Using a population-based observational cohort study to address difficult comparative effectiveness research questions: The CEASAR study

Daniel A. Barocas*, Vivien Chen, Matthew Cooperberg, Michael Goodman, John J. Graff, Sheldon Greenfield, Ann Hamilton, Karen Hoffman, Sherrie Kaplan, Tatsuki Koyama, Alicia Morgans, Lisa E. Paddock, Sharon Phillips, Matthew J. Resnick, Antoinette Stroup, Xiao Cheng Wu, David F. Penson

*Corresponding author for this work

Research output: Contribution to journalArticle

39 Scopus citations

Abstract

Background: While randomized controlled trials represent the highest level of evidence we can generate in comparative effectiveness research, there are clinical scenarios where this type of study design is not feasible. The Comparative Effectiveness Analyses of Surgery and Radiation in localized prostate cancer (CEASAR) study is an observational study designed to compare the effectiveness and harms of different treatments for localized prostate cancer, a clinical scenario in which randomized controlled trials have been difficult to execute and, when completed, have been difficult to generalize to the population at large. Methods: CEASAR employs a population-based, prospective cohort study design, using tumor registries as cohort inception tools. The primary outcome is quality of life after treatment, measured by validated instruments. Risk adjustment is facilitated by capture of traditional and nontraditional confounders before treatment and by propensity score analysis. Results: We have accrued a diverse, representative cohort of 3691 men in the USA with clinically localized prostate cancer. Half of the men invited to participate enrolled, and 86% of patients who enrolled have completed the 6-month survey. Conclusion: Challenging comparative effectiveness research questions can be addressed using well-designed observational studies. The CEASAR study provides an opportunity to determine what treatments work best, for which patients, and in whose hands.

Original languageEnglish (US)
Pages (from-to)445-460
Number of pages16
JournalJournal of Comparative Effectiveness Research
Volume2
Issue number4
DOIs
StatePublished - Jul 2013

Keywords

  • active surveillance
  • comparative effectiveness research
  • observational study
  • prospective cohort study
  • prostate cancer
  • quality of life
  • radiation therapy
  • surgery

ASJC Scopus subject areas

  • Health Policy

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    Barocas, D. A., Chen, V., Cooperberg, M., Goodman, M., Graff, J. J., Greenfield, S., Hamilton, A., Hoffman, K., Kaplan, S., Koyama, T., Morgans, A., Paddock, L. E., Phillips, S., Resnick, M. J., Stroup, A., Wu, X. C., & Penson, D. F. (2013). Using a population-based observational cohort study to address difficult comparative effectiveness research questions: The CEASAR study. Journal of Comparative Effectiveness Research, 2(4), 445-460. https://doi.org/10.2217/cer.13.34