SETPOINT2 Newsletter
September 2020
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Inside
- Study Update: Trial Closeout
- SETPOINT2 Timeline Summary
- Reminder
- Follow Up Visits
- Top Enrollers
- News
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Dear Investigators,
This is an exciting time as our statistical colleagues work with the final SETPOINT2 dataset to determine whether or not a strategy of early tracheostomy resulted in improved 6-month neurological outcomes compared to delayed-tracheostomy-if-necessary in patients with severe stroke, respiratory failure, and a SETscore>10. We have been working to answer this question for more than 10 years, and hope to have high-quality and compelling data soon to guide our clinical practice for years to come.
SETPOINT2 is a clinical effectiveness study, meaning that it compares two clinical strategies, both considered efficacious in common practice, to determine the better strategy. Since 2015, when we launched this trial, the equipoise of this clinical question has been demonstrated at every turn. There are, simply put, compelling arguments for both approaches.
Whether or not one of these strategies proves to be clearly superior, we will learn a tremendous amount about tracheostomy in stroke patients from SETPOINT2. Additionally, we will learn about how these severe strokes and the timing of tracheostomy affect families and patients, and specifically about how survivors, many with significant disability, feel about the processes of care and results of their treatment. In addition to the pragmatic work of comparing clinical practices, giving voice to our patients and families is the mission of the Patient Centered Outcomes Research Institute (PCORI), our funding agency. We expect those results to be every bit as interesting and impactful as the primary trial results.
It has been a great honor and a privilege to work with each of you on this trial, and we are anxious to let you know what we find - please be patient! We are also anxious to begin the next trans-Atlantic neurocritical care project, whatever it may be. You are a great group, and we must stick together to answer as many of the questions that plague us on rounds every day as we can.
Best regards,
Julian & Dave
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Julian Bösel, MD
Overall Study Principal Investigator
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David, Seder, MD
US Principal Investigator
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SETPOINT2 TIMELINE SUMMARY
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*IMPORTANT*
Keep SETPOINT2 open with your IRB until notified by Barbara McCrum
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SETPOINT2 Follow-Up Visits |
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US Sites With Follow-Up Visits Completed
Thank you!
Baylor College of Medicine
Houston, Texas
Columbia Presbyterian Medical Center
New York, New York
Duke Medical Center
Durham, North Carolina
Henry Ford Health System
Detroit, Michigan
Kadlec Regional Medical Center
Richland, Washington
Maine Medical Center
Portland, Maine
Mayo Clinic Florida
Jacksonville, Florida
Ohio State University
Columbus, Ohio
OSF St. Francis Medical Center
Peoria, Illinois
St.Joseph Health/St. Jude Medical Center
Fullerton, California
University of Maryland
College Park, Maryland
University of Michigan
Ann Arbor,Michigan
University of Tennessee
Knoxville, Tennessee
University of Texas Houston Health Sciences Center
Houston, Texas
Yale University
New Haven, Connecticut
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Congratulations to SETPOINT2
Top Enrollers
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Thank You to Our Top Enrollers
And thanks to all the SETPOINT2 Investigators, Research Nurse Coordinators, Patients & Families! The study could not have been successful without all your input, hard work, and dedication.
The graph below shows final enrollment data for all active SETPOINT2 sites.
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Neurocritical Care 18th Virtual Annual Meeting
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SETPOINT2 Partnering Centers
Click on the map to see locations.
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Do you have questions? Please email us at: setpoint@mmc.org
Visit the SETPOINT2 website for in-depth information for patients, families and investigators.
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Research reported in this newsletter was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1602-34137).
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