Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants.

ObjectiveTo analyze reasons for low enrollment in a randomized controlled trial (RCT) of the effect of hydrocortisone for cardiovascular insufficiency on survival without neurodevelopmental impairment (NDI) in term/late preterm newborns.Study designThe original study was a multicenter RCT. Eligibility: ⩾34 weeks' gestation, <72 h old, mechanically ventilated, receiving inotrope. Primary outcome was NDI at 2 years; infants with diagnoses at high risk for NDI were excluded. This paper presents an analysis of reasons for low patient enrollment.ResultsTwo hundred and fifty-seven of the 932 otherwise eligible infants received inotropes; however, 207 (81%) had exclusionary diagnoses. Only 12 infants were randomized over 10 months; therefore, the study was terminated. Contributing factors included few eligible infants after exclusions, open-label steroid therapy and a narrow enrollment window.ConclusionDespite an observational study to estimate the population, very few infants were enrolled. Successful RCTs of emergent therapy may require fewer exclusions, a short-term primary outcome, waiver of consent and/or other alternatives

Data cultures of mobile dating and hook-up apps : emerging issues for critical social science research

The ethical and social implications of data mining, algorithmic curation and automation in the context of social media have been of heightened concern for a range of researchers with interests in digital media in recent years, with particular concerns about privacy arising in the context of mobile and locative media. Despite their wide adoption and economic importance, mobile dating apps have received little scholarly attention from this perspective – but they are intense sites of data generation, algorithmic processing, and cross-platform data-sharing; bound up with competing cultures of pro- duction, exploitation and use. In this paper, we describe the ways various forms of data are incorporated into, and emerge from, hook-up apps’ business logics, socio-technical arrangements, and cultures of use to produce multiple and intersecting data cultures. We propose a multi-layered research agenda for critical and empirical inquiry into this field, and suggest appropriate conceptual and methodological frameworks for exploring the social and political challenges of data cultures

Dedicated bifurcation analysis: basic principles

Over the last several years significant interest has arisen in bifurcation stenting, in particular stimulated by the European Bifurcation Club. Traditional straight vessel analysis by QCA does not satisfy the requirements for such complex morphologies anymore. To come up with practical solutions, we have developed two models, a Y-shape and a T-shape model, suitable for bifurcation QCA analysis depending on the specific anatomy of the coronary bifurcation. The principles of these models are described in this paper, as well as the results of validation studies carried out on clinical materials. It can be concluded that the accuracy, precision and applicability of these new bifurcation analyses are conform the general guidelines that have been set many years ago for conventional QCA-analyses

Improving the public house in Britain, 1920-40: Sir Sydney Nevile and 'social work'

The ‘improved public house’ movement in the inter-war years was a central part of the shift towards retailing by the brewing industry. An important part of the reform movement was the alliance between certain brewers, notably Whitbread, and ‘social workers’, particularly those associated with the University settlement movement in London. Using the papers of Sydney Nevile, the importance of a particular social milieu is outlined, calling into question attempts to align the movement to improve public houses with transatlantic Progressivism. Rather, this alliance drew upon longstanding English traditions of public service and religious affiliation amongst a fraction of the gentry

Measuring and controlling medical record abstraction (MRA) error rates in an observational study.

BACKGROUND: Studies have shown that data collection by medical record abstraction (MRA) is a significant source of error in clinical research studies relying on secondary use data. Yet, the quality of data collected using MRA is seldom assessed. We employed a novel, theory-based framework for data quality assurance and quality control of MRA. The objective of this work is to determine the potential impact of formalized MRA training and continuous quality control (QC) processes on data quality over time. METHODS: We conducted a retrospective analysis of QC data collected during a cross-sectional medical record review of mother-infant dyads with Neonatal Opioid Withdrawal Syndrome. A confidence interval approach was used to calculate crude (Wald\u27s method) and adjusted (generalized estimating equation) error rates over time. We calculated error rates using the number of errors divided by total fields ( all-field error rate) and populated fields ( populated-field error rate) as the denominators, to provide both an optimistic and a conservative measurement, respectively. RESULTS: On average, the ACT NOW CE Study maintained an error rate between 1% (optimistic) and 3% (conservative). Additionally, we observed a decrease of 0.51 percentage points with each additional QC Event conducted. CONCLUSIONS: Formalized MRA training and continuous QC resulted in lower error rates than have been found in previous literature and a decrease in error rates over time. This study newly demonstrates the importance of continuous process controls for MRA within the context of a multi-site clinical research study