Researchers analysed if patient data as captured by EMR databases could be used to obtain information as effectively as randomised clinical trials, when evaluating drug therapies. “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,” lead researcher Richard Tannen says.
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 randomised trials.
To address criticisms, 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. The team selected six previously performed randomised 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 eight million patients. Treatment efficacy was determined by the prevalence of cardiovascular outcomes, such as stroke, heart attack and death.
After using standard biostatistical methods to adjust for differences in the treated and untreated groups in the analysis of the database information, there were no differences in the database outcomes compared to randomised 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 randomised clinical trials.
Though Tannen warns the ability to use EMR databases from the U.S. to measure the efficacy of therapies will take more than ten years of national data, he says the results of his study should serve as a catalyst for more research.
MEDICA.de; Source: University of Pennsylvania School of Medicine