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Objective-To determine the extent of agreement between clinical information recorded on surgery computers of selected general practitioners and similar information in manual records of letters received from hospital consultants and kept in the general practitioners' files.Design-Hospital consultants' letters in the manual records of selected general practitioners were photocopied and the consultants' clinical diagnoses were compared with diagnoses recorded on computer.Setting-General practices in the United Kingdom using computers provided by VAMP Health for recording clinical information.Subjects-2491 patients who received one of three non-steroidal anti-inflammatory drugs and who attended 58 practices whose computer recorded data were considered after a preliminary review to be of satisfactory quality.Results-Among 1191 patients for whom consultants' letters were forwarded a clinical diagnosis reflecting the diagnosis noted on a consultant letter was present on the computer record for 1038 (87%).Conclusion-Clinical information available on the computer records of the general practitioners who participated in this study is satisfactory for many clinical studies.

The United Kingdom General Practice Research Database (GPRD) is an office-based, computer-generated, medical resource designed from its inception to be used for epidemiologic research. A distinct version of the GPRD is maintained by the Boston Collaborative Drug Surveillance Program and has been the source of more than 130 scientific articles primarily addressing drug safety issues. We reviewed evidence related to the validity of the GPRD. Specifically, with our extensive experience with this automated database, we evaluated the quality and completeness of the data that it contains.

N 1991 THE US FOOD AND DRUG Administration (FDA) held a public meeting to address widespread concerns that a recently marketed selective serotonin reuptake inhibitor (SSRI) antidepressant, fluoxetine (Prozac), was causing severe suicidal behaviors. Dozens of attendees related personal experiences that described such behavior in relatives and friends shortly after they had started taking fluoxetine for depression. 1 Subsequently, a meta-analysis of clinical trial data pooled from 17 double-blind studies conducted by Eli Lilly & Co, the marketer of fluoxetine, concluded that "data from these trials do not show that fluoxetine is associated with an increased risk of suicidal acts. . . ." 2 The authors of 2 formal epidemiological studies on the relation of fluoxetine and suicidal behavior concluded that the findings indicated that the risk of such behavior in fluoxetine users was not materially different from that among users of certain other commonly prescribed antidepressant drugs. 3,4 More recently questions about the safety of paroxetine, another SSRI, in relation to suicidal behavior have been the subject of public broadcast programs such as Panorama in the United Kingdom, which highlighted a possible increased risk in young people.The UK Committee on Safety of Medicines issued an interim report of an Author Affiliations are listed at the end of this article.

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Background: Thiazolidinediones may adversely affect the skeleton owing to decreased bone formation and accelerated bone loss.Methods: This study examines the association between the use of thiazolidinediones or other oral antidiabetic drugs and the risk of fracture. This nested casecontrol analysis uses the UK General Practice Research Database, including case patients with fracture aged 30 to 89 years with an incident fracture diagnosis between January 1994 and December 2005 and control subjects who were matched to case patients on age, sex, calendar time, and general practice attended. We assessed the odds ratios (ORs) of having a fracture associated with the use of rosiglitazone maleate, pioglitazone hydrochloride, other oral antidiabetic agents, or insulin.Results: There were 1020 case patients with an incident low-trauma fracture and 3728 matched controls. After adjustment for age, body mass index, other antidia-betic drugs, comedication, and comorbidities, the ORs for users of 8 or more thiazolidinedione prescriptions (corresponding to approximately 12-18 months of therapy) compared with nonuse was 2.43 (95% confidence interval [CI], 1.49-3.95). Rosiglitazone (OR, 2.38; 95% CI, 1.39-4.09) and pioglitazone (OR, 2.59; 95% CI, 0.96-7.01) were used more frequently by case patients with fracture (predominantly hip and wrist fractures) than by controls. The association was independent of patient age and sex and tended to increase with thiazolidinedione dose. No materially altered relative fracture risk was found in association with the use of other oral antidiabetic drugs. Conclusion:This analysis provides further evidence of a possible association between long-term use of thiazolidinediones and fractures, particularly of the hip and wrist, in patients with diabetes mellitus.