As paramedics across Ontario, continue to provide exemplary care in the midst of a world-wide pandemic, it is with incredible pride that I am able to announce the enrollment of our 300th patient in the Double Sequential External Defibrillation for Refractory Ventricular Fibrillation (DOSE VF) Randomized Controlled Trial!!
The challenges we have faced in getting to this point have been significant. While we were able to move along nicely through the wildly acclaimed and successful pilot RCT (ending in September 2019) and the launch of the RCT at the completion of the pilot, the challenge of running an RCT in the midst of a global pandemic altered our course.
As a result, we put a halt on the enrollment in the DOSE VF RCT in April of 2020 only to restart again in September 2020 with both our County of Simcoe Paramedic Services and Halton Region Paramedic Services. Shortly, thereafter both Peel Regional Paramedic Services and Middlesex London Paramedic Services relaunched the study and we were overjoyed to add the Ottawa Paramedic Services in November of 2020.
Unfortunately, Toronto Paramedic Services, has been overwhelmed with the COVID-19 pandemic in their region and has yet to relaunch the study. We are cautiously optimistic that increased vaccination in the Toronto area will lead to a decrease in case count and a rejoining of the service to the study.
The study itself has garnered worldwide attention being presented at multiple conferences including the Canadian Association of Emergency Physicians (CAEP) Annual Conference, the American College of Emergency Physicians (ACEP) Annual Conference and the prestigious American Heart Association (AHA) Resuscitation Science Conference. As well, the study has been featured in numerous podcasts, editorials and commentaries.
The common theme in all the presentations was the incredible care provided by all paramedics, including the precision and consistency in performing a complex 3 arm trial with crossover. A true tribute to your amazing work. Although DSED was not recommended for routine use in the recently released AHA or ERC guidelines, the recommendations all came with a caveat: “as we await the results of an ongoing RCT”. Clearly, the research you are doing is much anticipated and will have implications for guidelines around the world.
What is the breakdown of our enrollment in the pilot study, the RCT pre-COVID and the RCT post-COVID?
| Pilot RCT: | 152 |
| RCT pre-COVID: | 95 |
| RCT post-COVID: | 53 |
| Total: | 300 |
What is important to note is the significant drop off in enrollment post-COVID. The reasons for this are twofold: The impact of COVID on the Toronto Paramedic Services relaunch and the decrease in VF (and subsequently refractory VF required for trial enrollment) seen around the world since the pandemic began.
Remarkably all three arms of the study are quite evenly balanced with a slightly lower number of patients enrolled in the vector change arm due to the cluster randomization of the study. Interestingly the majority of services will be in the vector change arm of the study shortly which will balance the arms almost perfectly. As well, the hopeful relaunch at some time in 2021 of Toronto Paramedic Services will certainly make a big difference in our numbers.
In closing, it is incredibly exciting to have enrolled our 300th patient in the DOSE VF RCT.
The feedback we have received has been superb and all paramedics have performed incredibly well despite practicing in the most challenging of all environments. The study team could not be more proud of the dedication you have shown to the profession and the furthering of science through your participation in the RCT.
Personally, I could not be more proud of each and every one of our paramedics. Please continue to practice in as safe a manner as possible knowing we appreciate the work you do in enrolling each and every patient in the study.
Yours Truly,
(Original signed by)
Dr. Sheldon Cheskes, MD, CCFP (EM), FCFP
Medical Director, Sunnybrook Centre for Prehospital Medicine, Regions of Halton and Peel
Scientist, Li Ka Shing Knowledge Institute Affiliate Scientist, Sunnybrook Research Institute
Professor, Department of Family and Community Medicine, Division of Emergency Medicine, University of Toronto