KEY TAKEAWAYS
- Phase III clinical trial aimed to devise and validate an algorithm that assigns unified numerical grades to specific items associated with adverse events.
- The resulting composite grading algorithm demonstrated favorable performance regarding validity, reliability, sensitivity, and differentiation between arms compared to individual item scores for adverse events.
- The developed composite grading algorithm provides singular numerical grades for adverse events assessed using the Patient-Reported Outcomes.
The patient-reported outcomes version of the common terminology criteria for adverse events is a medical tool created to gather information from patients regarding any negative experiences they may have encountered during their oncology treatment. For every adverse event, a maximum of three individual items are assessed for frequency, severity, and impact on daily activities. A method was devised and examined to harmonize the patient-reported outcomes version of the common terminology criteria for adverse events with other established tools for evaluating adverse events, such as the common terminology criteria for adverse events. This method involved creating and validating an algorithm that assigns a unified numerical grade to each item associated with an adverse event.
A five-step procedure was employed: 179 potential patient-reported outcomes versions of the standard terminology criteria for adverse events score combinations were presented to 20 clinical investigators to subjectively associate these combinations with single numerical grades ranging from 0 to 3. Combinations with less than 75% agreement were presented to investigator committees at a National Clinical Trials Network cooperative group meeting to obtain majority consensus through anonymous voting. The resulting algorithm underwent refinement through graphical and tabular methods to ensure directional consistency. The validity, reliability, and sensitivity were evaluated in a dataset from a nationwide study.
In step 1, out of the 179 score combinations, 12 had an initial agreement of less than 75%. In step 2, a consensus was achieved among the majority for all varieties. In step 3, five grades were modified to ensure directional consistency. In steps 4 and 5, composite rates demonstrated favorable performance and were comparable to individual item scores regarding validity, reliability, sensitivity, and differentiation between arms. A hybrid grading algorithm has been formulated, producing singular numerical grades for adverse events evaluated using the patient-reported outcomes version of the common terminology criteria for adverse events. This algorithm can be valuable in the examination and documentation of such events.
Source: https://pubmed.ncbi.nlm.nih.gov/33258687/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02066181/
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. doi 10.1177/1740774520975120. Epub 2020 Dec 1. PMID: 33258687; PMCID: PMC7878323.
