Q: How does the CHSS Data Center disseminate the findings of their analysis to medical and patient community?
A: The CHSS Data Center is committed about conducting high quality research in congenital cardiovascular surgery. The study results in the past have provided important insights into patient care and have immense bearing on the future outcomes of these patients. We regard the patients, member surgeons and participating hospitals as primary owners of the data we manage. It is important for us that they learn and understand the significance of our research. In order to achieve these goals, the Data Center publishes its research in high-impact peer reviewed scientific journals. Please take a look at our Publication section for details of the study results published over the number of years. We also involve our members in the knowledge dissemination process by inviting them to be a part of our traditional ‘work weekends’ in Toronto. These findings are also disseminated at large scientific conferences. Finally, common language summaries of these studies are made available on our website for all the patients, family members and individuals interested in the research on congenital heart diseases.
Q: How does the CHSS Data Center follow the study patients?
A: The CHSS Data Center employs cross-sectional follow-up method for all its prospective studies, i.e. the patients are being followed once every year. There is a defined timeline for every study follow-up. The Data Center has developed study specific follow-up forms. These forms are sent to the patients in physical mail and upon their return the information is extracted and entered into electronic databases. The Data Center has dedicated research staff with expertise and long experience in research study follow-up.
Q: What should I do if I come to know of changes in patient health status for those who have been enrolled in a CHSS Study?
A: As a research study coordinator, if you come to know of changes in patient health status for a patient enrolled with any of the CHSS Studies, we request them to let us know on firstname.lastname@example.org. We very much value your contribution in terms of time and efforts for the CHSS Studies, and any information that you can provide regarding a study patient helps improve accuracy of the data and improves the statistical results.
Q: What precautions will be taken to ensure the electronic patient data is secure at the CHSS Data Center?
A: The CHSS Data Center takes the issue of electronic data safety very seriously. All patient data extracted from paper charts or received from a member institution is stored within the premises of the Hospital for Sick Children, Toronto. This information is stored under the specific study numbers assigned to these patients. These databases are accessible only on the computers approved and controlled by The Hospital for Sick Children Information Services. These databases and computers are password protected and are physically located in rooms with access restricted to the CHSS Data Center staff members.
Q: What does the CHSS Data Center do with the data supplied by the member hospitals?
A: The CHSS Data Center has developed a highly refined data management process for every single piece of patient information. The information required is different at every stage of research, i.e. enrollment, follow-up, data entry as well as analysis. We have research staff members in specialist roles with expertise in patient health information collection, compilation, interpretation and extraction, analysis and presentation.
Q: How will the patient data be stored at the CHSS Data Center?
A: The CHSS Data Center works in compliance with the Health Insurance Portability and Accountability Act (HIPAA) as well as Ontario Personal Health Information Protection Act (PHIPA). Patient health data that arrives at the Data Center is screened and coded for their respective studies. It is then stored in locked cabinets in a room accessible to CHSS Data Center Research Staff only. Any data that is extracted into electronic form is also stored in computers with password protection and restricted access to CHSS Data Center research personnel.
Q: What information is needed once a child from our institution meets the criteria for enrolment?
A: There are currently 4 enrolling studies:
- Unbalanced Atrioventricular Septal Defect
- Tricuspid Atresia
- Left Ventricular Outflow Tract Obstruction
- Anomalous Aortic Origin of a Coronary Artery
Every cohort has a detailed patient enrollment form that lists inclusion and exclusion criteria and a checklist of medical reports required to enroll a patient into the study. You can find these forms here.
Q: What type of data should a member hospital send to the CHSS Data Center?
A: The type of data a member hospital should send to the CHSS Data Center depends upon the study. Some studies require detailed patient information including digital records like echocardiography tapes while the other studies require transmission of only clinical records – i.e. paper charts. The CHSS Data Center will usually specify the type of information required for the study on a case by case basis. Also the study enrollment form would have details regarding the information to be sent.
Q: How can CHSS Data Center help a member hospital participate in a research study?
A: There are many ways in which the CHSS Data Center works with the member hospitals for their successful participation in CHSS research studies.
Some of them include but are not limited to:
- Providing member hospitals with template documents required for the study to be approved by the Research Ethics Board (REB) / Institutional Review Board (IRB)
- Providing help with draft responses to questions that the REB/IRB may have about the study
- Making available a team of legal experts who will be able to draft a Data Sharing Agreement (DSA) that can be approved and signed by participating institution
- Providing help in continuing annual review and renewal of the REB/IRB applications for the study
- Providing annual status of enrollment in various studies for the respective institution in friendly and confidential manner
- Finally, when the study is up and running, the Data Center will take care of the annual follow up for the patients enrolled from the respective institutions
Q: What does a member hospital/surgeon have to do to join a CHSS Study?
A: Expressing interest to participate in a CHSS Study by a simple email to email@example.com is the first step a member surgeon or research coordinator can take. The CHSS Data Center will promptly respond and help them set up the study at their institution.