Client: Script Medical for Lilly
Ten-country “look don’t touch” study of ADHD in Europe reveals
clinicians dealing with the same issues in the same ways
Toronto, Canada Early results out of a two-year longitudinal study of health outcomes associated with attention-deficit/hyperactivity disorder (ADHD) in Europe has shed a bright light on the huge burden of illness experienced by children with ADHD and their families prior to diagnosis and treatment.
The good news is that in as little as three months, treatmentparticularly pharmacotherapyhas been shown to dramatically improve ADHD symptoms, global functioning and quality of life. This finding echoes previous reports out of large, randomized, university-based clinical trials in the U.S. and suggests that there may be more similarities than differences between the issues facing clinicians treating patients with ADHD whether they be in Europe or North America.
These and other revelations about the state of ADHD diagnosis and treatment in Europe were presented here to a standing-room-only crowd at the recent meeting of the American Academy of Child and Adolescent Psychiatry.
The Attention-Deficit/Hyperactivity Disorder Observational Research in Europe (ADORE) study, the largest of its kind, includes 1,478 patients and 245 investigators in 10 countries, from Iceland to Italy. It is the first to take a good, hard look at the typical ADHD patient coming into a physician’s office, the treatment prescribed and the outcome. “We are simply looking over the doctor’s shoulder,” explains Eli Lilly study co-author, Stephen Raulston. “
Mean age of the patients is 9.0 years and none of the children had been formally diagnosed with ADHD in the past; 85% of the group is made up of boys and 15% of girls, a ratio consistent with previous reports that ADHD is 2-3 times more prevalent in boys.
“This purely observational study we don’t seek to intervene at all really describes for the first time what’s happening in Europe in the real world,” said Dr. David R. Coghhill, senior lecturer and honorary consultant in child and adolescent psychiatry, Center for Child Health, Dundee, Scotland. “We found that across Europe and the U.S., the children have similar severity levels of ADHD symptoms, there’s a severely impaired group with similar co-morbid states and moderately high levels of anxiety and depression and so on.” There also appears to be a delay of one to two years between the time parents first become aware of their child’s symptoms and formal diagnosis and treatment, noted Dr. Coghill in an interview.
Pharmacotherapy most effective of all treatments
Children with ADHD in Europe also appear to receive pharmacotherapy early in the course of treatment, particularly when they are experiencing severe impairments. “We now know that in Europe, up to 70% of children receive medication in the first four months of treatment and that this results in a marked improvement in core ADHD symptoms as well as in behavioural and emotional problems, competency skills, general psychosocial functioning, general health and quality of life,” said Manfred Doepfner, PhD.
Dr. Doepfner, who is from the department of child and adolescent psychiatry and psychotherapy at the University of Cologne, Germany, presented longitudinal results from baseline to the first return visit.
In ADORE, treatments were reported as pharmacotherapy, psychotherapy, combined pharmacotherapy and psychotherapy, “other” and none. Assessments were completed using the ADHD Rating Scale (ADHD-RS), the Strengths Difficulties Questionnaire and the Child Health and Illness Profile. Global impairment was rated by physicians using the Clinical Global Impression-Severity (CGI-S) and the Child Global Assessment Scale (CGAS).
Patients treated with pharmacotherapy at baseline experienced the greatest mean change in the ADHD-RS score at their first return to the physician (38.0 to 22.2) while patients treated with a combination of pharmacotherapy and psychotherapy reported an improvement in mean baseline score from 35.5 to 32.8. Psychotherapy alone resulted in a much smaller drop in baseline score (35.5 to 32.8 at first return visit), a result that was similar to that reported by patients who received “other” treatment at baseline (35.3 to 32.2 at first return visit). Those who received no treatment reported a shift in ADHD-RS total score that went from 33.3 at baseline to 29.8 at the first return visit.
These findings mirror earlier results from the U.S. Multimodal Treatment Study of ADHD, or MTA. That study, first published in 1999, has shown that pharmacological interventions are far more effective than psychological interventions and community care in reducing impairment in ADHD and co-moribities such as anxiety, depression, conduct disorder (CD) and oppositional defiant disorder (ODD). “The combination of these two different kinds of studies a randomized clinical trial like the MTA with an observational study like ADORE will give us very important information and help us draw conclusions about the effects of different kinds of treatment,” said Dr. Doepfner.
ADHD is estimated to affect 3-7% of school-age children in the form of poor attention and concentration, hyperactivity, distractibility and impulsivity. In addition, the majority of children with ADHD have co- co-existing psychiatric and/or developmental problems. Children in the ADORE group were no exception. Co-morbidities included:
* oppositional defiant disorder (67%)
* conduct disorder (46%)
* anxiety (45%)
* coordination problems (33%)
* depression (32%)
* asthma (8%)
* tics (8%)
* Tourette’s (1%)
* obsessive-compulsive disorder (2%), and
* epilepsy (less than 1%).
Children with two or more co-morbidites at highest risk
While one-third of the group had ADHD alone, about 25% had two or more co-morbidities. “These are the children we should really be concerned about,” said Dr. Torunn Novik, PhD, a child and adolescent psychiatrist at the Buskerud Hospital, Drammen, Norway. Dr. Novik presented results from the cross-sectional overview of comorbid health in ADORE patients. “One really has to assess for co-morbid problems in ADHD, knowing that one or more co-morbidities will make quite a difference in the severity of impairment.” she told delegates. “So far we’ve found that most patients have co-morbidities and that this has resulted in a very high burden of illness for the patient and the family and an extremely poor quality of life.”
Children’s quality of life (QOL), somatic and emotional symptoms and limitations, and resilience were rated by parents using the Child Health and Illness Profile (CHIP-CE). The QOL scores came back two standard deviations below what was expected across all the measures at baseline. “On average,” explained Anne Riley, PhD, associate professor, department of health policy, school of public health, Johns Hopkins School of Medicine, Baltimore, MD, and developer of CHIP-CE, “these children are in the lowest 10th percentile for quality of life. We found this shocking.”
Not surprisingly, multiple co-morbidities were found to be more impairing than single co-morbidities or ADHD alone. With the exception of CD/ODD, however, ADHD symptoms were found to be more impairing than all the co-morbidity subgroups. Finally, a child’s impairment further increased when a parent also had physical or emotional health problems.
A final report on the ADORE findings will be released when the study is completed in July 2006.