There are two good news and bad news for researchers who were concerned about a new design released this week to the national study of Special Education a plan of $ 3 billion to follow 100,000 children from birth to 21 years of
the good news is that supervisors of the study from the National Institutes of Health (NIH) want to recruit from a geographic sample of hospitals rather than large health care providers. However, to reduce costs, NIH wants to recruit about half of these women when they give birth, not before, the NIH staff admit compromise studies on prenatal exposures. The new plan makes no mention of retaining 105 randomly selected counties where the study was originally to take place, including 40 locations "vanguard", where pilot studies were conducted.
requested by Congress in 00, NCS aims to explore the links between environmental exposures, genetics and health. So far, it has recruited about 3650 babies on pioneering and websites spent nearly $ 1 billion. In February, the NIH announced that trimming the budget NCS and could not afford to recruit women for the complete study as first planned by knocking on doors or using other methods in 105 counties . instead, the agency said it could recruit participants through large health care organizations. NIH also announced that sites vanguard led by 40 academics are awarded to a new contractor.
Vanguard leaders NCS website and some councilors were outraged. They argued that only a probability sample would yield results applicable to all American children, regardless of ethnicity or family income.
After a meeting in April where investigators pioneering NIH urged to stick with the plan 105-county, NIH now says it will recruit in randomly selected hospitals and birth centers in a sample geographic regions that "have yet to be determined." Two "layers cohorts" of women and babies would be recruited: half at birth in hospitals, and half of pregnant women registered by providers that deliver these same hospitals Although these cohorts would make up. 0% of study participants, two smaller cohorts could include women enrolled before conception.
epidemiologist Nigel Paneth of Michigan State University in East Lansing, who runs a pioneering center says the new plan could result in a representative sample at national level. "it is a much better design than we had heard," he said. However, he wonders why NCS can only recruit prenatally. This would allow rigorous studies of prenatal influences on health and make it easier to arrange to collect placentas and umbilical cord blood, he notes. It also questions the apparent decision to abandon the NIH pioneering sites where researchers have built relationships with hospitals. Those using NCS "probably do not realize how difficult it is," he said.
proposed new design of the NIH will be discussed on July 24 by the NCS advisory committee.
Although the councilors approve the new plan, what happens next is unclear. A bill in the House of Representatives directs the agency to hold off on all design changes until the Institute of Medicine did a study. Paneth said investigators fear that the NIH will issue a request for proposals for the main study this fall to avoid Directive House, which probably will not become law before the end of the year.
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