What is the CoULD Registry?
CoULD is a multicenter Registry for Congenital Upper Limb Differences. Congenital differences of the upper limb refer to hands or arms that do not form or develop normally. Examples include syndactyly (webbed fingers), polydactyly (having more than 10 fingers), radial dysplasia (a condition where one of the bones of the forearm is short or absent), or radioulnar synostosis (an abnormal bone connection between the bones of the forearm). Some of these differences are inherited, but the majority do not have a clear cause.
Because they are relatively uncommon, and because there is great variety in the types of congenital differences that occur, our understanding of congenital differences will only improve by following and studying large numbers of patients from multiple hospitals around the country. The CoULD registry has been created to achieve this goal.
What is the history of CoULD?
CoULD was started in St. Louis and Boston in 2014 to address the lack of scientific information on birth anomalies of the upper extremity. Charles Goldfarb and Summer Roberts in St. Louis and Don Bae and Fernanda Canizares in Boston worked to build the concept of the CoULD Registry over several years. Once we launched the project, we worked to obtain approval from our institutions, develop the protocols, and encourage other institutions across North America to join our effort. We are excited about our progress!
Why is this research study being conducted? What is its purpose?
Our children and patients are often our greatest teachers! We are doing this research study to better understand how children with congenital differences of their arms or hands function and how they improve after surgical or non-surgical treatment. By better understanding of their function and quality of life, we hope to improve the care we provide.
Who is conducting this research study and where is it being conducted?
CoULD is a multi-center registry, which means that multiple doctors from multiple hospitals across the country are involved. CoULD is led by Dr. Donald S. Bae at Boston Children’s Hospital and Dr. Charles A. Goldfarb at Washington University in St. Louis.
Currently, there are CoULD doctors working on this important project at:
- Boston Children’s Hospital in Boston, MA
- St. Louis Children’s Hospital in St. Louis, MO
- Shriners Children’s St. Louis, MO
- Seattle Children’s Hospital in Seattle, WA
- Nationwide Children’s Hospital in Columbus, OH
- Gillette Children’s Hospital in Minneapolis, MN
- Shriner’s Hospital of Northern California in Sacramento, CA
- Primary Childrens Hospital in Salt Lake City, UT
- Children’s Hospital of Philadelphia, PA
- Shriners Children’s Salt Lake City, UT
How are individuals selected for this research study?
All patients seen for congenital hand or upper limb differences are invited to participate in the CoULD registry. Patients who have been previously treated as well as new patients will be welcome to participate.
How long will my child be in this research study?
Once you/your child join the CoULD registry, we will follow your medical record and collect follow-up information at annual appointments for a period of 5 years, and then every three years until you/your child turns 18 years of age (or until you/your child want to stop participating).
What are the benefits of this research study?
There are no direct benefits from your participation. The primary benefit of this study is an increased understanding of the long-term benefits of treatment for congenital hand and upper limb differences, which may help future patients. Given the fact that some congenital deformities are very rare, having more information may help us to develop new and improved treatment options.
What will happen with the information obtained as part of this research study? What about confidentiality?
Our research staff is highly trained to protect your privacy and avoid breaches in confidentiality. An important part of this research involves keeping in touch with families over time, and a goal of this project is to make future research into specific diagnoses possible. For these reasons we store identifiable information. To protect your child’s privacy and confidentiality, only authorized study personnel have access to this information. When we analyze data to answer research questions, we only include necessary information from the dataset, and we can often do this without identifiers. In addition, all hard-copy information will be stored in locked filing cabinets at the sites where children are enrolled and typed into electronic, password-protected databases.
What do I have to do if I am in this research study?
During the scheduled clinical visit, you/your child will be asked to be part of the CoULD Registry. If you choose to participate, the number of hospital visits will be the same, and there won’t be additional treatments. The only differences will be:
1) We will ask you to answer some questions related to why are you having this visit at the hand clinic.
2) You and your child will be asked for permission to take a photograph of the arm or hand, to provide information about how the arm or hand changes over time.
3) We also will ask you to fill out questionnaires at the first clinic visit and at follow-up visits.
If it is not possible to complete the questionnaires during your clinic visit, surveys can be sent via email. By agreeing to participate in this study, you are also agreeing to allow research staff to review you/your child’s past medical records for study purposes.
If I do not want to take part in this registry, what are the other choices?
Participation in this registry is completely voluntary. You/your child may choose to withdraw from this study at any time. You/your child will be given an opportunity to ask questions of the research coordinator and doctors at any point during the study. Refusing to participate in this registry will not alter the treatment your child will receive.
For general questions about the study, research-related injuries or emergencies, or any research-related concerns or complaints:
Summer Roberts, Lead Study Coordinator – (314)-362-6669.
Maria “Fernanda” Canizares, Lead Study Coordinator – (617) 919-7752.
Email address: firstname.lastname@example.org