Clinical Data Registries

Here at ArborMetrix, we’re focused on creating and delivering powerful product roadmaps that align with the industry and the needs of our clients and partners. These roadmaps help prioritize work, set expectations, and point us ever forward, toward our long-term vision.

But, roadmaps aren’t simply our own internal tools. We often provide roadmaps to our customers for their clinical registries. These plans outline how to take their data and software assets to the next levels for their populations. To be effective long term, your registry must continually evolve to address the growing needs of your clinician and patient populations.

Clinical registries exist on a scale of momentum that spans three stages:

1. Foundational

2. Intermediate

3. Advanced

We guide our registry partners through each stage and set a strategic plan to help them progress to their ultimate goals.

Foundational Registry Momentum: Data Submission, Data Quality Review, Standard Reporting

Foundational registry momentum is defined by the compelling business and market needs that drive a registry’s framework. Often the impetus is collecting data for regulatory or post-market reporting, with features that include:

• Collecting data through a variety of channels and formats.
• Ensuring data is high quality through a robust data dictionary and supporting validation logic.

The Foundation stage is important because it serves to get data in the registry and drives membership and participation from affiliated organizations and clinicians. Most new registries achieve these goals within the first six months of launch.

However, if your registry launched a few years ago and you are feeling like your momentum is “stuck” or “limited” by not progressing past the Foundational stage, you’re not alone. This is a common situation that you can remedy with the right approach and technology.

Intermediate Registry Momentum: Clinician Performance, Quality Improvement, Patient Engagement

The momentum of your registry is truly unleashed when it builds deeper engagement.

This begins when it is used to highlight and change behavior. Our registry product and services are purpose-built for deep analytics and actionable insights related to measurable clinician and device performance, quality improvement, and patient engagement.

• Clinicians and industry stakeholders engage when the registry can be used to highlight their performance relative to peers and within their health system or specialty.
• Quality improvement is realized when the registry can indicate areas where treatments and interventions can be improved, and where guideline adherence is tracked and analyzed for impact.
• Patients engage when they are given the opportunity to safely share their health and quality of life related to diagnoses, treatments, and interventions, and know that data can be used in shared decision making.

Most of our clients spend a significant portion of their registry’s lifecycle building and growing these intermediate assets. This starts with our goals-oriented implementation process. These features can propel the momentum into new and relevant measurement areas and reporting domains that keep a registry fresh and engaging over time.

Advanced Registry Momentum: Publish and Predict

Finally, let’s talk about the hallmark of registry success: The ability to use it as a platform to publish research and clinical practice guidelines, and to predict outcomes. Advanced registries also expand their scope of participation and achieve sustainability through data commercialization.

Here’s how they reach this level. Registries arm us with trusted insights on clinician and device performance and quality improvement in care delivery. They also inform the patient experience through patient-reported outcomes. Registry owners and stewards share this knowledge and insights with the broader community to extend its impact.

Clinical Research and Practice Guidelines

Our customers have published a rich portfolio of registry-based research. Importantly, we help them achieve rapid-cycle research. On average, our customers publish their first peer-reviewed publication using registry data within a year of launch.

This is not just within scientific and medical journals, but also with the creation and publication of new clinical practice guidelines. The rigorous scientific process that we apply to registry data makes it ideal for evaluating the standards of care and long-term outcomes that impact patients.

Predictive Analytics and Outcomes Calculators

Predictive analytics is when data science principles are applied to model and forecast outcomes and risks at the point of care. This allows clinicals to make treatment decisions with better insight and, ultimately, avoid complications and negative outcomes.

The most advanced registries we support utilize outcomes calculators. These are built on complex data and models that combine foundational data assets with longitudinal patient data. Outcomes calculators provide powerful tools for shared decision-making between providers and patients and provide long-term registry value.

Predictive Analytics Registry Example

One example of an advanced registry using predictive calculators is the Michigan Bariatric Surgery Collaborative (MBSC). MBSC aims to advance the science and practice of bariatric surgery.  Registry data is used to feed the MBSC Predictive Outcomes Calculator, which is publicly available for clinicians to use to predict a patient’s weight loss, comorbidity resolution, and complication rate after bariatric surgery.

Specifically, the tool:

1. Predicts weight loss at years 1, 2, and 3 for five different procedures using patient information on demographics, comorbidities, and risk factors.
2. Predicts the likelihood of resolving weight-related comorbidities.
3. Predicts the likelihood of minor and major complications.

Notably, the predicted rates for weight loss, comorbidity resolution and potential complications are patient-specific, using risk-adjusted, real-world outcome data from similar patients.

These tools and other quality improvement initiatives helped MBSC and its members decrease rates of VTE by 43% and decrease post-surgical death rates by 67%.

Achieve Lasting Value with Your Registry

It’s important to remember that registry momentum happens over varying spans of time.

Some registries have been around for many years, and their momentum has been focused on providing foundational value to its members. Other registries are only getting started and are already looking at how they can propel their programs by quickly predicting outcomes and publishing results.

Whatever stage in which your registry exists, we have both the vision and the delivery model to help you build momentum and achieve lasting value.

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The Council of Medical Specialty Societies (CMSS) held their 2020 Virtual Annual Meeting with the theme of Covid-19 and Beyond: Digital Transformation of Healthcare, Research, and Education.

The dynamic group of presenters and panelists covered a variety of topics that demonstrate how digital technology, such as clinical registries and healthcare analytics, can be instrumental in advancing healthcare.

Our key takeaway: The digital transformations that are needed to make these advancements are less about how people transform technology and more about how technology transforms people and lives.

Registries, for instance, can be used to help solve some of the most intractable issues in healthcare like:

1. Addressing underlying root causes of health disparities.
2. Making it easier for patients to understand, navigate, and manage their care.
3. Monitoring and managing COVID-19 and other emerging priorities.

1. Addressing Root Causes of Health Disparities

There are widespread and longstanding health disparities among racial and ethnic minorities.

These disparities cause some populations to face unfair health burdens. Health is a fundamental human right, and consequently, healthcare stakeholders have an ethical obligation to ensure fair and just health experiences by acting to eliminate avoidable health disparities.

Clinical data registries are powerful tools for assessing health disparities, identifying the root causes, and tracking efforts to address health inequities. Importantly, these tools should provide actionable insight, as referenced by Rhea Boyd, M.D., M.P.H., Pediatrician and Child Health Advocate at Palo Alto Medical Foundation and UCSF Benioff Children’s Hospital.

This work includes implementing robust data logic rules to identify underperformance in need of equity-focused quality improvement efforts, as presented by Ernest Moy, M.D., M.P.H., Executive Director, Office of Health Equity, U.S. Department of Veterans Affairs. Those health equity efforts are made more effective with social determinants of health analytics that provide a comprehensive view of the interconnected factors influencing a patient’s health.

How Registries Can Advance Health Equity

Alongside several of our partners at medical specialty societies, we see the very real effects of longstanding and systemic health disparities – made evident through evaluating data in their registries.

Registries collect a high-volume of data from different sources and deliver high-quality, data-driven insights. Efforts to reduce health disparities require data to detect and measure the impact of disparities, identify the complex and interconnected determinants, and inform interventions and best practices.

Efforts to advance health equity through registries fall into three activities:

• Measuring health disparities. To reduce health inequities, we need methods to measure disparate health outcomes and methods to assess the impact of those disparities across different types of health indicators.
• Assessing underlying factors. Effectively addressing health disparities requires understanding the underlying factors influencing disparate outcomes.
• Forming and evaluating interventions. By assessing health disparities and their underlying factors, we will have insights to develop impactful interventions and sustaining widespread health equity improvements through tracking best practices.

2. Helping Patients Understand Their Care and Outcomes

Healthcare is complex. Patients can be overwhelmed as they try to understand, navigate, and make important decisions about their care.

Consider a patient with a chronic condition who might have up to 20 healthcare providers, all generating assessments and treatment plans that must be coordinated and aligned. Even people who have spent their life working in healthcare can feel overburdened by the amount and complexity of information presented to patients.

More patients are now turning to technology to help them through their care journey. And now more technology is becoming patient-centric to help patients overcome common barriers they face in their healthcare.

For example, registries can offer patient engagement tools that provide patients with meaningful support as they interact with their health. Registry patient portals should offer key types of support to improve patient experiences and health outcomes:

• Instrumental Support. Tangible services and functions, such as capabilities to directly connect to their care team or participate in clinical trials or research.
• Informational Support. Connection to tailored patient resources that provide advice, suggestions, and clinical insights.
• Appraisal. Personalized registry data can be presented back to patients in easy-to-review graphs. This can show patients how they are progressing throughout their treatment, which helps patients to self-evaluate their progress and health experiences.

As described by Donna Cryer, JD, President and CEO of the Global Liver Institute, these patient-centric technologies give patients supportive communities and influential tools to elevate a patient’s voice and help them maximize their health.

3. Understanding a Global Pandemic

Monitoring, managing, and understanding COVID-19 was top-of-mind throughout several sessions. Registries are playing a central role in this.

Modern registries can address emerging health issues like the pandemic with rapid measurement and quick discoveries.

There are three key parts to doing this successfully:

• Determining the priorities and research questions a registry can uniquely answer.
• Using trusted data and advanced analytics to address critical issues.
• Leveraging a flexible data infrastructure to pivot at any time – modern clinical data registries are designed to evolve.

Several organizations are already leveraging their registries and data infrastructure to be proactive in measuring, monitoring, and addressing the COVID-19 pandemic. You can learn from them and find more strategies in our blog post “Best Practices for Clinical Registries with New Research Priorities.”

Registry Technology Should be People-Centric

Overall, digital transformations are about using technology to solve issues for people, not simply about using people to solve technology issues.

It is less about being technology-centric than it is about making technology people-centric. Registries are powerful tools that can be designed to address some of the most widespread health issues affecting people, while also engaging patients in innovative ways to improve their health experiences.

From defining the vision for a registry program to designing surveys and reports for clinicians and patients, we take a person-driven approach.

Medical specialty societies were founded on two key principles: knowledge sharing and the exchange of clinical insights to improve medical practice. That central task has evolved as societies use clinical data registries to serve diverse and important stakeholders who are also involved in ensuring optimal health outcomes.

These clinical data registry stakeholders include:

• Clinicians
• Health Systems, Hospitals, and Provider Organizations
• Patients
• Public and Private Payers, and
• Life Science Organizations (Pharmaceutical and medical device companies)

Societies and their registries are vehicles to further data-driven care through collaboration with these health care stakeholders. New opportunities frequently arise for registries to add unique value through the data insights they provide — especially through partnerships with life science organizations.

Specifically, there are four common ways for registries to empower life science organizations with new understandings in patient outcomes. These opportunities further support real-time insights in clinical care.

1. Patient Cohort Analytics
2. Post-Market Surveillance
3. Clinical Decision Support
4. Registry-Based Clinical Trials

Let’s examine each to understand their value to industry and value to your mission.

1. Patient Cohort Analytics and Registries

Patient cohort analytics are useful in several ways. They provide analytic tools to facilitate activities like clinical trial enrollment and registry cohort comparison for research.

Registries transform raw data into tools that provide tremendous value to trial sponsors in two ways:

1. Identification of individual patients who match a specific cohort of interest and meet clinical trial inclusion and exclusion criteria. This allows trial sponsors to expand their trial network beyond standard academic centers and into community care settings, and through rapid enrollment of trial participants.
2. Creation of comparison cohorts of registry patients through propensity-score matching. This allows trial sponsors to allow for fair and accurate comparison between treatment cohorts within a trial external to the registry and non-treatment patients found within the registry.

2. Post-Market Surveillance and Registries

Patient registries are uniquely useful in their ability to facilitate post-market surveillance for three reasons:

1. They advance post-market surveillance activities to help us better understand the real-world safety and effectiveness of procedures, treatments, and devices.
2. They solve complex problems for device and pharma companies. These organizations in general are faced with complex barriers when seeking real-world data for purposes of research and development, quality improvement, or regulatory requirements.
3. They deliver the comprehensive technology needed to build a registry that collects real-world data, transform it into real-world evidence, and make it accessible and useful.

Simply stated, registries provide real-time answers to common post-market surveillance questions, like:

• How is a device or drug actually used in real-world settings?
• What does the average patient look like?
• How does a product truly perform?

3. Clinical Decision Support and Registries

Clinical decision support tools convert retrospective registry data into powerful point-of-care tools with immediate impact on patient care.

Decision support tools are built to take the guess work out of trade-off decisions between treatment courses. With real-world data and a user-friendly interface, decision support apps are valuable resources. They enable clinicians and patients to prioritize outcomes and establish appropriate expectations.

At the same time, decision support tools can be designed to demonstrate the degree to which device or pharmaceutical factors drive outcomes. These tools create significant value for industry stakeholders and set the stage for value-based reimbursement.

4. Clinical Trials and Registries

Registry-based clinical trials (RBCTs) set the gold standard for creating value for multiple stakeholders.

RBCTs rely on the registry’s network of participating clinicians, their patients, and the foundational registry dataset. They identify participating investigators and clinicians, facilitate patient enrollment, and support the majority of data elements required for trial completion. Registries also capture specialized clinical trial data through custom patient surveys, electronic case report forms, and data mapping.

The process ultimately leads to a clinical trial completion that is much quicker and more cost-effective than traditional methods.

Registry Data Partnership Readiness

There are a few key steps to determining your organization’s readiness for registry data partnerships with industry.

1. Understand the market opportunity. To design an effective program, conduct market research to understand who would find value in your registry data, what products or therapies they have on the market, and how those products are valued.
2. Assess your registry data. You’ll need to know what data in your registry would be valuable to medical device manufacturers or pharmaceutical companies. Assess those clinical situations where real-world registry data tracks either clinical practice or patient populations that can’t be easily studied via traditional trials.
3. Validate your registry data quality. Data quality is important for any registry work. Before initiating registry-based clinical trials or making de-identified registry data available to industry, you want to ensure the data quality is regulatory-grade. Achieving this requires a thorough data quality analysis to assess data integrity across dimensions such as completeness, concordance, precision, and currency.

Developing Registries for Many Stakeholders

Registries are powerful tools for effectively generating new clinical insights for key stakeholders and creating meaningful partnerships with life science companies.

These stakeholder collaborations use registries to employ valuable data tools to evaluate and improve patient outcomes, and in the process, help to further support the operations of registries and their underlying missions.

ArborMetrix offers an industry-leading, proven registry solution that meets the needs of medical device and pharma companies, medical specialty societies, and clinicians.

In the alphabet soup of healthcare, often the initial drivers of large-scale initiatives are government reporting and regulatory requirements, like All Payer Claims Databases (APCD) and Health Information Exchanges (HIE). These requirements encourage interoperability and data sharing between stakeholders.

These efforts aren’t new or news – but the past decade has focused on identifying assets, bringing the data in, and analytics that match patients across sources.

Government agencies at all levels (both in the U.S. and abroad) are moving into the next phase of this journey. They are going beyond data access and blending and focusing on using the data strategically to improve care and lower costs.

Registries Power Population Health Programs

When faced with a large population data set, it can be a challenge to target a single focus area that has both meaning and impact. Clinical data registries are a perfect example of macro-level data used for micro-level initiatives. When these targeted initiatives achieve measurable results, this leads to tremendous power for population health initiatives.

We’ve seen the role registries play in quality improvement successes at specialty-focused organizations. They’ve driven important and renowned innovations in care delivery. This has been accomplished through the symbiotic relationship between a culture of engaged physicians and the use of trusted data and powerful technology. The technology allows for a window into physician performance and patient outcomes.

When planning how to make a patient registry part of your population health program, there are two parts to consider:

1. Registry Technology
2. Registry Strategy

Part 1: Technology of Building a Clinical Data Registry for Population Health

A clinical data registry is built on the ingestion of real-world data and the transformation of that data through advanced analytics into actionable real-world evidence. Let’s break this process down into 3 key steps.

1. Data Acquisition: Acquisition can include a broad spectrum of options. One option is machine-to-machine connections to EHRs, government assets, and other databases. There are also human-to-machine connections as needed for data entry from providers and patients. This includes more granular disease-specific elements and longitudinal outcomes outside of routine care visits.
2. Data Assembly: Assembly can include validation and cleansing for quality, and transformation for analytic purposes. This includes creation of clinically specific measures, risk adjustment for fair case mix comparisons, patient matching, benchmark creation, predictive models, and more. This transformation is key to building trust in the data.
3. Acting on Evidence: Leveraging evidence is facilitated by our intuitive and user-friendly AMxCore product that provides visibility into all individual data elements attributed to patients, as well as aggregate reporting that provides deep insights into trends, patterns, and opportunities for change.

In large initiatives, so much time is spent on acquiring data that transforming it and utilizing it effectively are afterthoughts. While data is foundational and fundamental, a strong strategy behind the technology ensures a speed to value and long-term registry success.

Part 2: Strategy of Building a Clinical Data Registry for Population Health

A registry toolset needs to go beyond technology and data access and produce information of such quality that it can be relied upon to improve the standard of care across entire health systems, states, or countries.

At its strategic core, a registry is a very simple concept broken into 3 parts.

Curated Data Elements

The curated data elements are considered and selected from the broad set of data assets available and used to create a defined Data Dictionary. While in some cases, gathering as many data elements as available has value (often the foundation of initiatives like HIEs and APCDs), most successful quality improvement initiatives only utilize a subset of these elements. Strategically curating these assets ensures the most relevant and meaningful elements are being collected, validated, and transformed for purpose-driven use in the context of specific diseases or conditions.

Measurement Strategy

The measurement strategy transforms data into information through the rigorous application of data science principles. These principles create trusted data assets that can quantify outcomes and identify the drivers of those outcomes. This trusted data gives, agencies, hospitals, or physicians the resources they need to better understand and improve care. This is the strategic heart of a registry – data that is trusted to enact important care delivery changes.

Targeted Focus

A targeted focus is the identification of high-priority questions your agency or organization needs to answer about the providers, patients, and processes under your influence. Starting with a focus ensures that you are pointed at achievable opportunities for change.

Think: reduce surgical site infection rates, not reduce mortality. This focus ensures that you are targeting true opportunity for improvement that will be measurable and repeatable across the system of care.

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Operationalize Large Scale Quality Improvement

When you apply this strategic framework on top of strong registry technology, you can operationalize and catalyze large scale improvements in care delivery – across organizations, agencies, and around the world. To learn more about how to evaluate your registry technology, check out my post: 3 Technology Essentials for Patient Registries that Improve Care.