Limb Loss and Preservation Registry Provides Insight Into Challenges and Improves Quality of Care

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By Bill Oldham, Shawn Murphy, and Kenton Kaufman, PhD, PE

Despite the significant personal and societal impact associated with limb difference, limb preservation, and limb loss, there is little current evidence on effective clinical practices and technologies in this field. Published research studies rely on either administrative data sources, hospital discharge statistics, or small single-center studies with limited longitudinal follow-up. Although limb loss is a common outcome measure in studies that evaluate the effectiveness of diabetes and peripheral arterial disease care, little is known about the effectiveness of practices and technologies following a limb loss or a limb preservation surgery.

A registry can be a powerful tool to support research and improve the quality of care for its target population by providing a framework to assimilate data from multiple sources into a single, meaningful, and useful resource. After more than four years of intense market research and proof-of-concept development, the Thought Leadership & Innovation Foundation (TLI) is partnering with the Mayo Clinic to foster the initiation of a registry project through the National Institute of Child Health and Human Development  and the U. S. Department of Defense.

Under the direction of Kenton Kaufman, PhD, PE, professor of biomedical engineering and director of the Motion Analysis Laboratory at the Mayo Clinic, TLI is providing subject-matter expertise in strategy, information assurance, and technical project management for the development of the Limb Loss and Preservation Registry (LLPR). Given the cost and the quality of life impact and the enormous disparities of care across the nation for limb difference, limb loss, and preservation, this program aligns with TLI's organizational focus areas, and is a great opportunity for innovation within this area of healthcare.

Registry Opportunities

The LLPR presents an opportunity to compile substantiated metrics and statistics to accurately portray the personal and financial burden of limb loss in the United States. This will be the first national registry of its kind in the United States to include adults and children. It will link patient-level data derived on a national level for individuals with limb loss or preservation procedures.

Currently, there is no clear understanding of how decisions are made that affect the availability and usability of advanced surgical techniques, advanced prosthetics, and computer-aided rehabilitation systems. Because the published studies used most for analysis are outdated, objective evidence is limited and can be misleading when applied to today's population.

Clinicians lack definitive and reliable guidelines on treatment plans for subgroups of limb loss and limb preservation patients, and disagreement and variability exist within the rehabilitation community as to the approaches taken. For example, prosthetists and payers must choose between providing more advanced and expensive devices, such as a microprocessor-controlled knee, and a device of less advanced technology, such as a mechanical knee, without predictive tools or comparative outcomes data to guide their decisions.

While it seems logical that advanced technology would result in improved functional outcomes, there is a lack of data to support specific treatment approaches. If outcomes data were available to guide and justify the selection of a given technology for a given patient, then the clinician, third-party payer, and patient could be more confident that the most appropriate, beneficial, and cost-effective care is being provided.

Key Objectives for the LLPR

The primary objective is to establish a registry that has the capability of providing data that can be used to standardize, measure, and report patient outcomes. It needs to support evidence-based decision-making, enhance healthcare delivery, and establish and disseminate best practices to the profession. Clinicians, researchers, policy makers, and payers must have standardized data that they can use to perform research, draw conclusions, create education programs, and move the profession forward using current evidence-based data. TLI and Mayo Clinic's directive is to improve patient care and long-term patient outcomes.

As a quality registry, there is great value in the data that we will be collecting. What's more, the LLPR will give the medical community actionable data to serve patients and researchers more effectively.

Mission success will require active engagement from manufacturers, clinical specialists, and patient advocacy groups and societies to raise awareness within the target population and the broader community. Raising awareness of the existence of the LLPR and engaging hospitals, clinical practices, clinicians, and patient participants will be accomplished through community outreach and a communication plan.

Our first community outreach event was our attendance at the National Amputee Coalition conference in July. During the event, TLI and Mayo Clinic conducted focus groups for O&P manufacturers, individuals with limb loss and limb difference, and a variety of care providers, including prosthetists, orthotists, physiatrists, registered nurses, physical therapists, and case managers. The enthusiasm and support within the community for the development of the LLPR and how it can bring value to the community was overwhelming. We are profoundly encouraged by the support and found that all the focus group participants shared our vision for the registry.

LLPR Progress to Date

A landscape analysis was completed in which TLI and Mayo researched existing registries and research data and collected best practices and industry standards for handling and disseminating patient data, as well as lessons learned, such as what worked effectively and how it could have been done more efficiently. What we found was that many publications are all using the same frequently cited statistics on limb loss causality, prevalence of limb loss, and limb preservation surgeries—the demographic groups most likely affected.

We learned that the actual source of research data is not always available and, due to incomplete patient population records collected and projections based on limited and disparate data, the statistics available are merely educated guesses based on dated information.

Using that knowledge, and with the mission to remedy these issues, we have designed an architecture and preliminary workflow for how the data will move from its source, be validated and cleaned, and then stored in the LLPR so that more real-time data can be made available to researchers. We also convened a panel of industry experts from the manufacturers, legal counsel, patients, and a broad spectrum of clinical specialists to provide our team with insights and advice on how to shape the registry to achieve its objectives and provide needed data.

Our landscape analysis also confirmed that to have a complete and demographically diverse data set, the LLPR needs to be able to obtain and link data from hospitals, clinicians, and patients so it can be used to assess the effectiveness of different care approaches and timing of specific care procedures to enhance patient-centered clinical decision-making. This provides the capacity to evaluate disparities in access to care, care processes, and care delivery across geographic, demographic, etiological, and economic sectors.

This enables the LLPR to include data related to limb loss and preservation care, pre-operative care, operative care, acute and sub-acute management, device fitting and use, and rehabilitation care as provided by private, not-for profit, for-profit, and academic medical centers.

By collecting data from pediatric through geriatric patients treated throughout the nation, there will be opportunity to fill in data gaps for selected subgroups of patients. Ultimately, this will enrich the research and education opportunities for providers, have a positive impact on patient outcomes, and potentially reduce long-term costs of care across all geographic, demographic, and economic sectors of the country.

As with any registry, it will be necessary to provide data and operational solutions that support the conduct, management, research, and analysis across the LLPR. Frequently, this involves complex data operations with multiple data types, collection sites, formats, and business protocols. TLI and Mayo have identified and designed the registry to address some challenges that historically plague registries, such as:

In addition to addressing these challenges, certain data quality characteristics are critical for the registry's success and have been designed into its architecture, such as consistency, validity, accuracy, completeness, and timeliness. Because data only has value when it supports a business process or decision-making, we constantly returned to these questions during the design:

Building the LLPR is a highly complex task, but TLI and Mayo are determined to fulfill its mission. Fortunately, the burden is lightened by the support we are receiving from the community and our panel of experts.

The Road Ahead

The LLPR is scheduled to have an operational prototype deployed in 2020, and this will be tested with our panel of experts to verify that they can analyze the data by age, gender, and type of limb loss or preservation surgery. To date, most of the work has been focused on developing the design and architecture for the technical and governance infrastructure needed to support it.

The LLPR is an opportunity to organize an independent and robust data set that collects valid administrative and clinical data about all limb amputations and limb preservation patients in the United States. The registry is currently funded through development of the prototype, and the National Institutes of Health has committed to a five-year effort, subject to government funding capacity.

Long-term success of the LLPR will be dependent upon a sound business model and a robust retention strategy that minimizes the burdens and maximize the rewards of participation. We feel that we have developed a sound business model for continued funding of the registry beyond the awarded government commitment, which was discussed at a high level with participants at the July focus groups.

We envision multiple ways to incentivize stakeholders and patients. Incentives for hospitals and clinical practices will include membership in a community of researchers, access to useful data, and a means to comply with quality improvement requirements. Incentives for patients involve insight into their personal levels of mobility and the awareness that they are providing data to advance care for all individuals having limb preservation and/or amputation surgeries. We hope that, with a deep understanding of the LLPR's potential, our team will be able to bring it to full operational capacity and sustain it for many years to come.

Bill Oldham is the founder and chairman of the board, Thought Leadership & Innovation Foundation (TLI).

Shawn Murphy is executive director, TLI. 

Kenton Kaufman, PhD, PE, is director of the Motion Analysis Laboratory and research professor at the W. Hall Wendel Jr. Musculoskeletal Center, Mayo Clinic.