An investigation of the shortcomings of the CONSORT 2010 statement for the reporting of group sequential randomised controlled trials: a methodological systematic review

Background It can be argued that adaptive designs are underused in clinical research. We have explored concerns related to inadequate reporting of such trials, which may influence their uptake. Through a careful examination of the literature, we evaluated the standards of reporting of group sequential (GS) randomised controlled trials, one form of a confirmatory adaptive design. Methods We undertook a systematic review, by searching Ovid MEDLINE from the 1st January 2001 to 23rd September 2014, supplemented with trials from an audit study. We included parallel group, confirmatory, GS trials that were prospectively designed using a Frequentist approach. Eligible trials were examined for compliance in their reporting against the CONSORT 2010 checklist. In addition, as part of our evaluation, we developed a supplementary checklist to explicitly capture group sequential specific reporting aspects, and investigated how these are currently being reported. Results Of the 284 screened trials, 68(24%) were eligible. Most trials were published in “high impact” peer-reviewed journals. Examination of trials established that 46(68%) were stopped early, predominantly either for futility or efficacy. Suboptimal reporting compliance was found in general items relating to: access to full trials protocols; methods to generate randomisation list(s); details of randomisation concealment, and its implementation. Benchmarking against the supplementary checklist, GS aspects were largely inadequately reported. Only 3(7%) trials which stopped early reported use of statistical bias correction. Moreover, 52(76%) trials failed to disclose methods used to minimise the risk of operational bias, due to the knowledge or leakage of interim results. Occurrence of changes to trial methods and outcomes could not be determined in most trials, due to inaccessible protocols and amendments. Discussion and Conclusions There are issues with the reporting of GS trials, particularly those specific to the conduct of interim analyses. Suboptimal reporting of bias correction methods could potentially imply most GS trials stopping early are giving biased results of treatment effects. As a result, research consumers may question credibility of findings to change practice when trials are stopped early. These issues could be alleviated through a CONSORT extension. Assurance of scientific rigour through transparent adequate reporting is paramount to the credibility of findings from adaptive trials. Our systematic literature search was restricted to one database due to resource constraints.

Electronic, vibrational and related properties of group IV metal oxides by ab initio calculations

We present our theoretical results for the structural, electronic, vibrational and optical properties of MO(2) (M = Sn, Zr, Hf and Ti) obtained by first-principles calculations. Relativistic effects are demonstrated to be important for a realistic description of the detailed structure of the electronic frequency-dependent dielectric function, as well as of the carrier effective masses. Based on our results, we found that the main contribution of the high values calculated for the oxides dielectric constants arises from the vibrational properties of these oxides, and the vibrational static dielectric constant values diminish with increasing pressure. (c) 2008 Elsevier B.V. All rights reserved.

Incorporation of group 14 elements into siloxane-bridged paracyclophanes cyclo-[p,p´-Me2SiC6H4EMe2C6H4SiMe2O]2 (E = C, Si, Ge, Sn)§

The bis(arylene silanes) p,p'-HMe₂SiC₆H₄EMe₂C₆H₄SiMe₂H (E = C (10), Si (11), Ge (12), Sn(13)) were prepared by the in situ Grignard reaction of p,p'-BrC₆H₄CMe₂C₆H₄Br, Mg turnings, and HSiMe₂Cl (for 10) and the Grignard reaction using p-HMe₂SiC₆H₄Br, Mg turnings, and Me₂ECl₂ (E = Si for 11, Ge for 12, Sn for 13). The oxidation of 10-13 using Pearlman's catalyst, Pd(OH)₂/C, in aqueous THF provided the bis(arylene silanols) p,p'-HOMe₂SiC₆H₄EMe₂C₆H₄SiMe₂OH (E = C (14), Si (15), Ge (16), Sn(17)). The HCl-catalyzed condensation of 14-17 in highly diluted solutions of acetone/water afforded the siloxane-bridged paracyclophanes cyclo-[p,p'-Me₂SiC₆H₄EMe₂C₆H₄SiMe₂O]₂ (6-9) that incorporate the group 14 elements E = C, Si, Ge, and Sn. Compounds 6-17 were investigated by multinuclear solution and solid-state NMR spectroscopy and 6 and 9 also by X-ray crystallography.

Establishing best-practice principles for the teaching of group design projects

As student-to-staff ratios escalate, increasing numbers of undergraduate architects are finding the reduction of ‘one-to-one’ studio supervision an impediment to learning. Group design projects are becoming a widespread solution to this problem. However, little analysis has been undertaken as to their effectiveness both in terms of student assessment and as a design teaching methodology.
The two hundred years of apprentice/master tradition that underpins the atelier studio system is still at the core of much present day architectural design education. Yet this tradition today poses uncertainties for a large number of co-ordinating lecturers faced with current changes in the nature of tertiary education and its funding structure. In particular, with reductions in staff/student contact time, in sessional funding sources and in the relative weighting of design-based subjects with respect to other subject areas, many design teachers are finding it increasingly difficult to maintain an atelier system that has shaped both their learning and, more pointedly, their teaching. If these deficiencies remain unchecked and design-based schools are unable to implement strategies that successfully overcome the resource intensive one-to-one teaching program, then architecture may prove to be an untenable course structure for many institutions.
Rather then spreading their time thinly, many co-ordinating lecturers are setting group projects in order to review less assignments but at greater depth. However, while this learning model better reflects design teams in practice, this approach may pose other pedagogical and assessment questions. What is clear is the urgent need for structured research into the teaching and assessment problems experienced by design teachers, and for a readily adoptable pedagogy for group design projects. At Deakin University, research is underway aimed at establishing best-practice principles for group design projects by analysing students’ performance and recording and implementing their feedback to adjustments made to the pedagogical fundamentals of assessment, group configuration, and program structure. There are after two years of preliminary studies already clear indications of what changes can be made to these to encourage more effective team learning. This paper will present the findings of these studies.

Students` performance and perception linked to the use of group and audience response systems (GARS) in large classes

This paper reports an investigation into the impact of Group and Audience Response Systems (GARS) on students’ learning outcomes, and perceptions of learning in large classes. Performance is compared between students who used the technology, and students who did not, based on progressive assignment and exam results. Perception is assessed based on an online survey questionnaire. The key findings of this study indicate that students who used the technology achieved, on average, 6.70% higher grades compared to those who did not. Further, use of the technology improved the overall achievement of students, on average, regardless of their perception of whether or not it would provide
an academic advantage. Key findings and future use of the technology are discussed.

Building genetic networks using relatedness information : a novel approach for the estimation of dispersal and characterization of group structure in social animals

Natal dispersal is an important life history trait driving variation in individual fitness, and therefore, a proper understanding of the factors underlying dispersal behaviour is critical to many fields including population dynamics, behavioural ecology and conservation biology. However, individual dispersal patterns remain difficult to quantify despite many years of research using direct and indirect methods. Here, we quantify dispersal in a single intensively studied population of the cooperatively breeding chestnut-crowned babbler (Pomatostomus ruficeps) using genetic networks created from the combination of pairwise relatedness data and social networking methods and compare this to dispersal estimates from re-sighting data. This novel approach not only identifies movements between social groups within our study sites but also provides an estimation of immigration rates of individuals originating outside the study site. Both genetic and re-sighting data indicated that dispersal was strongly female biased, but the magnitude of dispersal estimates was much greater using genetic data. This suggests that many previous studies relying on mark–recapture data may have significantly underestimated dispersal. An analysis of spatial genetic structure within the sampled population also supports the idea that females are more dispersive, with females having no structure beyond the bounds of their own social group, while male genetic structure expands for 750 m from their social group. Although the genetic network approach we have used is an excellent tool for visualizing the social and genetic microstructure of social animals and identifying dispersers, our results also indicate the importance of applying them in parallel with behavioural and life history data.

Benefits of group foraging depend on prey type in a small marine predator, the Little Penguin

Group foraging provides predators with advantages in over-powering prey larger than themselves or in aggregating small prey for efficient exploitation. For group-living predatory species, cooperative hunting strategies provide inclusive fitness benefits. However, for colonial-breeding predators, the benefit pay-offs of group foraging are less clear due to the potential for intra-specific competition. We used animal-borne cameras to determine the prey types, hunting strategies, and success of little penguins (Eudyptula minor), a small, colonial breeding air-breathing marine predator that has recently been shown to display extensive at-sea foraging associations with conspecifics. Regardless of prey type, little penguins had a higher probability of associating with conspecifics when hunting prey that were aggregated than when prey were solitary. In addition, success was greater when individuals hunted schooling rather than solitary prey. Surprisingly, however, success on schooling prey was similar or greater when individuals hunted on their own than when with conspecifics. These findings suggest individuals may be trading-off the energetic gains of solitary hunting for an increased probability of detecting prey within a spatially and temporally variable prey field by associating with conspecifics.

Molecular characterization of group A bovine rotavirus in southeastern and central-western Brazil, 2009-2010

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Nest Digging by Leaf-Cutting Ants: Effect of Group Size and Functional Structures.

Leaf-cutting ant workers dig underground chambers, for housing their symbiotic fungus, interconnected by a vast quantity of tunnels whose function is to permit the entrance of food (leaves), gaseous exchanges, andmovement of workers, offspring, and the queen. Digging is a task executed by a group of workers, but little is known about the group effect and group-constructed functional structures. Thus, we analyzed the structures formed by worker groups (5, 10, 20, and 40 individuals) of the leaf-cutting ant, Atta sexdens rubropilosa, for 2 days of excavation. The digging arena was the same for the 4 groups, with each group corresponding to a different density. Our results verified a pattern of tunneling by the workers, but no chamber was constructed. The group effect is well known, since the 40-worker group dug significantly more than the groups of 5, 10, and 20. These groups did not differ statistically from each other. Analysis of load/worker verified that workers of the smallest group carried the greatest load. Our paper demonstrates the group effect on the digging of nests, namely, that excavation is proportional to group size, but without emergence of a functional structure such as a chamber.