Has NIH Finalized Design for Children's Study?

22:29
Has NIH Finalized Design for Children's Study? -

continues to dog the controversial one Advisory Board will be National children study (NCS), an ambitious federal plan to track the health of 100,000 children from birth up 'at age 21. next Tuesday to consider reducing cost alternatives to the design of the original study. But some researchers involved in the study believe that the National Institutes of Health (NIH) has already made a decision.

Study planners at NIH wanted originally to recruit pregnant women and their babies for $ 3 billion NCS provided by knocking on doors of households in a random sample of 105 US counties. When pilot studies begun in 09 found that it is too expensive, the NIH began testing alternatives, such as finding women through the offices of health care providers in counties. Then in February, the NIH announced a reduction of 15% of the $ 193 million annual budget of the NCS which could mean replacing sampling County with pregnant women recruited by providers who are part of health care organizations .

This caused an uproar (and two resignations adviser): Many researchers involved with NCS said that only a sample of the geographic base would yield results applicable to all American children, including the poor. And abandon the 105 counties would waste years of work on strengthening the support of the community, they said. National Institute of Child Health and Development Director Alan Guttmacher, whose institute runs NCS, said no final decision was taken.

Indeed, next week, the advisory committee will examine the NCS new sampling plans described in this white paper. Some providers even sample geographically; others would recruit women through interested health care providers; a third set would use hybrid designs.

Nigel Paneth of Michigan State University in East Lansing, who heads one of 40 NCS "vanguard" pilot sites, he and others have found ways to cut costs in 105 counties for example, collecting placentas but not cord blood at birth. Paneth expects many researchers Site pioneering sign a proposal that they will present to the Advisory Committee next week.

But Paneth also concerned that the spirit of NIH is already established. In a document dated April 13 said that Paneth ready NIH to inform members of Senator Thad Cochran (R-MS) staff, the agency wrote: "Thus, the main study used ... HMO and other networks health care providers that the main source of recruitment "He goes on to say." the main study will not be building a "national probability sample '."

"This is an illustration rather overwhelming the way they are [NCS leaders] not being honest with us, "Paneth.

NCS leaders deny that any decision was taken. in a statement, Director NCS Steven Hirschfeld said the three information pages of documents of the Senate was "only part of the more verbal briefing, which ... provided more detailed information." He says that "the design of the main study is still being finalizing "with the participation of the Advisory Committee and other stakeholders. Hirschfeld added that NCS has already cut some costs by making changes such as the use of non-proprietary software and a central ethics committee.

Community members in 105 counties are also angry about the NCS changes. Last month, the Community Advisory Board for the University of Mississippi-run NCS pilot site in Hinds County Hirschfeld wrote "to express our confusion, deep exasperation, and the major concern."

"We feel deceived," said the letter. The possibility that the 105 study sites will be removed from the main study "is a parody" and is especially troubling for a condition that gets worse and pregnancy the birth of the results of the nation and the significant health disparities, the letter said. "the Mississippi delta is the closest thing our nation needs a third world country," says the letter, and the abandonment of NCS sites in the state "seriously undermines the validity of the NCS."

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