Registries: They Work in Europe and Australia; Will They Here?

As you’ve probably heard, the American Academy of Orthopaedic Surgeons (AAOS) and the North American Spine Society (NASS) have both embarked on ambitious projects to create massive registries of diagnoses, treatments, and patient outcomes.

Also, the American Orthopedic Association (AOA) has a relatively small registry called Own the Bone, founded in 2009, which tracks fracture data in patients aged 50+.

Registries like these have been around a long time in Europe. Sweden, the leader, set up a The Swedish Knee Arthroplasty Registry in 1975 and the Swedish Hip Arthroplasty Registry in 1979 for joint replacement diagnoses, procedures and outcomes, and says the registry and its use have made it the world leader in successful hip arthroplasties with the world’s lowest levels of deaths and complications.^{(1) (2).}

Sweden’s joint registry has been so successful that the country has created 95+ other registries for various diagnoses (one paper said the number was more than 100). Other countries followed. Australia has a hip, knee, and shoulder replacement registry, too, but it was the Australian Orthopaedic Association, not the government, which established it in 1999.

So why has it taken so long here in the U.S.? Why, even now, aren’t insurers, Medicare Medicaid, and/or malpractice insurers (who stand the most to gain financially) stepping up to build registries here?

And why is the burden falling to physicians’ professional organizations to do the building, and hospitals, surgery centers, and group practices to pay for them?

The answer to that last question seems to be simply that no one else with skin in the game ever stepped up here, with an exception or two, such as Michigan Blue Cross-Blue Shield. So, professional academies and associations are taking on the hefty job of building national registries—and the next step: making them work.

Here’s an example of the raw data one can extract from a registry and analyze.

In Michigan, one stem/cup combination for hip arthroplasty was statistically 7.5 times as likely to require revision surgery within three years as another device.

However, a report on these Michigan results cautions, you cannot compare one device to another without looking at all other factors. Also, the higher risk was only 4.29%. (See: “Michigan Arthroplasty Collaborative Quality Initiative Report: 2012 – 2016,” page 27)

AAOS is modeling its array of registries on the American Joint Replacement Registry, which was first conceived under AAOS, then organized as a separate entity in 2009, and is now back under the AAOS umbrella.

AAOS is also borrowing ideas from the Michigan Blues’ registry. While the AJRR has the most records of any of these registries (1.3 million+ procedures), the Michigan registry seems to be farthest along of any U.S. orthopedic registry in using the data.

The goal of these registries is to provide verifiable, clear bodies of data on which interventions and devices have the best and worst outcomes, allowing physicians to compare their results to their colleague’s averages, and because of that feedback, make better care decisions.

Indeed, according to AJRR, the use of “Joint registries demonstrate up to a 50% reduction in revision rates after registry initiation and identification of best practices.” Furthermore, “If U.S. revision rates were cut by just 2%, Medicare could save more than $65 million.”

NASS Launches Their Registry

The newly launched NASS registry covers spinal diagnoses and procedures. AAOS has also started a spine registry, and the two organizations say they are discussing potential cooperation between the two.

We sent AAOS and NASS a list of questions about their registries. Below are some questions and summarized answers.

The NASS answers came by email from Zoher Ghogawala, M.D. FACS, Chairman of the Department of Neurosurgery at Tufts University and also the NASS Research Council Director and one of the architects of the NASS Spine Registry.

For AAOS and the AJRR, respondents in a live interview were Kevin Bozic, M.D., with the Dell Medical School at the University of Texas, Austin, Chair of the American Joint Replacement Registry’s steering committee; Paul Haisman, AAOS’ Chief Information Officer; and Lori Boukas, Director of Marketing and Communications for AJRR.

Who is running your registry?

NASS: The society and its vendor, Ortech Data Systems run the NASS system. Ortech develops registries for others as well.

AAOS/AJRR: The AJRR registry was developed in house by AJRR.

AOA (website): The registry, totally web-based, uses a framework called Tempo, owned by a contracted research organization, Clinipace Inc.

How does the data get into the registry?

NASS: Clinicians enter data manually at the time of patient encounter; patients enter data from Patient-Reported Outcome (PRO) surveys; both use “a secure and easy-to-use web portal.”

AJRR (Haisman): “Currently, registry participants extract files directly from their respective EHR and Patient Reported Outcome (PRO) systems into AJRR-supplied file formats. The files are then uploaded by the institutions directly to the AJRR SFTP (secure FTP) or HTTPS location.

AOA (website): Data is entered using web-based forms as well.

What kinds of data are being collected?

NASS Collects: “Confidential―Data is de-identified at point of entry. No personal health information reaches NASS or its vendor. NASS sees only the de-identified, aggregate data pool,” says a page at the NASS registry site. The website doesn’t say which data elements are collected.

AJRR Collects: (1) individually-identifiable patient data, diagnoses, and provider identifier; (2) the individual patient’s risk factors, comorbidities, and complications; and (3) patient-reported outcomes. For full details, see: http://www.ajrr.net/enroll-with-us/all-about-the-data/data-elements-we-collect-2.

AJRR says it is HIPAA-compliant and HITECH-compliant and uses industry-best security to protect patient privacy.

AOA’s Own the Bone Collects: The de-identified data described on these web pages: https://www.ownthebone.org/OTB/Enroll/Own_the_Bone_Registry/OTB/Enroll/Own_the_Bone_Registry.aspx and https://www.aoassn.org/aoaimis/OTB/About/What_Is_Own_the_Bone.aspx.

How often is it updated?

NASS and AOA: Each registry is continuously updated as new data is entered.

AJRR (Haisman, paraphrased): Some submit monthly, some quarterly. AJRR processes incoming files daily, validating and cleansing. Records which pass a quality verification are imported into the registry database. Users at participating institutions receive data quality reports and are given the opportunity to correct errors and resubmit. Typically, uploaded files are available in the registry within 24 hours of being uploaded to AJRR or sooner.

A potential delay is the time a hospital needs to extract a complete case record with all coding. In some instances, procedure codes may come from the billing system, the implant data may come from another system, and both must be linked with the patient record from the EMR to create a complete case record.

How many hospitals are participating at this point?

NASS: The registry just launched at the end of June 2018. Contracts with multiple sites will be completed over the next few months.

AJRR (Dr. Bozic, mostly paraphrased): More than 1,200 hospitals have signed agreements to send data to AJRR. About 800-900 have submitted data at one time or another. AJRR is adding vital data fields, which increase the burden on the hospital. So the number of hospitals submitting regularly is currently about 450-500. “But we certainly hope to get that number back up over a thousand, based on the business associate agreements that we have in place.”

Laurie Boukas, AJRR: So far, participating hospitals have entered over 1.3 million records, making it the biggest joint registry in the world. (There’s a counter of the current total on the AJRR home page.)

AOA (website): About 130 participating sites in 44, states, with 11,000+ post-fracture records.

Are group practices and individual physicians participating?

NASS: The registry is applicable to any size or type of practice, including group practices and individual physicians.

AJRR: Hospitals and ambulatory surgery centers only.

AOA: Anyone can join.

Do you have any “success stories,” such as from similar registries in Europe?

NASS: Just launched, so no success stories yet, but added: “While European countries have substantial experience with spinal registries, most are focused on procedure, as opposed to diagnosis…Follow-up has been a major concern in those registries, so we hope this easy-to-use format will help capture relevant data.”

AJRR (staff, paraphrased): Simply submitting data to a registry doesn’t, by itself, lead to better outcomes or quality improvement. Scandinavian registries pair their data collection with patient feedback mechanisms. For the past few years, the AJRR has been focused more on data collection and recruitment—to get to the scale to be meaningfully representative. Proof of benefits will become significantly more tangible and robust when we incorporate feedback reporting and quality improvement initiatives.

Who pays, and how much?

NASS: The care-giving corporate entity pays $3,250 per year for the first participant per practice. Each additional participant (regardless of specialty) is $300/year.

AJRR (Haisman): $3,500/year for a site license, plus a variable few hundred dollars per additional site from which data is uploaded. “We try to be flexible on that.”

AOA (website): a subscription to Own the Bone is $2,000 per year plus a setup fee.

AJRR Experience Hints of Early-Stage Challenges in Winning Participants

Why did the number of AJRR participants drop sharply from an additional 850-900 to 450-500? At least in part, that happened when AJRR revised its data collection template to include more fields of information. Other hospitals and ASCs [ambulatory surgery centers] may be holding back because, with the big benefits years away, they don’t want to be early contributors.

“AJRR is consistently looking at better ways of reducing the burden of extracting data and is exploring several different methods to allow more flexibility and options for those institutions that are capable of leveraging more sophisticated technical integrations. For example, FHIR* and similar secure web services’ API integrations are being considered by AJRR,” Haisman said.

* FHIR, Fast Healthcare Interoperability Resources is a standard describing data formats and elements and an application programming interface for exchanging electronic health records, created by the Health Level Seven International health-care standards organization.

Another Key Challenge: Maximizing Patient Participation

The 2016 annual report from the California Joint Replacement Registry (CJRR) (which has since been merged into the AJRR), shows that among participating hospitals, only 16.6% of the 21,167 who had surgeries, or 3,513, completed both the pre-operative and the post-operative surveys. (See: http://ajrr.net/images/annual_reports/CJRR_16_Annual_Report_PRO_Public_Reporting.pdf)

This 16.6% figure was despite the fact that there were multiple ways for patients to enter data. They could take PRO surveys online using a secure CJRR web-based interface (on a phone, computer, or tablet), or a paper form could be securely faxed.

For those who did complete all surveys, across all participating hospitals, 80.1% (lowest) to 91.7% reported significant improvement in their Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) scores as a result of their surgeries. Using two other scoring systems (Veterans Administration VR-12, which includes both physical and a mental components) and a UCLA activity score, improvements were also dramatic.

What It Takes to Derive Full Benefit From a Registry: Sweden’s Experience ^{(1), (2)}

Will enough U.S. hospitals, surgery centers, and physician practices pay the annual subscription costs, then go to the trouble of entering all that data, and then wait—years, if they are early users of a new registry—until there’s enough data in the registry to draw conclusions about best practices, best devices, et cetera? AAOS, NASS, AOA, and others are betting that they will.

Deriving benefit from registries takes far more than just sending in data. Next comes analysis of the data, then subsequent decisions on best practices based on the data analysis, and then multi-year analyses of the new results.

In Sweden, “The key to success has been yearly feedback to all units (all healthcare provider sites) and yearly conferences,” says the Swedish presentation cited below.⁽¹⁾

Even the most advanced U.S. registries here are just getting started on this path.

Alas, with significant differences between the Swedish and U.S. populations, the Swedish experience can’t simply be cloned here.

In addition to having a national healthcare system, which pays for the registries and can mandate participation, Sweden has a population of 9.5 million, which is much less ethnically diverse than the U.S. population. So, a smaller set of data is probably sufficient there.

Also, obesity stresses joints. Sweden is the sixth least obese country in the world, according to a 2017 OECD report,with a 12.3% obesity rate among adults.

Footnotes cited above:

1. Sweden’s hip arthroplasty registry has defined international best practice,” says the headline on page 32 of a presentation titled, “Swedish National Quality Registries and Their Contribution to the Best Possible Care for Patients” at the BMJ’s April 2016 International Forum on Quality and Safety in Healthcare, in Gothenberg, Sweden.
2. “It is credited to the pioneering work of the [Swedish Hip Arthroplasty Registry] that the revision rate following hip replacement surgery in Sweden is amongst the lowest in the world. This has been accomplished by the diligent follow-up of patients with feedback of outcomes to the providers of the healthcare along with post market surveillance of individual implant performance.” – BMC Musculoskelet Disord. 2016; 17: 414. Published online 2016 Oct 4. doi: 10.1186/s12891-016-1262-x.

A Benefit Already in Place: The Very Cool AAOS Hip-Knee Risk Calculator

The AAOS website has an AJRR page which calculates risks of two complications of knee or hip surgery: death within 90 days and infection in the joint within two years.

The calculator takes into account the procedure, a list of comorbidities the patient might have, and the patient’s gender, age, and race.

The page warns against a patient self-taking the risk calculator.

So, naturally, I did. Assuming that I’m correct about my comorbidities (I confessed to none), my risk of death and infection were close to zero, should I need a hip joint replacement.

Cut six inches from my height and add 120 pounds (effectively making me quite obese), and randomly add the comorbidity factors of alcohol abuse, cardiac arrhythmia, congestive heart failure, chronic liver disease, depression, diabetes, drug abuse, hypertension, ischemic heart disease, peripheral vascular disease, psychosis, and renal disease, and my risk of death within 90 days would rise to 7.5%, and risk of infection within two years to 9%.

Given that 7.5% risk of death right away, plus the additional risk of death in the subsequent year or two, and add to that the risk of infection, and you’d probably persuade that obese, sick version of me to stay in that wheelchair and forego the surgery.

A calculator caveat: “The estimated risk is not adjusted for the doctor, device or hospital.” (All are additional factors which would be in the registry for the participating caregiver). Feedback on those additional factors could lead to a small and useful set of choices as to what the individual physician or hospital might improve.

Try it yourself: http://riskcalc.aaos.org/index.html.