This post comes from Fred Nelson, MD, an orthopaedic surgeon in the Department of Orthopedics at Henry Ford Hospital and a clinical associate professor at Wayne State Medical School. Some of Dr. Nelson’s tips go out weekly to more than 3,000 members of the Orthopaedic Research Society (ORS), and all are distributed to more than 30 orthopaedic residency programs. Those not sent to the ORS are periodically reposted in OrthoBuzz with the permission of Dr. Nelson.
The broad term “big data,” when applied to health care, refers to the mining of large databases to find information that might predict and improve clinical outcomes on a national scale. A recent article in AAOSNow cites one example of the merging of big data with artificial intelligence (AI) as the 10-year partnership between the Mayo Clinic and Google to leverage cloud technologies, machine learning, and AI to accelerate change in healthcare delivery. The American Joint Replacement Registry (AJRR) is also using big data to help hospitals make more efficient supply-chain decisions and lower costs.
However, there are limitations and potential flaws in the use of big data. One is the high cost, making it unaffordable for some institutions. In addition, variations in how the data is collected and reported may lead to flawed analyses. Also, data collection may vary in completeness by region, which makes nationwide registries with consistent data collection so important. Big data can also be contaminated by bias. Even large datasets may over- or underrepresent certain groups of people, thereby skewing any analysis made with those data.
There are several solutions to improve the use of big data in orthopaedics. One is the development of registries with uniform and consistent data collection methods to ensure equity. Participation in registries by orthopaedic surgeons is critical. The authors of the AAOSNow article also emphasize that if patient data were linked longitudinally, researchers would have a powerful tool with which to study health outcomes and monitor public health trends. However, current HIPAA rules prevent clearinghouses from linking data that way. To update the law to match our data-driven reality, in 2017 US Rep. Cathy McMorris Rodgers (D-Ore.) introduced the Ensuring Patient Access to Health Records Act (H.R. 4613), which would allow greater access to big data for the purpose of research, public health, and personal patient use. The bill has been tied up in committee since December 15, 2017. The ultimate objective of using big data in medicine is to provide health care that is “predictive, preventive, personalized, and participatory,” conclude the authors.
Orthopaedic surgical procedures to correct axial and appendicular skeletal deformities are usually dependent upon fixation devices, either external or internal or both. These devices are often developed through close collaboration with engineers who are generally employed by major manufacturing companies. After the devices successfully clear rigorous bench, in-vitro, and in-vivo testing, the standard initial presentation of clinical results is a case series.
All too often the initial report of results comes from a co-developer of the device, with inherent selection and detection bias that constitute what most readers would consider a conflict of interest. McCarthy and McCullough’s case series on five-year results with Shilla growth guidance in 33 children with early-onset scoliosis in the October 7, 2015 JBJS is an exception to that rule. The authors report every conceivable major and minor adverse event without holding back any negative information. They categorize complications as infection secondary to wound breakdown, spinal alignment issues, and implant issues. The overall complication rate was 73%, a rate that is not surprising given the fact that the device under study is designed to maintain correction of spinal deformity in growing children.
Thankfully, the authors reported no neurologic complications. Also on the positive side, they found that spinal curves averaging 69° preoperatively averaged 38.4° at the most recent follow-up or prior to definitive spinal instrumentation. McCarthy and McCullough also calculated a 73% reduction in the number of surgical procedures among their cohort, relative to what would be necessary to treat the same population with distraction methods every six months.
I applaud the authors for comprehensively reporting the results of correction of spinal deformity in this difficult clinical situation with high accuracy and strict definitions of major and minor events. This is how we will make advances in correcting deformity for skeletally mature and immature patients—with innovation, incremental improvement, and the widespread sharing of adverse events with the orthopaedic community. Armed with the information from this study, we must now see what the number and severity of complications look like when the broader community of orthopaedic surgeons applies these devices.
Marc Swiontkowski, MD