PLoS medicine
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Editorial
The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.
In a Guest Editorial, Aaron S. Kesselheim and Michael S. Sinha show how federal and state legislation to allow promotion of drugs for non-approved uses threatens to undermine the FDA's public health mission.
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Measurement of mortality and injury in conflict situations presents many challenges compared with stable situations. However, providing information is important to assess the impact of conflict on populations and to estimate humanitarian needs, both in the immediate and longer term. Mosul, Iraq's second largest city, was overrun by fighters of the Islamic State of Iraq and Syria (ISIS) on June 4, 2014. In this study, we conducted household surveys to measure reported deaths, injuries, and kidnappings in Mosul, Iraq, both during the occupation of the city by fighters of ISIS and the months of Iraqi military action known as the liberation. ⋯ Death and injuries during the military offensive to liberate Mosul considerably exceeded those during ISIS occupation. Airstrikes were the major reported cause of deaths, with the majority occurring in west Mosul. The extensive use of airstrikes and heavy artillery risks an extensive loss of life in densely populated urban areas. The high probability of survivor bias in this survey suggests that the actual number of injuries, kidnappings, and deaths in the neighborhoods sampled is likely to be higher than we report here.
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In the context of a recent proposal to exclude research from consideration at the Environmental Protection Agency, John Ioannidis points out that "perceived perfection is not a characteristic of science, but of dogma" and envisions how governments can promote a standard of openness in science.
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Randomized Controlled Trial Multicenter Study
Breastfeeding during infancy and neurocognitive function in adolescence: 16-year follow-up of the PROBIT cluster-randomized trial.
Evidence on the long-term effect of breastfeeding on neurocognitive development is based almost exclusively on observational studies. In the 16-year follow-up study of a large, cluster-randomized trial of a breastfeeding promotion intervention, we evaluated the long-term persistence of the neurocognitive benefits of the breastfeeding promotion intervention previously observed at early school age. ⋯ ClinicalTrials.gov NCT01561612.
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Randomized Controlled Trial
Universal versus conditional day 3 follow-up for children with non-severe unclassified fever at the community level in Ethiopia: A cluster-randomised non-inferiority trial.
With declining malaria prevalence and improved use of malaria diagnostic tests, an increasing proportion of children seen by community health workers (CHWs) have unclassified fever. Current community management guidelines by WHO advise that children seen with non-severe unclassified fever (on day 1) should return to CHWs on day 3 for reassessment. We compared the safety of conditional follow-up reassessment only in cases where symptoms do not resolve with universal follow-up on day 3. ⋯ Conditional follow-up of children with non-severe unclassified fever in a low malaria endemic setting in Ethiopia was non-inferior to universal follow-up through day 8. Allowing CHWs to advise caregivers to bring children back only in case of continued symptoms might be a more efficient use of resources in similar settings.