Pediatrics
October 2015, VOLUME 136 / ISSUE 4
http://pediatrics.aappublications.org/current.shtml
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Monthly Feature
Treating Children With Cancer Worldwide—Challenges and Interventions
Trijn Israels, Julia Challinor, Scott Howard, and Ramandeep Harman Arora
Pediatrics 2015; 136:607-610
Summary
Although morbidity from childhood cancer is second only to unintentional injuries in high-income countries, in low-income countries, it hardly hits the radar screen compared with death from pneumonia, diarrhea, malaria, neonatal sepsis, preterm birth, and neonatal asphyxia. Nevertheless, the extraordinary progress made in treating childhood cancer in high-income countries brings into harsh focus the mammoth disparities that exist in impoverished areas of the world. As the capacity to diagnose and treat childhood cancer improves in low- and middle-income countries, the ability to improve outcomes for the more common diseases benefits as well. The authors have summarized the issues related to childhood cancer care with thoughtful attention to how children everywhere can gain from the advances in medical science in high-income nations.
Jay E. Berkelhamer
Column Editor
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Febrile Seizures After 2010–2011 Trivalent Inactivated Influenza Vaccine
Alison Tse Kawai, David Martin, Martin Kulldorff, Lingling Li, David V. Cole, Cheryl N. McMahill-Walraven, Nandini Selvam, Mano S. Selvan, and Grace M. Lee
Pediatrics 2015; 136:e848-e855
Abstract
OBJECTIVES: In the Post-Licensure Rapid Immunization Safety Monitoring Program, we examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) during the 2010–2011 influenza season, adjusted for concomitant diphtheria tetanus acellular pertussis-containing vaccines (DTaP). Assuming children would receive both vaccines, we examined whether same-day TIV and PCV13 vaccination was associated with greater FS risk when compared with separate-day vaccination.
METHODS: We used a self-controlled risk interval design, comparing the FS rate in a risk interval (0–1 days) versus control interval (14–20 days). Vaccinations were identified in claims and immunization registry data. FS were confirmed with medical records.
RESULTS: No statistically significant TIV-FS associations were found in unadjusted or adjusted models (incidence rate ratio [IRR] adjusted for age, seasonality, and concomitant PCV13 and DTaP: 1.36, 95% confidence interval [CI] 0.78 to 2.39). Adjusted for age and seasonality, PCV13 was significantly associated with FS (IRR 1.74, 95% CI 1.06 to 2.86), but not when further adjusting for concomitant TIV and DTaP (IRR 1.61, 95% CI 0.91 to 2.82). Same-day TIV and PCV13 vaccination was not associated with excess risk of FS when compared with separate-day vaccination (1.08 fewer FS per 100 000 with same day administration, 95% CI −5.68 to 6.09).
CONCLUSIONS: No statistically significant increased risk of FS was found for 2010–2011 TIV or PCV13, when adjusting for concomitant vaccines. Same-day TIV and PCV13 vaccination was not associated with more FS compared with separate-day vaccination.
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Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure
Marijke C. Jansen-van der Weide, Patrina H.Y. Caldwell, Bridget Young, Martine C. de Vries,
Dick L. Willems, William Van’t Hoff, Kerry Woolfall, Johanna H. van der Lee, and Martin Offringa
Pediatrics 2015; 136:e983-e992
Abstract
Treatments and interventions used to care for children in emergencies should be based on strong evidence. Well-designed clinical trials investigating these interventions for children are therefore indispensable. Parental informed consent is a key ethical requirement for the enrollment of children in such studies. However, if time is limited because of an urgent need for intervention, there are additional ethical challenges to adequately support the informed consent process. The acute situation and associated psychological impact may compromise the ability of parents to give informed consent. Little evidence exists to guide the process of consent seeking for a child’s research participation when time is limited. It is also unclear in what circumstances alternatives to prospective informed consent could be applied. This article describes possible options to manage the informed consent process in an appropriate, practical, and, we believe, ethical way when time is limited.