ROGERS — Changes federal officials have made to the long-term National Children’s Study have elevated one Arkansas researcher’s role in it, while her colleague and a number of other researchers around the country are being transitioned out of the project.

“What I fear is that we’ve lost some of the intellectual capital that would have propelled us,” said Dr. Charlotte Hobbs, a Little Rock-based researcher who started out as the principal investigator for the Benton County portion of the study.

After the National Institutes of Health revamped the study last year, Hobbs learned she would become one of two principal investigators for the study’s Southern Regional Operations Center. One of four such centers, the southern center encompasses Benton County and nine other study sites extending from Florida to New Mexico, she said Thursday, and its five-year contract began in September.

But Hobbs’ colleague on the study, James M. Robbins, will end his role with the study when Arkansas’ contract expires at the end of the federal fiscal year Sept. 30.

Both Hobbs and Robbins are pediatrics professors at the University of Arkansas for Medical Sciences. Both work out of Arkansas Children’s Hospital, where UAMS’ pediatrics department is housed.

Within the next week or two, Robbins said, researchers will begin notifying the 150 Benton County women recruited for the study that they’ll be dealing with different data collectors than the ones they’ve come to know.

“It was a surprise,” Robbins said of the institutes’ decision, announced last year. Arkansas Children’s Hospital Research Institute “signed on truly thinking, really believing, we’d be engaged for 25 years,” she said.

Virtually all of the academic health centers originally involved around the country “have been taken out of the loop,” he said, with the project turned over to contract research groups.

“So we were, needless to say, disappointed,” Robbins said. “We started this project in good faith. We told our community advisory boards and our women that as far as we know, we’re going to be with you for the first 21 years of your child’s life.”

Hobbs and the other principal investigator for the southern center, a researcher from Northwestern University, are the only two original investigators remaining with the national study from among the 30 or more who helped get the study started.

The study seeks to track children from the womb to age 21, looking at how genetics, lifestyle and the environment affect health and disease.

With about four years built in to get organized and begin the pilot studies needed before the main study begins, the entire effort will take about 25 years, Robbins said.

Robbins and Hobbs said the national changes came in part because of congressional budget-cutting but also because the study up to this point has been a pilot effort aimed at finding the most efficient way to undertake the main study, which has yet to begin.

Robbins recalled the project was cut from about $165 million in the fiscal year ended Sept. 30, 2012, to about $142 million in the current fiscal year.

In 2004, the federal government selected a single county in Arkansas - Benton - among 105 counties, parishes and other sites nationwide to participate in the study.

The National Children’s Study began work with seven pilot sites, known as “Vanguard Centers.” Benton County was among a second round of 30 Vanguard sites in February 2010 with the aim of all 37 working out the kinks for all eventual 105 sites.

Benton County was among 10 sites that experimented with what proved to be the most efficient method of recruiting pregnant mothers - finding them through their doctor’s offices, Robbins said.

“We were very proud of our accomplishment,” he said.

Nationally, there was debate as to whether door-to-door recruitment the original seven pilot sites used would produce the best results regardless of cost, according to coverage in national newspapers and magazines.

Robbins added that recruiting through Health Maintenance Organizations was also discussed, though it would have meant the uninsured and those with other types of health insurance were left out of the sampling.

According to the National Institutes of Health’s congressional justification documents for the project, published in May, the recruiting by household would have yielded a “national probability sample” based on geography.

By summer 2009, the Vanguard study suggested that door-to-door recruitment “would not allow the National Children’s Study to meet a target of 100,000 newborns in a reasonable time or at a reasonable cost.”

In 2010 and 2011, the study’s preliminary finding was that while not perfect, recruiting from health-providers’ offices could be the most efficient method.

Researchers with UAMS and Arkansas Children’s Hospital recruited the first pregnant woman from the designated Benton County study site Jan. 24, 2011.

By November 2011, the Arkansas site stopped recruiting after getting the participation of 150 study subjects, about 50 percent more than its original target.

Seven pregnant women who volunteered without being recruited were accepted into the study, Robbins said.

All of the babies enrolled for the Benton County study have since been born, a spokesman for the study, Sherry L. Lloyd, told the Benton County Community Coalition during a project update Thursday afternoon.

Robbins said the last baby who will be included in the study was born Aug. 8.

Officials with the National Institutes of Health have said the National Children’s Study will be the largest, long-term examination of children’s health in United States.

The Arkansas scientists have said the study aspires to have the effect of another longitudinal study, the Framingham Heart Study. Begun in 1948, it sought to demystify the underlying causes of heart disease and ultimately found leading risk factors such as smoking, high blood pressure, high blood cholesterol, obesity, diabetes and physical inactivity as leading risk factors.

Having a similar study of disease among people during their early, developmental years promises a huge effect, the Arkansas researchers said.

“The [institutes] dollars that go to pediatric research versus adult research - there was such a discrepancy,” Hobbs said. “A lot fewer dollars go to pediatric research. So this was an unprecedented opportunity.”

When the institutes released the new study design in July, ScienceInsider described the national study as “troubled.” Elsewhere, defenders said a main reason to conduct pilot studies was to see what worked best.

The agency’s decision to turn the project over to contract research organizations “is what most of the screaming is about,” Robbins said.

Hobbs said despite the negatives, she hopes the study will benefit overall from the decisions made for cost-efficiency.

Northwest Arkansas, Pages 7 on 02/04/2013