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Background: The controversy surrounding the actual and potential use of clinical databases partly reflects the huge variation in their content and quality. In addition, use of existing clinical databases is severely limited by a lack of knowledge of their availability. Objectives: To develop and test a standardised method for assessing the quality (completeness and accuracy) of clinical databases and to establish a web based directory of databases in the UK. Methods: An expert group was set up (1) to establish the criteria for inclusion of databases; (2) to develop a quality assessment instrument with high content validity, based on epidemiological theory; (3) to test empirically, modify, and retest the acceptability to database custodians, face validity and floor/ceiling effects; and (4) to design a website. Results: Criteria for inclusion of databases were the provision of individual level data; inclusion in the database defined by a common circumstance (e.g. condition, treatment), an administrative arrangement, or an adverse outcome; and inclusion of data from more than one provider. A quality assessment instrument consisting of 10 items (four on coverage, six on reliability and validity) was developed and shown to have good face and content validity, no floor/ceiling effects, and to be acceptable to database custodians. A website (www.docdat.org) was developed. Indications over the first 18 months (number of visitors to the site) are that it is increasingly popular. By November 2002 there were around 3500 hits a month. Conclusions: A website now exists where visitors can identify clinical databases in the UK that may be suitable to meet their aims. It is planned both to develop a local version for use within a hospital and to encourage similar national systems in other countries.

Objectives To describe the multicentre clinical databases that exist in the United Kingdom, to report on their quality, to explore which organisational and managerial features are associated with high quality, and to make recommendations for improvements. Design Cross sectional survey, with interviews with database custodians and search of electronic bibliographic database (PubMed). Studies reviewed 105 clinical databases across the United Kingdom.Results Clinical databases existed in all areas of health care, but their distribution was uneven-cancer and surgery were better covered than mental health and obstetrics. They varied greatly in age, size, growth rate, and geographical areas covered. Their scope (and thus their potential uses) and the quality of the data collected also varied. The latter was not associated with any organisational characteristics. Despite impressive achievements, many faced substantial financial uncertainty. Considerable scope existed for improvements: greater use of nationally approved codes; more support from relevant professional organisations; greater involvement by nurses, allied health professionals, managers, and laypeople in database management teams; and more attention to data security and ensuring patient confidentiality. With some notable exceptions, the audit and research potential of most databases had not been realised: half the databases had each produced only four or fewer peer reviewed research articles. Conclusions At least one clinical database support unit is needed in the United Kingdom to provide assistance in organisation and management, information technology, epidemiology, and statistics. Without such an initiative, the variable picture of databases reported here is likely to persist and their potential not be realised.

A survey of all patients with very high serum glutamic oxalacetic transaminase activity encountered during a 30-month period at The New York Hospital revealed 17 patients with cardiac disease who had 1 or more serum glutamic oxalacetic transaminase (SGOT) determinations exceeding 500 units. None had clinical evidence of primary liver or gallbladder disease. Eleven were admitted with acute myocardial infarction, 6 with severe heart failure. All 17 developed hypotension or shock and all but 1 right heart failure prior to high SGOT activity. Several patients had abnormalities of liver function when SGOT activity was very high. In 4 there was an excessive increase in prothrombin time following administration of anticoagulants. In the 8 patients who came to autopsy there was histologic evidence of acute hepatic central necrosis. In 4 there was necrosis of both heart and liver, in 4 necrosis of liver alone. Clinical and autopsy data from a control series of patients with heart disease selected without regard for the level of SGOT activity corroborate the association between hypotension, central necrosis of the liver, and increased SGOT activity. Increase in venous pressure in the absence of hypotension was not associated with acute central necrosis or elevated SGOT activity. It is concluded that very high SGOT activity (>500 units) in patients with heart disease is at least in part caused by acute hepatic central necrosis secondary to a drop in cardiac output and reduced hepatic blood flow. Caution is urged in the interpretation of increased blood activity of intracellular enzyme systems as evidence for myocardial necrosis. Acute circulatory changes may result in hepatic necrosis and increased blood enzyme activity without myocardial infarction.