Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent

Aim: To evaluate the reported use of Data Monitoring Committees (DMCs), the frequency of interim analysis, pre-specified stopping rules and early trial termination in neonatal randomised controlled trials (RCTs). Methods: We reviewed neonatal RCTs published in four high impact general medical journals, specifically looking at safety issues including documented involvement of a DMC, stated interim analysis, stopping rules and early trial termination. We searched all journal issues over an 11-year period (2003-2013) and recorded predefined parameters on each item for RCTs meeting inclusion criteria. Results: Seventy neonatal trials were identified in four general medical journals: Lancet, New England Journal of Medicine (NEJM), British Medical Journal and Journal of American Medical Association (JAMA). 43 (61.4%) studies reported the presence of a DMC, 36 (51.4%) explicitly mentioned interim analysis; stopping rules were reported in 15 (21.4%) RCTs and 7 (10%) trials were terminated early. The NEJM most frequently reported these parameters compared to the other three journals reviewed. Conclusion: While the majority of neonatal RCTs report on DMC involvement and interim analysis there is still scope for improvement. Clear documentation of safety related issues should be a central component of reporting in neonatal trials involving newborn infants.

A critical search for the ‘self’ in adult education: Bourdieuian insights into transformative possibilities

This study investigates the ‘self’ of six Irish working-class women, all parenting alone and all returned to the field of adult education. Bourdieu’s concepts of habitus, field and capital are the backdrop for the study of the ‘self’, which is viewed through his lens. This study commenced in September 2012 and concluded in August 2014, in a small urban educational setting in an Irish city. All of the women in the study are single parents, most of them did not complete second level education, and none of them had experienced adult or third level education. Their ages vary from 30 to 55 years. The study pursues the women’s motivations for returning to education, the challenges they faced throughout the journey, and their experiences, views and perspectives of Adult Education. The methodology chosen for this research is critical eethnography, and as an emerging ethnographer, I was able to view the phenomena from both an emic (inside) and an etic (outside) perspective. The critically oriented approach is a branch of qualitative research. It is a holistic and humanistic approach that is cyclical and reflective. The critical ethnographic case studies that developed are theoretically framed in critical theory and critical pedagogy. The data is collected from classroom observations (recorded in a journal) and interviews (both individual and group). The women's life experiences inform their sense of self and their capital reserves derive from their experience of habitus. It also attempts to understand the delivery of the programmes and how it can impact the journey of the adult learners. The analysis of the interviews, observations, field notes and reflective journals demonstrate what the women have to say about their new journey in adult education. This crucial information informs best practice for adult education programmes. This study also considers the complexity of habitus and the many forms of capital. The theme of adults returning to education and their disposition to this is one of the major themes of this study. Findings reflect this uncertainty but also underline how the women unshackled themselves of some of the constraints of a restricted view of self. Witnessing this new habitus forming was the core of their transformational possibility becoming real. The study provides a unique contribution to knowledge as it utilises Bourdieuian concepts and theories, not only as theoretical tools but as conceptual tools for analysis. The study examined transformative pedagogy in the field of adult education and it offers important recommendations for future policy and practice.