A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

<p>Abstract</p> <p>Background</p> <p>Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials.</p> <p>Methods</p> <p>We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination.</p> <p>Results</p> <p>110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods.</p> <p>Conclusions</p> <p>Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results.</p

Re-conceptualising culture in Virtual Learning Environments: from an 'essentialist' to a 'negotiated' perspective

The notion of 'culture' as an essential attribute of individuals and groups, owed to national or ethnic background, is critiqued in this article as unhelpful to the project of understanding how diverse participants in virtual learning environments (VLEs) individually and jointly construct a culture of interaction. An alternative conceptualisation of culture in VLEs is proposed, which views online discussion as just one of the sites in which the culture of a VLE is negotiated. Other sites are to be found in institutional practices of teaching and learning at a distance, and in the wider cultural narratives of the Internet. Examples from two online masters courses in online and distance education are used to contextualise this concept of culture, exploring the differences in patterns of participation that are produced by contrasting institutional cultures, even though such participation is explicitly valorised as the means and the subject of the learning that goes on in both these courses. Some implications for the understanding and management of student diversity in these environments are considered, in particular the need for emerging cultural narratives around VLEs to reflect all aspects of student engagement in distance education, not just those which relate to online interaction

Virtual teams and group member dissimilarity - Consequences for the development of trust

The consequences of demographic dissimilarity for group trust in work teams was examined in a virtual (computer-mediated) and a face-to-face (FTF) environment. Demographic dissimilarity (based on age, gender, country of birth, enrolled degree) was predicted to be negatively associated with group trust in the FTF environment but not in the computer-mediated environment. Participants worked in small groups on a creative task for 3 consecutive days. In the computer-mediated environment, participants worked on the task for an hour per day. In the FTF environment, participants worked on the task for 20 minutes per day. Partial support was found for the effectiveness of computer-mediated groups in reducing the negative consequences of dissimilarity. Age dissimilarity was negatively related to trust in FTF groups but not in computer-mediated groups. Birthplace dissimilarity was positively related to trust in computer-mediated groups. Implications for the successful management of virtual teams are discussed

Structuring of Genre Repertoire in a Virtual Research Team

Genres are considered \u201cas socially recognized types of communicative actions that are habitually enacted by members of a community to realize particular social purposes\u201d (Orlikowski and Yates, 1994, p. 542). This paper investigates the evolution of an e-mail-based genre repertoire and questions whether it is related to the degree of complexity associated to different tasks and to the phases of group development. The analysis has been carried out by studying the case of an international research team involved in a European project that principally collaborates through e-mail and other CMC technologies in order to execute different kinds of tasks