012) as well as training conducted for patients within primary care settings (e.g., Allen, Bromley, Kuyken, & Sonnenberg, 2009). In addition, their review includes studies based on self-reports of individual differences in mindfulness traits/skills (e.g., Hafenbrack, Kinias, & Barsade, 2014). Reviewing a broad cross-section of research is helpful to illustrate the wide-ranging nature of mindfulness research but also has the potential to obfuscate what we know about mindfulness as it pertains to workers and workplaces.

In this note, we revisit the work of Carson and Crespinto examine the effect of different redistricting plans on competitiveness in U.S. House elections. Similar to the previous results, our probit estimates on an expanded dataset that includes redistricting cycles from 1972 to 2012 reveal that commission and court-drawn districts experience more competition on average than those drawn by legislatures. These results provide additional support for the hypothesis that one way to increase the competitiveness of congressional elections is to allow extra-legislative bodies to draw congressional district boundaries.

We carried out an extensive photometric and spectroscopic investigation of the SPB binary, HD 25558 (see Fig. 1 for the time and geographic distribution of the observations). The ~2000 spectra obtained at 13 observatories during 5 observing seasons, the ground-based multi-colour light curves and the photometric data from the MOST satellite revealed that this object is a double-lined spectroscopic binary with a very long orbital period of about 9 years. We determined the physical parameters of the components, and have found that both lie within the SPB instability strip. Accordingly, both components show line-profile variations consistent with stellar pulsations. Altogether, 11 independent frequencies and one harmonic frequency were identified in the data. The observational data do not allow the inference of a reliable orbital solution, thus, disentangling cannot be performed on the spectra. Since the lines of the two components are never completely separated, the analysis is very complicated. Nevertheless, pixel-by-pixel variability analysis of the cross-correlated line profiles was successful, and we were able to attribute all the frequencies to the primary or secondary component. Spectroscopic and photometric mode-identification was also performed for several of these frequencies of both binary components. The spectroscopic mode-identification results suggest that the inclination and rotation of the two components are rather different. While the primary is a slow rotator with ~6 d rotation period, seen at ~60° inclination, the secondary rotates fast with ~1.2 d rotation period, and is seen at ~20° inclination. Our spectropolarimetric measurements revealed that the secondary component has a magnetic field with at least a few hundred Gauss strength, while no magnetic field was detected in the primary.

The detailed analysis and results of this study will be published elsewhere.

In recent years both the prevalence and duration of breast-feeding have decreased, especially in urban areas of the developing world (McCann et al., 1981). While the majority of births in these areas continue to be attended by traditional birth attendants, the proportion of mothers giving birth in hospitals is increasing. The potential for hospital personnel and practices to affect infant feeding preferences is likely to increase as the trend towards hospital births continues.

The objective of this study is to learn if participants with Parkinson disease (PD), when compared to normal controls, are impaired in making simultaneous but independent right and left hand movements. Participants were tested with Luria's Alternating Hand Postures (AHP) test and modified AHP tests. Twelve PD participants without dementia and twelve matched controls were assessed for their ability to perform the parallel AHP test (both hands remaining in the same coronal plane) and with modifications of this test into swimming (alternative arm extension with finger extension and arm flexion with finger flexion) and reverse swimming (alternative arm extension—finger flexion and arm flexion—finger extension) movements. The participants with PD were significantly impaired when performing the parallel and the reverse swimming movements AHP tests, but not impaired on the swimming movements AHP test. Swimming movements may be phylogenetically and ontogenetically more primitive and not as heavily dependent on frontal-basal ganglia networks; thus performance of swimming movements during the parallel AHP test may decrease this test's sensitivity. (JINS, 2011, 17, 702–708)

Collaboration is used by the US National Security Council as a means to integrate inter-federal government agencies during planning and execution of common goals towards unified, national security. The concept of collaboration has benefits in the healthcare system by building trust, sharing resources, and reducing costs. The current terrorist threats have made collaborative medical training between military and civilian agencies crucial.

This review summarizes the long and rich history of collaboration between civilians and the military in various countries and provides support for the continuation and improvement of collaborative efforts. Through collaboration, advances in the treatment of injuries have been realized, deaths have been reduced, and significant strides in the betterment of the Emergency Medical System have been achieved. This review promotes collaborative medical training between military and civilian medical professionals and provides recommendations for the future based on medical collaboration.

A colony of Glossina morsitans morsitans Westw. was established in the laboratory in Tanga, Tanzania. After being expanded to the planned level of 60 000 flies, the stabilised colony was used to support a field trial using surplus males that were sterilised and released. The production system consisted of an adaptation of the in vivo rearing techniques developed at the Tsetse Research Laboratory, England. Goats were hosts for 90 % of the production; the balance was fed on rabbits. Techniques were developed to standardise the pupal off-take from stabilised colonies in each of three separate insectary units. Puparia were collected daily and kept separately until 52% emergence had occurred; these emerging flies, mostly females, were used to replenish the stock colony as needed. Further eclosion was prevented by chilling the remaining puparia (mostly males) quickly at 4°C and then storing at 10 ± 1°C for up to four days prior to irradiation and shipment to the field. About 68 % of the males produced were available for sterilisation. During the 15-month period of production in support of the field experiments, 1·3 million puparia were produced; 0·6 million of these puparia were released at a production cost of $220 per thousand.

Detailed data from a preselected release site in Tanzania were collected preparatory to testing the insect sterility concept against Glossina morsitans morsitans Westw. The site was at Mkwaja Ranch, a north-eastern coastal cattle-ranching enterprise, in which about 195 km2 was encompassed by a 1-km-wide fly barrier constructed at an average cost of $37/ha. Weekly surveys of flyround transects spaced 1 km apart were conducted over a 14-month period. The estimated male density of G. m. morsitans in the release site was about 630/km2 and for G. pallidipes Aust., 255/km2. The only other species of tsetse found was G. brevipalpis Newst., which was restricted to drainage areas during periods of low rainfall.

A field trial of the sterile insect technique was conducted in Tanzania using males of Glossina morsitans morsitans Westw. that were reared, irradiated and packaged at Tanga. The experimental site was a 195–km2 area 110 km to the south. Following two applications of endosulfan as an aerosol at an interval of 28 days, irradiated puparia of G. m. morsitans were released twice weekly at stations distributed throughout the experimental site. Each of the 120 release stations was serviced every 14 days with puparia which produced sterile adults synchronously within 30 min after placement. Over the 15–month experimental period, an average of 81% control of G. m. morsitans was obtained, whereas G. pallidipes Aust., against which no releases were carried out, recovered to prespray levels within five months. The released sterile insects were found to be highly competitive and to survive well in the field. Immigration of indigenous flies from outside the perimeter barrier surrounding the experimental plot provided a continuous influx of fertile flies that provided the nucleus of the 19% residual population. Under operational conditions, the prevention of migration should result in the elimination of an indigenous G. m. morsitans population subjected to the combined stress of population reduction by two applications of endosulfan aerosols and sequential releases of sterile males.

Surplus puparia from a colony of about 50 000 females of Glossina morsitans morsitans Westw. provided males for sterilisation and release in an experimental assessment of the sterile insect technique in Tanzania. Excess males were stored late in the puparial stage at 10 ±1°C for up to four days prior to being irradiated at ambient temperatures in a nitrogen atmosphere with 11·8 krad in a radioactive caesium (137Cs) source. Puparia chilled at 8 ± 1°C were transported to the field release area twice weekly for manual release. At the release sites, the adults emerged synchronously within 60 min and were automatically marked as they crawled through sand containing fluorescent powder.

As part of a programme to test the sterile insect technique against Glossina morsitans morsitans Westw. in Tanzania, two aerial applications of endosulfan were applied to a 195-km2 test area. The applications were made with a 28-day interval to provide an initial reduction in the target species prior to the release of sterile males. A Cessna 310 aircraft equipped with a rotary atomiser and operating at night was used to apply the insecticide at a dosage of about 20 g/ha. Flyround surveys within 48 h following the spraying operations indicated that a 100% reduction of G. m. morsitans adults was achieved in both applications, while G. pallidipes Aust. was reduced by 91 5% in the first and 100% in the second.

Thirty schizophrenic patients (20 medicated, 10 off medication) were compared with 30 normal controls subjects matched for age, sex, handedness and intelligence. During the performance of a frontal activation task, normal subjects showed increased interhemispheric coherence between anterior brain regions. Schizophrenic patients did not show the same amount of bilateral anterior activation. During the performance of right hemisphere cognitive activation tasks, normal subjects and medicated schizophrenic patients showed significantly reduced bilateral interhemispheric coherence patterns, while the drug-free schizophrenic patients showed a trend towards this same pattern. It is suggested that these findings provide additional evidence for an aberrant functional organization of the brain in schizophrenia.