Here Comes the Spine Registry!

**Justin** · 04-13-2010, 08:12 PM

Here Comes the Spine Registry!
Elizabeth Hofheinz, M.P.H., M.Ed • Fri, Mar 26th, 2010
Copyright 2009-2010 RRY Publications

There are those who hear an increasingly louder government drumbeat…and it sounds like “proof, proof, proof.” Dr. Rick Guyer, co-founder of Texas Back Institute, explains, “In 2006, during my tenure as President of the North American Spine Society (NASS), I raised the possibility of creating a spine registry. It was becoming clear to me that we should have a way to objectively evaluate both treatment methods and surgeon performance. There was a lot of naysaying at the time, however. Views are shifting now, and people are beginning to see a day in the not too distant future when government will institute just such a program. I am of the opinion that it’s better to begin our own registry than wait to be told how exactly to implement one.”

Dr. Ray Baker, the current President of NASS, concurs…it’s time to get out in front of Uncle Sam.

"We have reached out to other societies to develop a collaborative registry and have received commitments from the Scoliosis Research Society, the American Association of Neurological Surgeons, the Congress of Neurological Surgeons, the International Spine Intervention Society, and The International Society for the Advancement of Spine Surgery. All are willing to participate in the development of a registry project."

“Many registries are set up for a specific reason, i.e., to look at one topic. In the end that is not a particularly useful tool. We are planning to include a variety of topics and will do it in such a way that the database is absolutely configurable. It is pointless to ask one subset of questions but then a year from now when a different issue arises you are unable to address it. I don’t want us to restrict ourselves by having to present all of the questions at the outset…the field is dynamic and the registry should be as well.”

While the surgeons and others at NASS who are working on a Spine Registry want to preempt any government “mandatoryness” coming their way, they don’t want to get ahead of themselves. Dr. Guyer says, “The pilot test will include one—probably simple—topic, which remains to be decided. We want to be able to follow patient progress from start to finish, including complication rates, etc. While there were some academicians who said that there were too many obstacles, we believe that it’s possible to do this on a simple level where methods are validated. We think it’s possible to move forward without taking a purist approach, i.e., you begin collecting data in a reliable fashion. Any form of detractor will eventually end up realizing that we are increasingly in a position where we must prove that what we do as surgeons is effective.”

In the meantime, Dr. Baker wanted to learn the lessons of those who have already waded in the registry waters. He explains, “I flew to Brussels to meet with representatives from the European research entity Spine Tango, but they themselves are struggling with the participation issue. Sweden has no such problem because participation is compulsory. Our plan for the pilot study is to select centers that are dedicated to research and ask those sites to commit to inputting all of their cases. This should allow us to work out the kinks in the system, and gain more information to move forward. Spine Tango spent 18 million Swiss francs to develop the database…to avoid initial large expenditures we want to get our toes wet one drop at a time.”

As for what not to do, Dr. Guyer says, “Trying to mandate registry participation is useless…we know we won’t get anywhere. Also, it is important to collect all of the appropriate data. You don’t want to go through the data and find that you have a lot of useless information—or that you have a glitch. For example, someone may forget to program in a particular field and then XYZ data can’t be retrieved.”

But back to the issue of participation. How indeed can doctors be motivated to input data? “It has to be a positive experience,” states Dr. Guyer. “Registry data would be helpful for educating patients or for improving the physician’s skillset. I envision a process where the doctor finishes surgery and immediately enters the information. Then when the patient returns there is a portal where you and the patient enter outcome measures.”

While some surgeons may think they wear a cape, Dr. X across town may be the real spine superhero. As Dr. Guyer notes, “There are numerous ads these days for treatments that are unproven. I look around Dallas, for example, and see laser treatment being offered as a cure all for all low back problems. With a registry, patients can utilize it like Consumer Reports and can look up Dr. X and see how he compares to his peers. At present, and well, forever, the selection of a physician has been based on personal recommendations and doctor/patient relationships. A registry would provide a more objective evaluation of their doctor, which will in turn improve patient care. Unless physicians have ways of evaluating themselves you may end up in a situation where you think you’re doing a great job, but in fact you need improvement.”

No resting on our laurels, says Dr. Guyer. And no ignoring the failures.

"We need to examine and learn from unsuccessful surgeries and move toward consensus on various clinical issues. Spine could take a lesson in thoroughness from the airline industry—there is a crash and they make improvements based on what they learn during the course of the investigation. We do procedures, attend meetings, and do presentations but we don’t course correct. This points to a uniformity of care issue. How can patients maintain confidence in the medical system if there are such varying approaches to treatment? Only recently I had a new patient who said, ‘I have been to three doctors, each of whom has suggested a different treatment. One recommended a three level surgery; another wanted to do a one level; the last one didn’t think surgery was indicated at all. How am I supposed to know that the one you’re recommending is correct?’"

With his eyes set on advocating for patients, physicians, and the field, Dr. Baker is taking his next steps on the registry. “There will soon be a meeting involving the Agency for Healthcare Research and Quality, NIH, the National Committee for Quality Assurance, the National Quality Forum, insurers including Blue Cross Blue Shield, Center for Medicare and Medicaid Services, AARP, employers, and researchers in which we will try to select common outcome tools that could be accepted across agencies and payers. (The meeting was not convened because of the NASS database but happened to be a convenient time.) The collaborating societies have also hired a value consultant, Boston Health Economics, and are going to examine what tools we need in order to incorporate value into the database. (Value is loosely defined as cost divided by quality.) But then there are the outcome measures that are important to patients. For example, let’s say you have a patient with cardiac issues and diabetes, and thus would not score well on the standard outcome measures. But, postoperatively he can now perform activities that are important to for his happiness and wellbeing.”

“Oh, they want cases?” says Dr. X. “I’ll input the five outrageously successful discectomies I did in the last few weeks.” As for the post surgical patients in the waiting room, Dr. X doesn’t think of those much. Dr. Baker states, “We designed the pilot as a feasibility study because if you don’t get 100% participation then the data in the registry becomes useless. For example, you’re a spine surgeon in private practice who only inputs one quarter of your cases. Which quarter? Perhaps you will opt to only include your most successful cases.”

In the event that all goes well for the pilot study, there is the omnipresent question “who will pay?” When the bill comes, will some conveniently need to visit the restroom? Dr. Baker: “There are three ways to fund this registry. The first possibility is that the government or third-party insurers will compensate doctors to maintain outcome data. The second option is that it will be funded by a combination of sources, including industry, and the data will be compartmentalized to include independent modules. The data can then be used for FDA applications whereby, say, they use the registry for two years and collect data to support the efficacy of a certain treatment…definitely less expensive than a company having to put together its own registry on multiple occasions. Lastly, and quite possibly, there is a chance that the government will place the cost burden on physicians.”

Whichever party ends up holding the bill, there is little question that patients will benefit from a registry. “Randomized, controlled trials are meant to evaluate whether a procedure/treatment is effective, but effective and efficacious are legally and technically different. These trials select a specific patient population in order to prove that a given treatment works in a specific population, but these patients are not the ones who walk through our doors. Take the situation with BMP2…it was originally authorized by the FDA for LT cages for standalone fusions, but has been used off label 99% of the time. So determining which of those patients is actually benefitting from it is a challenge. Going from an idealized population to an everyday population is where a registry excels because it involves the average doctor’s everyday population.”

In crafting the database, Dr. Baker and the NASS team have taken pains to encourage active participation from other important parties.

"If you have five different societies doing five registries it’s quite likely that they will not communicate. To undertake such an approach is all too expensive with few, if any, benefits. Not only have we at NASS taken every opportunity to include other societies, but we are stepping back from the lead. Foremost in our thoughts is that when groups work together egos and animosity can come into play…we want to avoid that at all costs."

And they also want to ensure that there isn’t even a hint of impropriety. Dr. Baker: “There has been absolutely no industry participation in the development or maintenance of the database. Such stringent firewalls are necessary so that it is clear to everyone that there are no conflicts of interest.”

So going forward, when the surgical gloves come off, well, just get ready to type.