Data use and effectiveness in electronic surveillance of healthcare associated infections in the 21st century: a systematic review

Bruin, Jeroen S. de; Seeling, Walter; Schuh, Christian

doi:10.1136/amiajnl-2013-002089

Cited by 52 publications

(46 citation statements)

References 50 publications

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“…In a large proportion of new drug approvals, registries are planned for the post approval period, suggesting that regulators and/or companies feel a need to collect “real world” data to supplement incomplete knowledge at time of approval. This may not be a surprising development in an era of increasing availability of electronic health data . The main reason for “real world” data collection is to address remaining safety concerns as well as generate data in low exposure groups notably pregnant women.…”

Section: Discussionmentioning

confidence: 99%

Registries supporting new drug applications

Jonker

Berg

Kwa

et al. 2017

Pharmacoepidemiology and Drug

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PurposeKnowledge of the benefits and risks of new drugs is incomplete at the time of marketing approval. Registries offer the possibility for additional, post‐approval, data collection. For all new drugs, which were approved in the European Union between 2007 and 2010, we reviewed the frequency, the type, and the reason for requiring a registry.MethodsThe European Public Assessment Reports, published on the website of the European Medicine Agency, were reviewed for drugs approved by the Committee for Medicinal Products for Human Use. We searched for key characteristics of these drugs, including therapeutic area (ATC1 level), level of innovation (the score is an algorithm based on availability of treatment and therapeutic effect), and procedural characteristics. In addition, we identified if these registries were defined by disease (disease registry) or exposure to a single drug (drug registry).ResultsOut of 116 new drugs approved in the predefined period, for 43 (37%), 1 to 6 registry studies were identified, with a total of 73 registries. Of these 46 were disease registries and 27 (single) drug registries. For 9 drugs, the registry was a specific obligation imposed by the regulators. The level of innovation and the orphan status of the drugs were determinants positively predicting post‐approval registries (OR 10.3 [95% CI 1.0‐103.9] and OR 2.8 [95% CI 1.0‐7.5], respectively).ConclusionsThe majority of registries required by regulators are existing disease registries. Registries are an important and frequently used tool for post‐approval data collection for orphan and innovative drugs.

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Section: Discussionmentioning

confidence: 99%

Registries supporting new drug applications

Jonker

Berg

Kwa

et al. 2017

Pharmacoepidemiology and Drug

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“…While the logistics of accomplishing the task of validating the data are daunting, validation is vital and must be performed on these systems 33 . Research has indicated that ESS studies which have performed the requisite numerator, denominator and/or external validation found high variability in sensitivity/specificity 7,34 . In addition, studies have also highlighted the lack of completeness 35 and bias 36,37 of electronic patient data.…”

Section: Discussionmentioning

confidence: 99%

“…While ESS using electronically available patient data have been found to be accurate and potentially time saving 3–5 , their performance is not consistent across settings 6 . The performance of ESS often depends on implementation issues related to data sources and data capture 7 . This review utilizes an adapted framework 8 to 1) describe primary data sources, data elements, and validation methods currently used in ESS for identification and surveillance of healthcare-associated infections (HAIs), and 2) compare these data elements and validation methods with recommended standards.…”

Section: Introductionmentioning

confidence: 99%

Data elements and validation methods used for electronic surveillance of health care-associated infections: A systematic review

Cato

Cohen

Larson

2015

American Journal of Infection Control

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Objective This study describes the primary data sources, data elements, and validation methods currently used in electronic surveillance systems (ESS) for identification and surveillance of healthcare-associated infections (HAIs), and compares these data elements and validation methods with recommended standards. Methods Using PRISMA guidelines, a PubMed and manual search was conducted to identify research articles describing ESS for identification and surveillance of HAIs published from January 1, 2009 through August 31, 2014. Selected articles were evaluated to determine what data elements and validation methods were included. Results Among the 509 articles identified in the original literature search, 30 met the inclusion criteria. While the majority of studies (83%) used recommended data sources and validated the numerator (80%), only 10 percent of studies performed external and internal validation. In addition, there was variation in ESS data formats used. Conclusions The findings of this review suggest that the majority of ESS for HAI surveillance are using standard definitions, but the lack of widespread internal data, denominator, and external validation in these systems reduces the reliability of their findings. Additionally, advanced programming skills are required to create, implement and maintain these systems and to reduce the variability in data formats.

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“…Despite numerous studies and reviews describing the benefits of electronic casefinding in HAI surveillance 80,[139][140][141]174,202,212 only a handful of systems of this type are actually in use in regular clinical routine, 174,213,214 and only some of these are applied in an SSI-surveillance setting. To the best of my knowledge, no national or statewide surveillance system depends solely on electronic detection of SSIs.…”

Section: -211mentioning

confidence: 99%

Methodology of the Norwegian Surveillance System for Healthcare-Associated Infections: The value of a mandatory system, automated data collection, and active postdischarge surveillance

Løwer

Eriksen

Aavitsland

et al. 2013

American Journal of Infection Control

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Data use and effectiveness in electronic surveillance of healthcare associated infections in the 21st century: a systematic review

Abstract: Driven by the increased availability of electronic patient data, electronic HAI surveillance systems use more data, making systems more sensitive yet less specific, but also allow systems to be tailored to the needs of healthcare institutes' surveillance programs.

Cited by 52 publications

References 50 publications

Registries supporting new drug applications

Registries supporting new drug applications

Data elements and validation methods used for electronic surveillance of health care-associated infections: A systematic review

Methodology of the Norwegian Surveillance System for Healthcare-Associated Infections: The value of a mandatory system, automated data collection, and active postdischarge surveillance

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