Pediatrics
March 2015, VOLUME 135 / ISSUE 3
http://pediatrics.aappublications.org/current.shtml

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Advancing Informed Consent for Vulnerable Populations
Willliam J. Heerman, MD, MPHa, Richard O. White, MD, MScb, and Shari L. Barkin, MD, MSHSa
Author Affiliations
aDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee; and
bDivision of Community Internal Medicine, Mayo Clinic, Jacksonville, Florida
Extract
Informed consent is essential for the conduct of ethical biomedical research.1 Despite its importance, obtaining informed consent is often a complex process, which raises concerns about the extent to which participants are truly informed. Effective implementation is especially difficult among research participants who have limited health literacy. Often, these potential participants are from traditionally high-risk groups, including underrepresented minorities and children. With this in mind, we suggest an innovative approach that uses low health-literacy communication strategies and visual aids to augment and potentially replace the traditional approach to informed consent.
The tension is clear. To provide a comprehensive review of the proposed research, the informed consent document and process are often lengthy, complex, and burdensome.2 Consequently, research participants who sign or verbalize consent often do so without truly understanding the form that they are being asked to sign. In a recent systematic review, participants in one-third of trials assessed did not have adequate understanding in the areas of risks, benefits, randomization, study aims, withdrawal, and voluntarism.3 There are no clear standards for “how much” understanding is adequate. Furthermore, we know that lower education levels, lower literacy, and a participant’s primary language are all associated with poor comprehension of the informed consent process.4 These issues are particularly important when studies are being done in children, adding an additional dimension to vulnerable populations….

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Vaccination, Underlying Comorbidities, and Risk of Invasive Pneumococcal Disease
Inci Yildirim, MD, MSca,b, Kimberly M. Shea, DSc, MPHa,b, Brent A. Little, PhDa, Amy L. Silverio, MAa, and Stephen I. Pelton, MDa,b on behalf of the Members of the Massachusetts Department of Public Health
Author Affiliations
aSection of Pediatric Infectious Diseases, Boston University Medical Center, Boston, Massachusetts; and
bDepartment of Epidemiology, Boston University, School of Public Health, Boston, Massachusetts
Abstract
OBJECTIVES: Children with underlying conditions remain at increased risk for invasive pneumococcal diseases (IPD). This study describes the epidemiology, serotype distribution, clinical presentations, and outcomes of IPD in children with and without comorbidity.
METHODS: Cases of childhood IPD in Massachusetts were identified via enhanced surveillance from 2002 through 2014. Demographic and clinical data were collected via follow-up telephone interviews with parents and/or primary care providers. Underlying conditions were classified according to the 2012 Report of the Committee on Infectious Diseases and 2013 recommendations by the Advisory Committee on Immunization Practices.
RESULTS: Among 1052 IPD cases in Massachusetts children <18 years old, 22.1% had at least 1 comorbidity. Immunocompromising conditions (32.7%) and chronic respiratory diseases (22.4%) were most common. Children with comorbidities were older at the time of IPD diagnosis (median 54 vs 23 months, P < .001), had higher hospitalization (odds ratio 2.5; 95% confidence interval 1.7–3.6) and case-fatality rates (odds ratio 3.7; 95% confidence interval 1.5–8.9) compared with children without known underlying conditions after adjusting for age, gender, year of diagnosis, and pneumococcal vaccination status. During the last 2 years of the study, IPD among children with comorbidities was caused by non–pneumococcal conjugate vaccine 13 serotypes in 23-valent polysaccharide pneumococcal vaccine (6/12, 50%) or serotypes that are not included in any of the vaccines (6/12; 50%).
CONCLUSIONS: In children with comorbidity, IPD results in higher mortality, and a large proportion of disease is due to serotypes not included in current conjugate vaccines. Further research is needed, specifically to develop and evaluate additional strategies for prevention of IPD in the most vulnerable children.