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Background <p>Patient-reported symptomatic adverse events (AE) are increasingly collected in oncology clinical trials to characterize treatment tolerability and inform clinical decision making using the Patient-Reported Outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®). Although there are numerous analysis methods and graphical approaches used for PRO-CTCAE data, the current PRO literature is limited in unified reporting and graphical approaches as well as public-facing analysis tools.</p> Results <p>Collaborative efforts from the Standardization Working Group of the National Cancer Institute Cancer Treatment Tolerability Consortium worked to develop the R package, ProAE. Testing and validation of widely used methods were implemented in the R package and deployed to various open-source outlets including the Comprehensive R Archive Network (CRAN).</p> Conclusion <p>ProAE is a free and publicly available collection of standardized statistical analysis tools for PRO-CTCAE and other PRO data used in patient care and research. The ProAE package provides oncology researchers with an efficient and modern means to apply the published analysis approaches, including hypothesis testing, descriptive and inferential tables, and longitudinal graphics, without the need for costly software or licensing.</p>

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ProAE: an R package for graphical tools and standardized analysis of patient-reported outcomes and adverse events data

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月20日

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  • Blake Langlais,
  • Brie Noble,
  • Briant Fruth,
  • Mia Truman,
  • Gina L. Mazza,
  • Brenda Ginos,
  • Carolyn Mead-Harvey,
  • Minji Lee,
  • Claire Yee,
  • Lauren Rogak,
  • Eric Meek,
  • Allison M. Deal,
  • John Devin Peipert,
  • Gita Thanarajasingam,
  • Ethan Basch,
  • Amylou C. Dueck

摘要

Background

Patient-reported symptomatic adverse events (AE) are increasingly collected in oncology clinical trials to characterize treatment tolerability and inform clinical decision making using the Patient-Reported Outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®). Although there are numerous analysis methods and graphical approaches used for PRO-CTCAE data, the current PRO literature is limited in unified reporting and graphical approaches as well as public-facing analysis tools.

Results

Collaborative efforts from the Standardization Working Group of the National Cancer Institute Cancer Treatment Tolerability Consortium worked to develop the R package, ProAE. Testing and validation of widely used methods were implemented in the R package and deployed to various open-source outlets including the Comprehensive R Archive Network (CRAN).

Conclusion

ProAE is a free and publicly available collection of standardized statistical analysis tools for PRO-CTCAE and other PRO data used in patient care and research. The ProAE package provides oncology researchers with an efficient and modern means to apply the published analysis approaches, including hypothesis testing, descriptive and inferential tables, and longitudinal graphics, without the need for costly software or licensing.