Clinical Trials Network
Leaders of academic anesthesiology organizations have recognized that there is a need to conduct large pragmatic trials in order to answer important questions in anesthesiology-related research. Although there are several successful anesthesiology clinical trial networks around the world, there is no collaborative network in the United States. There are several factors that enable anesthesiology researchers today to conduct large and efficient trials, in line with recommendations of the National Institutes of Health. (1) There are highly developed, specialized infrastructures already in place that can provide meaningful support to investigators and increase the likelihood of both successful funding and completion of research projects. Examples of these infrastructures include the Multicenter Perioperative Outcomes Group (www.mpog.org), the Duke Clinical Research Institute (www.dcri.org), and the NIH funded Clinical and Translational Science network. (2) With the near universal adoption of electronic health records in the US, it has become possible to conduct trials entirely within the context of routine care. For example clinically relevant outcomes such as respiratory failure, renal failure and delirium can often be reliably ascertained from the EHR. This potentially negates the need for dedicated trial-related visits. (3) We have access to multiple national registries with granular data from the HER, as well as information on complications and patient-reported outcomes. This obviates the need for a new, costly infrastructures to track patient outcomes. For anesthesiology related research, the establishment of MPOG approximately a decade ago was a great service to the field and now provides a valuable resource to clinical and translational scientists.
In an initial attempt to address this important opportunity, a consortium of academic anesthesiology organizations launched an initiative last year to stimulate pragmatic research. This effort was conceptualized and endorsed by organizations, which have as a common goal the advancement of knowledge in anesthesiology and the enhancement of care in perioperative medicine, critical care, pain management, and peri- and post-partum care. These organizations included the Association of University Anesthesiologists (AUA), early stage Anesthesiology scholars (eSAS), Foundation for Anesthesia education and Research (FAER), International Anesthesia Research society (IARs), and society of Critical Care Anesthesiologists (SOCCA). It was hoped that the pragmatic envisioned trials would (i) foster international collaboration, (ii) leverage big data and precision medicine, (iii) include multi-disciplinary teams, and (iv) adopt innovative and efficient designs.
The AUA Council energized this process by offering three start-up grants of $15,000 each, which would allow investigators to refine their proposals and compete for grants to pursue an ambitious research project. A call for letters of intent was made towards the end of 2017, and seventeen high quality applications were received. In order to conduct fair and rigorous peer review, a study section of experts was assembled, all of whom generously devoted considerable time and effort to this initiative. Hannah Wunsch and Duminda Wijeysundera, both at University of Toronto, headed up the study section. Other members were Jeanine Winer-Kronish (AUA), Jim Eisenach (FAER), John Butterworth (IARS), Avery Tung (SOCCA), Elizabeth Whitlock (eSAS), Paul Wischmeyer (DCRI) and Tim Houle (statistician). Six finalists were selected, and from these three winners were chosen.
On 1st May 2018, the first meeting of the Clinical Trials Network was held after the AUA, SOCCA and IARS meetings in Chicago. The agenda for this meeting was full and exciting. Kate Stoney from the National Heart Lung and Blood Institute provided valuable information on pragmatic trials from an NIH perspective. Eric Jacobsohn described how Canadian anesthesiology researchers have successfully launched and sustained a clinical trials collaborative. Sachin Kheterpal reported on the impressive growth of MPOG, and announced that MPOG was establishing an Infrastructure for Multicenter Pragmatic Anesthesiology Clinical Trials (IMPACT). With a strong track record of success in observational research and quality improvement through ASPIRE (Anesthesiology Performance Improvement and Reporting Exchange), IMPACT is a logical expansion for MPOG. Paul Wischmeyer from the DCRI delivered an inspiring talk, which included moving accounts of his experiences as a critical ill surgical patient. He passionately conveyed the importance of perioperative rigorous anesthesiology research, and illustrated the many ways that the DCRI can advance this important agenda and assist researchers.
A highlight of the meeting was the announcement of the three successful proposals and discussions around these. The winners with the titles of their proposals were (in no particular order):
- Michael Aziz, Oregon Health and Science University, Optimized Opioid Management or Usual Treatment to Reduce Persistent Opioid Use Following Surgery (OPT-OUT)
- Randal Blank, University of Virginia School of Medicine, Individualized Intraoperative Protective Ventilation using an Open Lung Approach with Driving Pressure Limitation
- Frederic T. (Josh) Billings, Vanderbilt University Medical Center, Intraoperative Normoxia versus Hyperoxia during Maintenance Anesthesia to Reduce Postoperative Complications
Hannah Wunsch and Duminda Wijeysundera chaired a science garage (grant review boot camp). Interestingly, all three applications proposed to use IMPACT (MPOG) as the logical infrastructure to conduct their research. More information on these projects can be found on the MPOG site: https://mpog.org/ctn/
I would like to thank Jeanine Wiener-Kronish for her tremendous efforts in helping to launch this initiative. I also want to thank Hannah Wunsch, Duminda Wijeysundera as well as all the other members of the study section. And in particular, I am grateful to Vivian Abalama, who is a member of the IARS/AUA/SOCCA administrative team. Without her dedication, professionalism and organization, this initiative would not have been a success. In order to build on these initial achievements, we hope to have a follow-up symposium at next year’s AUA/SOCCA/IARS meeting in Montreal. It is likely that we will be showcasing impactful pragmatic trials and having educational presentations from world leaders in clinical and translational research.