Q: Do I need to get my own IRB (Institutional Review Board) approval or exemption prior to participating?
Q: Are patient consent forms required?
Q: How is confidentiality assured?
Q. How long will the data collection period last?
Q. What if I miss inputting data on the scheduled 2-week interval?
Q. What data will be collected on the patients/surgeons?
Q. What is the purpose and anticipated significance of the KSAC study?
Q: Do I need to get my own IRB (Institutional Review Board) approval or exemption prior to participating?
A: That will depend on your institution. While this project has been determined exempt by Michigan State University (MSU), other hospitals, institutions, or universities may want to review the project themselves. All of the documents used by MSU to determine exemption are included on this website.
Q: Are patient consent forms required?
A: No, because the data collected from the patients is data normally collected in the course of preoperative evaluation and viewed only by the surgeon or his/her designee (residents, fellows, research assistants, anyone who normally has access to patient data). Data will be collected on the surgeons, and surgeon consent is included in the initial intake form to be filed out when they the study is initiated.
Q: How is confidentiality assured?
A: All surgeon and patient data is immediately de-identified upon entry to the database. Patient “3” can be linked to Dr. “A”, but there is no way to trace back to link patient or physician data to a particular physician or email address. All data is handled by a third party (The Center for Association Resources) not affiliated with the Arthroscopy Association of North America (AANA).
Q. How long will the data collection period last?
A. The initial data collection period is 6 months. Data will be entered every 2 weeks during this 6 month period. If inadequate data has been gathered at the end of the 6 months, surgeons may be asked if they would be willing to volunteer to collect additional data.
Q. What if I miss inputting data on the scheduled 2-week interval?
A. You will receive a “tickler” e-mail asking you to input your data for that biweekly period.
Q. What data will be collected on the patients/surgeons?
A. This is outlined in the attached document “KSAC Study Outline/Description”.
Q. What is the purpose and anticipated significance of the KSAC study?
A. Purpose – To establish a data base from which the incidence of acute complications in knee and shoulder arthroscopy can be determined; utilize the data base to determine the factors associated with these complications; and determine the incidence of complications by surgeon demographics
Significance - There are no well done, large study of arthroscopic complications to date. This study hopes to provide education/information to Centers for Medicare and Medicaid Services (CMS) regarding Surgical Adverse Events (SAE) in arthroscopy. We would also hope to establish a benchmark for arthroscopic surgeons to compare their individual complication rates.