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.

Knowledge, attitudes and beliefs of parents regarding fever in children: a Danish interview study

Aim: Fever and febrile illness are some of the most common conditions managed by parents. The aim of this study was to examine the knowledge, attitudes and beliefs of parents around fever in children under five years of age. Methods: Between July and August 2014, a convenience sample of parents was invited to participate in this study in Copenhagen, Denmark. Results were analysed thematically using a constant comparison method. Results: Twenty-one parents participated in the study. Five themes emerged from the data: parental concern, help-seeking behaviour, parental knowledge, parent fever management practices and initiatives. Parents used a range of information sources to obtain their knowledge on management of fever; however, due to issues of trust with these sources, reassurance was often sought from healthcare practitioners. There was a desire amongst most parents for initiatives to be introduced which provide general information on how to manage fever in children. Conclusion: Parents were very concerned when their child was febrile and instigated practices obtained from accessible information sources. This study has identified a need for specific and reliable information initiatives to be introduced as a means of reducing parental concern and ensuring evidence-based strategies for managing a child with fever.