Here's An Example of a Global Medical Device Registry that Delivers Real-World Evidence

Here's An Example of a Global Medical Device Registry that Delivers Real-World Evidence

Here's An Example of a Global Medical Device Registry that Delivers Real-World Evidence

Those who are held accountable for what happens in healthcare – whether a physician, care team member, pharmaceutical company, medical device manufacturer, or health system – need to understand what happens, why it happens, and how to improve.

But there’s a gap between what really happens in healthcare and what is “supposed” to happen. Clinical research, guidelines, and case studies tell us what is “supposed” to happen. Real-world data from the clinical setting or the patient themselves tells us what actually happened.

And it’s what actually happens that really matters.

Using Clinical Data to Fill the Medical Device Knowledge Gap

Addressing this gap requires collecting real-world data, transforming it into real-world evidence (RWE), and sharing it with those who can use it to advance care.

We can illustrate this with a relevant clinical example.

Extracorporeal membrane oxygenation, commonly referred to as ECMO, is a treatment that uses an artificial heart and lung to support the body when a person's own organs are too sick to do the job. ECMO itself will not cure a patient’s heart or lungs, but it buys time for patients to heal or for alternative treatments to be coordinated in cases of severe cardiac or respiratory failure.

Knowing what truly happens in clinical settings – having real-world evidence – is especially important here.

Physicians and ECMO practitioners need to have reliable data on how and when it is safe and effective to put patients on ECMO. But they are only part of the equation.

Given the complexity of care and the high rate of mortality and complications, ECMO care presents limitations for traditional clinical trials. This means despite decades of widespread use, until recently, ECMO has been largely performed off-label in the United States. 

This is a crucial clinical knowledge gap for the companies manufacturing devices used in ECMO. They know anecdotally that their devices are being used in this way, but they do not have access to any data demonstrating the safety and effectiveness of their devices used in a clinical context.

Clinical Quality Registry for Physicians

To solve for their data and knowledge needs, physicians from across the globe have come together as part of the Extracorporeal Life Support Organization (ELSO). They collaborate, share data, and learn from one another through the ELSO Quality Registry.

The registry tracks use of medical devices for ECMO and collects real-world data on the patients who have received ECMO. It contains details on patient and device demographics, clinical information, patient outcomes, and adverse events. ELSO Registry data has been used to:

  • Investigate high and low performing centers.
  • Establish clinical best practice guidelines.
  • Publish a wealth of detailed peer-reviewed research.
  • Demonstrate the safety and effectiveness of current ECMO treatments.
  • Improve when and how ECMO is provided in the future.

Medical Device Registry for Manufacturers

To help manufacturers fill their knowledge gap, ELSO leveraged its clinical Quality Registry to share data through a medical device registry.

The device registry, ELSO Evidence Explorer, takes real-time data from more than 700 centers worldwide and transforms it to help manufacturers know how clinicians are actually using their devices, what the average patient looks like, and how their device truly performs in the real-world.

Manufacturers leverage this data and review the usage, the incidence of mortality, and ECMO-specific complications where their devices were used as part of the circuit.

Using Registry Data for Real-World Evidence

ELSO’s long-standing registry is a rich data source with a lot of value. But it wasn’t enough to simply provide raw data exports to manufacturers. Creating a meaningful medical device registry required a few key steps.

1. Post-Market Surveillance of an Evolving Market

One of the greatest advantages of real-world registry data – that it is longitudinal – also presents unique challenges. Historical case data collected by ELSO provides invaluable benchmark information for current and new devices.

But this also means ELSO must continually work with industry stakeholders to make sure the devices being tracked within its registry accurately reflect an evolving market. As new devices and models hit the market, older devices are retired or devices and manufacturers are acquired, ELSO ensures registry data appropriately reflects these changes.

2. Conducting Data Discovery

ELSO conducted a data assessment to identify what data in its registry would be valuable to manufacturers, assessing in particular those clinical situations where real-world registry data tracks either clinical practice or patient populations that cannot be easily studied via traditional trial-based means.

For reasons described above, ECMO cannot be studied via a clinical trial, making this assessment process straightforward for ELSO. Other medical societies and registries should consider where their registry data tracks populations that are or cannot be studied through clinical trials.

Additionally, registries tracking patients with chronic conditions and longitudinal treatments can re-survey specific patient cohorts through patient-reported outcomes surveys. Ultimately, ELSO worked with manufacturers and regulators to inform how their registry data could meet the needs of ECMO manufacturers, and what reports they could provide.

3. Assessing Data Quality

Data quality is important for any registry work. For ELSO, this starts with automated validation of each data element, ensuring only appropriate data can be submitted to the registry. Additionally, they conduct randomized site audits to compare registry data to corresponding EHRs.

Using registry data with key stakeholders, including the U.S. Food and Drug Administration (FDA) and manufacturers, requires additional effort and coordination. ELSO works with these stakeholders to ensure they understand how and where data is collected. Accurately tracking how data elements have been added and removed from the registry over time is of particular importance.

4. De-Identifying and Analyzing Data

ELSO Registry data is de-identified to protect the privacy of participating institutions and patients. An automated analytic process also cleanses and transforms the real-world data collected into statistically validated real-world evidence. This ensures data can be used effectively by manufacturers and regulators while protecting registry participants.

5. Designing Dynamic Web-Based Reporting

Participating manufacturers review and interact with this RWE through a dynamic, web-based reporting tool. They can build their own custom reports and queries in real time - all in a way that protects the identities of participating institutions, patients and industry competitors.

Sharing Real-World Evidence Improves Outcomes

The way ELSO uses its registry to bridge the medical device knowledge gap with RWE is powerful. Other medical specialties and patient registries can do the same. Sharing insights from these clinically-rich data assets is one of the key ways to advance care and improve health outcomes for all.

For more information on our real-world evidence and registry solutions, contact us at

To learn more about ELSO Evidence Explorer, visit

Best Practices for Clinical Registries with New Research Priorities

Best Practices for Clinical Registries with New Research Priorities

Best Practices for Clinical Registries with New Research Priorities

You set goals, outlined plans, and hit milestones. Then 2020 changed - in a big way. Questions came. Priorities shifted. Opportunities emerged.

Despite uncertainty, there are a few things to be sure about:

  • Registries are essential to our understanding of the direct and indirect effects of the pandemic.
  • Registries must adapt to address emerging research priorities and questions.
  • Registries can pivot successfully with the right strategy, technology, and partners.

Successful patient registries are designed to pivot. Flexibility is inherent and technology scales as needs evolve. Consider how the following organizations changed course to address pressing issues and emerging research questions.

  • The current healthcare landscape: The American Academy of Physical Medicine and Rehabilitation (AAPM&R) is adapting its registry to answer important research questions and track long-term patient outcomes.
  • The COVID-19 pandemic: The Acute Care Quality Registry quickly adapted its technology to monitor and manage the effects of the pandemic on patients, hospitalists, and health systems.
  • The national opioid epidemic: The Michigan Surgical Quality Collaborative leveraged its registry to establish evidence-based guidelines, track adherence to those guidelines, and ultimately reduce post-op opioid prescribing by 30% and consumption by 50%.

We shared these examples during a recent webinar, “How to Pivot Your Registry and Meet New Priorities.” You can view it on-demand here and read on to learn the steps you can take to ensure your registry is ready to pivot and meet new priorities whenever they arise.

Step 1: Determine the Priorities and Research Questions Your Registry Can Uniquely Answer

Often with a registry, it's tempting to start with the data you can easily collect and then make sense of it all. But this quickly leads to overwhelming data volume with a lack of specificity.

Instead, flip the script and begin with the end in mind. Use this framework and ask yourself the following:

  • What are your goals and objectives? How have they changed? Which ones are inherently important – no matter what changes have happened?

Clinical guidelines, patient engagement, physician engagement, and research are all timeless goals. But they may require specificity and some shifts. Identifying what’s truth and accommodating necessary changes ensures that your registry will still point in your organization’s North Star, with a shared set of priorities. Documenting this will help to assess opportunities and minimize distractions, even when those distractions seem monumental.

  • What output will help you reach these priorities and goals? In other words, your goals should define what’s visible in your registry. What do your clinical, scientific, and patient communities need to achieve these aims. The reports, dashboards, workflows, and predictive calculators and tools in your registry should deliver the insights your stakeholders need to take action.
  • Your registry’s outputs drive how the data should be combined and adjusted. This includes your measures and cohorts, peer groups, benchmarks, and more. How will you measure what matters? What elements and assets need to be combined in order to support those measures?
  • Finally come the data. What individual data elements do you need? How will you collect that data securely, efficiently, and accurately?

This process isn't something to do only once or only during implementation. It is something to document and revisit every time there is a shift in your specialty or practice. Doing this will help ensure that the changes and adjustments to your strategy and registry continually serve both your people and your priorities.

Step 2: Use Trusted Data and Advanced Analytics to Address Critical Issues

Addressing new and emerging health issues requires rapid measurement and quick discoveries.

It involves having the right framework that involves two things:

  1. A comprehensive data collection strategy that ensures you have all the right data.
  2. Advanced registry analytics that help you answer all the right questions.

Registry Data Collection Strategy

Different data sources supply different information to ultimately evaluate a health issue. Most registries rely on clinical data from the EHR. But most data sources – EHR data especially – has inherent limitations. Clinical data alone often doesn’t provide all of the information needed to fully understand a health issue.

This means registries that rely on EHR or clinical data alone will have data gaps. Yet solving some of the most intractable issues in healthcare will require innovative methods of blending data to deliver a complete view of a patient population. In fact, multiple studies have shown that nearly 80% of health outcomes are attributed to what happens beyond the walls of a health system.

You can address these gaps with a comprehensive data acquisition strategy that leverages not only at EHR data but also administrative datasets, claims datasets, and governmental datasets. You can also use specialized case report forms, provider and patient surveys, and other methods for collecting patient-sourced data.

Collecting data in which you're able to assess root causes of health issues by having all sorts of associated factors that are at play will also enable you to effectively pursue data-driven interventions to improve outcomes and improve care delivery by our providers.

Advanced Registry Analytics

Once you start collecting data, you need to be able to use it to answer the right questions. Enter advanced analytics.

In healthcare, questions seem endless – especially with any emerging issue or research priority. These questions fall into four common types, and there are specialized analytics to address each.

  • What happened? Descriptive analytics answers this question by examining data from the past and producing dashboards around trend or benchmarking data. The uses of descriptive analytics can be very limited, especially for healthcare stakeholders who ultimately want to influence health outcomes and have foresight into what might happen in the future.
  • What is likely to happen next? Predictive analytics answers this question using modeling and forecasting techniques. Predictive analytics can have limitations, as it is based on determining what will happen if all conditions remain the same, and healthcare leaders often want to understand what will happen after novel interventions or actions.
  • What will the effects be if we take some type of action? Prescriptive analytics answers this question using machine learning and numerous inputs to suggest a course of action. For example, decision support calculators use real-time patient data and prescriptive analytics to determine optimal treatment courses based on expected outcomes and likely complications.
  • What do we need to explore further? Discovery analytics answers this question using machine learning to analyze raw data, which allows it to determine interconnections, patterns, and outliers that warrant further exploration.

Step 3: Leverage a Flexible Data Infrastructure to Pivot at Any Time

Your new aims, data strategy, and analytics approach can come to life with flexible registry technology and the right registry partner. Modern clinical data registries are designed to evolve as your needs change. Your clinical data registry technology should provide you the ability to:

  • Ingest data and apply analytics in real time.
  • Collect new data fields and add new measures.
  • Rapidly design, build, and distribute patient and provider surveys.
  • Intelligently make data available and accessible via web-based reports and dashboards.

Each of the organizations below leveraged their flexible registry technology and data infrastructure to be proactive in measuring, monitoring, and addressing the COVID-19 pandemic.

  • Sound Physicians embedded logic into their analytics technology and steps into their clinical workflows to understand the coronavirus impact on daily admissions, bed capacity, resource utilization, provider well-being, and standard acute care, at a local, regional, and national level. (Read this blog post to learn more about how the largest hospitalist group in the U.S. uses data and analytics to understand COVID-19).
  • The Extracorporeal Life Support Organization (ELSO) is using registry data and insights to lead education efforts around the use of extracorporeal life support (ECLS) and extracorporeal membrane oxygenation (ECMO) as a treatment for patients with COVID-19. (This blog post explains more about how a global ECMO organization uses a patient registry to track and educate on COVID-19.)
  • The American Society of Clinical Pathology (ASCP) launched COVID-19 specific reports in its National Pathology Quality Registry to better understand positive, negative, inconclusive, and cancellations. They are also tracking test processing times.
  • The Palliative Care Quality Collaborative (PCQC) rapidly designed, built, and deployed a survey to collate experiences of palliative care clinicians in caring for COVID-19 positive, PUI (Person Under Investigation), and recovered patients. They plan to share these experiences with the palliative care community to drive understanding and clarity in the field through continuous learning. (Learn more about how PCQC quickly adapted their registry.)
  • The National Hemophilia Foundation (NHF) added COVID-19-specific questions to patient surveys that inform their research registry centered exclusively on patient-sourced data.
  • Conquering CHD launched InformCHD, a patient-reported database, that will collect information directly from people with congenital heart disease who are potentially at risk for severe complications related to COVID-19. (Read more here about how they are using patient-sourced data to understand COVID-19 and Congenital Heart Disease.)

The Right Registry Technology Makes Discovery Possible

The ultimate purpose of a clinical data registry is to accurately observe, measure, and understand the true realities of healthcare today. Emerging questions and issues, along with the complexities of real-world data, make this more challenging. None of this important work comes easy. But, as Galileo once said, “All truths are easy to understand once they are discovered.”

When it comes to developing and growing clinical registries that address today’s most important questions, the right technology can support this discovery.