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Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Publication ,  Journal Article
Basch, E; Becker, C; Rogak, LJ; Schrag, D; Reeve, BB; Spears, P; Smith, ML; Gounder, MM; Mahoney, MR; Schwartz, GK; Bennett, AV; Mendoza, TR ...
Published in: Clin Trials
February 2021

BACKGROUND: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library designed for eliciting patient-reported adverse events in oncology. For each adverse event, up to three individual items are scored for frequency, severity, and interference with daily activities. To align the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events with other standardized tools for adverse event assessment including the Common Terminology Criteria for Adverse Events, an algorithm for mapping individual items for any given adverse event to a single composite numerical grade was developed and tested. METHODS: A five-step process was used: (1) All 179 possible Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events score combinations were presented to 20 clinical investigators to subjectively map combinations to single numerical grades ranging from 0 to 3. (2) Combinations with <75% agreement were presented to investigator committees at a National Clinical Trials Network cooperative group meeting to gain majority consensus via anonymous voting. (3) The resulting algorithm was refined via graphical and tabular approaches to assure directional consistency. (4) Validity, reliability, and sensitivity were assessed in a national study dataset. (5) Accuracy for delineating adverse events between study arms was measured in two Phase III clinical trials (NCT02066181 and NCT01522443). RESULTS: In Step 1, 12/179 score combinations had <75% initial agreement. In Step 2, majority consensus was reached for all combinations. In Step 3, five grades were adjusted to assure directional consistency. In Steps 4 and 5, composite grades performed well and comparably to individual item scores on validity, reliability, sensitivity, and between-arm delineation. CONCLUSION: A composite grading algorithm has been developed and yields single numerical grades for adverse events assessed via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, and can be useful in analyses and reporting.

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Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

February 2021

Volume

18

Issue

1

Start / End Page

104 / 114

Location

England

Related Subject Headings

  • United States
  • Statistics & Probability
  • Reproducibility of Results
  • Patient Reported Outcome Measures
  • Neoplasms
  • National Cancer Institute (U.S.)
  • Humans
  • Drug-Related Side Effects and Adverse Reactions
  • Antineoplastic Agents
  • Algorithms
 

Citation

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Basch, E., Becker, C., Rogak, L. J., Schrag, D., Reeve, B. B., Spears, P., … Dueck, A. C. (2021). Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Clin Trials, 18(1), 104–114. https://doi.org/10.1177/1740774520975120
Basch, Ethan, Claus Becker, Lauren J. Rogak, Deborah Schrag, Bryce B. Reeve, Patricia Spears, Mary Lou Smith, et al. “Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).Clin Trials 18, no. 1 (February 2021): 104–14. https://doi.org/10.1177/1740774520975120.
Basch, Ethan, et al. “Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).Clin Trials, vol. 18, no. 1, Feb. 2021, pp. 104–14. Pubmed, doi:10.1177/1740774520975120.
Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC. Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Clin Trials. 2021 Feb;18(1):104–114.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

February 2021

Volume

18

Issue

1

Start / End Page

104 / 114

Location

England

Related Subject Headings

  • United States
  • Statistics & Probability
  • Reproducibility of Results
  • Patient Reported Outcome Measures
  • Neoplasms
  • National Cancer Institute (U.S.)
  • Humans
  • Drug-Related Side Effects and Adverse Reactions
  • Antineoplastic Agents
  • Algorithms