Monthly Webinar Series February 2020
Today’s Agenda Announcements & Trial Updates/Reminders Shannon Hillery The Single Scull Regatta Shannon Hillery and Ryan Majkowski Monthly Randomization Race Shannon Hillery Q&A All
Announcements & Trial Updates SHANNON HILLERY
Study Updates As of February 4 th , 2020, we have 442 patients enrolled. We are SO CLOSE to the half way point!!! We have submitted materials to the central IRB for the continuing review. We had a DSMB meeting on January 31, 2020 and the DSMB voted to continue the trial without modification. Thanks to everyone for keeping the VISION database up-to-date and getting the continuing review documents back to us in a timely fashion.
Reminder – SAC Meeting in 3 Weeks! Wednesday, February 26, 2020 – 1:30- 5:00 pm Hilton West Palm Beach, Florida Looking forward to celebrating reaching our 50% enrollment milestone and strategizing to get to full enrollment! Please reach out to Susan Emrich (semrich1@jhmi.edu) with any travel/lodging questions.
Th The Single Scull Regatta SHANNON HILLERY
TIN Workgroup Informed Focus Why Game? ◦ Gaming Work Group Mission Statement: Incorporate gaming innovations into clinical trial operations for networks to enhance site engagement, using competition and team building to establish trust and rapport and ultimately improve performance. ◦ Friendly Competition ◦ Easy and Live method of assessing one’s own site performance ◦ Fun way to recognize top performers and highlight ways in which different sites excel
Rowing is one of the Fun Facts! Rowing was first used as a original sports in the means of transport in modern Olympic ancient Egypt, Greece and Games Rome A single sculler could reach Rowing was the first a top speed of more than intercollegiate sport 13 miles per hour, almost contested in the as fast as the top speed of United States between a boat with four rowers! Harvard and Yale in 1852
How do the games compare? ROWING COMPETITION SINGLE SCULL REGATTA Rowboat teams by region Sites are in their own rowboats or “single sculls” 5-6 sites to one rowboat Sites entered the competition when they Sites start the competition simultaneously became active to enrollment February 1, 2020 1 year competition 5 month competition (End: June 2020)
Point System Metrics Points Webinars 1.5 Screened 1 Randomized 4 % Data entered within 7 days of visit 10 % Queries within 2 weeks 10 Visits in-person completed 1 ePRO within 4 weeks (+/- 2 weeks), 0.5 0.25 ePRO in-person between 6 weeks-3 months Completion of all 3 Primary Outcome Assessments during in-person visits 2
Metrics Ongoing Variables In-person Visits ePROS Primary Outcome Assessments • • • • Visits completed ePRO completed within EDSS Webinar Attendance • • • M6 time period 25-Foot Walk Test Screened • • • • M12 Baseline 9-Hole Peg Test Randomized • • • M18 M3 % Data entered within 2 • • M24 M9 weeks • • • M30 M21 % Queries answered • • M36 M33 within 2 weeks • • M42 M45 • • M48 M48 • EOT
Webinars • One person from each site must be in attendance • 1.5 points are awarded per site (even if 3-4 members attend) Example: 8 live webinars attended = 12 points
Webinars: Missed the Live Broadcast? Watching the recording: • After the final broadcast (Thursdays. 9:00 AM EST) the webinar recordings and slides will be posted to our website: treat- mstrial.org in the “Webinars” folder • .25 points will be awarded to sites that were unable to make the live broadcasts if they watch the recording within 5 days of the final broadcast
Screened Patients • 1 point is awarded for each screened patient • Every screen* counts! Example: 30 patients screened; 26 randomized 4 screen fails = 30 points awarded *Patients entered into the EDC as a screen should be those who were approached face-to-face and given a consent form to consider the study
Randomized Patients • 4 points are awarded for each randomized patient Example: 20 patients randomized = 80 points awarded • Randomization Goal: 1 new candidate per week
% Data Entered within 7 Days of Visit • A maximum of Points Overall Data Entry 10 points can be 10 100% entered within 7 days earned per site 9 ≥ 90 -99.9% entered within 7 days 8 ≥ 80 -89.9% entered within 7 days Example: 7 ≥ 70 -79.9% entered within 7 days 86% of all data was entered within 7 days of each visit 6 ≥ 60 -69.9% entered within 7 days = 5 ≥ 50 -59.9% entered within 7 days 8 points 4 ≥ 40 -49.9% entered within 7 days 3 ≥ 30 -39.9% entered within 7 days • Note: this is an overall 2 ≥ 20 -29.9% entered within 7 days metric; not per patient 1 ≥ 10 -19.9% entered within 7 days 0 < 10% entered within 7 days
% Queries answered within 2 weeks • A maximum of 10 points Points Overall Query Resolution can be earned per site 10 100% queries answered within 2 weeks 9 ≥90 -99.9% queries answered within 2 weeks Example: 8 ≥80 -89.9% queries answered within 2 weeks 56% of queries issues 7 ≥70 -79.9% queries answered within 2 weeks were answered within 2 6 ≥60 -69.9% queries answered within 2 weeks weeks = 5 ≥50 -59.9% queries answered within 2 weeks 5 points 4 ≥40 -49.9% queries answered within 2 weeks 3 ≥30 -39.9% queries answered within 2 weeks • Note: this is an overall metric; 2 ≥20 -29.9% queries answered within 2 weeks not per patient 1 ≥10 -19.9% queries answered within 2 weeks 0 <10% queries answered within 2 weeks
In-person Visits Completed • 1 point is awarded for each visit completed per patient • 0 points are awarded if visit is missed Example: Month 6 4 separate patients complete 5 of their in-person visits Month 12 = Month 18 20 points are awarded Month 24 Month 30 Month 36 Month 42 Month 48
ePRO Completion Calculation Points ePRO Baseline completed within 45 days of randomization 0.5 Baseline only Month 3 Any ePRO completed +/-6 weeks from expected date 0.5 Month 9 Any ePRO completed between 6 weeks - 3 months from expected date 0.25 Month 21 Month 33 Any ePRO not completed 0 Month 48 Any ePRO completed out of window 0 End of Treatment Example: 20 completed ePROs at baseline + 10 completed ePROs between 6 weeks-3 months for all patients = 12.5 points
3 Primary Outcomes Completion • If all 3 of the Primary Outcomes Assessments are completed per visit, 2 points are awarded • If less than 3 primary outcome assessments are complete, 0 points are awarded Example: 40 patient visits EDSS all primary outcome 25-Foot walk Test assessments were completed 9-Hole Peg Test = 80 points awarded
Scoring System RYAN MAJKOWSKI
What’s different about the Single Scull Regatta Scoring? Competition will be balanced from 2/1/2020 onwards Points gained from subjects enrolled before 2/1/2020 will be balanced between sites with varying numbers of patients already in follow up Points used for balance are still dependent upon successful outcomes visits of those enrollments
What’s different about the Single Scull Regatta Scoring? Outcomes visits for subjects enrolled after 2/1/2020 will be scored normally Sites with no enrollments pre-2/1/2020 will receive balance updates based upon other measures Bottom Line: No site will have an advantage based upon outcomes visits from pre-2/1/2020 enrollments
Where can I follow along? Balance points will be entered manually every month by the DCC before the monthly webinars Additions will be visible on the site demographics tab in VISION and in a separate column on the Rowing Competition scoreboard
The team structures are still active in VISION! https://treat.preludedynamics.com
Where can I find my site’s score? https://treat.preludedynamics.com
Single Scull Regatta in TREAT-MS News SHANNON HILLERY
Single Scull Regatta JHU
In Monthly Bulletins The Top 5 sites will be showcased in the Monthly Bulletin The monthly bulletins are sent out the third week of the month, so be sure to keep up with the standings on the bulletins, as well as the webinars!
Monthly Randomization Race SHANNON HILLERY
Monthly Randomization Race January’s Top Performers: Site # of Randomizations Mayo Clinic 3 OhioHealth Research Institute 3 Swedish Health Services 3 University of South Florida 2 Dignity Health Medical Foundation 2 Johns Hopkins University 1
January’s Top Enroller: Mayo Clinic $50
Open for Questions
Thank You for attending today’s webinar! The March Monthly Webinar will be held on the 4 th at 3 PM and 5 th at 9 AM EST
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