Division of Clinical Epidemiology (DCE)
The Division of Clinical Epidemiology is a research division
of the Department of Pediatrics, Rainbow Babies and
Children’s Hospital and Case School of Medicine. Its
mission is to facilitate the conduct of high quality
clinical and epidemiological research relevant to the
promotion of health of children and to develop
state-of-the-art training programs in clinical research.
It has successfully supported the research needs of
dozens of investigators engaged in a wide variety of
research, including basic science, longitudinal studies
of infants and children, clinical trials, pharmokinetic
and pharmacoepidemiological studies, genetic
epidemiology, and health services research. Included
within the Division is a Center for Biostatistics, which
provides collaborative biostatistical support to
faculty, residents, and fellows in the Department of
Pediatrics. The
staff collaborates with researchers at all levels in the
Department of Pediatrics and is involved in both long
and short-term studies. Personnel in the center include a director,
several masters-level biostatisticians, a systems
administrator, a data manager, as well as part-time
student research assistants and data managers.
The DCE has supported > 100 clinical research and
epidemiology projects. Major collaborative research
projects include longitudinal and family studies of
chronic health conditions, including asthma, cystic
fibrosis, sleep disorders, metabolic syndrome, maternal
depression, international health, and prematurity. The
DCE houses comprehensive databases with population-based
data on children and adults. Projects are supported by a
large experienced technical staff of about 30 people. The staff of DCE includes computer programmers,
epidemiologists, biostatisticians, study coordinators,
research assistants, polysomnographers,
neuropsychologists, and database managers. The staff are experienced in issues related to
development of detailed manuals of procedures;
technician standardization, training and certification;
quality assurance monitoring, data validation and
verification procedures; study design; and
biostatistical analyses of clinical trial and
longitudinal study data. A new initiative includes a
collaboration with the School of Engineering to develop
web-based data dissemination for epidemiological and
physiological data.
Interactions
with Clinical Investigators:
To ensure the appropriateness of given study designs and
planned analyses, clinical researchers may interact with
a team of methodologists and technicians, including a
senior epidemiologist, a senior biostatistician, and
data manager early in the planning phases of a study and
periodically over the course of the study. Clinical
investigators also may access the data management and
statistical support systems.
Faculty:
Susan Redline, MD, MPH, Chief
Amy Heneghan, MD
H Lester Kirchner, PhD
Anna Mandalakas, MD, MS
Carol Rosen, MD
Sanjay Patel, MD, MS
Reena Mehra, MD, MS
James Spilsbury, PhD
Informatics Staff:
John Neely, MS, Systems Administrator
Nathan Johnson, MS, Programmer / Analyst
Xiaobei Zhu, MS, Biostatistician
Miriam Rosenblatt, Data Manager
Sue Caban, Data Manager
Case Sleep Research Group
UHHS Sleep Center
Adoption Health Service (AHS)
The Adoption Health Service at Rainbow Babies & Children's Hospital is the only adoption specialty
clinic serving northeast and central Ohio. The AHS was established in 1996
by Dr. Karen Olness in association with the Rainbow Center for International
ChildHealth. The AHS is composed of a multidisciplinary team of pediatricians
directed by Dr. Anna Mandalakas to serve the needs of internationally adopted
children and their families. The Adoption Health Service offers pre-parenting
classes three times a year and provides pre-adoption evaluation of medical
information for prospective parents as well as post adoption and follow-up medical
care for the children. Over the last year, there were almost 400 visits to the AHS,
including approximately 90 pre-adoptive evaluations and 100 post-adoptive evaluations.
The program also attracts active participation of trainees from a wide range of
disciplines, including behavioral pediatrics, psychiatry, and infectious diseases.
Active research is also supported that address the cost-effectiveness of alternative
approaches of infectious disease screening. Recent expansion includes development of
a domestic adoption program.
Clinical Pediatric Sleep Services
Clinical Pediatric Sleep Services has continued to expand services under the direction
of Carol Rosen, MD, Diplomate-ABSM. In the last year, more than 300 overnight sleep studies
and ambulatory visits were made to our multidisciplinary sleep clinic, including studies for
the diagnosis and treatment of complex breathing and sleep disorders. The focus include evaluation
and treatment of both sleep related breathing problems as well narcolepsy, insomnia and behavioral
problems impacting sleep. The program has set a new standard by using the family-centered care
model to prepare children and families for the sleep study procedure.
The Rainbow Research Network (RRN)
The Rainbow Research Network, a pediatric practice-based research network, has
grown under Dr. Amy Heneghan's directorship during the past 4 years in network
membership, participation and clinician-initiated projects. The RRN is part of
the Ohio Pediatric Research Consortium, a collaborative of 5 pediatric practice-based
networks in Ohio, which Dr. Heneghan helped to establish and have co-directed since
2002. To date, 92% of the 220 members have participated in at least one study. The
RRN is one of 6 national practice-based research networks (PBRN) and the only pediatric
PBRN selected to conduct the National Children’s Study Pilot Project. 9 pediatric
practices in Cleveland will participate in this effort that will inform the comprehensive,
longitudinal study of children set to begin in 2006.
Dr. Amy Heneghan has made ongoing contributions in the area of maternal depression. A
recent paper "Will mothers discuss parenting stress and depressive symptoms with their
child’s pediatrician?" published in Pediatrics May 2004 received extraordinary media
attention airing in 103 national markets reaching over 8.5 million viewers. In collaboration
with the Cleveland Regional Perinatal Network (CRPN) and several other city agencies,
her team developed a comprehensive resource guide for mothers. A Guide for Moms, initially
distributed to local health care providers and community-based health workers, has produced
requests for thousands of brochures from local hospitals and providers.
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