Two Advisers Now Gone From National Children's Study

The upheaval continues with a proposed 21-year health study of 100,000 U.S. children known as the National Children's Study (NCS). Last Friday, a prominent biostatistician who sits on the NCS advisory committee resigned, just 2 weeks after another committee member stepped down. Both are upset about a sudden shift in the study's sampling plan.

In an e-mail dated 16 March, the University of Pennsylvania's Jonas Ellenberg submitted his resignation to NCS Director Steven Hirschfeld at the National Institute of Child Health and Development (NICHD). His note contains no explanation but says: "I strongly urge that the NCS be reviewed a second time by the Institute of Medicine, since I believe that the current NICHD view of the NCS does not reflect the parameters of study design reviewed and endorsed by the IOM in 2008." The reference is to an IOM report that commended NCS's plan to recruit pregnant women living in a statistical sample of about 100 U.S. counties. Ellenberg's e-mail was first reported on Nature's blog.

The National Institutes of Health (NIH) has decided that this geographic approach is too expensive. Instead, the agency wants to cut 15% from NCS's current $193 million budget in 2013 by recruiting through health care providers, which might mean health maintenance organizations (HMOs). "The enrolled population would no longer be a national probability sample, but, instead, a well described cohort followed longitudinally" or over many years, a budget document says (see pp. 34-35).

Ellenberg told ScienceInsider that he's stepping down because the advisory committee wasn't informed about this proposed change in sampling design. "We were told nada," Ellenberg says. "If we're not there to give advice on this magnitude of a change, I don't know why we're there."

Ellenberg say he's not necessarily opposed to a provider-based sample, which could still be nationally representative. (This might mean randomly sampling the nation's health care providers, from single physician practices to large HMOs.) The Population Association of America, which represents demographers, told NIH in a 6 March letter that its members would support a provider-based sample if it's done "very carefully" and doesn't leave out groups such as immigrants and the uninsured. "Anything less than a national probability sample will compromise the quality of the data," the letter says.

A Johns Hopkins University environmental health researcher Ellen Silbergeld resigned from the advisory committee on 5 March, as reported by Nature's blog. She told ScienceInsider that her impression is that the study will no longer use a "consistent pattern" of recruitment but will instead employ "a mix of provider-based and community-based studies" that won't yield data that can be compared across sites. "I don't think it's going to be scientifically valid," she says.

Some NCS followers, including Ellenberg, are also concerned about another issue: That NICHD is terminating the contracts of seven "vanguard" centers that have recruited pregnant woman for a pilot study and plans to turn their operations to a single national contractor this summer.

Questions about NCS could come tomorrow and next week at House of Representatives and Senate hearings on NIH's 2013 budget. An article today about the loss of South Dakota State University's (SDSU's) $13.1 million, 5-year contract for its state's vanguard center shows what's at stake for some congressional districts. SDSU expects to lose 27 full-time jobs and eight part-time jobs. Several postdocs and graduate students will also be affected.

Losing the contract will be "a very significant loss" both to the university and to the local community, SDSU Vice President for Research Kevin Kephart told The Brookings Register. And the Dakotas have no HMOs, so they would be left out of an HMO-based study, the article points out.