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Pragmatic Clinical Trials Leverage Valuable Informatics Tools

September 13, 2017
by David Raths
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PCORI-funded centers developing approaches to identify and recruit potential patients and gather data

As the Patient-Centered Outcomes Research Institute (PCORI) funds more comparative clinical effectiveness research studies, informatics researchers are developing new tools to identify and recruit potential patients and gather data.

On Sept. 12, the Patient-Centered Outcomes Research Institute (PCORI) board approved spending $97.9 million to fund 11 studies comparing different approaches to improving care for a range of health conditions.

These comparative clinical effectiveness research studies rely heavily on informatics infrastructure to recruit patients and gather data.

In a recent presentation at Duke University, Russell Rothman, M.D., the vice president for population health research at Vanderbilt University Medical Center, described some of the informatics infrastructure of one PCORI-funded study, ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness).

ADAPTABLE is a $14 million, three-year pragmatic clinical trial that is comparing the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. Its goal is to enroll 20,000 patients. Pragmatic trials are designed to reflect “real-world” medical care by recruiting broad populations of patients, embedding the trial into the usual healthcare setting, and leveraging data from health systems to produce results that can be readily used to improve patient care.

The Duke Clinical Research Institute is the coordinating center for ADAPTABLE.

Dr. Rothman, who serves as the co-chair of the steering committee of the study, is also the principal investigator of the PCORI-funded Mid-South Clinical Data Research Network (CDRN), centered at Vanderbilt University Medical Center (VUMC). The CDRN includes academic health centers, community hospitals and a range of outpatient practices including primary care, specialty practices and safety net facilities that serve diverse populations across the Southern United States.

The Mid-South CDRN has data on 9 million patients, Rothman said. “We have data going back to as early as 2004 in the network,” he added.

It encompasses three large health systems:

 • The Vanderbilt Health System, which currently includes electronic medical records for over 2 million patients;

• The growing Vanderbilt Healthcare Affiliated Network (VHAN), which currently includes 45 hospitals, 300 ambulatory practices, and will cover over 3 million patients in the mid-South;

•  A partnership with Greenway Health and other national organizations to provide access to over 1,600 practices and 16 million patients across the country; and

•  The Carolinas Collaborative, which includes University of North Carolina at Chapel Hill, Duke University and Health Sciences South Carolina and reaches over 9 million patients.

The CDRN also has been working on linking EHR data to claims data such as an all-payer claims database in Tennessee to get more complete pictures about patients, which Rothman said is key to studying outcomes.

The Mid-South CDRN has developed tools and capacities to support comparative effectiveness research and pragmatic research. It has methods to develop and validate computable phenotypes for identification of particular patient groups.  It can extract clinical data from electronic health records, claims, and other data sources.  It also has developed tools for electronic identification, contact, consent and recruitment of patients. 

Based on his presentation and details from the CDRN website, here are some tools developed to support pragmatic clinical trials:

DATA

The Mid-South CDRN uses the PCORnet Common Data Model Version 3 as the main syntactic and semantic standard. It leverages standard terminologies and coding systems for healthcare to enable interoperability with and responsiveness to evolving data standards.

They have taken EHR data from health systems and transformed it into the common data model to run queries against. There are 80 such data marts nationwide. 

The CDRN also used REDCap, a secure, web-based application that allows users to build and manage online databases and surveys.

REDCap uses a study-specific data dictionary to eliminate all programming requirements for the creation of electronic case report forms and participant survey instruments for individual studies.

PHENOTYPING

The Synthetic Derivative Record Counter (RecordCounter) is a web-based tool that provides exploratory data figures for research planning purposes and feasibility assessment. The RecordCounter allows the user to input basic medical data such as demographic information, ICD 9 and CPT codes, medications, labs, keyword document searches, as well as searching for available genetic data on subjects.

The Phenotype Knowledgebase website, PheKB, is a collaborative environment for building and validating electronic phenotype algorithms. PheKB has tools to enable cross-site collaboration for algorithm development and validation. These include electronic discussion and phenotype update notifications for a given phenotype; the ability to post algorithm validation details and tools for validation of algorithms including chart review forms and automated calculation of validation statistics such as specificity and sensitivity; and an integrated data dictionary and dataset validation tool used to ensure consistent formatting and coding of data sets to be shared.

RECRUITING

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