Dr. Byron Schneider is currently an associate professor with the Department of Physical Medicine and Rehabilitation at Vanderbilt University Medical Center and serves as the Director of the Interventional Spine and Musculoskeletal Medicine Fellowship. Previously, he completed his residency and interventional spine fellowship at Stanford University. He has nearly 100 publications, with a research focus on the safety and outcomes of interventional spine procedures. He has given over 100 lectures at national and international meetings. He currently is on the Spine Intervention Society Board of Directors as the Chair of Research, and within the North American Spine Society is Chair of the Interventional Spine and Musculoskeletal Section as well as Co-Chair for the Coverage Committee.
In Part 2 of his presentation, he indicated that the study by Wolf and his group was observational and retrospective, so there are some missing data. They enrolled patients based on provocation discography, which you hope would result in better outcomes. He stated that this number, 50 percent of people saying that they are 50 percent better is very common in pain literature. He wouldn’t say it is favorable. Over and over, these are the numbers we see that turn out to be dead ends. These are non-compelling data unless we are able to show they are non-placebo. You need RCTs to do that. He is a huge proponent of observational studies. They can give you very meaningful clinical information, but unfortunately for a new technology like this, we need at least some evidence that these things are doing something beyond placebo. Next, he indicated the discussion in his presentation would shift to discussing some RCTs that have been published more recently. As of right now, however, the totality of evidence because of the negative RCTs in the research done today, stem cells do not work as a treatment for disc-related low back pain. He then described four new RCTs that came out in the last two years that will shed some new light. The first study involved a comparison with saline treatment. Unwanted side effects, such as infections and other complications have occurred as a result of the treatments in the four studies. Safety continues to be a concern in developing effective treatments using stem cell and PRP approaches.
Dr. Byron Schneider is currently an associate professor with the Department of Physical Medicine and Rehabilitation at Vanderbilt University Medical Center and serves as the Director of the Interventional Spine and Musculoskeletal Medicine Fellowship. Previously, he completed his residency and interventional spine fellowship at Stanford University. He has nearly 100 publications, with a research focus on the safety and outcomes of interventional spine procedures. He has given over 100 lectures at national and international meetings. He currently is on the Spine Intervention Society Board of Directors as the Chair of Research, and within the North American Spine Society is Chair of the Interventional Spine and Musculoskeletal Section as well as Co-Chair for the Coverage Committee.
In Part 1 of his presentation, the focus was on a systematic review that was done of how stem cells and PRP pertain to back pain. He began by going over the history and regulations. Traditionally as it pertains to all biologics, they were largely exempt from the pathway of the FDA. Because they did not go through that process, these medicines were allowed to be done, but really did not have any insurance coverage. They became a cash cow for those offering fee-for-service treatment for things that did not have a lot of evidence behind them yet. It led to much public confusion, but that gap has shrunk in recent years. The FDA began issuing more restrictive language in 2020 regarding treatments that were not approved by that agency. The primary purpose of the aforementioned review was to look at 50 or more percent relief of low back pain at a six-month outcome. Based on those criteria, the number of citations was whittled down from 3,000 citations reviewed to 37, then finally down to only 12 that actually met the criteria. Those results should be alarming given that hundreds of clinics in the U.S. were providing treatments for cash payments that were based on only 12 research papers. Only one paper was on PRPs and one on stem cell treatment. He then described a study on PRP in 2015. He also provided summaries of other investigations that entailed PRP and stem cell treatments.
Dr. Baumhauer is a tenured Professor and serves as the Senior Associate Dean of Academic Affairs for the University of Rochester School of Medicine and Dentistry. She also is the Associate Chair of Academic Affairs within the Department of Orthopaedics at the University of Rochester. In addition to providing clinical care and performing surgery, she holds the position as the Director of the Clinical Health Informatics Core for the UR Healthcare System and is a board of director of Accountable Health Partners, ACO for the Rochester Region. She received her Doctorate of Medicine from the University of Vermont College of Medicine. She completed orthopaedic residency at the Medical Center Hospital of Vermont and a Fellowship in Foot and Ankle Surgery at the Medical College of Wisconsin. She also completed a Masters in Public Health degree from the University of Rochester. Dr. Baumhauer is the past president of the American Board of Orthopaedic Surgery, American Orthopaedic Foot and Ankle Society (AOFAS), and Eastern Orthopaedic Association. She currently is the President of the Patient-Reported Outcomes Measurement Information System (PROMIS) Health Organization and has published over two hundred peer reviewed papers and book chapters.
In Part 2, Dr. Baumhauer described research showing that patients who were able to report at times that were important to the patient ended up visiting the emergency room less and were experiencing more favorable outcomes. She discussed how data are used. The first time seeing a patient, it is important to know what their baseline values are, e.g., mild depression and moderate symptoms for physical function and pain. Trends can be noted that make it possible before meeting with a patient to look at the PROMIS scores and be able to anticipate how much time to spend with this individual. It enables the physician to triage, which patients appreciate. Patients also are asked anchoring questions, such as general health status questions that make it possible to link the medical visit. An example is are you worse, better, or the same since your last visit? Another question is can you live with your symptoms? She also discussed how patients can ask questions, such as whether there will be substantial improvement as a result of surgery. If such an outcome is unlikely, surgery should not occur. Another question patients ask is which of various treatment options should be selected? It is important to know what the patient wants to measure.
Dr. Baumhauer is a tenured Professor and serves as the Senior Associate Dean of Academic Affairs for the University of Rochester School of Medicine and Dentistry. She also is the Associate Chair of Academic Affairs within the Department of Orthopaedics at the University of Rochester. In addition to providing clinical care and performing surgery, she holds the position as the Director of the Clinical Health Informatics Core for the UR Healthcare System and is a board of director of Accountable Health Partners, ACO for the Rochester Region. She received her Doctorate of Medicine from the University of Vermont College of Medicine. She completed orthopaedic residency at the Medical Center Hospital of Vermont and a Fellowship in Foot and Ankle Surgery at the Medical College of Wisconsin. She also completed a Masters in Public Health degree from the University of Rochester. Dr. Baumhauer is the past president of the American Board of Orthopaedic Surgery, American Orthopaedic Foot and Ankle Society (AOFAS), and Eastern Orthopaedic Association. She currently is the President of the Patient-Reported Outcomes Measurement Information System (PROMIS) Health Organization and has published over two hundred peer reviewed papers and book chapters.
Part 1: Data are needed to help understand how a patient is feeling and functioning to implement preventive health strategies, maximize healthy behaviors, assess their treatment response, and understand how health care resources are being allocated. Dr. Baumhauer defined a patient reported outcome as information directly reported by the patient who experiences it and is not interpreted as when we usually obtain some health history and tell it in our terms and report it into the patient’s note. She provided examples of the disconnect between what is important to the patient and what the clinician believes is important for the patient. A validated number can be placed on how the patient is feeling and functioning. It is important that a validated instrument be used that is quick and does not hold up the clinician. At the University of Rochester, they landed on the use of PROMIS (Patient-Reported Outcomes Measurement Information System) on a custom platform called UR VOICE (Validated Outcomes in Clinical Experience). They collect the same information for each patient. They try to ask the right questions when the information is needed most. The aim is to be domain specific, such as symptom-based, using the core package of pain, physical function, and depression rather than focusing on various diseases. Depending on the medical specialty, the symptoms emphasized can be different. Compared to SF-36, PROMIS is a better measure since it is more responsive to change.
Originally from Brooklyn, Dr. Klyachman is the son of two Russian speaking immigrants and among the first in his family to pursue a career in medicine. He attended the University at Buffalo for his undergraduate education and continued his medical education at Touro College of Osteopathic Medicine in Harlem. After graduating, he went to Florida to complete an internship and currently is in the fourth year of a rehabilitation residency at NYU Rusk. He recently matched into a fellowship at NYU where he plans to continue specialty training that starts in July 2023.