Related Papers
Drug safety
The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?
2018 •
Ettore Beghi
Enormous progress has been made globally in the use of evidence derived from patients' clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, claims databases and drug or disease registries. These data sources vary in nature from country to country, according to national healthcare system structures and national policies. In Italy, a growing number of healthcare databases have been used to evaluate post-marketing drug utilisation and safety in the last two decades. The aim of this narrative review is to describe the ava...
Journal of Innovation in Health Informatics
Creating and using real-world evidence to answer questions about clinical effectiveness
2015 •
Simon de Lusignan
Nature Communications
Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions
Mimi Zakarian
Studies that generate real-world evidence on the effects of medical products through analysis of digital data collected in clinical practice provide key insights for regulators, payers, and other healthcare decision-makers. Ensuring reproducibility of such findings is fundamental to effective evidence-based decision-making. We reproduce results for 150 studies published in peer-reviewed journals using the same healthcare databases as original investigators and evaluate the completeness of reporting for 250. Original and reproduction effect sizes were positively correlated (Pearson’s correlation = 0.85), a strong relationship with some room for improvement. The median and interquartile range for the relative magnitude of effect (e.g., hazard ratiooriginal/hazard ratioreproduction) is 1.0 [0.9, 1.1], range [0.3, 2.1]. While the majority of results are closely reproduced, a subset are not. The latter can be explained by incomplete reporting and updated data. Greater methodological tran...
International Journal of Statistics in Medical Research
The Current State of Validation of Administrative Healthcare Databases in Italy: A Systematic Review
2014 •
Iosief Abraha
Pragmatic randomised trials using routine electronic health records: putting them to the test
2012 •
Munir Pirmohamed, Adel Taweel
Health technology assessment (Winchester, England)
Can randomised trials rely on existing electronic data? A feasibility study to explore the value of routine data in health technology assessment
2003 •
Ian Russell
To estimate the feasibility, utility and resource implications of electronically captured routine data for health technology assessment by randomised controlled trials (RCTs), and to recommend how routinely collected data could be made more effective for this purpose. Four health technology assessments that involved patients under care at five district general hospitals in the UK using four conditions from distinct classical specialties: inflammatory bowel disease, obstructive sleep apnoea, female urinary incontinence, and total knee replacement. Patient-identifiable, electronically stored routine data were sought from the administration and clinical database to provide the routine data. Four RCTs were replicated using routine data in place of the data already collected for the specific purpose of the assessments. This was done by modelling the research process from conception to final writing up and substituting routine for designed data activities at appropriate points. This allow...
Scaling up health knowledge at European level requires sharing integrated data.pdf
Alexandra Prados Torres
Informatics in primary care
Randomised studies in general practice: how to integrate the electronic patient record
2005 •
Johan Lei
The 'randomised database study' strategy was first proposed in 1997, with the aim of combining the generalisability of observational database studies based on electronic patient records (EPRs) with the validity of randomised clinical trials (RCTs). The key feature was to randomly assign treatments and to use routine care data, as available in the observational database, for patient identification and follow-up. To our knowledge, however, the idea of the randomised database study has not been implemented yet. The conduct of a randomised study in an observational database requires adjustments to methods of medical information processing in the general practice. We developed a software system that facilitates the conduct of an RCT with observational databases based on EPRs. It identifies eligible subjects and presents them one by one to the physician once their EPR is accessed. The general practitioner can then start an interactive recruitment process; after completion, the com...
Medical Education and Ethics: Concepts, Methodologies, Tools, and Applications
Data-Driven and Practice-Based Evidence
2000 •
Hamzah Osop
