The American College of Surgeons (ACS) presented the 2013 Clinical Trials Methods (CTM) Course December 6–10, 2013, at the College’s headquarters in Chicago, IL. A total of 39 students and 13 faculty members participated in the course.
In addition to the didactic sessions that took place over each of the four mornings, the student participants from various surgical specialties were divided into six teams. Each team, under the mentorship of a senior surgeon and a biostatistician, developed a proposal for a clinical trial. The proposals were distributed to faculty and students on the last night of the course and were formally presented the last day of the course. The students evaluated the strengths and weaknesses of each proposal. The students and faculty then scored the proposals in accordance with the National Institutes of Health criteria for feasibility, innovation, and significance. After declaring the winner based on the combined faculty and students’ scores, the course director, Kamal M.F. Itani, MD, FACS, and William Henderson, PhD, senior biostatistician, Colorado School of Public Health, Aurora, provided the critiques for each proposal based on faculty comments.
The proposal with the best score, “ACUTE, Acute Uncomplicated Type B Aortic Dissection with Endovascular Repair,” was developed by Kristofer M. Charlton-Ouw, MD, FACS, assistant professor, department of cardiothoracic and vascular surgery, University of Texas–Houston; Randall R. De Martino, MD, MS, assistant professor, surgery, Mayo Clinic, Rochester, MN; Susan Graham, RN, research coordinator, Coastal Vascular & Interventional Research, Pensecola, FL; Mila H. Ju, MD, MS, resident, McGaw Medical Center, Northwestern University Program, Chicago, IL; Daniel Kendrick, MD, resident, University Hospital–Case Medical Center, Cleveland, OH; Saad Shebrain, MB, BCh, FACS, assistant professor, surgery, and associate program director, Western Michigan University School of Medicine, Kalamazoo; and Matthew R. Smeds, MD, assistant professor, University of Arkansas for Medical Sciences, Little Rock.
The faculty mentors were Peter Nelson, MD, FACS, associate professor of surgery and molecular pharmacology and physiology, University of South Florida Morsani College of Medicine, Tampa; and Robert Anderson, PhD, associate professor, biostatistics, division of epidemiology and biostatistics, School of Public Health, University of Illinois at Chicago. The other five proposals were as follows: “The Tester Trial,” Trial of EMR vs. Surgery for T1b Esophageal Cancer; “The TUMMY Ache Trial,” Trying to Understand Medical Management in the Young with Appendicitis; “The POWERS Trial,” Preoperative Optimization with Enteral Rehabilitation and Smoking Cessation in Radical Cystectomy; “The VIP Trial,” Looking at Vancomycin Instillation Prophylaxis in Spine Surgery; and “The CrIS CRInGL Study,” Looking at Critically Ill Surgical Care Randomized Insulin Plus or Minus Glucagon-like Protein. These proposals represented a spectrum of challenges in surgery where higher-level evidence is lacking.
Several participants reported that the course offered them an excellent learning experience, lauding the valuable mentorship provided and the opportunities to connect with other health care professionals who share their research interests. Participants noted that sharing meals and networking with faculty and colleagues during the five days of the course added to the educational opportunity.
The groups agreed to remain in contact with each other and pursue funding for their proposals.
A survey conducted in 2010 revealed that 61 percent of previous course participants obtained peer review funding to conduct a clinical trial. In that survey, 81 percent of the participants reported that the CTM Course fostered their interest and facilitated involvement in clinical trials.*
The next course is scheduled to take place in November or December 2015.
*Itani KMF. The ACS clinical trials methods course: Overview and assessment. Bull Am Coll Surg. 2011;96(8):62-65.