Building a Statewide Registry to Monitor Joint Implantations

PROCESS OF DEVELOPING THE STATEWIDE REGISTRY FOR JOINT IMPLANTATION OUTCOMES.

Our presidential election is only days away, 48 million people in America are uninsured and healthcare costs are rising two to three times faster than our nation’s GDP. Where will America’s healthcare system be in five years?

Welcome to ReachMD’s monthly series focussed on public health policy. This month, we explore the many questions facing healthcare today.

Many countries around the world maintain a National Joint Registry, collecting evidence of successful trends in joint implantation and providing opportunities to find areas for improvement. In the absence of a national system, as in the case in the Unites States, state level programs may help us gather data. What are the keys to building a statewide joint registry?

You are listening to ReachMD XM 157, The Channel for Medical Professionals. Welcome to a special segment focused on Healthcare Policy.

I am your host, Dr. Mark Nolan Hill, Professor of Surgery and practicing general surgeon. Our guest is Dr. William Jiranek, Associate Professor of Orthopedics and Chief of the Adult Reconstruction Section of Orthopedic Surgery at the Virginia Commonwealth University School of Medicine. Dr. Jiranek currently leads a campaign across the State of Virginia to create a statewide joint registry.

DR. HILL:

Welcome, Dr. Jiranek.

DR. JIRANEK:

Thanks Mark.

DR. HILL:

What motivated you in the first place to start this program?

DR. JIRANEK:

I had seen a delay in removal of a problem implant that had a manufacturing defect that led to it not becoming fixed to bone in hip replacement. I had seen it continued to be implanted long after there were lots of anecdotal reports of problems. This was about 8 years ago.

DR. HILL:

And what did you do because of it?

DR. JIRANEK:

Well, I thankfully was not implanting that specific product, but I began to do some research on how many had been implanted and what the company's response had been, what the delay had been, and then I began talking to several orthopedic surgeons in the state saying, you know, I think other countries have joint registries, our national registry appears to be bogged down in some political and legal problems, perhaps we should try a more grassroots approach and start a registry in the state. They agreed with me, that was about 6 years ago and we have been working on it since.

DR. HILL:

What made you take it upon yourself to do this as opposed to saying, well why doesn’t someone else to do this?

DR. JIRANEK:

I think that there was a clear need, this was something that I thought if I could establish it and establish it in the right way, it potentially could take off by itself and would not be as much work as now I know it is and I thought that it was probably something that was good for our profession and for our patients.

DR. HILL:

Have others worked to develop joint registry before?

DR. JIRANEK:

Others have. Yeah, in other states, there is a joint registry in the Kaiser Permanente System in California. There is a local registry in Minnesota. There are lots of smaller registries. We have had a lot of people in the State of Virginia who has been working from all over the state helping us to develop the database and enter data and figure out how we are going to report the data.

DR. HILL:

Well, who monitors the data in Virginia? How do you keep it and how is it safeguarded?

DR. JIRANEK:

It's monitored by a board of a 501(c)(3) Public Charity, the Virginia Joint Registry that is organized to provide this data and we're still in the beta part of developing the database and testing it. We're entering data. We're not yet to the point where we can make a yearly report about joint replacement. I think we have to be at least 75% compliance across the state before we can do that.

DR. HILL:

And how do you comply with the HIPAA regulations, the legal aspects, and the privacy concerns?

DR. JIRANEK:

Well, because this is a web-based database behind a standard firewall with logins and passwords, which is the way most of our electronic medical records are, so certainly it is compatible with HIPAA regulations.

DR. HILL:

Where did you find the funding for this process?

DR. JIRANEK:

You know, it's interesting. I had a grateful patient who I said, you know, we've been talking about doing this. I think it's something that needs to happen for the patients in the state and he agreed with me and gave us our initial donation of $50,000 which allowed us to do a lot of the legal work and set up the database.

DR. HILL:

Now, was this the patient who had a problem?

DR. JIRANEK:

No, this was a patient who had had multiple joint replacements and was quite thankful.

DR. HILL:

And since that $50,000, who funds you?

DR. JIRANEK:

We beg wherever we can, and I think we the surgeons occasionally have to depend to our coffers to fund, but we're funded by hospital chains in the State of Virginia. We have not yet received a grant, an industry grant, although we will try to get some of those if we can do it in a way that appears that we're not biasing the results.

DR. HILL:

Doctor, nationally physicians baulk at extra paperwork and legal claims from a registry, is there the same objection at the state level?

DR. JIRANEK:

There is. I think there is an objection anytime you ask us physicians to do more work as we are all overwhelmed and idea is that if we can take the physician out of the data collection somewhat, we have a chance and so our registry is set up to capture just trips to the operating room. So the initial surgery and plus any problems that would require return to the operating room and much of the data can be entered in by the circulating nurse in the operating room while the physician is operating and that's our model. The physician interacts with them in giving them the data to input, but it's not something that they have to finish a surgery, when they are tired and then go sit down and try and entering data.

DR. HILL:

How you are getting physicians and institutions to sign on to this?

DR. JIRANEK:

What we've found is that we are better off getting hospital chains to agree to enter in the data for all the joint replacements performed in their hospitals and that's the way we have approached it. The initial way we got a certain group of physicians, who were willing to enter in a data during our beta test, which we're still in, and those physicians have worked, you know, tirelessly and without pay to enter this data, but we realized that's not a long-term solution.

DR. HILL:

Well, overall would the participation be mandatory or voluntary?

DR. JIRANEK:

Well, we think that it ultimately needs to be mandatory. The registries across the world, some of them are mandatory, but most are voluntary, but they've created such a rationale for the registry that the physicians entering in are largely glad to do it, plus they have made it so that the data set is small enough that it's not an own risk of things for the physicians to enter in.

DR. HILL:

In my reading, in the State of Virginia there are a ballpark 200 orthopedic surgeons doing joint replacements, how many do you need for an accurate registry? Do you need all of them or can you just have some of them?

DR. JIRANEK:

Most of the people that talk about registries talk about a compliance number of above 90%. So, you know, I think, we need to get to 180 of those surgeons and I would prefer to think of it as the amount of hospitals that are performing joint replacement, we need to get to at least 90% of the hospitals performing joint replacement. Ultimately, I think our goal is if it is successful that we could ask the state to mandate that this data be provided to the registry.

DR. HILL:

What are the feelings of the prosthetic manufacturers about this whole process?

DR. JIRANEK:

I wouldn't say that they've been standing in line waiting to give us money, I wouldn't say that they certainly haven't come out against it, but they haven't been interested in developing their own internal registries.

DR. HILL:

Do you require their participation or their involvement?

DR. JIRANEK:

We don’t. We think it should be separated. We certainly don't want a registry that looks as if it may be influenced by one manufacturer or another.

DR. HILL:

Well, do you need their input?

DR. JIRANEK:

I don’t know that you need their input. You need their help with being able to correlate a lot numbers with specific prostheses and it would be very helpful if they would donate their bar codes, which could help us automate the process and make it more accurate and I think that in our discussions with them, they are willing to do this and I hope will do this.

DR. HILL:

I was just going to ask you what thus far has been your experience with your relationship with the manufacturers in terms of developing this registry?

DR. JIRANEK:

Well, I know that there has been a national group looking at trying to develop a national registry and they have had discussions with all of the big prosthetic producers, but we have not had any specific discussions in Virginia.

DR. HILL:

Now, we've learned that you've hired lobbyists to petition the lawmakers. What did this campaign teach you about the legal process at least in Virginia?

DR. JIRANEK:

Oh, it's interesting. It taught me that we as physicians shouldn't give up and that we do have power, every person has power if you're willing to work within the system.

DR. HILL:

What makes you say that sir?

DR. JIRANEK:

We wanted an amendment to the Patient Safety Act of Virginia that would allow us to collect this data without fear of a legal discovery and most peer review groups in hospitals have that already, but registries and other groups are not necessarily covered, and so we went after that and we found that lawmakers were by and large in favor of this. They think it's a good idea and they are willing to help us develop it.

DR. HILL:

Did you ever get discouraged?

DR. JIRANEK:

I get discouraged about every other day, but I guess unlike Albert Einstein, the definition of insanity is continuing to do the same thing.

DR. HILL:

Well, let's talk about looking in your crystal ball. What do you think looking in the future success of your campaign, 5 years, 10 years down the line? What factors are you looking towards that will make a difference?

DR. JIRANEK:

I think in 5 years, my goal is to have 90% compliance in the State of Virginia for hip and knee replacements and I believe that we're going to earn some demographic data about who is getting joint replacements, you know, what percentage of our population is getting joint replacement services, but I think we will also identify problem areas that we need to address and I think it's important that we come up with the right mechanism to address it because our goal is to improve healthcare and not punish healthcare providers or implant companies or anything else.

DR. HILL:

Finally, are you sharing your enthusiasm with other states?

DR. JIRANEK:

We've been in talks with three other states. We did a legal review of the Patient Safety Act statutes in all the 50 states and identified the states that would support a registry immediately and ones that would need some legal change and so we're approaching the states that could move forward immediately and see if we can develop registries in another states.

DR. HILL:

I want to thank our guest, Dr. William Jiranek. We've been discussing the process of developing the statewide registry for joint implantation outcomes.

I am Dr. Mark Nolan Hill and you have been listening to a special segment focused on Healthcare Policy on ReachMD XM 157, The Channel for Medical Professionals.

Be sure to visit our website at www.reachmd.com featuring on-demand pod casts of our entire library. For comments and questions, please call us toll free at 888MD-XM157 and thank you for listening.

You've been listening to Public Health Policy in America, a special ReachMD XM 157 interview series with our nation’s top thought leaders in public health. This month ReachMD XM 157 will be discussing the many issues challenging public health policy in America. For a complete schedule of guests and programming information, visit us at www.reachmd.com.