“Right now, there is no source of national data on limb loss in the United States,” says Dr. Kenton Kaufman. “And that’s a huge problem.”

The good news is that Kaufman is hard at work on a solution. He’s spent the last two-plus years leading the effort to build the National Limb Loss and Preservation Registry. Funded by the National Institutes of Health and directed by the Mayo Clinic, the project will generate the first comprehensive repository of statistical data about amputees ever assembled. The potential benefits for amputees are enormous, as the trove of information will yield a whole range of new insights about amputees’ quality of life, health status, mobility, financial status, and other indicators. That knowledge should lead over time to better solutions to the challenges of living with limb loss.

Although we’re only in Year 3 of a planned five-year rollout, the registry’s first provisional data are expected to be online at some point during 2021—or so we hear from Kaufman. We connected with him last week to find out where things stand with the registry and what we can expect in the coming months. Our conversation has been lightly edited for clarity.

Dr. Kenton Kaufman,
Mayo Clinic

Where do things stand right now in the overall trajectory of this project? If I’m not mistaken, you’re at about the halfway point.
Halfway point in terms of the five years, but not halfway in terms of what we need to accomplish. Our security requirements are very high, and we’re still waiting for the federal government to approve the security that we’re supposed to have. There are federal laws and regulations that are applied to data security so that there are no data breaches.

Has that stumbling block prevented the collection of data? Or just the publication of data?
That’s a good question. We cannot put any data into the servers until we have that security certification from the federal government. I’ve got data ready to load, but I can’t load it until I’ve got this certification. We’re not collecting any data on a large scale, but we have a list of the data that we want to collect. So we are starting to talk to sites who we want to participate once we have the approval to load the data.

And who are you talking to as partners in this project?
We want to get data from hospital medical centers, from prosthetists, and from patients themselves. For the hospitals, there’s no uniform health record system [HRS]. There are big-name HRS [platforms], but each one gets customized a little bit for each medical center, so there’s no standard where we can just hook up our pipe and flow in the data. We have to do that on a site-by-site basis. The prosthetist side might be more easy to standardize than the hospital record-keeping side. We’re actually working on the interface with the PHR [personal health record] vendors to define what data we think we can get across different vendors.

Once we’ve got a final list of data elements, the next step will be to do the technical part about how that data passes into the registry itself. So we’re not at a standstill. We can continue to make progress with regards to what the data is and how we build the the pipe.

I’ll give you an a simple example that maybe will help illustrate our approach. Only about 30 percent of patients with lower-extremity amputations actually get a prosthesis. So if you just work with prosthetists themselves, you’re missing 70 percent of the population. That’s why we need three sources of data. We need the hospital data to know who has an amputation or a limb-preservation procedure. We need to know whether they got some hardware. And then, what are their outcomes?

How will you reach the 70 percent who don’t get a prosthesis?
We have a couple of of options there. One is working with the Amputee Coalition. And the the second is, if we have the data from the hospitals, we know which patients had an amputation. So those patients could reach out to us directly to provide information [about their outcomes].

And if they don’t—if they’re unaware that you’re doing this project, or they just don’t take the initiativewill you be doing any proactive outreach yourselves?
We haven’t gotten that far yet. We don’t know if we need to or not. There will be a patient portal where they can just access the registry itself, and they will be able to put in information, and then they will get information back about how they’re doing relative to their peers.

So one incentive for individuals to participate is to get feedback that might impact their own health decisions or help them understand their optionsis that sort of a way to get people to buy in?
Exactly. The calls I get and the emails I get are from [amputees] who don’t think they’re doing well. They’re unhappy, and they want to know if there’s a better option. Entering their information [into the Limb Loss Registry] will give them a benchmark relative to people of the same age, the same gender, the same level of amputation, and tell them how they’re doing. You know, are they in the 20th percentile of their peers? Or the 80th percentile?

That could be incredibly robust. Can someone check back in six monthsafter they’ve changed their diet, their fitness routine, or the fitting on their prosthesisand see how their benchmarks look at that point?
Our hope is that patients would maybe do this quarterly or semiannually. If they’ve lost weight or gained weight or whatever, they could enter their data again. Not every week, obviously, but maybe every six months, every year, and just see how they’re doing. That information then allows them to make decisions about their care.

And presumably, if I’m not happy with where I am on my benchmark, perhaps the data yields some insight about what change I might need to make?
Yes. People always ask about components: Do I have right foot for myself? Do I have the right knee? And the biggest question always is, does the socket fit properly? We’re actually going to be talking among our group this week about the patient outcomes that will be the most useful. So we’re actually very actively doing this right now.

Is there anything at the policymaking level or the lawmaking level that you think could come out of this, as another benefit of having all this information?
I think this registry will allow us to standardize, measure, and report patient outcome data, which is of interest to the federal government so that they can make policies about healthcare delivery and best practices. Caregivers, researchers, policymakers, and payers all need standardized data from which they can draw conclusions. So having these patient-centric outcomes on the national scale will allow policymakers to better understand the best practices to provide the best care. If it means that some of the advanced technology gives better outcomes, the policymakers will want to know that so they can provide the best outcomes for people with limb loss.

I’m curious what feedback you’re hearing from manufacturers of prosthetic devices. Are they in active conversation with you, giving you ideas for what kinds of patient data might assist them in designing better technology?
Yes. There is an advisory board that has manufacturers’ representatives, research investigators, patients, and insurance providers to help guide us with regard to the information that’s needed. This is a multi-stakeholder registry, so we’re trying to get input from all the stakeholders to design it in a way that will be beneficial to all.

Are there any unresolved issues regarding limb loss that you think might be clarified or myths that might be completely overturned by this data?
I think there will be. With this data, it’ll be possible to look at health disparities, whether it’s a racial disparity, a gender disparity, or a geographic disparity. Or it could be a payer disparity. So I think this will be really important, because now you can start to look at public health gaps. When you look at the distribution of obesity in the United States, there are definitely geographic disparitiesand obesity is a common precursor to diabetes, which is a [common] precursor to limb loss.

What does the timetable look like going forward? When can people anticipate that they might be able to start interacting with the portal and start looking at some of this data?
Really important question. Task Order 1 is getting the [security] certification. Task Order 2 is to have information from hospitals and from prosthetists. That’s why we’re working with the health record vendors. We know what kind of data we want to get; we’ve basically got what they call the data dictionary defined. And then a future task order will be to build the patient portal.

Are you in any position to hazard a guess as to when that portal might be ready? 
We’re starting to work on the dashboards now. The next step will be to do the technical part about how that data flows into the registry itself, how we build the the pipe. I would think that sometime in 2021 there will be water in the reservoir.