EHRs Feed Clinical Research MachineOne-million-patient study provides further evidence that EHRs and analytics tools can advance clinical research.
The study, which was recently published in the online edition of the Journal of the American Medical Informatics Association, involved a team of data experts at MetroHealth Medical Center and Explorys Inc., a Cleveland Clinic spinoff company that provides a health data analytics platform.
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The study tried to find out whether height and/or weight can make a person more susceptible to blood clots in the lung or leg.
Using the Explorys tool, which standardized the data and de-identified patient information, researchers analyzed the clinical records of 959,030 patients, pooled from multiple healthcare organizations that use different EHR systems. Researchers examined the records of patients 26 years or older, going as far back as 1999.
The study found that a combination of obesity and height significantly increases the risk of blood clots. In fact, tall obese women were twice as likely to suffer from a blood clot in the lung or leg as shorter women of normal weight. Similarly, tall obese men are 20% more likely to get a blood clot than shorter men of normal weight.
[ To read about the role of EHRs in clinical research, see Health IT's next challenge: Comparative Effectiveness Research. ]
With regard to the racial makeup of patients, the study revealed that Hispanic women are about 50% less likely than white women to contract a blood clot. African-American women, the research shows, were twice as likely to develop a blood clot as white women.
In the male group, Hispanic men were about 20% less likely to get a blood clot than white men. However, black males have a 50% greater chance of contracting a blood clot compared to their white counterparts.
Unlike previous studies that have spent months or even years to complete research of this magnitude, the MetroHealth/Explorys data analysis took 11 weeks and involved only five people working part time, with no direct costs. "With the right clinical research informatics tools and EHR data, some types of very large cohort studies can be completed with minimal resources," the study states.
"This is a paradigm shift that can now occur for certain types of clinical research because we have all of this electronic data and we are starting to develop the tools to aggregate and analyze the data," said Dr. David Kaelber, chief medical informatics officer at MetroHealth. "This is a one-million-patient study--just imagine the resources that would be needed if we were going to try to recruit one million patients to a study and follow them for 13 years."
Kaelber, who is the lead author of the report, also said researchers can take advantage of analytics tools to circumvent the thorny issue of data privacy by de-identifying the data to make sure the information contains none of the privacy information that is protected by the Health Insurance Portability and Accountability Act. As a result, researchers do not need to go through the time-consuming human subjects' approval process with their institutions.
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