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Rebecca Persson,1 Todd Sponholtz,1 Catherine Vasilakis-Scaramozza,1 Katrina Wilcox Hagberg,1 Tim Williams,2 Dipak Kotecha,3 Puja Myles,2 Susan S Jick1,4 1Epidemiology, Boston Collaborative Drug Surveillance Program, Lexington, MA, USA; 2Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK; 3Institute of Cardiovascular Sciences, University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; 4Epidemiology, Boston University School of Public Health, Boston, MA, USACorrespondence: Susan S Jick Email sjick@bu.eduBackground: Validation studies of the Clinical Practice Research Datalink (CPRD) Aurum database in the UK are critical for making decisions about its suitability and validity for research purposes.Objective: To examine data source agreement of myocardial infarction (MI) diagnoses recorded in CPRD Aurum compared with linked Hospital Episode Statistics (HES) data. This comparison provides information on CPRD Aurum data correctness (accuracy, validity) and completeness (presence, missingness).Methods: Patients with MI diagnoses recorded in either data source were selected from a random sample of 50,000 patients in CPRD Aurum with HES linkage (1997– 2017). Correctness was defined as the proportion of MI cases in CPRD Aurum with a concordant MI diagnosis recorded in HES or with strong supporting evidence in either data source. Completeness was defined as the proportion of patients with primary HES-coded MIs with strong supporting evidence that were also present in CPRD Aurum.Results: There were 1260 patients with MI recorded in the CPRD Aurum sample. The overall correctness of the recorded MI diagnoses was 94%: 986 patients (78%) had concordant diagnoses in HES within 90 days; 123 (10%) were concordant with HES, but with an inconclusive date and another 71 (6%) had strong supporting evidence for being a true MI case. There were 1125 patients with MI recorded in HES primary diagnosis fields with strong supporting evidence in either data source. Of these, 880 (78%) were present in CPRD Aurum, with completeness somewhat higher in more recent years.Conclusion: MI diagnoses recorded in CPRD Aurum were highly likely to be correct, supporting its use in clinical research studies. Completeness was lower, indicating the need for data linkage for some studies.Keywords: clinical practice research datalink, CPRD Aurum, data validation, data completeness, data quality |
