Results Summary
PCORI funded the development of PCORnet®, the National Patient-Centered Clinical Research Network, to make research faster, easier, and less costly to conduct. PCORnet is made up of Partner Networks of healthcare systems, patients and communities, and health plans that harness the power of large amounts of health data.
PCORI supports projects, designed in partnership with federal funding organizations, to improve the quality of data used in clinical research. This project is one of several designed to assess the feasibility of linking patient-level data from research networks with other sources, including disease registries and health plans.
What was the project about?
Patients whose heart valves don’t work correctly may need a heart valve replacement. Patients in the United States who get a heart valve replacement become part of the Transcatheter Valve Therapy Registry, or TVTR. Patient registries store data about people with a specific health problem. Patient information in the TVTR is used in research studies. It’s also used to monitor the heart valve devices used in valve replacement surgery. But the TVTR doesn’t always include information about patients’ health after surgery. Adding that information would make the TVTR more useful.
PCORnet provides secure access to information about test results and treatments from patients’ health records. This shared data includes information from eight sites in a clinical data research network that’s part of PCORnet. In this project, the team had three goals:
Goal 1. Link the TVTR data with PCORnet data and Medicare data for patients who had surgery to get heart valve devices.
Goal 2. See whether the PCORnet and Medicare data had other data not currently in the TVTR.
Goal 3. Create a way to add results from echocardiograms to the PCORnet data, Medicare data, and TVTR. Echocardiograms use sound waves to take pictures of the heart.
What were the results?
Goal 1. The project team successfully linked TVTR and PCORnet data for 96 percent of patients who had surgery to get heart valve devices at one of the eight hospitals.
Goal 2. The project team found that combining PCORnet and Medicare data with TVTR added more information about patients’ health. For example, PCORnet and Medicare data added details about events that happened in the hospital, like strokes and irregular heartbeats. Both PCORnet and Medicare data also added details on events that happened after patients left the hospital, like strokes and death.
Goal 3. The project team created a way to link echocardiogram results into the PCORnet data. The team found that combining this new PCORnet data with TVTR data added more information about patients’ health.
What did the project team do?
The project team matched PCORnet health record data with the TVTR to create linked records for patients who had surgeries to get heart valve devices. Patients had surgery between 2011 and 2016. The team used a secure environment to protect patients’ information. The team also got a copy of the TVTR from 2011–2016 linked with Medicare claims data. They linked these records to records in the TVTR database.
What were the limits of the project?
PCORnet data don’t use a unique patient ID. This means that it’s hard to track patients if they get care at a different place from where they had surgery. Medicare data were only available for patients over age 65.
Future projects could have doctors review medical charts to see why each data source reports on different problems.
How can people use the results?
Researchers can use the database when doing studies about patients who had heart valve device surgery.
Professional Abstract
PCORI funded the development of PCORnet®, the National Patient-Centered Clinical Research Network, to make research faster, easier, and less costly to conduct. PCORnet is made up of Partner Networks of healthcare systems, patients and communities, and health plans that harness the power of large amounts of health data.
PCORI supports projects, designed in partnership with federal funding organizations, to improve the quality of data used in clinical research. This project is one of several designed to assess the feasibility of linking patient-level data from research networks with other sources, including disease registries and health plans.
Objective
To demonstrate the feasibility of linking the PCORnet database, the Transcatheter Valve Therapy Registry (TVTR), and Medicare claims data; to compare the similarity of PCORnet and Medicare claims data with data in the TVTR; and to create a way to add new data elements into the linked database
Project Design
| Design Elements | Description |
|---|---|
| Design | Retrospective descriptive analysis project |
| Data Sources and Data Sets | Records of patients who underwent a transcatheter aortic or mitral valve procedure from 2011 to 2016 at 8 sites |
| Analytic Approach | Review of data from EHRs, the TVTR, and Medicare claims |
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The project had three aims:
Aim 1: Create a linked database for PCORnet electronic health record (EHR) data, the TVTR, and Medicare claims data for patients who underwent a transcatheter aortic or mitral valve replacement (TAVR) from 2011 to 2016 at eight sites that are part of the PCORnet network.
Aim 2: Compare differences in baseline characteristics and in-hospital outcomes between patients in the linked database versus patients not in the linked database. Compare the additive value of linking PCORnet EHR or Medicare claims data on in-hospital outcomes and postdischarge data with the TVTR, compared with the TVTR alone.
Aim 3: Establish data standards for quantitative and qualitative echocardiographic data recorded within PCORnet and integrate these data into the linked database.
The project team matched PCORnet EHR data and records from TVTR (including linked Medicare data) to create a combined data set for patients at eight sites in LHSnet, a PCORnet Clinical Data Research Network, between 2011 and 2016. The team used a secure environment to protect patients’ information. The team also obtained a copy of the TVTR registry from 2011 to 2016 linked with Medicare claims data. They linked these records to records in the TVTR using a unique TVTR-specific identifier.
Results
Aim 1: The project team successfully linked TVTR and PCORnet EHR records for 2,809 (96%) of 2,913 patients.
Aim 2: The project team found that baseline characteristics, demographics, and outcomes were generally similar between patients whose PCORnet EHR records did or did not link successfully to PCORNet.
The project team found that combining PCORnet EHR or Medicare claims data with TVTR provided added value across a number of data points compared with the TVTR data alone. For example, for in-hospital outcomes, both PCORnet EHR and Medicare claims data identified additional cases of atrial fibrillation, stroke, and percutaneous coronary intervention not captured in the TVTR data. Both PCORNet and CMS data also identified additional cases of postdischarge events including mortality, stroke, and atrial fibrillation.
Aim 3: All participating LHSNet sites were able to successfully integrate left ventricular ejection fraction (LVEF) data from echocardiographic data sources into the PCORnet Common Data Model (CDM). The project team surveyed the participating sites to come up with a collaborative set of parameters to define LVEF.
The project team found that combining the newly defined LVEF variable in the PCORnet CDM with TVTR alone provided added value at 30 days and one year post-procedure. In addition, a survey administered to participating sites at the completion of the project revealed that the majority of sites had their LVEF data stored either in the EHR or in a separate supplemental storage system with structured data elements that could be extracted through electronic query.
Limitations
PCORnet’s CDM does not use a unique patient identifier. Therefore, tracking patients is difficult if they get follow-up care at a different facility than where they underwent the TAVR. Also, Medicare claims did not include outpatient data and were only available for patients over the age of 65.
Conclusions and Relevance
The project team was able to link PCORnet EHR data to the TVTR. PCORnet EHR and Medicare claims data showed added value as each data set identified a greater number of fatal and nonfatal outcomes when linked with the TVTR compared with the TVTR alone.
Future Needs
Future projects can use chart reviews to investigate why TVTR showed fewer reported fatal and nonfatal outcomes than PCORnet EHR or CMS Medicare claims data.