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

Pan Yi (), Rose Charles E. (), Haber Michael (), Ma Yan (), Carrasco Josep L. (), Stewart Brock (), Keitel Wendy A. (), Keyserling Harry (), Jacobson Robert M. (), Poland Gregory () and McNeil Michael M. ()
Additional contact information
Pan Yi: Immunization 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
Rose Charles E.: Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA
Haber Michael: Department of Biostatistics and Bioinformatics, Emory University, Rollins School of Public Health, Atlanta, GA, USA
Ma Yan: Biostatistics, Public Health Department, Hospital for Special Surgery, Weill Medical College of Cornell University, New York City, NY, USA
Carrasco Josep L.: University of Barcelona, Barcelona, Spain
Stewart Brock: Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA
Keitel Wendy A.: Baylor College of Medicine, Houston, TX, USA
Keyserling Harry: Emory University School of Medicine, Atlanta, GA, USA
Jacobson Robert M.: Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN, USA
Poland Gregory: Mayo Clinic, Rochester, MN, USA
McNeil Michael M.: Immunization 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

The International Journal of Biostatistics, 2013, vol. 9, issue 1, 19-32

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 (search for similar items in EconPapers)
Date: 2013
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DOI: 10.1515/ijb-2012-0001

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