2016
DOI: 10.1002/pds.4004
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Evidence generation from healthcare databases: recommendations for managing change

Abstract: There is an increasing reliance on databases of healthcare records for pharmacoepidemiology and other medical research, and such resources are often accessed over a long period of time so it is vital to consider the impact of changes in data, access methodology and the environment. The authors discuss change in communication and management, and provide a checklist of issues to consider for both database providers and users. The scope of the paper is database research, and changes are considered in relation to … Show more

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Cited by 13 publications
(17 citation statements)
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“…Decision makers understand that CDMs are of highest value if the underlying data are properly curated. 9 While economic considerations play a role in choosing CDMs, we focus here on the scientific value of CDMs in supporting decision makers in high-stakes operations. With all this in mind, we reviewed the types of CDMs that underpin evidence generation.…”
Section: Three Types Of Cdmsmentioning
confidence: 99%
See 1 more Smart Citation
“…Decision makers understand that CDMs are of highest value if the underlying data are properly curated. 9 While economic considerations play a role in choosing CDMs, we focus here on the scientific value of CDMs in supporting decision makers in high-stakes operations. With all this in mind, we reviewed the types of CDMs that underpin evidence generation.…”
Section: Three Types Of Cdmsmentioning
confidence: 99%
“…However, people active in real-world data analysis and healthcare decision making often have difficulty understanding the implications when choosing one data model over another. 9 Taking the perspective of a decision maker wishing to assess the effectiveness, safety, and value of medical products, 2 this article seeks to examine the support that different types of data models can provide for such decisions. We identify three generic types of data models and assess how they may affect the efficiency (ease of use), transparency, and adaptability to fit a specific research question.…”
mentioning
confidence: 99%
“…Considerable experiences have already been accrued in this developing field, as was summarized in a recent ENCePP survey of methodologies for EU publicly funded multi‐database safety studies . Irrespective of which RWD is used, including emerging data streams, ensuring sustained access to data, with transparent processes around data collection, curation, storage, access, and analysis, is essential for credible continual RWE generation that is essential for public health …”
Section: Text Boxmentioning
confidence: 99%
“…Several large occupational cohort studies have highlighted procedures for the reliable capture of mortality in US‐based epidemiology studies . The practice of data linkage for complete outcome ascertainment is well‐known to pharmacoepidemiologists following the guidelines for good pharmacoepidemiology practice . Recent work by Chung et al in TennCare data highlights the ascertainment of out‐of‐hospital death in an opioid study by linking to state‐specific computerized death certificate data.…”
Section: Introductionmentioning
confidence: 99%