It's just over five years since the U.K. Medicines Control Agency (now MHRA - Medicines and Healthcare products Regulatory Agency) assumed management responsibility for the U.K.'s General Practice Research Database (GPRD). Having achieved the initial objectives of reversing the declining contributing GP population, providing secure on-line access to all data and data quality markers via the newly developed FF-GPRD and reducing service fees, recent attention has focussed on:

• the development of tools to support researchers including
  • matching of cases to controls , e.g. by age, sex, practice, index date
  • daily dose conversion which translates unstructured free text into a numerical value
  • mappings of the clinical and drug/product terms used at data entry to hierarchical terminologies (MedDRA and ATC/GPRD Drug Dictionary respectively) and development of browsers to support the development and usage of comprehensive code lists.

• implementation of new services, for example
  • source data verification / follow-up questionnaires etc. for practices
  • key word searches of free text and provision of anonymised free text for selected patients

• increasing awareness of the broad range of research applications for the data

• expanding the Division's Research Team, which now comprises eight staff

The GPRD Division of the MHRA is the only source of updated GPRD data. Researchers using the FF-GPRD have been very enthusiastic about the richer, more structured data available from practices using Vision software compared to the historical VAMP Medical software and about recent changes in primary care which have had beneficial impact on GPRD data. For example, roughly 85% of GPRD practices now receive data electronically from laboratories. This is transferred into the patient record enabling researchers access to quantitative results and laboratory normal ranges as well as the qualitative descriptions available previously.

The new General Medical Services contract, which determines salary for about 75% of General Practitioners, will act as a major driver for more comprehensive data recording for chronic diseases. The contract's Quality and Outcomes Framework purports to resource and reward GPs on the basis of how well they care for their patients focussing on : coronary heart disease (including left ventricular dysfunction), stroke and transient ischemic attacks, hypertension, hypothyroidism, diabetes, mental health, chronic obstructive pulmonary disease, asthma, epilepsy, cancer.

Practices will be audited annually to determine the extent to which they are complying with framework guidance and the consequent impact on clinical outcomes. For example, in patients with diabetes, practices will receive payment on the basis of: their ability to produce a register of all patients with diabetes mellitus; evidence in the patient record of a recording of BMI, smoking status, HbA1C level, retinal screening, neuropathy testing, blood pressure, serum creatinine, total cholesterol and microalbuminuria testing within the previous 15 months and the percentage of diabetic patients whose last measured HbA1C was 7.4 or less in the last 15 months. Obviously practices need to ensure that they are recording such data in full to ensure they are remunerated appropriately. These data will be recorded in the patient record, extracted for the FF-GPRD and available for researchers.

Radical changes in the National Health Service (NHS) in England will be introduced via the Department of Health's National Program for IT (NPfIT). The Department is investing £6.2 billion ($11.1 bn; €9.2bn), in what is reported to be the largest IT program in the world, to implement a modern integrated IT infrastructure for all NHS organizations in England by 2010. The NPfIT deliverable of most importance to epidemiologists is the electronic Care Records Service which will provide a cradle-to-grave record for each patient across primary and secondary care.

Much of the NPfIT is at a design or an option appraisal stage so it is only possible to make general comments about its possible impact on research and databases such as FF-GPRD. Clearly it offers scope for achieving the "holy grail" of access to longitudinal integrated primary and secondary care data for large cohorts of individual patients, possibly even the whole population. In the UK excitement about the possible opportunities for enhancing public health research is being tempered by recognition of the significant technical challenges to be overcome and culture change needed in the NHS for successful implementation of the NPfIT.

You can keep in touch with GPRD developments via our website (www.gprd.com), Newsletter and User Group meetings (contact Gwenda Hughes at Gwenda.Hughes@mhra.gsi.gov.uk).

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