A big piece of providing evidence for optimal spine surgery is the use of randomized control trials. However, unlike most drug trials, surgery is irreversible. You can’t just switch someone to a different medication if it doesn’t work for them. Therefore, it’s difficult to establish equipoise, which is the ethical basis for assigning patients to different treatment arms of a clinical trial. I recently sat down with Dr. Zoher Ghogawala to discuss how he approaches randomization in clinical trials for spine surgery.
Achieving equipoise in clinical trials for spine surgery
Dr. Ghogawala’s first step towards achieving randomization in his trials was to identify and establish a population of patients for which there is equipoise. So he structured the trial so that anyone enrolled would have their case uploaded and reviewed by the panel, no matter which site they were at. This panel includes surgeons who are involved in the randomization of patients in the trial, as well as contact experts who are outside the trial. For example, a physician could see a cervical myelopathy case that was sent out to 15 investigators where nine surgeons said that they would do an anterior operation, and six surgeons said they would do a posterior operation. This is what Dr. Ghogawala calls “real-time equipoise” because people are committing to their opinion, but across the country, there are a mix of opinions.
Power to the patient
From a patient’s perspective, one of the most impressive aspects of the trials are the panels themselves. Both doctors and patients can participate in these “Nidus Reviews” by going to nidusai.com and submitting relevant images to the case they want to be reviewed. Because of how well Dr. Ghogawala and his team designed this system, patients have gone from a 20% rate of acceptance of randomization to a 60% to 70% acceptance of randomization. That level of randomization produces the kind of generalized results needed for optimizing spine surgery and improving patient outcomes. I can only hope this becomes the new standard for spine surgery clinical trials in the future with increased funding.