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Published on: December 3, 2017
Validity of physician-reported hospitalized infections in a US arthritis registry
Jeffrey R Curtis1, Nivedita M Patkar, Archana Jain
1Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 076 Spain Rehabilitation Center, 1717 6th Avenue South, Birmingham, AL 35294-7201, USA. jcurtis@uab.edu
Objective:
In safety studies, events reported as infections may be misclassified and, therefore, affect the validity of estimated risks associated with biologic agents. Using data from the Consortium of Rheumatology Researchers of North America (CORRONA), we evaluated hospitalized infection reports contributed by rheumatologists to establish their validity.
Methods:
All patients hospitalized with infections from 2002 to 2007 reported to CORRONA were examined and compared with information from hospital discharge summaries and other confirmatory data. Infectious episodes were classified by two physicians as confirmed, empirically treated, possible or unlikely.
Results:
Of 562 reported hospitalized infectious episodes, 9% were classified as unlikely and had minimal or no supporting evidence for infection, leaving 509 hospitalized infectious episodes. Of these, 53% of the infectious episodes were classified as confirmed, 15% empirically treated and 32% possible. The confirmation status of infectious episodes for younger or biologic-exposed participants was similar to older and biologic-unexposed participants.
Conclusion:
More than two-thirds of hospitalized infections reported by rheumatologists were confirmed or had evidence that the physician was treating an infection. In almost all cases, there was at least modest evidence for an infection. Future studies should consider case definitions for infections or sensitivity analyses, or both, regarding the certainty of an infection to account for possible misclassification and reduce bias.
Insights
Hospitalized infection reports from rheumatologists were reviewed for accuracy. Most reports showed evidence of infection, but future studies should account for potential misclassification of infection events.
Area of Science:
- Rheumatology
- Infectious Diseases
- Clinical Epidemiology
Background:
- Misclassification of infections in safety studies can impact risk assessment for biologic agents.
- The Consortium of Rheumatology Researchers of North America (CORRONA) collects valuable safety data.
Purpose of the Study:
- To evaluate the validity of hospitalized infection reports submitted by rheumatologists to CORRONA.
- To assess the accuracy of infection reporting in rheumatology safety studies.
Main Methods:
- Reviewed 562 hospitalized infection reports from CORRONA (2002-2007).
- Compared reports with hospital discharge summaries and other data.
- Classified infectious episodes as confirmed, empirically treated, possible, or unlikely by two physicians.
Main Results:
- 9% of reported episodes were unlikely to be infections.
- Of the remaining 509 episodes, 53% were confirmed, 15% empirically treated, and 32% possible.
- Confirmation status did not differ significantly between younger/biologic-exposed and older/biologic-unexposed participants.
Conclusions:
- Over two-thirds of reported hospitalized infections had confirmation or treatment evidence.
- Most reports indicated at least modest evidence for infection.
- Future studies should consider infection case definitions or sensitivity analyses to address potential misclassification bias.
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