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

Author

Listed:
  • 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)

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.

Suggested Citation

  • Pan Yi & Rose Charles E. & Haber Michael & Ma Yan & Carrasco Josep L. & Stewart Brock & Keitel Wendy A. & Keyserling Harry & Jacobson Robert M. & Poland Gregory & McNeil Michael M., 2013. "Assessing Agreement of Repeated Binary Measurements with an Application to the CDC’s Anthrax Vaccine Clinical Trial," The International Journal of Biostatistics, De Gruyter, vol. 9(1), pages 19-32, July.
    • Handle: RePEc:bpj:ijbist:v:9:y:2013:i:1:p:14:n:1
    DOI: 10.1515/ijb-2012-0001
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    References listed on IDEAS

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    1. Stuart Lipsitz & Michael Parzen & Garrett Fitzmaurice & Neil Klar, 2003. "A two-stage logistic regression model for analyzing inter-rater agreement," Psychometrika, Springer;The Psychometric Society, vol. 68(2), pages 289-298, June.
    2. Martin S. Ridout & Clarice G. B. Demétrio & David Firth, 1999. "Estimating Intraclass Correlation for Binary Data," Biometrics, The International Biometric Society, vol. 55(1), pages 137-148, March.
    3. Yan Ma & Wan Tang & Changyong Feng & Xin M. Tu, 2008. "Inference for Kappas for Longitudinal Study Data: Applications to Sexual Health Research," Biometrics, The International Biometric Society, vol. 64(3), pages 781-789, September.
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