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The International Journal of Biostatistics

Ed. by Hubbard, Alan E. / van der Laan, Mark J.

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Assessing Agreement of Repeated Binary Measurements with an Application to the CDC’s Anthrax Vaccine Clinical Trial

1Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA; Logistics Health Inc, La Crosse, WI, USA

2Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA

3Department of Biostatistics and Bioinformatics, Emory University, Rollins School of Public Health, Atlanta, GA, USA

4Biostatistics, Public Health Department, Hospital for Special Surgery, Weill Medical College of Cornell University, New York City, NY, USA

5University of Barcelona, Barcelona, Spain

6Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA

7Baylor College of Medicine, Houston, TX, USA

8Emory University School of Medicine, Atlanta, GA, USA

9Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN, USA

10Mayo Clinic, Rochester, MN, USA

11Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention; Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333

Citation Information: The International Journal of Biostatistics. Volume 9, Issue 1, Pages 19–32, ISSN (Online) 1557-4679, ISSN (Print) 2194-573X, DOI: 10.1515/ijb-2012-0001, July 2013

Publication History:
Published Online:
2013-07-27

Abstract

Cohen’s kappa coefficient, which was introduced in 1960, serves as the most widely employed coefficient to assess inter-observer agreement for categorical outcomes. However, the original kappa can only be applied to cross-sectional binary measurements and, therefore, cannot be applied in the practical situation when the observers evaluate the same subjects at repeated time intervals. This study summarizes six methods of assessing agreement of repeated binary outcomes under different assumptions and discusses under which condition we should use the most appropriate method in practice. These approaches are illustrated using data from the CDC anthrax vaccine adsorbed (AVA) human clinical trial comparing the agreement for two solicited adverse events after AVA between the 1–3 day in-clinic medical record and the patient’s diary on the same day. We hope this article can inspire researchers to choose the most appropriate method to assess agreement for their own study with longitudinal binary data.

Keywords: agreement; binary; kappa; longitudinal; adverse event; anthrax vaccine

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