National Children’s Study changes frustrate researchers

Plans have changed for an unprecedented decades-long research effort called the National Children’s Study, and some health researchers and community advisers say they’re frustrated.

Plans have changed for an unprecedented decades-long research effort called the National Children’s Study, and some health researchers and community advisers say they’re frustrated.

Epidemiologist Jennifer Culhane, with the Children’s Hospital of Philadelphia, helped lead a local pilot effort in Montgomery County.

“There are some participants that are furious, as well as the community advisory board, in the changes,” Culhane said. “They thought they signed up for something quite different than what it is turning out to be.”

More than a decade ago, Congress and scientists envisioned a study of the environmental exposures that influence health — from noise and food to chemicals and family dynamics. The study aims to enroll more than 100,000 babies before they are born and follow them until age 21.

In Montgomery County and at other pilot sites, researchers went door-to-door for several years to enroll participants. The study’s national director, pediatrician Steven Hirschfeld, said early research showed that the house-to-house recruitment approach and other study designs are too costly, time-consuming and unsustainable for a national roll-out. Now the plan is to primarily work through health-care providers, such as doctors and health clinics, to identify and sign up pregnant women.

Concerns arise about diversity of participants

Culhane and others worry the new sampling method won’t reflect the nation’s diversity and could undercount families without insurance, undocumented women and other hard-to-reach people. Locally, some members of the Montgomery County Community Advisory Board are drafting a critique letter to lawmakers.

In March, the Population Association of America sent a letter to Hirschfeld expressing concerns over the status of the study.

Critics have said a review of electronic medical records from doctors’ offices can’t approximate the original study design. During the pilot, researchers often began documenting a women’s life before pregnancy through in-home visits.

“Biological samples, anthropometric measurements, many hours of time,” Culhane said. “We met up with them again, in their third trimester. We attended their birth, at which point we collected maternal blood, cord blood, placenta, infant blood … pictures of the baby looking for dysmorphology. Huge, huge number of hours committed. We collected air and dust and water samples, and now what’s going to happen is, by and large, a short interview and a telephone call.”

As the research effort moves into the main study phase, the approach will change, Hirschfeld said, but researchers will continue to collect environmental samples.

“Rather than have these infrequent intense, multi-hour visits, we’ll do more frequent, but shorter visits, so our visits are now targeted to be somewhere between 45 and 90 minutes,” he said.

Hirschfeld became acting national director of the study in August 2009 and took the helm permanently in January. Study watchers say that leadership change coincides with scaled-down plans to test a series of hypotheses about the interplay of health and the environment.

Study focus shifts, widens

Hirschfeld says during a decade of planning the number of study questions people want to pursue has grown.

“Because we don’t know what the important questions would be five, 10, 15, 20 years from now, we decided to reorient the study so we would collect data in certain domains or areas.” Hirschfeld said. “We won’t attempt to do a specific series of analyses as we go along. We will do some, but most of the data we collect will go into data archives.”

Scientists from around the world will have access to the data repository to pursue their own research, Hirschfeld said.

In early 2009, the Children’s Hospital of Philadelphia opened a Montgomery County field office in Norristown as a base for recruitment. Some of the local disappointment over the study changes is surely tied to uncertainty about who will execute the local arm of the main study.

“There was lots of gratis work by community-based organizations, by community residents, area hospitals, the Montgomery County health department. We generated real commitment to this study,” Culhane said.

The National Children’s study has a $193 million budget this year; the scheduled 2013 appropriation is $165 million. Hirschfeld said the goal is to begin enrolling participants into the main study in 2014.