PROCESS OF
DEVELOPING THE STATEWIDE REGISTRY FOR JOINT IMPLANTATION OUTCOMES.
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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:
DR. HILL:
And since that $50,000, who funds you?
DR. JIRANEK:
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:
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:
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:
DR. JIRANEK:
DR. HILL:
Do you require their participation or their involvement?
DR. JIRANEK:
DR. HILL:
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:
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:
DR. HILL:
DR. JIRANEK:
DR. HILL:
Did you ever get discouraged?
DR. JIRANEK:
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:
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.
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in public health. This month ReachMD XM 157 will be discussing the many issues
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