Clinical Comparison Between Trial Participants and Potentially Eligible Patients Using Electronic Health Record Data: A Generalizability Assessment Method

2021 ◽  
pp. 103822
Author(s):  
James R. Rogers ◽  
George Hripcsak ◽  
Ying Kuen Cheung ◽  
Chunhua Weng
2021 ◽  
pp. 174077452110385
Author(s):  
Niina Laaksonen ◽  
Mia Bengtström ◽  
Anna Axelin ◽  
Juuso Blomster ◽  
Mika Scheinin ◽  
...  

Introduction: Feasibility evaluations are performed to create the best possible starting point for the set-up and execution of a clinical trial, and to identify any obstacles for successful trial conduct. New digital technologies can provide various types of data for use in feasibility evaluations. There is a need to identify and compare such data sources for trial site identification and for evaluating the sites’ patient recruitment potential. Especially, information is needed on the use of electronic health records. We investigated how different data sources are used by pharmaceutical companies operating in the Nordic countries for identifying trial sites and for evaluating their potential to recruit trial participants. Methods: This was a semi-structured qualitative interview study with 21 participants from pharmaceutical companies and contract research organizations operating in Finland, Sweden, Denmark and Norway. Qualitative content analysis was applied. Results: For identifying countries and trial sites on a global level, the trial sponsors mostly used databases on previous trial performance. The use of electronic health record data was very limited. Sites’ and investigators’ visibility in various databases was seen as fundamental for their countries becoming selected into new clinical trials. For estimating the sites’ recruitment projections, most sites were seen to base their patient count estimates solely on their previous experience. Some sites had reviewed their electronic health record data, which was considered to increase the accuracy of their recruitment estimates and these sites’ attractivity. Along with dialogs with investigators, the sponsors used various data sources to validate the investigators’ estimates. Legislative obstacles were seen to hinder the use of electronic health record queries for estimation of patient counts. Conclusion: Visibility in the databases used by trial sponsors is crucial for the countries and sites to be identified. Site selection appears to be based on trust and relationships built from experience, but electronic data provide the support upon which the trust is based. Estimation of the number of potential trial participants is a complex and time-consuming process for both investigators and sponsors. Sponsors seem to favour sites who could support their patient count estimates with electronic health record data as they were quicker in providing the estimates and more reliable than sites with no electronic health record evidence. The patient count evaluation process could be simplified, accelerated and made more reliable with more systematic use of electronic health record evidence in the feasibility evaluation phase. This would increase the accuracy of the patient count estimates and, on its part, contribute to improved recruitment success.


2011 ◽  
Vol 4 (0) ◽  
Author(s):  
Michael Klompas ◽  
Chaim Kirby ◽  
Jason McVetta ◽  
Paul Oppedisano ◽  
John Brownstein ◽  
...  

Author(s):  
José Carlos Ferrão ◽  
Mónica Duarte Oliveira ◽  
Daniel Gartner ◽  
Filipe Janela ◽  
Henrique M. G. Martins

2020 ◽  
Vol 41 (S1) ◽  
pp. s39-s39
Author(s):  
Pontus Naucler ◽  
Suzanne D. van der Werff ◽  
John Valik ◽  
Logan Ward ◽  
Anders Ternhag ◽  
...  

Background: Healthcare-associated infection (HAI) surveillance is essential for most infection prevention programs and continuous epidemiological data can be used to inform healthcare personal, allocate resources, and evaluate interventions to prevent HAIs. Many HAI surveillance systems today are based on time-consuming and resource-intensive manual reviews of patient records. The objective of HAI-proactive, a Swedish triple-helix innovation project, is to develop and implement a fully automated HAI surveillance system based on electronic health record data. Furthermore, the project aims to develop machine-learning–based screening algorithms for early prediction of HAI at the individual patient level. Methods: The project is performed with support from Sweden’s Innovation Agency in collaboration among academic, health, and industry partners. Development of rule-based and machine-learning algorithms is performed within a research database, which consists of all electronic health record data from patients admitted to the Karolinska University Hospital. Natural language processing is used for processing free-text medical notes. To validate algorithm performance, manual annotation was performed based on international HAI definitions from the European Center for Disease Prevention and Control, Centers for Disease Control and Prevention, and Sepsis-3 criteria. Currently, the project is building a platform for real-time data access to implement the algorithms within Region Stockholm. Results: The project has developed a rule-based surveillance algorithm for sepsis that continuously monitors patients admitted to the hospital, with a sensitivity of 0.89 (95% CI, 0.85–0.93), a specificity of 0.99 (0.98–0.99), a positive predictive value of 0.88 (0.83–0.93), and a negative predictive value of 0.99 (0.98–0.99). The healthcare-associated urinary tract infection surveillance algorithm, which is based on free-text analysis and negations to define symptoms, had a sensitivity of 0.73 (0.66–0.80) and a positive predictive value of 0.68 (0.61–0.75). The sensitivity and positive predictive value of an algorithm based on significant bacterial growth in urine culture only was 0.99 (0.97–1.00) and 0.39 (0.34–0.44), respectively. The surveillance system detected differences in incidences between hospital wards and over time. Development of surveillance algorithms for pneumonia, catheter-related infections and Clostridioides difficile infections, as well as machine-learning–based models for early prediction, is ongoing. We intend to present results from all algorithms. Conclusions: With access to electronic health record data, we have shown that it is feasible to develop a fully automated HAI surveillance system based on algorithms using both structured data and free text for the main healthcare-associated infections.Funding: Sweden’s Innovation Agency and Stockholm County CouncilDisclosures: None


Surgery ◽  
2021 ◽  
Author(s):  
Davy van de Sande ◽  
Michel E. van Genderen ◽  
C. Verhoef ◽  
Jasper van Bommel ◽  
Diederik Gommers ◽  
...  

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