Our Registries: FAQ’s
What registries are offered?
SSSF offers two registry options for clinicians: (1) the Surgeon Performance Program (SPP) Quality Improvement Registry and (2) the Research Database Registry.
The Surgeon Performance Program Quality Improvement Registry is strictly for quality improvement purposes and no data collected will be used for research of any kind. All data is de-identified in dashboard reports.
The Research Database Registry is designed for clinicians interested in utilizing data collected for both quality improvement and research.
How do I join SPP?
To learn how to join SPP, click here.
How do I join the Research Database Registry?
Contact Monica Lee at email@example.com for instructions on joining our Research Database Registry.
Surgeon Performance Program QI Registry: FAQ’s
What are the diagnostic specific modules offered to participants in SPP?
This registry collects data to be dashboarded over a period of time on patients with the same diagnosis. Currently, this registry offers modules for Idiopathic Scoliosis, Neuromuscular Scoliosis, and Spondylolisthesis. Participants have the ability to choose which module to participate in, and each module has distinct inclusion criteria:
- Idiopathic Scoliosis (IS): Patient with idiopathic scoliosis, under 26 years of age with no prior spinal surgery, who presents with a curve large enough that a definitive fusion or non-fusion surgery is recommended and the patient and/or family is proceeding with surgical treatment.
- Neuromuscular Scoliosis: Patient between the ages of 8-21 (inclusive) with spinal fusionbeing undertaken and the patient/family is proceeding with spinal fusion.
- Spondylolisthesis: Patient under 26 years of age with isthmic and/or dysplastic spondylolisthesis (excluding degenerative spondylolisthesis).
Does it cost anything to join SPP or are there any participation fees?
No; there is no cost to join and no annual participation fees at this time thanks to the generous support from our industry sponsors, Medtronic and NuVasive.
Is this considered research or does this involve human subjects and/or require consent forms?
SSSF has obtained an independent IRB exemption waiving oversight: quality improvement projects do not meet the definition of research based on federal regulation 45 CFR 46. Submit to your local IRB if required by your institution.
What will I see in my Dashboard Report?
How often will I receive a Dashboard Report?
Participating surgeons receive a dashboard report twice per year, with plans to increase this in the future.
Documents & Permissions
What is the IRB Process for the program?
Are there any legal requirements for participation?
Yes, a fully executed Registry Participation Agreement (RPA) is required prior to participation. If the participating site chooses to submit any optional PHI categorized as a Limited Data Set, the RPA will include supplemental Business Associate (BAA) and Data Use Agreement (DUA) provisions. Sites who opt to submit only deidentified data will execute an RPA without supplemental BAA/DUA provisions.
Cases & Data
What are the case requirements for participation in the registry?
Participants agree to submit 10 consecutive cases per calendar year for each diagnostic module they wish to participate in for eligibility for inclusion in and receipt of dashboard reports.
Do I have to submit PHI?
No, submitting PHI is optional. If you choose to submit PHI, your RPA will include DUA and BAA provisions.
Is PHI used in dashboard reports?
No; all data contained in participant dashboard reports is de-identified.
Why do sites opt to submit PHI if it is not used in Dashboard Reports?
The sole purpose of opting to submit PHI is for ease and accuracy during the data entry process, and regardless of if PHI is submitted, no PHI is ever used in surgeon dashboard reports generated by SSSF.
If I submit PHI, what are the variables?
The PHI you may opt to submit falls into the category of a Limited Data Set (LDS), and includes the following variables:
What if I choose not to submit PHI?
Sites may opt to submit only deidentified data (no PHI/LDS), and will receive an RPA that does not include additional DUA/BAA provisions. Sites who choose to submit only deidentified data will submit the following data in lieu of any specific dates:
Length of Hospitalization
Time of Surgery: Year and Quarter
Database User Program Research & QI Registry: FAQ’s
What is the cost to subscribe to this registry?
The cost for a yearly subscription to this registry is $5k.
What is the IRB process?
Once you have received the protocol and case report forms, submit to your local IRB for approval to enroll patients from your site for studies related to patient populations you choose.
What type of agreement will need to be executed?
Subscribers will execute a Database User Program Services Agreement prior to utilizing this registry.