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Published on: September 12, 2011
Feasibility of Conducting Autism Biomarker Research in the Clinical Setting
Laura Sices1, Katherine Pawlowski, Laura Farfel
1*Department of Pediatrics, Boston University Medical Center, Boston, MA; †Boston University School of Medicine, Boston, MA; ‡Department of Medicine, Boston Children's Hospital, Boston, MA; §Autism Consortium at Harvard Medical School, Boston, MA; ‖Center for Children with Special Needs, Floating Children's Hospital at Tufts Medical Center, Department of Pediatrics, Boston, MA; ¶Harvard Medical School, Boston, MA; **Lurie Center for Autism, Massachusetts General Hospital for Children, Departments of Neurology and Pediatrics, Lexington, MA; ††University of Massachusetts Memorial Medical Center, Departments of Psychiatry Cochran and Frazier) and Pediatrics (Frazier and Choueiri), Worcester, MA; ‡‡University of Massachusetts Medical School, Worcester, MA.
Insights
Integrating biomarker research into autism spectrum disorder (ASD) clinical visits is feasible. Participants completed most activities without negatively impacting clinical care, demonstrating a viable approach for neurodevelopmental disorder research.
Area of Science:
- Neurodevelopmental Disorders
- Autism Spectrum Disorder Research
- Biomarker Discovery
Background:
- Clinical research participation is often limited in complex neurodevelopmental disorders.
- Integrating research into routine clinical care may enhance participation.
- Autism Spectrum Disorder (ASD) clinics present an opportunity for embedded research.
Purpose of the Study:
- To assess the feasibility of conducting biomarker research within subspecialty autism spectrum disorder (ASD) clinical visits.
- To evaluate the impact of integrated research activities on the quality of clinical care.
Main Methods:
- Recruited 5-10 year old children from ASD clinics across 5 institutions.
- Collected biomarkers including growth measurements, examinations, digit ratio, and biochemical markers (serotonin, melatonin sulfate).
- Utilized parent questionnaires and medical record abstraction for behavioral and cognitive data; surveyed parents and clinicians on study impact.
Main Results:
- Eighty-three children participated; key barriers included phone contact and blood draw concerns.
- Participants completed a majority of research activities, irrespective of behavioral or demographic factors.
- While 44% of clinicians noted an impact, it did not correlate with activity completion levels.
Conclusions:
- Recruitment within ASD clinical visits requires substantial effort but is achievable.
- High completion rates for research activities were observed once participants were enrolled.
- Integrated biomarker research did not adversely affect the clinical visit experience.
Objective:
Recruitment and completion of research activities during regular clinical care has the potential to increase research participation in complex neurodevelopmental disorders. We evaluated the feasibility, and effect on clinical care, of conducting biomarker research within a subspecialty clinical visit for autism spectrum disorder (ASD).
Methods:
Children, aged 5 to 10 years, were recruited by providers in ASD clinics at 5 institutions. Biomarkers collected were growth measurements, head circumference, neurologic and dysmorphology examinations, digit ratio (2D:4D) measurement, and platelet serotonin and urinary melatonin sulfate excretion levels. Parents completed the Aberrant Behavior Checklist-Community and a medical/demographic questionnaire. Cognitive level was abstracted from the medical record. Parents and clinicians completed surveys on the effect of the study on the clinical visit.
Results:
Eighty-three children and their caregivers participated. Factors limiting participation included difficulty reaching families by phone and parent concern about the study blood draw requirement. All children completed at least 4 of 7 planned research activities. Demographic factors, educational placement, and child behavior were not associated with completion of study activities. Lower nonverbal cognitive function was weakly associated with fewer activities completed. Forty-four percent of clinicians reported an effect of the research study on the clinical visit. However, neither parent-reported nor clinician-reported effect was associated with the degree of study activity completion.
Conclusion:
Recruiting study participants in the context of scheduled ASD clinical visits required significant effort. However, once recruited, participants completed most study activities, regardless of behavioral symptom severity. Research activities did not adversely affect the clinical visit.
