Guidelines for Good Database Selection and use in Pharmacoepidemiology Research

Hall, Gillian; Sauer, Brian C.; Bourke, Alison; Brown, Jeffrey S.; Reynolds, Matthew W.; Casale, Robert Lo

doi:10.1002/pds.3343

Cited by 46 publications

(66 citation statements)

References 4 publications

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“…Researchers should assess the completeness and accuracy of the key study variables such as diagnosis, in terms of whether the quality of the variables is adequate for the completion and interpretation of a particular analysis. 9) We are planning to evaluate the breast cancer preventive benefits of a medication using a large claims database. Thus, it is necessary to assess the accuracy of breast cancer diagnoses based on claims data, in order to adopt it as the study outcome.…”

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confidence: 99%

The Accuracy of Japanese Claims Data in Identifying Breast Cancer Cases

2015

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In use of a claims database for a study, an inaccurate diagnosis of breast cancer based on claims data may lead to invalid study results. The aim of this study was to assess the accuracy of definitions for identifying breast cancer cases from the Japanese claims database. The study cohort consisted of women with no prior cancer-related history, from the claims data at a single institution between January 1 and December 31, 2011. We developed 14 definitions for identifying breast cancer based on claims data, using a combination of diagnosis codes and treatment procedure codes. We calculated the sensitivity, specificity, and positive predictive value (PPV) of each definition, compared to cases identified from the standardized hospital-based cancer registry as a standard reference. A total of 50056 women were included in the study cohort from the claims database. We identified 633 breast cancer cases from the cancer registry. Of 14 definitions, 12 exhibited higher sensitivity than 90%, while the others exhibited lower sensitivity than 40%. The specificities of all definitions were high (≥99%), and the PPVs were between 65.8 and 90.7%. We selected the most optimal definition obtained from combinations of diagnosis and cancer treatment codes (surgery, chemotherapy, medication, radiation procedure), which had high values for sensitivity (90.4%), specificity (99.8%), and PPV (87.3%). Definitions obtained via combinations of the diagnosis codes and procedure codes could be used to accurately identify breast cancer cases from the claims database. Further studies in a multi-institutional setting are planned to confirm our results.

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confidence: 99%

The Accuracy of Japanese Claims Data in Identifying Breast Cancer Cases

2015

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“…the pharmacoepidemiology guidelines cited above) and other more specific ones. [14][15][16] However, the literature is in agreement that they are insufficient. [17][18][19][20] The quality of pharmacovigilance data is a shared concern.…”

Section: Analysis Of the Existing Information And The Elaboration Of mentioning

confidence: 83%

How can the Quality of Medical Data in Pharmacovigilance, Pharmacoepidemiology and Clinical Studies be Guaranteed?

et al. 2013

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-The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies). The analysis was focused on the data and on the critical stages presenting critical quality problems, for which the current guidelines are insufficiently detailed, unsuitable and/or poorly applied. Finally, recommendations have been proposed, mainly focused on the origin of the data and its transcription.Abbreviations: see end of article.

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“…Abordant ces probléma-tiques, il existe quelques recommandations génériques (par exemples les guides de pharmaco-épidémiologie déjà cités) et d'autres plus spécifiques. [14][15][16] Cependant, la littérature s'accorde sur leur insuffisance. [17][18][19][20] La qualité des données en pharmacovigilance est une préoc-cupation partagée.…”

Section: Analyse De L'existant Et éLaboration De Recommandationsunclassified