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Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician’s input is relevant only to sample size/power and statistical analysis sections of a protocol. The comprehensive nature of a biostatistical review coupled with limited guidance on key components of protocol review motived this work. Members of the Biostatistics, Epidemiology, and Research Design Special Interest Group of the Association for Clinical and Translational Science used a consensus approach to identify the elements of research protocols that a biostatistician should consider in a review, and provide specific guidance on how each element should be reviewed. We present the resulting review framework as an educational tool and guideline for biostatisticians navigating review boards and panels. We briefly describe the approach to developing the framework, and we provide a comprehensive checklist and guidance on review of each protocol element. We posit that the biostatistical reviewer, through their breadth of engagement across multiple disciplines and experience with a range of research designs, can and should contribute significantly beyond review of the statistical analysis plan and sample size justification. Through careful scientific review, we hope to prevent excess resource expenditure and risk to humans and animals on poorly planned studies.
Classical stewardship efforts have targeted immunocompetent patients; however, appropriate use of antimicrobials in the immunocompromised host has become a target of interest. Cytomegalovirus (CMV) infection is one of the most common and significant complications after solid-organ transplant (SOT). The treatment of CMV requires a dual approach of antiviral drug therapy and reduction of immunosuppression for optimal outcomes. This dual approach to CMV management increases complexity and requires individualization of therapy to balance antiviral efficacy with the risk of allograft rejection. In this review, we focus on the development and implementation of CMV stewardship initiatives, as a component of antimicrobial stewardship in the immunocompromised host, to optimize the management of prevention and treatment of CMV in SOT recipients. These initiatives have the potential not only to improve judicious use of antivirals and prevent resistance but also to improve patient and graft survival given the interconnection between CMV infection and allograft function.
Public responsiveness to policy is contingent on there being a sufficient amount of clear and accurate information about policy available to citizens. It is of some significance then, that there are increasing concerns about limits being placed on media outlets around the world. We examine the impact of these limits on the public’s ability to respond meaningfully to policy by analyzing cross-national variation in the opinion–policy link. Using new measures on spending preferences from Wave 4 of the Comparative Study of Electoral Systems, merged with OECD data on government spending and Freedom House measures of press freedom, we assess the role of mass media in facilitating public responsiveness. We find evidence that when media are weak, so too is public responsiveness to policy. These results highlight the critical role that accurate, unfettered media can play in modern representative democracy.
Contemporary dictionary-based approaches to sentiment analysis exhibit serious validity problems when applied to specialized vocabularies, but human-coded dictionaries for such applications are often labor-intensive and inefficient to develop. We demonstrate the validity of “minimally-supervised” approaches for the creation of a sentiment dictionary from a corpus of text drawn from a specialized vocabulary. We demonstrate the validity of this approach in estimating sentiment from texts in a large-scale benchmarking dataset recently introduced in computational linguistics, and demonstrate the improvements in accuracy of our approach over well-known standard (nonspecialized) sentiment dictionaries. Finally, we show the usefulness of our approach in an application to the specialized language used in US federal appellate court decisions.
The calibration hardware system of the Large Synoptic Survey Telescope (LSST) is designed to measure two quantities: a telescope’s instrumental response and atmospheric transmission, both as a function of wavelength. First of all, a “collimated beam projector” is designed to measure the instrumental response function by projecting monochromatic light through a mask and a collimating optic onto the telescope. During the measurement, the light level is monitored with a NIST-traceable photodiode. This method does not suffer from stray light effects or the reflections (known as ghosting) present when using a flat-field screen illumination, which has a systematic source of uncertainty from uncontrolled reflections. It allows for an independent measurement of the throughput of the telescope’s optical train as well as each filter’s transmission as a function of position on the primary mirror. Second, CALSPEC stars can be used as calibrated light sources to illuminate the atmosphere and measure its transmission. To measure the atmosphere’s transfer function, we use the telescope’s imager with a Ronchi grating in place of a filter to configure it as a low resolution slitless spectrograph. In this paper, we describe this calibration strategy, focusing on results from a prototype system at the Cerro Tololo Inter-American Observatory (CTIO) 0.9 meter telescope. We compare the instrumental throughput measurements to nominal values measured using a laboratory spectrophotometer, and we describe measurements of the atmosphere made via CALSPEC standard stars during the same run.
Identifying prenatal environmental factors that have genuinely causal effects on psychopathology is an important research priority, but it is crucial to select an appropriate research design. In this review we explain why and what sorts of designs are preferable and focus on genetically informed/sensitive designs. In the field of developmental psychopathology, causal inferences about prenatal risks have not always been based on evidence generated from appropriate designs. We focus on reported links between maternal smoking during pregnancy and offspring attention-deficit/hyperactivity disorder or conduct problems. Undertaking a systematic review of findings from genetically informed designs and “triangulating” evidence from studies with different patterns of bias, we conclude that at present findings suggest it is unlikely that there is a substantial causal effect of maternal smoking in pregnancy on either attention-deficit/hyperactivity disorder or conduct problems. In contrast, for offspring birth weight (which serves as a positive control) findings strongly support a negative causal effect of maternal smoking in pregnancy. For maternal pregnancy stress, too few studies use genetically sensitive designs to draw firm conclusions, but continuity with postnatal stress seems important. We highlight the importance of moving beyond observational designs, for systematic evaluation of the breadth of available evidence and choosing innovative designs. We conclude that a broader set of prenatal risk factors should be examined, including those relevant in low- and middle-income contexts. Future directions include a greater use of molecular genetically informed designs such as Mendelian randomization to test causal hypotheses about prenatal exposure and offspring outcome.
Humpback whales (Megaptera novaeangliae) are known to utilize Massachusetts Bay as a feeding ground in the spring and summer, during the annual migration of the Gulf of Maine sub-population. However, there is a limited understanding of the pattern of humpback whale occurrence in this region outside of the feeding period. Passive acoustic monitoring of Massachusetts Bay over a two-year period, revealed an extended presence of acoustically active humpback whales throughout a majority of the study period (87%; 633 days of presence out of 725 days of acoustic monitoring). Humpback whale presence oscillated between lengthy periods of consistent presence (April to December) and relatively shorter periods of variable presence (December to March). Seasonal variation in presence was evident during three distinct phases: (1) maximum-presence from spring to early winter; (2) variable-presence in early winter and early spring; and (3) minimum-presence mid-winter. The variation in seasonal presence was concurrent with coarse migratory patterns of humpback whales, and yearly variations in presence presumably reflect a shift in the influx and efflux of whales between years. The extended presence of humpbacks in this area suggests that Massachusetts Bay is an important, year-round habitat for the Gulf of Maine sub-population, and may warrant revision of management and regulatory practices to reflect this presence.
There is evidence from North American trials that supported employment using the individual placement and support (IPS) model is effective in helping individuals with severe mental illness gain competitive employment. There have been few trials in other parts of the world.
To investigate the effectiveness and cost-effectiveness of IPS in the UK.
Individuals with severe mental illness in South London were randomised to IPS or local traditional vocational services (treatment as usual) (ISRCTN96677673).
Two hundred and nineteen participants were randomised, and 90% assessed 1 year later. There were no significant differences between the treatment as usual and intervention groups in obtaining competitive employment (13% in the intervention group and 7% in controls; risk ratio 1.35, 95% CI 0.95–1.93, P = 0.15), nor in secondary outcomes.
There was no evidence that IPS was of significant benefit in achieving competitive employment for individuals in South London at 1-year follow-up, which may reflect suboptimal implementation. Implementation of IPS can be challenging in the UK context where IPS is not structurally integrated with mental health services, and economic disincentives may lead to lower levels of motivation in individuals with severe mental illness and psychiatric professionals.
To determine the epidemiological risk factors associated with permanent access-site (PAS) infection in a population of chronic hemodialysis patients.
Retrospective cohort analysis.
Hemodialysis unit of a 400-bed Department of Veterans' Affairs hospital.
A cohort of 94 males (1,316 patient months) was studied. Fifty-one PAS infections in 31 patients were observed. SiX patients had two PAS infections, four patients had three infections, and two patients had four infections. Twenty-nine of the 31 patients with PAS infections were bacteremic at least once. Univariate analysis identified seven factors significantly associated with PAS infection in this population: location of PAS other than forearm, type of vascular access (poletrafluoroethylene [PTFE] versus endogenous arteriovenous [AV] fistula), limited ambulatory status, residence in a nursing home, bacterial infection at a distant site, number of access-site revisions, and number of hospitalizations. In a logistic regression analysis, only graft type and number of PTFE graft revisions were associated independently with PAS infection. The odds ratio for PAS infection in PTFE grafts compared to endogenous AV fistula was 7.8; the odds ratio for PAS infection with each PTFE graft revision was 1.5.
PAS infections were associated independently with the type of graft and the number of PTFE graft surgical revisions.
We report the pathological and molecular biological findings of human T-cell lymphotropic virus type 1 (HTLV-1) infection of the spinal cord in a patient with a chronic progressive myelopathy. Light microscopy disclosed loss of myelin and axons, thickening of blood vessels and a lymphocytic cell infiltrate in the spinal cord especially at the cervical and thoracic levels. Electron microscopy confirmed the vascuolar appearance seen with light microscopy but virus particles were not observed. The HTLV-1 gag gene could be amplified (by polymerase chain reaction) from cervical spinal cord tissue while not from elsewhere in the neuroaxis. The presence of HTLV-1 geonomic material in spinal cord tissue has not been previously reported.
We report the clinical and laboratory findings of six Canadian patients with progressive myelopathy associated with HTLV-1 infection. The diagnosis was suspected on clinical grounds and supported by serological studies and positive gene amplification. Only five had emigrated from an area endemic for HTLV-1 infection. Tropical spastic paraparesis should be considered in all patients with myelopathy, even those without standard serological markers of HTLV-1 infection. The pathogenesis of this condition and the serological and molecular biological means by which this diagnosis can be made are reviewed.
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