Recently, the Scoliosis Research Society (SRS), engaged with its membership and other research study groups, including the International Spine Study Group, European Spine Study Group, and the Harms Study Group, to develop a set of research priorities, from which, SRS will fund a directed research project to last three years.
Here are the top five research priorities and candidates for that directed research project.
Research Priority #1: Create and validate improved patient-reported outcomes measures (PROMS) for the assessment of spinal deformity patients.
According to Justin S. Smith, M.D., Ph.D., the Harrison Distinguished Professor in the University of Virginia (UVA) Department of Neurological Surgery, and SRS Research Council Chair, “We cannot hope to offer our patients targeted treatment if we can’t accurately measure the impact of their spinal deformity. This is indeed challenging because you must develop a validated tool to show that what you think you are measuring is what you are actually measuring. This kind of precision can help guide surgeons and patients in selecting operative versus nonoperative treatment.”
“I think the researchers may start by assessing what outcomes matter in this patient population, holding patient focus groups and asking roundtables of those who have and have not undergone surgery. Then they may put together questionnaires and test them to measure any changes after treatment.”
“The Oswestry Disability Index is a generic measure of back pain and disability, but it was not developed for spinal deformity. And the only spine deformity specific outcome measure we have to work with is the SRS-22r, a questionnaire originally designed for patients with adolescent idiopathic scoliosis—not for adult deformity patients.”
Research Priority #2: Study the utility and limitations of enabling technologies such as 3D planning/robotics in the treatment of spinal deformity patients.
“Enabling technologies for spine deformity surgery—such as 3D planning, navigation, and robotics—are everywhere now,” states Dr. Smith to OTW. “But should they be used across the board in every surgery?”
“This research topic focuses on obtaining specifics as to how these technologies can be optimally applied. Industry representatives are interested as well because they need to know the limitations of the technologies so that they can address them. On the physician side, surgeons who opt for these technologies have to be completely comfortable with anatomy. For example, if someone knows how to use an enabling technology, but isn’t 100% clear on anatomy, that person may not appreciate if the registration is off for navigation.”
Research Priority #3: Assess the potential relationships between biomarkers for aging/senescence and disease etiology, treatment decisions, and patient counseling in adult deformity patients.
“I treat a fair amount of elderly patients who have severe deformities. Yes, they are in pain…but when I tell them that this is a big surgery with months of recovery, they start asking questions such as, ‘Will I be too frail to fully recover?’ and ‘Will I have a long enough lifespan to enjoy the benefits of the surgery?’”
“Presently we don’t have a reliable way of answering these questions,” said Dr. Smith to OTW. “We need to look at the aging biomarkers, but no one is certain which ones are important. There is growing evidence that C-reactive protein levels may relate to bone density and potentially bone degeneration. In addition, shortened telomeres are associated with biological aging and life span.”
“Many adult deformities develop because of degenerative conditions. For example, cervical kyphosis can develop, in part, from frailty and sarcopenia. If we have more precise biomarker information on how these deformities develop, we can enhance the educational counseling we undertake with patients. When considering surgery, patients often wonder if it’s worth going through all these hurdles and the risks associated with operative treatment.”
Research Priority #4: “Apply predictive analytics/AI to spinal deformity care, including classification, management decisions, complication risk, and outcomes assessment..
“Predictive analytics and artificial intelligence are increasingly being mined for their ability to clarify the complex aspects of spine deformity classification, complication risk, management, and outcomes assessment,” states Dr. Smith to OTW. “
“For example, the International Spine Study Group has published several predictive analytics studies looking at the risk of complications in patients. Although the software is constantly improving, the biggest challenge is the amount of data needed. Typically, when using AI, you need tens or hundreds of thousands of patients; in the adult spine deformity arena, however, we only have thousands. While there are any number of administrative databases available, the data is typically less granular, and often lacking in comorbidities, deformity details, or other vital information.”
Research Priority #5: “Develop strategies to effectively address the European Medical Device Regulations.”
“The device industry is stymied by the new European Medical Device Regulations that pose a threat to innovation and patient access to care by imposing onerous requirements for implant approval. In the past, the U.S. FDA was quite strict, and the European regulators were relatively lax, meaning that a lot of studies were initially performed in Europe.”
“The pendulum has swung, and the European regulators are now requiring implant-related outcomes data, as well as patient outcomes and complications-related data. For every system and every implant that a company offers, they must have new, separate data showing safety and efficacy. Companies have been selling legacy systems for years and to enter that market, they would have to go back and collect more data. Ultimately, this means that European patients don’t have reasonable access to new technologies. Industry representatives asked if we could help to define the appropriate outcomes measures and complications to be collected.”
Formulating the Top Research Priorities for 2025 and Beyond
SRS, which was founded in in 1966, is doing an ever-more impressive, thoughtful, and comprehensive approach to pruning the number of research topics for investment of both financial and research resources. It’s an approach that could easily serve as a model for other foundations and research organizations.
Here is how SRS arrived at these impressive research priorities—each of which deserves immediate funding.
“In January 2019 the SRS Board of Directors initiated a research task force, which recommended that we increase the level of grant funding,” Dr. Smith to OTW, “The board listened, approving $150k per year for a directed research project to last three years.”
The SRS Research Council established a formal process whereby they met with numerous stakeholders to ensure they would move forward with addressing the right topics. Dr. Smith told OTW, “We took several months to survey members, meet with research study groups (such as the International Spine Study Group, European Spine Study Group, and Harms Study Group), discuss the priorities of our industry partners and meet with an NIH [National Institutes of Health] representative to determine their main concerns.”
From there the list of potential research topics made its way to the Board of Directors, which then identified one topic for the directed research process.
“The first directed research project was on the long-term outcomes of operative and nonoperative care of adolescent idiopathic scoliosis,” said Dr. Smith. “This work, which is underway, is rare in that it is providing 20- to 40-year outcomes of various treatments.”
“This year, our second funding cycle, a number of common threads emerged, namely topics related to new technologies and outcomes measurements. The board will soon select one topic for this cycle’s directed research proposal.”
So far, says Dr. Smith, the SRS research cycle is every three years. “Ideally, we will extend this to five years so that there is additional time for the directed research topic to come to fruition.”
Note: To see the full list of topics for the research agenda (those discussed in the article were the “top 5”) please visit SRS Research Agenda | Scoliosis Research Society
