ADVANCE system testing: Can safety studies be conducted using electronic healthcare data? An example using pertussis vaccination

Weibel, Daniel; Dodd, Caitlin; Mahaux, Olivia; Haguinet, François; Smedt, Tom De; Duarte‐Salles, Talita; Picelli, Gino; Tramontan, Lara; Danieli, Giorgia; Correa, Ana; McGee, Chris; Martín‐Merino, Elisa; Huerta, Consuelo; Berencsi, Klára; Emborg, Hanne‐Dorthe; Bollaerts, Kaatje; Bauchau, Vincent; Titievsky, Lina; Sturkenboom, Miriam

doi:10.1016/j.vaccine.2019.06.040

Cited by 10 publications

(6 citation statements)

References 24 publications

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“…[28] By adhering to the FAIR principles, the RWE-BRIDGE and analytical script can be made publicly available together with a digital object identifier. Furthermore, following the recommendations by [10] and [3], the FAIR characteristics and adaptation of the RWE-BRIDGE create opportunities for applying standard procedures and creating modular data engineering functionality for heterogeneous multi-database studies. Modularization and standardization are key aspects of efficient and reproducible programming.…”

Section: Discussionmentioning

confidence: 99%

Real-World Evidence BRIDGE: a tool to connect protocol with code programming

Cid Royo,

Elbers,

Weibel

et al. 2024

Preprint

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Methods Several statistical analysis plans (SAP) from the Vaccine Monitoring Collaboration for Europe (VAC4EU) were analyzed to identify the study design sections and specifications for programming RWE studies based on multi-databases standardized to common data models. We envisioned a metadata schema that transforms the epidemiologist's knowledge into a machine-readable format. This machine-readable metadata schema must also contain the different study sections, code lists, and time anchoring specified in the SAPs. Further desired attributes are adaptability and user-friendliness. Results We developed RWE-BRIDGE, a metadata schema with a star-schema model divided into four study design sections with 12 tables: Study Variable Definition with two tables, Cohort Definition with two tables, Post-Exposure Outcome Analysis with seven tables, and Data Retrieval with one table. We provide examples and a step-by-step guide to populate this metadata schema. In addition, we provide a Shiny app that checks the several tables proposed in this metadata strategy. RWE-BRIDGE is available at https://github.com/UMC-Utrecht-RWE/RWE-BRIDGE. Discussion The RWE-BRIDGE has been designed to support the translation of study design sections from statistical analysis plans into analytical pipelines, facilitating collaboration and transparency between lead researchers and scientific programmers and reducing hard coding and repetition. This metadata schema strategy is flexible by supporting different common data models and programming languages, and it is adaptable to the specific needs of each SAP by adding further tables or fields, if necessary. Modified versions of the RWE-BRIGE have been applied in several RWE studies within the VAC4EU ecosystem. Conclusion The RWE-BRIDGE offers a systematic approach to detailing what type of variables, time anchoring, and algorithms are required for a specific RWE study. Applying this metadata schema can facilitate the communication between epidemiologists and programmers in a transparent manner.

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Section: Discussionmentioning

confidence: 99%

Real-World Evidence BRIDGE: a tool to connect protocol with code programming

Cid Royo,

Elbers,

Weibel

et al. 2024

Preprint

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“… 32 33 Most recently, the ADVANCE project created a system for monitoring vaccine benefits and risks and is now continuing as the VAC4EU. 20 34–39 Most of these studies have involved data sharing to a hub and while some have involved a single methodology, others have allowed different study designs. Key issues to have arisen are the cost and timeliness of such studies and in LMIC having sentinel hospitals that code discharges and link to vaccination data.…”

Section: Studying Rare Eventsmentioning

confidence: 99%

“…There have also been bipartite collaborations such as Denmark and Sweden for human papillomavirus (HPV) vaccine and autoimmune conditions 32 33. Most recently, the ADVANCE project created a system for monitoring vaccine benefits and risks and is now continuing as the VAC4EU 20 34–39. Most of these studies have involved data sharing to a hub and while some have involved a single methodology, others have allowed different study designs.…”

Section: Studying Rare Eventsmentioning

confidence: 99%

“…Since the early 1990s, the number of publications internationally referring to multiple observational databases has exploded thanks to increased existence of electronic databases, the appreciation of the importance of data-linkage and information technology for analysing multiple databases 18. Recent collaborations such as Vaccine Adverse Events Monitoring and Communication (VAESCO), Accelerated Development of Vaccine Benefit-risk Collaboration in Europe (ADVANCE/VAC4EU), Systematic Observational Method for Narcolepsy and Influenza Immunisation Assessment (SOMNIA) and the WHO Global Vaccine Safety-Multi Country Collaboration (GVS-MCC) have successfully incorporated data from multiple countries to produce estimates of vaccine safety and effectiveness 12 19–22. The purpose of this paper is to appraise current methodologies in postmarketing vaccine safety in terms of how these can be used to assess rare events and special populations, and how evidence derived from these studies can be evaluated.…”

Section: Introductionmentioning

confidence: 99%

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Methodological frontiers in vaccine safety: qualifying available evidence for rare events, use of distributed data networks to monitor vaccine safety issues, and monitoring the safety of pregnancy interventions

et al. 2021

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While vaccines are rigorously tested for safety and efficacy in clinical trials, these trials do not include enough subjects to detect rare adverse events, and they generally exclude special populations such as pregnant women. It is therefore necessary to conduct postmarketing vaccine safety assessments using observational data sources. The study of rare events has been enabled in through large linked databases and distributed data networks, in combination with development of case-centred methods. Distributed data networks necessitate common protocols, definitions, data models and analytics and the processes of developing and employing these tools are rapidly evolving. Assessment of vaccine safety in pregnancy is complicated by physiological changes, the challenges of mother-child linkage and the need for long-term infant follow-up. Potential sources of bias including differential access to and utilisation of antenatal care, immortal time bias, seasonal timing of pregnancy and unmeasured determinants of pregnancy outcomes have yet to be fully explored. Available tools for assessment of evidence generated in postmarketing studies may downgrade evidence from observational data and prioritise evidence from randomised controlled trials. However, real-world evidence based on real-world data is increasingly being used for safety assessments, and new tools for evaluating real-world evidence have been developed. The future of vaccine safety surveillance, particularly for rare events and in special populations, comprises the use of big data in single countries as well as in collaborative networks. This move towards the use of real-world data requires continued development of methodologies to generate and assess real world evidence.

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“…Vaccines (J07) Pertussis vaccine adverse events 48 Coverage 22,49,50 Anti-inflammatory drugs (M01) Myocardial infarction 51 Colorectal cancer 52 Gastrointestinal bleeding 53 Ischemic stroke 54…”

Section: Studies Performed In Bifapmentioning

confidence: 99%

Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP): A data resource for pharmacoepidemiology in Spain

Maciá-Martínez

Gil

Huerta

et al. 2020

Pharmacoepidemiology and Drug

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Primaria (BIFAP) is a population based database administered by the AEMPS (Spanish Agency for Medicines) of longitudinal electronic medical records (EMR) of patients attended in primary care. Its main purpose is to serve as source of information for independent studies on drug safety and support of medicines regulation activities. This article aim is to describe the characteristics of BIFAP, how to access the database and a summary of its potential for research. Methods: Health problems are registered by primary care physicians as episodes of care and include socio-demographic data, results of diagnostic procedures, lifestyle data, general data, and interventions. A proportion of data on hospitalizations and specialist care are currently available through linkage with other data sources. EMRs

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ADVANCE system testing: Can safety studies be conducted using electronic healthcare data? An example using pertussis vaccination

Cited by 10 publications

References 24 publications

Real-World Evidence BRIDGE: a tool to connect protocol with code programming

Real-World Evidence BRIDGE: a tool to connect protocol with code programming

Methodological frontiers in vaccine safety: qualifying available evidence for rare events, use of distributed data networks to monitor vaccine safety issues, and monitoring the safety of pregnancy interventions

Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP): A data resource for pharmacoepidemiology in Spain

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