We are very proud of OHDSI work since last month’s study-a-thon, including several nearly completed manuscripts that we plan to submit for the peer-review process. However, our community also recognizes the critical need for OHDSI to take the next step and leverage its global community, high-level analytics and vast data sources to study which ongoing COVID-19 treatments are actually working.
That brings us to Project SCYLLA.
There is a new channel in MSTeams (Study-Estimation-COVID Effectiveness) where we will collaborate on the design of these studies. Patrick Ryan opened that channel with the post below, and Daniel Prieto-Alhambra followed with a link to the first version of the draft protocol, as well as a request for feedback by 10 am ET on Friday, April 24.
Anybody who was involved with the study-a-thon should still have their MSTeams login and can join the channel; for those who wish to get involved, please reach out to Craig Sachson (sachson@ohdsi.org) for log-in credentials. We are hoping to have community-wide feedback to ensure SCYLLA can generate the highest quality of evidence on therapies around COVID-19.
Below is Patrick’s introductory remarks about Project SCYLLA.
Dear colleagues,
We have been thinking, even before we launched our Study-A-Thon, of the potential to apply our OHDSI tools across the OHDSI network to study the safety and anti-viral effectiveness of all emerging therapies for the treatment of COVID19. Potential therapies against COVID19 are mentioned every day to all of us based on in vitro studies, previous SARS experience and/or experiments, or just clinical experience by colleagues working in different specialties.
Many of us have seen the publication of small observational studies and their impact on clinical practice with great concern. We clearly do not want to contribute to a large amount of research that will be seen in the future as wrong, or even harmful. Hence the reason we hadn’t declared our intention to conduct such studies in the OHDSI community. On the other side, it feels uncomfortable to do nothing if there’s a chance we can positively contribute when so many treatments being actively investigated with limited evidence of any sort about their real-world effects in patients with COVID-19. But much as Odysseus was forced to choose between Scylla and Charybdis on his voyage home, we now need to decide among the lesser of two evils. And following our protagonist’s lead, we also choose Scylla.
We’re announcing here our intention to set forth on another journey, to collaboratively design and implement a population-level effect estimation study to examine the comparative effects of COVID-19 treatments. We’re calling this effort: Project Sc(y)lla: SARS-Cov-2 Large-scale Longitudinal Analyses .
Akin to prior OHDSI LEGEND efforts, our aim is to avoid the pitfalls of cherry-picking specific hypotheses about a particular candidate treatment. Instead, we will create a systematic approach to evaluate all alternative treatments for a large constellation of outcomes of interest in a consistent and reproducible manner. SCYLLA will allow for evidence to accumulate across our network at observational data on COVID-positive patients accrue and additional data partners join the journey to execute our open-source analysis package and share aggregate summary statistics.
Like the Odyssey itself, this will be all about the journey. We recognize the threats and challenges ahead, and we are planning to conduct robust methodological research to test the robustness of our methods while we implement them. These are some of the foreseen difficulties:
- Source-specific outcome/s definition and phenotyping
- Relatively small sample size (by OHDSI standards…)
- Confounding by indication in the midst of continuously emerging therapies
- Prospective data collection
We have prepared a brief slide set (uploaded in the MSTeams page) that will hopefully inspire you to engage with us in the process of designing SCYLLA. We are now writing a first draft study protocol that we will aim to share with you for feedback in the coming few days. Please stay tuned if you are willing to contribute.
Let us start this journey together…
Cheers,
Patrick on behalf of Daniel Prieto Alhambra, Marc Suchard, George Hripcsak, Martijn Schuemie, Martijn, Kristin Kostka, Kristin, Jennifer Lane, Jamie Weaver, Talita Duarte-Salles, Albert Prats-Uribe, Ed Burn and Peter Rijnbeek