Laurel K. Leslie, M.D., M.P.H.
Laurel K. Leslie, M.D., M.P.H.
Associate Professor of Medicine and Pediatrics, Tufts Medical Center, Floating Hospital for Children, Boston, Massachusetts
The Comparative Effectiveness of ECG Screening in Children with ADHD
Administered by the NHLBI Division of Cardiovascular Sciences, Heart Development and Structural Diseases Branch
FY 2009 Recovery Act Funding: $495,907
Research focus: Should children with Attention Deficit Hyperactivity Disorder (ADHD) receive screening electrocardiograms (ECG) to help identify previously undiagnosed cardiac disorders before beginning prescribed stimulant medication such as Ritalin?
A team of researchers funded by the National, Heart, Lung, and Blood Institute under the American Recovery and Reinvestment Act (ARRA) launched a two-year comparative effectiveness study to resolve this important pediatric health question.
The incidence of sudden cardiac death (SCD) in children is small, but recent studies raised concerns that children taking ADHD medication face an increased risk of sudden cardiac death (SCD). There is debate among pediatric experts as to whether this risk is real and whether screening programs, which can be costly, are necessary.
The impact of the study is expected to be significant, given the large number of children diagnosed with ADHD. According to 2008 data from the U. S. Centers for Disease Control and Prevention (CDC), 5 million children in the United States between 3 and 17 years of age have been diagnosed with ADHD. This figure includes 11 percent of boys and 4.8 percent of girls.
The study's 16-member team, led by principal investigator Laurel Leslie, M.D., M.P.H. of Tufts Medical Center, will apply cutting-edge mathematical modeling methods to existing clinical data in order to evaluate the relative risks and benefits of different screening and management strategies. This should help determine which children (if any) may face increased risk of SCD with stimulant medication.
The next step after this study would be to test some of the results of these models in clinical studies comparing different screening strategies, which might include family history, an electrocardiogram, an echocardiogram, consultation with a pediatric cardiologist, or another approach.
"This issue continues to be raised by different groups," said Dr. Leslie. "There was a discussion about it at FDA hearings nearly 10 years ago, and the American Heart Association and the American Academy of Pediatrics brought the issue up again in 2008. These and other organizations, including support groups for parents of children with ADHD, continue to be concerned about the issue, so it's worth trying to address it."
"There are two important questions this study is trying to answer," said Dr. Leslie. "First, how can we best assess the available data to draw some conclusions about the use of a child's medical and family history, a physical, and an ECG prior to starting medications for ADHD? Second, given that a screening study may have false results (both in terms of identifying children with a possible cardiac disorder and missing children who do have a cardiac disorder), what are clinicians and parents' tolerance for uncertainty? That's an additional part of the complexity of this issue."
The study may have an impact beyond ADHD. There are many barriers to performing definitive comparative effectiveness trials in children, according to Dr. Leslie, including smaller patient populations and ethical concerns. If successful, the mathematical models created by Dr. Leslie's team could address some of these barriers and be applied to other pediatric public health issues, including the screening of pediatric patients for elevated cholesterol levels and testing the effectiveness of various vaccination strategies.
Economic impact: The project involves 16 part-time scientists (most are also clinicians) from nine different institutions, three project staff members (one full-time and two part-time), two parent consultants (one the former president of a national group of parents of children with ADHD), and two consultants affiliated with professional medical organizations that care for children.
The full-time employee, a recent college graduate with a political science degree, will help Dr. Leslie manage the project and develop a website for all members of the project team. The two part-time employees will assist with the statistical aspects of the study, including surveys with pediatricians and psychiatrists, as well as interviews with parents.
'Engaging the community': One of the study's most innovative features is its emphasis on community involvement. Researchers will interview parents with children who have ADHD, as well as pediatricians and psychiatrists, to find out their concerns about stimulant medications and the theoretical risk for adverse cardiac events, as well as how they make decisions about cardiac risk screening for their children.
"There's a growing understanding that when we come up with evidence-based best practices and we want to successfully implement them, we need to think through the implications from the provider's and from the family's perspectives," said Dr. Leslie, who is also director of the community engagement component of Tufts Clinical and Translational Science Institute (CTSI).
In a previous project for NIH's National Institute of Mental Health (NIMH), Dr. Leslie examined the physician and parent perspectives on the implementation of the American Academy of Pediatrics guidelines on ADHD that were issued in 2000.
"We had focus groups with physicians about how the care of children with ADHD was implemented in a primary care setting, and I realized there was a ton of variability," said Dr. Leslie. "So you really need to be eliciting input from many physicians instead of relying only on an individual's experience as a clinician."
Dr. Leslie's team also conducted open-ended interviews with parents, listening to their stories about how they sought care for their child with ADHD and decisions they made about treatment, using a similar methodology that will be used in this NHLBI ARRA project.