Abstract
Researchers claim that data in electronic patient records can be used for a variety
of purposes including individual patient care, management, and resource planning for
scientific research. Our objective in the project Integrated Primary Care Information
(IPCI) was to assess whether the electronic patient records of Dutch general practitioners
contain sufficient data to perform studies in the area of postmarketing surveillance
studies. We determined the data requirements for postmarketing surveil-lance studies,
implemented additional software in the electronic patient records of the general practitioner,
developed an organization to monitor the use of data, and performed validation studies
to test the quality of the data. Analysis of the data requirements showed that additional
software had to be installed to collect data that is not recorded in routine practice.
To avoid having to obtain informed consent from each enrolled patient, we developed
IPCI as a semianonymous system: both patients and participating general practitioners
are anonymous for the researchers. Under specific circumstances, the researcher can
contact indirectly (through a trusted third party) the physician that made the data
available. Only the treating general practitioner is able to decode the identity of
his patients. A Board of Supervisors predominantly consisting of participating general
practitioners monitors the use of data. Validation studies show the data can be used
for postmarketing surveillance. With additional software to collect data not normally
recorded in routine practice, data from electronic patient record of general practitioners
can be used for postmarketing surveillance.
Keywords
Postmarketing Surveillance - Electronic Patient Record - General Practitioner - Validation
