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General practice research databases are increasingly used to study intended and unintended effects of treatments. However, confounding by indication remains a major problem. The randomized database study methodology has been proposed as a method to combine the strengths of observational database (generalizability) and the strength of the randomized clinical trial (RCT) design (randomization). We developed an infrastructure that enables the execution of randomized database studies with treatment randomization facilitated by a general practice research database. The requirements posed by the methodology of randomized database studies were facilitated by software components. Our assessment showed that it is technically possible to conduct randomized trials in general practice according to the randomized database design. The infrastructure facilitated the conduct of randomized database studies in general practice but some practical difficulties and methodological issues remain. The technical infrastructure seems to be both promising and potentially feasible to facilitate future randomized database studies, although the methodology needs to be evaluated in more detail. [ABSTRACT FROM AUTHOR]

Objectives: As information technology creates opportunities for cooperation which crosses the boundaries between healthcare institutions, it will become an integral part of the Dutch healthcare system. Along with many involved organizations in healthcare the National IT Institute for Healthcare in the Netherlands (NICTIZ) is working on the realization of a national IT infrastructure for healthcare and a national electronic patient record (EPR)., Methods: An underlying national architecture is designed to enable the Dutch EPR virtually, not in a national database, nor on a patient's smartcard. The required secure infrastructure provides generic functions for healthcare applications: patient identification, authentication and authorization of healthcare professionals., Results: The first national applications in the EPR program using a national index of where patient data is stored, are the electronic medication record and the electronic record for after hours GP services. The rollout of the electronic medication record and electronic record for after hours GP services has been started in 2007., Conclusions: To guarantee progress of electronic data exchange in healthcare in the Netherlands we have primarily opted for two healthcare applications: the electronic medication record and the electronic record for after hours GP services. The use of a national switch-point containing the registry of where to find what information, guarantees that the professional receives the most recent information and omits large databases to contain downloaded data. Proper authorization, authentication as well as tracing by the national switchpoint also ensures a secure environment for the communication of delicate information.

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 surveillance 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.

Objectives: To quantify the risk of skin reactions to antibacterial drugs under everyday circumstances in a large population with automated data from general practitioners (GP)., Design: A retrospective cohort study in a dynamic population., Setting: Data came from the Integrated Primary Care Information (IPCI) database. The IPCI database consists of all data on consultations, morbidity, and prescriptions and other interventions, as registered by the GP in a source population of approximately 150,000 persons., Methods: The study period started on April 1, 1994, and ended on September 30, 1995. All patients who were treated with an antibacterial drug were enrolled on the first day of starting treatment until the end of the study period or until the occurrence of one or more of the following diagnoses within the risk period: allergic reaction, rash, erythema, pruritus and urticaria, or a notification of a skin reaction in the free text. Subsequently, patient profiles were assessed by two authors who were blinded to exposure. The risk period was defined as the legend duration of the antibacterial drug plus 14 days to control for carry-over of drug effects and delay in patient presentation. Age, gender, and comedication were examined as potential confounders., Results: In the study period 13,679 patients received 19,961 prescriptions of an antibacterial drug. It concerned 5330 men (39.0%) and 8349 (61.0%) women with a mean age of 41 and 42 years, respectively. One hundred thirty-five patients developed a skin reaction in the risk period. Rash, pruritus, urticaria, and miscellaneous skin reactions were encountered in 76 (56.3%), 18 (13.3%), 19 (14.1%), and 22 (16.3%) patients, respectively. The three most frequently reported causes of skin reactions were combinations of trimethoprim with sulfonamides (2.1% of users; incidence density [ID]: 2.1/1000 exposed days), fluoroquinolones (1.6% of users; ID: 1.5/1000 person days), and penicillins (1.1% of users; ID: 1.3/1000 person days). Compared to tetracyclines, the broad-spectrum penicillins showed an incidence density ratio (IDR) of 3.7, the combination of amoxicillin with clavulanic acid of 3.3, the fluoroquinolones of 2.8, and the combination of trimethoprim with sulphonamides of 4.4. The presence of infectious mononucleosis increased the risk of rash in amoxicillin users with a factor of 58., Conclusions: We found that the frequency of skin reactions to antibacterial drugs in general practice is around 1% and highest for the combination of trimethoprim with sulphonamides, penicillins, and fluoroquinolones. The outpatient incidence for skin reactions is probably lower than the incidence in hospitalized patients. Although this may be partly explained by negative misclassification, it is also likely that the actual incidence is lower as some hospitalized patient groups may be more prone to develop a skin reaction.

Objectives: To determine the risk of coughing as an adverse reaction to ACE inhibitors under everyday circumstances in a large population, and to study whether this adverse effect was duration or dose dependent., Design: A population-based case-control study., Setting: Ten general practices of 14 Dutch general practitioners (GP), in which all consultations, morbidity and medical interventions, including drugs prescribed, were registered over the 18 month period from 1st September, 1992 to 1st March, 1994., Subjects: 1458 patients with incident coughing and up to four controls per case were obtained (total 4182 controls), matched for GP. All cases and controls were 20 years or older and had no record of respiratory infection, influenza, tuberculosis, asthma, chronic bronchitis, emphysema, congestive heart failure, sinusitis, laryngitis, haemoptysis or respiratory neoplasms during the study period., Results: Cases were 2.1-times more likely than controls to have been exposed to ACE inhibitors (95% CI 1.5-3.1), but after adjustment the odds ratio was 1.4 (95% CI 0.9-2.1). The crude odds ratio for captopril was 1.3 (95% CI 0.7-2.5), for enalapril 2.6 (95% CI 1.6-4.2) and for lisinopril 2.0 (95% CI 0.5-9.3). The adjusted odds ratio for captopril was 0.9 (95% CI 0.4-1.7), for enalapril 1.7 (95% CI 1.03-2.8) and for lisinopril 1.7 (95% CI 0.4-7.9). For patients who had been on ACE inhibitor treatment for no longer than 2 months the odds ratio was 4.8 (95% CI 1.7-13.3). The odds ratio declined to 2.0 (95% CI 1.1-3.8) for those who had taken an ACE inhibitor for 2-6 months, and to 1.6 (95% CI 0.9-2.7) for those on ACE-inhibitors for more than 6 months., Conclusion: The risk of coughing was increased twofold among ACE inhibitor users, but the odds ratios were no longer significant after controlling for several confounding factors. The risk of developing cough due to ACE-inhibitors declines with the duration of treatment, possibly due to depletion of susceptible persons.

Postmarketing Surveillance (PMS) concerns the investigation of side-effects of drugs after they are introduced into the market. Traditionally, data collection for PMS-studies has been paper-based. The increasing number of general practitioners (GP) that use Computer-Based Patient Records (CBPR) and the central role these general practitioners in the Netherlands play in the delivery of care makes the use of CBPRs as a resource of data for PMS studies possible. Analysis of the current available CBPRs, however, proved them insufficient for PMS studies, because too much data is available only in free text, and other necessary data for PMS is lacking. To make the CBPR suitable for PMS, we had to build a software-module that could be plugged into the computer system of the GP. The module checks the data immediately after they it has been entered into the system, and missing data is requested. Initial filed studies have shown that, with this module, the collection of PMS data is feasible.