by Dr. Steve Elias, Dr. Jens Eldrup-Jorgensen, Dr. Marlin Schul, and Dr. Jack Cronenwett

VEIN Magazine Medical Director Dr. Steve Elias is joined by a panel of leading venous disease treatment specialists who are presently working with our medical societies to collect, analyze, and disseminate patient outcome data for the purpose of improved patient care. Here, from the inside, is a discussion about how data will transform the vein specialty.

We are joined by Dr. Jens Eldrup-Jorgensen of the Maine Medical Center Division of Vascular and Endovascular Surgery. He is also professor of surgery at Tufts University School of Medicine and serves as the medical director of the Society of Vascular Surgery (SVS) Vascular Quality Initiative.

We too are joined by Dr. Marlin Schul, who is the owner and medical director of Indiana Vascular Associates in Lafayette, Indiana. He is also president-elect of the American College of Phlebology (ACP), as well as a member of the ACP Research Scientific Committee and the ACP Membership Registry Operations Committee. He was also the chair of the ACP PRO Vein Registry Task Force.

Last but not least, we are joined by Dr. Jack Cronenwett, chief medical officer at Medstreaming/M2S, an intelligent registry-based cloud platform that links patients, care providers, hospitals, medical societies, and industry for quality improvement. He is medical director emeritus of Society for Vascular Surgery Vascular Quality Initiative and emeritus professor of surgery of the Dartmouth Institute for Health Care Policy and Clinical Practice at Dartmouth Medical School.

Steve: You all have been collecting and analyzing data by various registries and in other initiatives you are involved with. What are the principles when you start saying, this is what we want to put in?

Jens: The selection of variables is critical. It is important to choose data elements that provide value. You begin with experts in the field, picking the variables and the characteristics that they feel are important. You have to make sure that the variables are working. In the VQI, we’ve just completed an inter-rater reliability exercise, where we look at different variables to make sure that they are being interpreted properly and that we have consistency with the data entry.

We plan to do this on a regular basis, not only to help educate the data collectors who enter the data, but also to help us learn about what variables work and whether our help text or definitions need a little bit of correction.

You also asked about who is putting the data in. That’s quite variable, too. It is often a dedicated data manager or a third-party data abstraction service. It may be nurses, residents, PA, or even a physician. It is always someone with a clinical background, such as a nurse who is familiar with the terminology.

Steve: Does it matter who enters the data?

Marlin: In the ACP PRO Venous Registry, we really don’t need any manually-entered data. Everything that’s collected originates from formatted data that is put into the patient’s EMR file using templates that have been validated by an EMR vendor. In other words, the registry collects the data that is entered by the provider’s team on a routine day in the office.

Our experts detailed all of the important metrics to collect and then developed the templates that are part of the ACP PRO Registry user’s EMR. We avoid entry error and extra work by having the required data extracted from the EMR. StreamlineMD was the early leader in getting automated data flow started with our registry. StreamlineMD users could select templates formatted for the ACP PRO Venous Registry and simply perform their routine documentation. We have two large vein practice groups that have formatted templates with different EMRs (eClinicalworks, NexGen), as well as additional vendors (Aprima & MedStreaming).

Periodically scheduled data dumps submit data in a HIPAA compliant fashion, and it is then uploaded to the registry. Registry formatting will not allow data into columns that fail to fit formatting requirements. This ensures the data remains clean.

Jack: The ideal scenario is when the medical record contains the structured data elements that are required by the registry and that have been governed by the society, so the physicians are confident in them. The data then can be entered during the process of care into the medical record by various medical team members, depending on the workflow at any given vein center. What was entered into the medical record is always the gold standard.

If EMR-derived data can directly populate a registry, then there is no issue about fidelity or concern about data transfer. It’s really the ultimate goal of dual-purposing the data, instead of double data entry.

Jack: In some cases, as Marlin mentioned, specific EMR vendors have incorporated structured data elements. Another method is to use an app, if you will, that lies on top of any EMR system and provides an interface for a specific registry. This is more applicable to a hospital, which has an existing EMR system that doesn’t accommodate the type of situation that Marlin described.

Finally, the simplest way sometimes to get a center started that doesn’t have the ability to hire a data entry person, as Jens said, is to hire a data abstraction service where a remote person who is used to all of the data elements can more efficiently go through the EMR record and enter the data, and then be held responsible for accuracy.

There is always a push and pull between the desire to want more data, and then the pragmatic reality of how much data can a specific site enter in real practice.

Steve: How do we entice people to enter data into a registry? There are many people practicing vein care who are not entering data into any kind of registry at all. What are the impediments that people seem to express?

Jens: The main impediment, Steve, is that they have a very busy life and a lot of other things to do. You have to make it worth their while; you have to make it worth their time to enter the data. They may have to pay a cost or a subscription fee to join it. You have to provide value to them. There is a different value you can provide to these physicians. You can use it as a source of benchmarking.

Many physicians want to know how they are doing compared to their peers. Are they offering high-quality care to their patients? They can use this data—an objective performance of how they are doing compared to others—as benchmarking. This can be the basis for an internal quality assurance effort, or for quality improvement initiatives.

For the academic centers, the registry can be a robust source of data for analysis projects and coming up with ideas for presentations or publications.

Jack: At the highest level, these registries are quality improvement initiatives; they serve multiple purposes. At the outset, such initiatives are usually joined by physicians who are interested in assuring their quality. As Jens said, physicians really like to benchmark with others and try to figure out how to make improvements. That’s why we incorporated the concept of regional groups within VQI where members would get together in a region and talk about variation in care or outcome and then try to develop quality improvement initiatives that could improve everyone’s results.

I think now there is an additional, very important reason for physicians involved with vein treatment to join registries. There has been such a dramatic increase in a number of venous ablation procedures that it’s really captured the attention of a CMS. They have singled this out and had the MEDCAC Meeting, which concluded that there was little sound evidence available to support a lot of venous treatment.

I think that physicians who are treating venous disease need to step up and take some responsibility for generating the data that are needed to support reimbursement for this care. They can do that even if they are a single practitioner in private practice by contributing to a registry. Are there other ways to incent these physicians more? If participation in quality initiatives like this was required for reimbursement, that would provide great incentive but add cost that would have to be considered.

We have seen this happen now in Massachusetts where vein centers must be accredited to receive reimbursement. We’ve seen it in both the carotid and the cardiac space where a surgeon can’t be reimbursed unless they participate in an appropriate registry. I have to think, with the focus that CMS is showing, that this is something that they are considering for venous ablation.

Steve: Marlin, can you comment on this? How are we enticing people or showing people why it is important for them to be in a registry?

Marlin: If you’re not benchmarking yourself, you may believe that you are providing good quality care, yet in reality, you need to compare yourself to the aggregate to truly know how your care may shape up. A registry is a great opportunity to do that, especially if you have a dashboard like the one we use in the ACP Registry that can show you not just how your patients change over the course of time, but your incidence of complications as you march through years in the registry.

Can you make a dent in your performance from the outset and what improvements can you make over the course of time? For example, if you consider the incidence of paresthesias after thermal ablation is 3.1 percent, we all know that those generally go away within three to twelve months—complete resolution of the paresthesias.

Well, what I identified in my own data is that the majority of paresthesias emerged after thermal ablation of anterior accessory great saphenous veins, not great saphenous veins in the ankle or small saphenous veins down to the ankle. The traditional paresthesias were not the ones that I was seeing. These patients didn’t feel any heat during the ablation, but when I identified that pattern, I wanted to change this incidence.

I began to place a heck of a lot more tumescent anesthesia beneath that vessel to help protect the superficial femoral cutaneous nerve and provide sensation to the thigh. Since identifying this problem, the
instance of paresthesias in my practice has gone almost to zero. It can still happen, but it certainly isn’t 3.1 percent. Essentially, motivation should be about benchmarking your practice and quality improvement once you measure to the aggregate.

Steve: What are some examples of how registries can change a physician’s practice?

Jack: Appropriateness is one example of how registries can change practice. The Society for Vascular Surgery Vascular Quality Initiative (VQI) has measured adherence to SVS practice guidelines. For example, SVS/AVF have a guideline to not treat isolated perforating veins in a patient with only C2 disease.

We assume that everyone agrees with this. But, when we looked at the data in VQI, one-third of the first 2,000 patients who had perforator vein ablation had only C2 level disease. When you start giving people feedback about such practice, they realize that they are on the far end of this curve in their practice.

It’s probably the first time that these physicians have had a report card, if you will, that can incent them to change their practice. We’ve seen many examples in VQI where simple feedback has changed practice toward quality improvement.

Jens: Years ago, in the state of Maine, there was a Maine Medical Assessment Foundation (MMAF). They traveled around to different communities and looked at the rates of hysterectomy, back operations, and myringotomy procedures. What they did was send that information back to the surgeons, including the outliers, showing how often they performed the procedure based on their population.

Many times the surgeon who was doing five times as many back operations said, “I have a referral practice with many patients out of my catchment area.” MMAF broke it down by zip code and showed the surgeons who were high outliers how they compared with benchmarks. Almost all of those outliers, having been fed back this information, then started practicing much more appropriate care and adjusted their indications for operation.

I think the first thing to do is to feed the information back to the physicians. Yes, there are some who, no matter how they compare to benchmarks, are going to carry on with their current practice pattern. I think most physicians want to do the right thing for their patients and, if you give them that information, are going to want to practice good, high-quality medical care.

Surgeons or proceduralists tend to be somewhat competitive; they tend to be concerned about their results. If you show them that they are out of line, or they are an outlier from the general practice, they’re going to take that very seriously. I think the great majority are going to address it and probably revert towards the mean.

Steve: Those are the people, though, who are entering data into the registry. Now, the problem is those people who are not entering. They don’t really care if they are doing five perforators, or whatever, even in C2 disease, because they’re getting paid for it.

Jack: If the only physicians participating in registries are the ones who are really motivated, doing a good job, and learning from their practice, what about the physicians who aren’t participating? The friendly question for the societies would be, “Are you willing to go to the payers and recommend to them that they do not reimburse a physician who doesn’t participate in an appropriate quality improvement registry?” In other words, let’s put our money where our mouth is.

Marlin: We could go to the payers and say that everybody must participate in a registry. Or perhaps, it would be better to go to the payers and share what we see from the data of over 200 providers. Sharing what we see in terms of utilization and outcomes, as well as epidemiology, duplex patterns, complications of venous stasis, and ulcer healing rates with intervention, could help develop metrics for how to care for patients appropriately.

This might be naïve, yet if we can help them understand the standard patients that enter a vein practice, we may be able to make a case to adjust utilization policy being made purely to limit access to care. Wouldn’t it be better if those policies were driven-based upon evidence, as opposed to other objectives?

Steve: Jens, you’ve been involved with the SVS, with the appropriateness committees. What do you think about what Jack and Marlin are saying regarding what we do with these societies?

Jens: One way that we help people provide quality care is through an accreditation process. The basis of almost any accreditation process is participating in a registry. I’m a strong believer in registries, and I think it is important for everyone to participate in one.

Registry participation helps them understand how we are doing, not only as an individual, but as a specialty. It also helps us better understand how to practice. The greater the participation, the better the data we get for how people practice, what devices they use, and what their real outcomes are. This gives us real-world evidence of how these techniques, devices, and procedures are working.

That’s the sort of information that can help inform payers. I do think that it would be helpful if the payers were to require registry participation for those reasons.

Jack: If payers start requiring physicians to demonstrate, with data, that they are following the appropriateness guidelines and achieving good results, as well as evaluating patient-reported outcomes, physicians would be very motivated to participate in registries. One incentive could be to use registries to avoid the pre-approval process, which currently is costly and really doesn’t work for or more ablation procedures on CMS beneficiaries in 2017 will have performance data mailed to them through the Improving Wisely project.

Two metrics will be analyzed, although only one will be shared in our first iteration. The first quality metric that will be reported to each provider is the number of ablations per patient, which we have seen reported in some preliminary work to be between 1.7 or 1.8. More granular data, such as the number of ablation procedures per limb, would be interesting but that wasn’t specifically able to be sorted out with this particular query. The second variable that we plan to report in our next iteration is the intervention rate.

Should 100 percent of patients’ CMS beneficiaries that come to your practice ultimately have an intervention? Well, I would say, if you are in a wound center, possibly. If you’re not in a wound center, though, one could perceive that 100 percent is arguably an outlier. When you look at the peer-reviewed literature, multiple sources suggest an intervention rate should approximate 40 percent.

These are the two performance metrics that are going to be sent to every US doctor through this ACP initiative. We need to get the message out to them since knowledge about their performance, benchmarked to their peers, may influence their future decisions.

This is based on the Hawthorne effect, which parallels Jens suggestions that providers want to do a good job. If you get this report, and you’re an outlier, there’s enough evidence that says if you then re-query that same population a year or two later, you will see the respective curves aligning closer to the aggregate.

But you can’t do that alone and get this done. It doesn’t negate the work that we are doing with registries. What I’m getting at is, it is a multi-stage approach. In my opinion, we are going to reach all providers and it’s not just through the power of the data that we’re capturing; it’s also through other avenues. We can try to help providers know where they stand and what they can do to improve—whether they are currently doing a good job or when they are a utilization outlier.

Jack: I agree with Marlin, that the solution is multi-factorial. We’ve mentioned several things that could incent registry participation, including linkage to reimbursement, accreditation, or benchmark comparison with others.

I think the other important thing is that the societies can really help promote quality registry participation. At their annual meetings, they can have presentations that explain why it is important for everyone to be involved. Some subtle peer pressure, if you will, will help us reach a tipping point, so that instead of physicians asking why should I participate, they start to ask themselves why am I not participating?

Steve: Let’s talk a little bit about the societies, because I know there has been some cooperation. Clearly, already, the three of you have been cooperating together. How can we get all of the societies to cooperate together to get the word out? And do we have too many registries or not enough registries regarding the vein world?

Jack: The FDA, through the Medical Device Epidemiology Network (MDEpiNet) has promoted the concept of coordinated registry networks (CRNs) to generate real-world evidence about medical device performance. The concept is that data are aggregated from multiple different sources. anyone. This could be an effective, collaborative effort by societies and payer where they work together.

In the same light, I believe that we have tiptoed around the registry requirement question in terms of vein center accreditation. Currently, the IAC requirements encourage but do not require registry participation. But they do require a system to evaluate outcomes, including 30-day outcomes, which is really describing a registry.

I think that if we are going to have an accreditation system for vein centers, it should require participation in a quality improvement registry.

Steve: With regard to appropriateness, do you think it all comes down to money? If you stop paying people to do bad things, they’re going to have to stop doing it?

Jens: I think that with most people, if you show them that they are an outlier, and their practice is a deviation from benchmarks, they tend to revert towards the mean. In their current practice environment, they may not know what the standard of care is; they may not know what the proper care for C2 disease is. They may think the right thing to do is to treat perforators for C2 disease.

Once they get this information, once they get benchmarks, and once they see how they compare, then they can address it. Without that information, they can’t address it. And, yes, money influences behavior. If you stop paying for inappropriate care, more will stop.

Steve: What’s the most palatable way to get people to participate? How do we get the word out?

Jens: To get people to participate, a registry has to provide value—whether it is benchmarks, data for quality assurance or quality improvement projects, data that facilitates decreased resource utilization and enhances the bottom line, or data for analysis. I’ll tell you a couple of things we do with VQI.

Twice a year, we send out dashboards that allow providers in a center to see how they do on outcomes that we think are important. They can see how they are doing with their current skin preparation or carotid patching. There’s a dashboard report where they can see how they are doing compared to others in their group, others in their region, and others nationally.

Then, as part of our registry—which is a little bit unique—we have bi-annual regional meetings where physicians get together and meet with other physicians to discuss quality projects, including process measures and outcome assessments.

In our vascular quality initiative, less than half are vascular surgeons. We have interventional radiologists, cardiologists, general surgeons. We all get together. We talk about the data; we talk about quality improvement initiatives. This is where we start, and then we can make practice recommendations or develop guidelines based on the data. The problem is often the people who aren’t in the room, who don’t show up at these meetings, are the people who don’t read their dashboards.

Marlin: Aside from society-based registries, another way to conduct a QI program is to utilize claims data. For example, we have more than 3,000 providers who’ve performed 10 or more ablation procedures in 2017 based upon CMS claims data. This data is in the public domain and linked to each provider and patient.

One of the ways to look at this Medicare claims data is to develop meaningful quality benchmarks and share performance with respect to them with each provider. An ACP initiative called Improving Wisely, which is separate from our registry, is another tactic we are utilizing to connect with all providers. When we consider which providers we are currently not reaching, many of them aren’t going to meetings, aren’t subscribing to our journals, and will not consider participating in a registry. This makes it hard to educate them or give them an opportunity to compare their performance with their peers.

So, we thought we could help in another way. In the coming weeks, every provider who has performed 10 MDEpiNet has helped fund such efforts in other specialties and for arterial procedures in VQI, and I think there is the potential to do this with venous data from the ACP and VQI registries.

I would suggest that we work with MDEpiNet to create a CRN for venous ablation that can share data for specific projects that both societies support. As long as you have somewhat similar variables, you can do that kind of aggregating through a stand-alone analytic center, which has been done for other CRNs.

Although Nirvana would just have a single venous registry, different physicians are motivated to participate in different registries, where they feel an ownership stake. I don’t think it’s necessary or realistic to imagine that all of venous registries will coalesce, but I think they can coalesce functionally
with a CRN to work together on projects.

Jens: We’ve had some early conversations between our registries, and I think part of it is developing a relationship and level of trust and comfort. One way to start is by our data elements. The issue with different registries is that they may have slightly different variables that they collect, or slightly different definitions for variables, or different outcomes. If we can work together to harmonize or standardize, that allows us to collect the data from different registries and have a larger and better analysis.

Marlin: We have had several conference calls over the past few years to try and identify opportunities to collaborate between the various vein registries and to plan to share data fields being collected that have not been fruitful. We just haven’t been able to see how similar our data collection is, so that we can identify how much modification would need to be done.

Of course, modification is relative. You can have different data sets with separate variables. As an example, let’s say wavelength is recorded as an integer for the respective wavelengths as opposed to specific wavelengths (e.g., 810, 980, 1319, 1320, 1470, etc.). Even though each registry may collect and record the same data differently, each data is specific for a given variable and harmonizing the data may prove as simple as writing a macro.

With simple modifications, all of the sudden seemingly unlike data can become like data. In order for registries to work together, it’s important to understand where we have overlapped shared variables. There’s no reason that the data from two registries can’t be used to collaborate. Anything that permits a more global view of what is happening in all vein care sites of service could prove helpful and would be something I and the ACP would support.

Steve: Who is going to take the next step to try to make some of this happen? What’s it going to take? Give me a practical way that we can get little data to be even bigger data by us getting all together.

Jack: As I said earlier, I would suggest forming a CRN devoted to venous treatment, so that data from the VQI and ACP registries could be shared for mutually agreed upon research and device evaluation. MDEpiNet leadership could be approached by the SVS and ACP to help sponsor this as they have in other specialties. There may be some funding available from MDEpiNet and industry to create a venous treatment CRN.

The first step with other CRNs has been to bring together the registry leaders, industry, FDA, and MDEpiNet for a face-to-face meeting and planning. This can lead to harmonization of key data elements that allows data aggregation for a specific project.

Marlin: If it’s a pathway that can help us join our registry data, then I say it’s worth exploring, particularly if there is an opportunity to secure funding to support the effort.

Jens: I agree. Almost all of our registry efforts are to improve the care of the patient, and we share that common mission. There are the usual obstacles to coordination. As Jack has pointed out, the CRN is the solution to that. It gets us all in a room so we can share our common goal, and we can figure out a strategy and how to work together to do that. I fully support it.

I want to thank all of you. We really went to a place where I didn’t think we were going to go, but this is a good ending. I am happy we have identified a path to cooperative coalescence. Data from various sources will get us closer to the goal of having the right doctors treating the right patients for the right reasons. ~ Steve Elias

Are You Serious About Vein Care? Consider Venous Registry

If you are serious about vein care, consider registry participation for the benefit of all stakeholders. The ACP, SVS, and SIR are leading the charge in this arena and there is no time like the present to consider this commitment with your practice.

The Society for Vascular Surgery Vascular Quality Initiative offers registries on the treatment of varicose veins and IVC filter insertion. They plan to offer a venous stent registry in 2019. Please visit: https://www.vqi.org/, or contact our technology partner, M2S, at (603) 298-5509 for more information.

The ACP Patient Reported Outcomes (PRO) Venous Registry contains over 400 data fields covering the spectrum of deep and superficial venous disease and is updated by ACP certified EMR/EHR systems. To participate in the ACP PRO Venous registry or to learn more, visit: www.phlebology.org/registry or contact Naomi Sinclair, Director of Research and ACP PRO Registry at [email protected] or 510-346-6800.

The SIR/ACR Interventional Radiology (IR) Quality Registry is designed to promote quality of care for patients undergoing IR procedures. Visit: sirweb.org/practice-resources/quality-improvement2/ir-quality-registry for more info.

Venous Access: National Guideline and Registry Development (VANGUARD) is a multi-disciplinary initiative to understand and improve central venous access complications. Visit: sirfoundation.org/clinicalresearch2/clinical-registries/ for more info.

Medstreaming/M2S is a leading provider of health care information technology, creating workflow solutions for structured data entry and infrastructure for quality improvement registries. It supports the registries of the Vascular Quality Initiative. For more information visit: www.medstreaming.com and www.m2s.com.