To assist, alert: Use of registries in orthopedics
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Since the first orthopedic registry was developed in 1975, registry data have been used to identify implants and techniques with good outcomes and reduce revision rates, specifically in total joint arthroplasty.
“In general, registries have the capability to collect data in volume – data that are not only from tertiary centers, but from standard clinical practice, and generate data with sufficient volume that it could inform and drive quality improvements across a broad range of the things that we do in orthopedics,” Steven D. Glassman, MD, professor of orthopedic surgery at the University of Louisville, medical director at Norton Leatherman Spine and co-chair of the American Spine Registry, told Healio | Orthopedics Today.
Source: Casey Tingle
According to Bryan D. Springer, MD, of the OrthoCarolina Hip and Knee Center and professor of orthopedics at the Atrium Musculoskeletal Institute, orthopedic registries are multifaceted and can be used to gather different types of information. Springer said he believes registries should — first and foremost — “serve as an early warning signal/patient safety monitor from an implant perspective.”
“If we are truly entering hip and knee implants into a registry, then the foremost function of that registry should be to identify those implants that are safe and those implants that we might consider to be outliers,” Springer said. “That is particularly true for new implants that come onto the market where, if they are done in smaller numbers or certain pockets around the country, there may not be enough of a signal to detect if there are concerns with early failures of implants or implant performance.”
Registry analysis
To identify implants that may lead to failure, Timothy J. Wilton, MA, FRCS, medical director of the National Joint Registry in the United Kingdom, said there needs to be “regular, careful analysis of all of the patients on the registry,” which can be enhanced by linking the database to an analysis group that reviews data. Surgeons can also obtain more patient information if routinely collected data are linked across registries by a unique identifying number, according to Wilton.
“You need to have a unique identifying number and then you can identify that patient in other databases, such as the mortality, birth and deaths statistics, that are collected in most modern western countries,” he told Healio | Orthopedics Today. “We now use that so you cannot analyze how well an implant is doing or how well a hospital is doing without doing some form of survival analysis. And the survival analysis depends on whether the patient is still alive and, if they are not, when they died in relation to the operation.”
If an implant is later identified to not work properly, Wilton said registries also could be used to find the patient who received it.
“About 30 years ago, there was a serious problem with one of the hip replacement implants that was sold as a cheap version of a well-established joint replacement,” Wilton said. “Some of the types of that hip failed rapidly and in much higher numbers than expected, and then they found that they could not find all of the patients easily. And, even after several years of looking, they think probably 10% to 20% of the patients who had it put in were never tracked down.”
Even if a patient has not had a reoperation, Wilton said registries should be continuously updated with information provided by patient-reported outcome questionnaires to identify whether a patient did not have a good outcome but did not receive another surgery due to age, frailty or an underlying condition.
“[Routinely collecting patient-reported outcome questionnaires] is a good way of doing it, but it is much more difficult to get complete coverage,” Wilton said. “It is much more difficult to get everybody who has an operation to fill in a questionnaire, especially if you want them to do it several times over the years.”
National, individual scale
Registry data also can be used on national and individual scales, according to sources who spoke with Healio | Orthopedics Today. On a national scale, David G. Lewallen, MD, professor of orthopedics at Mayo Clinic, said registries are “the best way to get the most accurate information about what is happening across the whole population.” This includes physicians who may only perform a small amount of total joint replacements and patients who may be excluded from academic studies due to comorbidities or other factors.
“[Registries are] the best way to try to get the whole wrap up of the entire experience and see how things are doing across the whole population,” Lewallen told Healio | Orthopedics Today. “It also allows you, at the national level, to gather the largest amount of information possible in the shortest time. If you are capturing everything in your country, then that is obviously going to generate the answers a lot quicker than even the most well-done study at the biggest academic center where they have a fraction of the number of patients being done over time.”
On an individual scale, registry data allow surgeons to compare their outcomes to other clinics and identify which procedures are best for them to perform, according to Glassman.
“The ability to do quality improvement on an individual basis would be an amazing long-term benefit of an orthopedic registry that gives you benchmarks but allows you to look at your own data as compared to those benchmarks rather than reading a journal article that tells you in someone else’s hands what seems to work best,” Glassman said.
Economic impact
Although most registries do not collect financial information, Springer said registries may still have an economic impact on health care by allowing surgeons to identify procedures that have higher-than-expected failure rates and those that do not provide value and benefit to patients. For example, published research on registry data have shown use of a press-fit or cementless stem for femoral stem fixation in femoral neck fractures may lead to a significantly higher rate of periprosthetic fractures and early complications compared with a cemented stem, according to Springer. However, he said U.S. registry data suggest more than 60% to 80% of press-fit stems are used in femoral neck fractures.
“If you could somehow shift those patients from having cementless to cemented stems, reduce the risk of periprosthetic fractures [and] admissions to the hospitals, then you are going to create value and you are going to be creating a significant financial benefit to the health care system,” Springer said.
However, Ola Rolfson, MD, PhD, professor and director of the Swedish Arthroplasty Register, said it can be difficult to establish causality between the use of registry data and financial changes in health care.
“We have been using some publications from 15 years back when we were looking at the revision rate of hip and knee replacement in different countries. And if they have registries established, you can see that the longer the country have had a registry, the lower the burden of revision for hip and knee replacement was,” Rolfson told Healio | Orthopedics Today. “Then it could be calculated like: What is the difference in cost if we are taking care of all of these complications? [An economic impact] has been demonstrated in some publications, but, again, causality is difficult to prove there.”
Similarly, while surgeons may be able to identify associations from registry data, the data are not granular enough to determine causation between procedure and outcomes, Springer said.
“In a sense, we always say [registry data are] like a 30-thousand-foot view,” he said. “Oftentimes, it may not necessarily be the most granular data for certain types of questions that you may be trying to answer, simply because it paints this large swath, if you will, across the country of data that is captured.”
Challenges with registries
When starting a registry, Rolfson said one of the biggest challenges involves obtaining the funds to develop and maintain the database.
“To keep the register, to develop it and keep it running, it takes a lot of resources. And we have to make sure that we have that sorted out,” Rolfson said.
Lewallen said an initial challenge to starting a registry was “getting consensus across the community that provides this care to work together.”
“I am still convinced that the way to best improve care for patients is to have every group, every stakeholder, if you will, that is involved in delivering arthroplasty care at the table helping with the effort to collect the data, believing in the validity of the data and receiving their own data so they can then look at it, process the information and use it to improve their own performance,” Lewallen said.
According to Lewallen, this includes surgeons who choose the patients, implants and techniques for care; hospitals that have a role in improving care; manufacturers who depend on avoiding unexpected, serious complications of an implant or technology; and patients who have the most at stake.
“[Patients] deserve to have the best possible information about what works and, not only that, but what works for a patient like them — not just on average, but for somebody who fits their profile, maybe has their age, their sex, their medical comorbidities,” Lewallen said. “How do the results change in that circumstance?”
Mandatory participation
According to Wilton, to obtain a complete registry, it may be necessary to make registry participation mandatory.
“If you want [the registry] to be complete, if you want to have good data, then it should be mandated,” Wilton said. “We found we could get up to 90%, even in an environment where the surgeons were a bit nervous about what was going to be done with the data. They did want it, so they did cooperate to a remarkable extent, but it seemed to stabilize at 90%.”
However, Wilton said even if physician participation in registry data collection becomes mandatory, it does not mean physicians will participate.
“Making [registry participation] mandatory does improve things, in most circumstances, but not in all circumstances, and different countries have done it different ways,” Wilton said.
Rolfson said it is better when registry collection is not mandated, but when physicians want to participate because they know data produced are valuable.
Seamless data collection
Instead of mandating data collection, Springer said physicians need to figure out how to seamlessly collect and submit data to registries.
“The old days of having a person sit down in the basement of a hospital, fill-out bubble sheets and scan them in and having all that data get submitted or thinking that a surgeon in a busy practice is going to do it is going to be challenging and pose a lot of problems,” Springer told Healio | Orthopedics Today.
According to Lewallen, using electronic medical records and technology, such as natural language processing and other artificial intelligence (AI)-driven processes for harvesting information, should make data collection easier and routine for institutions.
“To let the box do the work instead of a person and by automating that process of data extraction and reporting will help expand participation and vastly improve the quality of the information that we collect,” Lewallen said. “That will allow us to make smarter decisions and provide better feedback to patients, surgeons and manufacturers to drive the process of improvement and also speed the introduction of newer technologies as they come along in a safe way.”
Personalized medicine
While much of the focus on registry data has been on the “performance of implants in terms of revision or risk of reoperation” and how the implants are performing long-term, physicians have also learned about patient risk factors and how registry data can be used to personalize medicine, according to Rolfson.
“We have learned a lot about patient-reported outcomes, how different groups improve and if there are differences between different techniques or implant systems in how [patients] improve after procedures,” Rolfson said.
Rolfson said he believes registry data will continue to be used to improve shared decision-making with the patient. While machine learning or AI systems can make updated predictions that can be used for individualized decision-making tools, Rolfson said imaging modalities also could be incorporated into registries in the future.
“There are some great examples of using the registries as the platform for conducting pragmatic, randomized clinical trials and that is another way of using the registries to ultimately improve patient care,” Rolfson said.
However, Lewallen said a system needs to be established that allows researchers to access patient information to improve care while providing good-faith protection or cooperation of institutions and protecting patient confidentiality.
“We are all in favor of protecting confidentiality of medical information, especially our own, but there are unintended consequences of some of the regulations and it prevents, in many cases, well-intended, good-faith institutions, for example, sharing information on a specific patient that would benefit the patient because of those protections,” Lewallen said.
It is also important to collect more granular data to input into the registry, which Glassman said can be hard to collect, hard to process and takes a tremendous amount of resources.
“You are never going to go from a general registry to a data-intensive registry in a single step,” Glassman said. “It is an incremental process making your registries more and more granular, which allows you to answer more and more complicated questions.”
- References:
- As AAOS sees record growth in fracture & trauma registry data submissions, technology partnership offering with PatientIQ expands to include nationwide registry participation options. https://www.aaos.org/aaos-home/newsroom/press-releases/fracture—trauma-registry-expands-participation-options/. Published Oct. 19, 2023. Accessed Oct. 20, 2023.
- Hailer NP. Acta Orthop. 2015;doi:10.3109/17453674.2014.1002183.
- Malchau H, et al. Acta Orthop. 2015;doi:10.3109/17453674.2014.1002184.
- Malchau H, et al. J Orthop Res. 2018;doi:10.1002/jor.24014.
- Mao J, et al. J Arthroplasty. 2019;doi:10.1016/j.arth.2019.01.063.
- von Knoch F, et al. Virtual Mentor. 2010;doi:10.1001/virtualmentor.2010.12.2.oped1-1002.
- Wilson I, et al. EFFORT Open Rev. 2019;doi:10.1302/2058-5241.4.180080.
- For more information:
- Steven D. Glassman, MD, of the University of Louisville School of Medicine, can be reached at sdg12345@aol.com.
- David G. Lewallen, MD, of the Mayo Clinic, can be reached at lewallen.david@mayo.edu.
- Ola Rolfson, MD, PhD, of the Swedish Arthroplasty Register, can be reached at ola.rolfson@vgregion.se.
- Bryan D. Springer, MD, of the OrthoCarolina Hip and Knee Center, can be reached at bryan.springer@orthocarolina.com.
- Timothy J. Wilton, MA, FRCS, of the National Joint Registry in the United Kingdom, can be reached at timothywilton@btinternet.com.
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