In case you haven't heard we’ve reached our enrollment goal with Duke Medical Center bringing in our last patient! The enrollment period ended on January 25 and we are now focusing on data collection and analysis and the case report form completion phase. To aid in this next phase please keep in mind the following:
1) Continue to complete all follow-up study visits. This is critically important as our goal is not to lose any patients to follow-ups. Best practice is to arrange these visits as close to the window opening as possible. Enter the data into REDCap as soon as you can and respond to any queries from your monitor in a timely fashion.
2) Review of case report forms and regulatory documents is in full swing. Check for emails from Barbara McCrum requesting documents.
This next phase is by far the most exciting – we now have the opportunity to learn from the work that was done and answer the research questions posed. The SETPOINT2 study outcomes will lead to improved patient care as well as advancing science.
We appreciate the hard work you have already done throughout the SETPOINT2 study. Our success would not be without the continued support of our: investigators, research staff, patients, families, stakeholders, and PCORI for their continued support of the SETPOINT2 Trial.
Thank you for your continued efforts!
Julian & Dave