Informed Consent: How Much Awareness Is There?

Improving the informed consent process in clinical research is of constant concern to regulatory authorities in the field and presents a challenge for both the specialists and patients involved. Informed consent is a process that should adequately match the complexity of clinical research. In analyzing the behaviour of 68 patients during the informed consent process related to the clinical research performed at Neomed Clinical Center in Brasov, we found that many patients do not ask any questions (35.3%). From those who do, part of the questions (20,6%) referred to general aspects (addressed the form but not the gist) of the clinical trial, some (72,8%) referred to specific aspects of the clinical trial they will attend and others (6,6%) unrelated to the clinical trial. These results suggest a lack of interest, awareness, and understanding of the information presented in the informed consent form. The possible underlying causes of this attitude and its bureaucratic, ethic, and legal implications are discussed.     

Is IMRT Superior or Inferior to 3DCRT in Radiotherapy for NSCLC? A Meta-Analysis

IntroductionThere are no adequate data to determine whether intensity-modulated radiotherapy (IMRT) is superior to three-dimensional conformal radiotherapy (3DCRT) in the treatment of non-small cell lung cancer (NSCLC). This meta-analysis was conducted to compare the clinical outcomes of IMRT and 3DCRT in the treatment of NSCLC.MethodsNo exclusions were made based on types of study design. We performed a literature search in PubMed, EMBASE and the Cochrane library databases from their inceptions to April 30, 2015. The overall survival (OS) and relative risk (RR) of radiation pneumonitis and radiation oesophagitis were evaluated. Two authors independently assessed the methodological quality and extracted data. Publication bias was evaluated by funnel plot using Egger’s test results.ResultsFrom the literature search, 10 retrospective studies were collected, and of those, 5 (12,896 patients) were selected for OS analysis, 4 (981 patients) were selected for radiation pneumonitis analysis, and 4 (1339 patients) were selected for radiation oesophagitis analysis. Cox multivariate proportional hazards models revealed that 3DCRT and IMRT had similar OS (HR = 0.96, P = 0.477) but that IMRT reduced the incidence of grade 2 radiation pneumonitis (RR = 0.74, P = 0.009) and increased the incidence of grade 3 radiation oesophagitis (RR = 2.47, P = 0.000).ConclusionsOS of IMRT for NSCLC is not inferior to that of 3DCRT, but IMRT significantly reduces the risk of radiation pneumonitis and increases the risk of radiation oesophagitis compared to 3DCRT.     

Can Centralized Sanctioning Promote Trust in Social Dilemmas? A Two-Level Trust Game with Incomplete Information

The problem of trust is a paradigmatic social dilemma. Previous literature has paid much academic attention on effects of peer punishment and altruistic third-party punishment on trust and human cooperation in dyadic interactions. However, the effects of centralized sanctioning institutions on decentralized reciprocity in hierarchical interactions remain to be further explored. This paper presents a formal two-level trust game with incomplete information which adds an authority as a strategic purposive actor into the traditional trust game. This model allows scholars to examine the problem of trust in more complex game theoretic configurations. The analysis demonstrates how the centralized institutions might change the dynamics of reciprocity between the trustor and the trustee. Findings suggest that the sequential equilibria of the newly proposed two-level model simultaneously include the risk of placing trust for the trustor and the temptation of short-term defection for the trustee. Moreover, they have shown that even a slight uncertainty about the type of the newly introduced authority might facilitate the establishment of trust and reciprocity in social dilemmas.     

When Is Visual Information Used to Control Locomotion When Descending a Kerb?

Background

Descending kerbs during locomotion involves the regulation of appropriate foot placement before the kerb-edge and foot clearance over it. It also involves the modulation of gait output to ensure the body-mass is safely and smoothly lowered to the new level. Previous research has shown that vision is used in such adaptive gait tasks for feedforward planning, with vision from the lower visual field (lvf) used for online updating. The present study determined when lvf information is used to control/update locomotion when stepping from a kerb.

Methodology/Principal Findings

12 young adults stepped down a kerb during ongoing gait. Force sensitive resistors (attached to participants'' feet) interfaced with an high-speed PDLC ‘smart glass’ sheet, allowed the lvf to be unpredictably occluded at either heel-contact of the penultimate or final step before the kerb-edge up to contact with the lower level. Analysis focussed on determining changes in foot placement distance before the kerb-edge, clearance over it, and in kinematic measures of the step down. Lvf occlusion from the instant of final step contact had no significant effect on any dependant variable (p>0.09). Occlusion of the lvf from the instant of penultimate step contact had a significant effect on foot clearance and on several kinematic measures, with findings consistent with participants becoming uncertain regarding relative horizontal location of the kerb-edge.

Conclusion/Significance

These findings suggest concurrent feedback of the lower limb, kerb-edge, and/or floor area immediately in front/below the kerb is not used when stepping from a kerb during ongoing gait. Instead heel-clearance and pre-landing-kinematic parameters are determined/planned using lvf information acquired in the penultimate step during the approach to the kerb-edge, with information related to foot placement before the kerb-edge being the most salient.     

SoilGrids1km — Global Soil Information Based on Automated Mapping

BackgroundSoils are widely recognized as a non-renewable natural resource and as biophysical carbon sinks. As such, there is a growing requirement for global soil information. Although several global soil information systems already exist, these tend to suffer from inconsistencies and limited spatial detail.Conclusions/SignificanceSoilGrids1km provide an initial set of examples of soil spatial data for input into global models at a resolution and consistency not previously available. Some of the main limitations of the current version of SoilGrids1km are: (1) weak relationships between soil properties/classes and explanatory variables due to scale mismatches, (2) difficulty to obtain covariates that capture soil forming factors, (3) low sampling density and spatial clustering of soil profile locations. However, as the SoilGrids system is highly automated and flexible, increasingly accurate predictions can be generated as new input data become available. SoilGrids1km are available for download via http://soilgrids.org under a Creative Commons Non Commercial license.     

How Global Is the Global Biodiversity Information Facility?

There is a concerted global effort to digitize biodiversity occurrence data from herbarium and museum collections that together offer an unparalleled archive of life on Earth over the past few centuries. The Global Biodiversity Information Facility provides the largest single gateway to these data. Since 2004 it has provided a single point of access to specimen data from databases of biological surveys and collections. Biologists now have rapid access to more than 120 million observations, for use in many biological analyses. We investigate the quality and coverage of data digitally available, from the perspective of a biologist seeking distribution data for spatial analysis on a global scale. We present an example of automatic verification of geographic data using distributions from the International Legume Database and Information Service to test empirically, issues of geographic coverage and accuracy. There are over 1/2 million records covering 31% of all Legume species, and 84% of these records pass geographic validation. These data are not yet a global biodiversity resource for all species, or all countries. A user will encounter many biases and gaps in these data which should be understood before data are used or analyzed. The data are notably deficient in many of the world's biodiversity hotspots. The deficiencies in data coverage can be resolved by an increased application of resources to digitize and publish data throughout these most diverse regions. But in the push to provide ever more data online, we should not forget that consistent data quality is of paramount importance if the data are to be useful in capturing a meaningful picture of life on Earth.     

Is Trust for Sale? The Effectiveness of Financial Compensation for Repairing Competence- versus Integrity-Based Trust Violations

Despite the popularity of financial compensation as a means for addressing trust violations, the question whether (more) money can indeed buy trust back remains largely unexplored. In the present research, we focus on the role of violation type and compensation size. The results of a scenario study and a laboratory experiment show that financial compensation can effectively promote the restoration of trust for transgressions that indicate a lack of competence. Conversely, for transgressions which signal a lack of integrity, financial compensation is not an effective tool to repair trust. Moreover, our findings indicate that for both violation types, overcompensation has no positive effects on top of the impact of equal compensation. These findings therefore show that when it comes to trust, money cannot buy everything.     

Is Attention Based on Spatial Contextual Memory Preferentially Guided by Low Spatial Frequency Signals?

A popular model of visual perception states that coarse information (carried by low spatial frequencies) along the dorsal stream is rapidly transmitted to prefrontal and medial temporal areas, activating contextual information from memory, which can in turn constrain detailed input carried by high spatial frequencies arriving at a slower rate along the ventral visual stream, thus facilitating the processing of ambiguous visual stimuli. We were interested in testing whether this model contributes to memory-guided orienting of attention. In particular, we asked whether global, low-spatial frequency (LSF) inputs play a dominant role in triggering contextual memories in order to facilitate the processing of the upcoming target stimulus. We explored this question over four experiments. The first experiment replicated the LSF advantage reported in perceptual discrimination tasks by showing that participants were faster and more accurate at matching a low spatial frequency version of a scene, compared to a high spatial frequency version, to its original counterpart in a forced-choice task. The subsequent three experiments tested the relative contributions of low versus high spatial frequencies during memory-guided covert spatial attention orienting tasks. Replicating the effects of memory-guided attention, pre-exposure to scenes associated with specific spatial memories for target locations (memory cues) led to higher perceptual discrimination and faster response times to identify targets embedded in the scenes. However, either high or low spatial frequency cues were equally effective; LSF signals did not selectively or preferentially contribute to the memory-driven attention benefits to performance. Our results challenge a generalized model that LSFs activate contextual memories, which in turn bias attention and facilitate perception.     

Hybrid Method Based on Information Gain and Support Vector Machine for Gene Selection in Cancer Classi?cation

It remains a great challenge to achieve suf?cient cancer classi?cation accuracy with the entire set of genes, due to the high dimensions, small sample size, and big noise of gene expression data. We thus proposed a hybrid gene selection method, Information Gain-Support Vector Machine(IG-SVM) in this study. IG was initially employed to ?lter irrelevant and redundant genes. Then,further removal of redundant genes was performed using SVM to eliminate the noise in the datasets more effectively. Finally, the informative genes selected by IG-SVM served as the input for the LIBSVM classi?er. Compared to other related algorithms, IG-SVM showed the highest classi?cation accuracy and superior performance as evaluated using ?ve cancer gene expression datasets based on a few selected genes. As an example, IG-SVM achieved a classi?cation accuracy of 90.32% for colon cancer, which is dif?cult to be accurately classi?ed, only based on three genes including CSRP1, MYL9, and GUCA2B.     

Is the effect of wounding on leaf senescence due to ethylene?

Wounding delays the loss of chlorophyll (Chl) that normally occurs when oat (Avena sativa L.) leaf segments are held in the dark. There was a continued increase in ethylene production during the senescence of the control segments; in contrast, ethylene production by the wounded segments, although it increased by a factor of 2–3 times, reached its peak in 48 h and then dropped sharply to below the basal level. Added 1-aminocyclopropane-1-carboxylic acid (ACC) caused a very large increase in ethylene production in both control and wounded segments, but it increased the rate of Chl loss, though only marginally. Aminoethoxyvinylglycine (AVG) inhibited ethylene production by both control and wounded segments and this did decrease the Chl loss, but only in the control segments. In the wounded segments, AVG antagonized the Chl-retaining action of the wound. Since wounding delayed the loss of Chl and yet caused a moderate increase in ethylene production, we conclude that the ethylene production by senescing oat leaves is not the main controlling influence in the wounding effect. The data also throw doubt on the causal participation of ethylene in normal Chl loss by these leaves in darkness.     

Is polychaete family-level sufficient to assess impact on tropical estuarine gradients?

Regular, robust monitoring programs set up to assess the environmental conditions of aquatic systems often target different biological groups. And, of these, macroinvertebrate communities and particularly the class Polychaeta are frequently used. Identifying these organisms takes time, money and specialized expertise to ensure correct identification to the lowest possible taxonomic level. Identification errors can lead to an erroneous assessment. The concept of taxonomic sufficiency has been proposed both to minimize errors and to save time and money. This study tested the usefulness of this concept in tropical estuaries in northeast Brazil. We selected two transitional systems with different degrees of human impact due to different land uses and different conservation systems: the Mamanguape estuary, which is in an environmental conservation unit for sustainable use, and the highly impacted, urban Paraíba do Norte estuary. The results clearly showed that nutrient concentrations were markedly higher in the Paraíba do Norte estuary in the dry season and that the composition of the polychaete assemblages differed between the two estuaries as well as along the spatial gradient of each estuary. The use of either genus or family level led to equivalent representation in each system in terms of taxon richness and both the Margalef and Shannon-Wiener diversity indices. Both taxonomic levels described similar changes in the polychaete assemblage along the estuarine gradients. Based on our findings, the use of a coarser taxonomic level (i.e., family) is a good option when the aim is to implement a monitoring program in tropical estuaries with the polychaete assemblages as one of the target groups. This time-efficient taxonomic resolution can help improve sampling designs and allow long-term monitoring studies without losing much vital information.     

Is height related to longevity?

Over the last 100 years, studies have provided mixed results on the mortality and health of tall and short people. However, during the last 30 years, several researchers have found a negative correlation between greater height and longevity based on relatively homogeneous deceased population samples. Findings based on millions of deaths suggest that shorter, smaller bodies have lower death rates and fewer diet-related chronic diseases, especially past middle age. Shorter people also appear to have longer average lifespans. The authors suggest that the differences in longevity between the sexes is due to their height differences because men average about 8.0% taller than women and have a 7.9% lower life expectancy at birth. Animal experiments also show that smaller animals within the same species generally live longer. The relation between height and health has become more important in recent years because rapid developments in genetic engineering will offer parents the opportunity to increase the heights of their children in the near future. The authors contend that we should not be swept along into a new world of increasingly taller generations without careful consideration of the impact of a worldwide population of taller and heavier people.     

Is MutaMouse insensitive to clastogens?

Several studies suggest that MutaMouse is insensitive to clastogens, including the accompanying paper by Mahabir et al., which describes a study with bleomycin, camptothecin, m-AMSA (4'-(9-acridinylamino)-methanesulfon-m-anisidide) and its ortho-analogue, o-AMSA (4'-(9-acridinylamino)-methanesulfon-o-anisidide). Only camptothecin was clastogenic in MutaMouse and none of these four compounds induced mutations at the lacZ locus. However, to improve exposure, dose range-finding studies were performed in CD2F1 mice, the parental strain of MutaMouse. Male CD2F1 mice (n=3) were treated with bleomycin (25-100 mg/kg bw, p.o. and i.p.), camptothecin (1-10 mg/kg bw p.o.) and m-AMSA (10-50mg/kg bw p.o. and 1-5 mg/kg bw i.p.) for 5 days and blood was sampled on day 3 and/or day 6 for analysis by flow cytometry to determine % MN-RETs. Camptothecin (1 mg/kg bw, day 6) induced a 3.6-fold increase in % MN-RET (P<0.05) but was toxic at higher doses. All day-3 camptothecin samples were positive (P<0.05). Bleomycin was negative when administered p.o. but positive at all doses on both days when given i.p. (P<0.05) whereas m-AMSA was negative when given i.p. or orally. Based on these results, male MutaMouse mice (5 per group) were dosed daily with bleomycin (50 mg/kg bw) for 5 days or with camptothecin (5 mg/kg bw) for 2 days. Peripheral blood was sampled 24 h after the final dose in each group and tissues were sampled 37 days later. Both compounds induced significant increases in % MN-RET, but only bleomycin induced a significant increase in MF (6-fold in liver, 4.5-fold in kidney and 2-fold in lung) compared with the untreated control. These studies support the view that MutaMouse is insensitive to compounds where the genotoxic mechanism of action is predominantly clastogenesis, but demonstrates that the peripheral blood micronucleus test is a useful adjunct to the transgenic gene-mutation assay.     

Is iNOS beginning to smoke?

Inducible nitric oxide synthase (iNOS) helps drive numerous inflammatory disorders, but its inhibition has not had therapeutic success. Now Seimetz et?al. (2011) make a case for inhibiting iNOS in an effort to treat one of the world's leading causes of death-chronic obstructive pulmonary disease.     

Consent for participating in clinical trials ‐ Is it really informed?

The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north‐eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (QuIC) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF, few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants’ decision‐making is meaningful and that their interests are protected.