Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical study, to gather information about children with Atrioventricular Septal Defect (AVSD) for a research registry.
We hope the information collected in the registry (a place where data and recordsare kept and made available for research) will help us to better understand the condition and help improve the lives of future patients. Specifically, we want to see if there are any differences in outcome after diagnosis in children who have different types of heart operations and find which treatment options are best.
This registry is a collaboration of member institutions of the Congenital Heart Surgeons Society (CHSS).
What is the Congenital Heart Surgeons’ Society (CHSS)?
CHSS is a group of approximately 170 surgeons from 70 hospitals in the United States, Canada and South America collecting information on children with congenital heart disease. The members of this group all share a common interest in treatment and management of congenital heart malformations and are committed to research in this area.
Since children with congenital heart disease have many different and sometimes rare conditions, gathering information from many centers gives CHSS better information on how these children are doing. We also learn what factors and treatments have a better or worse result.
Where is the information collected for this registry kept?
Information collected is kept in a secure and confidential registry at the CHSS Data Center, which is at the Hospital for Sick Kids in Toronto, Ontario, Canada.
What will happen in the study?
This is an observational study, and does not involve medicines. Your child will still take medicines he/she would normally need as prescribed by his/her doctor.
There are no additional research visits or exams for this study. Your child should continue with his/her regularly scheduled clinical doctor’s visits. All monitoring is performed as standard of care.
We would like to follow your child in this study throughout his/her life so that we can evaluate long-term outcomes of AVSD. By agreeing to participate in this study, you are giving permission for the study doctors to contact you or your child as mentioned below. Once your child is old enough to understand and participate in the consent process, we will ask if he/she is willing to continue in the study.
If you decide to take part in this study, your child will have his/her medical chart reviewed for certain information.
Information including your child’s name, address, and phone numbers, diagnosis, pediatrician’s name and address, medical and surgical reports, medications, and copies of echocardiograms, chest x-rays, exercise tests, nuclear medicine scans, MRI, CT scans, and cardiac catheterizations will be sent to the CHSS Data Center entered into a password-protected computer database there. De-identified compact discs of your child’s echocardiograms, nuclear perfusion scan, MRI, and/or CT scans will also be securely forwarded to the Data Center.
Once this information is collected and sent to CHSS, a unique study identification number will be created for your child so that personal health information is not used directly in any further analysis or correspondence.
A specially trained staff member from the CHSS Data Center will call you to welcome your child into the study. Then, every year, a staff member will contact you to ask how your child is doing and ask that you fill out a short survey lasting about 10 to 15 minutes. The survey, which can be completed over the phone or through the mail, will have questions about your child’s health, quality of life, medications, exercise limitations, and any surgery or procedures done since the previous questionnaire.
Information from the database, calls and surveys will be analyzed together with information from other children with the same heart defect from collaborating centers. It will be used to determine the impact of patient factors and different treatments on results and to examine the overall health status of children with AVSD.
You, as a parent/guardian, will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and/or your child and will be sure that all your questions are answered.
What are the bad things that can happen from this research?
There are no medical harms, discomforts, or inconveniences associated with taking part in this study. If you agree for your child to take part in the study, your child’s diagnostic testing, surgery, or other interventions will not be changed in any way.
All records associated with your child’s participation will be kept strictly confidential within the CHSS Data Center registry and at Cincinnati Children’s. His/her personal health information will not be released to any outside individuals or used in any publication. It is not likely, but possible, that confidentiality may be lost in this study. We will take every reasonable precaution to avoid this from happening.
If your child is old enough, he/she will be asked to complete a questionnaire. Some of the questions may make your child uncomfortable or cause him/her to remember situations that were upsetting. Your child does not need to answer any questions he/she does not wish to answer and can stop the questionnaire at any time.
All possible risks will be discussed with you or your child if you are interested in learning more about the study.