Catherine Schaefer

New Models for Large Prospective Studies: Is There a Better Way?

Large prospective cohort studies are critical for identifying etiologic factors for disease, but they require substantial long-term research investment. Such studies can be conducted as multisite consortia of academic medical centers, combinations of smaller ongoing studies, or a single large site such as a dominant regional health-care provider. Still another strategy relies upon centralized conduct of most or all aspects, recruiting through multiple temporary assessment centers. This is the approach used by a large-scale national resource in the United Kingdom known as the “UK Biobank,” which completed recruitment/examination of 503,000 participants between 2007 and 2010 within budget and ahead of schedule. A key lesson from UK Biobank and similar studies is that large studies are not simply small studies made large but, rather, require fundamentally different approaches in which “process” expertise is as important as scientific rigor. Embedding recruitment in a structure that facilitates outcome determination, utilizing comprehensive and flexible information technology, automating biospecimen processing, ensuring broad consent, and establishing essentially autonomous leadership with appropriate oversight are all critical to success. Whether and how these approaches may be transportable to the United States remain to be explored, but their success in studies such as UK Biobank makes a compelling case for such explorations to begin.

Iron and the exclusively breast-fed infant from birth to six months

This study was designed to determine whether normal, full-term, exclusively breast-fed infants develop iron deficiency anemia, as defined by hemoglobin or red blood cell indices more than two standard deviations below the age-specific mean, or depletion of iron stores, as defined by an abnormally low serum ferritin level. Thirty-three breast-fed infants were followed from birth to 6 months. Maternal blood and cord blood at delivery, and venous blood from the infants at 2, 4, and 6 months were analyzed for anemia as defined above. At 6 months of age, the mean hemoglobin concentration of these infants was slightly higher than the normal mean; four of 33 infants (12%) had a mean corpuscular volume greater than 2 SD below the reported normal mean; and two of 33 infants (6%) had a serum ferritin level less than 12 ng protein/ml. These data suggest that the infant who is exclusively breast-fed for the first 6 months of life is not at high risk for the development of iron deficiency anemia or the depletion of iron stores during that time.

Permanence and change: Psychosocial factors in the outcome of adolescent pregnancy☆

Past work suggests that stressful life changes and the availability of social support exert opposing effects on the health of adolescent mothers and their infants. We have developed a theoretical perspective in which the effects of both stressful and protective social factors are viewed as acting on health through their capacity to either undermine or sustain an individuals sense of permanence and continuity in life experience. To examine this hypothesis, a population of 89 unmarried, pregnant adolescents were studied to ascertain psychosocial influences on maternal and infant health outcomes. This paper reports a cross-sectional analysis of perinatal complications and psychological well-being as they relate to a variety of psychosocial variables, including stressful life events, social network support and a questionnaire measure of the sense of permanence. Multivariate analyses indicate that while life events and social support had effects in the expected directions, the sense of permanence constituted an important, additional factor in the effects of social experience on pregnancy outcomes.

Book Reviews : Social Support and Health, Sheldon Cohen and S. Leonard Syme, Eds. Academic Press, Orlando, 1984:

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