February 07, 2009
Using EMRs To Study Drug Efficacy
For years controversy has surrounded whether electronic medical records (EMR) would lead to increased patient safety, cut medical errors, and reduce healthcare costs. A new study suggests that there is another bonus from the implementation of electronic medical records: testing the efficacy of treatments for disease. Researchers from the University of Pennsylvania School of Medicine evaluated if patient data, as captured by EMR databases, could be used to obtain vital information as effectively as randomized clinical trials, when evaluating drug therapies. Their findings were published this month in the British Medical Journal.
Dr Richard Tannen, lead researcher and his group recognized that the large EMR databases containing compiled medical information could potentially give researchers the ability to study groups reflective of the total population, not just those who participate in clinical trials, and circumvent studies too costly or unethical for clinical trials. However, such databases contain observational information, which critics argue do not offer the same level of control as randomized trials.
“Our study cautiously, yet strongly, suggests that enormous amounts of information within electronic medical records can be used to expand evidence of how we should or shouldn’t manage healthcare,” Tannen says.
To address criticisms of observational studies, Tannen’s group had to first determine a way to use EMR databases for insights on therapy efficacy and then prove the results they found were valid. Beginning six years ago, the research team selected six previously performed randomized trials with 17 measured outcomes and compared them to study data from an electronic database -- the UK general practice research database (GPRD), which included the medical records of roughly 8 million patients. After using standard biostatistical methods to adjust for differences in the treated and untreated groups in the analysis of the database information, Tannen found that there were no differences in the database outcomes compared to randomized clinical trials in nine out of 17 outcomes.
In the other eight outcomes, Tannen’s group used an additional new biostatistical approach they discovered that controlled for differences between the treated and untreated groups prior to the time the study began. By using the new biostatistical method instead of the standard approach, the researchers showed there were no differences between the outcomes in the EMR database study compared to the randomized clinical trials.
“Our findings show that if you do studies using EMR databases and you conduct analyses using new biostatistical methods we developed, we get results that are valid,” states Dr Tannen. “That’s the real message of our paper — this can work.”
The authors warn that the ability to use EMR databases from the United States to measure the efficacy of therapies will take more than 10 years of national data, the results of this study should serve as a catalyst for more researchers to explore the accuracy of the information that can be obtained using EMR database studies.
“An appropriately configured EMR database could offer an invaluable tool, but we need to get to work now on how to configure it properly,” Tannen says. “If we don’t worry about this issue right now and promote a higher investment in the area of EMR research, we’ll lose an opportunity, an enormous health opportunity.”
BMJ Article
(full text)