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BACKGROUND AND OBJECTIVES There is widespread unwarranted antibiotic use and large individual provider variation in antibiotic use in NICUs. Vignette-based research methodology offers a unique method of studying variation in individual provider decisions. The objective with this study was to use a vignette-based survey to identify specific areas of provider antibiotic use variation in newborns being evaluated for early onset sepsis. METHODS This study was undertaken as part of a statewide multicenter neonatal antibiotic stewardship quality improvement project led by a perinatal quality improvement collaborative. A web-based vignette survey was administered to identify variation in decisions to start and discontinue antibiotics in cases of early onset sepsis. RESULTS The largest variation was noted in 3 of the 6 vignette cases. These cases highlighted variation in (1) decisions to start antibiotics in a case describing a well-appearing newborn with risk factors and an elevated C-reactive protein, (2) decisions to start antibiotics in the case of a newborn with risk factors plus mild respiratory signs at birth, and (3) decisions to stop antibiotics in the case of the newborn with a history of sepsis risk factors and mild clinical respiratory signs that resolved after 72 hours. CONCLUSIONS Clinical vignette assessment identified specific areas of variation in individual provider antibiotic use decisions in cases of suspected early onset sepsis. Vignettes are a valuable method of describing individual provider variation and highlighting antibiotic stewardship improvement opportunities in NICUs.

IntroductionIn a recent Research Ethics Review editorial [1] Roger Rawbone alludes to the importance of asking questions 1 , and the point is that hard thinking is needed to generate good understanding, eg as occurs with and after the development of a theory. After Harvey' s work showed that blood went through the lungs, it was easier to ask why it followed that path. Veblen' s growing of two questions from one [2] refers to the historical development of intellectual control; ie asking the right questions is not always easy. Talking about Harvey' s theory of the human heart, Miller says 'Things tend to look like what we know they are forand if we don't know what they do, we often find it hard to say how they look' [3]. What is the composition of the REC for? If one sees the question from the medical end of the spectrum, one might think a scientific analysis of the object would provide the answer. One may tend to overlook the political context and not see that the REC serves a political purpose. It is this one needs to see in order to start to understand the otherwise confusing aspects of the composition of research ethics committees. A scientific methodRawbone focuses on the researcher and the subject rather than on the political context of research, and approaches the puzzle with an analysis of the sorts of scientist and sorts of lay member involved. He refers to the technical specialist (TS) and the technical generalist (TG); and the specialist lay member (SL) and generalist lay member (GL). He then offers us definitions of these groups but the various definitions are not coherent. We find that the definitions of the TS and TG are relative to particular RECs rather than to individuals; whilst the SL is defined in terms of a particular study, and the GL in terms of membership of a REC. So from Rawbone' s account, a TS can be a TG; and the SL a GL; and the TS or the TG can be a SL. It may strike one that this difficulty is not caused by the object under investigation, but rather by the method of analysis.Rawbone' s chosen method of analysis is then used to answer the question of the proper membership of RECs. The SL, a member of 'the target group being researched' is taken as the appropriate model for the TS 'who has a direct interest in the subject matter of the research'. A difficulty here may be an assumption that the SL considers only practical matters in the research and not the accompanying ethical values; it seems that Rawbone' s definitions are guiding his analysis. But he tentatively concludes that 'a specialist peer review of the science should be divorced from the validation of the science from an ethical perspective'; his defined members have to have a role. His original method of analysis is leading him into a Procrustean treatment of the composition of RECs. The better approach is that the situated problem This paper focuses on the REC and its political context to clarify the process of ethical review. The examples initially considered are taken from a Research Ethics Review editorial to develop the...

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The role of the REC is to aim for a fair and effective trial protocol and to provide to potential trial subjects sufficient information to allow them to make a rational decision on whether to participate in it or not. The members are medical specialists and members of the public together fitted to these tasks. In his paper ‘Illegality in the research protocol: the duty of research ethics committees under the 2001 Clinical Trials Directive’ Roy-Toole has made a number of suggestions on how to improve the function of the RECs, but he has not given persuasive evidence to show that the RECs themselves are the most effective bodies to implement possible legal requirements to improve medical research.