While electronic health record data has the potential to be reused to identify which patients may be eligible to participate in clinical trials, the data capture is too incomplete and "fragmented" to be relied on for such a secondary use, according to new research published in BMC Medical Informatics & Decision Making.
Typically, eligibility criteria defined in study protocols is in free text, while the data in EHRs is collected as single elements, such as current disease or patient age.
The researchers sought to determine to what extent patient data requested in eligibility criteria is available from the EHRs of tertiary care providers. They used the EHR data of five different German University hospitals and 15 different clinical trials, breaking down the sentences in the clinical trial eligibility protocols into "patient characteristics," and then matching them to corresponding data elements in the EHRs.
The researchers found that, for the most part, the completeness of data for patient recruitment using this method was inadequate, with the overall completeness of data only 35 percent. Certain data elements, such as age and gender, were complete for 90 percent of patients, but the completeness of other data--such as medications and co-morbidities--was only 10 percent.
"Unfortunately, the absence of patient conditions is usually not recorded during treatment which leads to missing data," the researchers said. "Evaluating patient eligibility based on partly missing data risks missing eligible patients and the introduction of selection errors. ... We believe that manual review and additional documentation will remain necessary for most clinical trials."
Other studies have pointed to the future use of EHR data mining for identifying clinical errors, patients at risk of additional illness and research subjects.
To learn more:
- read the study